Medication Safety Book 13-09-2021 Complete PDF
Medication Safety Book 13-09-2021 Complete PDF
Prepared by
Directorate of Healthcare Quality and Safety
Ministry of Health
Sri Lanka
December 2021
2
National Action Plan on Medication Safety for Sri Lanka
© Copyright Ministry of Health, Sri Lanka, 2021
First Edition: 2021 September
Edited By:
Dr. G.S.K. Dharmaratne,
Former Director, Healthcare Quality and Safety,
Ministry of Health, Sri Lanka
Prof. PriyadharshaniGalappatthy
Department of Pharmacology,University of Colombo
Dr.D.G.A.S.Prabha,
Medical Officer,Directorate of Healthcare Quality and Safety,
Ministry of Health, Sri Lanka.
ISBN ………………………………………..
Published by
Directorate of Healthcare Quality and Safety
With the growing reliance on medication therapy as the primary intervention for most
illnesses, patients receiving medication interventions are exposed to potential harm as well as
benefits. Medication-related errors are a significant cause of morbidity and mortality around
the world. It can occur in all settings and may or may not cause an adverse drug event (ADE).
Medications with complex dosing regimens and those given in specialty areas (e.g., intensive
care units, emergency departments, and diagnostic and interventional areas) are associated
with increased risk of ADEs.
Lack of appropriate policies, procedures, and protocols can have a greater impact on
medication safety. Therefore, developing a national action plan on medication safety is a
timely intervention and I would like to convey my sincere gratitude to the team involved in
developing this document. I hope it will help to provide better outcomes in our healthcare
services.
Throughout the history of mankind, medicines of various forms and medical interventions,
have played a crucial role in treating and preventing diseases. Further,their multitude of
physical, chemical, and biological characteristics, pharmaceutical and therapeutic properties
also have been developed into their current status, thanks to the efforts and commitment of
large number of professionals representing different professions involving technologies,
experiments, heavy financial and other resource investments.
It is also a well-known fact that medicines similar to any other natural or manmade substance
used by humans also can produce hazards, errors or may lead into adverse or undesirable
effects or outcomes.
Therefore, it is a responsibility of a sound health system to establish and adopt a scientific
and practical medication safety mechanism to ensure a more safer health service at each level
of care.
In this context Directorate of Health Care, Quality and Safety has taken a pragmatic approach
to formulate a national action plan on medication safety, based on four major strands, system
and practices, medicines, healthcare professionals and patients in accordance with
international standards.
As Additional Secretary Medical Services, I do highly appreciate this endeavor, with the
assurance of my fullest support for its successful implementation.
Dr.A.K.S. De Alwis
Additional Secretary (Medical Services)
Ministry of Health
MESSAGE FROM THE DIRECTOR GENERAL OF HEALTH SERVICES
Sri Lanka has made remarkable progress in improving the health status of our population. Since
1920s, the country has made dramatic strides on key outcome indicators such as life expectancy
and maternal & child mortality, following delivery of productive and efficient healthcare free of
charge.
It is a timely initiative to develop a National Action Plan on Medication Safety for Sri Lanka to
minimise the medication related errors in both public and privet sector. Therefore, I appreciate
the efforts of the team of Directorate of Healthcare Quality and Safety and all the contributors
for developing this national action plan on medication safety for Sri Lanka.
Dr.AselaGunawardana
Ministry of Health
MESSAGE FROM THE DEPUTY DIRECTOR GENERAL MEDICAL SERVICES I
Sri Lanka holds a unique position in South Asia as one of the first developing nations to provide
universal health. The Health Ministry and the Provincial Health Services provide a wide range of
promotive, preventive, curative and rehabilitative health care. With all these efforts despite being
a lower middle-income country, Sri Lanka has achieved commendable health indicators.
Having achieved better outcomes in relation to maternal and child health and communicable
diseases, Ministry of Health has now focused to improve the quality and safety of care provided by
health sector, which will lead to further improvements in health indicators as well as the
satisfaction of the patents. Prevention of medication errors and establishment of medication
safety, play a major role in that purpose, since considering the unacceptably high number of
deaths and disabilities associated with it. A National action Plan on Medication Safety is therefore
a timely requirement for Sri Lanka in achieving future targets.
My sincere appreciation goes to the Directorate of Healthcare Quality and Safety, Professor
PriyadarshaniGalappatthy and all the other stakeholders for their contribution in development of
this national action plan.
Ministry of Health
Message from Senior Professor of Pharmacology, University of Colombo
Medication errors have become a global concern and a large number of preventable deaths
and serious harm occur globally due to medication errors. World Health organization(WHO)
has given leadership in preventing serious patient harm due to medication errors by
launching ‘Medication without harm’ as the 3rd global patient safety challenge in 2017. To
achieve this ambitious, yet achievable objective, each country was requested to develop
individualized national action plans to ensure medication safety.
The WHO expert working group on medication without harm identified four main strands to
focus during development of national action plans, the systems and practices, healthcare
persons, medicines and patients in each country with 3 further flagship areas, medication
safety in poly pharmacy, high risk situations and transitions of care, also to be covered.
Sri Lanka has achieved remarkable indices in universal health coverage which are far above
the rates achieved by other countries in WHO region and the world bank income group. The
next step for Sri Lanka is to target safer care and quality care. With a high overall literacy
rate in Sri Lanka, this is achievable with development of well-coordinated action plans and
proper monitoring of implementation of such action plans. The Directorate of Healthcare
quality and safety of the Ministry of Health is taking an enormous effort to achieve this goal
to take Sri Lanka to the next level in healthcare. Taking the responsibility and giving
leadership to the development of this national action plan on medication safety is one such
step taken by the Directorate. Involving all relevant stakeholders has made this national
action plan a collective effort of all stakeholders. As the initial draft was made based on
studies and observations relevant to medication safety in Sri Lanka, this action plan is
unique to Sri Lanka and covers the 4 strands and the 3 flagship areas identified by the WHO.
We hope and are confident that all the stakeholders who contributed to development of
this national action plan will be taking steps to implement the activities assigned, to prevent
serious patient harm and deaths due to medication errors in Sri Lanka.
Professor PriyadarshaniGalappatthy
Senior Professor of Pharmacology
FOREWORD
Medication safety has become a global concern since medication errors are associated with
high number of mortality and morbidity around the world. Therefore, considering the WHO
request at the second ministerial summit on patient safety, the Ministry of Health, Sri Lanka
decided to give the contribution to develop a national action plan on medication safety
through Directorate of Healthcare Quality and Safety.
The Directorate of Healthcare Quality and Safety functions as the focal point of National
Quality Assurance Programme of the country. It gives technical direction and guidance to
the various level of hospitals through Medical Officer of Quality (MO-QMU) network
connecting the centre with the line ministry health care organizations and MO-QMU units of
each district.
In 2019, the Directorate of Healthcare Quality and Safety started conducting consultative
meetings to develop the national action plan on medication safety based on the draft
prepared by Professor PriyadarshaniGalappatthy, senior Professor in Pharmacology, Faculty
of Medicine, University of Colombo, who is a member of the WHO expert working group on
medication safety, at WHO Headquarters in Geneva.
After conduction of six consultative meetings with relevant stakeholders and other
necessary steps, the document was finalised and the Secretary, Ministry of Health was given
the approval for the final document.
I wish to express my sincere gratitude and appreciation to all the technical experts
comprised of officials of Ministry of Health, Professional Collages & other organizations for
their valuable contributions in developing this National Action Plan on Medication Safety. I
express my special thanks to WHO country office, Sri Lanka, for their contribution in this
national endeavour. Proper implementation of this plan by all the relevant authorities is of
paramount importance to improve the quality and safety of healthcare services. .
Dr.Dewanee Ranaweera,
Director (Covering Up), Healthcare Quality and Safety,
LIST OF CONTRIBUTORS
Medication safety has become a global issue contributing to unacceptably high number of deaths
and disabilities in the world. Medical error is the third leading cause of death in United State of
America with 180,000 deaths occurring annually. Errors occurring in lower- and middle-income
countries are considered much higher than these reported figures from high income countries.
Major causes of medication errors include communication errors, including oral and written
communication; confusion with the name, such as look-alike and sound-alike drug names; labelling
errors; errors due to human factors, such as knowledge deficits and dose miscalculations; and errors
related to the improper packaging or design of the drug product.
Taking these factors in to consideration, the World Health Organization (WHO) launched medication
safety as a global patient safety challenge at the 2nd Ministerial Summit on patient safety in 2017. At
this international summit, all countries were requested to make a pledge to reduce medication
errors and develop national action plans to reduce severe harm due to medication errors by 50%
within 5 years
The Directorate of Healthcare Quality and Safety, Ministry of Health as the focal point, conducted six
consultative meetings with relevant stakeholders to finalize the draft, with the financial and
technical support provided by the WHO.
The draft was re-circulated to all relevant stake holders and considering all the inputs and
recommendations received, final document was prepared. Approval was taken from secretary of
health to publish this prepared document as the National Action Plan on Medication Safety.
NATIONAL ACTION PLAN ON MEDICATION
SAFETY FOR SRI LANKA
3
Action Plan on Medication Safety for Sri Lanka (2021-2025)
Plan based on the WHO global patient safety challenge on “Medication without harm”, by targeting the four strands identified by the WHO.
Objective: To minimize serious medication errors in public and private healthcare sectors in Sri Lanka
Activities to be conducted targeting both the public and private sector healthcare institutions through the following;
1
NATIONAL ACTION PLAN ON MEDICATION
SAFETY FOR SRI LANKA (2021-2025)
2
Persons/Institut
implementation
/Organizations
Responsibility
Stakeholders/
Sub activities
Performance
responsible
Time frame
Indicators
Proposed
activity
Strand
(KPIs)
ions
Key
for
1. Systems 1.1 1. Introduce a separate 1. Percentage of Director General of Director- DHQS
and Introduce 2021 medication incident hospitals Health Services
practices medication – reporting form. having a (DGHS), Heads of Institutions
incident 2023 functional Deputy Director
reporting 2. Integrate the medication Incident General / Medical Medical Officer -
system into incident reporting in to reporting Services -1 Quality Management
hospitals and adverse event reporting system. (DDG/MS -1), Units in hospitals
implement process in hospitals. DDG/MS - 11,
action plans to 2. Number of DDG/Dental Services, The Society of
prevent 3. Issue a circular from DGHS medication Director - Medical Government
occurrence of introducing the medication safety Supplies Division Pharmacists
similar events. incident reporting form to incidents (MSD),
all hospitals including reported Directorate of All Island Private
private hospitals and Healthcare Quality Pharmacy Owners
encourage reporting with 3. Number of and Safety (DHQS), Association (AIPPOA)
reporting guidelines, which sentinel Quality Management
would indicate assessment events Units (QMU) in State Pharmaceutical
of reports in a no blame reported hospitals, Cooperation
culture. Government
4. Number of Pharmacists,
near misses Sri Lanka Medical
4. Use MSMIS electronic reported Association (SLMA),
system to report in Sri Lanka Dental
hospitals where these Association (SLDA),
facilities are available. Ceylon College of
Physicians (CCP),
5. Reinforce establishment Sri Lanka College of
and function of Drugs and Pediatricians (SLCP),
therapeutic committee in Sri Lanka College of
all hospitals where General Practitioners
reported incidents are (SLGP),
3
discussed to take Pharmaceutical
preventive actions. Society of Sri Lanka
(PSSL),
6. Distribution of medication The Departments of
incident reporting Pharmacology in
guidelines to all colleges Universities,
and display it in the Sri Lanka Association
websites. of Clinical
Pharmacology and
Therapeutics
7. Encourage reporting from (SLACPT)
private pharmacies. Consultants in
8. Establishment of a national Clinical
incident reporting Pharmacology and
database. Therapeutics
9. Initiating an Incident
reporting systems from
private sector
hospitals/pharmacies.
10. Development of a guideline
on how to process incident
reports and giving
feedback.
6. A report of medication
safety steering committee
meeting to be attached to
the NDTC meeting minutes.
6
abbreviations”
in hospitals.
7
incidents reported and
issues at MoH and report to
be sent to “National
Medication Safety Steering
Committee”.
1.7Assign a 2021 1. Prepare Terms of 1. Percentage of Director - DHQS Director, HQS, Heads of
medication - Reference (TOR) for QMUs with an Government each QMU in hospitals
safety 2023 medication safety liaison assigned pharmacists and Directors of
pharmacist to pharmacist for QMU liaison The Society of hospitals
each QMUs and implement appointing pharmacist Government
established in liaison pharmacist through dedicated to Pharmacists
major hospitals a ministry circular. medication
and have safety
assigned 2. Develop the job activities
activities descriptions for this post.
2. Number of
medication
safety
activities done
by the
pharmacist
1.8 2021 1. Issuing a circular for 1. Percentage of Private Healthcare Private Healthcare
Encourage - consultants to use private Regulatory Authority Regulatory Authority,
private sector to 2023 electronic prescribing hospitals with (PHRA), MoH
use electronic when available. electronic College of GPs,
prescriptions by prescription
all consultants, 2. Appreciation of private facilities. Director/Information
through a sector for implementing Health -MOH
circular by electronic prescribing.
Private
Healthcare 3. Development of a software
Regulatory Unit for General Practitioners
of Ministry of for electronic prescribing.
Health
1.9 2021 1. Mechanism to appreciate 1. Number of PHRA, MoH, Private Healthcare
Encourage - the private sector hospitals accredited Regulatory Authority
accreditation of 2025 which are internationally Hospitals. DDG / MS - 2 MoH, DDG MS 2
private sector accredited.
hospitals, with
8
incentives for
getting
accredited (e.g.
JCI, ACHS)
9
safe 2. Pictorial/brail labels safe medication involved in work in
medication use available use services for these areas
among patients to be used in special groups. disabled
with visual, patients.
hearing
and other
disabilities.
(A medication
safety practice
package for use
throughout the
drug
management
cycle)
1.15 2022 1. Strengthening the Drug 1. Number of National Medicinal NMQAL-Head, NMRA-
Strengthening - quality quality Quality Assurance chairman, Govt
a Drug 2025 assurance program. failures Laboratory (NMQAL), Pharmacists
quality reported. NMRA,
assurance Society of
program to 2. Number of government
tackle poor quality pharmacists
10
quality testing
medicines done.
12
quality to avoid
confusion
between
different
brands.
2.5 2021 1. Asking for suitable changes 1. Number of Govt. pharmacists, NMRA,
– in the label when problems in NMRA, MSD
13
Requesting 2025 necessary at the point of formulations MSD, SPC,
necessary registration and calling for identified and AIPPOA. Govt Pharmacists,
formulation tenders. rectified. AIPPOA.
adjustments,
labeling 2. Not-registering irrational 2. Information on
changes, fixed dose combinations the details made
specifications (FDC). available
of medicines, through the
when calling (Such as antidiabetics with newsletter
for tenders for anti-hypertensives, FDC
prevention of including paracetamol etc.)
medication
errors
2.6 2021 1. Steps taken to inform about 1. Number of CME Universities, Academics,
Identify and the most commonly activities and SLACPT, researchers and other
publicize the - prescribed medicines and articles SLMA drugs healthcare workers
list of most errors noted, at Continuous published committee, involved in working in
commonly 2022 Medical Education (CME) focusing on, SLDA, this area
prescribed activities and articles commonly PSSL,
medicines in published. prescribed AIPPOA,
the private and medicine and SGP
public sector common errors
and common noted.
errors noted to
educate health
care
professionals
and public on
these
medicines
4.Number of
products
blacklisted.
3.Health 3.1 1. Adopting the “WHO patient 1. Number of Medical Faculties of Academics of
care Incorporating 2021 safety curriculum on universities, Universities Departments of
profession “WHO patient - medication safety” in to degree programs Pharmacology and
als safety 2023 universities, degree programs and higher Sri Lanka Association Pharmacy in
curriculum” on and higher diploma curricula. diplomas, adopted of Clinical Universities, Deans of
medication the “WHO patient pharmacology and Allied Health Faculties,
safety into the 2 Incorporating medication safety curriculum Therapeutics Director, ET and R,
undergraduate safety into Good Intern on medication (SLACPT), Director Nursing
and higher training program and Registrar safety” in to their Principles of Pharmacy
diploma training. curricula. All Allied Health and nursing schools,
curricula of all Faculties of
faculties of Universities
medical, conducting courses in
pharmacy and pharmacy and
nursing. nursing through the
respective
universities.
SLACPT, medical
Allied Health –
Pharmacy (AHSP)
Allied Health –
Nursing (AHN)
15
3.2 2021 1. Conducting different types of 1. Level of SLACPT, Academics,
Activities to - awareness programs for Legibility of Society of Govt. researchers and other
improvement 2025 health professionals on prescriptions Pharmacists, healthcare workers
of legibility of consequences of illegible shown in PSSL, involved in work in
handwritten prescriptions: prescription SPC, these areas
prescriptions. audits. MoH,
Good Intern training GMOA,
program 2. Survey results Sri Lanka Nursing
Registrar training on number of Association,
College of General hospitals using
Practitioners programs computerized SLMA,
All professional colleges prescriptions and SLDA,
printed The Society of Govt.
2.Introduction of the uniform dispensing labels. Dispensers Union.
prescription format for Sri
Lanka to be used in hospitals.
4. Pictorial/brail labels
available to be used in
special groups.
16
dispensing to
5.Pictorial/brail labels needy patients.
available to be used in special
groups.
3.Availability of a
circular issued
from the Ministry
of Health on “Do
Not Use
abbreviations”
and “Standard
abbreviations” for
HPs.
3.Organization of symposiums
on medication safety best
practices.
18
strategies as a compulsory Department of
employed”, as area for portfolios. Pharmacology,
one UoC.
compulsory
area of
portfolio
entries in log
books; by
intern
pharmacists,
trainee nurses,
medical
students and
post graduate
medical
trainees.
19
3.10 2021 1. Number of Department of Formulary committee
Disseminate - 1. Disseminating the medicines universities Pharmacology, UoC of the Department of
the Sri Lanka 2025 formularies to libraries of with the SLSF MSD, Pharmacology
student universities. available in MoH. University of Colombo
formulary their libraries.
(SLSF) 2018 2. Disseminating the drug
which focuses formulary to hospitals. 2.Number of
on “most hospitals where
commonly 3. Disseminating the drug formulary is
prescribed formulary to private available.
medicines pharmacies
currently in the 3. Number of
country and private pharmacies
highlighting using the SLSF.
high risk
medicines”, 4. Number of total
aimed at all copies
categories of distributed
students
trained as
health care
professionals.
(To be updated
once in 5
years)
3.11 2021 DHQS, Directorate HQS,
Regular - 1. Conducting regular 1. Number of SLMA Drugs University
training 2025 workshops on medication training Committee, Departments
programs and safety. programs and SLDA,
workshops workshops SLACPT,
aimed at 2.Improving the coverage of conducted on and Universities.
healthcare workshops in the country. medication to give expertise
professionals safety to
(nurses, different
pharmacists, healthcare
and medical professionals.
officers) on
medication 2. Number of
safety healthcare
workers who
attended
20
training
programs
3. Coverage of
workshops in the
country.
3.12 2022 1. Conducting training 1. Number of University SLMA Drugs
Training - courses /workshops on training Departments of committee, Govt
courses/ 2025 preventing medication courses Pharmacology, Pharmacists, AIPPOA
workshops on errors for external conducted for ET&R,
preventing Pharmacists and sales external and SLMA Drugs
medication assistants in the private private sector Committee,
errors for sector pharmacies. pharmacists. SLDA,
external SPC,
Pharmacists Pharmaceutical
and sales Society of Sri Lanka
assistants (PSSL)
working in the
private sector
pharmacies.
3.13 2021 1. Conducting CPD activities for 1. Number of CPD SLMA, SLMA and other
CPD activities - doctors on Medication activities SLDA, Colleges
with other 2023 safety in collaboration with conducted in CCP,
relevant Colleges. collaboration PSSL,
Colleges to with Colleges. College of Medical
ensure Administrators,
medication College of
safety targeting Anesthetists.
doctors - Liaise
with 3.11
21
collaboration with other 2. Number of Ministry of Health,
colleges. DTCs initiating PSSL.
studies on
3. Ensuring the availability of polypharmacy
explicit criteria for assessment with established
on polypharmacy benchmarks
prescriptions.
3.Number of
4.Conducting education and awareness
awareness programs on programs
rational and ethical practices conducted on
to doctors. polypharmacy.
3.15 2022 1. Conducting training courses 1. Number of Post Basic School of Director/Nursing
Training - at Post Basic School of Nursing post-basic nursing Nursing.
course for 2025 on “Prevention of medication schools
nurses through errors” during administration conducting these
Post Basic of medicine. training courses
School of for trainees.
Nursing on
“Prevention of 2. Survey results
medication on safe admin
errors” during practices of.
administration nursing officers
of medicine.
4.Number of
hospitals in the
state sector with
pharmaceutical
care units /clinics.
5.Number of
patients receiving
pharmaceutical
care services.
6.Number of
potential hospital
re-admissions
prevented
through clinical
pharmacy
services.
23
4. Patients 4.1 Collect 2021- 1.Identifying gaps of the 1. Number of studies University Academics,
available 2022 previous studies with the conducted on patient Departments of researchers and
studies involvement of postgraduate safety and correct use Pharmacology/ph other healthcare
conducted to trainees and convey the of medications. armacy workers involved
assess patients’ identified research priorities in working in this
knowledge on to Director, Education, area
1. n
medicines and Training & Research (ET& A
methods to R) –Ministry of health s
improve the s
knowledge. e
Carrying s
out new s
studies on i
Patient n
Safety and g
correct use t
of patients’ h
own e
medication
s
4.2 Activities to 2021- 1.Translating patient 1. Number of booklets i. SLMA Drug Academics,
improve 2026 formularies into Sinhala and proving information to committee researchers and
medication Tamil. patients ii. SLDA other healthcare
literacy of iii. Health workers involved
patients by 2.Conducting patient 2. Number of leaflets Promotion in working in
variety of counseling sessions and provided to patients Bureau (HPB) these areas,
methods educational programs/ on medicines iv. Patients for SLMA
i. Publishing workshops on safe patient safety –
books in Medication use for patients, 3. Survey of literacy Ms Christine
Sinhalese at institutional level rate in patients after v. University
and Tamil interventions Departments of
on 3.Conduct Pharmacology/
commonly Seminars/awareness 4. Survey on number of pharmacy
used programs for, patients asking vi. SLACPT
medicines i. School children questions about their vii. PSSL
ii. Providing ii. Elderly medications. viii. Society of
labeled iv. Pregnant mothers Government
medicines 4.Education programs for 5. Number of articles pharmacists
iii. Providing special groups (Visually in newsletters ix. SPC
leaflets on impaired, Hearing impaired) educating patients on x. Media – print
correct use medicines and electronic
24
of 5. Educating patients on how xi. National
medications to discard left pills. 6. Number of media Dangerous
for high risk campaigns done Drugs Control
medicines 6. Writing medication names Board
and other in patients’ native language 7. Number of medical (NDDCB)
drugs (Sinhala or Tamil) on the and pharmacy Sri Lanka
requiring package /envelope of students providing Antidoping
specific medications. information on Agency (SLADA),
information. medicines to their Ministry of Sports
E.g.: GTN, 7.Use teach back technique patients identified in
ORS, to ensure patients’ surveys.
Warfarin, understandability of their
Alendronate medications
, (at least 5 rights and
Methotrexat purpose of taking the
e, BB cream medications.)
iv. Workshops 8.use short video clips in
for doctors, patients’ waiting area to
nurses and educate patients on correct
pharmacists use of medications
to train
them on
providing
information
to patients
v. Media
campaigns
targeting
patients
using
television,
radio
programs
and print
media (e.g.
Posters) to
increase
medication
literacy
through
Health
25
Promotion
Bureau
(HEB)
focusing on
5 must
know facts
on
medicines.
vi. Providing
medication
plan in
patients
own
language
(eg; writing
the names of
medications
in Sinhala or
Tamil on the
envelop/on
the package)
with the
help of
pharmacy
and medical
students.
4.Number of
workshops /seminars
conducted for patients.
4.4Emphasize 1. Empowering 1. Number of awareness All professional Academics,
on five patient/caregiver on five programs conducted Associations, researchers and
moments of moments for medication to empower other healthcare
medication safety to reduce the risk of patients/caregivers. Universities, workers involved
safety (starting harm associated with the use in working in this
a medication, of their medications. Pharmacists and area
taking my nurses training
medication, schools.
adding a
medication,
reviewing my
medication,
stopping my
medication)
27