Poor-quality medicines pose major global public health risks. To reduce their availability in the marketplace, USP–through the Promoting the Quality of Medicines (PQM) Program–helps to develop sustainable Medicines Quality Monitoring (MQM) programs in collaboration with countries in Africa, Asia, Eastern Europe, Latin America, and the Caribbean.
USP’s Medicines Quality Database currently contains the results of MQM activities established through PQM collaborations, and the information included is approved for dissemination by the authorities of participating countries. The Poor-Quality Medicines Alert contains information from multiple sources, either reported to or identified by PQM within the last year.
Reports from MQDB may be cited and/or reproduced by properly acknowledging their source. USP and PQM accept no responsibility or legal liability for the use and/or accuracy of the cited or reproduced data or for decisions made based on this data.
Medicines in MQDB are relevant to national health programs in USAID priority countries. Many are used to treat endemic diseases such as malaria, HIV/AIDS, and tuberculosis. The most common medicines used to treat these and other diseases are listed in the WHO Model List of Essential Medicines.
- Collection sites (World region; Country; Province)
- Sampling Date
- Type of sampling facility
- Medicine information (Product name, Name of the Manufacturer, Therapeutic indications, Active Pharmaceutical Ingredient, Dosage form; Batch or Lot number)
- Types of tests performed
- Test results, including identification of counterfeits
For poor-quality medicines, information regarding actions taken by a country's authorities may also be provided.
Medicines are collected in the public, private, and informal sectors in urban and rural areas.
- Public Sector: Institutions under the direct control of the Ministry of Health, other governmental institutions, or faith-based organizations.
- Private Sector: Establishments licensed to dispense and/or commercialize medicines independent of government programs.
- Informal Sector: Unregulated establishments and vendors operating without a license to sell medicines.
- Medicines included in MQDB underwent testing according to country's protocol.
- The majority of the medicines in MQDB are screened initially in the field by PQM-trained personnel following standardized procedures. Medicines undergo physical and visual inspection initially and subsequently analytical tests, currently consisting of disintegration and thin layer chromatography. Failing and a subset of passing samples are subjected to the same screening analytical tests under more controlled conditions or using more sophisticated equipment (verification testing) and/or to analysis according to compendial methods or another validated methodology recognized by the country's regulations (confirmatory testing). Verification and confirmatory testing are usually performed in the country's Official Medicine Control Laboratory or other designated laboratory.
- Screening tests only assess some medicine’s quality attributes—thin layer chromatography provides information on identity, content, and, in certain cases, impurities; disintegration tests whether a solid dosage form disintegrates completely in a preset period of time. Thus, screening testing assesses only a limited number of quality attributes, while confirmatory tests can assess all the quality attributes required by a country’s regulations.
- In some countries, sampled medicines directly undergo compendial or other validated methodology testing in their Official Medicine Control Laboratory or other designated laboratory.
- A medicine passes or fails quality testing when it does or does not conform to the standards set for the specific methodology utilized for screening and confirmatory testing.
- For samples submitted to both screening and confirmatory testing, the results in the Results Page are those of compendial testing.
MQDB can generate Quick Reports and Customized Reports.
- For Quick Reports users can request data for only one country and one year, and will include all medicines sampled in the country, Default results include the Province where the medicines were sampled, Medicine/Brand Names, Test Results and type of tests, and whether the medicine was a Counterfeit or not.
- For Customized Reports, users can select multiple regions, countries and years, multiple therapeutic indications, medicines, dosage forms, facilities' types (pharmacy, health clinic, hospital, etc.) and sectors (public, private, and informal), and other criteria.
- Both Quick and Customized Reports can be printed or exported into Microsoft Excel?
Watch the video demonstration. Step-by-step instructions and information will guide users through the process.