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

1. Role of Pharmacist in ADR Reporting in Pakistan: A myth or reality? Dr. MadeehaMalik PhD (Pharmacy Practice), Post Doctorate (Pharmacy Practice) Director/Associate Professor, Pharmacy Department, HamdardUniversity, Pakistan

2. 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.

3. 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

4. Inappropriate Prescribing Practices Lack of pharmacovigillance system Factors Promoting ADRs Poor communication between healthcare professionals Lack of global standardization of ADR reporting Form Inadequate Knowledge and lack of motivation among Pharmacists Lack of research and linkage between academia & Industry

5. Concept of Pharmacovigilance

6. 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.

7. Evidence Based Data on Role of Pharmacist in ADR Reporting in Developed World Pharmacist has helped to improve outcomes including reduction in ADRs and medication errors by 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

8. 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.

9. 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.

10. 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

11. 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

12. 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 Statistics of Pakistan Regarding ADR Reporting 4 hospitals are targeting specific ADRs. 80% of the hospitals have no proper ADR monitoring system. Only 1 hospital is having online reporting system Community pharmacies are not involved in ADR reporting

14. 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.

15. Study Findings Pharmacovigilance System in Pakistan MustUndergo 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

16. 83.2% of the pharmacists were familiar with the term pharmacovigilance and 95.2% thought its important to report an ADR 93.2% agreed to designate pharmacist as the chief personnel to be involved in development of ADR reporting system Findings 94 % agreed that ADR reporting should be mandatory for practicing pharmacists. Only 38.7 % of the pharmacists were of the view that pharmacist is well trained to report an adverse drug reaction in Pakistan Only 7 % of the pharmacists agreed on effective and efficient working of current pharmacovigilance centre’s in Pakistan

17. 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 Findings 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

18. 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 22.2 % of pharmacists didn’t submit the report due to unawareness of how to report an ADR Findings 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 %)

19. What Should Happen in the Next Decade for Effective ADR Reporting Practices in Pakistan?

20. 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. How to Take a Start??? Priorities: 2016 and Beyond

21. 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.

22. “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)

23. Thank you! Email: madeehamalik15@gmail.com