Pharmacovigilance October - December 2022/2023 (Q2)

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 515 adverse events reports were submitted to PPB. 281 of the total reports were of suspected adverse drug reactions (sADRs), 16 adverse events following immunizations (AEFI), 100 from members of the public (PADRs) and 113 were medication error reports, 1 report of incident following use of a medical device and 1 blood transfusion reaction.

Since the introduction of PV in Kenya, a total of 16,051 individual case safety reports has been submitted to the global data reports 32,760,345 (0.05%).