Regulator seeks changes in labelling of imported drugs

Post-market surveillance is an important tool in monitoring the quality of health products. [iStockphoto]

Drug manufacturers importing to Kenya will be required to attach patient information to individual medicine packs as opposed to primary packaging, according to a new report. 

The Pharmacy and Poisons Board (PPB) also seeks to clear all donated medicine before it is distributed to medical facilities.

This includes donations made through the Kenya Medical Supplies Authority(Kemsa). 

According to PPB, the move is to ensure the safety and efficacy of all medicine used in the country. 

The report on post-marketing quality surveillance of selected health products and technologies used in public health programmes in Kenya targets therapies used to treat HIV/AIDS, Tuberculosis (TB) and malaria.

The report recommends a review of the technical specifications of drugs, which should rope in manufacturers. 

"The primary health programs (PHP) should review their technical specifications to require all manufacturers to enclose patient information leaflets into the individual package as opposed to sticking them on the primary packaging," the report says. 

Traditionally, a patient information leaflet (PIL) is usually attached to the main packaging of the drug and not the pack itself.

This information includes possible side effects of the medicine, prescription and precautions. 

The report notes that post-market surveillance is an important tool in monitoring the quality of health products and technologies, post-authorisation.

''Poor quality HPTs pose a major risk to public health and safety. This can be as a result of therapeutic failure, which affects treatment outcomes and, in turn, leads to increased morbidity and mortality," reads the report published earlier this month.  

Samples were collected from 109 facilities across 26 counties. The counties are considered relatively risky when it comes to medical products. They are Bungoma, Nairobi, Samburu, Siaya, Homabay, Kajiado and Kakamega. 

The report found that five products out of the 334 from the primary sample were unregistered. They were CloserinE 250mg, Lumartem DT (Artemether/Lumefantrine dispersible tablets) and three products of clofazimine capsules.