Nairobi, 1 October 2011 – On 5 and 7 September, Médecins Sans Frontières (MSF) missions in Kenya detected quality problems with one antiretroviral medicine (ARV) named Zidolam-N used to treat people with HIV. MSF nurses reported irregularities on the appearance of the product such as friability and discoloration of the tablets.
Last week, these ARVs were confirmed to be falsified versions of World Health Organization (WHO) quality-assured (‘prequalified’) drugs that were purchased via a distributor certified by the Kenya Pharmacy and Poisons Board. These antiretrovirals contain lamivudine (150mg), zidovudine (300mg), and nevirapine (200mg).
“MSF takes this supply lapse seriously and is focused on ensuring that patients are informed and receive appropriate medical follow-up,” says Dr. Alexandra Vandenbulcke, MSF medical coordinator in Kenya.
As soon as the quality alerts were reported by the MSF nurses, MSF informed the Kenyan Ministry of Health, WHO and other international partners involved in procurement of medicines. MSF put the drugs under quarantine and the falsified batches were sent back to the supplier.
MSF has started to trace and notify patients who have received the falsified products, and has secured adequate replacement drugs for affected patients. MSF will offer adapted medical follow-up to these patients and optimise treatment options when necessary.
MSF places great importance on the quality of the drugs used in its projects, using WHO-prequalified ARVs. MSF is demanding a full investigation into the circumstances of this supply lapse to ensure the best quality of medicines for patients.