Pharmacovigilance

The Department of Pharmacovigilance

The Department of Pharmacovigilance was set up in late 2004 at the Pharmacy and Poisons Board with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya. The department also carries out routine post market surveillance on all medicines in Kenya.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems with the view to:
Early detection of hitherto unknown adverse reactions and interactions
Detection of increases in frequency of (known) adverse reactions
Identification of risk factors and possible mechanisms underlying adverse reactions
Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.

The ultimate goals of Pharmacovigilance are:

  1. The rational and safe use of medicines
  2. The assessment and communication of the risks and benefits of drugs on the market
  3. Educating and informing patients.

Guidelines and the tools to implement Pharmacovigilance in Kenya have been developed and sensitization workshops have been carried out for various cadres of health professionals in Kenya such as Pharmacists, Pharmaceutical technologists, nurses, Clinicians and Clinical officers. The system plans to cover all provinces, for all medicines and for all patients. All manufacturers and distributors are expected to submit all findings and reports on adverse events with drugs to PPB.

Pharmacovigilance Newsletter

PV Guidelines

Reporting Forms

PMS Strategy

PV Updates