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Pharmacovigilance April – June 2021/2022 (Q4)

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Pharmacovigilance April - June 2021/2022 (Q4)

The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates the Practice of Pharmacy and the manufacture and trade of drugs and poisons.

PPB has 4 directorates and one of them is the directorate of Health Products and Technologies (HPT). Pharmacovigilance & Post Marketing Surveillance are divisions in the department of product safety that falls under HPT. Other divisions Clinical Trials & Medicines Information. Product safety shares quarterly pharmacovigilance reports with stakeholders to serve as a feedback mechanism and also encourage all stakeholders to report.

In this quarter 1 period, a total of 510 adverse events reports were submitted to PPB. 210 of the total reports were of suspected adverse drug reactions (sADRs), 47 adverse events following immunizations (AEFI), 86 from members of the public (PADRs) and 165 were medication error reports, 1 on blood transfusion reaction and 1 report of incident following use of a medical device.

Since the introduction of PV in Kenya, a total of 15,283 individual case safety reports has been submitted to the global data reports 32,760,345 (0.05%).

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