E-DRUG: Substandard and Counterfeit Antimalarial Drugs in Ghana
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Dear E-Druggers:
Please see the below press release from USP.
Francine Pierson
USP
Substandard and Counterfeit Antimalarial Drugs in Ghana Discovered by
Cooperative Program of USP, Ghana Food and Drugs Board
Fake Medications in Use in Public Hospital, Many Other Sites
Rockville, Md., November 8, 2010
Substandard and counterfeit versions
of thirteen key antimalarial medicines were uncovered in multiple
locations across Ghana by the Medicines Quality Monitoring surveillance
program. Set up by the Ghana Food and Drugs Board (FDB) in collaboration
with the U.S. Pharmacopeial Convention (USP) and the U.S. Agency for
International Development (USAID), the program samples antimalarials
across the public and private sectors. It was established in 2008 and is
implemented by USP's Promoting the Quality of Medicines (PQM)
initiative. USP is a scientific nonprofit organization that develops
globally recognized standards for the quality of medicines. Through the
PQM program, USP works in developing countries to help verify and
improve the quality of medications intended to treat life-threatening
neglected diseases such as malaria, HIV/AIDS and tuberculosis.
'Few people fully realize the devastation that distribution of
substandard or counterfeit medications can wreak on vulnerable
populations,' said Stephen Opuni, M.D., chief executive officer of the
FDB. 'In this case some of the drugs discovered contained no active
pharmaceutical ingredient, while others failed to meet required quality
standards. This causes great harm in two ways: the individual patients
taking the drugs get no relief, and drug-resistant strains of malaria
may grow stronger. In addition, people lose confidence in the efficacy
of medicines and may be reluctant to seek medical help when they need
it. I'm very pleased with the outcomes we're seeing from the Medicines
Quality Monitoring program.'
In 2009 the same program uncovered a counterfeit version of Novartis'
Coartem®, another widely used antimalarial. In that case an alert
citizen notified the authorities after suspecting the drug he bought
might be fake. 'Last year's seizure of counterfeit drugs showed the
importance of public education,' said Patrick Lukulay, Ph.D., director
of the PQM program. 'In the current case, rigorous surveillance worked
very well. The fact that the fake and poor quality drugs were so
widespread - found in many areas across Ghana, and in many types of
outlets - underscores the need not only for continuing surveillance but
also for active enforcement of anti-counterfeiting laws.'
The discovery of the counterfeits - tragically, in use at a
government-run hospital and private clinic, and being distributed
through many pharmacies - has resulted in a nationwide recall of all
thirteen drugs, including publicizing the names of the outlets where
they were found. This is intended as a strong deterrent, making
pharmacy and hospital procurement personnel more vigilant about their
suppliers. Manufacturers of some of the recalled medications will be
required to meet with the FDB for required regulatory sanctions. Noted
Dr. Lukulay,' 'It's important to keep in mind that all these fake and
substandard medicines were found just in one round of post-market
surveillance, just of antimalarials. The existence of many more
substandard and counterfeit medications for other types of medicines and
in other locations and facilities must be assumed. Public education and
official collaborations between public and private sectors are both
essential to protecting public health here in Ghana and in many other
developing nations.'
For more information about the PQM program and its work, please email
mediarelations@usp.orgor visit http://www.usp.org/worldwide/
"Francine Pierson" <FP@usp.org>.