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 25-30oC.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 42oC.5
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References
- 1.Department of Health. British pharmacopoeia: 2001. Vols I, II. London: Stationery Office; 2001. [Google Scholar]
- 2.Shakoor O, Taylor RB, Behrens RH. Assessment of the incidence of substandard drugs in developing countries. Trop Med Int Health. 1997;2:839–845. doi: 10.1046/j.1365-3156.1997.d01-403.x. [DOI] [PubMed] [Google Scholar]
- 3.Po ALW. Too much, too little, or none at all: dealing with substandard and fake drugs. Lancet. 2001;357:1904. doi: 10.1016/s0140-6736(00)05092-3. [DOI] [PubMed] [Google Scholar]
- 4.Consten EC, van der Meer JT, de Wolf F, Heij HA, Henny PC, van Lanschot JJ. Risk of iatrogenic human immunodeficiency virus infection through transfusion of blood tested by inappropriately stored or expired antibody assays in Zambian hospital. Transfusion. 1997;37:930–934. doi: 10.1046/j.1537-2995.1997.37997454020.x. [DOI] [PubMed] [Google Scholar]
- 5.Verheyden B, Andrus K, Rombart B. Capsid and RNA stabilization of the oral poliovaccine. Vaccine. 2001;19:1899–1905. doi: 10.1016/s0264-410x(00)00442-4. [DOI] [PubMed] [Google Scholar]
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