Intended for healthcare professionals

Letters

Adequate quality of HIV drugs must be ensured

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7331.235b (Published 26 January 2002) Cite this as: BMJ 2002;324:235
  1. Subhash C Arya, research physician (subhashji{at}hotmail.com)
  1. Centre for Logistical Research and Innovation, New Delhi 110048, India

    EDITOR—A large global health and AIDS fund would have a lasting impact on morbidity and mortality only if the potency of antiretroviral drugs and the quality of diagnostic tools were adequately monitored in the field.

    With the exception of ritonavir, antiretroviral drugs require constant storage in a controlled temperature not exceeding 25-30°C.1 Inadvertent exposures to extremes of high temperature and humidity can affect drug potency. For example, in Nigeria and Thailand an assessment of the quality of chloroquine, amoxycillin, co-trimoxazole, ampicillin, and cloxacillin—which have similar storage requirements to antiretroviral drugs—found that 35.5% of samples were substandard.2 Six samples of chloroquine contained no active ingredient at all. Substandard and fake drugs are found in Latin America, Africa, and Asia.3 If the quality of antiretroviral drugs was poor this might lead to therapeutic or prophylactic failure and the emergence of resistant strains of HIV.

    Establishing an effective HIV treatment service requires high quality kits and reagents for diagnosing and monitoring HIV/AIDS. The sensitivity and specificity of HIV assays decline if they are inappropriately stored or used after their expiry date. This decline compromises the reliability of blood testing for HIV before blood transfusions.4

    A global strategy to tackle the HIV epidemic must therefore incorporate regular sampling of drugs for HIV infection and diagnostic laboratory reagents from the field to assess drug potency and the sensitivity and specificity of diagnostic reagents. The addition of chemical stabilisers to drugs and reagents may help to maintain their quality: the least stable of the common childhood vaccines, the oral polio vaccine, is stabilised by the addition of pirodavir and deuterium oxide, which allow it to resist even a 10 hour exposure to 42°C.5

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