Policy Directive

Medication Handling
Summary This Policy Directive consolidates procedures and standards on medication
procurement, storage, prescribing, supplying, dispensing and administration at NSW
public health facilities with the requirements of the NSW Poisons and Therapeutic
Goods Act 1966 and Regulation 2008, NSW Health policies and NSW Health
directives relevant to medication handling
Document type Policy Directive
Document number PD2022_032
Publication date 11 August 2022
Author branch Legal and Regulatory Services
Branch contact (02) 9391 9606
Replaces PD2013_043, IB2021_023, IB2019_041, IB2017_045, IB2013_064
Review date 11 August 2027
Policy manual Not applicable
File number H21/111448
Status Active
Functional group Clinical/Patient Services - Governance and Service Delivery, Pharmaceutical
Population Health - Pharmaceutical
Applies to Ministry of Health, Public Health Units, Local Health Districts, Board Governed
Statutory Health Corporations, Chief Executive Governed Statutory Health
Corporations, Specialty Network Governed Statutory Health Corporations, Affiliated
Health Organisations, NSW Health Pathology, Public Health System Support Division,
Cancer Institute, Government Medical Officers, Community Health Centres, NSW
Ambulance Service, Dental Schools and Clinics, Public Hospitals
Distributed to Ministry of Health, Public Health System, Divisions of General Practice, Government
Medical Officers, NSW Ambulance Service, Private Hospitals and Day Procedure
Centres, Health Associations Unions, Tertiary Education Institutes
Audience All Clinical and Allied Health Staff

Secretary, NSW Health

This Policy Directive may be varied, withdrawn or replaced at any time. Compliance with this directive is
mandatory for NSW Health and is a condition of subsidy for public health organisations.
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POLICY DIRECTIVE

Medication Handling

POLICY STATEMENT
NSW Health organisations must have appropriate processes in place to ensure the
appropriate, safe, efficient and cost-effective use of medications in NSW public health
facilities.

SUMMARY OF POLICY REQUIREMENTS

The Chief Executive is responsible for establishing a Drug and Therapeutics Committee for
the governance of medication management.
Each Drug and Therapeutics Committee will be responsible for the governance of quality and
safe medication procurement, storage, prescribing, supply, administration and recording
protocols and procedures at the facilities assigned to the Committee. The Drug and
Therapeutics Committee also has oversight of facility procedures for medication safety alerts,
recalls, shortages and incident management.
Facility procedures for the procurement, storage, labelling, prescribing, dispensing,
supplying, administering and recording of medications must be in accordance with the
Poisons and Therapeutic Goods Act 1966, Poisons and Therapeutic Goods Regulation 2008
and applicable NSW policies and guidelines.
Each facility must establish a High-Risk Medicines Program with a High-risk Medicines
Register in accordance with NSW Health Policy Directive High-Risk Medicines Management
(PD2020_045). Facility procedures must be developed for all high-risk medicines specified
on this register.
Authorised prescriber requirements under the Poisons and Therapeutic Goods Regulation
2008 to direct the administration of medication and issue prescriptions for pharmacist
dispensing are in section 4 of the Policy procedures. The Regulation restricts the prescribing
of specific medications to certain authorised prescribers and/or under the Authority of the
NSW Health Secretary. Authorised prescribers may also supply medications for patient take
home use from health facility stocks when the Pharmacy Service is not available.
Medications at the Pharmacy Service are under the governance of the director of pharmacy,
or authorised pharmacist delegate where there is no director of pharmacy. At a facility where
there is no employed/contracted pharmacist the medication supply service is managed by the
director of nursing or medical superintendent authorised by the Chief Executive. Schedule 8
medications are to be stored in a safe or vault apart from all other medications and
accounted for in a drug register.
Pharmaceuticals prepared for by, or on behalf of, a public health facility, must be managed in
accordance with the Policy Directive Pharmaceuticals – Preparation in NSW Public Health
Facility Pharmacy Services (PD2015_007).
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Medications stored and used within a patient care area are under the governance of the
registered nurse or midwife in charge. Specific storage requirements apply for Schedule 4
Appendix D and Schedule 8 medications as they are vulnerable to diversion. Schedule 8
medication transactions are to be recorded in a drug register.
Authorised staff administer and supply medications under facility procedures, such as:
 on a medication chart order, or
 on a verbal (face to face), telephone or video call, email or facsimile order, or
 under a Standing Order, or
 under a nurse-initiated medication protocol, or
 under a Schedule 4 medication clinical protocol.
Certain medications require a second person check in specified circumstances.

REVISION HISTORY
Version Approved By Amendment Notes

August - 2022 Deputy Secretary, Full review of policy in PD2013_043 Medication Handling
(PD2022_032) People, Culture and in NSW Public Health Facilities.
Governance
November 2013 Deputy General New policy to consolidate and update PD2007_077
PD2013_043 Medication Handling in NSW Public Hospitals and
Section 3 of PD2005_105 Medication Handling in
Community-Based Health Services/Residential Facilities
in NSW - Guidelines.

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CONTENTS
1 BACKGROUND ............................................................................................................................. 6
1.1 About this document ................................................................................................................ 6
1.2 Key definitions ......................................................................................................................... 6
1.3 Legal and legislative framework ............................................................................................ 11
2 GOVERNANCE ............................................................................................................................ 12
2.1 The Drug and Therapeutics Committee ................................................................................ 12
2.2 High-risk medicines management ......................................................................................... 14
2.3 Medication safety alerts, recalls, shortages and incident/problem reporting ....................... 14
2.3.1 NSW Health Safety Alert Broadcasting System ............................................................ 14
2.3.2 Medication recalls........................................................................................................... 14
2.3.3 Medication shortages ..................................................................................................... 15
2.3.4 Medication incident reporting ......................................................................................... 16
2.3.5 Medication problem or defect reporting ......................................................................... 16
3 PRESCRIBING............................................................................................................................. 17
3.1 Authorised prescribers – general limitations to prescribing .................................................. 17
3.2 Consistent prescribing terminology ....................................................................................... 19
3.3 Medication orders in patient care areas ................................................................................ 19
3.3.1 Medication orders for administration .............................................................................. 19
3.3.2 Medication reconciliation ................................................................................................ 22
3.3.3 Review of medication orders .......................................................................................... 22
3.3.4 Documentation of patient allergy and adverse drug reactions ...................................... 23
3.3.5 Verbal, telephone, video call, email and facsimile medication orders........................... 23
3.4 Issuing prescriptions for pharmacist dispensing ................................................................... 24
3.4.1 Forms of prescriptions .................................................................................................... 24
3.4.2 Handwritten prescriptions for medications other than Schedule 8 medications ........... 24
3.4.3 Handwritten prescriptions for Schedule 8 medications ................................................. 26
3.4.4 Discharge summary ....................................................................................................... 26
3.4.5 Emergency verbal, telephone, video call, email and facsimile prescriptions ................ 27
3.4.6 Security of prescription stationery and eMeds passwords ............................................ 27
3.5 Medications for ‘off-label use’ and unregistered medications ............................................... 28
3.6 Medications for clinical trials .................................................................................................. 28
3.7 Restrictions on issuing prescriptions for certain Schedule 4 medications............................ 28
3.8 Requirements for certain Schedule 8 medication prescriptions ........................................... 32

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4 THE PHARMACY SERVICE ....................................................................................................... 34

4.1 Responsibility ......................................................................................................................... 34
4.2 Medication procurement ........................................................................................................ 34
4.2.1 Medication purchasing ................................................................................................... 34
4.2.2 Medication purchasing from a community pharmacy .................................................... 35
4.2.3 The Life Saving Drugs Registers (antidotes and antivenoms) ...................................... 36
4.2.4 Deliveries to the Pharmacy Service ............................................................................... 36
4.2.5 Receipting for the delivery of Schedule 8 medications.................................................. 36
4.3 Medication storage in the Pharmacy Service........................................................................ 37
4.3.1 Medication security and access – general provisions ................................................... 37
4.3.2 After-hours access to the Pharmacy Service ................................................................ 37
4.3.3 General medication storage requirements..................................................................... 37
4.3.4 Storage of Schedule 8 medications ............................................................................... 38
4.3.5 Schedule 8 medication requiring refrigerated storage................................................... 39
4.4 Medication supplies ............................................................................................................... 39
4.4.1 Authorised recipients of Pharmacy Service medications .............................................. 39
4.4.2 Patient payment for medications .................................................................................... 40
4.4.3 Emergency supplies of morphine ampoules to NSW Ambulance paramedics ............. 40
4.4.4 Pharmaceuticals preparation ......................................................................................... 40
4.4.5 Sensitisation due to occupational exposure .................................................................. 41
4.4.6 Schedule 8 medication deliveries by a facility staff member ......................................... 41
4.4.7 Schedule 8 medication delivery by a courier ................................................................. 42
4.5 Dispensing patient-labelled medications ............................................................................... 42
4.5.1 Orders for dispensing patient-labelled medications ...................................................... 42
4.5.2 Schedule 8 prescriptions – additional requirements...................................................... 43
4.5.3 Emergency verbal, telephone, video call, email or facsimile prescriptions ................... 44
4.5.4 Prescription forgeries ..................................................................................................... 44
4.5.5 Child resistant packaging ............................................................................................... 44
4.5.6 Labelling of dispensed medications ............................................................................... 46
4.5.7 Mandatory ancillary labels and warning statements ...................................................... 47
4.5.8 Unregistered medications for clinical trials .................................................................... 48
4.5.9 Records of dispensing .................................................................................................... 48
4.6 Imprest and stock supplies to patient care areas ................................................................. 49
4.6.1 Requisitions for medications .......................................................................................... 49
4.6.2 Re-packaging and labelling of imprest and stock medications ..................................... 50

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4.7 Pharmacy Service Schedule 8 medication accountability .................................................... 50

4.7.1 Entries in the Schedule 8 drug register .......................................................................... 50
4.7.2 Schedule 8 medication balance checks......................................................................... 52
4.8 Disposal/destruction of medications ...................................................................................... 52
4.8.1 Disposal of medications – general requirements........................................................... 52
4.8.2 Destruction of expired, unusable or unwanted Schedule 8 medications ...................... 52
4.8.3 Recommended methods for the destruction of Schedule 8 medications ...................... 53
4.9 Reporting the loss, theft or deficit of accountable medications ............................................ 55
4.10 Reporting a lost, destroyed or tampered Schedule 8 drug register ...................................... 56
4.11 Retention periods for records, prescriptions and drug registers ........................................... 56
5 PATIENT CARE AREAS ............................................................................................................. 57
5.1 Responsibility and oversight .................................................................................................. 57
5.2 Medication procurement by patient care areas ..................................................................... 58
5.2.1 General provisions ......................................................................................................... 58
5.2.2 Receipting Schedule 8 medication deliveries ................................................................ 58
5.2.3 Transferring Schedule 8 medications between patient care areas ............................... 59
5.2.4 Pharmacy Service packs and re-packs ......................................................................... 60
5.2.5 Use of patient own medication including complementary medication........................... 60
5.3 Methadone and buprenorphine for Opioid Treatment Program patients .............................. 63
5.4 Medication Storage in patient care areas ............................................................................. 64
5.4.1 General storage requirements ....................................................................................... 64
5.4.2 Storage of Schedule 8 medications ............................................................................... 64
5.4.3 Storage of Schedule 4 Appendix D medications ........................................................... 66
5.4.4 Schedule 8 and Schedule 4 Appendix D medications requiring refrigeration ............... 67
5.4.5 Unscheduled, Schedule 2, 3 and non-Appendix D Schedule 4 medications ................ 67
5.4.6 Storage of medications in automated dispensing cabinets ........................................... 68
5.5 Principles for the safe storage of accountable medications ................................................. 70
5.6 Procedural units/operating theatres – additional considerations .......................................... 72
5.7 Radiopharmaceuticals – additional considerations............................................................... 73
5.8 After-hours medication store supplies ................................................................................... 73
5.9 Supply for patient at home use by an authorised prescriber ................................................ 74
5.10 Medication kits for home visits and patient transport services ............................................. 75
5.10.1 Community nursing, Hospital in the Home and outreach services ............................... 75
5.10.2 Patient transport services ............................................................................................... 76
5.11 Disaster packs supplies ......................................................................................................... 77

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5.12 Discharge medications and return of patient own medications ............................................ 77

5.12.1 Supply of discharge medications ................................................................................... 77
5.12.2 Return of patient own medications................................................................................. 78
5.13 Additional supplies by registered nurses............................................................................... 79
5.13.1 Emergency after hours supply by registered nurses in rural and remote areas ........... 79
5.13.2 Supply of tenecteplase to NSW Ambulance Paramedics ............................................. 80
5.14 Patient care area Schedule 8 drug register .......................................................................... 80
5.14.1 Records in the Schedule 8 drug register ....................................................................... 80
5.14.2 Witness to Schedule 8 medication transactions ............................................................ 82
5.14.3 Balance checks in the Schedule 8 drug register ........................................................... 82
5.14.4 Schedule 8 drug register audits ..................................................................................... 83
5.15 Additional accountable medication recording in a register ................................................... 84
5.16 Disposal of expired, unwanted or unusable medications ..................................................... 84
5.16.1 Disposal of medications – general requirements........................................................... 84
5.16.2 Destruction of expired, unusable or unwanted Schedule 8 medications ...................... 84
5.17 Managing and reporting the loss, theft or deficit of accountable medications ..................... 85
5.17.1 Reporting the loss, theft or deficit of accountable medications. .................................... 86
5.18 Reporting a lost, destroyed or tampered Schedule 8 drug register ...................................... 87
5.19 Retention of records .............................................................................................................. 88
6 ADMINISTERING MEDICATION ................................................................................................ 88
6.1 Staff administering medication .............................................................................................. 88
6.2 Orders for medication administration .................................................................................... 90
6.3 Administering from a verbal, telephone, video call, email or facsimile order ....................... 90
6.3.1 Verbal (face to face) medication orders ......................................................................... 90
6.3.2 Telephone and video call orders .................................................................................... 91
6.3.3 Email and facsimile orders ............................................................................................. 92
6.4 Standing orders and administration/supply under a protocol ............................................... 92
6.4.1 Standing orders for emergency treatment ..................................................................... 93
6.4.2 Standing orders for dosage adjustments only ............................................................... 94
6.4.3 Individual prescriber standing orders ............................................................................. 94
6.4.4 Standing orders for routine procedures and programs.................................................. 94
6.4.5 Administration/supply under a protocol .......................................................................... 95
6.5 Nurse/midwife initiated medication ........................................................................................ 95
6.6 Principles for safe medication administration........................................................................ 96
6.7 Administration by injection – additional requirements......................................................... 100

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6.8 Second person checks prior to administration .................................................................... 101

6.8.1 Second person checks – general requirements .......................................................... 101
6.8.2 Table 1. Inpatient settings (except Hospital in the Home) excluding Schedule 8
medications ................................................................................................................................ 103
6.8.3 Table 2. Inpatient Schedule 8 medication procedure requirements............................ 104
6.8.4 Table 3. Inpatient settings (Except Hospital in the Home) – Schedule 8 medications 105
6.8.5 Table 4. Hospital in the Home with one nurse/midwife ............................................... 106
6.8.6 Table 5: Palliative care in the home setting with one nurse/midwife........................... 107
6.8.7 Table 6. Community Home Care with one nurse/midwife ........................................... 108
6.8.8 Table 7. Other clinical settings operated with only one nurse/midwife (remote health
facilities, community health centres) .......................................................................................... 109
6.9 Schedule 8 medication discards.......................................................................................... 109
6.9.1 General principles ........................................................................................................ 109
6.9.2 Home care setting ........................................................................................................ 110
6.9.3 Patient care areas ........................................................................................................ 110
6.10 Patient self-administration of medications .......................................................................... 111
6.10.1 Patient training and education programs ..................................................................... 112
6.10.2 Non-inpatient day centres ............................................................................................ 112
6.11 Time critical medications ..................................................................................................... 112
6.12 Dose administration aids ..................................................................................................... 113
7 REFERENCES ........................................................................................................................... 114
7.1 Related documents: ............................................................................................................. 114

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1 BACKGROUND

1.1 About this document

This Policy consolidates:
 the statutory requirements of the NSW Poisons and Therapeutic Goods Act 1966 and
the Poisons and Therapeutic Goods Regulation 2008
 NSW Health policies relevant to medication handling
 recognised professional practice standards, such as those published by the Australian
Commission on Safety and Quality in Health Care (ACSQHC) and the
Commonwealth Department of Health.
The Policy applies to all Public Health Organisation health facilities including hospitals,
clinical services, outpatient clinics, community health centres, day centres, day procedure
centres, community-based services, Hospital in the Home and outreach services within the
NSW Health system’s jurisdiction (including where a public health service is contracted to a
non-government organisation).
The Policy can be used as the basis for public health facilities to develop detailed protocols
and procedures specific to the local situation and circumstances, including where services
are contracted to a non-government organisation.
Although the principles may be relevant, this Policy does not apply to HealthShare NSW
patient transport service. Medication handling and administration within HealthShare NSW
patient transport service is mandated in the separate Patient Transport Service Medication
Management Policy endorsed by the HealthShare NSW Chief Executive.
Although the principles may be relevant, this Policy does not apply to medication handling
and administration by paramedics and flight nurses employed by NSW Ambulance except for
the following specific services provided by public hospital emergency departments:
 the provision of emergency supplies of morphine to NSW Ambulance paramedics
(section 4.4.3)
 the provision of tenecteplase to NSW Ambulance paramedics under the Pre Hospital
Thrombolysis Program (section 5.13.2).
Medication handling and administration within NSW Ambulance is mandated in the
Medications Management Operating Procedure endorsed by the NSW Ambulance Chief
Executive.

1.2 Key definitions

Accountable All Schedule 8 medications and Schedule 4 Appendix D

medication medications, as well as other Schedule 3 or 4 medication
directed by the chief executive (or delegate) of the facility to be
accounted for in a register.

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Administration The decision to give a medication, giving the medication (such

as by mouth, topically or by injection) then documenting that the
medication has been given.

Authorised prescriber A person approved by the facility to prescribe medications, but

only in accordance with any practice conditions imposed by the
person’s place of employment and the endorsements, notations
and conditions on the person’s health practitioner registration,
as:

 Medical practitioner  Dentist

 Nurse practitioner  Midwife practitioner
 Endorsed midwife  Optometrist
 Podiatrist

Note: For the purpose of this Policy, ‘authorised prescriber’ does

not relate to a medical practitioner approved under the
Commonwealth Therapeutic Goods Act 1989 to prescribe a
Special Access Scheme medication or to prescribe
Pharmaceutical Benefits Scheme medications under the
National Health Act 1953.

Closed-loop A communication method used to minimise communication

communication errors that involves confirming and verifying orders. In closed-
loop communication the sender gives a message, the receiver
repeats this back and the sender then confirms the message.

Dispensing The labelling and supply of a medication, and recording of the

supply, by a pharmacist for use by a particular patient on the
order of an authorised prescriber. The order may be for patient
take-home use of the medication or for administration to an
inpatient or outpatient. In specific circumstances an authorised
practitioner may be authorised for this activity (see section 5.9).

Dose administration A sealed tamper-evident device that allows individual medication

aid doses to be organised according to the prescribed dose
schedule. Dose administration aids referred to in this Policy are
those filled by the Pharmacy Service only.

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Electronic medication The software and associated hardware used to create and
management system, document the entire medication procedure from the authorised
eMM system, eMeds prescriber’s medication order, the pharmacist’s review of the
system medication order and supply of medication, the recording of
administration of the medication, and all the procedures in
between.
eMM systems are sometimes referred to as ‘eMeds’ within the
electronic medication record (eMR).

Hospital in the Home A clinical model that provides admitted acute/sub-acute care in
the patient’s home or the community as a substitute for in-
hospital care. Instead of receiving care and hospital
accommodation, patients receive hospital level care whilst being
accommodated in their own home. Hospital in the Home
services may include care in an ambulatory/clinic environment.

Imprest system The method by which medications are supplied from the
Pharmacy Service of a hospital to the health service or the
wards, theatres, departments or clinics thereof, either in
containers of the original manufacturer, or repacked containers
in order to establish and maintain a stock of medications at a
pre-determined level for use in such places.

Medication Describes a drug, medicine, pharmaceutical preparation

(including an extemporaneously compounded preparation),
therapeutic substance, complementary and alternative medicine,
vaccine, diagnostic agent for patient administration, medicated
dressing, device containing a medicine and a fluid for
intravenous use. Includes Scheduled medication and
unscheduled medication.

Medication order A direction to administer a medication as a written order by an

authorised prescriber on a Drug and Therapeutics Committee
approved chart such as a National Standard Medication Chart or
a speciality medication chart (including where approved as a
State Form). An electronic order in the health facility’s eMeds
system and verbally (face to face) or by telephone, video call,
email and facsimile.

Medication recall The person assigned by the health facility who is responsible for
coordinator coordinating the prompt removal of medications which are the
subject of a recall, and for keeping staff informed of current
medication recalls as well as medication problem alerts.

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Medication review A minimum standard of systematic appraisal of all aspects of

patient medication management conducted or supervised by a
qualified and suitably trained health practitioner (ideally a
pharmacist) acting as part of a multidisciplinary team. It includes
objective review of medication prescribing, dispensing,
distribution, administration, monitoring of outcomes and
documentation of medication related information in order to
optimise Quality Use of Medicines.

Off-label use The use of a medication other than that specified in the TGA-
approved product information including when the medicine is
prescribed or administered:
 for an alternative indication
 at a different dose
 via an alternate route of administration, or
for a patient of an age or gender outside the registered use.

Off-label use The use of a medication other than that specified in the TGA-
approved product information including when the medicine is
prescribed or administered:
 for an alternative indication
 at a different dose
 via an alternate route of administration, or
 for a patient of an age or gender outside the registered
use.

Patient care area Any area, clinic or unit in a hospital, health facility, health
institution, health centre, health service or health support service
where patient treatment or care may be carried out. Includes a
hospital ward, emergency department, operating theatre,
specialised treatment unit (for example haemodialysis,
oncology, radiology, dental), day surgery unit, community health
centre, Hospital in the Home service, day centre, community-
based service at the patient’s home and Justice Health and
Forensic Mental Health Network controlled health service.

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Pharmacy Service A service administered by a director of pharmacy which is

responsible for the procurement, distribution, preparation and
dispensing of medications as well as the delivery of clinical and
other services as defined by the Society of Hospital Pharmacists
of Australia.
For the purpose of this Policy includes the medication supply
service (that is not part of a patient care area) at a facility where
no pharmacist is employed or contracted for whom the
responsibility of the distribution of medications is assigned to the
director of nursing or medical superintendent of the facility.

Printed standard A hard copy medication regimen comprised of printed

medication order set medication names with medication orders on which the
authorised prescriber may include additional particulars such as
dosage calculations in handwriting. Used for inpatients and
patients being treated in outpatients’ clinics and includes and
order that combines a medic
To become a valid medication order the authorised prescriber
must sign and date the medication order set in handwriting

Scheduled medication A medication containing a substance in the NSW Poisons List

as;
 Schedule 2 ‘Pharmacy Medicine’ (pharmacy ‘over the
counter’ medication),
 Schedule 3 ‘Pharmacist Only Medicine’ (pharmacist
controlled ‘over the counter’ medication),
 Schedule 4 ‘Prescription Only Medicine’ (also defined as
a ‘restricted substance’ in the Act and Regulation), or,
Schedule 8 ‘Controlled Drug’ (also defined as a ‘drug of
addiction’ in the Act and Regulation).

Schedule 4 Appendix Schedule 4 medications listed in Appendix D to the Poisons and

D medications Therapeutic Goods Regulation 2008 known to be liable to abuse
or misuse, which require more secure storage in patient care
areas. They include benzodiazepines (except those in Schedule
8), anabolic-androgenic steroids, ephedrine, erythropoietins,
phentermine, phenobarbitone, pregabalin, quetiapine, tramadol
and Schedule 4 barbiturates. See the Schedule 4 Appendix D list
on the Ministry of Health website.

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Schedule 4 Appendix Schedule 4 medications listed in Appendix B to the Poisons and

B medications Therapeutic Goods Regulation 2008, prescriptions (but not
medication chart orders) for which must include intervals for
repeats (if repeats are ordered), and after dispensing must be
retained separate from all other prescriptions (except Schedule
8 prescriptions) at the Pharmacy Service. They include anabolic-
androgenic steroids, injectable amylobarbitone and injectable
pentobarbitone. See the Schedule 4 Appendix B list on the
Ministry of Health website.

Schedule 8 cannabis A therapeutic good containing cannabinoid/s found in the

medication cannabis plant, prepared or packed for human therapeutic use,
and included in Schedule 8 of the NSW Poisons List.

Special Access Arrangements through the Therapeutic Goods Administration

Scheme (TGA) which provide for the import and/or supply of a non-
approved therapeutic good for individual patient use.

Standard for the The Poisons Standard is the legal title for the Standard for the
Uniform Scheduling of Uniform Scheduling of Medicines and Poisons. The Poisons
Medicines and Standard consists of decisions regarding the classification of
Poisons (SUSMP) medicines and poisons into schedules and controls such as
packaging and labelling. The NSW Poisons List adopts the
Schedules of the SUSMP as in force at any time.

Unregistered A medication or dosage form that is not currently approved for

medication use in Australia and hence is not listed or registered on the
Therapeutic Goods Administration (TGA) Australian Register of
Therapeutic Goods (ARTG).

1.3 Legal and legislative framework

The Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic
Goods Regulation 2008 (NSW) regulate the procurement, storage, labelling, prescribing,
dispensing, supplying, administering and recording of both Scheduled and non-Scheduled
medications in New South Wales at health facilities, and by health practitioners and
pharmaceutical wholesalers. The Poisons and Therapeutic Goods Regulation 2008 (NSW) is
referred to as the ‘Regulation’ throughout this Policy.
This legislation is administered by Legal and Regulatory Services Branch of the NSW
Ministry of Health.

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2 GOVERNANCE

2.1 The Drug and Therapeutics Committee

All public health facilities in NSW must have a formally constituted, multidisciplinary Drug and
Therapeutics Committee in place, or have access to a local health district or specialty health
network drug and therapeutics committee.
The Committee must include representation from the facility’s executive and the pharmacy,
medical and nursing disciplines.
The Drug and Therapeutics Committee is responsible for governing the medication
management systems, and ensuring the appropriate, safe, efficient and cost-effective use of
medications in the health facility, local health district or speciality health network.
The Council of Australian Therapeutic Advisory Group (CATAG) Guiding Principles for the
Roles and Responsibilities of Drug and Therapeutics Committees in Australian Public
Hospitals provides guidance on the role, operation and evaluation of Drug and Therapeutics
Committees.
Under facility procedures, the Committee/s will report to the Chief Executive of the public
health organisation via a senior executive officer, such as the Director of Clinical
Governance. The Committee/s must also report quarterly to the facility’s clinical quality
committee (however named).
The Chief Executive must ensure each Drug and Therapeutics Committee is established with
appropriate terms of reference that include integrated governance systems to promote
patient safety and quality medication use and clearly articulate organisational and individual
accountabilities throughout the organisation, and also that the committee’s effectiveness is
monitored.
Each Drug and Therapeutics Committee will be responsible for the governance of quality and
safe medication procurement, storage, prescribing, supply, administration and recording
protocols and procedures at the facilities assigned to the Committee.
The Committee will, among other duties, be responsible for determining the range, number
and quantities of medications to be made available in the facility through formulary
adherence, monitor medication use, and provide guidance to all health workers in the rational
use of medications and the treatment guidelines that apply in the facility.
The Drug and Therapeutics Committee must include persons with relevant expertise in the
safe, rational, high quality and cost-effective use of medications. Subcommittees with
relevant expertise for specific projects or aspects of the quality use of medications, such as
antimicrobial stewardship, medication safety, paediatrics, opioid stewardship, venous
thromboembolism prophylaxis and eMeds systems may also be appointed to assist the work
of the Drug and Therapeutics Committee.
The functions of the Drug and Therapeutics Committee (or subcommittee where appropriate)
for each facility assigned to the Committee must include:
 the development and approval of medication protocols and facility procedures that
support the quality, safe and cost-effective use of medications, including all aspects of
medication management, aligned with relevant NSW Health policies
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 assisting in the implementation of NSW Health policies concerning medications and

medication management
 approval of medications for use in accordance with NSW Health Policy Directive
Approval Process of Medicines for Use in NSW Public Hospitals (PD2016_033)
 oversight of any formulary restrictions
 oversight of compliance with NSQHS Medication Safety Standards
 oversight of eMeds systems in use
 monitoring of medication safety systems through review and analysis of medication
data, for example, audits, self-assessments and analytics from eMeds systems
 collation and analysis of incident reports involving medications
 oversight of medication recall and product defect management procedures
 development and implementation of strategies for medication error prevention in
accordance with NSW Health policies on incident management and patient safety
 design and approval of all specialty medication charts
 approval and review of standing orders for medication administration
 approval and review of the list of nurse-initiated medications and protocols for use
 oversight of non-medical prescribing
 oversight of risks of clinical trials to the organisation (other than the clinical
considerations assessed by an ethics committee)
 communicating formulary decisions and any related safety requirements to relevant
clinicians and medication-related governance committees
 oversight of the establishment and use of Fixed Interval Variable Dose (FIVD) order
sets, especially in the facility’s eMeds system, and ensure:
o the construction of order sets containing fixed interval variable doses must enable
the prescriber to meet their obligations to ensure orders are not open to
misinterpretation, and enable the prescriber to specify the maximum individual
dose, the maximum daily dose, the hourly frequency for administration, and the
maximum number of doses or maximum duration of treatment
o the prescriber is able to specify which clinical factors are to be used determine
which dose is selected and administered at each dose interval. This detail may be
contained in a clinical protocol
o nursing staff must have skills and experience to assess such clinical factors and
document the basis on which the dose has been chosen
o documentation of effects and adverse effects from an administered dose be made
to enable appropriate dose titration for the next dose
o the prescriber is able to specify when an opioid dose would be withheld if adverse
effects (especially respiratory depression) occur due to administration of a dose at
the high end of the dose range.
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2.2 High-risk medicines management

All facilities must establish a high-risk medicines program in accordance with NSW Health
Policy Directive High-Risk Medicines Management (PD2020_045). All public health facilities
must maintain, as part of the high-risk medicines program, a specific high-risk medicines
register.
The register must include medicines used locally within the facility identified to be at ‘high-
risk’ of misadventure. Facility protocols must be developed for all identified high-risk
medicines specified on the register.
Standards are also included in NSW Health Policy Directive High-Risk Medicines
Management (PD2020_045) for specific high-risk medicines.
Supporting tools and information on safety and quality around high-risk medicine use are
available on the Clinical Excellence Commission webpage.

2.3 Medication safety alerts, recalls, shortages and

incident/problem reporting

2.3.1 NSW Health Safety Alert Broadcasting System

The NSW Health Policy Directive Safety Alert Broadcast System (PD2013_009) details the
mechanism used to provide a systematic approach to the distribution of patient safety
information to the NSW Health on the Safety Alert Broadcast System Register.

2.3.2 Medication recalls

A medication recall involves the removal of the medication from supply on the Australian
market for reasons relating to the product’s quality, safety or efficacy.
Nationally the medication recall procedure is administered by the Commonwealth TGA in co-
operation with the particular product’s sponsor (the Australian manufacturer or the
distributor), as detailed in the Commonwealth’s Uniform Recall Procedure for Therapeutic
Goods.
In NSW, the Clinical Excellence Commission leads the response to urgent system-level
medication issues in accordance with NSW Health Policy Directive Co-ordination of
responses to urgent system-level medicine or medical device issues (PD2019_019).
Medication recalls vary in the risk they pose to patient safety. All facilities must respond
effectively and promptly to any medication recall notification.
Under facility procedures the medication recall coordinator is responsible for:
 coordinating the prompt removal of recalled medications (or implements other recall
letter instructions) from use in all locations in the facility including for:
o Hospital in the Home, community nursing and outreach program medications
o medications brought into the facility by a patient, (including in a dose administration
aid) residential aged care and flexible care units
 coordinating stock replacement strategies and/or replacement stock when required
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 informing affected staff and facility executives about recalled medications

 during business hours, regularly monitoring the recall coordinator point of contact is
current
 informing staff about medication alerts that require action other than the removal of the
medication from use, such as those alerts broadcast as NSW Health Safety Alert
Broadcast System Notifications.
Facility procedures must include the management of recalls after-hours. In circumstances
where medications have been transferred to another health facility, that facility’s medication
recall coordinator must be notified for appropriate action.
The medication recall coordinator is responsible for notifying the Clinical Excellence
Commission by email of any change to the email address assigned by the facility for the
purpose of TGA medication recall notifications. To provide for periods of absence,
management of the appointment of a person to deputise as medications recall coordinator in
accordance with NSW Health Policy Directive Coordination of Responses to Urgent System-
Level Medicine or Medical Device Issues (PD2019_019).

System for Australian Recall Actions

The System for Australian Recall Actions provides health care facilities, health care
professionals, sponsors, wholesalers, retailers and consumers with access to information
about recall actions occurring in Australia for therapeutic goods.
The database is managed by the TGA and holds information on recall actions that have been
undertaken in Australia since 1 July 2012. (Note: The database includes recalls relating to
therapeutic devices as well as medications).

Retention of Recall Records

Records relating to the recalled medications must be retained at the facility for ten years, and
then stored as State Records in accordance with NSW Health Policy Directive Health Care
Records – Documentation and Management (PD2012_029). Related records include policies
for dealing with recall matters not related to individual issues, such as negotiation of
jurisdiction and recalls procedure development.

2.3.3 Medication shortages

The Clinical Excellence Commission reviews and assesses critical shortages of medicines for
NSW Health and where necessary establishes an inter-agency management team to
formulate a plan that includes stock management as well as issuing a Shortage
Communication or a Safety Notice.
Under NSW Health Policy Directive Coordination of responses to urgent system-level
medicine or medical device issues (PD2019_019) in extreme instances of immediate, life-
threatening risk or major system impact, coordination of the response may transition to the
Chief Health Officer or Deputy Secretary, System Purchasing and Performance (depending
on the nature of the incident).
The TGA monitors critical medicines shortages and initiatives for the Accessing medicines
during a shortage. A Serious Scarcity Substitution Instrument may apply, which outlines
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alternative products (for example, a different strength or dosage form of the same medicine)
that could be substituted by a pharmacist.
The exercise of social and ethical responsibilities to ensure that purchasing for a constrained
supply medication is managed sensitively with the whole of health system is under facility
procedures.

2.3.4 Medication incident reporting

All incidents, including near-miss incidents, associated with medication use must be reported
in the facility’s incident management system in accordance with NSW Health policy on
incident management.
Where a dispensing incident involves an individually patient-labelled medication obtained
from the Pharmacy Service the detail of the incident must also be recorded in the patient’s
record in the Pharmacy Service dispensing system. Reporting an incident relating to the
administration of a patient own medication in their home is under facility procedures.
Any suspected adverse drug reaction must be reported in accordance with facility procedures
and to the TGA using the ‘Blue card’ adverse reaction reporting form ‘Report of Suspected
Adverse Reaction to Medicines or Vaccines’ or the Australian Adverse Drug Reaction
Reporting System.
Adverse events following immunisation must be reported to the local Public Health Unit. An
Adverse Events Following Immunisation (AEFI) reporting form must also be completed.

2.3.5 Medication problem or defect reporting

All staff must be alert to the possibility of defects in the medications they handle and must
report any anomaly which may indicate a deficiency in the quality, safety or efficacy of the
product to the facility’s medication recall coordinator. Such problems could include incorrect
or illegible product labelling, discolouration, cloudiness, contamination or incorrect
tablets/capsules or faulty packaging.
The facility’s medication recall coordinator must report any suspected or known problem or
defect with a medication promptly in the facility’s incident management system and also to
the Commonwealth TGA since this may indicate a fault in a manufacturer’s procedures or be
part of a wider problem and which may ultimately require a recall.
The TGA Medicine Problem Report Form must be used for problem or defect reporting.
Problems requiring urgent investigation must be reported immediately to the TGA
Pharmacovigilance and Special Access Branch by telephone at 1800 020 653.
Products which are suspected or known to be faulty must not be exchanged by a supplier or
manufacturer without first establishing that the problem has been correctly reported to the
TGA.

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3 PRESCRIBING

3.1 Authorised prescribers – general limitations to prescribing

Prescriptions may only be written for patients being treated by the service and relating to that
episode of care. Prescribers must not write prescriptions for persons who are not patients of
the service, for example, colleagues or family members. Prescribing is limited to formulary
restrictions, including for individual or classes of prescribers.
The following staff are authorised to both issue a prescription for dispensing by a pharmacist
and create a medication order for administration in accordance with:
 any endorsements, notations and conditions included with the person’s registration on
the Australian Health Practitioner Regulation Agency website
 any condition imposed on the person’s employment at the facility
 Drug and Therapeutics Committee approved protocols and procedures
 formulary restrictions
 Drug and Therapeutics Committee approved limitations on non-medical prescribers,
for example, limiting the prescribing of systemically active medications to admitting
medical teams.

Medical Practitioner
Other than a Provisionally Registered Medical Practitioner (medical intern).

Provisionally Registered Medical Practitioner (‘Medical Intern’)

Only for the prescribing (medication chart orders and prescriptions) to a patient while at the
facility, and under the supervision of a medical practitioner in accordance with the
organisation’s medical internship program.
Note: Medical students are not authorised to issue prescriptions or create medication chart
orders for administration.

Nurse Practitioner
Within the approved scope of practice in accordance with NSW Health Policy Directive NSW
Health Nurse Practitioners (PD2020_034).
Transitional Nurse Practitioners or Registered Nurses undertaking studies leading to
endorsement as a Nurse Practitioner are not authorised to issue a prescription or order
medications on a medication chart.

Midwife Practitioner
Within the approved scope of practice and in accordance with the medication list approved by
the Secretary, NSW Health under section 17A of the Poisons and Therapeutic Goods Act
1966.

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Endorsed Midwife
Holds an endorsement with the Nursing and Midwifery Board of Australia to obtain, possess,
administer, prescribe or supply Scheduled medicines.

Dentist
Dental treatment only. While there is no restriction on a medication chart order for dental
treatment, issuing a prescription for a Schedule 8 medication for an outpatient, or a patient on
discharge from a hospital by a dentist is limited to a Schedule 8 medication included in the list
of preparations that may be prescribed by participating dental practitioners for dental
treatment only, set out in the Schedule of Pharmaceutical Benefits issued by the
Commonwealth Department of Health.

Optometrist
Endorsement on the person’s registration by the Optometry Board of Australia to prescribe
(and supply) specified Schedule 2, Schedule 3 and Schedule 4 medications for optometrical
treatment only.

Podiatrist
Endorsement on the person’s registration by the Podiatry Board of Australia to prescribe and
supply specified medications in Schedule 2, Schedule 3, Schedule 4 and Schedule 8 (with
endorsement as a podiatric surgeon) for podiatry treatment only.
Note: All podiatrists may use topical anaesthetics and Schedule 4 injectable local
anaesthetics for parenteral use.

Hospital pharmacist initiation and administration of vaccines

The NSW Poisons and Therapeutic Goods Regulation 2008 (clause 48A) authorises
appropriately trained pharmacists to administer the specified vaccines to specific patient
groups. More information is available on the NSW pharmacist vaccination
program webpage.
A registered pharmacist employed at a public hospital who initiates and administers vaccines
must comply with the following three components of clause 48A of the which prescribes rules
for:
 completing an accredited vaccination training course
 conducting vaccinations under the NSW Pharmacist Vaccination Standards
 recording each vaccination.
The vaccinations must be conducted under a program approved by the public health facility’s
chief executive in accord with the NSW Pharmacist Vaccination Standards.
Note: Pharmacists are not authorised to write an order for the administration of a vaccine by
another health practitioner (such as on a medication chart).

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3.2 Consistent prescribing terminology

The use of potentially dangerous abbreviations and dose expressions in the prescribing of
medications is a critical patient safety issue and a major cause of medication errors.
The facility’s Drug and Therapeutics Committee must ensure that endorsed standard
prescribing terminology and abbreviations are used, consistent with the ACSQHC
Recommendations for Terminology, Abbreviations and Symbols used in Medicines
Documentation on prescriptions, medication chart orders, administration and dispensing
records and other related documents.
Note: For eMeds systems this is in the eHealth NSW Design Standard Terminology,
Abbreviations and Symbols used in the Electronic Prescribing and Administration of
Medicines – see in NSW Policy Directive Electronic Medication Management Systems
Governance and Standards (PD2019_050).
Additionally:
 medication names must not be abbreviated
 the route for administration must be specified
 prescriptions for pharmacist dispensing and medication orders must be written as the
active ingredient/s of the medication. Except in specific circumstances when the
ordering by the brand name is authorised by the Drug and Therapeutics Committee
and in accordance with NSW Health policies (such as in combination products). Note:
Under the Hydromorphone Standard in NSW Health Policy Directive High-Risk
Medicines Management (PD2020_045) prescribers must include the brand name of
the hydromorphone preparation
 oral liquid medications must be prescribed with the strength of the medication and
both the quantity of the dose and the volume to be administered (in brackets), for
example ‘Xyz Mixture 5 mg/mL, dose 10 mg (= 2 mL)’.
The TGA updated medicine ingredient names are now in force. A small number of
medications require dual names, for example adrenaline (epinephrine).

3.3 Medication orders in patient care areas

3.3.1 Medication orders for administration

Only hard copy (paper-based) medication charts that have been approved by the Drug and
Therapeutics Committee for a particular patient care area can be procured for use in that
area.
The requirements in NSW Health Policy Directive Electronic Medication Management System
Governance and Standards (PD2019_050) which must be met where an eMeds system is
used to prescribe medications, record the administration and review or dispense medications
in a NSW public health facility.
Where an eMeds system is not in use, the National Standard Medication Charts (NSMC) and
associated guidelines published by the ACSQHC must be adopted in accordance with the
NIMC Local Management Guidelines.

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The NSMC includes the Paediatric National Inpatient Medication Chart (PNIMC) which allows
for signatures of two staff members for each dose administered and provides a field for the
calculation of weight based dosages. The PNIMC must be used in patient care areas as
directed by the Drug and Therapeutics Committee.
There are also a range of State Form approved speciality medication charts (such as those
developed by the Agency of Clinical Innovation) available through the state contracted
supplier including:
 the NSW Adult Subcutaneous Insulin Chart
 the suite of NSW Pain Charts.
Where multiple eMeds systems or hybrid systems (paper based with electronic) are used,
facility procedures must be in place that address the risk of duplicate orders or non-
contemporaneous orders during the patient’s admission and at transfer of care.
The facility’s Drug and Therapeutics Committee must approve and review (annually or more
frequently as deemed appropriate) the use of any specialty (hard copy) medication charts
including the appropriateness of the ongoing use of the chart in the particular patient care
area.
Printed standard medication order sets must be approved for use in the ward or clinic by the
Drug and Therapeutics Committee, or a delegated standing interdisciplinary committee for:
 complex medication regimens for specialist inpatient and outpatient settings such as
oncology, haematology, immunology, neurology and rheumatology
 advanced pain management medications in setting such as anaesthesia and palliative
care
 naloxone, when ordered for use as an antidote to accompany orders for patient
controlled analgesia using opioids
 medication on a medication chart endorsed as a State Form that aligns with the design
and standards described in the ACSQHC NIMC User Guide (for example, for warfarin,
insulin, venous thromboembolism prophylaxis).
The order set must be signed and dated in the authorised prescriber’s handwriting to be a
valid direction to administer and/or dispense the medication.
Prescribers must ensure that medication orders are clear, legible and not open to
misinterpretation.
Prescribing terminology and abbreviations must be consistent with the ACSQHC
Recommendations for Terminology, Abbreviations and Symbols used in Medicines
Documentation.
A medication order on a hard copy (paper-based) medication chart must clearly specify:
 the medication’s active ingredient/s and/or brand name (where approved for use at
the facility and under NSW Health policies) with the strength, form and route of
administration
 the indication for treatment. (Note: Indication must be listed/used when a medication
is initiated by the prescriber. Where the medication is continued on admission and the
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indication is unknown to the prescriber is to use “TBC” (To be Confirmed). The

indication must be reviewed during the admission and at discharge and when
indication/s for ongoing medications have been confirmed must be updated. eMeds
order sets pre-populate the indication in the medication order and must be determined
by the Drug and Therapeutics Committee
 for a ‘regular’ medication;
o the dose to be administered
o the frequency and times for administration to the patient
o the maximum number of doses or the maximum duration of treatment with the
medication, (except where the prescriber’s intention is for ongoing treatment)
 for a ‘when required’ (‘prn’) medication;
o the maximum individual dose
o the maximum daily dose
o the hourly frequency for administration to the patient
o the maximum number of doses or the maximum duration of treatment with the
medication (except where the prescriber’s intention is for ongoing treatment)
 the date the medication order is issued
 the prescriber’s name (printed) and handwritten signature, or electronic authorisation
in an eMeds system, and contact telephone/pager number.
 where used to direct pharmacist dispensing the NSW Health authority number, where
required under the Regulation (see section 3.7 for the specialist restricted Schedule 4
medications and section 3.8 for certain Schedule 8 medications).
Use of Fixed Interval Variable Dose (FIVD) eMeds medication orders is to be under eHealth
NSW design standards with appropriate testing for use with oversight by the Drug and
Therapeutics Committee.
Medication orders with a variable dosage range (for example, 5 to 10 mg) over a fixed
interval for administration (for example every 6 hours) must be clear and unambiguous. This
type of order is to be avoided for opioids unless specific clinical criteria are provided for
nurses on selection of the dose and the times for administration. Nursing staff must have
skills and experience to assess such clinical factors and document the basis on which the
dose has been chosen.
Medication orders on hard-copy charts must be re-written if any changes are made. The
reason for ceasing a medication order prior to when originally prescribed must be
documented in the patient’s health care record, signed and dated by the prescriber with their
name and contact telephone/pager number.

Hospital pharmacist medication chart entries

A hospital pharmacist may make a medication entry on a patient’s medication chart for
subsequent checking and signing by an authorised prescriber. This applies to medication
charts in paper form and in hospital eMeds systems.

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The hospital pharmacist’s entry in the medication chart is not a valid order to direct a nurse
to administer the medication until it is signed by an authorised practitioner.
The hospital pharmacist must be authorised under facility procedures approved by the Drug
and Therapeutics Committee. Facility procedures must include:
 the circumstances where the hospital pharmacist may make the medication entries,
such as during eMeds system downtime or for rollback to eMeds use post downtime
 the procedure for forwarding the medication entries to an authorised prescriber for
subsequent checking and signing.

3.3.2 Medication reconciliation

Medication reconciliation is the procedure of ensuring that patients receive all intended
medications and that accurate, current and comprehensive medications information follows
them at all transfers of care. Formalised medication reconciliation procedures have been
shown to improve patient safety and the continuity of medication management.
In accordance with the NSQHS Standards, facilities must implement formal procedures for:
 obtaining information to compile a list of the patient’s current medication regimen
(including known allergies and previous adverse drug reactions)
 verifying the accuracy of the information obtained to achieve a best possible
medication history (using at least two sources, for example, patient’s general
practitioner, community pharmacist, patient own medications)
 comparing the patient’s current medication orders against their best possible
medication history and the documented treatment plan and reconcile any
discrepancies
 supplying a current medicines list and the reasons for any changes to the receiving
clinician/s and patient.
The Clinical Excellence Commission Continuity of Medication Management program provides
tools and resources to support facilities implement and improve medication reconciliation
procedures.
The list of current medications must be used:
 to inform medication treatment
 for reference by prescribers preparing medication orders for a patient on admission.

3.3.3 Review of medication orders

Medication orders must be regularly reviewed in accordance with NSQHS Medication Safety
Standard, relevant NSW Health policy requirements and Drug and Therapeutics Committee
approved procedures.
Facility procedures must provide for the timely follow up by prescribers and pharmacists
when medication orders have been highlighted for review. Procedures must address
medication review prioritisation based on:
 patient clinical needs
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 the presence of medication related problems.

The outcome of the follow up and any resulting medication changes must be documented in
the patient’s health care record.

3.3.4 Documentation of patient allergy and adverse drug reactions

Facilities must have procedures for documenting patient allergies and adverse drug reactions
in the health care records including:
 documenting on admission information on known allergies and adverse drug reactions
in the medication history, all forms on which medications are ordered, in the electronic
health record and eMeds system
 documenting allergies and adverse drug reactions experienced by patients during an
episode of care in the health care record and in the incident management system
 documenting medication allergies and adverse drug reactions in dispensing systems
 communicating allergy and adverse drug reaction information during clinical handover
and transitions of care.
Procedures must include clinician roles and responsibilities for documentation of allergy and
adverse drug reaction history.
Clear instructions must be provided to patients and/or their carer on how to report their
allergy or adverse drug reaction to all future care providers.
Specifically, prescribers must:
 include the active ingredient/s name, the brand where the reaction is brand specific,
description of reaction experienced and its severity, and date of when the reaction
occurred (if known) when documenting allergies
 check both hard-copy and electronic health record (including sources such as the
patient’s My Health Record) for medication allergies and adverse drug reactions where
hybrid systems are used
 ask patients/carers about their medication allergy and/or adverse drug reaction history
at each admission
 not prescribe medications to which patients have previously experienced severe
allergic reactions, even if having demonstrated tolerance leading up to that event. An
exception to this is if the patient has undergone desensitisation/delabelling to that
medication, or use is under specialist advice
 refer to the patient’s medication allergy and/or adverse drug reaction history before, or
at the point of, decision-making on every occasion when prescribing medications.

3.3.5 Verbal, telephone, video call, email and facsimile medication

orders
Procedures for an authorised prescriber to provide verbal (face to face), telephone, video
call, email and facsimile orders are in section 6.3.

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Following the order the prescriber must attend the patient for review as soon as he or she
considers appropriate in the circumstances of the case.
Note: Under the Regulation, the requirements for the prescriber to attend the facility to review
the patient do not apply to the medication order for a patient of Justice Health and Forensic
Mental Health Network if confirmation of the order for administration is given in accordance
with the requirements in the approved facility procedures.

3.4 Issuing prescriptions for pharmacist dispensing

3.4.1 Forms of prescriptions

Prescriptions for pharmacist dispensing may be issued by an authorised prescriber either:
1. Handwritten by the prescriber (see section 3.4.2 and section 3.4.3), or
2. Issued in electronic form (only, with no printed paper-based prescription) by the
prescriber using the eMeds system approved for use by the public health facility Chief
Executive. The data elements for the prescription are in Standard 16 of NSW Health
Policy Directive Electronic Medication Management System Governance and
Standards (PD2019_050), or
3. Created and printed in paper using an electronic system compliant with the NSW
Ministry of Health TG184 Criteria for Issuing Printed Computer-Generated
Prescriptions. The Cerner Millennium eMeds ‘Prescription Output Version 2’ (POV 2)
meets the printed (paper) prescriptions requirements and is a legally valid form of
prescription, or
4. Created and printed in paper on the discharge summary document (however named)
in accordance with facility procedures. The prescription must be dispensed at the
Pharmacy Service of the public health facility where the prescription is issued.
The authorised prescriber must document the issuance of a prescription in the patient’s
health care record in accord with facility procedures.
An authorised prescriber’s medication chart order may also be used to direct a pharmacist to
dispense:
 discharge or leave medication for patient take home use
 medication for individual patient use at the public health facility (inpatient or
outpatient).
Active ingredient prescribing is now in force for medications prescribed under the
Pharmaceutical Benefits Scheme (PBS). It means that prescriptions dispensed under the
PBS must include the active ingredient of the medication other than in specified
circumstances.

3.4.2 Handwritten prescriptions for medications other than Schedule 8

medications
A handwritten prescription for a medication (other than a Schedule 8 medication – see
section 3.4.3 below) must include:

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a) the date the prescription is issued

b) the patient’s name
c) the patient’s address (as applicable to outpatient/discharge dispensing)
d) the patient’s date of birth (in force from 1 November 2022)
e) the medication’s active ingredient/s and/or, brand name (as applicable), form and
strength
f) the quantity of the medication to be supplied. Take home supplies of regular use
medications must not exceed 7 days' supply to patients when they are discharged
from hospital in accord with facility procedures
g) adequate directions for use, including the dose, route for administration and frequency
of administration
h) the number of repeat supplies, if any
i) the authorised prescriber’s handwritten signature
j) the name, address and telephone number of the facility
k) the name and the designation of the prescriber (for example, Resident Medical Officer,
Staff Specialist, Nurse Practitioner) and the prescriber’s contact telephone/pager
number
l) for Schedule 4 Appendix B medications (such as anabolic-androgenic steroids), an
interval for repeat dispensing
m) the endorsement required for the Schedule 4 medications with restricted prescribing
rights listed in section 3.7.
The particulars must be in the prescriber’s clear and legible handwriting.
A dose that could be regarded as being dangerous or unusual must be confirmed in writing
by underlining the dose and initialling the prescription in the margin.
Additionally, pre-printed patient ‘addressograph’ labels may be used on a prescription for a
Schedule 4 medication when:
 the prescription is for dispensing solely within a hospital and is endorsed ‘For hospital
use only’
 the addressograph label includes the patient’s name, date of birth, address and/or
patient care area and medical record number (if applicable)
 Under facility procedure the prescriber is to confirm the details included on the
addressograph label at the time of writing the prescription, for example by signing
across both the addressograph label and the prescription or hand writing the patient’s
name under the addressograph.
The authorised prescriber must document the issuance of a prescription in the patient’s
health care record in accord with facility procedures.

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3.4.3 Handwritten prescriptions for Schedule 8 medications

Pre-printed ‘addressograph’ labels containing the patient’s name and address/patient care
area must not be used on a prescription for a Schedule 8 medication.
In addition to requirements for a paper-based Schedule 4 medication prescription above in
section 3.4.2 at a)-k) a prescription for a Schedule 8 medication:
 must include the quantity being prescribed in both figures and words
 must include an interval for repeat dispensing (if repeats are prescribed)
 must not include any other medication (Note: Different strengths of the same
medication, for example buprenorphine sublingual film/tablets, are allowed)
 in the case of a type A drug of addiction prescribing, must include the NSW Health
authority reference number issued to the prescriber (see section 3.8), either;
o as an individual reference number issued to the prescriber on a patient-by-patient
basis in the form ‘AUXXXXXXX’’, or
o as a reference number in the form ‘S28CXXXXXX’ issued to a specialist medical
practitioner for prescribing in accordance with the associated NSW Ministry of
Health approved criteria, or
o as a reference number in the form ‘CNSXXXXXX’ issued to a specialist medical
practitioner for prescribing in accordance with the associated NSW Ministry of
Health approved criteria.
The authorised prescriber must document the issuance of a prescription in the patient’s
health care record in accord with facility procedures.

3.4.4 Discharge summary

At the time of discharge, an inpatient's medication regimen must be reviewed by an
authorised prescriber as part of the patient's review prior to leaving the facility.
The discharge summary must:
 identify changes to the medication regimen during the patient’s stay and outline the
reason/s for the changes
 include an ongoing plan for medication management including the duration of
treatment, any ongoing monitoring requirements and any dose adjustment
requirements.
The discharge summary and any ‘patient held’ medication list prepared for the patient must
be amended as changes are made to the discharge medications.
A legible copy of the discharge summary must be despatched or otherwise communicated to
the patient’s nominated general practitioner (or other primary care provider) in a timely
manner (ideally on discharge).

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3.4.5 Emergency verbal, telephone, video call, email and facsimile

prescriptions
In an emergency, an authorised prescriber may either verbally (face to face), by telephone,
video call, email or facsimile direct a pharmacist to dispense a prescription for any
medication. Medication orders via Short Message Service (SMS) or texting are not permitted
and are not legally valid. Relevant details as listed in section 3.4.3 for Schedule 8 medication
and section 3.4.2 for other medication must be included in the order to the pharmacist.
The authorised prescriber must make a record of the verbal, telephone, video call, email or
facsimile direction to the pharmacist to dispense a prescription. Under the Regulation, the
authorised prescriber must:
 immediately issue a prescription
 endorse the prescription with words that indicate the prescription has been issued in
confirmation of a verbal (face to face), telephone, video call, email or facsimile
direction to the pharmacist
 send the prescription without delay and within 24 hours to the pharmacist to whom the
direction was given.

3.4.6 Security of prescription stationery and eMeds passwords

Due to the risk of prescription forgeries on stolen prescription stationery, all health facilities
and authorised prescribers must ensure that prescription stationery is securely stored when
not in immediate use. Prescription stationery must not be held within a patient care area
Schedule 8 medication storage unit.
Pre-printed prescription stationery may include under facility procedures:
 unique, consecutive numbering of each form
 the words ‘not valid for Schedule 8 drugs’ (or the like) pre-printed or stamped on the
form, if applicable to the patient care area.
Under facility procedures strategies to support security of prescription stationery must be
implemented including:
 distribution through a centralised service such as the facility’s Pharmacy Service
 the return of unwanted prescription stationery to the Pharmacy Service for destruction.
Forged and fraudulently altered prescriptions and lost or stolen prescription stationery from
the facility must be reported in the facility incident management system and to the NSW
Ministry of Health Pharmaceutical Regulatory Unit.
The pharmacist must report a forged or fraudulently altered prescription presented to
pharmacy to the local police. The pharmacist must document the Event Number issued by
the police in accordance with facility procedures.
Facilities must have Drug and Therapeutics Committee approved procedures to maintain the
security of user identity and passwords for eMeds systems to prevent unauthorised access to
medication ordering.

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3.5 Medications for ‘off-label use’ and unregistered medications

Prescribers considering use of a specific medicine (formulary or individual patient use) in an
off-label manner, or the use of an unregistered medication, must follow a systematic
procedure to assist with their assessment on whether such use is justified.
NSW Health Policy Directive Approval Process of Medicines for Use in NSW Public Health
Facilities (PD2016_033) establishes a standard procedure for the approval of medicines and
their use.

3.6 Medications for clinical trials

A clinical trial involving a medication administered to or on humans must be approved by a
committee involved in the approval of clinical trials at the facility including the human
research ethics committee (however named), and also approved by, or notified, to (as
applicable in the circumstances) the Commonwealth TGA.
Drug and Therapeutics Committees must be notified of any clinical trials involving
medications occurring in the health service organisation and must also have oversight of
risks of clinical trials to the organisation (other than the clinical considerations assessed by
an ethics committee).
Detail on the ethical and scientific standards for the conduct of a medication clinical trial for
human research is included in NSW Health Policy Directive Ethical and Scientific Review of
Human Research in NSW Public Health Organisations (PD2010_055), which references the
National Health and Medical Research Council National Statement on Ethical Conduct in
Research Involving Humans.
Authorisation for the commencement of a human research project must be in accordance
with NSW Health Policy Directive Authorisation to Commence Human Research in NSW
Public Health Organisations (PD2010_056).

3.7 Restrictions on issuing prescriptions for certain Schedule 4

medications
Due to potential hazards with their use, the prescribing of certain Schedule 4 medications is
restricted under the Regulation to authorised prescribers in accordance with the
corresponding qualifications and/or conditions.
However, in an emergency, under Clause 37 of the Regulation, a pharmacist may obtain a
telephone, video call, email or facsimile order from the prescriber (see section 3.4.4).
The Schedule 4 medications with restricted prescribing rights are:

A. isotretinoin for oral use, acitretin, etretinate

Prescribing is generally restricted to a specialist dermatologist who is a current Fellow of the
Australasian College of Dermatologists.
A patient admitted for unrelated treatment already being prescribed the medication by a
specialist dermatologist and still undergoing treatment at the time of admission may be
prescribed the medication on a medication order by an authorised prescriber at the hospital
for the term of the patient’s inpatient stay.
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An authority to prescribe isotretinoin for oral use may be issued to a relevant specialist
medical practitioner on a patient-by-patient basis for certain approved (non dermatological)
medical treatments.
Applications are to be forwarded by the specialist medical practitioner to NSW Ministry of
Health Pharmaceutical Regulatory Unit.
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’, or alternatively, with the individual authority reference
number (RA........) that has been issued to a particular prescriber by the NSW Ministry of
Health.

B. tretinoin for oral use

Prescribing is restricted to a specialist haematologist who is a Fellow of the Royal
Australasian College of Physicians or a Fellow of the Royal College of Pathologists of
Australasia, or both.
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’.

C. clomifene, cyclofenil
Prescribing is restricted to a specialist who is either:
 A Fellow of the Royal Australian and New Zealand College of Obstetricians and
Gynaecologists or a Fellow of the Royal College of Obstetricians and Gynaecologists,
or
 A Fellow of the Royal Australasian College of Physicians and is practising
endocrinology in a Specialist Endocrinology Unit.
A patient admitted for unrelated treatment already being prescribed the medication by a
relevant specialist medical practitioner (as above) and still undergoing treatment at the time
of admission may be prescribed the medication on a medication order by an authorised
prescriber at the hospital for the term of the patient’s inpatient stay.
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’, or alternatively, with the individual authority reference
number (CL........) that has been issued to a particular prescriber by the NSW Ministry of
Health Pharmaceutical Regulatory Unit.

D. follitropin beta, luteinising hormone, urofollitrophin

Prescribing is restricted to a specialist endocrinologist who is a Fellow of the Royal
Australasian College of Physicians.
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’.

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E. dinoprost
Prescribing is restricted to either:
 A specialist who is either a Fellow of the Royal Australian and New Zealand College of
Obstetricians and Gynaecologists or a Fellow of the Royal College of Obstetricians
and Gynaecologists, or
 A ‘GP Obstetrician’, defined as a medical practitioner who is not a specialist
obstetrician or gynaecologist but who has completed the Diploma of the Royal
Australian and New Zealand College of Obstetricians after January 1992, or who has
completed the Diploma of the Royal Australian and New Zealand College of
Obstetricians prior to 1 January 1992 and has attended a course approved by the
Royal Australian and New Zealand College of Obstetricians and Gynaecologists or
Royal Australasian College of General Practitioners on the use of prostaglandins in
obstetrics.
The prescribing must be in accordance with the NSW Health guideline on Prevention,
Detection, Escalation and Management of Postpartum Haemorrhage.
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’, or alternatively, with the individual authority reference
number (PGT........) that has been issued to a particular prescriber by the NSW Ministry of
Health Pharmaceutical Regulatory Unit.

F. dinoprostone (in any form)

Prescribing is restricted to either:
 A specialist who is either a Fellow of the Royal Australian and New Zealand College of
Obstetricians and Gynaecologists or a Fellow of the Royal College of Obstetricians
and Gynaecologists, or
 A ‘GP Obstetrician’, defined as a medical practitioner who is not a specialist
obstetrician or gynaecologist but who has completed the Diploma of the Royal
Australian and New Zealand College of Obstetricians after January 1992, or who has
completed the Diploma of the Royal Australian and New Zealand College of
Obstetricians prior to 1 January 1992 and has attended a course approved by the
Royal Australian and New Zealand College of Obstetricians and Gynaecologists or
Royal Australasian College of General Practitioners on the use of prostaglandins in
obstetrics, or
 A Registrar in obstetrics in a hospital, subject to the following conditions;
o The registrar is approved in writing by the Director of Obstetrics and
Gynaecology to perform obstetrics, including the use of dinoprostone, provided
that the hospital is equipped to carry out foetal and maternal monitoring and
operative delivery
o The registrar prescribes, supplies or administers the substance at all times in
accordance with a written protocol for the use of the substance in the hospital
that includes relevant warnings, contraindications, precautions and possible

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adverse reactions and which has been approved and signed by the Director of
Obstetrics and Gynaecology.
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’, or alternatively, with the individual authority reference
number (PGT........) that has been issued to a particular prescriber by the NSW Ministry of
Health Pharmaceutical Regulatory Unit.

G. hydroxychloroquine
Prescribing is restricted to either:
 A medical practitioner practicing in a public hospital to treat patients of the hospital, or
 A medical practitioner registered in the specialty of either;
o dermatology
o intensive care medicine
o paediatrics and child health
o emergency medicine
o physician, or
 A medical practitioner practicing in general practice for the purpose of continuing
treatment initiated by a medical practitioner registered in such a specialty, or
 A dentist registered in the specialty of oral medicine, or
The prescription or medication order used for pharmacist dispensing must be endorsed by
the prescriber with words to the effect ‘Issued under clause 37 of the Poisons and
Therapeutics Goods Regulation’.

H. ivermectin
Prescribing is restricted to either:
 A medical practitioner registered in the specialty, or field of specialty practice, of either;
o dermatology
o gastroenterology and hepatology
o paediatric gastroenterology and hepatology
o infectious diseases
o paediatric infectious diseases, or
 A medical practitioner or nurse practitioner using ivermectin as part of a clinical trial
approved by, or notified to, the Secretary of the Commonwealth Department of Health
under the Therapeutic Goods Act 1989, or
 A medical practitioner or nurse practitioner practising in a public hospital to treat
patients of the hospital, or

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 A medical practitioner or nurse practitioner prescribing or supplying topical

preparations of ivermectin.

3.8 Requirements for certain Schedule 8 medication

prescriptions
An authority to issue a prescription for Schedule 8 medications issued under the specific
requirements at section 28 of the Poisons and Therapeutic Goods Act 1966 (a “NSW Health
Authority’) is distinct from an authority issued by Medicare Australia for the prescribing of
Pharmaceutical Benefits Scheme listed medications.
When prescribing a Schedule 8 medication, it is the responsibility of the prescriber to ensure
they have obtained the appropriate Schedule 8 medication NSW Health Authority,
administered by the NSW Ministry of Health Pharmaceutical Regulatory Unit.
The specific circumstances for requiring a NSW Health Authority are:
A. For a Type A drug of addiction (being dexamfetamine, lisdexamfetamine,
methylphenidate or an extemporaneously compounded Schedule 8 medication),
including for a clinical trial, either by:
 An authorised prescriber issued with a NSW Health Authority reference number
on a patient by patient basis in the form ‘AUXXXXXXX’, or
 a specialist medical practitioner who has been issued an approval under the
Regulation that includes a reference number in the form ‘S28CXXXXXX’, for
prescribing in accordance with the associated NSW Ministry of Health approved
criteria, or
 a specialist medical practitioner who has been issued an approval under the
Regulation that includes a reference number in the form ‘CNSXXXXXX’, for
prescribing in accordance with the associated NSW Ministry of Health approved
criteria.
The authorised prescriber must include the NSW Health Authority reference number on
the prescription.
B. For any person who, in the opinion of the authorised prescriber, is a drug dependent
person, as defined in the Poisons and Therapeutic Goods Act 1966 as a person who
has acquired, as a result of repeated administration of either a Schedule 8 medication
or a prohibited drug (for example heroin, methylamphetamine, ecstasy), an
overpowering desire for the continued administration of the substance.
C. To a person for continuous treatment for a period exceeding two months of;
 a Schedule 8 medication packaged and labelled for injection, inhalation, spray,
or for application to mucous membranes, other than if a Schedule 8 cannabis
medicine
 alprazolam
 buprenorphine other than as transdermal patches
 flunitrazepam

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 hydromorphone
 methadone.
Note: If the patient is, in the opinion of the authorised prescriber, is a drug dependent
person, as defined in the Poisons and Therapeutic Goods Act 1966, a NSW Health
Authority must be obtained prior to prescribing any of the above medications.
D. A Schedule 8 preparation extemporaneously compounded for a particular patient for
use outside of a public health facility, including for a clinical trial. The authorised
prescriber must include the NSW Health Authority reference number on the
prescription.
E. An unregistered Schedule 8 medication for a clinical trial.

Exemption for prescribing to a hospital inpatient

An exemption to obtaining a NSW Health Authority in the circumstances at A. to C. above
applies for the prescribing to an inpatient for a period of up to 14 days following admission.
Following this 14 day period the hospital authorised prescriber may continue to prescribe in
accord with the NSW Health Authority issued to a community based authorised prescriber
prior to the patient’s admission, or obtain a NSW Health Authority from the NSW Ministry of
Health if there is no such NSW Health Authority (meaning the medication was initiated in
hospital).
Schedule 8 discharge medications for inpatients on release from the facility must be
prescribed in accordance with a NSW Health Authority issued to the hospital authorised
prescriber required in the specified circumstances A. to E. above.

Prescribing for children

A general exemption order has been issued by the Secretary, Department of Communities
and Justice under the Children and Young Persons (Care and Protection) Act 1998 (NSW)
published on the Department of Communities and Justice website.
Under the Children and Young Persons (Care and Protection) Act 1998 (NSW), a person
must not carry out a special medical treatment on a child, including any medical treatment
that involves the administration of a drug of addiction within the meaning of the Poisons and
Therapeutic Goods Act 1966 (NSW) (a Schedule 8 medication) over a period or periods
totalling more than 10 days in any period of 30 days.
Under this general exemption order, a medical practitioner may treat a child:
 with any drug of addiction for the medical treatment of cancer, or
 with dexamfetamine, lisdexamfetamine or methylphenidate for the medical treatment
of Attention Deficit Hyperactivity Disorder (ADHD), or
 with dexamfetamine or methylphenidate for the medical treatment of narcolepsy.
For any other special medical treatment of a child a medical practitioner must apply for an
exemption under the Act for consideration on a case-by-case basis.

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4 THE PHARMACY SERVICE

4.1 Responsibility
The director of Pharmacy Service, or the pharmacist delegated by the Chief Executive where
there is no director of pharmacy, is responsible for the storage of all medications at the facility
other than those that have been supplied to a patient care area.
In addition the director of pharmacy is responsible for overseeing and advising on the storage
of medications in other areas of the facility including patient care areas, pathology
departments and intravenous fluid stores.
Where no pharmacist is employed or contracted at the facility the responsibility of the storage
and distribution of medications from the facility’s medication supply service is assigned to the
authorised officer at the facility, defined as:
 the director of nursing of the facility (however named), or
 the medical superintendent of the facility (however named)
appointed by the facility’s chief executive.
The range and quantities of medications held at the Pharmacy Service must include
consideration of circumstances when a patient will present to the facility seeking a previously
prescribed essential medication for which his/her supply has been unexpectedly exhausted.
Particular care must be taken to ensure that stocks of substances known to be diverted for
illicit use, including preparations containing pseudoephedrine, are stored/managed and
supplied/used under the supervision of suitably qualified or delegated staff.

4.2 Medication procurement

4.2.1 Medication purchasing

NSW public health facilities are eligible to obtain medications from a licensed pharmaceutical
wholesaler as a public institution under the NSW Poisons and Therapeutic Goods Act 1966.
Orders for medications may be placed with the pharmaceutical wholesaler in writing, or
electronically (telephone, electronic document interface, email or facsimile).
All hospitals must have procedures in place to ensure contract compliance as part of their
purchasing process.
The order for a Schedule 8 medication must be approved by:
 The director of pharmacy or a delegated pharmacist, or
 The authorised officer at a facility where no pharmacist is employed/contracted.
NSW Health Policy Directive Goods and Services Procurement Policy (PD2019_028)
provides further guidance regarding purchasing procedures. Medication safety and equity of
access must be considered in purchasing decisions.
Procurement of NSW contract and non-contract medications

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Facilities are required to purchase medications in accordance with the supply contracts
arranged by the NSW State Contracts Control Board. If a contracted medication is not
available, the supplier is obligated to substitute with an equivalent ARTG product where
available. Items for which there is no contracted equivalent may be purchased as required.
Procurement concentrates on the strategic process of product or service sourcing, for
example researching, negotiation and planning. Purchasing process focuses on how
products and services are acquired and ordered, such as raising purchase orders and
arranging payment.
HealthShare NSW negotiates and manages the state pharmaceutical contract that is a
Whole-of-Health contract for the supply of pharmaceuticals for all health facilities. All state
contracts have a continuous best price clause and therefore suppliers are required to report
any local offer for a contracted item below the contract price to the pharmaceutical
procurement team at HealthShare NSW.
Facilities can undertake all procurement related activities up to $250,000 within the
framework of the procurement policy at a local level. For procurements over $250,000,
Facilities are to seek assistance from HealthShare NSW or the Ministry of Health.
HealthShare NSW local contracts team coordinates and manages all local contracts.

Medicines Access Programs

Medicines Access Programs are offered by pharmaceutical companies (sponsors) to facilitate
deferred cost, cost-free or subsidised access to medicines for hospital patients before the
implementation of relevant funding arrangements.
Medicines Access Programs include, but are not limited to, the following:
 Compassionate Use Programs
 Expanded Access Programs
 Product Familiarisation Programs (also known as patient familiarisation programs –
PFPs)
 Cost-Share Programs.
See CATAG Guiding Principles for the Governance of Medicines Access Programs in
Australian Hospitals.

4.2.2 Medication purchasing from a community pharmacy

Under facility procedures, in circumstances where a medication required for a particular
patient is not in stock at a facility, and not available through the patient’s primary health
practitioner, an arrangement for supply from a community pharmacy may be made.
Medication supplied under a sponsor facilitated Medicine Access Program may be included.
In addition, a facility may enter into a service agreement with a community pharmacy for
medication supply and other services. These arrangements must incorporate appropriate
safety and accountability considerations, compliance with the relevant ordering and recording
provisions of this Policy and any licensing of wholesale supply required under the legislation.
NSW Health Policy Directive Pharmaceuticals - Preparation in NSW Public Health Facility

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Pharmacy Services (PD2015_007) outlines the conditions and requirements for procuring
non-ARTG listed products from a community pharmacy.

4.2.3 The Life Saving Drugs Registers (antidotes and antivenoms)

The Life Saving Drugs Registers for NSW and ACT public hospitals provide indicative stock
holding information of life saving drugs, including antivenoms and antidotes, in hospitals, their
location within the hospital and hospital contact details to enable access to stock in urgent
situations.

4.2.4 Deliveries to the Pharmacy Service

Medication deliveries that are received by a non-Pharmacy Service staff member, such as by
stores or administration staff, must be transferred to the Pharmacy Service immediately on
arrival.
Where after-hours access to the Pharmacy Service is required for non-Schedule 8
medication deliveries, this must be in accordance with a procedure approved by the Drug and
Therapeutics Committee, and restricted to delegated senior nursing and/or medical staff.
After-hours deliveries of Schedule 8 medication(s) must be handled in accordance with the
procedure in section 4.2.5 below.

4.2.5 Receipting for the delivery of Schedule 8 medications

Under the Regulation, when a parcel containing a Schedule 8 medication is delivered to a
facility the recipient at the facility must sign the courier’s ‘proof of delivery’ document (either
electronically or in hard copy) for the unopened sealed parcel.
Under the Regulation, when the Schedule 8 medication sealed parcel is received at the
Pharmacy Service, a delegated pharmacist, or the authorised officer of the medication supply
service at a facility where no pharmacist is employed/contracted must:
 check the contents against the original purchase order
 sign and date a receipt confirming the supply of the Schedule 8 medication(s)
 forward this receipt confirmation by post or courier to the supplier within 24 hours of
the delivery.
A copy of the signed and dated receipt confirmation must also be retained at the Pharmacy
Service.
Schedule 8 medication(s) received at the Pharmacy Service must be immediately recorded in
the corresponding Pharmacy Service drug register and locked in a Schedule 8 medication
storage unit (safe or vault).
Facility procedures must include the provision for the after-hours delivery of a sealed parcel
containing a Schedule 8 medication being stored unopened in an appropriate patient care
area Schedule 8 medication storage unit (for example the Emergency Department) pending
the return to duty of a pharmacist, or the authorised officer of the medication supply service
at a facility where no pharmacist is employed/contracted.

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The corresponding Schedule 8 drug register entry in the patient care area must be on a
separate page to all other medications, and recorded as, for example ‘one unopened sealed
package’ with the consignment/invoice number where available, pending transfer to the
Pharmacy Service.

4.3 Medication storage in the Pharmacy Service

4.3.1 Medication security and access – general provisions

The Pharmacy Service is an area requiring high security. Refer to the NSW Health Protecting
People and Property Manual for advice concerning the management of security in the
Pharmacy Service.
Access to the Pharmacy Service must be restricted to staff authorised by the director of
pharmacy, or the authorised officer of the medication supply service at a facility where no
pharmacist is employed/contracted. Procedures for authorising and auditing access to the
Pharmacy Service by keys or other means must also be implemented. Only a pharmacist
may be authorised to access the Schedule 8 medication safe or vault at the Pharmacy
Service.

4.3.2 After-hours access to the Pharmacy Service

Access to the Pharmacy Service must be in accordance with Drug and Therapeutics
Committee approved procedures and restricted to delegated senior nursing and/or medical
staff. After-hours to the Pharmacy Service where a pharmacist is employed/contracted must
not include access to the Schedule 8 medication safe or vault.
The facility’s security officer may enter the Pharmacy Service after hours at times of an
emergency, such as during a fire or an alarm sounding. Any keys or codes used for
emergency access to the Pharmacy Service must be held under maximum security with the
facility’s security service.
Facilities must implement appropriate systems for recording every occasion of after-hours
access to the Pharmacy Service, including documenting the purpose of this access.

4.3.3 General medication storage requirements

All stocks of medications in the Pharmacy Service must be regularly checked to ensure
proper storage conditions are met, including temperature control and security.
Storage temperatures must be consistent with the range specified on the manufacturers’
labels (typically not above 25°C for ‘general’ storage, and 2-8°C for refrigerated storage) and
monitored accordingly.
In the event of temperature storage conditions falling outside those specified by the
manufacturer, the director of pharmacy must evaluate the event and take appropriate action.
Facilities must have procedures for cold chain management in place.
Vaccines must be stored in accordance with the Commonwealth National Vaccine Storage
Guidelines ‘Strive for 5 and NSW Health Policy Directive Vaccine Storage and Cold Chain
Management (PD2020_028). This policy provides mandatory requirements for the storage

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and management of vaccines in all public health facilities to ensure vaccine potency and that
all vaccine cold chain breaches are identified and managed effectively.
A system of stock rotation, monitoring of expiry dates, quarantining and disposal of expired
and unwanted medications must be in place under facility procedures approved by the
director of pharmacy.
Where additional access controls are deemed appropriate, under facility procedures specific
non-Schedule 8 medications:
 may be stored separately in locked cupboards with restricted access by authorised
staff members, and/or
 may be accounted for in a register.
Medications that could be considered for increased access controls include Schedule 4
benzodiazepines, propofol, methoxyflurane, tramadol, codeine phosphate hemihydrate
combination products or pseudoephedrine containing products.

4.3.4 Storage of Schedule 8 medications

Under the Regulation all Schedule 8 medications in the Pharmacy Service or medication
supply service at a facility where there is no employed/contracted pharmacist must be stored
in a separate safe or vault apart from all other medications or goods other than cash or
documents.
Note: An exception applies to a Schedule 8 medication requiring refrigerated storage (see
below). A safe must be firmly attached to a wall or to the floor and must comply, as a
minimum with the requirements of clause 76 of the Regulation, ‘Storage in Pharmacies’. The
safe/vault must be kept locked when not in immediate use.
Requirements for the management of key (metal keys, electronic keys, electronic swipe card
access and key pad codes) security in the Pharmacy Service and key control is in NSW
Health Protecting People and Property Manual. Where fingerprint security is in use, facility
procedures must include security requirements.
Where a key is used to unlock the safe/vault, it must be retained by a pharmacist, or the
authorised officer of the medication supply service at a facility where no pharmacist is
employed/contracted, on his/her person. After-hours, the key may be retained in a safe/key
safe to which only a pharmacist/authorised officer of the medication supply service has
access.
Where a code, combination or electronic access is required to unlock the safe/vault, this must
only be known to authorised pharmacists, or the authorised officer of the medication supply
service at a facility where no pharmacist is employed/contracted.
Schedule 8 medications held at the Pharmacy Service pending the collection by, or delivery
to a patient care area or an individual patient must be stored in a Schedule 8 medication
safe/vault until collected or delivered.

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4.3.5 Schedule 8 medication requiring refrigerated storage

As an exception to storage in a safe or vault, the refrigerator containing a Schedule 8
medication be in a room or enclosure (such as a cupboard or other receptacle) to which the
public does not have access, and:
 the refrigerator must be securely attached to the premises and kept locked when not in
immediate use
 the locked refrigerator may contain other medications, but not food or other goods
 the refrigerator may be accessed only by a pharmacist
 any key or other device, or any code or combination required to access or unlock the
refrigerator, room, cupboard or other receptacle must be kept, and be accessible only
by, a pharmacist.

4.4 Medication supplies

4.4.1 Authorised recipients of Pharmacy Service medications
The Pharmacy Service at a public health organisation is authorised to supply medications:
 to patient care areas and other Pharmacy Services in the public health organisation’s
own public hospitals, public health facilities, health services and health support
services, as stock and imprest medications or as patient-labelled medication, including
medications for Hospital in the Home, community nursing and outreach services
 to another public health organisation under the Special Licence for wholesale supply,
being to the director of pharmacy or authorised officer at a facility where no pharmacist
is employed/contracted (Note: Schedule 8 medications are excluded)
 as patient-labelled medication to inpatients on discharge and non-admitted
patients/outpatients attending a public health facility or receiving community nursing or
outreach services. For immunoglobulins see under NSW Health Guideline
Establishing a Subcutaneous Immunoglobin Hospital Program (GL2020_024) for
eligible patients for patient-labelled medications
 in an emergency, morphine ampoules to a NSW Ambulance paramedic (see
section 4.4.3)
 under a routine procedure or program approved by the NSW Ministry of Health or the
Drug and Therapeutics Committee, for example nicotine replacement therapy, in a
public health response and for disaster management
 for the urgent treatment of a specific non-health facility patient upon receipt of a
prescription where approved by the director of pharmacy, or Chief Executive, Medical
Administrator/nominee in accord with NSW Health Policy Directive Pharmaceutical
and Safety Net Arrangements for Outpatients and Patients on Discharge
(PD2022_017)
 for a clinical trial drug dispensed for an individual patient of a public health facility or at
a private health facility under a service level agreement and facility procedures for
participation in the trial.
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4.4.2 Patient payment for medications

There is no charge for medication supplied to an inpatient during their hospital stay or on
discharge, or for an outpatient treated during the outpatient encounter.
The provision, payment, and quantities of medications supplied to eligible outpatients for take
home use, including Section 100 Highly Specialised Drugs (S100 HSD) under the National
Health Act 1953 is detailed in NSW Health Policy Directive Pharmaceutical and Safety Net
Arrangements for Outpatients and Patients on Discharge (PD2022_017).

4.4.3 Emergency supplies of morphine ampoules to NSW Ambulance

paramedics
The director of pharmacy must have oversight of procedures for emergency supplies of
morphine ampoules to NSW Ambulance paramedics. In emergency circumstances, a
pharmacist may supply a NSW Ambulance paramedic with a reasonable quantity of
morphine sulfate pentahydrate 10 mg/mL, 1 mL ampoules from the Pharmacy Service stock.
The pharmacist must obtain from the NSW Ambulance paramedic a copy of the person’s
paramedic authority issued by the NSW Ambulance as well as a written order and receipt for
the supply, signed and dated by the paramedic, for retention at the Pharmacy Service.
The supply of morphine ampoules to a NSW Ambulance paramedic must not be made by an
Emergency Department staff member, or any other patient care area staff member.

4.4.4 Pharmaceuticals preparation

Pharmaceuticals prepared on or behalf of a NSW public health facility must be prepared in
accordance with NSW Health Policy Directive Pharmaceuticals - Preparation in NSW Public
Health Facility Pharmacy Services (PD2015_007).
Public health facility Pharmacy Services must not dispense compounded or reconstituted
pharmaceutical preparations unless the director of pharmacy has confirmed there are
appropriate standards of training, skill, facilities, and preparative and quality assurance
procedures in place to provide a high level of confidence that the preparations are of a
consistently high quality standard.
There are a range of professional standards that may apply including those from the
Pharmacy Board of Australia, the Pharmaceutical Society of Australia, the Society of Hospital
Pharmacists of Australia and the Therapeutic Goods Administration (TGA).

Barcode scanning during dispensing

All pharmacy services must have barcode verification incorporated into dispensing
procedures to reduce the rate of product selection errors. Barcode verification must be used
for all medications which have a barcode on the packaging. Barcoding verification must be
incorporated into the dispensary workflow such that it acts as to confirm the correct product
selection when the dispensing label is applied. The only exclusion is the dispensing of
medication packs that do not include an appropriate barcode, for example:
 When dispensed for a clinical trial, or

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 Obtained under the Special Access Scheme or Authorised Prescriber Scheme (and
not on the ARTG), or
 A compounded or reconstituted medication, either outsourced to an external
manufacturer or prepared locally.
All pharmacy staff involved in the dispensing procedure including pharmacists, pharmacy
technicians and pharmacy interns, must be provided with education and training on how to
use barcode scanning to confirm the correct product selection.
The Clinical Excellence Commission has an Information for Staff education package to assist
pharmacy services implement of barcode scanning.

4.4.5 Sensitisation due to occupational exposure

All staff are to be aware that allergy or sensitisation to pharmacological agents can occur
through occupational exposure. Any symptoms experienced by a staff member that may be
related to such exposure must be reported as soon as possible, and appropriate action taken
under facility procedures.
NSW Work, Health and Safety legislation requires that all workplace risks, including those
associated with the handling of pharmacological agents, be identified, assessed and
controlled. NSW Health Policy Directive Work Health and Safety: Better Practice Procedures
(PD2018_013) provides guidance on implementing the Work Health and Safety Act 2011 and
Work Health and Safety Regulation 2017.
The Pharmacy Service has a role in ensuring that the risk of sensitisation is reduced as far as
practical when preparing medications including:
 avoiding unnecessary occupational exposure
 the use of appropriate personal protective equipment such as masks, gloves, gowns
and respirators
 applying facility procedures specific to the situation to minimise exposure
 taking prompt action where symptoms of allergy or sensitisation occur
 regularly reviewing effectiveness of facility procedures.
4.4.6 Schedule 8 medication deliveries by a facility staff member
Under facility procedures, imprest and stock Schedule 8 medications ordered by the
registered nurse/midwife in charge of a patient care area may be delivered to the patient care
area by a facility staff member, under the direction of a pharmacist, or by the authorised
officer of the medication supply service at a facility where no pharmacist is
employed/contracted.
The package containing the Schedule 8 medication must be handed by the facility staff
member to a registered nurse/midwife, who must sign and date a receipt confirming the
quantity of the medication supplied. This receipt must be returned by the facility staff member
to the Pharmacy Service for retention. A copy of this receipt must also be retained at the
patient care area.

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Alternatively, a registered nurse/midwife from a patient care area may collect Schedule 8
medication/s ordered from the Pharmacy Service when ordered by the registered
nurse/midwife in charge of the patient care area. The registered nurse/midwife collecting the
medication must sign and date a receipt confirming the quantity of the medication supplied,
and again the receipt must be retained at the Pharmacy Service. A copy of this receipt must
also be retained at the patient care area.
In both scenarios, the registered nurse/midwife receiving the Schedule 8 medication must
immediately record the acquisition in the patient care area Schedule 8 drug register and
immediately store the medications in the patient care area’s Schedule 8 medication drug
storage unit. A witness must be present to confirm both actions by the registered
nurse/midwife and sign the relevant entry(s) in the patient care area drug register.
4.4.7 Schedule 8 medication delivery by a courier
When imprest and stock Schedule 8 medication is being delivered to a patient care area or
health facility remote to the Pharmacy Service by a courier who is not a facility staff member:
 the Schedule 8 medication must be packed by the Pharmacy Service separate to any
other goods and the outside of the package must not indicate that it contains Schedule
8 medication
 the courier must sign and date a document to confirm he/she has collected the
package, and this document be retained at the Pharmacy Service.
Under the Regulation, the courier must obtain a ‘proof of delivery’ receipt (either electronically
or in hard copy) for the unopened sealed parcel from the person to whom the parcel is
delivered. Under facility procedure, the courier must then arrange for this ‘proof of delivery’
receipt to be forwarded to the Pharmacy Service that supplied the medication.
Under the Regulation, the registered nurse/midwife who receives the medication at the
patient care area must sign and date a receipt confirming the quantity of the medication(s)
received. This receipt must be forwarded by the registered nurse/midwife to the Pharmacy
Service within 24 hours, for retention at the Pharmacy Service in accordance with facility
procedures. A copy of this receipt must also be retained at the patient care area.

4.5 Dispensing patient-labelled medications

4.5.1 Orders for dispensing patient-labelled medications

Patient-labelled medications for inpatient or clinic administration

For inpatient or clinic use, dispensing of patient-labelled medications may be:
 From the authorised prescriber’s clear and legible medication order either forwarded to
the Pharmacy Service as a photocopy, by facsimile or as a scanned copy in an email,
or
 On an authorised prescriber’s electronic order in the eMeds system, or
 On a paper-based prescription issued by an authorised prescriber, with the relevant
details listed in section 3.4.3 for Schedule 8 medications and in section 3.4.2 for
Schedule 4 medications and other non-Schedule 8 medications, or
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 From a verbal (face to face), video call, telephone, email or facsimile order of an
authorised prescriber (see section 4.5.3).
Under facility procedures, medications dispensed for an individual patient are to be reviewed
by a pharmacist in the context of the patient’s full medication regimen (where available) prior
to the administration of a dose to the patient.

Discharge Medications
Discharge medications may be dispensed from either:
 A prescription issued by an authorised prescriber, with the relevant details listed in
section 3.4.3 for Schedule 8 medications and in section 3.4.2 for Schedule 4
medications and other non-Schedule 8 medications. See section 3.4.5 for verbal (face
to face), telephone, video call, email or facsimile order of an authorised prescriber
provisions, or
 The discharge medication order section of a paper-based medication chart either
sighted then photocopied by the pharmacist, or forwarded to the Pharmacy Service by
facsimile, email or another approved electronic form. Note that for Schedule 8
discharge medication orders, the authorised prescriber must also issue a paper-based
prescription as the original is required as detailed in section 3.4.3, or
 Where approved at the facility, the discharge summary document (however named)
printed and signed by the authorised prescriber. For Schedule 8 discharge medication
the authorised prescriber must also issue a paper-based prescription as detailed in
section 3.4.3), or
 An electronic discharge prescription using the eMeds system approved for use by the
public health facility Chief Executive.
Under facility procedures, the pharmacist dispensing medication(s) for an individual patient
must review the medication order or prescription in the context of the patient’s full medication
regimen and clinical status (where available) prior to the medication(s) being provided to the
patient (or patient’s carer).

Outpatient Dispensing
Prescriptions for dispensing Schedule 4 medications and Schedule 8 medications for
outpatients to take home must be in the paper form detailed in section 3.4.2 and section 3.4.3
respectively or in the eMeds system under facility procedures.
All pseudoephedrine preparations may only be dispensed for patient take home use on a
prescription in the format detailed in section 3.4.2, that is treated as a Schedule 4 medication.
4.5.2 Schedule 8 prescriptions – additional requirements
A pharmacist must not dispense a prescription for a Schedule 8 medication if the authorised
prescriber’s authority to prescribe such a medication has been withdrawn under the Poisons
and Therapeutic Goods Regulation 2008.
The current list of withdrawn Schedule 8 drug authorities under the Regulation is on the
Ministry of Health website. Withdrawn authorities are also published in the NSW Government
Gazette as they occur.
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A paper-based prescription for a Schedule 8 medication must not include any other
medication. Orders for dispensing discharge medications on the patient’s medication chart
are excluded from this requirement.
The Regulation requires that a pharmacist must not dispense a paper-based prescription for
a Schedule 8 medication unless he/she:
 Is familiar with the handwriting of the prescriber who issued the prescription, or
 Knows the patient for whom the medication is prescribed, or
 Has verified that the prescriber named on the prescription has actually issued the
prescription. In the case where the prescriber is not contactable, a pharmacist may
supply the Schedule 8 medication in a quantity sufficient for no more than 2 days’
treatment pending verification with the prescriber reported to have issued the
prescription.

4.5.3 Emergency verbal, telephone, video call, email or facsimile

prescriptions
In an emergency, a pharmacist may dispense a prescription for any medication on the verbal
(face to face), telephone, video call, email or facsimile order of an authorised prescriber (see
section 3.4.5).
A pharmacist can only dispense an unregistered Schedule 8 medication, including an
unregistered Schedule 8 cannabis product, on receipt of a prescription or medication order.
Dispensing on an emergency telephone, video call, email or facsimile order is not permitted
under the Regulation.
For all other Schedule 4 or Schedule 8 medication orders, the prescriber must send the
prescription without delay (and within 24 hours) to the pharmacist to whom the direction was
given. If this prescription is not received with 7 days, this fact must be reported by the
pharmacist involved to the NSW Ministry of Health Pharmaceutical Regulatory Unit.

4.5.4 Prescription forgeries

Detected prescription forgeries for any medication must be reported by the director of
pharmacy or delegated senior pharmacist to NSW Police and obtain the NSW Police issued
Event Number. Prescription forgeries are to be reported to the NSW Ministry of Health
Pharmaceutical Regulatory Unit where related to the theft of prescription pads from the
facility.

4.5.5 Child resistant packaging

The Pharmacy Service must have a system in place to identify at the time of dispensing
those medications requiring child resistant packaging. The Pharmacy Service must hold
adequate stocks of the complete range of containers that include a child resistant closure for
re-packing medications.
Therapeutic Goods Order No.95 ‘Child-Resistant Packaging Requirements for Medicines’
(TGO 95) specifies those medications that must be supplied in child resistant packaging, the

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standards that must be met and the situations and conditions under which they are exempt
from these requirements.
TGO 95 also provides exemptions to the use of child resistant packaging, including the
following:
 medications to be used by, or administered to, a patient for treatment in a public
hospital, private hospital, nursing home, dental hospital or dental surgery
 medications intended to be administered by injection
 a solid or semi-solid (excluding solid dosage forms) preparation intended for
application to the skin or mucous membrane, including transdermal patches
 a liquid or semi-solid preparation intended for application to the eye, ear or mucous
membrane, and supplied in a container that;
o has a nominal capacity of not more than 20 millilitres
o is fitted with a restricted flow insert
 an individually wrapped powder
 a liquid preparation in spray presentation if;
o the delivery device is engaged into the container in such a way that prevents it
from being readily removed,
o direct suction through the delivery device results in delivery of no more than
one dosage unit
o actuation of the spray device is ergonomically difficult for young children to
accomplish.
Medications identified by TGO 95 as requiring child resistant packaging, and are not
exempted, must carry the appropriate warning flag or statement relating to child resistant
packaging where they appear in pharmacy information systems.

Pharmacy information systems – format of the warning flag and statement for child
resistant packaging
Child resistant closure warning flags and statements are intended to provide information for
staff involved in the dispensing of the medications.
The warning flag or statement must be printed on labels produced by the pharmacy
information system in order to be visible to all staff involved in the dispensing procedure. The
warning flag or statement does not need to be printed on the main dispensing label used for
the labelling of patient medications, or may be printed on any portion of the dispensing label.
However, it must be positioned in such a way as to ensure that it is printed for all medications
that it is associated with. It must not be obscured by other text. If this requires the warning
flag or statement to have a unique field and space created for it on dispensing labels, such
space must be created.
Warning flag text in the dispensing system. Where the warning flag appears it will be
presented as the text ‘KIDCAP’

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Warning statement text in the dispensing system. Where the warning statement appears it
will be presented as the text ‘Child resistant packaging required’ with ‘This medicine MUST
be supplied in child resistant packaging except if it is to be administered in a hospital or
nursing home’.
Medications within scope of the Hospital Pharmacy Product List (HPPL) that require child
resistant packaging as per TGO95 will have the KIDCAP warning flag assigned in the
iPharmacy application for HPPL affiliated sites. A comprehensive list of these medications is
captured in the Hospital Pharmacy Product List Warning Codes document and can be found
via the eHealth NSW Service Delivery SharePoint page. Users must check this page for the
current list as updates are made regularly.
Facilities that do not subscribe to HPPL must have procedures in place to identify
medications requiring child resistant packaging.

Settings where child resistant packaging must be used

All medications identified by TGO 95 as requiring child resistant packaging, and are not
exempted, must be supplied in child resistant packaging. This includes the supply by both a
pharmacist and an authorised prescriber.
Medications for use within the hospital and outside of the hospital that require child resistant
packaging include:
 outpatient medications dispensed/supplied for take-home use
 discharge medications
 medications dispensed for day or weekend leave
 pre-packs of medication in patient care areas where the medication may later be
supplied to a patient for take-home use.
Labels generated by pharmacy information systems for medications used in these settings
must carry the warning flag ‘KIDCAP’ or the warning statement ‘This medicine MUST be
supplied in child resistant packaging except if it is to be administered in a hospital or nursing
home’.
Under facility procedures, a pharmacist can exercise discretion, in consultation with the
authorised prescriber as appropriate, and not dispense the medication in child resistant
packaging when the pharmacist and/or the authorised prescriber is of the opinion that the
patient would suffer undue hardship through difficulty in opening the container. This must be
documented in the pharmacy dispensing system.
In this case, adequate instructions in writing, and verbally where possible, must be given to
the patient and/or the patient’s carer (as applicable) about the potential risk if the medication
is swallowed by a child.

4.5.6 Labelling of dispensed medications

Dispensed medications must be labelled in accordance with Appendix A to the Regulation,
with:
 the patient’s name

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 the medication’s active ingredient/s, brand name (where applicable), form, strength
and the quantity supplied
 adequate directions for use including, where ordered, the instructions specified by the
prescriber (Note: Under facility procedures, may be excluded for inpatients where
administration is by staff)
 the Pharmacy Service’s dispensing reference number
 the date of dispensing (unless that date is also in the dispensing reference number)
 the name and address of the hospital
 the words KEEP OUT OF REACH OF CHILDREN in red on a white background
 if the substance is intended for external use only, the words FOR EXTERNAL USE
ONLY or the word POISON in red on a white background
 if the substance is supplied in the circumstances referred to in section 4.5.3 on a
verbal, telephone (face to face), video call, email or facsimile order, the words
‘EMERGENCY SUPPLY’
 any ancillary label/s required for the particular active ingredient/s with the associated
warning statement.
In the case of a preparation for which a ARTG product or a standard Australian Formulary
does not exist, pharmacists must ensure that the dispensed medication clearly indicates the
strength of the preparation with the dose prescribed and any additional detail relevant to the
formula used.

4.5.7 Mandatory ancillary labels and warning statements

Specified sedating medications

The container of the specified sedating medications listed in Appendix K to the Poisons
Standard must bear a label with Warning Statement 39, 40 or 90. The warning must be
immediately preceded by a symbol in the form of an open equilateral triangle at least 4.5
millimetres high in bold print, coloured red. The Warning Statements are:
No. 39 ‘This medication may cause drowsiness. If affected do not drive a vehicle or
operate machinery. Avoid alcohol’, or
No. 40 ‘This medication may cause drowsiness and may increase the effects of
alcohol. If affected do not drive a motor vehicle or operate machinery’, or
No. 90 ‘This preparation is to aid sleep. Drowsiness may continue the following day. If
affected do not drive or operate machinery. Avoid alcohol’.

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Specified stimulant medications (in Appendix A of the Regulation)

The medications are:
amphetamine chlorphentermine dexamfetamine
ephedrine diethylpropion lisdexamfetamine
methylphenidate phentermine propylhexedrine

The container of such a substance (being a substance that is represented as being for oral
use by a person other than a child under 16 years old) must bear a label with the words
‘THIS MEDICATION (or MEDICINE) MAY AFFECT MENTAL ALERTNESS OR CO-
ORDINATION OR BOTH. IF AFFECTED, DO NOT DRIVE A MOTOR VEHICLE OR
OPERATE MACHINERY’.
The warning must be immediately preceded by a symbol in the form of an open equilateral
triangle at least 4.5 millimetres high in bold print, coloured red.

Quinine
The container of quinine must bear a label with the words ‘WARNING - MAY BE FATAL TO
CHILDREN’.

4.5.8 Unregistered medications for clinical trials

A clinical trial drug which is not registered or listed on the ARTG must be labelled, stored,
prescribed, administered and recorded either:
 Where the substance or a similar substance is currently included in the Poisons
Standard (or is exempt from the Poisons Standard), in accordance with that Schedule
(or exemption), or
 Where there is no similar substance on the Poisons Standard, as a Schedule 4
substance.

4.5.9 Records of dispensing

A pharmacist must record the dispensing of patient-labelled medication by:
 entering the details in the electronic dispensing system (such as ‘iPharmacy’), or
 writing the details in a prescription book, or
 retaining the prescription, or a copy of the prescription or medication order (as
applicable) in chronological order of the date on which the medications were
dispensed.
The record of the dispensing of a patient-labelled medication must include:
 the date on which the prescription or order was issued
 the patient’s name, and address and/or patient care area
 the patient’s date of birth when required under the Regulation

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 the medication’s active ingredient/s, brand name (where applicable, as supplied),

strength, form and the quantity supplied
 adequate directions for use including, where ordered, the instructions specified by the
prescriber
 where prescribed, the number of repeat supplies of the medication
 where repeats are ordered for Schedule 8 or Schedule 4 Appendix B medications the
interval at which the medication may be repeat supplied
 the name and designation of the authorised prescriber, and the name, address and
telephone number of the facility
 the unique reference dispensing number issued at the Pharmacy Service
 the date on which the medication was dispensed
 the name of the pharmacist who dispensed the medication.
Where a medication is dispensed as an ‘EMERGENCY SUPPLY’ on a telephone, video call,
email, or facsimiled order from an authorised prescriber in accordance with section 4.5.3, the
pharmacist must report to the NSW Ministry of Health Pharmaceutical Regulatory Unit the
circumstance of a prescription that is not received within seven (7) days.
Irrespective of the recording system used, dispensed paper-based prescriptions for Schedule
8 and Schedule 4 Appendix B medications must be retained at the Pharmacy Service and
must be stored apart from all other prescriptions.
All dispensing records, as well as the (original) dispensed paper-based prescriptions for
Schedule 8 and Schedule 4 Appendix B medications, must be retained at the Pharmacy
Service and must be available for inspection on request by an authorised inspector of NSW
Health or a NSW police officer.
Where the name and designation of the authorised prescriber of the medication order is
recorded in an eMeds system and is linked with the record of dispensing through a unique
identifying number, these prescriber details may be omitted from the dispensing record. The
link must remain in place for the required period for retaining records (see section 5.11).

4.6 Imprest and stock supplies to patient care areas

4.6.1 Requisitions for medications

Medications may be supplied from the Pharmacy Service either:
 With reference to the approved imprest list for the patient care area including the list
generated by an automated dispensing cabinet system, or
 On the clear and legible requisition of the registered nurse/midwife in charge of the
patient care area where the medication is to be used, either as the original hand
written (hard copy) order, by facsimile, by email or electronic order such as generated
by an automated dispensing cabinet, or
 From a clear and legible medication order by an authorised prescriber, either sighted
then photocopied by the pharmacist (or the authorised director of the medication
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supply service at a facility where no pharmacist is employed/contracted) or

alternatively forwarded to the Pharmacy Service by facsimile, email or eMeds order.
The range of medications and respective stock levels on an imprest list must be set by
agreement between the nurse/midwife or appropriately authorised person in charge of the
patient care area and the facility’s director of pharmacy and regularly reviewed using a risk
assessment approach in accordance with protocols approved by the Drug and Therapeutics
Committee.
The Pharmacy Service must maintain a record of all supplies of medications to patient care
areas.

4.6.2 Re-packaging and labelling of imprest and stock medications

Medications supplied from the Pharmacy Service to patient care areas must preferably be in
the manufacturers’ original packs. These original packs do not have to be further labelled but
supplementary labelling may be applied as deemed appropriate by the supplying pharmacist.
Re-packaging of medications must be carried out by, or under the supervision and checked
by, a pharmacist before delivery to the patient care area.
The packaging of re-packed items must be in accordance with the provisions of Part 2,
sections 2.1 to 2.6 of the Poisons Standard.
Medications requiring child resistant packaging must be re-packed as such when provided to
the Emergency Department and other settings where the medication may later be supplied to
a patient for take-home use (see section 4.5.5).
Labelling of re-packed medications must include, as a minimum, the following details:
 the medication’s active ingredient/s, brand name (where applicable), form, strength
and the quantity supplied
 the name and address of the facility
 the batch number and expiry date of the original pack, or the Pharmacy Service’s
batch number in the case of a Pharmacy Service manufactured preparation
 any applicable additional information included on the manufacturer’s original pack
 the words KEEP OUT OF REACH OF CHILDREN in red on a white background
 if the substance is intended for external use only, in red on a white background the
words FOR EXTERNAL USE ONLY or the word POISON
 if applicable under facility procedures, that the preparation is a Schedule 8 or
Schedule 4 Appendix D medication.

4.7 Pharmacy Service Schedule 8 medication accountability

4.7.1 Entries in the Schedule 8 drug register

The director of pharmacy or delegate is responsible for ensuring that a record is kept of all
Schedule 8 medication transactions in a drug register. Unless in an approved electronic form
under NSW Health Framework for Use of an Electronic Drug Register Requiring Signal

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Signature, the drug register must be the State Forms bound book with consecutively
numbered pages. A separate page must be used for each form and each strength of the
Schedule 8 medication. Brands of the same strength and form (for example, Methadone
Syrup and Methadone Oral Solution) may be recorded on separate pages under facility
procedures.
Only a pharmacist, or the authorised officer of the medication supply service at a facility
where no pharmacist is employed/contracted, may make an entry in the Schedule 8 drug
register.
The record in the drug register must be made on the day the transaction occurred and must
include in handwriting or in an approved electronic form:
 the date of the transaction
 the name and address of the supplier from whom the medication was received or the
name and address of the person to whom the medication was supplied, except;
o In the case of dispensing to an in-patient only, the patient’s medical record number
may be entered instead of the address
o In the case of a supply to a patient care area, the name of the ward, unit, clinic or
service
 the quantity of the medication received, supplied, or destroyed
 the physical balance on hand after the transaction. An overage (excess) to the
physical balance in the Schedule 8 medication storage unit is accounted for by
adjusting the balance upwards on the next available line of the page. Deficits must be
recorded, reported and investigated in accordance with the procedure detailed in
section 4.9
 the prescription reference number in the case of a medication supplied on a
prescription, or the supplier’s invoice or reference number in the case of a medication
obtained from a pharmaceutical wholesaler
 for imprest supplies, the name of the requisitioning registered nurse/midwife in charge,
or the name of the authorised prescriber for patient-labelled medications
 the full and legible name and signature of the pharmacist, or the authorised officer of
the medication supply service at a facility where no pharmacist is
employed/contracted, making the entry
 where the Schedule 8 medication is destroyed, in accordance with the additional
requirements detailed in section 4.8.2.
Under the Regulation, a pharmacist, or the authorised officer of the medication supply
service at a facility where no pharmacist is employed/contracted, who makes an entry in the
Schedule 8 drug register:
 must not make a false or misleading entry
 must not make any alterations, obliterations or cancellations. That is, no lines may be
drawn through entries, no entries scribbled out or crossed out in any way, or numerals
altered. If a mistake is made, the entry must be left as it is, marked with an asterisk,

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rewritten as corrected on the next line with a note explaining the error (signed and
dated) also marked with an asterisk.

4.7.2 Schedule 8 medication balance checks

Under the Regulation, a count of the balance of all Schedule 8 medications held in the
Pharmacy Service, or medication supply service at a facility where there is no
employed/contracted pharmacist, must be made during March and September each year as
a minimum, and at other times under facility procedures, including:
 opened containers of liquids must be decanted and measured by a pharmacist to
obtain the physical balance on hand
 the balance must be recorded under the last entry for each medication, and signed
and dated. It is not sufficient to make a single entry on one page of the drug register to
cover the count of all Schedule 8 medication stocks
 any detected loss (deficit) must be reported to the NSW Ministry of Health
Pharmaceutical Regulatory Unit, as described in section 4.9.
A delegated pharmacist or authorised officer of the medication supply service at a facility
where there is no employed/contracted pharmacist who assumes control over the Schedule 8
medication stock for one month or more must, immediately on assuming control, perform a
full balance check as described above.

4.8 Disposal/destruction of medications

4.8.1 Disposal of medications – general requirements

The Pharmacy Service or medication supply service at a facility where there is no
employed/contracted pharmacist must have procedures to dispose of all expired, unusable
unwanted medications, including cytotoxic medications, in accordance with NSW Health
Policy Directive Clinical and Related Waste Management for Health Services (PD2020_049).
Expired, unusable or unwanted medication must not be collected for the purpose of donation
for humanitarian relief, in accordance with the Australian Guidelines for Drug Donations to
Developing Countries.

4.8.2 Destruction of expired, unusable or unwanted Schedule 8

medications
Under Drug and Therapeutics Committee approved procedures, the following staff may
destroy expired, unusable, or unwanted Schedule 8 medications at the Pharmacy Service:
 the director of pharmacy of the Pharmacy Service or a pharmacist authorised by the
director of pharmacy, or
 at a facility where there is no employed/contracted pharmacist, the authorised officer
of the medication supply service.
The destruction of Schedule 8 medication must be in the presence of a witness, being:
 a pharmacist, or
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 a medical practitioner or dentist, or

 a registered nurse/midwife in charge of a patient care area at the hospital that has
been authorised by the facility’s director of nursing for this purpose.
The record of destruction in the Schedule 8 drug register must include:
 the quantity of the particular Schedule 8 medication destroyed
 the date of the destruction
 the name, signature and health practitioner registration number of the person
destroying the medication
 the name, signature and health practitioner registration number of the person who
witnessed the destruction.
A NSW Ministry of Health inspector appointed under section 42 of the Poisons and
Therapeutic Goods Act 1966 or a NSW police officer may also destroy Schedule 8
medications at a Pharmacy Service or medication supply service at a facility where there is
no employed contracted pharmacist. A witness to the destruction is not required.
Schedule 8 medications must be destroyed in such a way:
 that a medication is made unidentifiable (that is, not disposed of intact in the original
labelled packaging)
 that a medication is made unusable and unrecoverable (by having them absorbed on
to absorbent material such as cat litter or commercial medication disposal product that
renders the medication unrecoverable)
 that is not likely to cause damage to the environment and not likely to pose a risk to
any person.
Recommended procedures for the destruction of Schedule 8 medications are detailed in
section 4.8.3.

4.8.3 Recommended methods for the destruction of Schedule 8

medications
The destruction of Schedule 8 medications at the Pharmacy Service must be recorded in the
drug register.
Where appropriate, the person destroying the medication must wear disposable gloves
and/or a disposable mask.
After the destruction:
 the containers and implements used in the destruction must be thoroughly washed
 hands must be thoroughly washed with warm soapy water
 a final check of the area where the medications were destroyed must be conducted to
make sure that no drug material has been inadvertently left on the floor, bench, sink or
surrounding areas.

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The packaging must also be destroyed or defaced. When separated from the medication
being destroyed, cardboard packs and emptied foils must be cut or torn, and the labels of
emptied bottles, vials and bags defaced. All such material must then be disposed of in a
suitable secured receptacle. Recommended procedures to render Schedule 8 medications
unusable and unrecoverable are:

Tablets, capsules and suppositories

1. Remove the medication from the foil, blister platforms or bottles and place in a mortar
or other suitable strong container, taking care that no medication falls outside the
container. Check each foil/blister platform/bottle carefully before discarding to make
sure that no medication remains. Large capsules (for example Kapanol® 100mg) may
be pulled apart and the contents and shells placed in the mortar/container.
2. Crush the medication in the mortar/container with a pestle or similar implement, mixing
with an adequate quantity of hot soapy water, methylated spirits, or methyl salicylate
liniment or the like. Take care that no drug material is forced out of the container
during this procedure.
3. Pour the resulting slurry onto absorbent material such as cat litter granules or
shredded paper or commercial absorption system and dispose of in a pharmaceutical
waste bin.

Liquids
1. Pour the liquid onto absorbent material such as cat litter granules or shredded paper.
2. Dispose of in a pharmaceutical waste bin.

Powders, granules and botanical material

1. Grind the material if necessary, then mix the powder in a suitable container with an
adequate quantity of hot soapy water, methylated spirits, or methyl salicylate liniment
or the like.
2. Pour the resulting slurry onto absorbent material such as cat litter granules or
shredded paper and dispose of in a pharmaceutical waste bin.
Note: Additional caution must be taken when handling MS Contin® controlled release
suspension - granules for reconstitution, as the granules contain an intense dye.

Injectable medications
Glass ampoules/small vials;
1. In most cases ampoules which are in a cardboard carton may be crushed in the
manufacturer’s pack, enclosed with newspaper. Alternatively, remove the
ampoules/vials from the carton and enclose with newspaper.
2. Place the wrapped pack of ampoules/vials on a hard floor on additional newspaper
and crush underfoot (wearing sturdy hard soled shoes), or with an implement such as
a hammer.
3. Pick up the wrapped ampoules carefully and dispose of in a sharps container.

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Plastic ampoules, plastic IV infusion bags and large vials;

1. Pour the contents onto absorbent material such as cat litter granules or shredded
paper.
2. Dispose of in a pharmaceutical waste bin.

Transdermal patches and sublingual film

1. Cut each sachet with the patch enclosed into several pieces.
2. Disperse in a small quantity of hot soapy water, methylated spirits, or methyl salicylate
liniment or the like, then dispose of the solution in a sharps container or
pharmaceutical waste bin.
Caution: Fentanyl patches, even after being used or when expired, contain sufficient fentanyl
to cause life-threatening respiratory depression in an opioid-naïve person if absorbed. If
during the destruction of fentanyl patches the active layer come into contact with the skin or
other body surface, immediately wash off thoroughly with soap and water. See the NSW
Therapeutic Advisory Group advisory on Fentanyl Oromucosal Formulations.

4.9 Reporting the loss, theft or deficit of accountable

medications
Accountable medications are Schedule 8 medications, Schedule 4 Appendix D medications
and other medications also accounted for in a register under facility procedures.
A pharmacist who detects the loss, theft or deficit of an accountable medication must
immediately report this fact to the director of pharmacy. The pharmacist or authorised officer
of the medication supply service at a facility where there is no employed/contracted
pharmacist who detected the loss, theft or deficit of the Schedule 8 medication must also
immediately record the physical balance on hand in the Schedule 8 drug register with an
explanatory note highlighting the deficit from the arithmetical balance.
The director of pharmacy, or authorised officer of the medication supply service at a facility
where there is no employed/contracted pharmacist, must complete and submit a report in
accordance with the facility’s incident management system under the requirements of NSW
Health Policy Directive Incident Management (PD2020_047).
This includes all medication that cannot be supplied or used, such as the loss of liquid by
spillage, and the loss in broken or damaged bottles and ampoules, but does not include
medication that is intact but expired, unusable, unwanted, and is instead destroyed in
accordance with section 4.8.2 for Schedule 8 medications and section 4.8.1 for other
accountable medications.
The director of pharmacy, or the authorised officer of the medication supply service at a
facility where there is no employed/contracted pharmacist, must notify the NSW Ministry of
Health Pharmaceutical Regulatory Unit of the loss, theft or deficit of the Schedule 8
medication immediately using the on-line notification form (and retain a copy of this
notification). An exception is provided for the loss of liquid by spillage and the loss in broken
or damaged bottles and ampoules that the director of pharmacy does not consider
suspicious.

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This immediate notification to the NSW Ministry of Health must be marked on the form ‘Initial
Notification’. As soon as all notifiable details become available, such as when further
investigation has been conducted, a follow-up notification must be submitted to the NSW
Ministry of Health using the on-line notification form.
The director of pharmacy or authorised officer of the medication supply service at a facility
where there is no employed/contracted pharmacist must also:
 ensure that a full investigation of the loss, theft or deficit of the medication is
conducted
 with a confirmed theft, report the event to the local police
 with confirmed misappropriation by a health practitioner, under facility procedure,
ensure the matter is reported to the particular health practitioner’s national registration
board as well as to the NSW Ministry of Health Pharmaceutical Regulatory Unit.
Where there is no apparent loss of medication, but a concern exists of possible, or admitted,
misappropriation of medication by a staff member, this also must be reported to the NSW
Ministry of Health Pharmaceutical Regulatory Unit. Failure to report may result in harm to a
patient or to the member of staff, particularly where a possibility exists that this staff member
has substance use problems and/or is health impaired.

4.10 Reporting a lost, destroyed or tampered Schedule 8 drug

register
A pharmacist who detects that a drug register (including electronic drug register) appears
lost, destroyed, has had pages removed, or has tampered entries or pages must immediately
report the matter to the director of pharmacy.
The director of pharmacy or authorised officer of the medication supply service at a facility
where there is no employed/contracted pharmacist must immediately:
 notify the NSW Ministry of Health Pharmaceutical Regulatory Unit in writing of the
known detail of the circumstances of the loss, destruction or tampering
 enter the balance on hand of the Schedule 8 medications involved in a drug register
 under facility procedures and in accordance with NSW Health Policy Directive Incident
Management (PD2020_047), complete and submit a report.

4.11 Retention periods for records, prescriptions and drug

registers
The following retention periods apply to records relating to dispensing and supply of
medications by the Pharmacy Service, as State Records in accordance with NSW Health
Policy Directive Health Care Records – Documentation and Management (PD2012_069)
under General Retention and Disposal Authority 17 (GDA 17):
 2 years for;
o prescriptions (except ‘Section 100’ Highly Specialised Drugs prescriptions which
are for 7 years)

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o records of medication orders, requisitions, receipts/records of deliveries, inventory

control records, manufacturing records and purchase orders
 7 years for;
o drug registers
o records relating to the supply of ‘Section 100’ Highly Specialised Drugs including
prescriptions and declaration forms
o Special Access Scheme approvals and records relating to the organisation’s
compliance with mandatory or optional standards or with statutory requirements,
whether the medication is held at the Pharmacy Service or in a patient care area
 10 years for;
o records relating to reports of loss or theft of Schedule 8 and Schedule 4 Appendix
D medications
o Schedule 8 drug registers
 15 years for clinical trial medication supplies or until the patient attains 25 years of
age, whichever is longer.

5 PATIENT CARE AREAS

5.1 Responsibility and oversight

The Drug and Therapeutics Committee must have oversight of medications used in patient
care areas. The registered nurse/midwife in charge of a patient care area is responsible for
the procurement from the Pharmacy Service or medication supply service at a facility where
there is no employed/contracted pharmacist, and the storage of all medications.
This person must ensure that the medications are stored in accordance with all legal
requirements and that the correct provisions are met in relation to medication security,
temperature control, stock rotation, and disposal of expired and unwanted medications.
Exceptions are provided in patient care areas where a registered nurse/midwife in charge is
not employed, and the responsibility for the procurement and storage of medications is
delegated to an appropriately authorised person (for example certain nuclear medicine
departments, radiography departments, dental clinics, Needle and Syringe Program units).
Patient care area medication management systems must include:
 the range and quantities of medications stocked in each patient care area being
appropriate for the needs of the area
 storage that minimises medication error due to a mix-up between preparations
 a routine procedure of stock rotation and monitoring of expiry dates under facility
procedures, with unwanted, unusable, or expired medications disposed of in
accordance with section 5.15.1 and also section 5.15.2 for Schedule 8 medications
 temperature storage consistent with the specifications on the manufacturer’s pack.

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The range of medications and respective stock levels on an imprest list must be set by
agreement between the nurse/midwife, or appropriately authorised person (described above),
in charge of the patient care area and the facility’s director of pharmacy and regularly
reviewed using a risk assessment approach in accordance with protocols approved by the
Drug and Therapeutics Committee.
NSW Health Policy Directive High-Risk Medicines Management (PD2020_045) also includes
requirements regarding imprest and stock high-risk medicines.

5.2 Medication procurement by patient care areas

5.2.1 General provisions

Patient care areas may obtain medications either from:
a) The Pharmacy Service or medication supply service at a facility where there is no
employed/contracted, either as imprest stock or labelled for an individual patient in
accordance with a medication order or prescription issued by an authorised prescriber.
Individually dispensed medications must only be used for the patient for whom the
medication was dispensed, or
b) Directly from a pharmaceutical wholesaler (commonly referred to as ‘Vendor Managed
Inventory’), in accordance with facility procedures.
The Drug and Therapeutics Committee is responsible for formulary management at the
facility’s patient care areas in accordance with NSW Health Policy Directive Approval
Process of Medicines for Use in NSW Public Hospitals (PD2016_033). This policy
establishes a standard procedure for the approval of medications and their use.
Medications may be ordered from the Pharmacy Service/medication supply service by the
registered/nurse midwife, appropriately authorised person in charge of the patient care area
or by an authorised prescriber. Orders must be an (original) written order, facsimile or email.
Medications must not be transferred to, or received from, private health facilities other than
under specific licence such as during a pandemic response.

5.2.2 Receipting Schedule 8 medication deliveries

In accordance with facility procedures, Schedule 8 medication in a sealed package may be
delivered to a registered nurse/midwife of the patient care area either:
 By a facility staff member, for example, a pharmacy technician or ward porter, where
the Schedule 8 medication is ordered from the Pharmacy Service, where the staff
member is acting under the direction of a pharmacist, or the authorised officer at the
Pharmacy Service. where no pharmacist is employed/contracted, or
 By a courier arranged by the Pharmacy Service for transfers to a patient care area
remote to the Pharmacy Service, or
 By a courier arranged by the pharmaceutical wholesale supplier in the case of
deliveries directly from the supplier.
A Schedule 8 medication may also be collected from the Pharmacy Service by a registered
nurse/midwife from the patient care area.
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Under the Regulation, the registered nurse/midwife who receives the Schedule 8 medication
on behalf of the patient care area must provide to the Pharmacy Service/medication supply
service or pharmaceutical wholesaler (as applicable) a signed and dated receipt confirming
the quantity of the medication supplied. A copy of this receipt must also be retained at the
patient care area. An exception is for a Schedule 8 discharge medication for on-supply to the
patient under facility procedures.
Where Schedule 8 medication is delivered by a courier who is not a facility staff member, the
person receiving the unopened sealed parcel must also sign and date a ‘proof of delivery’
receipt (either electronically or in hard copy) for the parcel.
The registered nurse/midwife who receives the Schedule 8 medication delivery must
immediately enter the receipt in the patient care area drug register and lock the medication in
the Schedule 8 drug storage unit with a witness. Under facility procedures, a pharmacist or
pharmacy technician may witness the entry of receipt in the patient care area drug register.
Systems for the delivery, collection and transfer of Schedule 8 medications must include
procedures designed to minimise the opportunities for misappropriation, for example:
 by checking that tamper-evident seals are intact
 conducting audits with checks against the signed and dated receipts of supplies to,
and transfers from the patient care area (see section 5.14.4)
 that the ordering, supply, delivery and receipting of Schedule 8 medications are not
undertaken by the same staff, that is, there is clear separation of staff/persons
involved in the procedure.

5.2.3 Transferring Schedule 8 medications between patient care areas

Transfer of Schedule 8 medications between facilities must only occur where there is no
Pharmacy Service at the facility requesting the Schedule 8 medication. The requisitioning
and supply must be by the registered nurse/midwife in charge at the facility.
Facility procedures must detail the circumstances under which Schedule 8 medication may
be transferred between patient care areas, including the need for this to only occur after-
hours when the Pharmacy Service/medication supply service is not available.
When transferring Schedule 8 medication to another patient care area:
 a signed and dated requisition and receipt must be provided by the registered
nurse/midwife in charge of the patient care area receiving the Schedule 8 medication
 two registered nurse/midwives, one of whom must be a senior registered
nurse/midwife such as an After Hours Nurse Manager, must be involved in the
transfer. The two registered nurse/midwives must maintain custody of the Schedule 8
medication throughout the transfer.
This signed and dated requisition and receipt must be retained in the patient care area
supplying the medication, and a copy retained at the patient care area obtaining the
medication. The corresponding drug register entries detailing the transaction must be
completed for both patient care areas concurrently, in accord with the detail included in
section 6.13.1.

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5.2.4 Pharmacy Service packs and re-packs

All medications must be stored in patient care areas in the same container as received from
the Pharmacy Service/medication supply service. This applies to either the manufacturer’s
original pack, or a re-pack labelled by a pharmacist.
An exception is provided for medications required urgently in medical emergencies or
emergency, resuscitation or anaesthesia trolleys, where rapid access is essential and the
quantity held is minimal, and in accordance with a standard stock list appropriate for the
purpose.
Re-packing must not occur outside of the Pharmacy Service, including the ‘pooling’ of
medication from multiple containers into one container, re-labelling or over-labelling of
containers, or re-packing from bulk stock into smaller containers.

5.2.5 Use of patient own medication including complementary

medication
A patient’s own medication generally may only be used in the event that the patient care area
does not have immediate access to the facility’s stock of the medication. The medication
must be obtained by the patient care area as soon as possible, and when received, the
patient's own supply must be withdrawn from use. However, regular use patient own
medication is to be used for Hospital in the Home and community nursing services.
Under Drug and Therapeutic Committee approved procedures, in specialised residential
services patients may be deemed responsible for their own medication administration and for
administration to infants/children in their care, for example Karitane Child and Family Health
Services and Tresillian Family Care Centres. Procedures must ensure safe medication
storage. Schedule 8 medications must be stored and accounted for in accordance with
sections 5.4.2, 5.4.4 and 5.14.1.
Under facility procedures, ongoing use of patient own medications, dispensed and labelled by
a pharmacist where applicable, may be permitted for the following medications/therapies:
 implantable pump therapy
 insulin pump therapy
 disposable insulin pen
 specialised formulations for individual patients (such as paediatric patients)
 adrenaline (epinephrine) autoinjectors (see additional requirements below)
 clinical trial medications
 medication obtained under the Special Access Scheme
 medication supplied under a sponsor facilitated Medicine Access Program
 non formulary medications (for example specific eye drops or inhalers)
 complementary medications
 unregistered Schedule 8 cannabis medicines (additional requirements below).

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All patients must have their complete medication regimen reviewed on admission to establish
the appropriate regimen to continue during the admission. The use of a patient own
medication in a patient care area must be specifically notated on the medication order as
appropriate for use. A hospital pharmacist must verify the medication is suitable for use.
Storage of the patient’s own medications for self-administration must be in accordance with
section 5.4.3 and not remain with the patient, with the exception of adrenaline (epinephrine)
autoinjectors or under facility procedures for other medications. An exception is also provided
for patients attending a non-inpatient setting (see in section 6.10.1) where a staff member is
assisting the patient in self-administration.
When not returned to the patient on discharge for whatever reason, the patient’s own
medications must be disposed of in accordance with section 5.15, and must not be retained
as stock for administration to other patients.
The CATAG Guiding Principles for the Use of Complementary and Alternative Medicines in
Hospitals provides guidance to facilities in the development of facility procedures for the
management and use of complementary and alternative medications alongside conventional
medical or surgical treatments.

Adrenaline (epinephrine) autoinjector

Patients and/or carers who are assessed as capable to self-administer may retain their
adrenaline (epinephrine) autoinjector (for example EpiPen®) on their person/at the bedside in
accordance with facility procedures.
The adrenaline (epinephrine) autoinjector must be stored out of other patient access. In
circumstances where adrenaline (epinephrine) is required for an anaphylactic reaction, staff
(who have the required skills and knowledge) may administer adrenaline (epinephrine) using
the ‘patient own’ autoinjector.
In circumstances of anaphylaxis/suspected anaphylaxis, the facility Clinical Emergency
Response System must be activated in accordance with facility procedures whenever
adrenaline (epinephrine) is used.
Facility procedures must include:
 the requirement for a pharmacist to check the adrenaline (epinephrine) autoinjector is
fit for use
 storage requirements: adrenaline (epinephrine) autoinjector must be stored out of
other patient access
 staff education required to correctly use the autoinjector
 arrangements for replacing the patient’s own used adrenaline (epinephrine)
autoinjector.

Disposable insulin injector pens

Patients who normally administer their insulin using a disposable insulin injector pen may
continue to do so under supervision in accordance with facility procedures. Insulin injector
pens must be stored out of other patient access.

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To reduce the risk of administering the wrong dose, patients prescribed high concentration
insulin, must self-administer their insulin under supervision. Safety Alert Broadcast
SN:007/19 High Concentration Insulin Products - Updated includes information on managing
high concentration insulin products. Also refer to NSW Health Policy Directive High-Risk
Medicines Management (PD2020_045).
Facility procedures must include:
 requirement for a pharmacist to check the insulin injector pen is fit for use
 storage requirements
 guidance on conducting a patient assessment to ascertain their suitability to self-
administer insulin using an insulin injector pen.

Suspected illicit substances including illegal cannabis plant and cannabis

preparations
A substance suspected to be illicit which is brought to the health facility by the patient must
be removed by the patient’s family member or carer or destroyed with the patient or carer’s
consent under facility procedures. As the content of the substance (such as in powder, liquid,
tablet, capsule or plant form) is unknown it must not be managed as a Schedule 8
medication.
Where consent is not granted by the patient or carer for the facility to destroy the substance
the matter must be escalated to a medical officer suitably qualified to assess the patient’s
continuing risk of self-harm (where relevant) and decision-making capacity. It may be
appropriate to consider treating the patient under the provisions of the NSW Mental Health
Act 2007 and/or the NSW Guardianship Act 1987 – see also SN:008/18 on Return of
Patient’s Own Medicines.
Facility procedures must include circumstances where the matter is to be escalated to the
NSW Police, such as when:
 the patient has what seem to be trafficable quantities in their possession, or
 if harm has, or could have, resulted from use of the substance and the supplier can be
identified.
Some patients may be using illegal ‘black market’ cannabis preparations in expectation of
symptom relief or hoping to modify the course of a disease. Possession of these prohibited
drugs/plants is illegal under the Drug Misuse and Trafficking Act 1985 (NSW), even where
patients are registered with the NSW Government Medicinal Cannabis Compassionate Use
Scheme.
As such, NSW Health staff cannot store or administer these preparations in the hospital, nor
administer them when providing care in the home setting. The preparations cannot be legally
prescribed.
A history must be taken and disclosure of use encouraged. The risks of using these
preparations of unknown composition and concentration of cannabinoids and other
potentially dangerous substances, and the risk of drug interactions (some unpredictable or
undocumented), must be discussed with the patient/carers.

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It is recommended and good practice to document substance use in the patient’s clinical
record. This must include information about advice given, any changes to therapy, and the
decision of the patient. Ongoing open communication remains essential.
Notwithstanding the above, patients must be made aware that continued use of any illegal
cannabis preparation remains unlawful.

5.3 Methadone and buprenorphine for Opioid Treatment Program

patients
The NSW Health NSW Clinical Guidelines: Treatment of Opioid Dependence (GL2018_019)
provides guidance for opioid treatment in NSW.
Other than at public Opioid Treatment Program clinics or dosing points, due to security and
safety issues, methadone syrup/liquid for the management of opioid dependence must be
supplied to patient care areas from the Pharmacy Service as separate daily doses either as
pre-packed and labelled (stock) doses or as individual patient labelled doses.
However, facility procedures may provide for specific high use patient care areas, such as
drug detoxification units, to obtain the manufacturer’s 200 mL pack size, or a smaller (for
example 50 mL) re-packed supply from the Pharmacy Service.
The oral buprenorphine preparations Subutex® and Suboxone® (with naloxone) may be
supplied to the patient care area in the original manufacturer ’s pack, as pharmacist labelled
re-packs, or labelled by the pharmacist for an individual patient.
Long acting injectable buprenorphine formulations must be administered by health care
professionals who are trained and competent in depot injection administration. Long acting
injectable buprenorphine formulations must not be dispensed or supplied directly to the
patient or the patient’s carer.
Patient’s own (‘take-away’) supplies of Opioid Treatment Program medications must not be
administered to inpatients.
Patient’s own (‘take-away’) supplies of Opioid Treatment Program medications handed over
by the patient on admission must only be returned to the patient on discharge when both the
patient’s Opioid Treatment Program prescriber and dosing point have been advised and
agreed accordingly.

Use of an electronic administration and recording device

An electronic medication administration device (such as iDose®) may be used to accurately
extract methadone oral solution/syrup from a bottle and record each dose administered in an
electronic medication administration record – see in NSW Health Information Bulletin Use of
the iDose™ System by Registered Nurses (IB2020_049).
Registered Nurses may transfer methadone between bottles of the same brand and batch
number with use of the device if they are trained and competent to safely do so under facility
procedures.
Any residual methadone oral solution/syrup remaining in a partly used stock bottle at the end
of each day’s dosing must be transferred to another partly used stock bottle of the same
brand and batch number. In circumstances where the residual amount cannot be transferred

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into another partly used bottle (of the same brand and batch number), both bottles are to be
returned to the safe and the balance recorded.
Handling and recording of medications when electronic ‘downtime’ prevents the use of the
electronic device is under facility procedures.

5.4 Medication Storage in patient care areas

5.4.1 General storage requirements

Medications in patient care areas must be secured out of access to staff not authorised to
administer to patients.
Secure storage of public health facility supplied medications in the patient’s home for Hospital
in the Home and community nursing/outreach services is under facility procedures.
Facility procedures for medications requiring refrigeration in patient care areas may include
temperature sensor monitoring and alarm when the required temperature range (normally 2-
8°C) is breached. Appropriate action following events when the storage temperature deviates
from the manufacturer’s nominated temperature range must be taken, further to the
assessment of the risk by the director of pharmacy that the quality, safety and/or efficacy of
the medication(s) has been compromised.
Vaccines must be stored in accordance with NSW Health Policy Directive Vaccine Storage
and Cold Chain Management (PD2020_028). This policy includes mandatory requirements
for the, monitoring and management of vaccines including procedures for managing cold
chain breaches.

5.4.2 Storage of Schedule 8 medications

Stock levels of Schedule 8 medications must be kept to the lowest practical level in patient
care areas.
All Schedule 8 medications must be stored in the Schedule 8 medication storage unit,
including patient own Schedule 8 medication(s) and Schedule 8 medication(s) labelled for
supply to a patient on discharge. Schedule 8 medicines requiring refrigeration, for example
some cannabis medicines, may be stored in a refrigerator rather than the Schedule 8
medication storage unit (see section 5.4.4).
Under the Regulation, all Schedule 8 medications must be stored apart from all other
medications, except when stored with Schedule 4 Appendix D medications or propofol, and
apart from all other goods (such as keys, cash, documents) in an appropriate Schedule 8
medication storage Unit.
A Schedule 8 medication storage unit must be a sturdy cabinet, preferably a metal safe,
securely attached to the floor or a wall and kept locked when not in immediate use. The lock
is to be a five lever lock, or have a locking mechanism which provides at least equivalent
security. Consideration is to be given for the security of the Schedule 8 medication storage
unit(s) to include closed circuit television (cctv) monitoring.
When new facilities are built, or existing facilities renovated, any remaining wooden Schedule
8 cupboards are to be upgraded with the installation of metal safes.

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Access to the Schedule 8 medication storage unit must be with the witness who signs the
record of the transaction (procurement, supply or administration) in the drug register.
Where a key is used to access the Schedule 8 medication storage unit, transfer of the
custody of the key must be strictly controlled, including being kept separate to all other keys.
Where fingerprint security is in use, facility procedures must include security requirements.
The registered nurse/midwife in charge of the patient care area must hold the Schedule 8
medication storage unit key/s during his/her work shift or keep the key/s secured under
facility procedure. The key is to be provided to the registered nurse/midwife or authorised
prescriber requiring access to the Schedule 8 medication storage unit. When the particular
task is completed, the registered nurse/midwife or authorised prescriber must immediately
return the key to the registered nurse/midwife in charge.
Provision must be made for when the registered nurse/midwife currently in charge of the
patient care area is unavailable, for example during meal breaks, by handing the key/s to a
delegated registered nurse/midwife.
In the case of a Schedule 8 medication storage unit within an operating theatre, under facility
procedures a delegated registered nurse/midwife in charge or an authorised prescriber (such
as an anaesthetist) is to hold the key on behalf of the registered nurse/midwife in charge.
In accordance with facility procedures, when a patient care area is closed for any purpose,
any keys to that area’s Schedule 8 medication storage units must be either:
 Stored in a securely attached metal torch and drill resistant key safe in the patient care
area, or
 Handed over to the registered nurse/midwife in charge of the facility, or
 Handed over to the facility’s Nursing and/or Midwifery Administration for securing in a
safe or a key safe.
A code, combination or swipe card access required to unlock the Schedule 8 medication
storage unit must only be provided to a registered nurse/midwife or an authorised prescriber,
in accordance with facility procedures. Regular changing of the code or combination is
required, also in accordance with facility procedures.
Requirements for the management of keys (metal keys, electronic keys, electronic swipe
card access and key pad codes), is detailed in NSW Health Protecting People and Property
Manual on key control. A spare key to a patient care area Schedule 8 medication storage unit
or an override key for electronic locks (the downtime key) must be retained in a safe or key
safe at the facility’s Nursing and/or Midwifery Administration.
Schedule 8 medications must not be transferred to medication trolleys for administration
during a medication round, except in accordance with facility procedures. Where this practice
is approved, at the conclusion of the medication round the Schedule 8 medication packs
must be returned to the Schedule 8 medication storage unit.
Patient care areas that are routinely closed over short periods of time must be securely
locked to prevent unauthorised access. Under facility procedures, when a patient care area is
closed for an extended period of time, the Schedule 8 medication packs must be sealed with
tamper evident tape or in tamper evident packs, and transferred into another appropriate

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patient care area Schedule 8 medication storage unit or to the Pharmacy Service/medication
supply service.
NSW Health Policy Directive High-Risk Medicines Management (PD2020_045) includes
additional high-risk medicine storage requirements. The Hydromorphone Standard includes
requirements for hydromorphone storage including separating hydromorphone from
morphine, not storing hydromorphone in clinical areas where use is infrequent and
restrictions on routinely storing high-concentration formulations of injectable formulations.

5.4.3 Storage of Schedule 4 Appendix D medications

Schedule 4 Appendix D medications must be stored apart from all other medications and
goods (such as keys, cash and documents), except:
 When stored with propofol, or
 When stored in the Schedule 8 medication storage unit, or
 When stored on an emergency trolley or cupboard, anaesthetic trolley, or operating
theatre trolley. In these cases, Schedule 4 Appendix D medications must be kept at
minimal levels and the trolley kept in a locked room when the patient care area is
closed, with access only by authorised persons, or
 For refrigerated Schedule 4 Appendix D medications, in accordance with the
requirements in section 5.4.4.
Facility procedures to enhance security and accountability of Schedule 4 Appendix D
medications on an emergency trolley or cupboard must be implemented.
Where Schedule 4 Appendix D medications are stored apart from Schedule 8 medications,
this must be in a separate safe or cupboard securely attached to the premises, and which is
kept securely locked when not in immediate use. This may include the ‘Schedule 8 drug
cabinet within a Schedule 4 Appendix D drug cupboard’ model.
A code, combination or swipe card access required to unlock the Schedule 4 Appendix D
medication storage unit must only be provided to a staff member authorised by the registered
nurse/midwife in charge of the patient care area to access the medication. Code and
combination lock access provisions must be changed regularly.
Where the same key is used to access both Schedule 4 Appendix D and Schedule 8
medications, this key must be kept separate from all other keys (other than another key used
to access a separate Schedule 8 medication storage unit).
Under the Regulation, where Schedule 4 Appendix D and Schedule 8 medications are stored
in the same storage unit, the procedures for the custody of the Schedule 8 medication
storage unit key must be followed as detailed in section 5.4.4. This will restrict access to the
key to a registered nurse/midwife or an authorised prescriber.
Under facility procedures, Schedule 4 Appendix D medication packs may be moved to a
medication trolley for the purpose of administering doses during a medication round. At the
conclusion of the medication round, the Schedule 4 Appendix D medication packs must be
returned to the Schedule 4 Appendix D medication storage unit.

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5.4.4 Schedule 8 and Schedule 4 Appendix D medications requiring

refrigeration

Schedule 8 medications
Schedule 8 medications requiring refrigerated storage, for example some cannabis
medicines, may be stored as follows:
 in a locked refrigerator securely attached to the ward, or in a refrigerator that is in a
locked room which is accessible only to persons authorised to access Schedule 8
medications
 apart from all other medications except Schedule 4 Appendix D and other Schedule 8
medications.
If goods other than Schedule 4 Appendix D medications are to be kept in the refrigerator, the
Schedule 8 medications must be kept separated from them, such as in a locked box attached
to the refrigerator. Hospital engineering may be able to assist with fixing and fitting the
refrigerator to the premises and the locked box to the refrigerator.
The usual requirements apply to access to a Schedule 8 medication stored in a patient care
area including:
 keeping the locking device (such as a key) on the person of a registered nurse or
midwife in the patient care area, or in a separately locked safe to which only a
registered nurse/midwife has access when the patient care area is closed
 ensuring any code or combination that is required to unlock the room or refrigerator is
not divulged to any unauthorised person.

Schedule 4 Appendix D medications

The refrigerator containing the following Schedule 4 Appendix D medications may be kept in
a locked room containing any other medications:
 epoetins and erythropoietins including darbepoetin
 lorazepam injections.
Access to this room must be restricted to staff authorised by the registered nurse/midwife in
charge of the patient care area.
This is an alternative to the usual requirements for Schedule 4 Appendix D medication
storage in a patient care area. However, the requirements for reporting loss, theft or deficit of
accountable medications apply.
The medications must be accounted for under facility procedures that ensures the detection
and reporting of any loss.

5.4.5 Unscheduled, Schedule 2, 3 and non-Appendix D Schedule 4

medications
Medications in Schedule 2 (‘Pharmacy Medicine’), Schedule 3 (‘Pharmacist Only Medicine’),
non-Appendix D Schedule 4 medications and unscheduled medications must be stored out of

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patient and public access, in a locked room or a locked cabinet securely attached to the wall
or floor of the premises, with the following exceptions:
 on a medication trolley used for medication rounds, which must be kept in a locked
room when not in use
 on an anaesthetic trolley or operating theatre trolley which is kept in a locked room
when not in use
 minimal quantities of medications held on an emergency trolley
 in a secure cabinet (such as a bedside cabinet), including that used for patient self-
administration in an approved program (such as disposable insulin injector pens), in
situations for which it may be impractical to attach the cabinet to the wall or floor of the
premises. Note: Schedule 8 medications must not be included in a bedside storage
unit for self-administration. Facility procedures must determine whether Schedule 4
Appendix D medications are included for patient self-administration and if so, provide
for the requirement for these medications to be stored apart from the other
medications
 patient own adrenaline (epinephrine) autoinjector in accordance with section 5.2.5.
The key, code, combination or swipe card access used to unlock the room, cabinet, or trolley
must only be provided to a registered nurse, registered midwife, an enrolled nurse, or
authorised prescriber, as approved by the registered nurse/midwife in charge of the patient
care area, and for patients approved for self-administration. Cleaners must not access
medication storage areas unless supervised by one of the above clinicians. The registered
nurse/midwife in charge of the patient care area may also approve access to the room,
cabinet or trolley by Pharmacy Service staff members.

Separately stored non-Appendix D Schedule 4 medications

The Drug and Therapeutics Committee must consider the risk of misappropriation of
medications with a risk of misuse in addition to Schedule 4 Appendix D medications.
To mitigate the risk facility procedures can require that specific non-appendix D Schedule 4
medications be stored in separate (discrete) medication storage areas with similarly separate
key, code, combination or swipe card access to all other medications. Examples of
medications that may be considered for separate storage include propofol, methoxyflurane
and the Schedule 4 codeine phosphate hemihydrate combination products.
Non-Appendix D Schedule 4 medications may also be accounted for in a register at the
patient care area in accordance with facility procedures as described in section 5.15 and then
must also be managed as accountable medications, with any loss, theft or deficit reported to
the NSW Ministry of Health Pharmaceutical Regulatory Unit.

5.4.6 Storage of medications in automated dispensing cabinets

The Drug and Therapeutics Committee may approve the use of (electronic) automated
dispensing cabinets at particular patient care areas. Drug and Therapeutics Committee
approval is also required for the size and type of the automated dispensing cabinets used in
each patient care area. An electronic dual signature drug register integrated with the
automated dispensing cabinet storing Schedule 8 medications must accord with the
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requirements in NSW Health Framework for Use of an Electronic Drug Register Requiring
Dual Signatures.
Facility procedures must address:
 training required to access the automated dispensing cabinet for all staff members
 staff access to the cabinet including detailed procedures for assigning user access
credentials for electronic access
 verifying the requirement for ongoing access
 requirements for storing patient own medications in the cabinet
 transferring medications including Schedule 8 medications to/from automated
dispensing cabinet (if required)
 auditing the access to accountable medications
 downtime events including:
o contact details for assistance both during hours and after-hours times
o procedures for unlocking the cabinet
o procedures for circumstances when the cabinet is unable to be unlocked
o procedures for accounting for medications taken from the cabinet when it is
unlocked (non-accountable and Schedule 8)
o post-downtime procedures to ensure that the cabinet is relocked.
The following requirements must also be addressed:
1. The automated dispensing cabinet(s) must be securely attached to the wall or floor in
a manner approved by the facility’s security service, with the key, code or combination
to any associated locking device under the governance of the nurse/midwife in charge
and any spare key retained in a safe or key safe at the facility’s Nursing and/or
Midwifery Administration. Note: An exception to non-attachment to the wall or floor is
when the automated dispensing cabinet is kept in a locked room accessible only by
staff authorised by the nurse/midwife in charge, but only when Schedule 4 Appendix D
and/or Schedule 8 medications are excluded.
2. Assessment for use of an alarm monitoring system approved by both the facility’s
Drug and Therapeutics Committee and security service to detect and alert any
tampering or unauthorised movement of the automated dispensing cabinet(s).
3. Assessment to include cctv monitoring of the automated dispensing cabinets.
4. Electronic access to the particular medications in the automated dispensing cabinets
must be restricted to staff members authorised to administer those medications and
approved by the registered nurse/midwife in charge of the patient care area.
5. The automated dispensing cabinet system is to be evaluated ISMP Guidelines for the
Safe Use of Automated Dispensing Cabinets to confirm the safe and quality use of the
system.

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6. Medications stored in the automated dispensing cabinet in the packs received from the
Pharmacy Service.
7. Under facility procedures, Pharmacy Service staff members may be permitted access
to the cabinets for the purpose of stocking medications, other than Schedule 8
medications.
8. Schedule 8 medication stocking must be completed by a registered nurse/midwife with
a witness (second person) authorised by the registered nurse/midwife in charge of the
patient care area.
9. Each staff member must be assigned unique electronic access to the respective
medication receptacles within the automated dispensing cabinet that the person is
authorised to access.
10. The use of an authorised second person to witness medication administration must
include that person logging into the automated dispensing cabinet system to access
the particular medication required.
11. All access events by staff members must be recorded and retained in the automated
dispensing cabinet system for the purpose of audits.

5.5 Principles for the safe storage of accountable medications

Schedule 8 medications and Schedule 4 Appendix D medications are defined collectively as
‘accountable medications’. Under facility procedures, other medications that are also
accounted for in a register at the patient care area as described in section 5.15 are
accountable medications for the purpose of this section.
Actions to minimise risks associated with storing and handling accountable medications are
to include the following:
 under the Regulation, accountable medications being stored in accordance with a)
section 5.4.2 for Schedule 8 medications, b) section 5.4.3 for Schedule 4 Appendix D
medications, and c) section 5.4.4 for non Schedule 4 Appendix D medications when
accounted for in a register in accordance with section 5.15. Note that non-Schedule 4
Appendix D (other than propofol) and Schedule 8 medications must not be stored with
Schedule 4 Appendix D or Schedule 8 medications even when recorded in a register
 regular review of the range and quantity of accountable medications, with;
o an annual review of usage and frequency of ordering using pharmacy information
system reports
o minimisation of the range of strengths and quantity of each medication routinely
stocked
o establishing an agreed list of routinely stocked medication and quantities, and
adding this list to pharmacy inventory systems
 checking the facility’s incident management system reports to identify incidents or near
misses including those that may have resulted from selection error, and identify high-
risk medications in NSW Health Policy Directive High-risk Medicines Management
(PD2020_045) that may require further consideration including;

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o high potency medications such as hydromorphone

o unusual strengths or routes of administration
o multiple strengths of the same medication
o look alike or sound alike preparations, such as MS Contin and OxyContin
o similar manufacturer packaging
o bulky items, such as one litre bottles
o oral liquids, as it may be difficult to perform balance checks
 reviewing controls based on risk assessment, for example;
o identifying items which must not be routinely stocked, but must instead be
dispensed for individual patients and returned to the Pharmacy Service when no
longer in use
o separate shelf locations for items prone to mix-up, such as oxycodone,
hydromorphone and morphine preparations. NSW Health Policy Directive High-
Risk Medicines Management (PD2020_045) includes a Hydromorphone Standard
that details requirements for hydromorphone storage
o redesigning accountable medication storage units, such as increasing capacity,
separated storage of Schedule 8 and Schedule 4 Appendix D medications, or
separate storage for large volume preparations
o labelling medication storage units with the included contents
o maintaining separate, clearly labelled drug registers for items prone to mix-up and
the associated risk of a selection error
o matching the order of medications in drug registers to the shelf order in the storage
units
 reviewing workflow by;
o ensuring authorised persons are not accessing a Schedule 8 medication storage
unit alone
o ensuring a second person check can be performed with both people sighting the
original medication order at the time of the selection of the medication and
preparation of the prescribed dose, and both being present for the administration of
the dose and the discarding of any unused portion
o ensuring oral/enteral dispensers are in use for oral/enteral liquid medications
o checking for clutter, and reviewing signage
o adding a workbench underneath medication storage units to reduce spillage and
breakage
o eliminating the location of waste bins from under medication storage units to
reduce potential losses
 labelling of shelves and medications with;
o the inclusion of suggested order (imprest level) quantities
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o the inclusion of warning labels for high risk preparations, applied to shelf labels
and/or to individual products
o the use of ‘Tall Man’ lettering. The National Tall Man Lettering List was developed
to help reduce the risk of medication selection errors for medications with look-a-
like, sound-a-like medication names. . A Tall Man Lettering resource for staff is on
the Clinical Excellence Commission webpage.
Medication safety, as well as routine storage/access requirements, must be considered
during the development or redevelopment of clinical areas.
Considerations in the redesign must include:
 reviewing number of patients, patient case mix, and therefore medication requirements
which may inform different storage requirements
 increasing the size of medication storage units that are routinely supplied, depending
on the anticipated volume of medication to be stored
 considering lockable refrigerators to enable refrigerated accountable medication to be
appropriately stored
 considering the appropriateness of the use of automated dispensing cabinets, in
accordance with legislative and NSW Health policy requirements
 ensuring adequate bench space surrounding the medication storage units, and
positioning in a low traffic area
 ensuring medication storage units are accessible without undue bending or reaching
 reviewing the proximity of the sink and waste disposal unit to the medication storage
units
 ensuring larger metal safes have floor reinforcement or supports.

5.6 Procedural units/operating theatres – additional

considerations
Systems must be established to minimise misadventure associated with medication supply
and use in procedural units and operating theatres.
Systems must include:
 the regular review of requests for non imprest list medications by the registered
nurse/midwife in charge of the unit with the pharmacist and attending authorised
prescribers, for the purpose of additional medications being included on the imprest
list
 assessment and verification by a pharmacist of the suitability for use of additional
imprest medications before being placed into stock
 separated storage of imprest and non-imprest medications
 Under facility procedures, unused patient-labelled medications being returned to the
Pharmacy Service

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 a registered nurse/midwife checking all stock on receipt to identify any variation from
the current medication packs, pack sizes or brand names
 facility procedures to notify staff when new medications, or variations to existing
medications, are introduced
 facility procedures to regularly review medication storage units (including size and
design) and shelf labelling to confirm suitability.

5.7 Radiopharmaceuticals – additional considerations

Nuclear medicine facilities are required to have a Radiation Management Licence and
Radiation Management plan for the safe use of radiopharmaceuticals.
Good Radiopharmacy Practice is covered in the Australian Radiation Protection and Nuclear
Safety Agency Radiation Protection Series (RPS) 14.2 Safety Guide for Radiation Protection
in Nuclear Medicine.
The corresponding Code of Practice, RPS14, has been gazetted in NSW under the Radiation
Control Regulation 2013 and is enforceable by law in NSW. RPS14 and RPS14.2 cover all
aspects of radiopharmaceutical use including justification of the procedure, optimisation of
the activity, safe administration, storage requirements, protection of carers and members of
the public and waste disposal.
Standards for the security of radioactive substances is in the NSW Health Protecting People
and Property Manual.

5.8 After-hours medication store supplies

To minimise the need to access the Pharmacy Service after hours, where appropriate, a
separate medication store may be used to access medications for inpatient use that are
currently unavailable in a particular patient care area.
The store must be stocked by the Pharmacy Service with an appropriate range of
medications, either in the manufacturers' original packs, or re-packed and labelled by a
pharmacist. Schedule 8 and Schedule 4 Appendix D medications must be stored apart from
all other medications. The medications in NSW Health Policy Directive High-Risk Medicines
Management (PD2020_045), which includes methotrexate tablets, must not be included in
the after-hours medication store.
The medication store must be located in a convenient, supervised area and must be locked
when not in immediate use. Consideration must be given to the layout of the store to reduce
the risk of medication selection errors.
Under facility procedures, the store must only be accessed after hours and only by senior
nursing or midwifery staff, for example the after-hours nurse/midwife manager/delegate, or
medical staff. Procedures must include the maintenance of a register to track the date and
time each staff member accesses the store and procedures for reviewing medication orders
to ensure medication selection is correct. Schedule 8 drug register transactions must be
made with a witness.
Any removal of stock from this store must be recorded, including, as a minimum:

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 the date and time the store is accessed

 the name, strength, form and quantity of the medication removed
 the name of the patient
 the name of the patient care area where the medication was used
 the name and designation of the staff member removing the medication.

5.9 Supply for patient at home use by an authorised prescriber

It is always safer for medications for patients to take home to be dispensed from the
Pharmacy Service. To accommodate situations when patients are discharged after-hours and
the Pharmacy Service is unavailable, the patient care areas must have access to a store of
medications that are packed and labelled suitable for discharge, such as in the after-hours
medication store.
Where there is no after-hours medication store, or the required medication is not in the store,
the authorised prescriber may access medications in a patient care area (such as the
Emergency Department) under facility procedures. The medication store must include Drug
and Therapeutics Committee approved stock of essential medications for supply by an
authorised prescriber, or by an authorised registered nurse/midwife in a remote area facility
in the circumstances provided for in section 5.13.1. The use of this store will minimise the
need to access the Pharmacy Service after hours.
The store is for use in the following circumstances:
 non-admitted patients requiring immediate treatment upon leaving the facility
 circumstances when a patient presents to the facility seeking a previously prescribed
essential medication for which his/her supply has been unexpectedly exhausted
 inpatients discharged after-hours when the Pharmacy Service is unavailable
 palliative care in the home setting when crisis packs are required after hours.
The facility must have a Drug and Therapeutics Committee approved procedure for
documenting supply from this store. The procedure must include the maintenance of a
register to track the date and time each staff member accesses the store and procedures for
reviewing medication orders to ensure medication selection is correct.
The Drug and Therapeutics Committee must have procedures in place that significantly limit
in what circumstances an authorised prescriber may dispense Schedule 8 and Schedule 4
Appendix D medications as there is a significant risk of persons having these medications
supplied by multiple prescribers. In such circumstances pre-packaged and labelled doses are
preferable. Schedule 8 medication recording in the patient care area drug register must be in
accordance with section 5.14.1.
The medications dispensed by an authorised prescriber for a patient to take home must be
recorded in full in the patient’s medication record. Under facility procedures, health facilities
may require an additional record for stock control purposes.
The authorised prescriber must label the medication with:
 the date of supply
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 the patient’s name

 the name, strength, form and quantity of the medication supplied
 adequate directions for use
 the words KEEP OUT OF REACH OF CHILDREN in red on a white background
 the name, address and telephone number of the hospital
 if the substance is intended for external use only the words FOR EXTERNAL USE
ONLY or the word POISON, in red on a white background
 if applicable, the ancillary label with the associated warning statement required for the
particular medication (see section 4.5.7).
A supply of ‘blank’ labels with the name, address and telephone number of the facility, the
words KEEP OUT OF REACH OF CHILDREN in red on a white background and the required
ancillary label with the associated warning statement required for the particular medication is
recommended for this purpose.
The medications specified in section 4.5.5 are to be supplied in child resistant packaging,
although the authorised prescriber can exercise discretion and not supply the medication in
child resistant packaging of the opinion that the patient would suffer undue hardship through
difficulty in opening the container.
Repacked medication in blister sheets must be supplied in a carton or zip-lock bag.

5.10 Medication kits for home visits and patient transport

services

5.10.1 Community nursing, Hospital in the Home and outreach services

A patient care area such as a community health centre, clinic or ward may hold a range of
medications in a locked bag or box that can be taken for home care services such as
community nursing services, outreach services and Hospital in the Home, then immediately
returned to the patient care area.
The list of medications and the quantities stored in this medication kit must be approved by
the Drug and Therapeutics Committee. The Pharmacy Service must oversee the medication
storage and temperature requirements.
Maintenance of the stock levels in the medication kit is the responsibility of the registered
nurse/midwife in charge of the patient care area or service. The kit must be kept in a locked
room or cupboard at the centre or clinic when not in use, and which may be with other non-
Appendix D Schedule 4 medications held at the facility.
If the kit needs to be kept in the car during a home visit, the car must be locked and the kit
kept out of sight.
The staff member (registered nurse/midwife or authorised prescriber) carrying the kit must
consider the potential for the medications to be subjected to temperatures in excess of that
stated on the medication packs, and storage in an insulated container (such as an esky)
could be used accordingly as advised by the Pharmacy Service.

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The kit must not include Schedule 4 Appendix D medications or Schedule 8 medications.
Where these medications may be required for a particular patient visit, they may be added to
the kit from the stocks held at the health facility on a visit-by-visit basis, then returned to the
respective patient care area storage unit(s). Facilities must make and retain a record of the
transfers, as well as the associated administration, of Schedule 4 Appendix D and Schedule
8 medications procured for the kit. Entries documenting Schedule 8 medication transfers,
supplies and administrations must be recorded in a separate Schedule 8 drug register
maintained for each kit. Corresponding entries documenting the Schedule 8 medication
transfers to the kit must also be recorded in the patient care area’s Schedule 8 drug register.
Under facility procedures, medications administered from the kit may either be nurse-initiated
medications, on a medication order by an authorised prescriber, as a telephone, video call,
email or facsimile order to the staff member or under a Standing Order. The administration
must be recorded on the medication order (as applicable) as if the medication was
administered in a patient care area.
Unwanted medications may be taken by the patient or patient’s carer to a community
pharmacy for disposal. Where this is not practical, the public health facility staff member may
deliver the medications to the community pharmacy or return these to the public health facility
for disposal under local procedures.
NSW Health Protecting People and Property Manual section Working in the Community
details standards for staff in patients’ homes, within community health centres and public
venues such as schools or community halls and in mobile units.

5.10.2 Patient transport services

When patients are transported between facilities or a home address by a public health
organisation patient transport service, arrangements may be made for the patient to self-
administer patient-labelled medications during transit. The medications must be securely
packed, for example, in a sealed plastic bag. The bag must be labelled with the patient
details. During transportation the medication can be placed with the patient’s luggage. This
must be communicated in handover to the receiving facility or at the patient’s home (as
applicable).
Otherwise a nurse is to administer any required medications on a medication chart order as if
the patient was at a public health facility.
A nurse may also carry a kit of medications that may be required for emergency use during
transport, however, only a registered nurse or midwife may carry a stock supply of a
Schedule 8 medication. The administration of the medication is to be:
 On a telephone or email order from an authorised prescriber, or
 Under a standing order, or
 Under nurse-initiated medication protocols (excludes Schedule 4 and Schedule 8
medication).
Note: HealthShare NSW nurses have been authorised under the Poisons and Therapeutic
Goods Regulation 2008 to administer a small range of medications for emergency use under
protocols in the HealthShare NSW Patient Transport Service Medication Management Policy.

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5.11 Disaster packs supplies

Medications included in disaster medical equipment kits are determined in accordance with
the NSW Health Guideline Major Incident Medical Services Supporting Plan (GL2018_017).
Prepared packs, which may include Schedule 8 medications, must be stored in a locked
room or cabinet, with access limited to authorised personnel only. A suitable person, such as
the registered nurse/midwife in charge of the adjacent patient care area or the director of
pharmacy must be appointed as being responsible for ensuring secure storage of the packs,
and for the maintenance of the medications held in the packs.

5.12 Discharge medications and return of patient own

medications
Under facility procedures a registered nurse/midwife, enrolled nurse, authorised prescriber or
pharmacist may provide the following medications to a patient, or the patient’s carer, on
discharge:
 discharge medication dispensed and labelled by the Pharmacy Service, or labelled
and recorded by an authorised prescriber
 the patient own medications surrendered by the patient to the patient care area on
admission.

5.12.1 Supply of discharge medications

All discharge supplies must be recorded in the patient’s health care record as having been
provided to the patient (or the patient’s carer).
Schedule 4 Appendix D and Schedule 8 medications must be stored separate to all other
medications pending supply to the patient in accordance with section 6.3.2 and section 6.3.3.
An exception is for discharge medications supplied in a sealed, tamper evident container
labelled with the contents and patient details which may be stored in the Schedule 4
Appendix D medication cabinet or Schedule 8 medication safe or cabinet. Schedule 8
medications kept in the patient care area must be recorded in the drug register with a
witness.
Hospitals must develop appropriate systems for the supply of medications to patients at
discharge to ensure continuity of care between the hospital and the community in accordance
with NSW Health Policy Directive Care Coordination: Planning from Admission to Transfer of
Care in NSW Public Hospitals (PD2011_015) and the provided in the Guiding principles to
achieve continuity in medication management.
Systems must include the following:
 planning for a patient’s discharge, temporary leave, or transport to another point of
care, including the arrangement for medication supply during the Pharmacy Service
opening hours so that an adequate quantity of medication is dispensed to ensure
continuity of care until the patient is able to obtain future supplies. Where a dispensed
supply from the Pharmacy Service has not been arranged and the Pharmacy Service
is closed, an authorised prescriber may dispense the medication appropriately packed
and labelled with full directions for use
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 the dispensing pharmacist taking into account the individual needs of the patient, for
example those with visual impairment or manual dexterity impairment, who may
experience difficulty in opening certain containers
 the prescriber reviewing the patient’s medication prior to authorising discharge
medication, where applicable in conjunction with the ‘Medication Management Plan’
form (or equivalent, in accordance with facility procedures) initiated for the patient at
the time of admission. This includes checking patient own medications scheduled for
return to the patient to exclude conflict with the discharge supplies being provided by
the Pharmacy Service
 accurate information on the patient’s medication being communicated to the patient’s
general practitioner (or primary care provider as applicable) at the time of discharge
 written information being provided to patients on how to take their medication at home,
and of any changes to their medication regimen since admission. This may also
include Consumer Medicine Information and/or facility published information pertaining
to the treatment.

5.12.2 Return of patient own medications

Medications surrendered by the patient on admission must be placed in a labelled and sealed
transparent bag. The patient identification sticker/label must not be applied directly to the
patient’s own medications as this may be misconstrued to be a dispensing label and/or may
obstruct important information.
Under facility procedures all patient own medications and medications for discharge
(meaning Schedule 4 Appendix D, Schedule 8 and all other medications) may be kept
together and stored out of public access pending being provided to the patient for at home
use. Access to the storage unit must only be by staff authorised by the nurse/midwife in
charge of the ward/clinic.
Under facility procedures, patient own medications are to be retained in the patient care area
and disposed of with the patient or carer’s consent, where a medication or substance:
 Cannot be identified/verified, or
 Is in a dose administration aid, or
 Is unlabelled, or
 Does not have a dispensing label affixed or is labelled for another person, or
 Has been ceased since admission, or
 The amount of medication brought in is excessive.
In addition, for patients who have been admitted with deliberate self-poisoning, the attending
medical officer must determine whether it is appropriate for the patient own medications
brought into the hospital to be returned to the patient on discharge.
Where consent is not granted by the patient or carer for the facility to retain patient own
medication, the matter must be escalated to a medical officer suitably qualified to assess the
patient’s continuing risk of self-harm (where relevant) and decision-making capacity.
Decision-making capacity can be impaired by mental illness and other conditions such as
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dementia and delirium. It may be appropriate to consider treating the patient under the
provisions of the NSW Mental Health Act 2007 and/or the NSW Guardianship Act 1987 – see
also Safety Notice SN008/18 Return of Patient’s Own Medicines.
Any medications returned on discharge must be recorded in the patient’s health care record
as having been returned to the patient or carer.

5.13 Additional supplies by registered nurses

5.13.1 Emergency after hours supply by registered nurses in rural and

remote areas
Registered nurses are authorised by an instrument issued under the Regulation to supply
emergency Schedule 2, 3 or 4 medications (Schedule 8 medications are excluded) to
outpatients (including the emergency department) attending a rural or remote Local Health
District hospital when the Pharmacy Service is unavailable and an authorised prescriber is
not present at the facility, in accordance with the following requirements:
 the registered nurse is employed by the Local Health District
 an authorised prescriber is unable to attend the facility to supply the medication to the
patient
 an authorised prescriber has authorised the supply (dispensing) of the medication to
the patient for emergency use remotely (outside of the health facility) by electronic
order in the facility’s eMeds system, or by telephone, video call, facsimile, or email
 the patient is in immediate need of the medication and neither a community pharmacy
nor hospital Pharmacy Service is available in close proximity
 the medication is included on the list (with the associated quantity) of medications
which may be supplied for emergency patient supply as determined by the Drug and
Therapeutics Committee
 the registered nurse records the details of the medication order received from the
authorised prescriber and the quantity of medication supplied to the patient in the
patient’s health care record
 where possible, the authorised prescriber’s telephone order is confirmed by a second
person
 the medication is supplied in its unopened pack
 a label containing the information in section 5.9
 where the medication is a paediatric mixture requiring the calculation of the dose for
the individual patient the authorised prescriber must calculate the dose according to
the weight of the patient and then specify the actual dose volume in mL for the nurse
to enter on the medication label
 where applicable, the labelled medication is checked by the second person who
confirmed the authorised prescriber’s telephone order.

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5.13.2 Supply of tenecteplase to NSW Ambulance Paramedics

A registered nurse in charge (or his/her delegate) of the Emergency Department of a public
hospital that receives a patient following prehospital administration of thrombolytic therapy, is
permitted to supply a NSW Ambulance paramedic with one vial of tenecteplase 50 mg from
Emergency Department stock to restock the Ambulance medication kit in accordance with
the NSW Health Information Bulletin on Tenecteplase Replacement in Public Hospitals for
Ambulance Paramedics (IB2013_063).

5.14 Patient care area Schedule 8 drug register

5.14.1 Records in the Schedule 8 drug register

The registered nurse/midwife in charge of the patient care area is responsible for ensuring
that a record is kept of all transactions in a drug register relating the Schedule 8 medications
stored in the Schedule 8 medication drug safe/cabinet.
Unless otherwise approved in electronic form under NSW Health Framework for Use of an
Electronic Drug Register Requiring Dual Signatures, the drug register must be the State
Forms bound book with consecutively numbered pages (unless otherwise approved under
facility procedures).
A separate page must be used for each form and each strength of the Schedule 8 medication
active ingredient. Where brands of the same strength and form need to be differentiated (for
example, methadone liquid formulations) they may be on separate pages under facility
procedures.
A separate page may be used for each individual patient use medication also under facility
procedures. Patient own medication and discharge medication in a tamper-evident bag
labelled with the contents may be recorded on a separate page.
The record in the drug register must include in handwriting or in an approved electronic form:
 the date and time of the transaction
 in the case of medications received into stock, the name of the source (for example
the Pharmacy Service), and the quantity received
 in the case of a medication which is administered to a patient, supplied to a patient (for
example as discharge medication or returned patient own medication) or supplied to
an authorised prescriber (such as an anaesthetist) for a procedure, the patient’s name,
the name of the prescriber, and the amount administered or supplied as;
o for liquids, in millilitres (mL), or
o for solid dosage forms, as discrete units, for example 1 or 0.5 with tablets (if the
medication is suitable to be given as a part tablet), or
o for ampoules, as discrete units, (for example 1 or 0.5) OR as the dose (for example
10 mg or 5 mg) in accordance with Drug and Therapeutics Committee approved
procedures

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 the amount discarded, where only a portion of the medication (tablet or injection) is
administered. Note: The exception is for a medication supplied to an authorised
prescriber (such as an anaesthetist) for a procedure (see section 6.9.1).
 where known, the irretrievable and discarded amount in the delivery device, such as in
the dead space of an oral/enteral syringe (for example, 0.2 mL, depending on the
particular syringe)
 for a medication which is expired, unusable or unwanted, the amount destroyed by a
pharmacist or the authorised officer of the medication supply service at a facility where
there is no employed/contracted pharmacist (see section 5.16.2).
 the balance remaining in the drug register after the transaction. Any deficit must be
recorded and reported in accordance with section 5.17
 the full and legible name and signature of the person making the entry, either
receiving, administering, discarding, destroying, or carrying out a balance check
 the full and legible name and signature of the witness to the transaction.
The authorised person making an entry in a patient care area drug register:
 must not make any false or misleading entry
 must not make any alterations, obliterations or cancellations. That is, no lines may be
drawn through entries, no entries scribbled out or crossed out in any way, nor
numerals altered. If a mistake is made, the entry must be left as it is, marked with an
asterisk, rewritten as corrected on the next line (and countersigned by the second
person) with a marginal note or footnote explaining the error (signed and dated by
both staff members), also marked with an asterisk.
Implementing the New Ward Register of Drugs of Addiction (November 2015) is available on
the NSW Health webpage.
Notes
For oral liquids, reconciliation of the balance on hand must occur after the last available dose
is removed from the bottle. Overage (excess) is accounted for by adjusting the balance
upwards with an additional entry on the next line of the drug register page.
Other than for reconciliation after the last available dose is removed, liquids must not be
decanted for measuring by anyone other than a pharmacist, or delegate approved by the
nurse/midwife in charge of the patient care area. Exceptions are for methadone liquid dosing
devices, see section 5.3.
Where the Schedule 8 medication is being administered to a patient temporarily transferred
from another patient care area, this must be noted by the administering person in the
patient’s health care record for the purpose of future reference, as well as for Schedule 8
medication audit purposes.
Unused doses such as those refused by the patient or ampoules drawn up but not used (for
example in resuscitation units) must be entered back into the drug register by the
administering person with the same witness, with a footnote explaining the circumstance. The
reason for the non-use must also be documented in the patient’s health care record (as
applicable in the circumstance). Under facility procedures, the medication is to be secured in
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a sealed, clear container and labelled with the medication name and amount and kept in the
Schedule 8 drug safe/cabinet. Destruction must be by a pharmacist, or the authorised officer
of the medication supply service at a facility where there is no employed/contracted
pharmacist (see section 5.16.2).
For spillage or breakage of a Schedule 8 medication witnessed by at least two staff
members, as it actually happens, the two staff members must immediately discard the
medication (see in section 6.9). The circumstances of the spillage or breakage must be
entered in the drug register with a witness as a footnote (or under facility procedures in an
electronic drug register) and reported to the nurse/midwife in charge of the patient care area
(see section 5.17.1).

5.14.2 Witness to Schedule 8 medication transactions

The witness to a Schedule 8 medication transaction must be a person who is fully familiar
with Schedule 8 medication handling and recording procedures. This may include a
registered nurse or registered midwife, an authorised prescriber, a pharmacist, and any other
person authorised by the registered nurse/midwife in charge of the patient care area to
complete this task, such as an enrolled nurse or anaesthetic technician.
The witness must be present during the entire procedure that is:
 the removal and replacing of the medication from the Schedule 8 medication storage
unit
 the preparation of the medication (as applicable), such as drawing up into a syringe
 the discarding and rendering unusable any unused portion of the medication (as
applicable)
 the recording in the Schedule 8 drug register
 the transfer to the patient
 the administration to the patient.
Facility procedures must include risk mitigation strategies for circumstances where the
witness cannot be present throughout the procedure. For example, throughout the
administration of an infusion containing a Schedule 8 medication and second person checks
in the circumstances specified in section 6.8.

5.14.3 Balance checks in the Schedule 8 drug register

The registered nurse/midwife in charge of the patient care area must ensure that the balance
of Schedule 8 medications recorded in the drug register is checked against the physical
balance in the Schedule 8 medication storage unit(s) at least once every 24 hours. However,
an exception is provided if the patient care area is closed when the balance check is due and
the drug safe key (where used) is secured under facility procedures (see section 5.4.2).
In accordance with facility procedures, in high usage patient care areas a Schedule 8
medication balance check is be done every shift change, such as two to three times daily
depending on the setting.

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A registered nurse/midwife who assumes control over the Schedule 8 medication stock as
the person in charge of a patient care area for a period of one month or more must also
conduct a full balance check at the time of the handover.
Each balance check must be carried out by a registered nurse/midwife with a witness and
recorded in the drug register on the relevant page for each Schedule 8 medication. The entry
must state the quantity of medication actually held at the time of the balance check. A visual
estimate of liquid medications is to be conducted.
Where there is a discrepancy between the drug register balance and the physical balance in
the Schedule 8 storage unit, this must be recorded and reported in accordance with section
5.17.

5.14.4 Schedule 8 drug register audits

In addition to balance checks, regular audits of patient care area Schedule 8 drug registers at
intervals approved by the Drug and Therapeutics Committee must be conducted to confirm
records are meeting legislative and policy requirements and also to detect any possible
misappropriation.
Where an area of non-compliance or concern is revealed, appropriate steps must be
instituted to rectify the issue.
Audits must be performed by two staff members authorised under facility procedures to
perform the task, one of which must be independent of the patient care area’s
nursing/midwifery staff.
Facility audit procedures must include:
 checks of entries recording stock received against the patient care area and Pharmacy
Service records
 checks and verification of signatures for the purpose of detecting forgeries
 verification of the drug register contents page against the corresponding drug register
pages
 verification of the ‘carried forward’ balances
 verification that the routine 24-hour balance checks (or more frequently in accordance
with facility procedures) have been conducted
 verification that the Schedule 8 medications that have been found to be lost or stolen,
including broken ampoules, have been reported and recorded in accordance with the
procedure described in section 5.17
 a review of the frequency of broken ampoules and discarded portions of ampoules and
tablets
 a review of the presence of altered, obliterated and cancelled entries
 a selection of patient medication chart checks against the respective Schedule 8 drug
register entries.

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5.15 Additional accountable medication recording in a register

In order to minimise the risk of misappropriation or misuse, under the Drug and Therapeutics
Committee approved procedures, the facility Chief Executive may direct certain medications
in addition to Schedule 8 medications to be recorded in a register, and also if directed, with a
witness to the transaction (as if it was a Schedule 8 medication). This may apply particularly
in areas of high usage of medications known to have a risk of misappropriation such as in
operating theatres and recovery wards.
Where used, the register is to be kept separate to the Schedule 8 drug register.
Typical medications that may be recorded in a register are:
 Schedule 4 Appendix D medications such as benzodiazepines, particularly midazolam
 non-Appendix D Schedule 4 medications such as;
o propofol
o methoxyflurane
o the Schedule 4 codeine phosphate hemihydrate combination products.
Note: Additional medications, other than a Schedule 4 Appendix D medication or propofol,
recorded in a register must not be stored with Schedule 8 and/or Schedule 4 Appendix D
medications.

5.16 Disposal of expired, unwanted or unusable medications

5.16.1 Disposal of medications – general requirements

Unwanted medications in patient care areas include:
 expired, contaminated or damaged medication
 patient own medications not returned to the patient
 partly used packs no longer required for use.
Each patient care area must have Drug and Therapeutics Committee approved procedures
for the disposal of unwanted medications, which also must be in accordance with NSW
Health Policy Directive Clinical and Related Waste Management for Health Services
(PD2020_049).
The specific requirements for the destruction of Schedule 8 medications are detailed in
section 5.16.2. For other medications, facility procedures will direct either the disposal at the
patient care area, or return to the Pharmacy Service for disposal.
Unwanted medications that are not in the manufacturer’s original immediate container (blister
platform, foil, or sealed bottle/vial, as applicable) must not be returned to the Pharmacy
Service for the purpose of re-supply.

5.16.2 Destruction of expired, unusable or unwanted Schedule 8

medications
Expired, unusable, or unwanted Schedule 8 medications must:
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 remain recorded in the Schedule 8 drug register with the usable medication of the
same type, except for patient own Schedule 8 medication which must remain where
initially entered in the drug register
 remain stored in the Schedule 8 medication storage unit at the patient care area
pending destruction by a pharmacist or the authorised officer of the medication supply
service at a facility where no pharmacist is employed/contracted, with a registered
nurse/midwife acting as the witness to the destruction.
The expired, unusable or unwanted Schedule 8 medications must be included in the routine
stock checks pending destruction, with a procedure for securing and identifying these
medications from the usable stock of the same medication in the Schedule 8 medication
storage unit, such as storage in a sealed, clear container, with the description and quantity of
the medication enclosed written on the container.
A record of the destruction of the medication must be made in the patient care area drug
register, signed and dated by the person destroying the medication and with the registered
nurse/midwife witness also signing the drug register, in accordance with the detail listed in
section 5.14.1.
The recommended procedures for destroying the various forms of Schedule 8 medications
are detailed at section 4.8.3.

5.17 Managing and reporting the loss, theft or deficit of

accountable medications
Managing and reporting the loss, theft or deficit of the following medications is in the table in
section 5.17.1 below for:
 Schedule 8 medications
 Schedule 4 Appendix D medications
 Non-Appendix D Schedule 4 medications accounted for in a register
Reporting is not required for:
 An intact but expired, unusable or unwanted medication when;
o for an accountable Schedule 4 medication, disposed of in accordance with
section 5.16.1
o a Schedule 8 medication destroyed in accordance with section 5.16.2
 the unwanted portion of a tablet or ampoule discarded when a dose is prepared
 where known, the irretrievable amount in the delivery device such as in the dead
space of an oral/enteral syringe (for example, 0.2 mL depending on the particular
syringe) that is accounted for in the drug register as discard.
Under facility procedures, in all other cases the person who detects the loss, theft, or deficit
of an accountable medication must immediately:
 for an accountable Schedule 4 medication in a register, immediately record the
physical balance on hand in the register

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 for a Schedule 8 medication, record the physical balance on hand in the drug register
with a witness) with a note highlighting the deficit from the arithmetical balance.

5.17.1 Reporting the loss, theft or deficit of accountable medications.

Situation Report to the Report in Report to director Report to the NSW
nurse/midwife facility of nursing (see Ministry of Health (see
in charge incident Note A below) and Note B below)
management director of
system pharmacy
Loss of an Required, by Required Required, by Required, by the director
accountable nurse/midwife nurse/midwife in of pharmacy or the
medication who detected charge immediately director of nursing
(including the loss. (and within 24 immediately (and within
unwitnessed spilt hours). 24 hours). The director
medications or of pharmacy must be
broken ampoules). copied into the
notification made by the
director of nursing and
vice versa.
Suspected theft of Required, by Required Required, by Required, by the director
an accountable nurse/midwife nurse/midwife in of pharmacy or the
medication. who detected charge immediately director of nursing
the loss. (and within 24 immediately (and within
hours). 24 hours). The director
of pharmacy must be
copied into the
notification made by the
director of nursing and
vice versa.
Deficit detected at Required, by Required Required, by Not required unless
the change of a nurse/midwife nurse/midwife in deemed necessary by
liquid medication who detected charge immediately the director of pharmacy
bottle (eg 205 mL the deficit. (and within 24 and/or director of
stock on hand and hours). nursing.
210 mL balance in
the drug register).
Spilt medications Required, by Required Required, by the Not required, except
and broken nurse/midwife nurse/midwife in when the loss gives rise
ampoules witnessed who observed charge immediately to any suspicion of the
by at least two staff the spillage, or (and within 24 theft of the medication.
members when it breakage. hours).
actually happens
(see Note C below).

Note A: Under facility procedures, the director of nursing must:

 ensure that a full investigation of the loss, theft or deficit of the medication is
conducted
 with regard to a confirmed theft, report the event to the local police

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 With confirmed misappropriation by a staff member, ensure the matter is reported to

the particular health practitioner’s national registration board as well as to the NSW
Ministry of Health Pharmaceutical Regulatory Unit.
Where there is no apparent loss of an accountable medication, a staff member with
knowledge of possible or admitted misappropriation of medication must submit a report to the
director of nursing for further appropriate action. Failure to do this may result in harm to a
patient or the staff member of concern, particularly where a possibility exists that this staff
member has substance use problems and/or is health impaired.
Staff in patient care areas can pro-actively prevent the misappropriation of medications by
ensuring strict adherence to NSW Health and facility procedures.
Note B: For the loss, theft or deficit of medication that must be reported to the Ministry of
Health (in Table 1) the director of pharmacy or the director of nursing must immediately notify
the NSW Ministry of Health Pharmaceutical Regulatory Unit using the on-line notification form
and retain a copy of this notification.
The immediate notification to the NSW Ministry of Health Pharmaceutical Regulatory Unit
must be marked on the form ‘Initial Notification’. As soon as all notifiable details become
available, such as when further investigation has been conducted, a follow-up notification
must be submitted to the NSW Ministry of Health again using the on-line notification form.
Note C: For spillage or breakage of Schedule 8 medication witnessed by at least two staff
members, as it actually happens, the two staff members must immediately discard the
medication. The circumstances of the spillage or breakage must be entered in the drug
register with a witness as a footnote (or under facility procedures in an electronic drug
register) and reported to the Director of Nursing and Director of Pharmacy (see section
5.14.1).

5.18 Reporting a lost, destroyed or tampered Schedule 8 drug

register
A registered nurse/midwife at a patient care area who detects that a drug register appears
lost, destroyed, has had removed pages, or has tampered entries or pages, or with an
electronic drug register has lost data, must immediately report the matter to the registered
nurse/midwife in charge of the patient care area.
The registered nurse/midwife in charge of the patient care area must immediately:
 complete and submit a report in accordance with the facility’s incident management
system and the requirements of NSW Health Policy Directive Incident Management
(PD2020_047)
 notify the director of pharmacy and the director of nursing (however named).
The director of pharmacy must then immediately (and within 24 hours) notify the NSW
Ministry of Health Pharmaceutical Regulatory Unit in writing immediately detailing the known
circumstances of the loss, destruction or tampering.
A balance check of all Schedule 8 medications stock must be performed and entered in a
new drug register with a witness.

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Note: The disposal of a Schedule 8 drug register after the required retention period of 7 years
is not reportable.

5.19 Retention of records

The following retention periods apply to records relating to the procurement, prescribing,
administration and supply of medications in patient care areas in accordance with NSW
Health Policy Directive Health Care Records - Documentation and Management
(PD2012_069) and Government Retention and Disposal Authority 17 (GDA 17):
 2 years for;
o for medication requisitions and purchase orders
o receipts and records of medication deliveries
o inventory control records
 7 years for;
o for medication charts
o Schedule 8 drug registers
 10 years for;
o records relating to reports of the loss or theft of Schedule 8 or Schedule 4
Appendix D medications
o records of the loss or theft of Schedule 8 drug registers
 15 years for records relating to clinical trial drugs or until the patient attains 25 years
of age, whichever is longer.

6 ADMINISTERING MEDICATION

6.1 Staff administering medication

Facilities must ensure that staff members administering medications have appropriate
qualifications, training, and demonstrated current competency. Responsibility for ensuring
appropriately qualified and trained clinicians rests with the lead clinician in each department.
This section addresses medication administration from a medication order described in
section 6.2.
Competency to administer medications is included in the qualifications of medical
practitioners, dentists, nurse practitioners, midwife practitioners, registered nurses, registered
midwives, enrolled nurses and, under scope of practice, podiatrists and optometrists.
However, this is only in accordance with any practice conditions imposed by the person’s
place of employment and the endorsements, notations and conditions on the person’s
registration.

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Other health care workers may administer medications under the Regulation and in
accordance with facility procedures. Procedures for medication administration must address
the following:
 the Schedule of the medications
 the route of administration
 whether the medication is imprest or requisition stock, or labelled for a particular
patient including if in a dose administration aid
 the health care worker’s role at the facility
 any training and accreditation requirements
 risks associated with the administration of the medication.
Examples of health care workers which may be authorised under facility procedures, which
include allied health practitioners, are:
 pharmacists
 oral health therapists
 physiotherapists
 orthoptists
 radiographers (for contrast)
 radiation therapists (for contrast)
 podiatrists, for topical anaesthetics and Schedule 4 local anaesthetics for parenteral
use (Note: Podiatrists with a registration endorsement to prescribe and supply
medications on the National Board list may also administer these medications at
health facilities)
 respiratory physiologists
 nuclear medicine technologists (for radiopharmaceuticals, contrast)
 certified anaesthetic technicians
 cardiopulmonary technicians certified as clinical perfusionists
 health care staff for non-inpatients at a day centre, community setting (such as
community mental health) or domiciliary setting (such as the patient’s own home) for
the purpose of assisting the patient to self-administer the medication that has been
dispensed and labelled for the patient
 care workers at Local Health District residential care and flexible care services.
Facilities must ensure all persons authorised to administer medications have completed
training that addresses the necessary competencies and relevant workplace safety and
infection control practices in completing specific tasks, and as appropriate be re-assessed
and re-accredited for the tasks. Where applicable, procedures must address medication
administration by trainees or students.

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A higher level of skill may be needed for the safe administration of an individual medication or
class of medication, or for carrying out certain clinical functions, such as intravenous
administration. The level of clinical support required must also be considered relevant to each
clinical situation and according to best professional practice guidelines.

Trainees and students undertaking medication administration

A student placement agreement must be in place for a student to administer medications
within the facility. Trainees or students in any category must adhere to facility procedures
when administering medication and recording the administration. A trainee or student must
be directly supervised by the appropriate authorised person when administering any
medication.

6.2 Orders for medication administration

An authorised prescriber’s order for the administration of unscheduled, Schedule 2, Schedule
3, Schedule 4, and Schedule 8 medications to a patient may be in the form of:
 a written order on an individual patient’s medication chart or anaesthetic record
 an electronic order in the eMeds system
 a Standing Order
 a verbal (face to face), telephone, video call, email or facsimile order
Medication orders via Short Message Service (SMS) or texting are not permitted and are not
legally valid.
The person administering the medication must record the administration in the appropriate
section of the patient’s medication record. Where applicable, the staff member witnessing the
administration must countersign the administration record.

6.3 Administering from a verbal, telephone, video call, email or

facsimile order

6.3.1 Verbal (face to face) medication orders

Verbal (face to face) orders must not be used with the exception of:
 emergency situations where providing a written or eMeds order would compromise the
speed of delivery/administration of the emergency medication
 during circumstances where the prescriber is undertaking a procedure on a patient
and is unable to create a written order for that patient.
The person receiving a verbal order must be an authorised person to administer the
particular medication in the patient care area. The prescriber must verify with the person
receiving the order that all medication records have been checked, and that the patient does
not have an allergy or has not experienced a significant adverse drug reaction to the
medication before giving the order.

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Due to the risk of misinterpretation, all verbal (face to face) orders must be verified with the
prescriber prior to administration. A ‘closed-loop’ communication technique must be used to
verify the:
 patient identity (including the patient’s name, date of birth and medical record number)
 medication, form and strength
 route for administration
 dose (with numbers in figures and words (for example, 50mg: fifty milligrams, five zero
milligrams)
 patient’s allergy and adverse drug reaction status.
Verbal (face to face) orders must be documented in the patient’s health care record.
Under the Regulation, the prescriber must confirm all doses administered on a verbal (face to
face) order as soon as possible either by:
 Counter-signing the record of administration (in electronic form where recorded in an
eMeds system), or
 Sending written confirmation of the order via email or facsimile for inclusion, as
applicable, on the patient’s hard copy (paper) medication chart or scanned in the
patient’s electronic health care record.
If verbal (face to face) orders are not confirmed by the prescriber within 7 days, the facility is
required to report this in writing to the NSW Ministry of Health Pharmaceutical Regulatory
Unit so that Ministry officers can monitor compliance.

6.3.2 Telephone and video call orders

Telephone or video call orders must only be provided in circumstances when the prescriber is
unable to write directly into a medication chart or provide an eMeds system order. The
person receiving a telephone or video call order must be an authorised person to administer
the particular medication in that patient care area. The prescriber must verify with the person
receiving the order that the patient does not have an allergy or has not experienced a
significant adverse drug reaction before giving the order. Due to the risk of misinterpretation,
all telephone or video call orders must be verified with the prescriber prior to administration.
A ‘closed-loop’ communication technique must be used to verify the:
 patient identity (including the patients name, date of birth and medical record number)
 medication, form and strength
 route for administration
 dose (with numbers in figures and words (for example, 50mg is stated as ‘fifty
milligrams, five zero milligrams’)
 patient’s allergy and adverse drug reaction status.
Under facility procedures, the prescriber is to repeat the telephone or video call order to a
second person authorised to administer the particular medication in that patient care area
(where available). The order is to be verified by the second person with the prescriber prior to
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administration. However, facility procedures to mitigate risks associated with telephone or

video call orders must be in place where the staff member taking the order does not have a
person present, such as for Hospital in the Home and community nursing/outreach services.
When a person administers a medication from a telephone order, the administration must be
recorded on the medication chart in the ‘Telephone Orders’ section or in the eMeds system
under facility procedures.
Where a prescriber's telephone instruction is to cease a medication, the person receiving the
instruction may endorse the medication chart accordingly with the words ‘ceased as per
phone order’, the prescriber’s name, the staff member’s name and signature, and the date
and time. A corresponding entry must also be made in patient’s health care record, including
the reason given for ceasing the order.
The prescriber must confirm within 24 hours all doses administered on a telephone or video
call order either by:
 Counter-signing the record of administration (in electronic form where recorded in an
eMeds system under facility procedures), and attending to review the patient as soon
as appropriate, or
 Sending written confirmation of the order via email or facsimile for inclusion, as
applicable, on the patient’s hard copy medication chart or scanned in the patient’s
electronic health care record.
If telephoned or video call orders are not confirmed by the prescriber in writing, by facsimile
or by email within 7 days, the facility is required to report this in writing to the NSW Ministry of
Health Pharmaceutical Regulatory Unit so that Ministry officers can monitor compliance.

6.3.3 Email and facsimile orders

Email and facsimile orders must only be provided in circumstances when the prescriber is
unable to write directly into a medication chart or provide an electronic order. The person
receiving such an order must be an authorised person to administer the particular medication
in that patient care area. The prescriber must verify with the person receiving the order that
the patient does not have an allergy or has not experienced a significant adverse drug
reaction before giving the order.
When a person administers a medication from an email or facsimile order, this order must, as
applicable, be attached to the patient’s hard-copy medication chart or scanned in the
patient’s electronic health care record. This order is used to administer the medication until
the order is updated with the other medication orders on the patient’s medication chart or
electronic medication order by an authorised prescriber. Under the Regulation email or
facsimile orders must not be used for ongoing medication administration.
Note: The above requirements do not apply to the medication order for a patient of Justice
Health and Forensic Mental Health Network if confirmation of the order for administration is
given in accordance with the requirements in the approved facility procedures.

6.4 Standing orders and administration/supply under a protocol

Standing orders provide authorisation by an authorised prescriber for the administration (or
supply for administration where applicable) of medication without a patient-specific written
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order in specific clinical and emergency situations (with the exception of a standing order for
dose adjustments only which require a medication order prior to commencement).
Facilities must identify appropriate governance, identify and manage the risks of
misadventure, and approve the relevant standing order protocols. Authorising the use (and
subsequent administration recording) of specific medications will vary according to the
context.
The Drug and Therapeutics Committee must:
 maintain oversight of all standing orders
 approve all standing orders
 have a program for re-approving and re-endorsing all standing orders under the locally
determined time period for review (such as every one to two years).
All standing orders must be:
 consistent, as applicable, with the respective medication’s approved Product
Information, evidence-based clinical practice guidelines (including for off-label use)
and other relevant NSW Health policies and directives
 endorsed, signed and dated by an appropriate senior medical officer.
A standing order must contain sufficient detail for the information of staff administering the
medication (or supplying for administration where applicable) including:
 indications and contraindications for use (including possible interaction with other
medications)
 the medication’s form, strength, dose, route of administration and frequency of
administration.
In addition, standing orders include:
 any specific training, qualifications, skills or competencies required to prescribe or
administer the medication
 any restriction on the categories of staff who may administer or supply the medication
 the clinical areas where the standing order can be used.
The NSW Health Policy Directive High-Risk Medicines Management (PD2020_045) must be
referred to when developing a standing order for a high-risk medicine.
When a medication is administered according to a standing order, the details must be
recorded on the patient’s medication record or anaesthetic record where applicable.

6.4.1 Standing orders for emergency treatment

An authorised prescriber approved under the standing order must confirm the administration
by countersigning the record of the administration relevant to the order within 24 hours.

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6.4.2 Standing orders for dosage adjustments only

Standing orders for protocols in which doses are adjusted according to an approved set of
clinical criteria may include intravenous unfractionated heparin, insulin or infusions of
inotropes. A medication order is required prior to commencement.
Dose adjustments must be recorded in the patient’s medication record. Under facility
procedures, an approved prescriber must document every 24 hours on the medication record
that the order is to continue.
NSW Health Policy Directive High-Risk Medicines Management (PD2020_045) includes the
Anticoagulants Standard which includes requirements for intravenous unfractionated heparin
protocols.

6.4.3 Individual prescriber standing orders

An individual prescriber’s standing order authorisation provides for administration of
medication to their patients only. Examples may include medications and fluids administered
peri-operatively or for analgesia during labour at the specific request of an individual
prescriber. The individual prescriber or approved delegate must countersign the record of
administration relevant to the order in the patient’s medication record within 24 hours.

6.4.4 Standing orders for routine procedures and programs

In the absence of an authorised prescriber, medication administration or supply for patient
take-home use for routine procedures and under certain programs conducted at or by a
facility may be carried out under a standing order within the particular context of the
administering/supplying person’s practice (see also section 6.1 ‘Who May Administer
Medication’). Examples include:
 agents administered by anaesthetic technicians
 agents administered by clinical perfusionists
 contrast administered by radiographers or radiation therapists
 radiopharmaceuticals and contrast administered by nuclear medicine technologists
 registered nurses for a public health emergency response in accordance with NSW
Health Policy Directive Statewide Standing Orders for the Supply and Administration
of Medication for Public Health Response (PD2016_035).
 registered nurses in emergency departments under NSW Health Policy Directive
Emergency Department, Nurse Delegated Emergency Care, Medication Standing
Orders (PD2015_024).
Facility procedures must determine whether the particular procedure or program requires that
an authorised prescriber approved under the standing order must confirm the
administration/supply by countersigning the record of the administration/supply
Note: A standing order for a Schedule 4 or Schedule 8 medication must be confirmed by an
authorised prescriber by countersigning the record of the administration/supply relevant to
the order within 24 hours.

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6.4.5 Administration/supply under a protocol

Statewide protocols have been implemented for health facility staff administration and/or
supply of medication for patient at home use. An authorised prescriber’s counter signature
subsequent to the administration or supply is not required. Protocols have been implemented
for:
 vaccine administration by accredited registered nurse/midwife vaccinators for the
purpose of a vaccination program under NSW Health Policy Directive Authorised
Nurse Immunisers and Authorised Midwife Immunisers (PD2022_016)
 sexual health treatments under NSW Health Policy Directive RN Supply and
Administration of STI Therapies in Publicly Funded Sexual Health Services
(PD2020_024)
 naloxone (Schedule 3) under NSW Health Policy Directive Take Home Naloxone
(PD2020_027)
 pharmacist initiation and administration of vaccines under the NSW Pharmacist
Vaccination Standards, under a program approved by the Chief Executive.

6.5 Nurse/midwife initiated medication

Nurse/midwife initiated medications are those medications for minor symptom relief and short
term use that may be administered without an authorised prescriber’s order. Schedule 4 and
Schedule 8 medications must not be a nurse/midwife initiated medication.
Written protocols must be developed for nurse/midwife initiated medications. The Drug and
Therapeutics Committee must:
 maintain oversight of all nurse/midwife initiated medications
 approve all nurse/midwife initiated medication protocols
 have in place a program for re-approving and re-endorsing all nurse/midwife initiated
medication protocols under the locally determined time period for review (such as
every one to two years).
Nurse/midwife initiated medication protocols must include:
 the medication name, strength, dose, route and frequency of administration
 the maximum number of nurse/midwife initiated doses that can be administered.
Generally protocols must include requirement that only one dose is administered, with
the exception being protocols that address emergency circumstances where additional
doses may be required
 indications and contraindications
 any restrictions on administering to specific patients, for example children up to 16
years of age
 any restrictions on categories of nursing/midwifery staff who can administer, for
example only registered nurses or midwives. (Note: Enrolled nurses may administer
locally approved nurse initiated medications under the supervision of a registered

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nurse/midwife. The supervising registered nurse must confirm verbally with the
enrolled nurse prior to the administration that the medication is appropriate and safe
for the patient)
 the time frame for protocol review and re-endorsement (a minimum of every two
years).
Prior to administering a nurse/midwife initiated medication, the nurse/midwife must ascertain
that:
 the patient does not have a known allergy and/or adverse drug reaction to the
medication
 no other formulations of the same medication are concurrently being prescribed or
administered.
A record of the administration must be made in the patient’s medication record, such as the
‘nurse initiated medications’ section of a chart in the National Standard Medication Chart
suite. The medication must be reviewed and ordered by an authorised prescriber if required
for ongoing treatment.
It is important for nursing and midwifery staff to remain aware that:
 minor ailments may be symptoms of other more serious diseases or may be adverse
reactions to medication already prescribed
 nurse-initiated medication may interact with the patient’s prescribed medication
 the maximum daily recommended dose of the medication must not be exceeded.

6.6 Principles for safe medication administration

NSW Health policy adopts safe and accurate medication administration in the 5 Rights (‘the 5
R’s’) of:
 The Right Patient
 The Right Drug
 The Right Dose
 The Right Time
 The Right Route.
For every medication administered the staff member must:
 refer directly to the medication order which must be clear, legible and not open to
misinterpretation
 check the patient’s allergy or adverse drug reactions status
 read the product label and verify the name, strength, form and route of administration
of the medication against the medication order, and any warning statements on the
label, for example, ‘FOR INTRAVENOUS ADMINISTRATION ONLY’
 prepare the medication including checking the medication name, strength, form, route
of administration and expiry date against the medication order
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 check the dose, form and route of administration of the medication and the time for
administration
 confirm the patient’s identity prior to administration
 re-check, at the point of administration to the patient, the patient’s identification, known
allergies, adverse drug reactions and any additional second person check
requirements (see section 6.8)
 document the administration on the medication administration record
 monitor the effects of the medication.
In addition:
 the staff member administering a medication must contact the pharmacist, prescriber
(or authorised delegate) for clarification prior to administering the dose if:
o they consider a medication order is unclear or ambiguous, or
o they are concerned that the order may be incorrect or inappropriate for the
particular medical condition or patient
 if the patient and/or carer states that the medication or dose is incorrect, the staff
member must check any documentation in the patient’s health care record to ascertain
if there has been an intentional change in the patient’s medication or dose. If the staff
member is unable to ascertain that the change in medication or dose is intentional,
they must contact the prescriber prior to administering the dose
 the same person must select, prepare, administer and record the administration
 doses must be prepared for one patient at a time, and prepared for immediate
administration. Prepared medications must not be retained for later use due to the
risks of contamination, potential instability, potential mix-up with other medications and
to maintain security of the medication. Exceptions include nurses preparing parental
injections or oral medications for future self-administration by the patient (or where
assisted by a carer), such as under the Caring@Home project. In addition, Justice
Health and Forensic Mental Health Network has medication procedures with delayed
and advanced administration provisions including during patient transit
 all Schedule 8 oral medications must be witnessed as having been administered
to/consumed by the patient. All other medications requiring a second person check
must be witnessed as having been administered to/consumed by the patient (Note:
Exceptions are for patients self-administering medications at the health facility or
home care setting)
 unwanted portions of tablets must be discarded in accordance with facility procedures
at the time the dose is prepared. For Schedule 8 medications, the procedures detailed
at section 6.9 must be followed
 medications must be administered, or prepared for administration, directly from the
container supplied by the Pharmacy Service
 medication storage areas and medication trolleys must not be left unlocked unless in
immediate use
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 administration documentation must be made on a National Standard Medication

Charts in accordance with the implementation and user-guides, on another Drug and
Therapeutic Committee approved medication chart or in the eMeds system
 staff members must access further information on medications if required by
contacting the prescriber, pharmacist and referring to facility procedures and protocols
or resources provided in the Clinical Information Access Portal (CIAP).

User-applied labelling of injectable medications, fluids and lines

Injectable medications, fluids and lines must be labelled in accordance with the ACSQHC’s
National Standard for User-applied Labelling of Injectable Medicines Fluids and Lines
(Labelling Standard).
The Labelling Standard ensures accurate communication of injectable, medications, fluids
and lines information through standardised user-applied labelling. Labelling Standard labels
must not be customised. Facilities must ensure that the required labels are available for use
in clinical areas.
The Labelling Standard sets out the requirements for labelling of:
 containers of injectable medications and fluids that can no longer be identified by their
original packaging
 conduits (for example, intravenous administration lines, intravenous catheters,
epidural lines) used to deliver injectable medications
 fluids and non-injectable fluids (oral, enteral, buccal, rectal and inhalation medications)
that can no longer be identified by their original packaging.

Topical lotion, cream or ointment in multi-dose tubes/pots/containers (excluding hand

hygiene products)
 Open multi-dose lotion or cream or ointment in tubes/pots/containers must only be
used for an individual patient’s use in accordance with NSW Health Infection
Prevention and Control Policy (PD2017_013)
 Standardised connectors for liquids and gases
 Where available, products compliant with International Organization for
Standardization ISO 80369 Small-Bore Connector Standards must be used.

Administration of liquid medications using enteral or oral route – additional

requirements
Luer lock syringes (used for parenteral injections) must not be used for oral or enteral
medication administration. Oral/enteral dispensers (also called oral/enteral syringes) or
graduated medication cups must be used to prepare, measure and administer all liquid doses
intended for oral or enteral use.
The enteral dispensers and the devices (‘straws’ and ‘stoppers’) to assist measurement and
withdrawal of medication doses from liquid containers, must be ISO Small-Bore Connectors
Standard (ISO 80369-3) compliant. ISO 80369-3 Enteral Feeding Standard specifies the
dimensions and requirements for small-bore connections on enteral medical devices and
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accessories. Enteral dispensers and devices to assist administration purchased from NSW
Health Enteral Nutrition and Support Services Feeding Contract (Contract 955) are
ISO 80369-3 compliant and will meet the necessary safety requirements.
Oral/enteral dispensers:
 must be used when liquid doses are not readily measured by available calibrations
using an oral medication measure or cup
 must be disposable, meaning for single patient use then discarded. If several liquid
medication doses are to be given to one patient at the same time of day, they must
each be separately prepared and administered
 must be over-wrapped, individually or in small quantities, to facilitate clean handling
 must be readily available in clinical areas where liquid medication doses for routes
other than injection are prepared
 must be stored separately from parenteral syringes and storage areas clearly
identified.
Medications administered via the enteral route must be administered in accordance with
facility procedures and the medication’s Product Information. Consideration must be given to:
 whether the tip of the enteral tube is lying in the stomach, duodenum or jejunum
 whether an alternative non-solid presentation (for example, syrup) is required
 the compatibility, solubility, stability of medication
 the appropriateness of crushing any tablet or opening any capsule.
For patients who are unable to swallow tablets whole, clinicians must refer to the ‘Don’t Rush
to Crush Handbook’ (available via CIAP) and/or a pharmacist for advice. The Handbook
provides advice on whether tablets can be crushed or broken, and administration
recommendations for patients with swallowing difficulties or with enteral feeding tubes.

Liquids for buccal, inhalation, intranasal or rectal administration

Liquids for buccal, inhalation, intranasal, or rectal administration must be purchased in ready
to use units wherever possible.
Preparing liquid medications for buccal, inhalation, intranasal or rectal administration in
clinical areas is considered a high-risk procedure. Due to the risk of accidental intravenous
administration, luer lock syringes used for parenteral medication administration must not be
used to prepare and administer buccal, inhalation, intranasal or rectal medications except in
circumstances where withdrawal of doses from vials requires the use of a needle and luer
compatible syringe.
In circumstances where ready to use units are not available for buccal, inhalation, intranasal
or rectal administration:
 prepare the dose at the bedside to reduce the risk of inadvertent parenteral injection
 label the dispenser with the intended route of administration
 conduct a second person check (see section 6.8).
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If a multi-dose container of liquid for inhalation is used, a non-luer dispenser must be used to
withdraw doses and expel them into labelled inhalation reservoirs.

Cytotoxic and other hazardous medications

Cytotoxic medications must be prepared, administered and disposed of by appropriately
accredited staff members. Cytotoxic and other hazardous medications must be handled in
accordance with any cautionary advisory labelling. The NSW Government guide on Cytotoxic
Drugs and Related Waste - Risk Management provides advice on minimising the risk to
health associated with handling cytotoxic drugs and related waste within health care
establishments and community settings.

Additional medication handling requirements included in Safety Alert Broadcasts

The NSW Health Safety Alert Broadcast System may specify specific medication handling
requirements above those mentioned in this Policy identified through serious medication
incidents. These specific requirements must be followed in addition to the requirements set
out in this Policy.

Clinical handover
Clinical handover must address ongoing medication issues and identify actions and
monitoring that need to occur in accordance with NSW Health Clinical Handover
(PD2019_020).

6.7 Administration by injection – additional requirements

Facilities must develop procedures for the administration of medications by injection. Facility
procedures must include:
 second person check requirements in accordance with section 6.8
 any infection control or workplace safety requirements.
Clinicians must also refer to Australian Injectable Drugs Handbook in CIAP for information
regarding preparing and administering medications by injection. Information in the handbook
must be used in conjunction with facility procedures.

Administration of epidural anaesthesia or analgesia

Epidural administration must be governed by facility procedures. Nursing and midwifery staff
that are required to reload or adjust epidural infusions subsequent to the initial dose must
have completed additional appropriate training and be accredited to administer medication
via this route.

Single use injections

When only a portion of a dose is required for a patient, the unused balance must be
discarded, with the exception of circumstances where incremental dosing is used, in
accordance with facility procedures. Requirements for discarding of part doses of Schedule 8
injections are included in section 6.9.

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Multi-dose injections
In accordance with NSW Health policy on Infection Prevention and Control, injections must
not be shared between patients (‘multi-dosed’), except for multi-dose vials where there is no
other alternative available on the Australian pharmaceutical market.

Additions to intravenous fluid container

When available, pre-mix infusion of high-risk medications are to be used in preference to
those additions to intravenous fluids prepared in clinical areas. Additions of medications or
electrolytes to an intravenous fluid container must be made under controlled environmental
conditions where possible, or else prepared immediately prior to administration using aseptic
technique.
In particular, high-risk medicine potassium chloride ampoules must not be available as
ward/imprest stock. Commercially prepared pre-mix potassium chloride solutions must be
used. NSW Health Policy Directive High-Risk Medicines Management (PD2020_045)
includes a Potassium (Intravenous) Standard that outlines the minimum actions required to
mitigate risks associated with intravenous potassium, including requirements for
commercially prepared pre-mixed solutions and requirements for storing potassium ampoules
only in critical care areas or operating suites where higher doses of potassium are
considered necessary.
Mandatory requirements for potassium chloride pre-mixed infusion solutions include:
 clear differentiation from other intravenous fluids, for example, through use of colour
coded over-pouches and labelling
 orders for intravenous potassium salts must be expressed in millimoles (mmol). In
addition, weight such as grams (g) or milligrams (mg) may be included.
 small volume intravenous solutions (minibags) must not have an additive port or, if
prepared in-house, the additive port must be capped.

6.8 Second person checks prior to administration

6.8.1 Second person checks – general requirements

Independent second person checks are an important medication safety strategy. An
independent second person check requires two people to separately check each component
of selecting, preparing and administering a medication.
To be effective, a second person check must be conducted independently by the second
person to reduce the risk of bias that occurs when the person preparing and checking the
medication is likely to see what they expect to see, even if an error has occurred. Two people
are unlikely to make the same mistake if they work independently. If they work together or
influence the checking procedure by suggesting what the checker must find, both could follow
the same path to error. When performed correctly, independent second person checks have
been found to detect 95% of errors (ISMP, 2013).
This Policy does not mandate a second person check when the medication is administered
by an authorised prescriber or when self-administered by the patient, except when under
NSW Health policy or facility procedures. Patient self-administration of high concentration
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insulin under supervision is in section 5.2.5 in accord with Safety Alert Broadcast SN:007/19
High Concentration Insulin Products - Updated.
Exceptions are also for the administration of Schedule 8 medications in home care settings,
including for patient’s self-administering of facility supplied medications – see medications in
a facility home care setting).
When conducting an independent second person check, each person must independently
follow the procedure steps below:
Procedure steps
1 Product selection confirm the selection of the correct medication and fluid against the
medication and/or fluid order.
2 Preparation confirm that the dose is appropriate and the calculations are correct
confirm that the dose is being administered using the correct route and at
the correct time
when in use, check that the rate limiting device, for example, infusion pump,
is correctly set.
3 Administration confirm the identity of the patient prior to administration (at the bedside or
with the patient present) and in accordance with facility procedures
4 Documentation document the administration, preferably in the same record, in accordance
with facility procedures.

A video demonstrating how to conduct an independent second person check is available at

My Health Learning within the Safe Use of High-Risk Medicines module.
For Schedule 8 medications, a second person check is required under the Schedule 8
medication witness requirements outlined in section 5.14.2. The purpose of the Schedule 8
witness procedure is to account for the Schedule 8 medication. The purpose of a second
person check prior to administration is to reduce risks associated with medication
administration.
Facility procedures must include procedures to confirm the suitability of staff members to act
as a second person checking the preparation and administration of the medications specific
to the patient care area. NSW Health Policy Directive High-Risk Medicines Management
(PD2020_045) includes second person check requirements for high-risk medications.
The Drug and Therapeutic Committee must determine what additional medications and
circumstances, in addition to those outlined in the tables below, require a second person
check. Tables 1, 3, 4, 5, 6 and 7 outline second person check requirements and required risk
mitigation strategies. The Table 2 outlines Schedule 8 medication witness, and additional
second person check requirements.

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6.8.2 Table 1. Inpatient settings (except Hospital in the Home)

excluding Schedule 8 medications
Inpatient Second person check requirements Notes
Circumstance / condition
Medications administered by Independent second person check
injection to patients aged 16 required in all circumstances. In
years and over. emergency situations, for example
cardiac arrest, the principles of an
independent second person check
must be followed for verbal (face to
face) orders..
Medications administered to Independent second person check The Drug and Therapeutics
children aged up to 16 years. required for all doses administered by Committee must approve the
injection (including in emergency list of medications (if any), and
situations). conditions in which they can
Independent second person check be administered, based on a
required for all doses requiring a drug risk assessment, without a
calculation (including in emergency second person check, for
situations). example topically applied
lotions and creams.
Contrast administered by a Independent second person check The second person check can
radiographer via all routes, required in all circumstances. be conducted by an
including under a standing order Includes at outpatient clinics. authorised prescriber,
registered nurse, enrolled
nurse or medical radiation
practitioner.
Radiopharmaceuticals for Independent second person check The second person check can
diagnostic or therapeutic required in all circumstances. be conducted by an
purposes administered by a Includes at outpatient clinics. authorised prescriber,
nuclear medicine radiation registered nurse, enrolled
technologist or a nuclear nurse or medical radiation
medicine scientist practitioner.
Inhalation, intranasal, buccal or Independent second person check
rectal administration for patients required if dose is not in a ready to use
aged 16 years and over. form.

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6.8.3 Table 2. Inpatient Schedule 8 medication procedure requirements

Procedure Stage Schedule 8 witness
Additional second person check requirements
requirements
Product selection Observe the removal and Independent second person check required.
replacement of medication Two persons (person administering and witness)
from the Schedule 8 must independently:
medication storage unit.
Confirm the selection of the correct medication
and/or fluid (including strength and form).
Confirm dosage form.
Documentation Make a record in the
Schedule 8 drug register.
Preparation Observe preparation of the Confirm that the dose is appropriate and the
medication. calculations are correct.
Observe the discarding and Confirm that the dose is being administered using
rendering unusable any the correct route and at the correct time.
unused portion of the When in use, check that the rate limiting device, for
medication. example, infusion pump, is correctly set.
Documentation Document the discard in the
Schedule 8 drug register.
Transfer Observe transfer of the
medication to the patient.
Administration Observe administration or Confirm the identity of the patient prior to
commencement of the administration (at the bedside or with the patient
medication to the patient. present) and in accordance with facility procedures.
Documentation Document the administration, preferably in the
same record, in accordance with facility
procedures.

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6.8.4 Table 3. Inpatient settings (Except Hospital in the Home) –

Schedule 8 medications
Circumstance Second Person Check Documentation Additional risk mitigation
Requirement requirements requirements
Inpatient Independent second All dose Facility procedures include
administration of person check required administrations must circumstances where the
Schedule 8 prior to administration of be signed for on the second person is not at the
medications for all every dose. medication order by bedside, such as in an
routes (including two authorised isolation room.
children aged up to 16 persons.
years).
Administration of an Independent second All dose adjustments Drug and Therapeutics
intravenous or person check required must be documented Committees must approve any
subcutaneous on commencing the and signed for on the circumstances where, based
infusion containing a infusion. medication order. on a risk assessment, a
Schedule 8 Two authorised persons All medication second person check is not
medication via an must check all dose discard (including required for dose adjustments.
infusion device adjustments including zero discard) must For example, the Drug and
(including children checking: be documented in Therapeutics Committee may
aged up to 16 years). the patient’s health determine that a single nurse
 against the check is sufficient for dose
medication order care record and
signed by two adjustments if infusion device
 that the infusion pump authorised persons. dose error reduction software
rate has been is in use.
correctly set.
Injectable incremental Independent second Document the time of See below Injectable
dosing of Schedule 8 person check is the incremental dose incremental dosing of
medications using a required. administration. Schedule 8 medications
syringe. Incremental dose protocol requirements*.
Note: The use of administrations must The registered
incremental dosing is be signed by two nurse/registered midwife
not encouraged due to authorised persons administering the Schedule 8
risks of medication on the medication medication must maintain
error and drug order. possession of the syringe.
diversion. Medication discard Syringes containing Schedule
(including zero 8 medications must not be left
discard) must be unsecured (at the bedside or
witnessed and elsewhere).
signed by two Syringes must be labelled with
authorised persons a user-applied label and in
(see section 5.14.2). accordance with the Labelling
Standard.

* Injectable incremental dosing of Schedule 8 medications procedure requirements

In clinical areas where it is determined that incremental dosing of an injectable Schedule 8
medications via a syringe is required, facility procedures and ensure inclusion of the
following:
 incremental Schedule 8 medication dosing via a syringe must be limited to post-
anaesthetic care units and emergency departments

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 specific staff training, qualifications, skills or competencies to administer Schedule 8

medication incremental doses
 the requirement for an independent second person check. Details of those
circumstances (if any) where only a single registered nurse or registered midwife is on
duty or available in the department to administer an incremental dose when delay in
accessing a second person to check the dose would be detrimental to patient care
 the Iist of medications, doses and minimum time interval for incremental dosing
 the time period after which syringes must be discarded, for example, discarding
residue in the syringe after 30 minutes
 patient criteria for incremental administration including additional considerations for
high-risk patient groups such as paediatric, pregnant and elderly patients
 patient assessment requirements prior to incremental dose administration and
monitoring to ensure a timely response to adverse events or side-effects
 procedures for managing adverse events or side-effects
 instructions for documentation.

6.8.5 Table 4. Hospital in the Home with one nurse/midwife

Hospital in the Home Check Documentation Additional risk mitigation
circumstance / requirements requirements (with strategies
condition witness requirements)
All doses administered Check by the (single) Medications must be dispensed
by injection. nurse preparing and by a pharmacist and labelled for
administering the an individual patient. If
injection (see above medication is taken from imprest
single nurse check supply, an independent second
requirements). person check of all components
that can be checked, such as the
Administration of a Check by (single) All medication discard medication name, formulation
subcutaneous fixed nurse preparing and (including zero discard) and dose must be conducted
rate infusion administering the must be documented before stock leaves the facility.
containing a Schedule infusion (see above). according to facility
8 medication to a procedures and signed Palliative care crisis packs:
palliative care patient by the nurse (see In the circumstance where a
in a home care section 5.14.2). crisis pack is required it must be
setting. dispensed by a pharmacist and
labelled for an individual patient,
Administration of non- Check by (single) All medication discards or
injectable Schedule 8 nurse preparing and must be documented
medications in home administering the according to facility When required for a patient
care setting. medication (see procedures and signed after-hours, crisis packs must be
above). by the nurse (see dispensed in accordance with
section 6.9). section 5.9.

Generally medications must be dispensed by a pharmacist and labelled for an individual

patient to reduce the risk of medication selection error.
When a single nurse is preparing and administering medications they must:
 check the identity of the patient
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 check the patient’s allergy and adverse drug reaction status

 check the selection of the correct medication and fluid
 check that the dose is appropriate and the calculations are correct
 check that the dose is being administered using the correct route and at the correct
time
 when in use, check that the rate limiting device, for example, infusion pump, is
correctly set
 sign for the administration against the medication order.

6.8.6 Table 5: Palliative care in the home setting with one

nurse/midwife
Palliative care home Check Documentation Risk mitigation
care setting requirements requirements
Administration of a Check by a All medication Medications must be dispensed by
subcutaneous fixed rate (single) nurse discards (including a pharmacist and labelled for an
infusion containing a administering zero discard) must individual patient. If medication is
Schedule 8 medication infusion. be documented in taken from imprest supply, an
to a palliative care accordance with independent second person check
patient in a home care facility procedures of all components that can be
setting. (see section 6.9). checked, such as the medication
name, formulation and dose must
Administration of non- Check by nurse All medication be conducted before leaving the
injectable Schedule 8 administering discards must be
facility.
medications in home medication. documented in
care setting. accordance with Palliative care crisis packs:
facility procedures In circumstances where a crisis
(see section 6.9). pack is required it must be
dispensed by a pharmacist and be
All doses administered Check by nurse labelled for an individual patient, or
by injection. administering
medication. When required for a patient after-
hours, crisis packs must be
dispensed in accordance with
section 5.9).

When a single nurse is preparing and administering medications they must:

 check the selection of the correct medication and fluid
 check that the dose is appropriate and the calculations are correct
 when in use, check that the rate limiting device, for example, infusion pump, is
correctly set
 check the identity of the patient prior to administration
 sign the record of administration against the medication order
 check the patient’s allergy and adverse drug reaction status.

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6.8.7 Table 6. Community Home Care with one nurse/midwife

Community setting Check Documentation Risk mitigation requirements (all
circumstances requirements requirements (with circumstances)
witness requirements)
Administration of a Check by All medication discard Medications must be dispensed by
subcutaneous fixed rate (single) nurse (including zero discard) a pharmacist and labelled for an
infusion containing a administering must be documented individual patient. If medication is
Schedule 8 medication infusion (see according to facility taken from imprest supply, an
to a palliative care above). protocol and procedure independent second person check
patient in a home care (see section 6.9). of all components that can be
setting. checked, such as the medication
name, formulation and dose must
be conducted before leaving the
Administration of non- Check by All medication discards facility.
injectable Schedule 8 (single) nurse must be documented Palliative care crisis packs
medications in home administering according to facility
care setting medication (see procedures (see section In circumstances where a crisis
above) pack is required it must be
6.9)
dispensed by a pharmacist and be
All doses administered Check by labelled for an individual patient.
by injection (single) nurse When required for patients after-
administering hours, crisis packs must be
injection dispensed in accordance with
All doses administered Check by For Schedule 8 section 5.9).
to children aged up to (single) nurse medication: All discard
16 years administering (including zero discard)
medication must be witnessed and
signed by nurse (see
section 6.9)

When a single nurse is preparing and administering medications they must:

 check the selection of the correct medication and fluid
 check that the dose is appropriate and the calculations are correct
 check that the dose is being administered using the correct route and at the correct
time
 when in use, check that the rate limiting device, for example, infusion pump, is
correctly set
 check the identity of the patient prior to administration
 sign the medication order
check the patient’s allergy and adverse drug reaction status.

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6.8.8 Table 7. Other clinical settings operated with only one

nurse/midwife (remote health facilities, community health
centres)
Clinical settings Check requirements Documentation Risk mitigation
where there is requirements (with
only one nurse or witness
midwife requirements)
Administration of Check by (single) nurse All medication discards Medications must be dispensed by
Schedule 8 or midwife must be documented in a pharmacist and labelled for an
medications administering accordance with facility individual patient. If medication is
(including children medication. procedures (see taken from imprest supply, an
aged up to 16 Schedule 8 medication section 6.9) independent second person check
years) transactions must be of all components that can be
witnessed in checked, such as the medication
accordance with facility name, formulation and dose must
protocol and be conducted.
procedures (see
section 5.14.2)
All doses Check by (single) nurse
administered by or midwife
injection (including administering
children aged up to medication
16 years)

When a single nurse or midwife is preparing and administering medications they must:
 Check the selection of the correct medication and fluid
 Check that the dose is appropriate and the calculations are correct
 When in use, check that the rate limiting device, for example, infusion pump, is
correctly set
 Check the identity of the patient prior to administration
 Sign the record of administration against the medication order
 Check the patient’s allergy and adverse drug reaction status.

6.9 Schedule 8 medication discards

6.9.1 General principles

Procedures involving Schedule 8 medications with a witness must in accordance with section
5.14.2, other than those conducted by an authorised prescriber, such as an anaesthetist.
Note that an authorised prescriber must expel a partly used injectable Schedule 8 medication
into a sharps container and only discard empty vials, ampoules and syringes/infusions in the
sharps container. The amount discarded must be recorded in the patient’s health care record
or anaesthetic record, as applicable.

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For patients who die in hospital or home care setting, infusions of Schedule 8 medications
must be left attached to the body, where required, in accordance with NSW Health Policy
Directive Coroner’s Cases and the Coroners Act 2009 (PD2010_054).

6.9.2 Home care setting

Where applicable, facility procedures must address requirements for discarding partly used
Schedule 8 medications in a home care setting including discarding patient own Schedule 8
medications.
Procedures must include:
 Requirement for the discard to be documented and signed by the nurse
 Procedures for discarding oral medications and ampoules
 Requirements for discarding used Schedule 8 transdermal patches, including
requirement to fold transdermal patch in half so that the medication is trapped within
the adhesive surface, wrap and dispose in the garbage, out of reach of children.

6.9.3 Patient care areas

Tablets or ampoules
Where only a portion of a Schedule 8 tablet is required for administration, any unused tablet
portions must be discarded in the sharps container in the presence of the witness to the
administration.
Where only a portion of a Schedule 8 ampoule is required for administration unused portions
of an injectable medication must be drawn up into a syringe and the contents expelled into a
sharps container in the presence of the witness to the administration. Ampoules containing
Schedule 8 medications must not be discarded with any medication remaining in the
ampoule.
The discarded amount must be recorded in the drug register with the record of the
administration.

Oral liquid medications

The irretrievable amount in a delivery device such as in the dead space in an oral/enteral
dispenser (for example, 0.2 mL, depending on the type of syringe used) must be discarded in
the sharps container in the presence of the witness to the administration. The discarded
amount must be recorded in the drug register with the record of the administration.

Infusions
Any remaining Schedule 8 medications in replaced or discontinued infusions (for example,
intravenous, epidural, or patient controlled analgesia preparations) must be discarded in the
presence of a witness in a manner that renders the drug unusable and unrecoverable in
accordance with facility procedures.
The quantity of the discarded portion must be recorded on the relevant medication order,
signed and dated by the registered nurse/midwife and countersigned and dated by a witness
to the procedure. It is not necessary to record the discard from partially used infusions into
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the Schedule 8 drug register. Medication orders and/or charts used for documenting infusions
containing Schedule 8 medications must include an area for documenting the discard
including the date, time, total drug discarded and signatures of registered nurse/midwife
discarding the drug and witness to the procedure.
For a syringe driven device, the syringe graduations provide for the measurement of the
discard. For an infusion device it is accepted that only the arithmetically calculated amount
can be recorded as discarded. However, if there is an apparent discrepancy between the
arithmetic amount and the physical residue, the registered nurse/midwife must report this to
the registered nurse/midwife in charge of the patient care area for further appropriate action.

Transdermal patches
Used transdermal patches must be removed from the patient in the presence of a witness,
even if a new patch is not to be applied.
Discarded transdermal patches must be folded in half so that the medication is trapped within
the adhesive surface, then disposed of in a sharps container. The time of the discarding must
be recorded on the medication order or in the patient’s health care record (as applicable),
signed and dated by the registered nurse/midwife and countersigned and dated by the
witness to the procedure. eMeds systems must provide an area to document Schedule 8
transdermal patch removal.
Where a Schedule 8 transdermal patch is found to be missing from the patient, this must be
treated as a loss and reported immediately in accordance with section 5.17.
Fentanyl patches, even after being used or when expired, contain sufficient fentanyl to cause
life-threatening respiratory depression in an opioid-naïve person if absorbed. If in the
disposing of fentanyl patches the active layer comes into contact with the skin or other body
surface, immediately wash off thoroughly with soap and water.
Care must be taken to ensure that a Schedule 8 transdermal patch is not misplaced in the
patient’s clothes/bed linen or dropped onto the floor.
Additional information regarding opioid skin patch safety is in NSW Health Policy Directive
High-risk Medicines Management Policy (PD2020_045) and in the NSW Therapeutic
Advisory Group document Opioid skin patches are high-risk medicines.

Oromucosal medications
Partially used oromucosal medications (for example fentanyl lozenges and disintegrating
tablets) must be disposed of by a registered nurse/midwife in the presence of a witness into a
sharps container.
The discarding must be recorded in the patient’s health care record, signed and dated by the
administering registered nurse/midwife and countersigned and dated by the witness.

6.10 Patient self-administration of medications

Generally patient self-administration of medications is not permitted at public health facilities.
However, the Drug and Therapeutics Committee must approve all specific circumstances and
procedures where the patient may self-administer medication either independently or with the

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assistance of a non-nurse carer – see in section 5.2.5. In specific circumstances, medications

may include those dispensed for the patient in a dose administration aid (see section 6.12).
Under local procedures, facilities providing residential services such as Karitane and
Tresillian parents and/or carers may self-administer, or administer medication to the child in
their care. Inmates at Correctional Centres may self-administer medications under the Justice
Health and Forensic Medicine Network Medication Procedures.
Consideration must be given for self-administration by patients on medication regimens
requiring strict adherence to a schedule where delays in dosing may adversely affect patient
care, such as adrenaline (epinephrine), medications for Parkinson’s disease and medications
for diabetes including insulin). See section 6.11.
Medication orders for medication self-administration must contain an explicit instruction by
the prescriber that the medication is for self-administration.
Medications for patient self-administration must be stored in accordance with the
requirements in section 5.4.

6.10.1 Patient training and education programs

The Drug and Therapeutics Committee must implement a formal patient education program
for patients whom a treating clinician is concerned may not be able to manage his/her own
medications in the community after leaving the facility without being given detailed instruction
and training.
These programs must include, as a minimum, protocols for appropriate patient selection,
assessing the appropriateness of the inclusion of the medications in a dose administration
aid (see section 6.12), practical education and training, assessment of the patient’s acquired
knowledge and capacity to self-manage his/her medications, and monitoring of the ongoing
self-use by the patient while the patient is at the facility.

6.10.2 Non-inpatient day centres

Staff may assist a patient to self-administer patient own medications in a non-inpatient day
centre in accordance with facility procedures.

6.11 Time critical medications

Time critical medications are those where early or delayed administration by more than 30
minutes may cause harm to the patient or result in suboptimal therapeutic effect.
Drug and Therapeutics Committees must identify a facility specific list of time critical
medications. Written protocols must be developed for medications on this list. Protocols must
include:
 the time critical window in which the medication must be given, for example;
o insulin which must be administered within a specified period of time before, after,
or with meals
o conventional levodopa formulations for Parkinson’s disease must be administered
within the specified time as normally taken by the patient

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 instructions for managing administration of the time critical medication while the
patient is admitted in hospital (administration times must be kept as close as possible
to the patient’s normal dosing times)
 instructions for managing time periods when the patient is nil by mouth
 requirements for patient self-administration of the medication.

6.12 Dose administration aids

Dose administration aids must not be used for the routine administration of medications,
other than as an option to residential care or flexible care residents under the Commonwealth
Aged Care Act 1997 at a public hospital or Multi-Purpose Service, or at Correctional Centres.
Under facility procedures, dose administration aids may also be used in patient care areas to
train or assess a patient’s ability to self-medicate (see section 6.10).
Additionally, patients may present to day centres with medications packed in a dose
administration aid by a community pharmacist.
Dose administration aids may comprise blister packs, plastic ‘packettes’ (sachets) or ‘dosette
boxes’. Dose administration aids packed and labelled by a pharmacy service are preferred
and safer than patient/carer filled dosette boxes. A registered nurse may only fill a ‘dosette
box’ compliance aid for the purpose of educating a patient on how to fill the container
him/herself, and only from individual medication packs that have been dispensed and
labelled by a pharmacist.
The packing and labelling, with the inclusion of the required warning and precautionary
labels, must be in accordance with Pharmacy Board of Australia Guidelines on Dose
Administration Aids and Staged Supply of Dispensed Medicines.
The facility’s Drug and Therapeutics Committee is responsible for establishing the
circumstances for the use and type of a dose administration aid, and the criteria for
assessing patient suitability for use, with particular consideration of:
 strategies for managing changes to therapy
 recording the administration of dose administration aid packed medication on the
patient’s medication chart
 confirming the dose administration aid meets the child resistant packaging
requirements in section 4.5.5
 the need for a moisture-proof container for some medications, and the protection of
individual doses from contamination
 minimising the risk of spillage and the potential mix-up of medication, especially for a
person with visual impairment or poor manual dexterity
 use with patient self-administration of ‘time critical’ medications (see section 6.11).

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7 REFERENCES

7.1 Related documents:

 Agency of Clinical Innovation
o NSW Adult Subcutaneous Insulin Chart
o Suite of NSW Pain Charts
 ACSQHC
o Electronic Medication Management Systems: A Guide to Safe Implementation
o National Safety and Quality Health Service (NSQHS) Standards
o National Standard Medication Charts
o Recommendations for Terminology, Abbreviations and Symbols used in Medicines
Documentation
o National Guidelines for On-Screen Display of Medicines Information
o National Inpatient Medication Chart User Guide
o National Standard for User-Applied Labelling of Injectable Medicines Fluids and
Lines
o National Tall Man Lettering List
 Australian Government Department of Health
o Australian Guidelines for Drug Donations to Developing Countries
o National Vaccine Storage Guidelines ‘Strive for 5’
 Council of Australian Therapeutic Advisory Groups
o Achieving Effective Medicines Governance: Guiding Principles for the Roles and
Responsibilities of Drug and Therapeutics Committees in Australian Public
Hospitals
o Guiding Principles for the Use of Complementary and Alternative Medicines in
Hospitals
 eviQ
 National Health and Medical Research Council
o National Statement on Ethical Conduct in Research Involving Humans
 NSW Government Guide
o Cytotoxic Drugs and Related Waste – Risk Management
 NSW Health Information Bulletins, Guidelines and Policy Directives:
o Adult and Paediatric Hospital in the Home Guideline
o Approval Process of Medicines for use in NSW Public Hospitals

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o Care Coordination: Planning from Admission to Transfer of Care in NSW Public

Hospitals
o Clinical and Related Waste Management for Health Services
o Clinical Handover
o Coordination of Responses to Urgent System-Level Medicine or Medical Device
Issues
o Coroners Cases and the Coroners Act 2009
o Documentation and Management of Health Care Records
o Electronic Medication Management System Governance and Standards
o Goods and Services Procurement
o Health Care Records – Documentation and Management
o High-Risk Medicines Management
o Incident Management
o Infection Prevention and Control Policy
o Major Incident Medical Services Supporting Plan
o Maternity – Prevention, Early Recognition & Management of Postpartum
Haemorrhage (PPH)
o NSW Clinical Guidelines – Treatment of Opioid Dependence
o Pharmaceutical and Safety Net Arrangements for Outpatients and Patients on
Discharge
o Patient Safety and Quality Program
o Pharmaceuticals – Preparation in NSW Public Health Facility Pharmacy Services
o Protecting People and Property: NSW Health Policy and Standards for Security
Risk Management in NSW Health Agencies
o RN Supply and Administration of STI Therapies in Publicly Funded Sexual Health
Services
o Rural Adult Emergency Clinical Guidelines
o Rural Paediatric Emergency Clinical Guidelines
o Safety Alert Broadcast System Notifications
o Tenecteplase Replacement in Public Hospitals for Ambulance Paramedics
o Vaccine Storage and Cold Chain Management
o Work Health and Safety Better Practice Procedures
 Society of Hospital Pharmacists of Australia
o Standards of Practice for Clinical Pharmacy Services

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