0% found this document useful (0 votes)
218 views57 pages

Pharmacy Gazetted

IUSS Hospital Design Principles

Uploaded by

Jihad Chahla
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
218 views57 pages

Pharmacy Gazetted

IUSS Hospital Design Principles

Uploaded by

Jihad Chahla
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 57

IUSS HEALTH

FACILITY GUIDES

Pharmacy

Gazetted
8 May 2015
Task Team: A:10

Supported by:
Document tracking
Version Date Name
Preliminary outline 29 July 2013 JN

Draft 1a 23 October 2013 JN

Proposal V.1 25 April 2014 JN


Proposal V.2 22 August 2014 JN
NHC sub committee 28 August 2014 JN
Proposal V.2 review 05 September 2014 SP, JN, CvW
Proposal V.3 distribute online for 09 September 2014 SP, JN, CvW
review
Gazetted 30 June 2014 National Health Act, 2003(Act
no.61 of 2003)

INFORMATION NOTES
Form: Health facility guides
Status: Gazetted,8 May 2015

Title: Pharmacy
Original Title: Pharmacy
Description: “Pharmacy “ contains health facility guidance in five parts covering the
infrastructure norms and standards for pharmaceutical services for facilities
providing primary, regional, tertiary, central and national healthcare services
including referral services. It is to be read in conjunction with the full norms and
standards suite and covers policy and service context (Part A) planning and
design (Part B), room data (Part C), accommodation schedules, (Part D) and case
studies (Part E)
Reference: CSIR 59C1119 A:10- 001
Authors: IUSS N and S task group A:10
Stakeholders: National Department of Health, Provincial Departments of Health and Public
Works, South African Pharmacy Council
Accessing of these guides
This publication is received by the National Department of Health (NDoH), IUSS Steering Committee
Chairman, Dr Massoud Shaker and Acting Cluster Manager: Health Facilities and Infrastructure
Management, Mr Ndinannyi Mphaphuli. Feedback is welcome.
The CSIR and the NDoH retain the moral rights conferred upon them as author by section 20(1) of the
Copyright Act, No. 98 of 1978, as amended. Use of text, figures or illustrations from this report in any
future documentation, media reports, publications, competition entries and advertising or marketing
material is solely at the discretion of the Health Infrastructure Norms Advisory Committee and
should clearly reference the source. This publication may not be altered without the express permission
of the Health Infrastructure Norms Advisory Committee. This document (or its updates) is available
freely at www.iussonline.co.za or the forthcoming Department webportal.
Application and development process
These IUSS voluntary standard/ guidance documents have been prepared as national Guidelines,
Norms and Standards by the National Department of Health for the benefit of all South Africans. They are
for use by those involved in the procurement, design, management and commissioning of public
healthcare infrastructure. It may also be useful information and reference to private sector healthcare
providers.
Use of the guidance in this documentation does not dissolve professional responsibilities of the
implementing parties, and it remains incumbent on the relevant authorities and professionals to ensure
that these are applied with due diligence, and where appropriate, deviation processes are exercised.
The development process adopted by the IUSS team was to consolidate information from a range of
sources including local and international literature, expert opinion, practice and expert group
workshop/s into a first level discussion status document. This was then released for public comment
through the project website, as well as national and provincial channels. Feedback and further
development was consolidated into a second level development status document which again was
released for comment and rigorous technical review. Further feedback was incorporated into proposal
status documents and formally submitted to the National Department of Health. Once signed off, the
documents have been gazetted, at which stage documents reach approved status.
At all development stages documents may go through various drafts and will be assigned a version
number and date. The National Department of Health will establish a Health Infrastructure Norms
Advisory Committee, which will be responsible for the periodic review and formal update of
documents and tools. Documents and tools should therefore always be retrieved from the website
repository www.iussonline.co.za or Department web portal (forthcoming) to ensure that the latest
version is being used.
The guidelines are for public reference information and for application by Provincial Departments of
Health in the planning and implementation of public sector health facilities. The approved guidelines will
be applicable to the planning, design and implementation of all new public-sector building projects
(including additions and alterations to existing facilities). Any deviations from the voluntary
standards are to be motivated during the Infrastructure Delivery Management Systems (IDMS) gateway
approval process. The guidelines should not be seen as necessitating the alteration and upgrading
of any existing healthcare facilities.
Acknowledgements
This publication has been funded by the NDoH.

IUSS N and S task team (Pharmacy): Jako Nice, Richard Hussey, Corry van der Walt, Susan Putter, SAPC,
NDoH, WC DoH

Reviewed by:

Helecine Zeeman NDoH


Lindile Mabuya SIAPS/MSH
Edwina Fleming CSIR
Vincent Tlala SAPC
Vuyo Mokoena SAPC
Duncan Rendall WC DoH
Yasmina Johnson WC DoH
Sheena Ainsbury WC DoH
CONTENTS
CONTENTS ....................................................................................................................... 5
OVERVIEW ...................................................................................................................... 8
DEFINITIONS .................................................................................................................. 9
PART A - POLICY AND SERVICE CONTEXT ..................................................... 11
1. Objectives and Requirements .................................................................................................... 11
2. Standards, Policies and Legislation ......................................................................................... 11
3. Service context ................................................................................................................................ 13
3.1. Determining the size of a pharmacy, dispensary, medicine room or
pharmaceutical service .................................................................................................................................. 18
3.2. Hours of operation:............................................................................................................................ 18

PART B - PLANNING AND DESIGN ..................................................................... 20


1. Overview ............................................................................................................................................ 20
2. Pharmacy classification ............................................................................................................... 20
3. Pharmaceutical Service Delivery model – South Africa ................................................... 20
4. Institutional Pharmacies ............................................................................................................. 23
4.1. Services to be provided ................................................................................................................... 23
4.2. Location .................................................................................................................................................. 24
4.3. Space requirements ........................................................................................................................... 24
4.4. Clinical and outpatient service requirements ....................................................................... 25
4.5. Pharmacies with dispensary and Bulk store separation .................................................. 26
4.6. Storage .................................................................................................................................................... 26
4.6.1. Cold Chain Storage ....................................................................................................................... 26
4.7. Compliance for facility registration and approval ............................................................... 27
4.8. PHC Dispensing service specific rooms / medicine rooms .............................................. 28
5. Satellite pharmacies for oncology services .......................................................................... 28
6. Infrastructure for medicine rooms for mobile health services ..................................... 28
6.1. Services to be provided ................................................................................................................... 28
6.2. Space requirements ........................................................................................................................... 28
6.3. Storage .................................................................................................................................................... 29
7. Wholesale / Depot pharmacies: ................................................................................................ 29
7.1. Service to be provided ...................................................................................................................... 29
7.2. Space requirements ........................................................................................................................... 29
7.3. Storage .................................................................................................................................................... 29
7.1. Compliance for facility registration and approval ............................................................... 30

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
5
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
8. Design and Planning Principles ................................................................................................ 31
8.1. Overview ................................................................................................................................................ 31
8.2. Healing environment ........................................................................................................................ 31
8.3. General design and planning requirements ........................................................................... 31
8.4. Access and circulation ...................................................................................................................... 32
8.5. Infection control ................................................................................................................................. 32
8.6. Ergonomics in design ....................................................................................................................... 33
8.7. Materials ................................................................................................................................................. 33
8.8. Universal access .................................................................................................................................. 34
8.9. Way finding and signage ................................................................................................................. 34
8.10. Telecommunication and IT systems support: ................................................................. 35
8.11. Ventilation and Air-management .......................................................................................... 35
8.12. Day and night time illumination ............................................................................................ 36
8.13. Fire detection and alarms ......................................................................................................... 36
8.14. Safety and security ....................................................................................................................... 37
9. Location and inter departmental relationships principles ............................................ 38
10. Flow Patterns ............................................................................................................................ 40
11. Functional Zones ..................................................................................................................... 41
12. Activities ..................................................................................................................................... 43
13. Operational Considerations ................................................................................................ 43
13.1. The patient expectations: .......................................................................................................... 43
13.2. Staff expectations: ........................................................................................................................ 43
13.3. Dispensing standards ................................................................................................................. 44
13.4. Patient records and administration procedures ............................................................ 44
13.5. New developments ...................................................................................................................... 44
14. Specialised Components ....................................................................................................... 44
15. Pharmaceutical Equipment and Furniture .................................................................... 45
16. Room List .................................................................................................................................... 48
17. Selected room type requirements ..................................................................................... 49
17.1. Dispensing rooms - private/semi private and public ................................................... 49
17.2. Goods receiving area ................................................................................................................... 51
17.3. Internal Receiving Area ............................................................................................................. 51
17.4. Bulk Store ......................................................................................................................................... 51
17.5. Compounding ................................................................................................................................. 52
17.6. Sterile preparation area (compounding, cytotoxic) ...................................................... 52
17.7. Flammable Store ........................................................................................................................... 52
17.8. Empty boxes/ bottle store ........................................................................................................ 52

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
6
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
BIBLIOGRAPHY .......................................................................................................... 53
ANNEXURE 1. DRAWINGS ................................................................................ 54
18. IUSS generic room requirement drawings ..................................................................... 54
19. Pharmacy examples................................................................................................................ 55

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
7
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
OVERVIEW
This document outlines the policy and service context and attempts to illustrate the desired
planning principles and design considerations for pharmacies and pharmaceutical services
in primary healthcare facilities.
• Part A outlines the national and provincial service and policy
context which are the basic determinants of the planning and
design principles;
• Part B contains planning and design guidance, design
considerations, functional relationships between hospital
departments with respect to pharmacies, and relationships within
the various pharmacy unit types;
• Part C develops these principles into a series of schedules of
accommodation;
• Part D contains room data sheets and
• Part E includes some indicative equipment lists and case studies.
Parts C, D and E are intended to demonstrate how the principles prescribed in Part B can be
applied in worked examples. Parts C or D if applied directly are deemed-to-satisfy the
principles developed in Part B, but are not the only acceptable solutions.
Case studies (Part E) provide illustrative worked solutions and should not be adopted
without appropriate contextual adaptation.
While this document outlines design requirements and acceptance criteria which have an
impact on clinical services, these requirements are prescribed within the framework of the
entire IUSS set of guidance documents and cannot be viewed in isolation.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
8
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
DEFINITIONS
Aseptic preparation means the process by which a sterile (aseptic) pharmaceutical product
is prepared and packaged in a sterile container in a way that maintains sterility and involves
the use of clean rooms, bacteria retaining filters and dry or steam heat;
Compounding means the preparing, mixing, combining, packaging and labelling of a
medicine for dispensing as a result of a prescription for an individual patient by a pharmacist
or person authorised in terms of the Medicines and Related Substances Act 101 of 1965;
Cytotoxic preparation means the preparation of oncology medicines in a specialised area
due to the toxicity of the products and is often undertaken in satellite oncology pharmacies;
Dispensary means a room situated in a primary healthcare clinic which is dedicated to the
dispensing of prescriptions;
Dispensary: Dispensing means the interpretation and evaluation of a prescription, the
selection, manipulation or compounding of the medicine, the labeling and supply of the
medicine in an appropriate container according to the Medicines and Related Substances Act
and the provision of information and instructions by a pharmacist to ensure the safe and
effective use of medicine by the patient and “dispense” has a corresponding
meaning;.Institutional pharmacy (hospital pharmacy) means a pharmacy situated in a
public health establishment, wherein or from which some or all of the services as prescribed
in regulation 18 of the Regulations relating to the practice of pharmacy are provided to
persons requiring pharmaceutical services from or at that health establishment but excludes
a community pharmacy;
Licensing means the granting of authority by a designated authority to a person or entity to
provide a pharmaceutical service or dispense medicines.
Medicine Room means room situated in a primary healthcare clinic or hospital ward which
is dedicated to the storing of medicine but where no dispensing of prescriptions takes place;
Pharmacy means any place wherein or from which any service specially pertaining to the
scope of practice of a pharmacist is provided. A pharmacy must be licensed by the National
Department of Health (NDOH) and recorded with the South African Pharmacy Council
(SAPC). The pharmacy must operate under the direct personal supervision of a responsible
pharmacist who is registered as such with the SAPC.
Responsible pharmacist means a natural person who is a pharmacist and who shall be
responsible to the council for complying with all the provisions of this Act and other
legislation applicable to services which specially pertain to the scope of practice of a
pharmacist, and the legislation applicable to the pharmacy which is under his or her personal
supervision;
Thermolabile
Wholesale pharmacy means a pharmacy wherein or from which some or all of the services
as prescribed in regulation 17 of the Regulations relating to the practice of pharmacy are
provided and who shall sell medicine only to a wholesale pharmacy or a community
pharmacy or an institutional pharmacy or to persons who are authorised to purchase
medicines in terms of the Medicines and Related Substances Act or to an organ of State;

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
9
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
Table 1: IUSS:GNS Reference Documents
CLINICAL SUPPORT HEALTHCARE PROCUREMENTand
SERVICES SERVICES ENVIRONMENT/ OPERATION

Recommended

Recommended

Recommended

Recommended
CROSSCUTTING
ISSUES

Essential

Essential

Essential

Essential
Adult x Administration x Generic Room x Integrated x
Inpatient and Related Requirements infrastructure
Services Services planning
Clinical General x Hospital Design x Briefing Manual x
Diagnostic Hospital Principles
Laboratory Support
Guidelines Services
Mental Health x Catering x Building x Space Guidelines x
Services for Engineering
Hospitals Services
Adult Critical x Laundry and Environment and x Cost Guidelines x
care Linen Sustainability
Department
Emergency x Hospital Materials and x Procurement
Centres Mortuary Finishes
Services
Maternity x Nursing Future Healthcare x Commissioning x
Care Facilities Education Environments Health Facilities
Institutions
Adult x Health Facility Healthcare x Maintenance x
Oncology Residential Technology
Facilities
Outpatient x Central Sterile Inclusive x Decommissioning x
Facilities Service Environments
Department
Paediatrics x Training and Infection x Capacity
and Neonatal Resource Prevention and Development
Facilities Centre Control
Pharmacy Waste x Information x
Disposal Technology and
Infrastructure
Primary x Regulations x
Healthcare
Facilities
Diagnostic
Radiology
Adult Physical x
Rehabilitation
Adult Post- x
acute Services
Facilities for x
Surgical
Procedures
TB Services x
Colours Legend
Consultants
Administrators
Related documents

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
10
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
PART A - POLICY AND SERVICE CONTEXT

1. Objectives and Requirements


The objective of this document is to align current Good Pharmacy Practice
(GPP) and pharmaceutical dispensing standards in a single document. The
‘The core of pharmacy activity document intends to address the clinical, planning, statutory, and
is the supply and distribution of administrative and management requirements for any category of public
medicines and other health care sector pharmacy in South Africa to align infrastructure requirements with
products.’ GPPSA, 2010 the services provided. The Rules relating to Good Pharmacy Practice
This service necessitates
published in terms of Section 35A of the Pharmacy Act 53 of 1974 deal
appropriate and dynamic
infrastructure consideration. with four key elements namely:
1. Professional standards of premises;
2. Professional standards of service;
3. Professional standards for pharmacy human resources;
4. Professional standards for pharmacy management.
Each one of these elements will be discussed in more detail with reference
to the Good Pharmacy Practice rules.

2. Standards, Policies and Legislation


The pharmaceutical services are the lifeblood of any healthcare establishment. It is a
dynamic, information-driven and patient-orientated discipline and service1. Not only does it
serve and facilitate the inner workings of a healthcare establishment, but it is often, the
patient’s last stop within any healthcare establishment visit.
The pharmaceutical environment needs to meet the requirements for effective and efficient
patient medication distribution, and adhere to health and safety standards and meet
recognised infection control principles, while maintaining patient privacy and dignity.
This document provides guidance to design, function and flow management and should be
read in conjunction with the IUSS set of standards applicable to patient service provision.
The specialised variations of pharmaceutical services will be outlined and described in
sufficient detail to equip the health planner, engineer, architect, medical practitioner and
healthcare specialist/professional to effectively and efficiently manage their project, design,
task or institutions pharmaceutical service delivery.

A. Pharmaceutical services are governed by the following legislation -


• The Pharmacy Act, 1974 (Act No. 53 of 1974), as amended
 Fees Payable to the Council under the Pharmacy Act published as Board
Notice 83 of 2012
 Regulations relating to the Ownership and Licensing of Pharmacies published
as Government Notice No. R. 553 of 25 April 2003,
 Regulations relating to the Practice of Pharmacy (GNR 1160 of 20 November
2000)

1Office of the Registrar. (2010). Good Pharmacy Practise in South Africa (4th ed.). Pretoria: The South
African Pharmacy Council.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
11
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
 Regulations relating to the registration of persons and the maintenance of
registers (GNR 1160 of 20 November 2000)
 Rules relating to the Services for which a Pharmacist may levy a Fee and
Guidelines for Levying such a Fee or Fees published as Board Notice 33 of
2012
 Rules relating to Good Pharmacy Practice in South Africa
 Rules relating to acts or omissions in respect of which the Council may take
disciplinary steps

• Basic Conditions of Employment Act, 1997 (Act No.75 of 1997), as amended


 The Equity Employment Act, 1998 (Act No.55 of 1998), as amended
 The Skills Development Act, 1998 (Act No. 97 of 1998), as amended
 Broad Based Black Empowerment Act, 2003 (Act No.53 of
2003), as amended
 Consumer Protection Act, 2008 (Act No. 63 of 2008), as
amended
 Hazardous Substance Act, 1973 (Act No.15 of 1973), as
amended
 Health Professions Act, 1974 (Act No.56 of 1974), as
amended
 Labour Relations Act, 1995 (Act No.66 of 1995), as
amended
 Liquor Act, 2003 (Act No.59 of 2003), as amended
• Medicines and Related Substances Act, 1965 (Act No.101 of 1965), as
amended
 General Regulations published in terms of the Act
• Municipal By-Laws, as applicable
 Municipal Finance Management Act, 2003 (Act No.56 of
2003), as amended
 National Building Regulations and Building Standards Act, 1977 (Act No.103 of
1977), as amended
• National Environmental Management Act, 1998 (Act No. 107 of 1998), as
amended
• National Health Act, 2003 (Act No.61 of 2003)
• Nursing Act, 2005 (Act No.33 of 2005), as amended
• Occupational Health and Safety Act, 1993 (Act No.85 of 1993), as amended
• Preferential Procurement Policy Framework Act, 2000 (Act No.5 of 2000), as
amended
• Public Finance Management Act, 1999 (Act No.1 of 1999), as amended
 Treasury Regulations
 Supply chain management regulations
• Public Service Act, 1994 (Act No. 103 of 1994), as amended

B. The pharmaceutical services are guided by the following policies and procedures

• Expanded Program on Immunisation – EPI


• Good Manufacturing Practice – GMP
• Good Wholesale Practice -GWP
• Good Warehousing Practice
• National Drug Policy – NDP

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
12
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
• Provincial policies
• Standard Operating Procedures – SOPs
• Standard Stock Account

C. The pharmaceutical services are guided by the following Guidelines

• Cold Chain Management Guidelines


• Expanded Program on Immunisation – EPI
• HIV guidelines
• Standard Treatment Guidelines and Essential Medicine List
• TB treatment guidelines

D. International publications with regards to Pharmaceutical practices


• Developing pharmacy practice, A focus on patient care, Handbook - 2006 Edition,
WHO
• Joint FIP/WHO guidelines on good pharmacy practise: Standards for quality of
pharmacy services, 2011, No 961

3. Service context
The business case and the clinical brief define the approved package of service to be
provided from an institution and the required bed distribution per facility based. This is
based on the Provincial Strategic Transformation Plan and the Government Policy
Document: Government Notice - R. 185, National Health Act 61/2003. Regulations:
Categories of hospitals: Government Gazette No.35101, 2nd March 2012.
Pharmaceutical service package is a guideline which presents various matrixes outlining the
pharmaceutical services which can be provided in different kinds of healthcare
establishment and which impact on the infrastructure required. The matrixes relate to -
1. Facility type (health infrastructure category) related to medicine supply
management;
2. Facility type (health infrastructure category) related to preparation of medication;
3. Facility type (health infrastructure category) related to provision of services to
patients and/ or care givers.
It has become apparent that there is a need to relate these pharmacy categories to the various
nd
categories of hospital as outlined by the R.185, 2 March 2012, National Health Act 61/2003
Regulations: Categories of hospitals : No.35101. To date no clear guidance has been offered as
to the required pharmaceutical services to be offered at the various categories of healthcare
facilities. A summary of activities relating to pharmaceutical services provided in the different
categories of health establishments for purposes of determining infrastructure requirements
has thus been developed, is shown in Table 1, 2 and 3.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
13
Health Facility Guides:
Pharmacy [Gazetted,8 May 2015]
TABLE 1: INFRASTRUCTURE RELATIONSHIP WITH ACTIVITIES RELATING TO MEDICINE SUPPLY AND MANAGEMENT

TYPE OF FACILITY ACTIVITIES RELATING TO MEDICINE SUPPLY MANAGEMENT


Receipt Storage of Storage of Storage of Storage of Stock Distribution of Distribution of bulk Keeping
of stock stock stock stock stock taking stock to stock to other record of
(general (thermolabile (Schedule (flammable consulting rooms facilities, ward based stock
medicines) stock) 5/6, products) for dispensing outreach teams
vulnerable (WBOTs)
stock)
Mobile clinic (not
pharmacy) YES YES YES YES N0 YES NO NO YES
PHC clinic (dispensary or MAYBE
medicine room) YES YES YES YES NO YES MAYBE YES
(WBOTs)
Community Day
Centre/Community MAYBE
Health Centre
YES YES YES YES NO YES MAYBE YES
(WBOTs)
(pharmacy*)
District Hospital (small, MAYBE
medium, large) YES YES YES YES YES YES NO YES
(PHC clinics)
(pharmacy*)
Regional Hospital
(pharmacy*) YES YES YES YES YES YES NO NO YES
Tertiary Hospital
(pharmacy*) YES YES YES YES YES YES NO NO YES
Central Hospital
(pharmacy*) YES YES YES YES YES YES NO NO YES
Specialised Hospital
(pharmacy*) YES YES YES YES YES YES NO NO YES
Pharmaceutical Depot
(wholesale pharmacy) YES YES YES YES YES YES NO NO YES

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
14
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
TABLE 2: INFRASTRUCTURE RELATIONSHIP WITH ACTIVITIES RELATING TO PHARMACEUTICAL SERVICES AND PATIENT

TYPE OF FACILITY ACTIVITIES RELATING TO THE PROVISION OF PHARMACEUTICAL SERVICES TO PATIENTS/CAREGIVERS


Inpatients Outpatients Preparation of prescriptions for Record
collection at other facilities e.g. keeping of
PHC clinics, off site collection patient
points, distribution by WBOTs services
Dispensing Providing Providing Dispensing Handing medicine Providing Dispensing of Distribution of
prescriptio stocks of pharmacy medicine for to outpatients counsellin prescriptions prescriptions to
ns for medicine for services in outpatients which has been g and other facilities
inpatients wards, wards prepared at a informatio
theatres, chronic dispensing n to
emergency facility patients
rooms
Mobile clinic (not
NO NO NO YES YES YES NO YES YES
pharmacy)
PHC clinic (dispensary
NO NO NO YES YES YES NO NO YES
or medicine room)
Community Day
Centre/Community
NO NO NO YES YES YES NO NO YES
Health Centre
(pharmacy*)
District Hospital
(small, medium, large) YES YES YES YES MAYBE YES MAYBE MAYBE YES
(pharmacy*)
Regional Hospital
YES YES YES YES MAYBE YES MAYBE MAYBE YES
(pharmacy*)
Tertiary Hospital
YES YES YES YES NO YES MAYBE MAYBE YES
(pharmacy*)

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
15
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
TYPE OF FACILITY ACTIVITIES RELATING TO THE PROVISION OF PHARMACEUTICAL SERVICES TO PATIENTS/CAREGIVERS
Inpatients Outpatients Preparation of prescriptions for Record
collection at other facilities e.g. keeping of
PHC clinics, off site collection patient
points, distribution by WBOTs services
Dispensing Providing Providing Dispensing Handing medicine Providing Dispensing of Distribution of
prescriptio stocks of pharmacy medicine for to outpatients counsellin prescriptions prescriptions to
ns for medicine for services in outpatients which has been g and other facilities
inpatients wards, wards prepared at a informatio
theatres, chronic dispensing n to
emergency facility patients
rooms
Central Hospital
YES YES YES YES NO YES MAYBE MAYBE YES
(pharmacy*)
Specialised Hospital
YES YES YES YES MAYBE YES MAYBE MAYBE YES
(pharmacy*)
Pharmaceutical Depot
NO NO NO NO NO NO NO NO YES
(wholesale pharmacy)
*Institutional pharmacy as per definition in the Regulations relating to the practice of pharmacy

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
16
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
TABLE 3: INFRASTRUCTURE RELATIONSHIP WITH ACTIVITIES RELATING TO PREPARATION OF MEDICATION

TYPE OF FACILITY ACTIVITIES RELATING TO THE PREPARATION OF MEDICINE


Compounding of medicine Compounding of Repackaging of medicine Preparation of cytotoxic Preparation of
(dry) medicine (wet) into patient-ready medicines aseptic products
packs** (aseptic dispensing
e.g. intravenous
products) NOTE TPN
preparation
discouraged

Mobile clinic (not pharmacy) NO N0 NO NO NO


PHC clinic (dispensary or
NO NO NO NO N0
medicine room)
Community Day
Centre/Community Health NO NO NO NO NO
Centre (pharmacy*)
District Hospital (small,
YES YES MAYBE NO NO
medium, large) (pharmacy*)
Regional Hospital (pharmacy*) YES YES MAYBE NO NO
Tertiary Hospital (pharmacy*) YES YES MAYBE YES YES
Central Hospital (pharmacy*) YES YES MAYBE YES YES
Specialised Hospital (pharmacy*) MAYBE
MAYBE MAYBE MAYBE MAYBE
(Oncology Hospital)
Pharmaceutical Depot (wholesale
NO NO MAYBE NO NO
pharmacy)
*Institutional pharmacy as per definition in the Regulations relating to the practice of pharmacy
** Practice is being discouraged

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
17
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
3.1. Determining the size of a pharmacy, dispensary,
medicine room or pharmaceutical service
To determine the optimal functional size of any pharmacy, dispensary, medicine room or
pharmaceutical service, various factors need to be considered:

 The approved service package in accordance with the approved hospital category as
per the nationally approved provincial STP;
 Distribution dependence of the local health facilities;
 Specific location and related functional challenges;
 The prevailing distribution model and its effect on required stock holding levels;
 Geographical proximity to the nearest provincial pharmaceutical bulk distribution
store or regional hospital distribution store, if applicable;
 Pharmaceutical services provided as per the approved service package;
 Volume of current and anticipated work output;
 A recommended minimum working space allocated per person is 11 cubic meters.
(For a minimum room size, where the ceiling is 2.4 metres high, a floor space of 4.6
square metres per person is required. If the ceiling is three metres or above, the
minimum space decreases to 3.7 square metres.) 2

3.2. Hours of operation:


Medicines need to be available 24 hours per day, seven days per week. The hours of
operation of most pharmacies are limited to normal office hours, viz. eight hours per day for
weekdays only. The hours of operation depend on the facility type: Hospitals pharmacies
may operate during normal working hours, extended working hours (longer days through
shifts, periods open over weekend days) and have to provide for after-hours access to
medicines. The responsible pharmacist must ensure that medicines prescribed outside
normal pharmacy hours are made available either by the use of an emergency medicine
cupboard or are provided by a pharmacist who is on call. Refer to Rule 4.3.6.2 (Gov. Gazette
37193 - board Notice 272) for dispensing standards.
Pharmacies in community health centres (CHCs) normally operate eight hours per day five
days per week.
The dispensaries in PHC clinics normally operate the same hours as the clinic, eight hours
per day five days per week.
The medicine storage area for mobile clinics is normally accessed twice daily in order to
replenish or return supplies for the mobile unit; and at a pre-determined time to order and
receive stock.

Personnel:
Hospital pharmacies have to be under the constant personal supervision of a pharmacist, and
may be assigned further staff, e.g. pharmacists, interns, pharmacist’s assistants and
administrative staff. Note: Two new categories of pharmacy support personnel namely pharmacy
technicians and pharmaceutical technical assistants have been proposed but are not yet in place.
Cleaning services may be performed by pharmacy-based or assigned facility staff on a daily or

2 Western Cape Department of Health; MDHS Infrastructural recommendations for Pharmacy

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
18
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
weekly basis. Maintenance support is performed on an intermittent basis. Visiting, teaching and
volunteering activities may also take place within the pharmacy space.
CHC pharmacies have to be under the constant personal supervision of a pharmacist, with
the support of pharmacist’s assistants.
Pharmaceutical services in PHC clinics are normally provided by a pharmacist’s assistant or
by the nursing staff.
Operational Policies:
Operational policies could have an influence on the planning, design and function of
pharmacies and other spaces used for the provision of pharmaceutical services. The National
and Provincial Departments of Health as well as the SAPC prescribe professional, clinical and
operational policies and guidelines to optimise the quality of pharmaceutical service
delivery.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
19
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
PART B - PLANNING AND DESIGN

1. Overview
This document discusses the desired planning principles and design
considerations with applied examples to support the planning process for
“The interpretation and evaluation pharmaceutical services. Part B contains planning and design guidance,
of a prescription, the selection, design considerations, functional relationships between other departments
manipulation or compounding of in the health establishment with respect to the pharmaceutical services, and
the medicine, the labelling and internal relationships within the pharmacy unit.
supply of the medicine in an
appropriate container according Workflow diagrams are provided to explain the flow of patients, pharmacy
and the provision of information ad staff, medicines, support goods and services and other institutional staff
instruction by a pharmacist to interacting with the pharmacy.. Way-finding should support patients and
ensure safe and effective use of visitors in understanding the facility, out- and inpatient unit spaces. The
medicine by the patient”. pharmacy should provide for the needs of both able-bodied and disabled
GNR. 1158 of 20 November 2000. people.

The detailed room diagrams with accompanied norms and standards are
provided to outline different space requirements and room specific
specifications.

2. Pharmacy classification
The Regulations relating to the registration of persons and the maintenance of registers (GNR
1160 of 20 November 2000) published in terms of the Pharmacy Act make provision for the
recording of five different categories of pharmacy. The five categories of pharmacy are:
manufacturing pharmacy, wholesale pharmacy, consultant pharmacy, community pharmacy
and institutional pharmacy. Institutional or hospital pharmacies may be allocated in a public
or a private sector facility.
The services which may be provided in the different categories of pharmacy, are prescribed
in the Regulations relating to the practice of pharmacy (GNR. 1158 of 20 November 2000)
published in terms of the Pharmacy Act. In the context of this document, the focus will be on
institutional pharmacies, with aspects of wholesale pharmacy practice being considered.
The provision of pharmaceutical services in CHCs is guided by the general standards for
institutional pharmacies, whilst that for PHC clinics is guided by the Rules relating to the
supply of medicines in a primary health care clinic included in the GPP.

3. Pharmaceutical Service Delivery model – South Africa


The complexity and diversity of pharmaceutical service delivery presents challenges to the
built environment designer and infrastructure coordinator. The impact that policy changes
make along the delivery chain has a major impact on infrastructure planning. This document
presents the various delivery points as service gates; and the associated infrastructure
required per service delivery point. Alternative service delivery models currently under
consideration include one with increased direct deliveries and a lesser dependence on depot
stock holding – specifically for large volume items - and a cross-docking model to service
remotely located PHC clinics. The former will impact on infrastructure requirements
(increased stockholding, administrative and receiving capacity at hospital pharmacies and

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
20
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
decreased storage capacity requirements at depots); while the latter may require restructuring of
existing infrastructure or custom-made facilities.
The opportunity exists for the built environment designer and coordinator to revaluate
infrastructure demand from a service delivery perspective, and reconfigure of facilities to
optimise infrastructure requirements or functionality.
Below is a table of built environment facilities, presented by a diagram representing service
gates. Following this detailed requirements for the various pharmacy types – broadly categorised
under Institutional, Wholesale and Oncology pharmacies.
FIGURE 1: THE CURRENT PHARMACEUTICAL SERVICE SUPPLY CHAIN MODEL IN SOUTH AFRICA

Source: MSH/SPS

FIGURE 2 : THE CURRENT PHARMACEUTICAL MEDICAL SUPPLY CHAIN

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
21
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
Source: MSH/SPS

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
22
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
The proposed pharmaceutical service supply chain model in South Africa

List of infrastructure gateways

4. Institutional Pharmacies
The following sub categories have been proposed for the purposes of this document with the
infrastructure, service, location, space requirements, storage requirements and compliance
being discussed
a. Pharmacies in hospitals
i. Central and Tertiary Hospitals
ii. Regional Hospitals
iii. District Hospitals (small, medium and large)
b. Pharmacies in Community Health Centres(CHCs) or Community Day Centres
(CDCs)
c. PHC dispensing services
i. Clinics with Medicine Rooms and Dispensaries
ii. Clinics with Medicine Rooms only.
iii. Off-site storage and dispensing model (Mobile PHC services)
d. Pharmaceutical Depots (Wholesale storage and distribution centres)

4.1. Services to be provided


1. In terms of Regulation 18 of the Regulations relating to the practice of pharmacy the
following services may be provided under the constant personal supervision of a
pharmacist in an institutional pharmacy in a hospital, CHC or CDC - The provision of
pharmaceutical care by taking responsibility for the patient’s medicine related
needs and being accountable for meeting these needs, which shall include but not be
limited to the following functions:
1.1. Evaluation of a patient’s medicine related needs by determining the
indication, safety and effectiveness of the therapy
1.2. Dispensing of any medicine or scheduled substance on the prescription of
an authorised prescriber
1.3. Furnishing of information and advice to any person with regard to
medicine
1.4. Determining patient compliance with the therapy and follow up to ensure
that the patient’s needs are being met; and
2. The compounding, manipulation or preparation of any medicine or scheduled
substance; compounding can only occur if the necessary equipment is provided.
3. Recording keeping: Suitable floor area provision to be allocated for use of electronic
data collection systems, integrated with the electronic bulk storage and dispensing
data collection system
4. The purchasing, acquiring, keeping, and supplying of any medicine or scheduled
substance
5. The re-packaging of medicine where required
6. The provision of information and education regarding the promotion of human
health
7. The initiation and conducting of pharmaceutical research and development

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
23
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
8. The distribution of medicine or scheduled substances to other health facilities.
Specific services to be provided at PHC clinics
1. Ordering, receiving, and storage of medicines at PHC facilities may be conducted
by a registered pharmacist’s assistant (post- basic) (PA) or nurse
2. Dispensing may be done by the PA in PHC facilities which have a dispensary
3. The facility must receive patient-ready packs, or pre-package for distribution
4. A pharmacist needs to make regular visit and review procedures and processes.

Specific services to be provided at Pharmaceutical warehouses /


depots:
In terms of Regulation 17 of the Regulations relating to the practice of pharmacy the
following services may be provided under the constant personal supervision of a pharmacist
in a wholesale pharmacy (depot):
(1) the wholesale distribution of any medicine or scheduled substance through
the purchasing, acquiring, keeping, possessing, using, supplying or selling of
any medicine or scheduled substance;
(2) the furnishing of information and advice to any person with regard to
medicine distributed by him, her or
(3) the initiation and conducting of pharmaceutical research and development

Warehousing of medicines and distribution must be in accordance with Good Wholesale


Practice (GWP) and Good Distribution Practice (GDP) Guidelines as published. No dispensing
services or patient care services will be provided at depots.

4.2. Location
Considerations relating to Institutional pharmacies

1. An institutional pharmacy is associated with a healthcare facility, or institution. It


serves as the place where medicine is stored and from which medicine is supplied to the
rest of the institution. It is on the site of the facility, being either close to, or within the
main building. This equally applies to CHCs, CDCs or PHC clinics.
2. For detail general consideration regarding location of pharmaceutical service refer to
section: 9 – Location and inter departmental relationship principles

4.3. Space requirements


1. Clear segregation of work spaces is required, with sufficient area for stock transfer
2. Work areas must be designated and sufficient area allotted for each of the functions
conducted at the level of care, e.g. dispensing, clinical services, compounding, pre-
packing, and, where applicable, perinatal admixture preparation and other aseptic
compounding or cytotoxic preparation
3. Area for journals, books and equipment
4. Separate facilities for outpatients and for staff, with areas allocated for provision of
information and advice in a confidential manner.
5. Compounding areas must be separate and comply with GMP standards, as well as the
Medicines and Related Substances Act.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
24
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
6. Recording keeping: Suitable floor area and work space provision be allocated for use of
electronic data collection systems, integrated with the electronic bulk storage and
dispensing data collection system, or the manual data collection.
7. Aseptic or oncology dispensing: An appropriate class airflow cabinet is required for the
appropriate class of particulate, appropriate administration, preparation and
procedures to be followed. Procedures and equipment to be validated regularly. Quality
control to be adhered to in accordance with the Occupational Health and Safety Act,
1993
8. Where oncology products are prepared all operations must be in accordance with
applicable legislation including the GPP. The premises must comply with requirements
for aseptic preparation and aligned with GMP standards. The cabinets used must also
comply with GMP
9. Detail description of specific requirements are contained in the GMP as follows:
 Section 3: Dedicated area for counselling, and advice as well as patient waiting area
 Section 12: Sufficient storage to be provided, No storage of medicine on floors
 Pharmacy department to be equipped with an emergency medical trolley in case of
cardiac arrest or other emergency
10. Detail description of specific requirements are contained in the GMP as follows:
 Section 3: On general design and planning for details regarding room finishes,
environmental conditions, fire and safety etc.
 Section 11: Equipment requirements
 Section 3: Dedicated area for counselling, and advice as well as patient waiting area.
 Section 12: Sufficient storage to be provided. No storage of medicine on floors
 Section 3.11: Security and access control

4.4. Clinical and outpatient service requirements


1. In hospital pharmacies the distribution of pharmaceuticals to inpatient areas (ward
stock) is done under the direct supervision of the pharmacist. Provision of ward stock
and dispensing for inpatients forms part of hospital pharmacy services. This includes
ward medication management, and patient care through medicine information and
assistance.
2. A dedicated area with 'pigeonhole' compartments for transfer of ward stock medicines.
 Access is required by trolleys for collection
 An area for staff contact and dispensing of inpatient medication
 Note that this process may change with the introduction of mechanised systems for
distribution within the institution
3. At PHC facilities, the provision and management of stock to consulting rooms is done
according to standard operating procedures under supervision of the pharmacist’s
assistant from the dispensary or medicine room
4. Sufficient space must be provided for safe dispensing: namely the “The interpretation
and evaluation of a prescription, the selection, manipulation or compounding of the
medicine, the labelling and supply of the medicine in an appropriate container
according to the Medicines and Related Substances Act and the provision of information
ad instruction by a pharmacist to ensure safe and effective use of medicine by the
patient, GNR. 1158 of 20 November 2000
5. Preparation and labelling: pre-packing and extemporaneous preparation must be done
on clean surfaces, using clean counting trays, clearly labelled containers and
appropriate dispensing procedures

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
25
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
6. In PHC facilities, the pharmacist’s assistant or authorised dispenser will provide
patient-ready products according to their scope of practice.

4.5. Pharmacies with dispensary and Bulk store separation


1. Where the medicines bulk store is separated from the main pharmacy in hospitals, CHCs
or CDCs, these are jointly under the authority of the responsible pharmacist; they may
not exist and /or operate independently.
2. Detail description of specific requirements
 Section 3: On General design and planning for details regarding room finishes,
environmental conditions, fire and safety of which pharmacies and healthcare facilities
 Section 15: Equipment requirements
 Section 12: Sufficient storage to be provided, No storage of medicine on floors
 Section 3.11: Security and access control.

4.6. Storage
1. Stores and general storage must be under control of responsible pharmacist
2. Medicines should be delivered directly to the pharmacy, medicine room or dispensary
3. Temperature control must be in place in all storage areas for medicines. Refer to Section
8.11 for ventilation and air management
4. Storage of thermolabile medicines and vaccines refer to section 4.7 for cold chain storage.
5. Expired or obsolete medicines must be removed and placed in a dedicated demarcated
area for appropriate disposal or collection
6. A separate, secure and under cover goods receiving and goods dispatch area is required,
that is under security control
7. The storage area for medical consumable items must be in close proximity to the
pharmacy store if the pharmacist has to perform an oversight role for these products
8. Flammable store to be provided for inflammable substances, this must be in the delivery
yard outside the pharmacy building but inside the pharmacy locked area
9. Storage of disinfectants to be separate from medicines for oral use.

FIGURE 3: VARIOUS STORAGE AREAS – MITCHELLS PLEIN HOSPITAL

4.6.1. Cold Chain Storage


1. Thermolabile or cold chain pharmaceutical products are defined as all products which
require constant cold storage at product specific temperatures below room temperature.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
26
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
This also includes vaccines which are normally stored between 2 °C and not exceeding 8
°C
2. Procedures must be followed to prevent deterioration or damage of the goods.
Thermolabile pharmaceutical products must be stored in a temperature regulated
environment. Storage areas may include inter alia cold rooms, refrigerators and freezers
and these must be of a suitable size and quality to allow safe cold chain storage
3. Controlled temperature storage areas must be equipped with appropriate temperature
recorders of a suitable standard. Control must be adequate to maintain all parts of the
area within the specified temperature range. Recording devices/instruments must be
calibrated annually against a certificated standard
4. A suitable number of WHO approved temperature recording instruments, being at least a
logging device, must be installed to record temperatures
5. Large commercial refrigerators and walk-in cold rooms must be monitored with an
electronic temperature-recording device that measures load temperature in one or more
locations, depending on the size of the unit. In the monitoring of large refrigerators and
walk-in cold rooms, portable data-loggers that can be downloaded onto a computer
should be used
6. No domestic refrigerators shall be deemed suitable for the storage of thermolabile
pharmaceutical products. Where possible, WHO-approved refrigerators with adequate
stand-over time should be used, especially for the large-scale storage of vaccines
7. The storage area or refrigerator must be large enough to allow for orderly arrangement
of products, to permit air circulation and for proper product rotation, without exposing
stored products to the risk of freezing
8. It is preferable that vaccines and other thermolabile medicines are stored in separate
refrigerators
9. All storage areas, such as refrigerators or cold rooms must be properly maintained
10. Condensation from chillers must not collect inside the storage area, and no condensation
from chillers may collect or drip onto the products
11. The refrigerator, cold room or freezer must be connected to a standby generator or other
emergency power system to ensure uninterrupted power supply in the event of power
failure. The refrigerator, cold room or freezer must be connected to an alarm system that
will alert the pharmacist in the event of a power failure or if the storage area temperature
limits are exceeded
12. The refrigerator, cold room or freezer must be clearly designated to store medicines or
vaccines only. No food or drinks may be stored in medicine fridges
13. Within an institutional pharmacy the storage area must be inside the pharmacy and must
be easily accessible to the pharmacist and pharmacy support personnel and other
authorised healthcare professionals
14. Within a primary healthcare facility, the cold chain storage area must be easily accessible
to authorised healthcare professionals
15. Receipt, distribution and transportation of thermolabile products must be done with
urgency and maintenance of the cold chain according to standard operating procedures.
Sufficient cold boxes of a suitable standard and cold packs should be available to allow for
this

4.7. Compliance for facility registration and approval


1. Good Pharmacy Practice rules
2. Good Manufacturing Practice (compounding, pre-packing)
3. Good Wholesale Practice
4. Pharmacy Act 53 of 1974

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
27
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
5. Medicines and Related Substances Act 101 of 1965

4.8. PHC Dispensing service specific rooms / medicine rooms


There are two categories for the provision of pharmaceutical services in PHC Clinics.
1. Category 1: Service provided by a pharmacist assistant’s (post -basic)
 Suitable area provided for use as a storage room for medicine (medicine room)
 Suitable room required for use as a dispensary
2. Category 2: Service provided by a licensed dispenser (professional nurse)
 Suitable area provided for use as a storage room for medicine (medicine room)
 Dispensing is done from the consulting rooms,
(This practice may change especially for chronic medication collection)
 No storage of medicine in the consulting rooms, The medicine trolley must be stored
in the dispensary area.
 Daily top-up to the consulting room by lock-up trolley, medicine to be kept in the
medicine room under security access control.
 Controlled access, see section 3.11
3. The following fixtures are mandatory for dispensary /medicine rooms:
 Controlled air temperature and qaunity
 Refrigerator well serviced. Refer to Section 4.7 on cold chain storage.
 Hand wash basin, hot and cold supply. Separate basins for hand washing and
equipment.

5. Satellite pharmacies for oncology services


Refer to the IUSS:GNS Adult oncology service document for pharmacy requirements. All
pharmacies must be under the constant personal supervision of a pharmacist

6. Infrastructure for medicine rooms for mobile health


services

6.1. Services to be provided


1. Mobile health services are provided from vehicles to predetermined health posts or
stops. Medicines for chronic conditions and minor ailments are provided by
professional nurses
2. A specific store room in a fixed facility is designated to serve as base and departure
point for these services
3. No medicine may be stored in mobile units after trips
4. Vehicles are packed daily according to an approved list of medicines.

6.2. Space requirements


1. General storage requirements for pharmaceuticals apply to the storage area, including
cold chain storage, air conditioning and cross-ventilation
2. Storage in the mobile unit must be safe for short-term transportation of medicines with
cold chain storage, air conditioning and sufficient ventilation in the vehicle, Preferences
to cross ventilate
3. Finishes and surface material to comply with requirement for institutional pharmacies

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
28
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
4. Required environmental conditions must comply with the required storage of medicine
and dispensing of medicine standard
5. Hand washing and equipment cleaning facilities to be provided
6. Equipment and space must be provided for recording keeping
7. Detail description of specific requirements
 Section 3: On General design and planning for details regarding room finishes
environmental conditions, fire and safety etc.
 Section 15: Equipment requirements
 Section 12: Sufficient storage to be provided, No storage of medicine on floors
 Section 3.11: Security and access control

6.3. Storage
1. Direct delivery of medication to the pharmacy
2. Expired or obsolete medicines must be removed and placed in the expired medicine
store for collection by supplier.

7. Wholesale / Depot pharmacies:

7.1. Service to be provided


3. The wholesale distribution of any medicine or scheduled substance through the
purchasing, acquiring, keeping, possessing, using, supplying or selling of any medicine or
scheduled substance
4. The furnishing of information and advice to any person with regard to medicine
distributed
5. The initiation and conducting of pharmaceutical research and development
6. Any other health service as may be approved by council from time to time.

7.2. Space requirements


7. Detail description of specific requirements
a. Section 3: On General design and planning for details regarding room finishes
environmental conditions, fire and safety etc.
b. Section 15: Equipment requirements
c. Section 12: Sufficient storage to be provided, No storage of medicine on floors
d. Section 3.11: Security and access control
8. Separate and clearly demarcated receiving and dispatch areas, with quarantine and
checking areas
9. Demarcated separate area for returned medicines
10. If prepacking is done on the premises, adequate provision should be made for a GMP
compliant area for this purpose
11. Recording keeping: Suitable floor area provision to be allocated for use of electronic data
collection systems, integrated with the electronic bulk storage and stock management
data system.

7.3. Storage
12. Stores and general storage must be under control of responsible pharmacist
13. Direct delivery of medication from manufacturer to the pharmacy

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
29
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
14. Expired or obsolete medicines must be removed and placed in the expired medicine
store for collection by supplier or waste disposal service as applicable
15. Flammable store to be provided for inflammable substance if handled, this must be in
the delivery yard outside the pharmacy building but inside the pharmacy locked area
16. A separate, secure and under cover goods receiving with a separate goods dispatch area
is required, that is under security control
17. Cold storage and vaccine storage - refer to Section 4.7 for cold chain management
18. Cold room, refrigerator and freezer maintenance - refer to GPP chapter 2, pg47-48.

7.1. Compliance for facility registration and approval


19. Good Manufacturing Practice for Medicine
20. Good Wholesale Practice for Wholesalers
21. Good Pharmacy practice in South Africa
22. Pharmacy Act 53 of 1974
23. Medicine and Related Substances Act 101 of 1965

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
30
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
8. Design and Planning Principles

8.1. Overview
Way-finding should support patients, visitors and the community navigating the health
establishment. The detailed room diagrams with accompanied norms and standards are
provided to clarify understanding of the different space requirements and room specific
specifications that relate to the pharmaceutical service platform. Patients enter a facility
either as in-, day- or as outpatients. This document describes the process flow of these three
categories.

8.2. Healing environment


The pharmacy unit has both a patient contact interface, and a highly functional staff
interface. The planning of the pharmacy patient interface will benefit from salutogenic
planning principles to ensure a holistic healing environment with, where possible, clear
external views, consideration of noise levels, natural ventilation, as much morning sun or
light as possible and spaces that would create a pleasant healing environment. While this will
also be beneficial to the staff area, more consideration is required to the functional efficiency
of the design.
The planning of the required space includes the following:
a. Personnel – How many people there are at any given time in a specific place to
perform a specific task or procedure?
b. Activities– What procedures are to be performed?
c. Equipment – What equipment is required that will occupy the space?
d. Security – Access control to be determined by the management
e. Patients - The varying nature of patient illness, i.e. the presence of patients with
airborne diseases such as TB etc.

8.3. General design and planning requirements


Design of the pharmacy or dispensary should provide:
• A clinically safe, effective and confidential medication dispensing environment
• Design and policies that maximise patient safety and reduce the risk of errors
and accident
• Ergonomically safe and risk-free work environment for staff
• Design that avoids large sprawling designs, it is both resource and cost
intensive
• Efficient workflow that will support effective resource utilisation
• Design that considers noise impact in the facility
• Recognised infection control policies
• Compliance with quality assurance principles
• Communication and information systems that will support patient management
and administration
• Layouts that reflect the service needs of the patients
• An aesthetically pleasing environment for patients and that assist staff to
perform the required activities in the most efficient and supportive
environment
• Maximum use of natural light and views for patients and staff

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
31
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
• Minimise staff travel distances to obtain supplies and equipment
• Design that balances requirements for clinical need and capital and recurrent
budget considerations
• The careful consideration at master planning stage, for the optimum placement
of the pharmacy unit, enabling efficient and effective service delivery to both
patient and by staff
• Importance should be placed on patient privacy and confidentiality
• All sanitary requirements should be on external walls as far as possible
• Design that enables good observation by overseeing pharmacist
• Adequate storage space for bulky equipment
• Access to and within the area for physically and sensory impaired people
• Waiting areas to be sufficient and well ventilated, refer to the IUSS:GNS –
Generic room requirement sheets for functional space waiting for size and seat
spacing.
FIGURE 4: PHARMACY WAITING AREA – MITCHELLS PLEIN HOSPITAL AND KHAYELITSHA (L - R)

Design principles and green building approaches are addressed in IUSS:GNS Environment and
sustainability and IUSS:GNS Hospital design principles respectively.

8.4. Access and circulation


The workplace design should minimize public access to all areas of the workplace. Ideally,
visitors should have access to one main entrance.
Security should be placed at this entrance if necessary. However, support services such as
emergency response teams should have maximum access to all areas of the workplace to
facilitate their intervention in emergencies.

8.5. Infection control


(Refer to the IUSS:GNS Infection prevention and control guideline)
The primary objective of hospital design is to place the patient at no risk of infection while
hospitalised or in the hospital environment. Particular attention is to be focused on patients
with infectious diseases (TB in particular), immune-compromised patients, healthcare
workers and paediatric patients.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
32
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
The following aspects contribute to effective infection prevention and control and are
relevant within the context of the pharmacy:
• Hand hygiene facilities;
• Storage;
• Waste management: GPP requires a written sanitation procedure
plan relating waste material and equipment, no down surface
substance disposal are permitted, such as storm water drains etc.
All waste disposal must be conducted in accordance with the
applicable regulation requirements.
• Ventilation;
• Surface finishes.
All areas of the facility shall be designed, constructed, furnished and equipped in keeping
with the principles of infection control.
A number of strategies contribute to the control of infection, such as hand washing, careful
aseptic technique and the observance of 'standard precautions'. By far the most important of
the infection control strategies is effective hand washing. Hand-washing facilities shall be
installed in all patient care areas, nurses’ stations and also in all areas where careful
attention to hygiene is essential, such as: kitchens, laundries, pharmacies and laboratories.
Staff amenities areas, such as bathrooms, toilets and change rooms shall also be equipped
with hand-washing facilities.
The administrative infection control measures and protocols of the hospital are to be
followed and implemented in the design.

8.6. Ergonomics in design


All facilities shall be designed and built in such a way that patients, staff, visitors and
maintenance personnel are not exposed to avoidable risks.
Designers are to consider the optimum comfort of all situations for staff, patients and
visitors.
The GPP recommends the use of 900mm clear work surface for dispensing areas.

8.7. Materials
(Refer to the IUSS:GNS Materials and finishes guidelines)
The choice of materials has a cost and longevity relationship. Pharmacies have specific
requirements for each designated area of work. However, a few general requirements are of
importance.
• Walls, floors, ceilings must be kept clean.
• Countertop shelves, shelves and walls must be finished in smooth,
washable and impermeable material.
• Fittings are to be made of durable, smooth, impermeable and
washable material.
• Walls to be smooth plastered, with no cracks or rough sections.
• Walls to be painted with a durable and washable paint.
• Ceilings must not permit dust through, no cracks or flaking paint.
• Floors

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
33
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
1. The floor should be screeded to a smooth even, level, high quality finish, with
neat joins between wall and floor.
2. Vinyl sheeting is recommended throughout. Sheet edges should be welded and
all cracks, gaps and joints suitably closed and smooth. The sheeting should be
laid with a suitable adhesive, evenly applied and leaving no bubbles etc.
3. Ceramic tiles may be used in toilets and kitchens as well as areas that may be
subject to frequent washing or spillage, e.g. manufacturing area. Grouting must
be appropriate for the use, even and correctly done.
4. Epoxy coating may be used in both storage areas, offload and receiving areas.
Surface must be prepared as in a) above, and the epoxy applied so as to be even,
smooth, and free of lumps or cracks.
5. Carpets may be used only in offices or tea lounges. A durable, hardwearing, stain
resistant synthetic carpet should be selected. Leading edges, for example at
doorways, should be suitably protected with a metal strip.
• Skirting may be used cover poor joins at wall and floor. The
objective is to eliminate any cracks, gaps etc. They should be either
vinyl, aluminium or painted/ varnished wood. They should not
allow water or dirt to be trapped behind them. However, it is
preferable that they be eliminated by achieving a high standard of
finish by joins at wall and floor which are smooth, square and
without gaps.
• Expansion joints must be suitable covered. All cracks should be
filled with suitable filler that would allow for expansion and
contraction without cracking.

8.8. Universal access


(Refer to the IUSS:GNS Inclusive environments guideline)
The pharmacy entrance, dispensing counters and doorways must be accessible to disabled
persons. Consideration must be given to the wide range of clients and especially inclusive of
disabled person consisting of:
• Mobility impairment,
• Visual impairment,
• Hearing impairment.

8.9. Way finding and signage


(Refer to the IUSS:GNS Inclusive environments guideline)
Way finding and signage must be considered from the inception of the design process. The
layout of the health establishment must be logical, and signage must be simple and easy to
follow. Each department and inpatient unit should be individually and clearly marked. The
requirement for strict access control in the establishment makes it very important for
patients and visitors to be directed along routes accessible to them.
Appropriate signage for all the internal rooms and the external buildings should make use of
universal signage as far as possible taking cognisance of the Provincial Policy on Signage and
way-finding. Comprehensive signposting shall be provided for all health establishments
Signposting shall clearly identify staff, patient and visitor areas, and draw attention to
restricted areas.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
34
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
Room Signs
Non-illuminated, internal and external room-function identification signs that are located on
doors require the following considerations:
Staff signage
The GPP prescribes that the name of the pharmacist on duty should be displayed either in or
outside the pharmacy for public identification.
The GPP prescribes that the pharmacists must wear name badges or name tags for
identification.
• The format used for signage should allow easy replacement of the sign or sign
inset when the room function changes.
• Equipment: Signage
Display of the following signs on the exterior of the pharmacy are recommended:

 “Responsible Pharmacist” – with space for name of incumbent on or next to main


entrance door (pharmacy only)

 “Authorised Personnel Only” sign on external doors e.g. Delivery to store.

 “Deliveries” or “Medicine Deliveries” on the outside of the delivery door

 “Pharmacy” sign at or close to the patient interaction point


 “Folders in” at the “in” hatch or patient service point (as applicable)
 “Medicine here” at the “out” hatch or second patient service point (as applicable)
 “Staff on duty” display sign with spaces for names to be filled in/displayed inside
dispensary/pharmacy where it is visible to patients but does not hamper work flow.

Signage must be affixed to the wall or door to prevent it being damaged or removed.

8.10. Telecommunication and IT systems support:


(Refer to the IUSS:GNS Information technology and infrastructure guideline)
• Telecommunication system
• Nurse call to all patient areas with central control system
• Paging and personal telephones replacing some aspects of call systems
• Bar coding for supplies and X-rays / records
• Computer network connections in all management and patient administration
and information system
• Hospital information system (HIS)/Electronic Patient Records
• Patient Administration System (PAS)
• Radiology Information system (RIS) (Digital x-rays and Picture Archiving)
Communication System (PACS)
• Laboratory system ( NHLS link)
• Pharmacy system
• Alarm - HVAC

8.11. Ventilation and Air-management


(Refer to the IUSS Building engineering services guideline)

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
35
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
• Natural ventilation and light should be provided to all patient areas as well as
all public and patient waiting areas. Considering must be given in the event of
power failure, an open window policy must be adopted
• Windows should be able to open without patients being able to harm
themselves.
Specialist Pharmaceutical service space HVAC regulations:
• Temperature in the dispensing area, storage areas and medicine rooms should
at all times be kept to below 25'C
• Medicine and vaccine refrigeration must meet temperatures of between 2'C -
8'C
• Freezers to be provided for storage of certain vaccines below 20'C and for
preparing ice packs.
• Compounding areas are subject to specific HVAC regulatory standards; refer to
the IUSS HVAC guidelines.
• All medicine storage areas must comply with the required humidity, light and
temperature regulations refer to the IUSS HVAC guidelines.
• Medicine rooms should be cooled and kept at a constant temperature to protect
pharmaceuticals. Specific regulations regarding this item please refer to the
IUSS HVAC guidelines.
• For institutional pharmacies where a central HVAC system is utilized that
service the entire complex, it is advisable that the pharmacy department
(stores, dispensing, etc.) be under separate control. This will ensure that the
correct and constant temperatures and environmental conditions are met as
specified above.

8.12. Day and night time illumination


(Refer to the IUSS Building engineering services guideline)
• All rooms should be provided with the required electrical
illumination
• Night lights should be provided in passages at appropriate lux
levels;
• Daylight saving to be incorporated with room sensors as part of the
hospital BMS system to ensure energy saving.

8.13. Fire detection and alarms


(Refer to the IUSS Building engineering services guideline) and SANS 10400 regulations
• All patient areas, including pharmacy waiting should be provided
with escape doors in cases of fire
• Smoke detection is preferred, sprinkler systems are not
recommended
• Fire extinguishers should be provided, slightly recessed so as not to
cause obstruction
• All patient areas as well as the pharmacy should have an evacuation
plan that is aligned with escape routes
• A health and safety procedure must be available, read and signed by
all staff.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
36
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
8.14. Safety and security
(Refer to the IUSS:GNS Hospital design principles: security guideline)
• The security of the pharmacy/dispensary and storage areas are of great
importance. The pharmacy/dispensary must be under controlled access and
lockable to prevent any unauthorized entry
• A security policy must be drafted and implemented to ensure safety for both
staff and medicine
• The impact of crime in South Africa must be taken into consideration, this
includes appropriate burglar bars for windows, flooring construction and
finishes for raised flooring and celling finishes must be specified The celling
requirement being either enclosed void with no way of external access oro
concrete slab overhead the selection of ceiling requires a deemed to satisfy
proposal
• The responsible pharmacist is responsible for the collection and accountability
for every key, key card, pin or other manner of entry of the pharmacy
• In the event of an emergency evacuation or closure, the security system and
policy must comply with the Occupational Health and Safety Act 85 of 1993.
• It is required that the delivery or collection of stock be done in and under a
controlled environment, the delivery and/ or collection truck is required to
drive into an enclosed cage that is locked during the period of delivery and/ or
collection
• All access doors must be supplied with internal access control limited to the
staff working in the area
• All windows must be fitted with burglar-proofing and with roller shutters at the
serving hatches. No opening windows in the stores
• Security gates on all stores and external doors. Security gates should be fitted
on all stores and exterior doors. They should be code 10 that either has a pin
going into the floor and one going up into the frame. Alternatively they must be
able to lock with a bolt and padlock. A double locking system to external doors
must be fitted
• Exterior walls and those interior walls dividing off the pharmacy and the bulk
store are to be up to the underside of the roof (or slab above) to exclude access
into the pharmacy or stores via the ceiling cavity
• Burglar alarm, Smoke detectors
• CCTV in specified areas, especially the Outpatients and Inpatient pharmacies,
CCTV. Local arrangements should be made for monitoring and response
• Emergency exits to be provided
• Roller shutter doors should be fitted to all patient hatches. They are to be
closed and locked after hours
• Roller shutter doors should be fitted on all goods receiving entrances. They are
to be keep locked when not specifically needed
• Temperature monitoring control should be fitted to cold rooms, with an out or
range warning / alarm sent to some central point in the hospital. Local
arrangements should be made for monitoring and response. The addition of a
data logger which records temperatures at set intervals is advised, and helps to
decide what should be done to the affected stock if the cold room fails.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
37
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
9. Location and inter departmental relationships principles
In addition to the notes on institutional pharmacy locations, the following general principles
require consideration. The pharmacy service serves the outpatients, PHC clinics and
inpatient departments. The service should be placed central to the core services near
outpatients, inpatients, emergency centres. The placement of the pharmacy must also
support patient flow. Patients served at outpatients/emergency centres (trauma units)
should be served at the pharmacy as the last stop before leaving the facility.
FIGURE 5: CLINICAL FLOW DIAGRAM FOR INTER DEPARTMENTS:

The generic diagram above indicates the clinical workflow dependencies between the clinical
service departments within a health establishment, based on the hospital type and service
package this diagram will either be reduced or departments added.
The point of service provision must be disabled-friendly, baby and child friendly. Adequate
security is essential with restricted access. Cooling must be provided to ensure that
medicines are stored at an appropriate temperature.
1. Delivery area for stock should be placed on the outer wall of building to allow for secure
delivery of stock to the pharmacy and allow for truck access. In the unlikely event of a
facility being located on more than one level, the pharmacy should be on ground level to
facilitate access and deliveries.
2. Layout: should support movement of stock - From delivery area to bulk storage area to
“reworking“ area (if applicable i.e. repacking, compounding, reconstituting) to
dispensing area to patient/staff contact

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
38
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
 Avoid stock delivery through patient access areas or patient waiting areas
 Avoid stock delivery through the dispensary access door/office door
 Avoid placing the pharmacy far from the exit of the facility, as medicine receipt is
usually the last service point for patients.
 Avoid having public toilets close to entrances and serving points in the pharmacy
3. The pharmacy must be accessible and centrally located to staff and patients; in addition
the following consideration must be taken into account
4. The stock storage areas should be grouped together in close proximity to the receiving
and holding areas. Single level is advisable and efficient, depending on site conditions a
spilt in the stores and dispensing can be considered with an internal service lift. It must
be noted that this is not the ideal workflow scenario
a. The staff rest room should be sited away from the main work areas
b. Pharmacist offices should be central
c. The compounding, tablet pre-packing and sterile suite may be sited further
awa.
d. Basket issue section may preferably be sited in the stores section, and needs
easy access for collection by the hospital messengers
e. The Pharmacy Managers office and seminar room should be central to all
functions
f. There must be electronic access control to the pharmacy
g. The sterile suite should be situated on the outer perimeter as the laminar
flow unit has to vent to the exterior
h. The Inpatient Pharmacy will require a walk-in cold room or fridge (2-
8degrees)
i. Both Adult and Paediatric outpatient pharmacies will need a 1 week store
room
j. The Pharmacy Unit shall be located for convenient access, staff control, and
security.
k. Outpatient Dispensaries require fridges.
l. Outpatient Pharmacies require Schedule 5 and 6 = High Risk room under
controlled access.
m. The Schedule 5 and 6 store room shall be next to the Schedule 5 and 6 issue
room and office and the latter shall be near both outpatients and inpatient
dispensing area. In ward departments, medicine rooms require schedule
medicine cupboards that are under controlled lock and supervised by head
matron
5. Outpatient service:
a. Be centrally located with easy access to treatment areas/consulting rooms
as well as near to the entrance/exit (where possible) and close to the
reception point
6. Staff and ward / consulting room service:
a. Be within the main building within easy access for stock replenishment
7. Environmental conditions:
a. Be located on the south side of the building to assist temperature control
and limit direct sunlight.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
39
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
FIGURE 6: DEPARTMENTAL RELATIONSHIPS

10. Flow Patterns


Point of entry into the facility:
• Patients or visitors will access the facility through a secure entrance
to a parking area or drop off point from where there should be clear
direction (signage) to the required point of entry
• Alternatively, a patient will arrive via the emergency services to the
emergency unit or the maternity services entrance
• Staff access through a secure entrance to a staff parking area or
drop off point from where they may enter the facility through a
separate staff entrance. The deliveries will be accessed through a
secure delivery yard with restricted access.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
40
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
FIGURE 7: ENTRANCE TO AND FROM THE PHARMACY

11. Functional Zones


The Pharmacy unit functions as a standalone unit consisting of six separate functional zones:
TABLE 1: SIX SEPARATE FUNCTIONAL ZONES

ZONE ACCOMMODATION SPACES

ADMINISTRATION SPACES  Offices, labelling. receive and dispatch counters

 Reception and waiting areas


PUBLIC SPACES
 Medicine information areas
 Patient accommodation and patient day rooms
PATIENT SPACES
 Patient counselling and consult areas
 Dispensing areas which may include separate areas for
inpatients and ambulatory patients
 Spaces for the handover of medicines prepared at
another facility
 Medicine information areas
 Preparation and compounding areas
SERVICE AND SUPPORT AREAS
 Storage areas including active stores for preparation
and dispensing areas, bulk stores, secured stores for
vulnerable medicines and refrigerated stores
 Dispatch area for deliveries to inpatient units and other
facilities
 Delivery yard for bulk deliveries and distribution to
clinics .
 Staff areas including offices, workstations, meeting
STAFF SPACES
rooms, staff room, change and toilets
TEACHING SPACES  Training/meeting room (In district hospitals staff
restrooms could be used )

FIGURE 8: PHARMACY: INTERNAL ZONING AND RELATIONSHIP

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
41
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
Pharmacy layouts will vary depending on individual needs per project as outlined in the
health and design briefs. However general principles of design apply and the location of
facilities within the pharmacy unit should be a logical process optimizing the workflow and
travel distances for staff from service and storage areas to the patients at service cubicles
and counselling rooms.
Flow and priority areas of service to be further developed and discussed in more detail.
Principle
No one particular pharmacy unit layout has been found to be universally superior. Some
layouts are, however, more appropriate than others. In all cases, the final decision must be a
response to the physical constraints of the site, local service needs and operational policies.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
42
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
12. Activities
The pharmacy need to provide for the following patient activities and services:
TABLE 2: PHARMACY ACTIVITIES

CATEGORY ACTIVITY

Patient
1.  Patient may be disabled and wheelchair-bound;
 Patient to receive medicines by clinical staff, either lying down
or sitting up in bed or in a chair ;
 Washing hands.
 Patients to receive counselling
 Patients to receive medication

Staff
2.  Teaching ;
 Taking notes, entering of data into computers, making and
receiving of phone calls and washing hands.
 Compounding
 Pre-packing medication
 Unpacking medication
 Wet and dry manufacturing
 Labelling
 Sorting, packing forward distribution
 Administrating medicines to patients
 Doing patient assessment and counselling
 Patient education

Clerical/administrative
3.  Answering telephones,
 Writing reports and collecting and entering data and statistics,
Ordering pharmaceuticals and other consumables.
 Washing hands

Maintenance
4. Staff  Maintenance – replace globes, fix fittings, resealing of floor
and repair work to maintain the inpatient unit.
 Washing hands

13. Operational Considerations

13.1. The patient expectations:


• That patient privacy and dignity will be afforded the patient both in
the design of the facility and in the treatment of the patient
• That patient comfort will be provided in the facility i.e. A clean and
uncluttered environment, an outside view, low noise levels in the
facility, availability of technical services
• That the availability of pharmacy staff is adequate.

13.2. Staff expectations:


• A work environment with reduced walking distances.
• Improved patient risk management
• A safe work environment e.g. suitable height of shelves and service
outlets, non-slip floors, view of unit entrance/exit, access control
etc.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
43
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
• Personal safety and security of possessions e.g. staff lockers, staff
room etc.

13.3. Dispensing standards


(HIV) - (ARC) Human Immune Virus - Aids Resource Centre procedures; (EPC) - Emergency
Postcoital Contraception procedures
Future additions to this document include: Electronic dispensing
General dispensing standards to be considered:
24. At least one dispensing counter to be disabled-friendly and accommodate wheelchair
patients.
25. Clients to be served at confidential service booths that will allow client privacy. The
booths must be provided with lockable roll-down shutters to ensure security after hours.
A glass partition with counter hatch for medication and a speaker system.
26. Counter to be at a suitable height for both patient and staff.
27. Closed telephone booth in the waiting area
28. Ablutions for: male, female, paraplegics and a baby change area.
29. The inpatient services require management of ward stock, medicine supply and issue of
discharge scripts. The ward stock will be collected by the wards.

13.4. Patient records and administration procedures


The patient records are recommended to be digital, with a central records room, preferably
placed at the main admission desk. However smaller local records rooms can be provided,
that feed intermittently based on hospital administration protocol to the main hospital
records.
Patient administration is done at the dispensing cubicles for new patients, chronic patients
and existing patients. For more information on administration and records refer to both the
IUSS:GNS Adult inpatient services document and IUSS:GNS Administration and related services
document and the GPP.

13.5. New developments


Based on current NHI service developments, the possibility of combining medicine depots
into either district, regional or central hospitals is under consideration. This will include
distribution to clinics, CHC, and other hospitals etc.

14. Specialised Components


Compounding
Pharmaceutical compounding involves the creation of a particular pharmaceutical product to
fit the unique need of a patient. This process is used for medical reasons, such as: changing
the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient
that the patient is allergic to, or to obtain the exact dose(s) needed or deemed best of
particular active pharmaceutical ingredient(s). Refer to the Pharmacy type service matrix
table for applicable pharmacies that may provide compounding services in South Africa.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
44
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
Aseptic dispensing
This is the process by which a sterile (aseptic) pharmaceutical product is packaged in a
sterile container in a way that maintains sterility. Pharmaceutical sterile processing includes
use of clean rooms, bacteria retaining filters and dry or steam heat. For further information
one can refer to: Guidance for Industry Sterile Medicine Products Produced by Aseptic
Processing — Current Good Manufacturing Practice; U.S. Department of Health and Human
Services Food and Medicine Administration.
Cytotoxic Preparation
This process is commonly used at chemotherapy pharmacies for cancerous and other disease
and illness. Cytotoxic refers to the quality of being toxic to cells. Examples of toxic agents
are immune cells or some types of venom. The killing ability of the medication is related to
the ADCC - Antibody-dependent cell-mediated cytotoxicity. Cytotoxic preparation commonly
occurs at oncology pharmacies and is a specialist division.
Cold chain
Cold chain refers to temperature - controlled supply. An unbroken cold chain is an
uninterrupted series of storage and distribution activities which maintain a given
temperature range. It is used to help extend and ensure the shelf life of pharmaceutical
medicines.
A common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C. but
the specific temperature (and time at temperature) tolerances depend on the actual product
being shipped. Cold chain is important in the supply of vaccines to distant clinics.

15. Pharmaceutical Equipment and Furniture


The schedule of equipment required varies according to the service provided as outlined in
the pharmacy matrixes. Following is an indicative guideline list of minimum equipment
required for a functional pharmacy provided by the GPP and Provincial recommendations.
The referred list is indicative and not exhaustive and can vary per pharmacy category, type,
service provision and size.
All fixtures should be of durable materials, but most importantly, be able to withstand
regular washing to both ensure and maintain cleanliness. Further, any cracks, loose, peeling
or flaking paint or coatings, must be excluded.
30. Counter tops.
1. Must be smooth and of adequate size, as determined by the staff working in the
area
2. They must be finished in a washable and impermeable material which is easy to
maintain in a hygienic condition
3. Joints and cut edges must be correctly sealed to prevent penetration by liquids
or dust
4. A clear working surface area of 90 x 100cm must be provided for each
pharmacist or other registered person working there.
5. They must be stable, supported either on top of a “kitchen-type unit”, or
adequately secured to the wall
6. Formica or similar materials are generally suitable for use, however in
manufacturing, pre-packing and sterile suites, a suitable grade of stainless steel
would be preferable.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
45
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
2. Shelving
1. The shelving should be of metal, that is epoxy powder coated, and be washable
2. The shelving should be adjustable
3. Size and height need to be appropriate for the particular circumstanceThey
should not be higher than 1.8m
4. Shelving that is over counter-tops may be mounted on wall-bands
5. All other shelving should be freestanding and shelf-supporting unitsSuitable
backing sheets are required to stabilize the fixture, and prevent stock falling
down the back. Where the unit stands against a wall, attachment to the wall
may be desirable if it can lend further stability
6. No medicines are to be stored on the floor.

FIGURE 9: PHARMACY SHELVING – KHAYELITSHA HOSPITAL

3. Pallets
1. Pallets may be used to store bulky cartons of medicines, where the volumes
dictate
2. Sufficient space must be allowed within the store area for the numbers of
pallets required.

4. Equipment: Electronic and electrical equipment required (for which provision should
be made)
1. Dedicated / separate Burglar Alarm and movement sensor(s)
2. Personal Computer(s) in main dispensary
3. Label Printer
4. Personal Computer in pharmacist’s office
5. Printer
6. Fax machine or fax function on PC
7. Telephones: Dispensing area, store, office
8. PA system
9. Refrigerators – large medicine fridge with 40 hour hold over period
10. Vaccine fridge bulk stock: minimum 40 hour hold over period
11. Microwave or hot plate : if compounding is performed – to heat/melt
ingredients

5. Equipment: Dispensing
1. Wall mounted metal cabinet for Schedule 5 and 6 medicines ( controlled
substances)

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
46
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
2. Lockable Cabinet for ARV medicines or “hot” items
3. Wall mounted roll dispenser for labels
4. Equipment: General (for which provision / space should be made)
5. Waste bins approx. 80 – 100 litre capacity i.e. large domestic – with lid
6. Waste bin – pedal action 30 – 50 litre capacity
7. Waste bin – designated, purpose specific bin for expired medicine disposal
8. Delivery trolleys: stainless steel - moderate to heavy duty
9. Staff lockers
10. Pin board for displaying notices 1m x 1m ( approx.) affixed to wall of dispensing
area
11. White Board with markers 1m x 1m (approx.) affixed to wall of dispensing area
or staff room
12. Kettle – compounding if required and to allow staff to make liquid refreshments
without leaving the department
13. Pin board for displaying notices 1m x 1m ( approx.) affixed to side wall of
pharmacist’s office
14. Fire extinguisher – wall mounted – 5 kg charge

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
47
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
16. Room List

Standard Non Standard


ROOM
Component Component

Archives x

Baby Change x

Box room (storage of boxes) x

Bulk Store x

Cleaners store x

Clinic distribution store x

Clinic make-up store x

Cold Room x

Counselling room x

Data Capture x

Dirty Utility x

Disabled Toilet x

Dispatch x

Dispatch Area x

Dispensing Counter/Cubicles x

Dry Manufacturing x

Expired medicine store x

Flammable store x

Good Receiving x

Labelling x

Manufacturing Area x

Multipurpose Room/Meeting Room x

Off Load Platform x

Office x

Office x

Office - Chief x

Office - Manager x

Office - Manufacturing x

Office - Manufacturing Clerk x

Office - Ward Issues/Stock x

Packing Area x

Patient Waiting Area x

Post-pack sStore x

Prepack Store x

Private dispensing room x

Processing Area x

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
48
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
Standard Non Standard
ROOM
Component Component

Public Ablutions - Female x

Public Ablutions - Male x

Receiving x

Scheduled Medicine Store + High Risk x

Staff meeting room x

Store - Bottles x

Store - Cold Room x

Store - Empty Boxes x

Store - Flammable Store x

Store - General x

Store - IV Fluid x

Store - Post Manufacturing x

Store - Pre manufacturing x

Store - Scheduled Medicines x

Telecommunications and IT x

Truck Parking x

Waiting Area x

Ward issue area x

Ward Trolleys x

Waste Disposal x

Wet Manufacturing x

Wheelchair counter x

Workstation x

Workstation - Clerks x

17. Selected room type requirements


The room list as listed in section 13 - Room List considers all room types. The rooms
described in this section are only representative of rooms that require special consideration
as related to pharmacies. Further room layouts, descriptions and requirements can be found
in the IUSS GNS suite of documents as well as the IUSS:GNS Generic room requirements .

17.1. Dispensing rooms - private/semi private and public


Private/semi-private room: This room is used for private dispensing and counselling
purposes. This area requires a confidential environment, ensuring privacy and noise
reduction. This room must be sufficient in size for practical demonstration if required.
Cubicle: This area is generally directly of the pharmacy waiting area, with clear view to the
pharmacist. This area must provide a semi private environment, a pass through area for

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
49
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
medication, and clear audible sound communication. At the dispensing cubicle advice and
directions of use or application and counselling are given and communicated to the patient.
Patient service hatches:3
Minimum of two service hatches per pharmacy (IN and OUT). Most facilities will require
three service hatches i.e. one “IN” and two “OUT” hatches. Standard should be for facility to
have SEMI PRIVATE AREA(s) for provision of information and advice to patients, in area
visible to other patients. In order to support privacy – it is recommended that the flooring for
1.5 x 1.5 m directly in front of each hatch be a contrasting colour to surrounding flooring.
Side panels should extend out on the patient side to screen the patient off. A small ledge
approximately 25cm wide should be placed at the bottom of the aperture i.e. level with
bottom of hatch on the patient side. All aspects of the semi-private area shall be constructed
of opaque or non-transparent material to prevent sight of medication or prescription during
the counselling process. Minimum size of hatch: 1. 05 m high (from waist height i.e. 1m to
2m) by 1m wide. If the hatch must have a closure / barrier to protect staff from
communicable disease risk, due to air flow/ droplet transmission, this should not hamper
communication or professional service. E.g. clear, shatterproof glass or perspex with
“communication holes”/gap/adjustable opening. A minimum of a 20 cm space must be kept
between countertop and bottom of barrier for the full width of the hatch to allow medicines
to be given to the patient/staff. Lockable roller shutters should be used to secure the
openings after hours. AVOID having the hatches in a thoroughfare or directly in a
passageway. Wherever possible the waiting room and service hatches should be in a “cul de
sac”.
“Drop box” for patients to “drop” folders into pharmacy - “Folders in” Calling system linked
with reception + electronic bill board with name/waiting time Patient Service Hatch (Staff
side)
FIGURE 10: PHARMACY DISPENSING HATCH – KHAYELITSHA HOSPITAL

Fittings and fixture recommendations:2


Double basin s/steel sink with metal splash plate at the back and mixer tap with draining
boards on both sides for compounding as well as the hand wash basin, standard oval
ceramic, should be positioned between the dispensing area and bulk store area, i.e. not near
to the patient contact area.

3 Western Cape Department of Health; MDHS Infrastructural recommendations for Pharmacy

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
50
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
The fixtures in the main dispensing area should be adjustable / moveable as far as possible
to accommodate change in volume or work orientation if needed. Computers should NOT be
placed at the patient contact area, but on a work surface some distance away. Number will be
determined by workload (volume) handled by facility as well as systems (e.g. JAC) used in
facility. Provision for JAC systems: printers, keyboards, screens, power supplies, connectivity
etc.

17.2. Goods receiving area


The goods delivery access must be directly into the pharmacy store and into a secure
receiving area, from where goods will be signed in on a computer before being transferred to
the bulk store. Goods will be received at a separate goods entrance onto an off loading
platform that is at least 1m above ground level to allow for the truck to offload with ease. The
entrance must be supplied with a button operated steel roller shutter door and a call system
on the outside door. The entrance must be in a secure area. A locked wire partition must
separate the holding area from the internal receiving area with a double door entrance into
the internal receiving area.
There must be an office attached to this area with an unobstructed view of the incoming and
outgoing goods/traffic. The goods will be checked and entered into the computer before they
are transferred to the bulk store room. Goods will be dispatched to clinics through a separate
exit but in the same area.

17.3. Internal Receiving Area


The receiving area requires an office for the storekeeper’s workstation, with drawers under
the worktop and shelves above the worktop. The workstation requires telephone, computer
and network connectivity. A wire partition separates the internal goods receiving from the
general bulk store. The office should be large enough to accommodate all the clerical staff in
the main pharmacy store area.

17.4. Bulk Store


The bulk store must be fitted with shelving that will allow for optimum flexible shelving
space. The shelves must be adjustable, modular, impermeable surface of suitable quality to
comply with weight/usage and must be washable. The shelves must be sturdy and strong,
deep and wide refer to section 15 sub section 2: shelving. The bulk store must have: A
separate Intravenous Fluid Store with strong off the floor pallets. A section of the store must
make provision for ARV medication and a lock-up facility for scheduled medicines. Medicine
fridges/ cold room will be fitted with alarms and provision must be made for these to be
relayed to the control room, and the after hour’s pharmacist on call. The size of the store will
increase based on national policy on bulk medicine store distribution transferring to regional
and/ or district hospitals for distribution to PHC facilities. Counter and serving hatches are
required.
Storage areas to consider: Box area, expired stock area and archives. Bulk store clerk
requires an office with a worktop, with drawers under the worktop and shelves above the
worktop. The workstation requires telephone, computer and network connectivity. Provide
a vacoliter store with a double door and easy access for the pallet jack. Schedule 5 and 6
medicine store, pre-packing store, post-packing store (to be part of main store.) Windows
must have burglar-proofing and must be positioned such that medicines are not
contaminated by light.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
51
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
17.5. Compounding
The pharmacy could prepare wet solutions and salves and there will have to be a pre-
packing area for medication. The location of the area should be between the store and the
main pharmacy. The compounding area should not form a direct part of the main pharmacy.
A deep double basin with hot water and a splashboard is required for washing of utensils;
seamless stainless steel work surfaces must be supplied to prevent contamination of
mixtures. There must be washable shelving above the worktop. There must be cupboard
space for the storage of utensils.

17.6. Sterile preparation area (compounding, cytotoxic)


If intravenous solutions are prepared in the pharmacy, provide a sterile work area with
laminar flow bench and hood. Consideration shall be given to the physical requirements of
specialist activities such as cytotoxic preparations.

17.7. Flammable Store


The store must open directly onto an external area, accessible to delivery area. It must have a
floor drainage sump for collection of leakage and spillages. Note: the maximum litres of
liquid to be stored must equal the volume of sunken floor up to bottom of door height to
prevent leakage and spill contamination. The sump shall be easily accessible for drainage.
The store must be equipped with fire proof doors and have a concrete roof. It would be
advisable to situate the flammable store outside the premises in the secured delivery area.
For clinic level PHC facilities it may be also be sufficient to provide a lockable cabinet, built of
adequate fire resistant material, located preferably in the holding area. For bigger facilities it
is necessary to build a dedicated room, complying with the SABS 0400-1990 -National
Building Regulations.

17.8. Empty boxes/ bottle store


This store must be positioned within the pharmacy, near the manufacturing and pre-packing
are. This store should, where possible have separate access route for collection and disposal
of boxes and bottles such that the operations of the pharmacy are not compromised with
respect to infection control.

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
52
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
BIBLIOGRAPHY
Africa, Republic of South. "Government Gazzette." Regulation Gazzette No.9570, Regulations
relating to categories of hospitals. Vol. 554. no. 9570. Pretoria: Government Printing Works,
August 12, 2011.
Council, South African Pharmacy. "GNR.1158 of 20 November 2000: Regulation relating to
the practise of pharmacy." Government Notice Regulation. Department of Health South Africa,
November 2000.
Office of the Registrar. Good Pharmacy Practise in South Africa. 4th. Pretoria: The South
African Pharmacy Council, 2010.
DH, N.U. 2013, Health Building Note 14-01, Pharmacy and radio pharmacy facilities, 01st
edn, Department of health UK. NHS, UK.
Western Cape Department of Health; MDHS Infrastructural recommendations for Pharmacy
Design; D, Rendall; WCGH Infrastructure Planning; Pharmacy Layout, Fixtures and Fittings;
March 2013

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
53
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
ANNEXURE 1. DRAWINGS

18. IUSS generic room requirement drawings

ROOM NAME - FORMAL IUSS CODES STATUS NOTE IUSS AREA


BABY CHANGE ROOM BHE Rev 01_ PUB_25_04_2014 3
BREAST FEEDING MOTHERS ROOM BED Rev 01_ PUB_25_04_2014 4
CLEANERS ROOM BLA Rev 01_ PUB_25_04_2014 5
COUNSELLING ROOM AGA Rev 01_ PUB_25_04_2014 13
FUNCTIONAL SPACE - CLINICAL WASH HAND BASIN BEI Rev 01_ PUB_25_04_2014 Multiple drawings
FUNCTIONAL SPACE - CONSULTING COUCH BEM Rev 01_ PUB_25_04_2014 Multiple drawings
FUNCTIONAL SPACE - RECORDS BGD Rev 01_ PUB_25_04_2014 Multiple drawings
FUNCTIONAL SPACE - STORAGE FUNCTIONS BG Rev 01_ PUB_25_04_2014 Multiple drawings
FUNCTIONAL SPACE - WAITING CAAK Rev 01_ PUB_25_04_2014 Multiple drawings
FUNCTIONAL SPACE - WORK STATIONS BCI Rev 01_ PUB_25_04_2014 Multiple drawings
MEETING ROOM BDC Rev 01_ PUB_25_04_2014 22
PHARMACY CLINIC DISPENSARY BPEA Rev 01_ PUB_25_04_2014 36
PHARMACY HOSPITAL DISPENSARY BPE Rev 01_ PUB_25_04_2014 38
STAFF ROOM + LOCKERS BKNA Rev 01_ PUB_25_04_2014 18
STORE - MEDICINE BGLA Rev 01_ PUB_25_04_2014 10
TOILET BEAAA Rev 01_ PUB_25_04_2014 Multiple drawings
TOILET WHEEL CHAIR ACCESSIBLE BEAAG Rev 01_ PUB_25_04_2014 4

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
54
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
19. Pharmacy examples
FIGURE 11: TSHILIDZINI HOSPITAL PHARMACY FLOOR PLAN_CSIR

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
55
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
FIGURE 12: MITCHELL'S PLAIN PHARMACY FLOOR PLAN_ MAGQWAKA ASSOCIATES ARCHITECTS

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
56
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]
FIGURE 13: DELFT CHC PHARMACY FLOOR PLAN_DHK ARCHITECTS

INFRASTRUCTUREUNITSUPPORTSYSTEMS(IUSS)PROJECT
57
Health Facility Guides: 09 September 2014
Pharmacy [DISCUSSION DRAFT v3]

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy