Drug suppliers put on notice as audit exposes breach of ethics
Pharmacy and Poisons Board Senior Inspector of Drugs, Julius Kaluai (Left), Pharmacy and Poisons Board Coast regional head Dr Agoro Paddy (Right) and officers from the Ministry of Health address a press conference at their Nyali offices in Mombasa after a crackdown on illegally operating pharmacies in the coastal region.
What you need to know:
- The audit also highlighted that many personnel handling medications are not registered pharmacists.
The Pharmacy and Poisons Board has warned pharmaceutical distributors against selling drugs to unlicensed pharmacies. The board directed the distributors to strictly adhere to good distribution practices to ensure the safety of Kenyans after an audit revealed significant malpractice within the supply chain.
The extensive audit focusing on supply chain integrity within both private and public hospitals was conducted over the past four months.
According to Head of Good Distribution Practices Julius Kaluai, several wholesale outlets have been identified as sources of distribution to unlicensed retailers.
Mr Kaluai explained that the audit aimed to assess compliance with distribution regulations and the enforcement of guidelines regarding the transport of pharmaceuticals and disposal of pharmaceutical waste.
The official said although these wholesalers are licensed, they must adhere strictly to good practices to prevent unregistered outlets from accessing medications.
“Some wholesalers have registered their outlets but change their locations without informing the board, making inspection difficult,” he said, adding that this lack of communication contributes to a higher risk of illegal products reaching the public.
Mr Kaluai further explained that the vehicles used for transporting medicines—often matatus and lorries—are mostly unlicensed, failing to meet established transportation guidelines.
The audit also highlighted that many personnel handling medications are not registered pharmacists.
In these cases, qualified pharmacists may pick the medicines but subsequently leave them in the hands of unqualified individuals, raising serious concerns about the safety of the drugs being distributed.
“We have illegal wholesalers, which is a very serious area now under focus. There are retailers licensed to operate but are also engaging in illegal wholesale practices,” Mr Kaluai noted.
The board is preparing at least 20 cases involving public and private hospitals and individual professionals to be presented to the Office of the Director of Public Prosecutions (ODDP) for further action.
The board’s central regional regulatory coordinator James Gathongo emphasised the importance of having qualified personnel in pharmacy departments within hospital settings.
He insisted that patients must receive the correct medication and value for their money.
“Private hospitals should comply with the ministry’s staffing norms, ensuring that there is a qualified person attending to patients at all times,” he said.
Additionally, he urged hospitals to verify their suppliers to confirm that they are regulated before engaging in business with them.
As part of the impending changes, starting in 2025, hospitals will be required to have pharmacy licences overseen by licensed pharmacists.
Dr Gathongo said that this requirement is crucial for maintaining high standards in patient care.
Mr Muiname Kamau, a senior regulatory officer in enforcement and surveillance, reiterated that the guidelines for the transportation of pharmaceuticals mandate compliance from all involved in the distribution chain.
“The rules state that the transportation of pharmaceuticals must be supervised by a registered pharmacist. This applies to everyone in the business, from manufacturers to end-users,” Mr Kamau noted.
The board's moves aims to address the growing concerns about the safety and efficacy of pharmaceuticals available to the public and ensuring compliance with good distribution practices is paramount to preventing the distribution of counterfeit or substandard medications.
