Substandard and Falsified Anti-Tuberculosis Drugs: A Preliminary Field Analysis

The International Journal of Tuberculosis and Lung Disease, Volume 17, Number 3, March 2013, pp. 308-311(4)

5 Pages Posted: 3 Nov 2013

See all articles by Roger Bate

Roger Bate

American Enterprise Institute (AEI)

Paul Jensen

Pivit

Kimberly Hess

Africa Fighting Malaria (US)

Lorraine Mooney

Africa Fighting Malaria (UK)

Julissa Milligan

American Enterprise Institute (AEI)

Date Written: October 5, 2012

Abstract

Setting: Pharmacies in 19 cities in Angola, Brazil, China, Democratic Republic of Congo, Egypt, Ethiopia, Ghana, India (n=3), Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, United Republic of Tanzania and Zambia.

Objective: To assess the quality of the two main first-line anti-tuberculosis medicines, isoniazid and rifampicin, procured from private-sector pharmacies, to determine if substandard and falsified medicines are available and if they potentially contribute to drug resistance in cities in low- and middle-income countries.

Design: Local nationals procured 713 treatment packs from a selection of pharmacies in 19 cities. These samples were tested for quality using 1) thin-layer chromatography to analyze levels of active pharmaceutical ingredient (API), and 2) disintegration testing.

Results: Of 713 samples tested, 9.1% failed basic quality testing for requisite levels of API or disintegration. The failure rate was 16.6% in Africa, 10.1% in India, and 3.9% in other middle-income countries.

Conclusions: Substandard and falsified drugs are readily available in the private marketplace and probably contribute to anti-tuberculosis drug resistance in low- and middle-income countries. This issue warrants further investigation through large-scale studies of drug quality in all markets.

Suggested Citation

Bate, Roger and Jensen, Paul and Hess, Kimberly and Mooney, Lorraine and Milligan, Julissa, Substandard and Falsified Anti-Tuberculosis Drugs: A Preliminary Field Analysis (October 5, 2012). The International Journal of Tuberculosis and Lung Disease, Volume 17, Number 3, March 2013, pp. 308-311(4), Available at SSRN: https://ssrn.com/abstract=2349075

Roger Bate (Contact Author)

American Enterprise Institute (AEI) ( email )

1150 17th Street, N.W.
Washington, DC 20036
United States

Paul Jensen

Pivit ( email )

Washington, DC 20002
United States

Kimberly Hess

Africa Fighting Malaria (US) ( email )

Washington, DC
United States

Lorraine Mooney

Africa Fighting Malaria (UK) ( email )

Cambridge
United Kingdom

Julissa Milligan

American Enterprise Institute (AEI) ( email )

1150 17th Street, N.W.
Washington, DC 20036
United States

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