Pharmacovigilance in Kenya

1. Dr. Jayesh M. Pandit Head Dept. of Pharmacovigilance Pharmacy and Poisons Board Ministry of Medical Services 2nd December 2009 5th Global Congress, INTERPOL Cancun, Mexico Pharmacovigilance in Kenya Jayesh- Pharmacovigilance

2. The Pharmacy and Poisons Board Jayesh- Pharmacovigilance

3. Role of Pharmacy and Poisons Board The PPB is the Drug Regulatory Authority of the Ministry of Health, Kenya. It was established in 1957 under the Pharmacy and Poisons Act- Cap 244 of the Laws of Kenya, with the mandate: “to make better provision for the practice and profession of pharmacy and the trade in pharmaceutical products.” Jayesh- Pharmacovigilance

4. Jayesh- Pharmacovigilance

5. What is Pharmacovigilance? Jayesh- Pharmacovigilance

6. Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines, with the view to: ·  Identifying new information about hazards, and · Preventing harm to patients. From: Greek pharmakon- drug Latinvigilare- to keep awake or alert, to keep watch Safety……Efficacy Pharmacovigilance Jayesh- Pharmacovigilance

7. Post-market surveillance ensures that, even after registration, drugs continue to meet the required standards whilst in the market. Safety……Efficacy……Quality Post Market Surveillance All drugs are dangerousSomemayalsobeuseful N. Moore, BMJ, 2005, 330;539-40

8. Widening scope of Pharmacovigilance These include: • Substandard and counterfeit medicines • Product development • Medication error reporting • Adverse interactions of medicines with chemicals, other medicines, and food reports • Assessment of drug-related mortality • Abuse and misuse of medicines reports • Efficacy monitoring • Off-label use of medicines • Case reports of acute and chronic poisoning

9. Globally, much attention is paid to the infringement of intellectual property rights, loss of monopoly, loss of millions of US$ with counterfeits... And unfortunately, lesser attention is provided to the number of lives lost, number of severe drug reactions experienced and the morbidity associated with the murderous trade of counterfeiting! Jayesh- Pharmacovigilance

10. Thalidomide tragedy!Phocomelia

11. Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

12. Recent Global Cases of Counterfeit MedicinesMurder by fake drugs BMJ 2002; 324:800-801 P. Newton et al • Philippine survey- 8% fake • Cambodia 1999, 60% of 133 drug vendors sold ineffective and much cheaper sulphadoxine-pyrimethamine as mefloquine tabs. • 38% of tablets sold in 5 South East Asia countries as artesunate were fake. • Fake packaging, fake holograms, harmful ingredients… • Neomycin eye drops and meningococcal vaccine made of tap water • Paracetamol syrup made of industrial solvent • Ampicillin containing turmeric • Contraceptive pills containing wheat flour • Antimalarials, antibiotics and snake venom containing no active ingredients It is high time that industry, drug regulatory authority, police, standards authority, customs, public et al all come together against this crime! Jayesh- Pharmacovigilance

13. Guidelines for the National PV System in Kenya’ developed- ver 2.0 Tools developed: Suspected ADR Reporting Form Alert Card Form for Reporting Poor Quality Medicinal Products Definitions in PV Training material developed: training curricula, guides and manuals Start with a 45 min video on counterfeit medicines (BBC/WHO) Tutorial on identifying counterfeits Reporting of suspected cases Pharmacovigilance in Kenya Jayesh- Pharmacovigilance

14. Guidelines for the National Pharmacovigilance System in Kenya

15. Pharmacovigilance tools Jayesh- Pharmacovigilance

16. What to report? • Report allsuspected adverse reactions to allopathic (modern) medicines, traditional / alternative / herbal medicines, x-ray contrast media, medical devices and cosmetics. • Report product quality problems, e.g. • Suspected contamination, moulding, colour change • Poor packaging / poor labeling • Therapeutic failures • Suspected counterfeit medicine • Receiving expired medicines Jayesh- Pharmacovigilance

17. Benefits of Pharmacovigilance • Prevention of drug-related morbidity • Prevention of drug-related mortality • Minimize in-patient and out-patient morbidity • Huge savings in healthcare costs • Better patient compliance • Greater understanding of drug-induced disorders • Early signals / warnings to potentially serious ADRs • Greater awareness of agents that commonly cause drug-induced disorders • Better patient care • Greater importance of Role of the Healthcare Worker Jayesh- Pharmacovigilance

18. Benefits of Post-Market Surveillance • Continuous quality assessment of pharma products in Kenya • Reduce, if not alleviate, sub-standard, illegal and counterfeit medicines • Understand the range, availability and use of various medicines in various diseases • Closer working relationship with other departments within the NRA, especially: • Medicines Regulation Dept, Inspectorate Dept, GMP Dept. • Greater importance of Role of a Healthcare Worker Jayesh- Pharmacovigilance

19. Past: Surveys of medicines to evaluate: Range and availability, Registration status with PPB and Quality analysis Antimalarials (baseline pre-ACT, QAMSA), cough and colds, ARV, Anti-TB (research thesis, country-wide) Present: Pro-active and reactive surveillance Similar sounding / spelt medicines Drug interactions highlights Now and Ahead: Routine PV and PMS of all pharmaceutical products PMS strategy (under development) PPB Post-Market Surveillance activities Jayesh- Pharmacovigilance

20. Activities with INTERPOL… • Working closely with INTERPOL since 2008 • Educate, train and partner with the police, KIPI, Pharmacy and Poisons Board • Better collaboration with inspectors, drug registration, public • IMPACT - Operation MAMBA II : joint efforts in Kenya, Uganda, Tanzania to combat counterfeits Aug 2009 • Foster link with the Kenya Bureau of Standards (KEBS), Surveillance Department and jointly enforce the new Anti-Counterfeit Bill, 2008 • Better networking with this Congress Jayesh- Pharmacovigilance

21. More steps ahead… • Sensitize and train field staff across all provinces- for both MoMS and MoPHS • Collaboration with KMA, NC, professional societies, stakeholders to encourage reporting of suspected cases • Include course on PV at University, Schools and Training Institutions • Stakeholders meeting to combat counterfeiting Jayesh- Pharmacovigilance

22. Challenges • Legal backing- Cap 244 Pharmacy Law outdated 1957 • Personnel • Dedicated confirmed financial support- routine • Advocacy and awareness- within healthcare fraternity, media + cover • Encouraging reporting- no punitive action on reports • Strengthening Pharmaceutical & GMP inspectors and the link with Pharmacovigilance Jayesh- Pharmacovigilance

23. PharmacovigilanceCurriculum and Implementation Guide Jayesh- Pharmacovigilance

24. If you are still wondering how Pharmacovigilance affects you? “To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine” Molière Jayesh- Pharmacovigilance

25. THANK YOUAsante sana… “You need not be certain… Just be suspicious” Jayesh- Pharmacovigilance

26. Department of Pharmacovigilance Pharmacy and Poisons Board Lenana Road P.O. Box: 27663-00506 Tel: +254-(020) 3562107 Nairobi KENYA 2716905/6 Fax: +254-(020) 2713431 / 2713409 e-mail:pv@pharmacyboardkenya.org www.pharmacyboardkenya.org Our contact … Jayesh- Pharmacovigilance