Counterfeit Antiretroviral Drugs

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Counterfeit Antiretroviral Drugs

Question

I run an International Monetary Fund (IMF)-supported directly observed therapy

program in Nigeria using a Qday AZT+3TC+nevirapine regimen obtained in Lagos

from a Western pharmaceutical vendor. We recently experienced virologic failure

that was picked up during random viral load checks. The nevirapine was

found to be counterfeit and devoid of any active nonnucleoside reverse

transcriptase inhibitor (NNRTI). Because conducting laboratory quality assurance

of antiretroviral bioactivity is expensive, do you know of other methods aside

from pill inspection to ensure that we are getting bioactive drugs?

Response from Nkengasong, MD

Chief, HIV International Diagnostic Laboratory,

Lilburn, Georgia

In 2001, the Nigerian government initiated a program to provide antiretroviral

therapy to 10,000 adults and 5000 children at 25 pilot sites. Under the Nigerian

program, generic drugs would be purchased from 2 Indian pharmaceutical firms,

Cipla and Ranbaxy, at an annual cost of about $3.6 million. Three drugs --

lamivudine, nevirapine, and stavudine -- are being provided under the program.

Because the Indian-supplied drugs were not yet registered in Nigeria, the

Nigerian drug regulatory agency monitored the quality of the drugs.

Although it is not clear how the IMF-supported directly observed therapy program

in Nigeria knew that nevirapine was counterfeit and devoid of any active

NNRTI, as antiretroviral drugs become available in Africa the issue of ensuring

that the drugs have the appropriate quality is critical. Carrying out chemical

and bioactivity testing is the only guaranteed way of ensuring that the drugs

have the active ingredients.

However, most countries do not have the capacity to carry out detailed chemical

analysis of biological activity of the imported drugs. Thus, at this time, a

good way to address this issue is by a World Health Organization process: The UN

Pilot Procurement Quality and Sourcing Project, which can be accessed at

http://www.who.int/medicines.

Although not foolproof, using products that have passed the prequalification

process is the best way to ensure the quality of antiretroviral drugs.

shok Rau

E-mail: Ashok Rau <ashokrau@...>