Removal of antiretroviral products from WHO prequalification

Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS

Practical implications for prescribers and patients

In principle, patients should discontinue using withdrawn medicines and switch to other prequalified products (see Annex 1). However, in many cases it may be difficult to find alternative prequalified products immediately. In this situation it is recommended that patients continue to use withdrawn products, as the risk of interrupting treatment is higher than that of taking medicines whose bioequivalence is not proven but which have otherwise been prequalified.

A switch to non-prequalified products is not recommended as their quality has not been documented by WHO. The patient should be informed that there is no reason to believe continued use of the withdrawn products is dangerous, and that suspending the treatment or switching to alternative ARVs whose quality has not been assured is far riskier.