New database to help track quality of medicines in global markets

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.

As more poor-quality medicines—both substandard and counterfeit—make their way into pharmacies and other outlets in developing countries, there is a higher risk to the health of people exposed to those medicines. Poor-quality medicines may bring little or no relief to patients, and may contribute to resistance to treatments for which there are no foreseeable alternatives in the near future. Additionally, patients may begin to lose confidence in the public health system, making them reluctant to seek proper medical help when most needed.

"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."

More information: To access the Medicines Quality Database online, go to: http://www.usp.org … ityDatabase/

Provided by US Pharmacopeia