The NTIS website and supporting ordering systems are undergoing a major upgrade from 8PM on September 25th through approximately October 6. During that time, much of the functionality, including subscription and product ordering, shipping, etc., will not be available. You may call NTIS at 1-800-553-6847 or (703) 605-6000 to place an order but you should expect delayed shipment. Please do NOT include credit card numbers in any email you might send NTIS.
Documents in the NTIS Technical Reports collection are the results of federally funded research. They are directly submitted to or collected by NTIS from Federal agencies for permanent accessibility to industry, academia and the public.  Before purchasing from NTIS, you may want to check for free access from (1) the issuing organization's website; (2) the U.S. Government Printing Office's Federal Digital System website http://www.gpo.gov/fdsys; (3) the federal government Internet portal USA.gov; or (4) a web search conducted using a commercial search engine such as http://www.google.com.
Accession Number PB2012-114038
Title Ensuring Drug Quality in Global Health Programs.
Publication Date Aug 2012
Media Count 29p
Personal Author N/A
Abstract 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.
Keywords Drugs
Global
Grants
Health care programs
Implementation
Laboratory tests
Procedures
Public health
Quality assurance
Regulations

 
Source Agency General Accounting Office
NTIS Subject Category 57Q - Pharmacology & Pharmacological Chemistry
57U - Public Health & Industrial Medicine
44D - Health Care Assessment & Quality Assurance
Corporate Author Government Accountability Office, Washington, DC.
Document Type Technical report
Title Note N/A
NTIS Issue Number 1226
Contract Number N/A

Science and Technology Highlights

See a sampling of the latest scientific, technical and engineering information from NTIS in the NTIS Technical Reports Newsletter

Acrobat Reader Mobile    Acrobat Reader