The Pharmacy and Poisons Board (PPB) of Kenya has issued a stern warning to wholesalers supplying medicines to unregistered outlets. This crackdown, spearheaded by the PPB, underscores the regulator’s commitment to safeguarding public health by tightening controls around drug distribution and ensuring compliance with Good Distribution Practices (GDP) across the pharmaceutical sector. Julius Kaluai, the Head of Good Distribution Practices at PPB, recently outlined the measures that target both wholesalers and licensed pharmacies to eliminate unsafe practices that endanger the health and safety of the Kenyan public.
The Nationwide Pharmaceutical Audit Initiative
Beginning on October 13, 2024, with audits focusing on wholesale suppliers, and later expanding to Level 4 hospitals on October 20, PPB’s initiative aims to enforce critical compliance standards, particularly around the distribution and handling of medicines. By implementing stringent inspection protocols, the Board seeks to mitigate health risks associated with unlicensed outlets, improper pharmaceutical handling, and unauthorized personnel within the industry. The initiative places significant scrutiny on the activities of wholesalers, ensuring they adhere to legally mandated protocols and do not distribute pharmaceutical products to unauthorized or unlicensed outlets.
According to Kaluai, the PPB’s efforts are backed by the Judiciary, which has increased fines for offenders, thereby creating a robust deterrent against unregulated practices in the pharmaceutical industry. He highlighted that recent fines have ranged from Ksh. 60,000 to over Ksh. 100,000, with the most severe penalties exceeding Ksh. 300,000 for repeated offenses. “Such heavy fines are a testament to the judiciary’s understanding of the public health risks posed by unlicensed outlets,” Kaluai said, emphasizing that heightened fines underscore the collaboration between PPB and judicial authorities to ensure strict compliance.
Unlicensed Pharmacies and Absentee Superintendents
A crucial aspect of the crackdown involves addressing the issue of absentee superintendents—qualified personnel who leave licensed pharmacies under the care of unqualified or unauthorized individuals. This practice compromises the safe dispensing of pharmaceuticals, putting patients at risk of receiving incorrect or mishandled medications. Kaluai clarified that the Board would hold these superintendents accountable, as their negligence contributes to unsafe practices. “Essentially, you cannot use other people to commit a crime while you are comfortable somewhere,” he asserted, signaling the PPB’s intent to enforce stringent accountability measures on absentee professionals.
Additionally, the Board warned against the sale of medicated creams at cosmetic shops. These regulated products are to be sold exclusively in pharmacies under the supervision of a qualified medical professional, typically a dermatologist with a prescription. Kaluai pointed out that such guidelines are not only critical to maintaining treatment integrity but also play a vital role in mitigating misuse and adverse effects.
Challenges in Mapping Distribution Networks
While PPB’s initiative has received significant support, challenges remain, particularly with unlicensed wholesalers and pharmacy outlets that relocate without notifying the Board. This lack of transparency impedes PPB’s ability to conduct thorough audits and accurately map distribution networks, leaving gaps in the regulatory framework. In response, PPB has called on all registered practitioners to remain compliant with the Board’s distribution and labelling requirements, as stipulated under the Pharmacy and Poisons Act (CAP 244). Practitioners are further required to keep accurate records, which must be available for review by authorized officers at any time.
The PPB has developed and issued guidelines for GDP, covering aspects such as pharmaceutical transportation, waste management, and proper labelling. Adhering to these standards not only ensures compliance but also reinforces the safety and efficacy of medicines available to the public. The Board’s audits are scrutinizing compliance in various critical areas, including the cold-chain management of medicines and adherence to pharmaceutical waste disposal practices, particularly in environments where medication errors and drug misuse could result in serious health risks.
Threats to Healthcare Integrity
The PPB flagged the unauthorized sale of government-supplied medicines as a significant threat to the integrity of healthcare services. Stolen medications, when distributed outside of regulated outlets, are often sold without professional oversight, increasing the risk of improper use and potential health hazards. Such illicit practices compromise the public’s access to safe and reliable healthcare, eroding trust in the pharmaceutical sector and putting patient lives at risk. PPB’s collaborative efforts with the Interior Ministry aim to put an end to this malpractice, ensuring that government-procured medications reach the intended recipients and are used within regulated channels.
To support these efforts, PPB has also implemented a verification system, encouraging the public to use the health safety code “21031,” displayed in registered pharmacies, to confirm the legitimacy of the outlets from which they purchase medicines. This measure empowers consumers to make informed choices and avoid counterfeit or unregulated drugs, which are more likely to be sold in unlicensed establishments.
Addressing Antimicrobial Drug Resistance
In tandem with the distribution audits, PPB recently launched its inaugural plan to monitor the consumption of antimicrobial drugs, including antibiotics and antifungals. This initiative is a direct response to the alarming rise of antimicrobial resistance (AMR), a global health crisis that threatens the effectiveness of life-saving medications. By tracking antimicrobial use, PPB aims to prevent the overuse and misuse of these drugs, thereby curbing the growth of resistant strains. Kaluai underscored the Board’s commitment to this cause, asserting that efforts to monitor and regulate antimicrobial consumption are crucial to preserving the long-term efficacy of available treatments.
The Role of Private Hospitals and Wholesalers
The Board has appealed to private hospitals to employ only licensed pharmacy personnel and ensure that all practices align with both PPB and National Environmental Management Authority (NEMA) guidelines. Wholesalers, too, have been reminded of their responsibility to store medicines under conditions that maintain their efficacy. In addition, the PPB’s distribution audits now cover various compliance factors, including legal certifications, batching processes, client complaint handling, and corrective actions for past infractions.
Another major area of focus in the audits involves narcotic and psychotropic substances. PPB is working to ensure that the distribution of these controlled substances is closely monitored, reducing the risk of diversion and misuse. According to Kaluai, maintaining a high level of vigilance in the distribution and dispensing of such substances is essential for public safety and healthcare integrity.
Public Awareness and Cooperation
Kaluai stressed the importance of public vigilance in combating illegal pharmaceutical practices. By avoiding pharmacies that operate without proper signage, customers can reduce the risk of purchasing unregulated or unsafe medicines. Outlets lacking clear names or accreditation should be approached with caution, as they may not meet PPB standards and could pose serious health risks to consumers.
Additionally, PPB has urged the public to report any suspicious activity related to the sale or distribution of pharmaceuticals. Kaluai emphasized that these reports are invaluable to the Board’s mission of eradicating unlicensed practices and ensuring safe, high-quality healthcare across the country.
Conclusion: Safeguarding Healthcare Standards
PPB’s nationwide audits are part of a sustained commitment to uphold the safety, efficacy, and quality of healthcare in Kenya. By targeting unregistered pharmaceutical outlets, absentee superintendents, and unauthorized wholesalers, PPB’s approach is both preventive and corrective, aiming to establish a strong compliance culture within the industry. The recent enhancements in penalties, combined with increased public awareness and judicial support, mark a significant step forward in regulating the pharmaceutical sector.
As PPB continues to enforce GDP and the proper handling of medicines, it urges all stakeholders practitioners, wholesalers, and the public to collaborate in maintaining healthcare standards. This coordinated effort highlights the shared responsibility of ensuring that medicines are safely distributed, dispensed, and consumed, ultimately preserving public health and reinforcing trust in Kenya’s healthcare system.
