Fwd: KENYA: Government grapples with counterfeit ARVs
Elisabeth Janaina
NAIROBI, 19 October 2011 (PLUSNEWS) - 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 [ http://www.msfaccess.org/about-us/media-room/press-releases/falsified-medicines-enter-supply-chain-kenya
] - 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) [
http://www.pharmacyboardkenya.org ], 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 [
http://www.who.int/prequal/info_press/documents/Falsified_ZidolamN_23September2011.pdf
] 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 [ http://www.who.int/mediacentre/factsheets/fs275/en ] 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.
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 [
http://www.plusnews.org/report.aspx?reportid=83599 ], 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.
ko/kr/mw
[END]
This report online: http://www.plusnews.org/report.aspx?reportID=94012
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