Call repeated for outside investigation On Sept. 5 and 7, HIV/AIDS medical teams working for Médecins Sans Frontières (MSF) in Kenya detected quality problems on two batches of Zidolam-N, a World Health Organization-prequalified antiretroviral drug (ARV). MSF nurses reported unusual characteristics of the pills such as moulding and discolouring. Verifications by the manufacturer of Zidolam-N and MSF later revealed that two further batches were also affected. MSF has followed-up nearly 3,000 of the HIV/AIDS patients who received the drugs ARVs from falsified batches and provided them with replacement ARVs. MSF is working hard to get in contact with the remaining patients who might need to have their drugs switched.
As soon as the quality alerts were reported by the MSF nurses, MSF informed the Kenyan Ministry of Health via the Pharmacy and Poisons Board, WHO and other international partners involved in procurement of medicines. MSF put Zidolam-N under internal quarantine and the falsified batches that had been purchased via a distributor approved by the Kenyan authorities were sent back to the supplier. Subsequently, laboratory tests by Kenya’s National Drug Quality Control Laboratory have indicated that the contents of the bottles comply with the manufacturers’ and with international pharmacopoeial specifications. Nevertheless, the MSF teams started to contact all patients who may have received the suspect ARVs to inform them of the quality problem. Their drugs were immediately replaced with ARVs procured from a different source. These patients were also offered an evaluation to ensure their good health. MSF’s medical teams will continue to monitor these patients’ health closely offering both clinical and biological examinations, such as viral load tests, to check the progress of their treatment generally. To date in MSF’s project in Mathare, 513 out of 561 patients have come to the clinic for intensive counselling, drug substitution and a health evaluation. In Kibera these figures are 983 out of 1,058 and in Homa Bay, 1,451 out of 2,100 patients. MSF places great importance on the quality of the medicines distributed to patients in its projects. While continuing to focus on providing the best possible care and follow-up for its patients, MSF repeats that the authorities should conduct a full investigation into the circumstances of this supply lapse. MSF will continue to work proactively with the authorities and push for them to take appropriate measures to ensure the best quality of medicines in Kenya.