Falsified antimalarials: a minireview

Abstract

Malaria is a curable disease, provided timely access to efficacious drugs is sought. Poor quality and, in particular, falsified antimalarial drugs harm the population of malaria endemic areas; they put lives in peril, cause economic losses to patients, families, industry, and generally undermine the trust in health systems. The extent of the problem is not easily assessed, and although a prevalence of up to 35% of poor-quality antimalarials has been reported, this number should be interpreted with caution given the heterogeneity of methods used to measure it. The trade in falsified antimalarials can be curtailed by putting in place drug quality surveillance, better legislation and improving the access and affordability of these essential drugs.

Keywords:

• antimalarials
• artemisinin
• artesunate
• counterfeit drugs
• falsified drugs
• malaria
• poor-quality drugs
• substandard drugs

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The WHO defines counterfeit medicine as ‘one which is deliberately and fraudulently mislabeled with respect to identity and/or source’. There is a fundamental difference with substandard and degraded drugs. Conflicts of interests challenge the consensus on a universal definition of falsified (counterfeit) drugs.

• Information on the quality of antimalarial drugs for the majority of malaria endemic countries is scarce.

• Sample collection using specific methods needs to be the key component in accessing and reporting the prevalence of drug quality.

• Investment in drug testing facilities at country level needs to be determined for endemic countries.

• Inducing resistance by exposing the parasite to subtherapeutic levels of the drug is a true risk associated with substandard antimalarials.

• Lack of definitive regulations precludes appropriate law enforcement and conviction of the criminals involved in this trade.

Notes

API: Active pharmaceutical ingredient; NMRA: National medicines regulatory authority; OOS: Out-of-specification; SFFC: Spurious/falsely labeled/falsified/counterfeit.