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Guidelines on the Safety and Vigilance of Health Products and Technologies

The Pharmacy and Poisons Board (PPB) is committed to ensuring the provision of quality, safe, and efficacious Health Products and technologies (HPTs). Despite their obvious benefits, HPTs are known to have a possibility of causing adverse events. As the National Pharmacovigilance Centre, PPB monitors adverse events and promotes the safe use of medical products.

Key Objectives:

• Enhance patient care and safety by encouraging safe, rational, and effective use of HPTs.
• Ensure public health safety through effective safety monitoring of HPTs and timely communication of safety information.
• Encourage rational use of medicines and educate stakeholders on pharmacovigilance.

Your Role in Pharmacovigilance:

• Healthcare Providers:Identify, detect, manage, and report adverse events and poor-quality products promptly.
• County Health Management Teams: Investigation of Serious Adverse Events and submit reports to the NPC.
• Marketing Authorization Holders (MAHs):Monitor the safety of their products in the market and comply with pharmacovigilance and post-market surveillance requirements.
• Public Health Programs:Collaborate on safety data sharing and risk management.

How to Report Adverse Events:

• Report all suspected adverse events through ouronline reporting tool, PvERS, as soon as possible.
• For further guidance, concerns, and clarifications, do not hesitate to reach out to the National Pharmacovigilance Centre by calling the number +254 795 743 049 or by sending an email to pv@ppb.go.ke.

PPB is dedicated to maintaining global standards in pharmacovigilance by contributing safety data to the WHO database through the Uppsala Monitoring Centre. Together, we can ensure the well-being of all patients and the safety of health products in Kenya.

The Guidelines on Safety and Vigilance of Health Products and Technologies, therefore, guide all the health care workers, patients, marketing authorization holders, and the public on the reporting of adverse drug reactions and adverse events in health products and technologies in Kenya.

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