Pharmacy and Poisons Pharmacy and Poisons Board MOMS-Kenya Jayesh- Pharmacovigilance Pharmacovigilance in Kenya 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
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Pharmacy and Poisons Board Pharmacy and Poisons Board MOMS-Kenya Jayesh- Pharmacovigilance Pharmacovigilance in Kenya Dr. Jayesh M. Pandit Head Dept. of.
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Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
Pharmacovigilance in Kenya
Dr. Jayesh M. PanditHead
Dept. of Pharmacovigilance
Pharmacy and Poisons Board
Ministry of Medical Services
2nd December 2009
5th Global Congress, INTERPOL
Cancun, Mexico
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
The Pharmacy and Poisons Board
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
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.”
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
What is Pharmacovigilance?
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
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
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
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
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Widening scope of PharmacovigilanceThese 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
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Jayesh- Pharmacovigilance
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Thalidomide tragedy!
Phocomelia
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
Pharmacy and Poisons Board
Pharmacy and Poisons Board MOMS-Kenya
• 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.