How Kenya’s new pharmacy rules put medicine access under scrutiny

Kenya's effort to strengthen pharmacy standards is raising crucial questions about whether the country can meet these demands without creating staffing gaps that hinder access to medicines. The Kenya Pharmaceutical Association (KPA) has rejected Draft 11 of the proposed Good Pharmacy Practice (GPP) Guidelines, arguing that these rules would remove pharmaceutical technologists from supervisory roles at Level 3 health facilities and limit their access to controlled medicines.

This move could have far-reaching implications, given that pharmaceutical technologists form a significant portion of Kenya's pharmacy workforce.

KPA claims that there are approximately 10,533 licensed pharmaceutical technologists, compared to 2,931 pharmacists, and that Kenya has 2,559 Level 3 facilities. The association argues that requiring only degree-qualified pharmacists to manage all these facilities could be operationally impractical when considering other healthcare professionals, specialized services, industry, academia, regulatory institutions, research, wholesale, and other areas of pharmacy practice.

KPA president Chitechi Amboka emphasized that a regulatory framework should not make medicines inaccessible due to unnecessary restrictions on the professionals who can facilitate their safe and lawful access.

The dispute extends beyond who should supervise pharmacy services. KPA is also concerned about proposed restrictions on narcotic and psychotropic medicines, including those used for severe pain management and mental-health conditions. KPA president asserts that while tighter controls on such medicines are necessary, the current proposal unnecessarily limits pharmaceutical technologists' ability to provide lawful and safe access to these drugs.

KPA objects to this blanket exclusion, emphasizing that the goal should be patient protection rather than merely reallocating responsibilities between professional groups.

The proposed standards aim to enhance professional practice and patient safety, but the implementation faces challenges. The Pharmacy and Poisons Board (PPB), responsible for regulating pharmacy practice, has acknowledged human resource gaps as a significant issue affecting its regulatory mandate. PPB has licensed 15,679 pharmaceutical professionals and assessed 605 facilities across 43 counties, highlighting the need for support to address these gaps.

The Pharmaceutical Society of Kenya (PSK), whose president Wairimu Njuki supports the guidelines, suggests that stakeholders can still offer practical improvements while upholding the objective of strengthening professional standards and protecting patients. The disagreement also revolves around the level of consultation. KPA was excluded from substantive engagement after an earlier draft and rejects Draft 11 "in its entirety," calling for another review involving affected professional groups.

The debate is particularly pertinent for patients and policymakers. For patients, the critical question is whether tighter professional controls will enhance medicine safety without causing new shortages at facilities where many Kenyans receive basic healthcare. For policymakers, the key challenge is determining whether Kenya has sufficient pharmacists and an efficient deployment system to enforce higher standards without disrupting medicine access.