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Self-regulation of pharmacists in Kenya - Pharmaceutical Society of Kenya (PSK)


Pharmacy practice is regulated under the Pharmacy and Poisons Act, 1957 (Rev, 1989 and 2012) (Cap 244). The purpose of the Pharmacy and Poisons Act is to make better provision for the control of the profession of pharmacy and the trade in drugs and poisons through the Pharmacy and Poisons Board (PPB).

In 2014, PSK lobbied for the enactment of the proposed Pharmacy Practitioners Bill 2014 which was expected to repeal Cap 244. The Bill provided for the training, registration and licensing of pharmacists (graduates) and pharmaceutical technicians (Diploma and Certificate holders). It also proposed to establish a more empowered and better functioning Pharmacy Practice Council, which would regulate pharmacy practice and professional conduct for both levels of professionals.  However, the process to lobby for the enactment of the Pharmacy Practitioners Bill came to a stop with the development of a Health Act.

The Health Act (HA) was enacted in 2017 after extensive engagements between private sector and government. The HA proposes the separation of pharmacy practice, and health products. To effect the proposed change, the Ministry of Health (MoH) has drafted a Kenya Food and Drug Authority Bill which is expected to revise the mandate of the Pharmacy and Poisons Board as it relates to health products. The MoH has requested the PPB together with PSK to develop a draft Bill to regulate pharmacy practice.

PSK has expressed concerns about the regulation of pharmacy practice by the government citing the following key issues:

  • There are currently 15,000 retail pharmacies in the country, PPB has only licensed 5000.
  • There are 3,500 pharmacists in the country with only 200 working in retail, leaving 9,000 Pharmacy Technicians to run retail pharmacies.
  • Non-verification of source of medicines – buying from unauthorized distributors and briefcase traders
  • Dispensing of prescription drugs without a valid prescription leading to:
  • Poor storage of medicines in a manner that exposes them to harsh environmental conditions that cause their degradation and subsequent toxicity and lack of efficacy in patients– such as non-cold chain storage of cold chain products
  • Lack of keeping records of prescriptions and medicines dispensed as prescribed in the Pharmacy and Poisons Act
  • Lack of prescription audit to save patient from prescribing errors made by the prescriber
  • Prevalence of errant professionals operating pharmacies who play the role of doctor, nurse or pharmacist without concern for patient safety. The most alarming outcome of malpractice is drug related morbidity and mortality.
  • Lack of public disclosure of registered pharmacies by the PPB
  • Lack of consistent disciplinary measures by PPB
  • Outdated drug schedules (Part I and II) that don’t reflect modern drugs leaving a vacuum as to who can handle drugs not contained in the schedules.

PSK posit that self-regulation of pharmacy practice will address these key constraints and lead to; disciplinary mechanisms for errant professionals; weeding out of quacks; standardised management of pharmacies across the country and a more informed public through public disclosure of registered pharmacies.

Following the codeine-containing cough syrups debacle, PSK and PPB have been tasked by the Cabinet Secretary of Health to reign in errant pharmacy practitioners. PSK now seeks to utilise this policy window to conduct research to determine the extent of malpractice in the country. PSK intend to use the research findings to justify self-regulation of the practice in line with international best practice. 

 

 


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