E-DRUG: Database on quality testing of medicines
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The WHO Bulletin reports on the 'The Medicines Quality Database: a free
public resource' in its latest issue.
http://www.who.int/bulletin/volumes/92/1/13-130526.pdf
http://www.usp.org/around-world/pqm-uspusaid/medicines-quality-database-mqdb
This database has been compiled from the quality testing initiated by
the Promoting the Quality of Medicines program supported by USAID and
implemented by USP in a number of countries. It provided data from 12
countries (Cambodia, Colombia, Ecuador, Ghana, Guyana, Kenya, the Lao
People's Democratic Republic, Mozambique, Peru, the Philippines,
Thailand and Viet Nam) that participate in the program using
standardised sampling methodology and can generate reports of the
medicines tested and whether they passed or failed.
Reports can be generated as to which medicines were tested, the sector
(public, private, informal) they were drawn from.
The database is welcomed as part of moves to increase transparency in
the quality testing of medicines - many regulatory authorities do
testing but don't publish their results or otherwise make them available
to the public; we and the public therefore keep hearing rumours of poor
quality medicines whereas there may be data to support the fact that
most medicines are of good quality.
However, it is limited in that it only includes testing from the PQM
program and countries, there is no synthesis of the data (one can export
the data to Excel and make one's own graph and tables) and they report
of whether medicines are counterfeit or not using each countries own
legal definition (legal definitions that are known not to match
scientific/technical definitions - often include substandard medicines -
and that can vary considerably. One should be careful about
using/interpreting the counterfeits reported and rather use the
Pass/Fail classification unless one is aware of the relevant country
definition of 'counterfeit' - information that is not available from the
database or website.
As an extra note, the Global Fund has been requiring recipient countries
to implement quality testing of pharmaceutical procured under their
grants but to date no data on the results of this testing have been made
available. Test results and certificates of analysis are available for
those products that the GF arranges preshipment QC testing for
(http://www.theglobalfund.org/en/procurement/quality/pharmaceutical/#PreShipmentQC).
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Douglas Ball
Pharmaceutical consultant
Public Health and Development
E-mail: douglasball[AT]yahoo.co.uk