E-DRUG: Falsified medicines in Africa
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Dear E-druggers,
At the end of this note, I am posting an interesting letter in response to
Paul Newton's original article in Lancet Global Health on 'Falsified
medicines in Africa' which was shared in E-DRUG earlier. The author
describes a unique US government-funded initiative to combat the epidemic
of counterfeit medicines.
Best wishes,
Rizwan
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with Special Interest to Strengthen National Medicines
Regulatory Authorities in Resource-limited Countries
Formerly (1998-2013) with the U.S. Food and Drug Administration
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
Email: drugsafetyconsultant@gmail.com
www.drugsafetyconsultant.com
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Lancet Global Health Vol.3, No. 2, Feb 2015
Correspondence
Falsified medicines in Africa
Tim Ziemer
Open Access
DOI: http://dx.doi.org/10.1016/S2214-109X(14)70363-8
In their letter on falsified medicines in Africa (September issue),1 Paul
Newton and colleagues lament obstacles to improving the global supply of
drugs, especially in unregulated informal markets in Africa. We share their
concerns, but the authors do overlook important efforts to curb the flood
of fake and substandard malaria medicines. The US President's Malaria
Initiative, for one, is teaming up with local police, customs agents,
national medicines regulatory authorities, and drug sellers to help reduce
the availability of counterfeit drugs in informal private sector outlets
and marketplaces.
The President's Malaria Initiative is working programmatically with the US
Agency for International Development's Office of Inspector General (USAID
OIG) to address and mitigate availability of counterfeit drugs in the
market place.2 For example, in Benin, in a mostly unregulated market in
which shop owners and street vendors sell drugs, including antimalarials,
the Initiative is partnering with the USAID OIG, local law enforcement, and
Ministry of Health officials to launch an anticounterfeit outreach
programme by educating and incentivising shopkeepers to report suspected
counterfeit medicine networks, while informing consumers on the dangers of
substandard drugs and how to recognise them. Benin is the first of several
sub-Saharan African countries where this initiative will be implemented.
And, the USAID OIG is actively investigating crimes, working with local law
enforcement agencies in several countries, leading to arrests and
prosecutions.
In all 19 focus countries in Africa, the President's Malaria Initiative is
partnering with national medicines regulatory authorities to help
strengthen local capacities regarding drug quality as part of the US
Government's overall technical assistance towards strengthening health
systems. The Initiative is helping countries improve surveillance capacity
to better monitor drug quality through randomly testing drugs commonly
found in both the private and public sectors,3 including mini-laboratory
sentinel sites,4, 5 and pilot activities in collaboration with the US Food
and Drug Administration and their CD-3 device.6
Although we agree that medicines regulatory authorities need to be
strengthened, we are seeing important progress. Recently, two national drug
reference laboratories in sub-Saharan Africa received ISO-17025
accreditation—an internationally recognised standard regarding laboratory
competency.7 These long-term gains represent sustainable health systems
capacity building, enabling partner country medicines regulatory
authorities to perform much needed quality testing.
The President's Malaria Initiative is providing substantial support to
countries to improve regulation and enforcement capacity of both the public
and private sectors, and we are expanding efforts with partner countries to
strengthen all areas of their pharmaceutical supply chain, including
forecasting, storage, transportation, and inventory management.8
Finally, as a major procurer of artemisinin-based antimalarials,9 the
Initiative employs a stringent quality assurance and quality control
strategy, ensuring that only good quality drugs are used in support of US
Government malaria programmes not only in sub-Saharan Africa, but also the
greater Mekong subregion.
Although there are various estimates of the burden of fake drugs, WHO
believes that fake medicines are now a US$75 billion per year industry.10
We agree with Newton and colleagues that more must be done to assure
quality of medicines, and second their call for an international public
health convention on the topic.
I declare no competing interests. The opinions expressed herein are those
of the author and do not necessarily reflect the views of the US Agency for
International Development.
References
1.Newton, PN, Tabernero, P, Dwivedi, P et al. Falsified medicines in
Africa: all talk, no action. Lancet Glob Health. 2014; 2: e509–e510
2.US President's Malaria Initiative (PMI) approach and steps to counter
theft and diversion of medicines.
http://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/malariadrugs_counteringtheft.pdf?sfvrsn=4.
((accessed Dec 19, 2014).
3.PMI. President's Malaria Initiative Increases Vigilance, Global Response
To Combat Counterfeit Antimalarial Drugs.
http://www.pmi.gov/news/all/news-full-view/president-s-malaria-initiative-increases-vigilance-global-response-to-combat-counterfeit-antimalarial-drugs.
((accessed Dec 19, 2014).
4.PMI. Countering Unregistered and Illegal Antimalarial Drugs in Ethiopia.
http://www.pmi.gov/news/stories-from-the-field/stories-from-the-field---detail/countering-unregistered-and-illegal-antimalarial-drugs-in-ethiopia.
((accessed Dec 19, 2014).
5. Global Pharma Health Fund. http://www.gphf.org/web/en/gphf/projekte.htm.
((accessed Dec 19, 2014).
6. US Pharmacopeial Convention. Field testing for rapid counterfeit drug
screening tool begins in Africa.
http://www.usp.org/news/field-testing-rapid-counterfeit-drug-screening-tool-begins-africa.
((accessed Dec 19, 2014).
7. ISO. General requirements for the competence of testing and calibration
laboratories.https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en.
((accessed Dec 19, 2014).
8. PMI. US President's Malaria Initiative (PMI) approach to health systems
strengthening.
http://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/pmi-and-health-systems-strengthening_final.pdf?sfvrsn=4.
((accessed Dec 19, 2014).
9. PMI. Eighth annual report to Congress.
http://www.pmi.gov/docs/default-source/default-document-library/pmi-reports/pmireport_final.pdf?sfvrsn=16.
((accessed Dec 19, 2014).
10. Beard, S. Fake pharmaceuticals are a $75 billion global industry.
http://www.marketplace.org/topics/world/fake-pharmaceuticals-are-75-billion-global-industry.
((accessed Dec 19, 2014).