Transcript Role of Pharmacist in ADR Reporting in Pakistan: A myth or reality?

Role of Pharmacist in ADR Reporting
in Pakistan: A myth or reality?
Dr. Madeeha Malik
PhD (Pharmacy Practice), Post Doctorate (Pharmacy Practice)
Director/Associate Professor, Pharmacy Department,
Hamdard University, Pakistan
Adverse Drug Reactions
WHO defines adverse drug reaction (ADR) “ a
response to a drug which is noxious, unintended and
which occurs at doses normally used in man for
prophylaxis, diagnosis or therapy of disease or for
modification of physiological function ".
Adverse drug reactions are posing biggest challenge
to healthcare system as they compromise on safety
of drug therapy
ADRs are not only the cause of mortality and
morbidity but also increase the healthcare cost.
Global Statistics
 Average 4% of hospital admissions are due to ADR’s
1 in 1000 deaths in medical wards, 10 to 20 % of in-patients and
5% of patients in general practice are due to ADR’s
Factors Promoting ADRs
Inappropriate
Prescribing
Practices
Poor
communication
between healthcare
professionals
Inadequate
Knowledge and
lack of motivation
among Pharmacists
Lack of
pharmacovigillance
system
Lack of global
standardization
of ADR reporting
Form
Lack of research
and linkage
between academia
& Industry
Concept of Pharmacovigilance
National pharmacovigilance
centre of different
countries co-ordinate with
WHO Collaborating Centre
for International Drug
Monitoring in Uppsala,
Sweden
International drug
monitoring
program was
initiated in 1970.
An increasing
number of
developing
countries are also
participating in
this program along
with the 78
member countries
The centre
promote rapid
identification of
signals by
facilitating
communication
among different
countries
This Centre
maintains
international
database of
adverse drug
reactions after
reviewing reports
from national
centers
Evidence Based Data on Role of Pharmacist in
ADR Reporting in Developed World
“If pharmaceutical care can prevent treatment failure or other
drug related morbidity or mortality, it is much more valuable
than the services incident to selling a drug product”.
 Evidence supports that:
 Pharmacists are better in detection of ADRs as an inpatient
chart reviewer as compared to charts reviewed by other
healthcare professionals.
 Pharmacist’s knowledge of drugs and clinical therapeutics as
well as patient safety place them in a better position to identify
ADRs and make them more committed to drug surveillance
programs.
 Pharmacist led monitoring system at the hospital are effective
in detecting ADRs of newly marketed drugs, where as only
computer program not designed as patient focused is not able to
identify patients taking newly marketed drugs which should be
under strict surveillance.
Evidence Based Data on Role of Pharmacist in
ADR Reporting in Developed World
 Pharmacist
has
reduction
ADRs
in
helped
and
to
improve
medication
outcomes
errors
by
including
improving
medication adherence through counseling and telephone follow
up which has resulted in identification of preventable ADEs.
 Similar findings were highlighted in a study which reviewed
the role of pharmacists in intensive care units
Community pharmacists in developed countries are well aware
of their role regarding ADR monitoring
Evidence Based Data on Role of Pharmacist in
ADR Reporting in Developing Countries
 In many developing countries concept of ADR monitoring is
not matured yet, there is strong need to develop monitoring
systems at hospitals level to initiate the idea of
Pharmacovigilance.
 Many developing countries like India, Jordan, Brazil, Malaysia,
South Africa and Ukraine have reporting systems engaged in
ADR monitoring and add on the collected data to international
data base by sending it to WHO ADR monitoring centre at
Uppsala, Sweden.
 Evidence based data from developing countries report:
 Poor participation and attitude of hospital pharmacists
regarding their role in drug safety issues.
 Poor knowledge and practices of community pharmacists
toward ADR reporting as most of them are involved in
traditional practices of dispensing at community pharmacies.
Evidence Based Data on Role of Pharmacist in
ADR Reporting in Developing Countries
Pharmacists have positive attitude towards their role in ADR
monitoring but poor reporting of ADRs was due to being
unfamiliar with any pharmacovigilance system and reporting
methods.
 Pharmacists are well aware of their professional obligations to
report ADRs but they still under estimate the importance of
reporting ADR which lead to under reporting of ADRs.
Profile of Pakistan
 Population of 191.71 million in 2015
 The literacy rate of the country is 58% with government expenditure
on education being 2.5% of total GDP.
 The life expectancy at birth for men is 66 years and for females is 68
years.
 The total expenditure on health during 2014-15 is estimated to be
0.4% of GDP
 Health services consists of:
 1,142 public hospitals
 5,499 dispensaries
 5,438 Basic Health Units (BHUs)
 669 Rural Health Centres (RHCs) In Pakistan
 73,650 private healthcare institutions (8 tertiary care hospitals, 692
small and medium sized hospitals)
 175,223 doctors
 15,106 dentist
 90,276 nurses
Profile of Pakistan
 32,511 pharmacists.
 According to international standards, there should be 1
pharmacist per 6 doctors leading to a shortfall of 29,574
pharmacists in Pakistan
 Out of the total pharmacists:
 55% are engaged in the production of pharmaceuticals
 15% are working at the federal and provincial drug control
authority and hospital pharmacy level
 15% are involved in sales and marketing of pharmaceuticals
 10% in community pharmacy
 5% are working in teaching and research
Statistics of Pakistan Regarding ADR
Reporting
More than 500 national pharmaceutical
industries and more than 20 multinational
Pharma companies are working in Pakistan
meeting 70% of country’s medicinal needs
but no pharmaceutical participation
towards Pharmacovigilance
80% of the hospitals
have no proper ADR
monitoring system.
Only 1 hospital is
having online
reporting system
4 hospitals are
targeting specific
ADRs.
Community
pharmacies are
not involved in
ADR reporting
WHO Criteria
Established national pharmacovigilance centre.
Legal or structural framework.
Pakistan
Established
Periodic Safety updates are mandatory in
but no policy exists.
Designated Staff (at least one should be full time)
1 full time pharmacist only
Stable basic funding
MOH does not have a separate budget
Clear mandates and well defined structures and roles
Not yet defined
Collaborating with the WHO Programme for
Lack capacity
international drug monitoring
National spontaneous reporting system in existence
There is no functional electronic system.
with a national ADR reporting form
A national database or system for collecting and
Database is not compatible and it is
managing ADR reports
difficult to access and analyse the data.
A national pharmacovgilance advisory committee for
Not clearly defined
feedback and recommendations for on safety issues
Validate casualty, participate in crisis management
Not clearly defined
and crisis communication
A communication strategy that is clear both routine
and crisis communication.
No therapeutic or drug bulletin has been
published and there is no public relations
Methodology
A cross-sectional study design was used to explore the
perceptions’ and attitudes of pharmacists regarding ADR
reporting in Pakistan.
 The study was approved by ethical committee of Hamdard
University and Ministry of Health, Pakistan.
 A validated semi-structured questionnaire was distributed to
a sample of 382 pharmacists from all fields selected by using
convenient sampling technique for data collection
 After data collection data was cleaned, coded and analyzed
using SPSS vs. 16.
Study Findings
Pharmacovigilance System in Pakistan Must
Undergo Through Unprecedented
Change!
Status Quo is not an option!
Optimal drug therapy outcomes through
patient-centred care can be achieved by
involving pharmacist in ADR reporting
Findings
83.2% of the
pharmacists were
familiar with the term
pharmacovigilance and
95.2% thought its
important to report an
ADR
94 % agreed that ADR
reporting should be
mandatory for
practicing pharmacists.
Only 7 % of the pharmacists
agreed on effective and
efficient working of current
pharmacovigilance centre’s
in Pakistan
93.2% agreed to
designate pharmacist
as the chief personnel
to be involved in
development of ADR
reporting system
Only 38.7 % of
the pharmacists
were of the view
that pharmacist
is well trained to
report an adverse
drug reaction in
Pakistan
Findings
68.23% of the pharmacists from industry, 90.32%
from academia, 76.20% from hospital, 70.21%
from marketing, 79.75% from community
pharmacy and 75% from regulatory authorities
were not satisfied with working of current
pharmacovigilance centers and recommend
improvement
Only 27 % of pharmacists ever
reported an ADR they came across
while 71.73% of pharmacists never
reported it
5 % of pharmacists submit the report to
supervisor/chief pharmacist, 1.83% submit the
report to drug regulatory authority, 12.3 % of
pharmacists submit the report to prescribers,
4.7 % of pharmacists submit the report to
concerned authority within organization in
which they were working
Findings
22.2 % of pharmacists
didn’t submit the report
due to unawareness of
how to report an ADR
3.99% didn’t report
ADR due to work load
53.3 % of pharmacists
didn’t report ADR as
there is no ADR
reporting center
The suggestions given by the pharmacists for
effective ADR reporting in Pakistan were:
Training (31.6%), Establishment of proper
ADR reporting system (39.8%), improve
interaction between healthcare professionals
(16.4%), recognize role of pharmacist in
healthcare system (9.38%), concern authority
should Publish reported ADRs (44 %)
What Should Happen in the Next Decade for Effective
ADR Reporting Practices in Pakistan?
Developed
Critical
Thinking
Developed
Critical
Mass
Produced
Empirical
Research
Data
How to Take a Start??? Priorities: 2016 and Beyond
 ADR data based on the Pakistani population must be generated within built
mechanism for automatic sharing of the information with global health-care
community through WHOUMC.
 Establishment of national pharmacovigilance systems (NPS) for the reporting of
adverse events, including national and regional pharmacovigilance centers
The official website should be linked to several email subscription services,
accessible for health care providers and must be integrated with international
database.
 Development of legislation/regulation for medicine monitoring under PV
 The operational pharmacovigilance systems connected to NPS must be developed
at all primary, secondary and tertiary health care facilities. Reporting and
documentation must be simple and easy for all.
The culture of ADE notification must be developed in Pakistan. Healthcare
providers need to be motivated by their professional conscience to comply with
ADR-reporting requirements.
Education and clinical training in pharmacovigilance must be mandatory
Follow up and feed back mechanism must be devised.
 Media must be engaged to promote risk benefits of drugs.
 Role of pharmacist must be accepted and collaborative working among
healthcare professionals must be promoted.
Pharmaceutical industry of Pakistan should aggressively take up the challenge to
start research in Pharmacovigilance by collaboration with Universities.
 Finally, the future of effective pharmacovigillance system will get a direction in
Pakistan.
Conclusion
 The findings concluded that concept of ADR monitoring is still
not matured in Pakistan and there is need to develop monitoring
systems to implement the idea of pharmacovigilance seriously in
Pakistan.
 Appropriate training programs on ADR reporting must be
designed for capacity building of healthcare professionals. This
will provide opportunities for the pharmacists to take the
profession to the next level in order to cope up with advanced
concept of public healthcare.
 Pharmacists have a strong voice in healthcare system
transformation while working with other health providers – the
role of the pharmacist in primary care and health teams must
be promoted.
“To bring about a change within a diverse
profession such as pharmacy, one needs a
large number of people pulling in the same
direction. Before one can get folks pulling
in the same direction, one needs general
agreement about the best direction to
move”. (William .A. Zellmer)
THANK YOU!
Email: [email protected]