Pharmacy requires own regulatory council

Pharmacy is a profession with a unique body of knowledge and special skills derived from research, continuous education and training. Pharmacists apply this knowledge and skills across all levels of the healthcare value chain to ensure the safety of the public.

Practising in research, development, production, regulation, supply chain management, quality assurance, medication safety and direct patient care, pharmacists ensure the medicines and health products the public consumes are safe, efficacious and of acceptable quality.

Pharmacists must have an independent regulatory council whose members have the same knowledge and skills.

A profession holds a systematic body of theory and knowledge, wields authority in a field of practice, bears credibility, is accountable for a social contract with the community and is regulated for the protection of the public. While the lowest allowable level of professional practice is determined by regulation, professional ethics demand the highest attainable standard of practice, guided by a code of ethics.

The code describes the attitudes, skills and practices of professionals that guide them as they discharge their social contract to the community. Professionals are thus inherently by training, practice and self-regulating.

The Pharmaceutical Society of Kenya prescribes a Code of Ethics for Pharmacists. The code is in line with the Kenya National Patient Rights’ Charter 2013 that is premised on the principles of health protection, access, information, participation and informed consent, privacy and confidentiality, dignity and respect and safe healthcare. In this charter are described the rights and responsibilities of patients as well as the route of recourse for dispute resolution.

The Code of Ethics for Pharmacists aims to foster an environment where the general public can be confident that choices regarding their treatment are made in the best interest of their healthcare needs. It covers five domains abbreviated as the five P’s: The patient, the profession, the practice, the premises of practice and the product.

The outcomes attained when pharmacists follow the code of ethics are as important as they are many: pharmaceutical-sector governance is enhanced; the institutional and human resource capacity for pharmaceutical management and services is increased; regulation of medical products is strengthened; availability and use of pharmaceutical information for decision making is increased; the global learning agenda is advanced; pharmaceutical-sector financing, including resource allocation and use, is optimised; pharmaceutical services including product availability and patient-centered care are improved; and health outcomes for the public are optimised. The Code of Ethics for Pharmacists is, therefore, a very important instrument.

Another aspect of self-regulation is the presence of the regulated professionals in the government body that is established for their regulation. In the case of pharmacists, we currently have the Pharmacy and Poisons Board that has the double mandate of regulating health products and technologies as well as regulating pharmacists’ and pharmaceutical technologists’ training and practice.

As the country moves to establish a separate authority for the regulation of health products and technologies, we must establish in tandem a Pharmacy Practice Council with pharmacists as a majority sitting in all levels of its governance structure.

A professional regulatory council is not a management board. Due to its mandate, a Pharmacy Practice Council takes an active approach to regulation. It is directly tasked with determining, prescribing, and revising the course requirements for Pharmacy, developing guidelines, making recommendations for pharmacy advancement.

It is also tasked with visiting and inspecting schools of pharmacy as well as pharmacy outlets, investigating violations of set professional standards, adjudicating cases against erring professionals and suspending, revoking, issuing and reissuing registration certificates and practice licenses.

This wide spectrum of hands-on activities necessitates that a regulatory council holds more members than a typical management Board.

The Pharmacy Practice Council in Kenya shall have the mandate of ensuring the highest quality of pharmacy care and the appropriate use of medicines and health products through education, communication, licensing, legislation, regulation and enforcement for the safety and interest of the public.

Dr Daniella Munene MPSK is a registered pharmacist, the CEO of Pharmaceutical Society of Kenya and Director at Kenya Healthcare Federation