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.