Dr. Jayesh M. Pandit Head Dept. of Pharmacovigilance Pharmacy and Poisons Board Ministry of Medical Services 2 nd December 2009 5 th Global Congress, INTERPOL Cancun, Mexico. Pharmacovigilance in Kenya. The Pharmacy and Poisons Board. Role of Pharmacy and Poisons Board.
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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.”
· Identifying new information about hazards, and
· Preventing harm to patients.
Greek pharmakon- drug
Latinvigilare- to keep awake or alert, to keep watch
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!
It is high time that industry, drug regulatory authority, police, standards authority, customs, public et al
all come together against this crime!
Suspected ADR Reporting Form
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 casesPharmacovigilance in Kenya
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)
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
“To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine”
“You need not be certain…
Just be suspicious”