Health CS Aden Duale/HANDOUT
Health Cabinet Secretary Aden Duale has clarified that the 2026 Good Pharmacy Practice Standards do not bar diploma holders from practising or working at any level of the health system.
In a statement on Thursday, Duale said pharmacy professionals, regardless of whether they are diploma or degree holders, would continue working across the health sector provided they are operating within their lawful scope of practice.
"It is necessary to clarify that the Standards do not bar any category of pharmacy professionals (whether diploma or degree holders) from practising or working at any level of the health system, provided they are duly enrolled or registered, licensed and operate within their lawful scope of practice," he stated.
The clarification comes amid concerns raised over the new standards, which are set to take effect on January 1, 2027.
The CS said the standards distinguish between working as a pharmacy professional at a particular level of care and serving as the superintendent of a pharmacy facility.
According to Duale, the superintendent carries overall professional and regulatory responsibility for a facility.
This means the minimum qualification required for the position must correspond to the nature, complexity and level of risk of the pharmaceutical services offered.
He said pharmacy professionals from different cadres would continue working together across the health system, describing the requirements for superintendents as a competency-based patient safety measure.
“As services become more specialised and the risks to patients increase, the qualifications and competencies of the person bearing overall responsibility (the superintendent) must increase accordingly,” Duale said.
He added that the approach was consistent with the Ministry of Health’s Human Resources for Health Norms and Standards Guidelines, which align staffing and professional responsibility with the services provided at each level of care.
Duale said the principal purpose of the Good Pharmacy Practice Standards was to protect patients and ensure the quality of pharmaceutical care.
He added the standards would also strengthen the sector’s ability to address illegal and unethical practices that continue to pose risks to patients.
"These include the ‘renting’ or ‘leasing’ of professional licences, operation of premises without proper professional oversight, inappropriate dispensing, misuse of antimicrobials and diversion or misuse of narcotic and psychotropic substances," he said.
The Cabinet Secretary said the standards were grounded in existing laws and constitutional provisions protecting the right to health and consumer rights.
He cited Articles 43 and 46 of the Constitution, which provide for the right to the highest attainable standard of health and protection of consumers’ rights to quality services, adequate information and the protection of their health and safety.
Duale also stressed that the standards were not developed abruptly, noting that the process had taken more than five years and involved 11 iterations, alongside multiple rounds of stakeholder engagement and technical review.
The process, he said, involved the Ministry of Health, county governments, professional associations representing diploma and degree holders, academia, public and private healthcare institutions, the pharmaceutical industry and development partners.
According to the CS, views submitted during the consultations were considered and incorporated where appropriate, guided by the law, professional competencies, patient safety and the wider public health interest.
The Ministry reiterated its commitment to continued engagement with pharmacy professionals as implementation of the standards approaches.
"The Ministry remains committed to constructive engagement with all pharmacy professionals and the Pharmacy and Poisons Board will continue providing clarification and implementation support ahead of the commencement of the Standards on 1st January 2027," the statement concluded.
A section of pharmaceutical technologists have challenged the new guidelines raising concerns over wat they describe as lack of meaningfully engagement with them during the drafting process.
The professional associations claim several requests for dialogue with the regulator went unanswered, while concerns raised by members were not reflected in the latest draft.
The dispute has prompted the professionals to demand further engagement before implementation.