Ensuring Drug Quality in Global Health Programs.

摘要

U.S.-funded global health programs have put regulatory and policy requirements in place to help prevent procurement of substandard drugs. USAID, for example, reviews quality assurance information for all drugs before they are procured. Specifically, USAID requires implementing partners to obtain written approval from the agency before purchasing drugs. Through its approval process, USAID determines whether there is sufficient information available to assure that the drug is of acceptable quality. Although USAID's review process varies for some drugs, the type of information USAID reviews generally includes prior FDA approval of the drug or approval by a comparable stringent regulatory authority, as well as results of prior testing of the drug by an independent laboratory. As an additional quality assurance measure, USAID prequalifies selected wholesalers to procure drugs for U.S.-funded global health programs based on factors such as site visits to the wholesalers facility and a review of the wholesalers quality assurance practices and procedures. According to CDC officials, CDC requires its implementing partners to follow program-specific quality assurance requirements. For example, CDC's implementing partners must follow the same requirements as the USAID/PMI program when procuring malaria drugs and as the PEPFAR program when procuring antiretroviral drugs. The Global Fund requires grant recipients to procure antiretroviral, tuberculosis, and malaria drugs that are prequalified by the World Health Organization or authorized by a stringent regulatory authority. When there is only one drug available or no drug meeting these requirements, grant recipients may procure drugs recommended for use by an independent expert review panel convened by the Global Fund.