AFM update on recent drug quality studies

16 Aug 2012
Africa Fighting Malaria Last month, AFM published two studies in the peer-reviewed journal Research and Reports in Tropical Medicine on the quality of WHO-approved drugs, which were purchased through donor-funded programs. The studies, available here and here, revealed that some WHO-approved drugs failed basic quality testing.

In keeping with AFM's policy of transparency, it has come to our attention that the U.S. Pharmacopeial Convention has tested some drugs with the same batch numbers as those that failed our testing and reports that their drugs passed; a failure in our study was defined as having less than 75% of the stated amount of API. To be clear, USP did not test pills from the same treatment packs that we tested, but rather tested drugs with the same batch numbers as some of those that failed our testing. (The WHO is testing a few of the remaining pills from failing treatment packs in our study). It is possible that there may be some variability in the quality of drugs with the same batch number or it is possible that our treatment packs contained degraded pills.
Regardless the reason, this is encouraging news for patients taking drugs with these same batch numbers.

Further, an article was recently published in The Namibian regarding our study results. AFM does NOT recommend that WHO-approved drugs be withdrawn from the market. While our studies did find that some WHO-approved drugs failed quality testing, we also found that these drugs failed roughly five-times less often than those not approved by the WHO. The results of our studies stress the need for improved post-market surveillance of drugs by donor agencies and national drug regulatory authorities to ensure the availability of good quality drugs in endemic countries and to identify any quality problems.