Amongst its many functions as spelt out in the Pharmacy and Poisons Act, Cap 244, Laws of Kenya, the Pharmacy and Poisons Board (PPB) charted out a mission to regulate and control the pharmaceutical services and ensure accessibility, quality, safety and efficacy of human and veterinary medicines and medical devices. With this in mind, the Pharmacy and Poisons Board has developed this guideline for healthcare workers and the public at large on detecting and reporting Adverse Drug Reactions and poor medicinal products.

The purpose of this guideline is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to patients.

This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.

The PPB, in consultation with various stakeholders, will review this guideline and tools periodically, to ensure that they continue to meet the goals of the Pharmacovigilance system.