Kenya's government is scrambling to remove thousands of batches of counterfeit antiretrovirals (ARVs) from circulation after patients and health workers reported irregularities in the appearance and texture of a widely used drug.
In September, nurses working with the medical NGO, Médecins Sans Frontières - which runs HIV and tuberculosis clinics in the capital, Nairobi, and western Kenya - reported irregularities in the appearance of the antiretroviral Zidolam-N, a combination treatment containing the ARVs zidovudine, lamivudine and nevirapine.
The ARVs were found to be falsified versions of a World Health Organization (WHO)-certified generic drug purchased through a distributor endorsed by the Kenya Pharmacy and Poisons Board (KPPB), the country's drug regulatory authority.
According to the KPPB, one batch of the fake Zidolam-N, with the number E100766, is marked as manufactured in 2009 and set to expire in May 2013, while a second carries the batch number A9366 with manufacture and expiry dates of June 2009 and May 2012 respectively. The main irregularities included discolouration, mould and crumbliness; the packaging is also of varying quality and the text differs in font and colour from the genuine drug.
Certified, generic versions of Zidolam-N distributed in Kenya are manufactured by Hetero Drugs Limited, based in India. WHO's investigations found that Hetero's batch number E100766 had been manufactured and controlled according to WHO-recommended specifications and was of acceptable quality and had not been supplied to Kenya.
"We have asked all patients with the said drugs to return them to clinics so we can ascertain if they are the fake ones and supply the patients with fresh drugs," said Jacinta Wasike, director of surveillance and inspection at the KPPB.
The KPPB estimates that 16,340 batches of the counterfeit drug have been released, 15,000 of which have now been returned.
"We are tracking down some of the patients who may have received them but haven't returned them," Wasike said. "The samples of the drugs which were recalled have already been sent to laboratories... Once the results are known, we will be able to know any side-effects they might have on the patients and what remedies to take to minimize these side-effects, if any."
WHO describes a counterfeit drug as one that is deliberately and fraudulently mis-labelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products.
|It is very scary, especially with a disease whose treatment calls for strict adherence to a regimen|
Representatives of people living with HIV in Kenya have castigated the KPPD for allowing the counterfeit drugs to filter into the supply chain and jeopardizing their treatment.
"It is very scary, especially with a disease whose treatment calls for strict adherence to a regimen," said Nelson Otuoma, coordinator of the Network of People Living with HIV and AIDS in Kenya (NEPHAK).
Senior officials say the government is investigating how the drugs found their way into the country, and is looking into strengthening surveillance systems.
"Investigations are being carried out by relevant authorities, but as a government we take very seriously issues of treatment of HIV and AIDS. Loopholes at times do exist but when we learn our lessons, we work to seal them," said Anyang Nyong'o, Minister for Medical Services.
NEPHAK's Otuoma accused the government's drug procurement system of being riddled with corruption, and said unless this issue was addressed, the risk of fake drugs penetrating the market would remain.
Health experts say it is crucial for the government to urgently address the situation in order to allay patients' fears and retain the confidence of HIV-positive people in the government's ability to provide them with effective care.
"News of fake drugs might affect treatment, not just in the possible side-effects but in the sense that patients might shy way from taking drugs because they don't know who or what to trust," said Alan Mabeya, a doctor at Kenyatta National Hospital, the country's largest referral facility.