1. Pharmacovigilance in Kenya
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
Jayesh- Pharmacovigilance

2. The Pharmacy and Poisons Board
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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.”
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5. What is Pharmacovigilance?
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6. Jayesh- Pharmacovigilance
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
Latin vigilare- to keep awake or alert, to keep watch
Safety……Efficacy
Jayesh- Pharmacovigilance

7. Post Market Surveillance
Post-market surveillance ensures that, even after registration, drugs continue to meet the required standards whilst in the market.
Safety……Efficacy……Quality
All drugs are dangerous Some may also be useful
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. Jayesh- Pharmacovigilance
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. all come together against this crime!
Recent Global Cases of Counterfeit Medicines Murder by fake drugs BMJ 2002; 324: P. Newton et al
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
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…
It is high time that industry, drug regulatory authority, police, standards authority, customs, public et al
all come together against this crime!
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13. Pharmacovigilance in Kenya
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
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14. Guidelines for the National Pharmacovigilance System in Kenya
Use the slide introduce the guideline and ensure that all participants have copy of the same

15. Pharmacovigilance tools
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What to report?
Report all suspected 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
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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
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19. PPB Post-Market Surveillance activities
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)
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
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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. Jayesh- Pharmacovigilance
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. Pharmacovigilance Curriculum and Implementation Guide
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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
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25. “You need not be certain…
THANK YOU Asante sana…
“You need not be certain…
Just be suspicious”
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26. Department of Pharmacovigilance Pharmacy and Poisons Board
Our contact …
Department of Pharmacovigilance
Pharmacy and Poisons Board
Lenana Road
P.O. Box: Tel: (020)
Nairobi KENYA /6
Fax: +254-(020) /
Jayesh- Pharmacovigilance