Removal of antiretroviral products from WHO prequalification
Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS
Practical implications for programme managers
In countries where bioequivalence data are not required by the national drug regulatory authority there is no legal need to withdraw the products; and even in countries where these data are required, the authorities may (temporarily) decide not to withdraw them (see above). In all cases, a careful balance must be sought between the risks associated with the lack of proof of bioequivalence in these products and the individual and public health risk of interrupting treatment should no alternative medicines be found.
In general, switching to similar antiretrovirals (ARVs) from alternative, prequalified suppliers would be the most appropriate response, if and when such products are available (see Annex 1 below) However, switching to non-prequalified ARVs is not advised since not only has their bioequivalence not been confirmed, but, in addition, other quality aspects have not been verified by WHO.
- Consult with the national drug regulatory authority to establish the best course of action.
- Prepare and implement a communication strategy addressed to prescribers and patients.
- Take the necessary measures to switch to alternative prequalified products (listed in Annex 1 below). In this regard, the following actions are recommended in specific situations:
- The procurement of the withdrawn drugs is considered, but they have not yet been ordered. Withdrawn products should not be ordered. Instead, other prequalified products should be ordered until the withdrawn medicines are reinstated on WHO’s list of prequalified products.
- Withdrawn drugs have been ordered to continue or scale up treatment programmes. Withdrawn drugs that have been ordered, but not received, should not be accepted. In this case, alternative prequalified products should be ordered instead. However, if alternative suppliers are not immediately available and the non-acceptance of the ordered products could lead to an inability to continue or to start treating patients, the risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have, otherwise, been prequalified. In this case it would be justified to accept and use the withdrawn products. For follow-up orders, only prequalified products should be used.