Pharmacy and Poisons Board Kenya: Q2 2024 Pharmacovigilance Summary Report Released

• The Pharmacovigilance Summary Report for Q2 2024 in Kenya reported 123 adverse drug reactions.
• 65% of reports were related to antibiotics, followed by antimalarials and analgesics.
• Pharmaceutical companies must report all serious adverse drug reactions within seven days under the Pharmacy and Poisons Act (Cap 244).
• Non-compliance with pharmacovigilance regulations can result in severe penalties.

The majority of these reports (65%) were related to antibiotics, followed by antimalarials and analgesics.

The Pharmacovigilance Summary Report for the second quarter of 2024, covering October 1st to December 31st, has been released by the Pharmacy and Poisons Board (PPB) in Kenya. The report provides an overview of adverse drug reactions reported during this period. According to the PPB, a total of 123 adverse drug reaction reports were received, with 85% of these reports being spontaneous, meaning they were not solicited by the PPB. The majority of these reports (65%) were related to antibiotics, followed by antimalarials and analgesics.

The Pharmacovigilance Authority in Kenya is responsible for ensuring that pharmaceutical companies comply with regulations regarding the reporting of adverse drug reactions. The PPB has implemented a pharmacovigilance system to monitor and manage adverse events associated with medicinal products. Under the Pharmacy and Poisons Act (Cap 244), pharmaceutical companies are required to report all serious adverse drug reactions within seven days of becoming aware of them. Failure to comply with these regulations can result in severe penalties, including fines and suspension of licenses.

The Pharmacovigilance Summary Report highlights the importance of monitoring and reporting adverse drug reactions in Kenya. The report's findings have significant implications for pharmaceutical companies operating in the country. Lawyers should be aware that non-compliance with pharmacovigilance regulations can lead to serious consequences, including reputational damage and financial penalties. As such, it is essential for companies to ensure they are meeting their reporting obligations under the Pharmacy and Poisons Act (Cap 244).

Lawyers should watch for potential compliance exposures related to the reporting of adverse drug reactions in Kenya, as outlined in this Pharmacovigilance Summary Report.

Source: Original reporting via the Pharmacy and Poisons Board Kenya