Comment on: Surveillance of the overall use of antimicrobial drugs in humans over a 5 year period (1997–2001) in Kenya

Abstract

Sir, The baseline 5 year data on antimicrobial drug usage in Kenya as procured from the Kenyan national licensing authority for all drugs is interesting. The quantities of antimicrobial agents available for bacteria, including mycobacteria, were procured from the Pharmacy and Poisons Control Board responsible for approval of the import licenses. The cooperation of the manufacturers in obtaining this data is commendable. Certainly, this could address any irrational and indiscriminate usage of antimicrobials in Kenya. However, no information was supplied about antimicrobial storage practices at manufacturers’ warehouses. The results could be depressing. The quality of 33 formulations of antimicrobial and antimalarial drugs (namely amoxicillin capsules, metronidazole tablets, sulfamethoxazole/32#trimethoprim tablets, quinine tablets and sulfadoxine/pyrimethamine tablets) marketed in Rwanda and Tanzania was assessed, and the influence of tropical storage conditions on potency and in vitro dissolution addressed. In both countries, essential drug formulations met pharmacopoeial potency requirements, but some had poor in vitro drug release profiles. Some of the formulations tested were not stable upon storage under simulated tropical conditions. In Nigeria, five samples of ampicillin capsules with a label claim of 250 mg were purchased from different dispensing points in a small town. The pharmaceutical quality of the products and a sample from a batch produced by a local manufacturer was evaluated, and five of the capsule samples were examined in an in vivo bioavailability study. Three of the five capsule samples from dispensing points were found to be of lower quality than the officially prescribed standard of pharmaceutical quality. Unfortunately, these substandard capsules were being dispensed from authorized and unauthorized sources. Recently, a serious threat to public health was identified. The prevalence of counterfeit antimalarial drugs in Southeast Asian pharmacies and shops selling antimalarial drugs in Myanmar (Burma), Lao PDR, Vietnam, Cambodia and Thailand was found to be widespread. Of the 188 tablet packs labelled as artesunate, 53% did not contain any artesunate. Of the 44 mefloquine samples, 9% contained ,10% of the expected amount of active ingredient. Efforts to procure fundamental data regarding the consumption of antimicrobials consumed in developing countries should therefore take into account evidence of potency and appropriate storage conditions. Funding sources should also be identified to facilitate this process from a worldwide perspective.