Tracking Substandard Medicines; USP, FDA to Evaluate OTC Drugs

In the growing global battle against substandard and counterfeit medicines, the Promoting the Quality of Medicines (PQM) program has launched a new public database of medicines collected and analyzed in collaboration with stakeholders from countries in Africa, South America and Southeast Asia. Free of charge and available to anyone with access to the internet, the Medicines Quality Database (MQDB) includes information on the quality of medicines collected from a variety of sources. To date, more than 8,700 records of tested samples collected from Ghana, Laos, Vietnam, Cambodia, the Philippines, Thailand, Peru, Guyana and Colombia have been entered into the database.

Supported by USAID and implemented by the U.S. Pharmacopeial Convention (USP), PQM provides technical assistance to help strengthen quality assurance of medicines in developing countries primarily in Sub-Saharan Africa, Southeast Asia, Latin America, and the Caribbean, as well as Russia. PQM has a special emphasis on verifying and improving the availability of quality medications intended to treat life-threatening diseases such as malaria, HIV/AIDS and tuberculosis. The MQDB will assist in-country health authorities and the general public through evidence-based data on poor-quality medicines circulating in several regions of the world.

Data on the collected and tested samples recorded in the new database include:

• Geographic location: country and province/state in which a medicine sample was found
• Date of sampling (by year)
• Facility from which sample was collected: organized by sector (i.e., public, private or informal) and type (e.g., pharmacy, hospital, clinic)
• Medicine information: product name, manufacturer name, therapeutic indication, active pharmaceutical ingredient, dosage form, batch/lot number
• Test result (i.e., “passed” or “failed” with regard to authenticity)
• Substandard/counterfeit status (i.e., “yes” or “no”, depending on a country’s classification for substandard or counterfeit medicines).

According to Patrick Lukulay, Ph.D., USP’s director of the PQM program: “Pharmaceutical markets operate globally, and sharing information on the quality of medicines among and within countries is crucial to patients, regulatory authorities, pharmacies, and manufacturers as well as agencies and organizations involved in international procurement and distribution of medicines. Having a publicly-available database that provides quick and easy access to information on medicines tested for their authenticity is a vital tool in helping to protect the public against the threat of substandard and counterfeit drugs.”

Information in the MQDB is collected from health authorities responsible for testing the quality of medicine samples in a given country. Data on tested samples are included in the MQDB only after verification for accuracy. As a central repository for information sourced from different parts of the world, the database will provide health authorities with an additional tool for surveillance of the quality of locally-acquired as well as imported medicines delivered through a global supply chain.

 “While multiple lines of intervention are critical for eliminating diseases like malaria, wide dissemination of information about poor quality medicines and their sources is vital in addressing the threats posed by the development of drug resistance to progress in disease control,” said Dr. Jaime Chang, M.D., project management specialist from the Health Office of USAID-Peru and coordinator of the Amazon Malaria Initiative (AMI), supported by USAID. “The new database has broader applicability than malaria, of course, including invaluable data on tuberculosis and HIV/AIDS medications as well. However, in AMI’s expanding efforts to contain and eventually eliminate malaria, an easily-accessible and reliable surveillance database like MQDB will be a great support in accomplishing our goals. I’m certain that those combating all three diseases around the world will find this database equally useful.”

To access the Medicines Quality Database online, click here.

Last month, USP also announced an effort that, with FDA and the Consumer Healthcare Products Association (CHPA), would aim to update quality standards for widely used medicines and ingredients. It had begun to plan for this several years ago, to assess written standards for over-the-counter drugs published in the National Formulary. The effort will focus on an initial list of priority medicines and ingredients identified by FDA.

Last year, FDA Commissioner Margaret Hamburg, M.D., cited this effort as one of the most pressing tasks facing both USP and FDA given documented incidents of poor-quality prescription and OTC products. “FDA and USP have a long-standing partnership in law that helps ensure the quality of the American drug supply,” said Roger L. Williams, M.D., USP’s chief executive officer. “In the current effort, we are pleased to be joined by CHPA as well, as this initiative would not be possible without the active participation of industry. FDA has identified a number of medications and ingredients commonly used in prescription and OTC products that may be vulnerable to economically motivated adulteration or are associated with other concerns, which has helped focus our efforts. USP is working to make sure the quality standards for these products are based on the best current analytical procedures and allied reference materials to resolve such concerns. American patients, consumers and practitioners have a right to expect this.”

In addition to the first list of products and ingredients for USP’s priority attention, FDA will continue to recommend candidate standards for updating. An example of an FDA recommendation is a test for impurities and degradants in products containing acetaminophen—one of the highest-volume OTC drugs and one that is also used in many prescription medications. Other commonly used ingredients to be updated include dextromethorphan (a cough suppressant) and diphenhydramine (an antihistamine).

FDA’s priority list and background information on the standards modernization initiative may be found at www.usp.org/hottopics/monographs.html. Also on this Web page, USP has issued a call for volunteer experts for the Acetaminophen Monograph Expert Panel, which will provide recommendations for revisions to the Expert Committee.