E-DRUG: New Database to Help Track Quality of Medicines in Global Markets
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Dear E-Druggers:
Please find below information on a new database to help track the
quality of medicines.
Francine Pierson
U.S. Pharmacopeia
fp@usp.org
New Database to Help Track Quality of Medicines in Global Markets
Evidence-Based Data to Assist Health Authorities, Manufacturers and
Regulators in Surveillance for Poor-Quality Medicines
Rockville, Md., April 5, 2011
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 8700 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., US'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.'
To access the Medicines Quality Database online, go to:
http://www.usp.org/worldwide/medQualityDatabase/
For parties interested in a free, Web-based tutorial on using the
Medicines Quality Database, contact Theresa Laranang-Mutlu at
trl@usp.org.
"Francine Pierson" <FP@usp.org>