Pharmacy and Poisons Board intensifies hospital, wholesale audits to enforce compliance

The initiative, which began with wholesaler audits on October 13, and expanded to Level 4 hospitals on October 20, 2024, aims to ensure adherence to critical compliance standards in the distribution and handling of medicines.

In a media briefing on Monday, Julius Kaluai, PPB’s Head of Good Distribution Practices emphasized the Board’s commitment to cracking down on unlicensed practices in both hospital pharmacies and wholesale networks. 

The audits focus on key compliance areas, such as handling of cold-chain medicines, adherence to pharmaceutical waste disposal guidelines, and ensuring that only qualified personnel manage pharmacies.

Kaluai raised concerns over the presence of unqualified staff and unregistered medicines in hospitals, warning that these increase the risks of medication errors, drug misuse, and improper handling of pharmaceuticals, endangering patient safety. 

Additionally, he stressed the importance of registering all pharmaceutical transport vessels with PPB and called on wholesalers to store medicines under conditions that maintain their efficacy.

The PPB also highlighted challenges related to wholesalers relocating without notifying the Board, making it difficult to accurately map distribution networks and conduct effective audits. Theft of government-supplied medicines and unauthorized sales to unlicensed outlets were also flagged as serious threats to the integrity of healthcare services.

Kaluai urged private hospitals to enforce compliance by employing only licensed pharmacy staff and aligning pharmaceutical waste disposal with PPB and NEMA guidelines.

Reaffirming its dedication to regulatory enforcement, PPB stated that this ongoing initiative is essential to maintaining safe, effective, and high-quality healthcare standards across Kenya.