Technical Reports

Operational Guide

Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide  (2MB)—can help guide developing nations through the steps needed to improve all aspects of drug quality and assurance controls. The Operational Guide was developed in a collaborative effort with experts in drug quality from the World Health Organization, Management Sciences for Health, PATH, and Organon, as well as government health officials from Malaysia, Vietnam, Uganda, and Zimbabwe. Originally released as a Draft for Field Testing in 2006, the Operational Guide reflects the valuable comments and feedback received during the past two years from over 100 individuals, institutions and organizations to whom it was distributed for use in the field.

Zinc Guidelines

Production of Zinc Tablets and Zinc Oral Solutions:Guidelines for Programme Managers and Pharmaceutical Manufacturers  (668KB)— The World Health Organization (WHO) and UNICEF revised recommendations for the management of diarrhea aimed at reducing the number of deaths due to diarrhea by adding zinc supplementation to traditional rehydration therapy. It required that a product be formulated to contain zinc alone with a taste that children would find acceptable. This report guides policy makers and program managers to procure quality zinc products, and pharmaceutical manufacturers to develop them. These guidelines were developed through collaboration among WHO, UNICEF, USAID and USP DQI.

ANE Review

Review of Drug Quality in Asia with Focus on Anti-Infectives  (1.9MB)—This paper reviews the drug quality in eleven Asian countries, focusing on anti-infective drugs. Increasing resistance to anti-infective drugs is a significant problem for the health sector in Asia that has resulted in increased morbidity and mortality. USP DQI has assembled available data on drug quality (and aspects of health systems dealing with drug quality), identifies gaps in information, and recommends areas for potential intervention at the global, regional, and national levels.

Misoprostol

Misoprostol Poster and Report—The poster  (687KB) provides an overview of information on the evidence-based literature review recommending misoprostol as a promising alternative drug for use in preventing post-partum hemorrhaging. The full report  (605KB) is also available.

Polio

Poliomyelitis, OPV, and Misconceptions on Vaccinations—Created to support the global campaign to eradicate polio, this updated technical document addresses misinformation and superstitions about polio and oral polio vaccine that may inhibit people in various parts of the world from fully immunizing their families. (Available in English  (713KB), French  (767KB), or Russian  (815KB).)

Nepal Case Study

Nepal Case Study  (80KB)—A summary detailing USP's involvement with the Rational Pharmaceutical Management project in Nepal, from how the country was selected to how programs were established.