Kenya’s healthcare system is approaching a major reform moment with the Draft Quality Healthcare and Patient Safety Bill, 2025. While much attention has focused on the Bill’s provisions for patient rights and hospital standards, it also proposes consequential amendments to the Pharmacy and Poisons Act (Cap. 244) – the law that has regulated pharmacy and medicines since 1956. These changes will shift pharmacy practice from a focus on regulatory control to a broader mandate centered on patient safety and quality care.
From Drug Control to Patient-Centered Care
For decades, Cap. 244 has concentrated on who may dispense medicines, how premises are licensed, and the classification of drugs and poisons. The new Bill reframes these provisions. Clause 16 of the Draft Bill introduces a patient’s explicit right to “safe and quality health products and technologies”. This single clause elevates the role of pharmacists and pharmaceutical technologists from dispensers of medicines to legal custodians of patient safety.
Under the proposed framework, licensing and dispensing move beyond procedural requirements to become active assurances that the medicines provided are safe, effective and used appropriately.
Strengthening Oversight on Medicines
The Bill imposes new obligations on the supply and monitoring of medicines. Clause 16(2) requires healthcare providers to prescribe and administer only products approved by the relevant regulatory authority, reinforcing the Pharmacy and Poisons Board’s oversight role under Sections 25–29 of Cap. 244 on poisons and controlled substances.
It further mandates reporting of adverse drug reactions to the regulator and providing patients with counselling on risks and safe use. These provisions make pharmacovigilance – previously a policy recommendation under Cap. 244 – a statutory requirement, integrating safety into every stage of pharmaceutical care.
Quality Assurance as a Licensing Condition
Under Section 23 of Cap. 244, licensing has been tied mainly to professional qualifications and premises suitability. The Draft Bill introduces a higher standard.
Clause 20 obligates health facilities to take “all reasonable measures” to meet prescribed quality standards, while Clause 23(2) requires facilities to maintain structured quality improvement programmes, including clinical audits and outcome analysis. This links pharmacy licensing to active medication safety audits, risk management protocols and evidence-based dispensing practices, making quality assurance a legal condition of operating a pharmacy.
Introducing a New Oversight Authority
While Cap. 244 currently empowers the Pharmacy and Poisons Board under Section 3 to regulate pharmacy practice, Part III (Clause 27) of the Draft Bill establishes the Quality Healthcare and Patient Safety Authority. Its mandate covers registering and inspecting health facilities for compliance with quality standards, including pharmaceutical services. Clause 28 gives the Authority power to enforce standards, conduct inspections, and impose administrative penalties. This adds a second layer of oversight, focusing not only on licensing compliance but also on whether pharmaceutical services meet national patient safety benchmarks and risk management protocols.
Accreditation and the Digital Health Link
A critical innovation is the integration of pharmacy safety with Kenya’s digital health infrastructure. Clauses 58–63 link accreditation to traceable supply chains and good distribution practices. Facilities, including pharmacies, will be required to feed adverse event data and quality metrics into the Comprehensive Integrated Health Information System (CIHIS), established under the Digital Health Act. For pharmacy practice, this moves compliance from paper-based records to a real-time, national digital reporting ecosystem designed to monitor patient safety.
Professional Accountability and Patient Rights
Cap. 244 has always restricted the handling of medicines to registered pharmacists and enrolled pharmaceutical technologists under Sections 6, 7 and 19. The Draft Bill reinforces this in Clause 9, which guarantees every patient the right to care from “qualified and licensed healthcare professionals”.
It further introduces Clause 25, mandating professional indemnity cover for all health facilities and extending that requirement to individual healthcare providers, including pharmacists and pharmaceutical technologists. This provision formalises pharmacists’ role as frontline protectors of patient safety and recognises that medication errors carry consequences comparable to surgical mistakes.
Harmonising Definitions and Modernising Cap. 244
The Draft Bill’s Clause 102 provides for consequential amendments to existing legislation, including Cap. 244. It calls for harmonising definitions such as “health products and technologies,” “adverse event,” and “quality improvement” to align pharmacy regulation with a modern, patient-focused framework. Updating these terms ensures that Cap. 244, first enacted in 1956, can operate within the 2025 patient safety landscape.
Implications for Pharmacists and Technologists
For practising pharmacists and pharmaceutical technologists, these reforms will transform day-to-day practice. Compliance will no longer be limited to obtaining and renewing licences but will require demonstrating continuous adherence to patient safety standards. The emphasis on evidence-based dispensing and mandatory safety reporting means professionals must stay current with clinical guidelines and pharmacovigilance practices. At the same time, the Bill elevates the profession by embedding pharmacists as essential actors in Kenya’s patient-centred healthcare system.
A Safer Experience for Patients
Patients stand to gain significantly from these amendments. Medicines will be tracked for safety throughout their lifecycle, from manufacturing and importation to dispensing. Patients will have clearer information about treatment risks and options, and the assurance that qualified, indemnified professionals are managing their care.
The focus shifts from controlling products to protecting people, signaling a cultural change in healthcare delivery.
The Quality Healthcare and Patient Safety Bill, 2025 is still a draft and subject to public participation and parliamentary scrutiny. Yet its vision is clear: to embed quality and patient safety into every facet of healthcare, including pharmacy. For Cap. 244, this is not a repeal but a recalibration, aligning an historic statute with the demands of modern, patient-centred care.
For pharmacists, pharmaceutical technologists, and health facilities, the Bill offers both a challenge and an opportunity – a call to step forward as key custodians of safety and quality in Kenya’s evolving healthcare system.
