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Drug Quality Bill Brieger | 10 Feb 2010 09:18 am

Substandard malaria drugs – whose responsibility?

While research for new malaria drugs continues, supplies of existing drugs are threatened by poor quality, parasite resistance and counterfeiting.

With USAID support, US Pharmacopeia (USP) has been studying malaria drug supplies in 10 Sub0Saharan Africa countries, and has recently issued a press release on its findings in three locations. USP found that, “a high percentage of medicines circulating on national markets are of substandard quality and thus may contribute to the growth of drug-resistant strains of Plasmodium falciparum, the most virulent form of malaria.”

proportion-of-substandard-malaria-drugs-tested-by-usp.jpgReports on the first three countries, Madagascar, Senegal and Uganda, looked at the recommended first line case management drugs, artemisinin-based combination therapy (ACT), and sulfadoxine-pyrimethamine (SP), which is used to prevent malaria in pregnancy. Between 26% and 44% of the drugs that were tested were sub-standard, that is they …

  • do not contain the correct amount of the active ingredient(s)
  • do not dissolve properly in the body or
  • include unacceptable levels of potentially harmful impurities.

While USP called on local drug regulatory authorities to step up to the challenge of testing and enforcement, but also recognized that the problem traces back to the manufacturer. “The results also showed that, as a general rule, when a brand passed or failed in one country, it would also pass or fail in other countries. This indicates that the problem of quality is created at the source, rather than during passage through the distribution chain.”

Other countries included in USP the study are Cameroon, Ethiopia, Ghana, Kenya, Malawi, Nigeria and Tanzania. In a smaller scale study two years ago, Roger Bate and colleagues reported similar poor quality in 35% of malaria drugs sampled in 6 countries, five of which overlap with the USP work.

Last July VOA reported that fake pharmaceuticals are a bigger threat to West Africa than drug trafficking. At that time “The UN estimate(d) that more than half of anti-malaria medication available in West Africa is of sub-standard quality.”  A seminal study on drug quality in Nigeria in The Lancet supports the USP’s conclusions that the problem often lies at the source – “the main reason for such products not complying with pharmacopoeial limits is poor quality control and quality assurance during manufacture.”

We hope that the malaria medicines used by national control programs and purchased with WHO’s pre-qualification recommendations in mind, are safe, but the private market for antimalarials is wide. It may be unreasonable to expect that each country’s drug regulatory authority take full responsibility for guaranteeing drug quality when we could go to the source – the manufacturers, or at least the importers – and prevent the problem from even entering endemic countries.

Is the international community living up to its responsibilities to protect the quality of malaria drugs and thus save lives?

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