Thursday, February 07, 2013

Study: Substandard & Falsified TB Drugs


(From the 2011 TB Progress Report)

# 6914


A topic we’ve looked at before – the proliferation of substandard or fake medications – is back in the news today with the publication of a field analysis of the quality of first line anti-Tuberculosis drugs (isoniazid and rifampicin) collected from pharmacies from 17 low- and middle-income countries.


The results are reminiscent of those we saw a year ago in an report in The Lancet that looked at the quality of Malarial drugs (see Lancet: 1/3rd Of Malaria Drugs Fake Or Sub-Standard).


Not only can using substandard (or fake) drugs endanger the person taking them, their use can lead to the rise of greater drug resistance.


And that endangers everyone.


Last October, in Interpol & FDA: Operation Pangea V, we looked at some of the International efforts to curb the trafficking in counterfeit drugs.


FDA PSA on Counterfeit Drugs


Today’s study, published this month in the International Journal of Tuberculosis and Lung Disease, found  9.1% of the drugs tested failed to have the requisite levels of API (Active Pharmaceutical Ingredients) or failed a disintegration test. 


The abstract was published on PubMed last month.


Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis

R. Bate, P. Jensen, K. Hess, L. Mooney, J. Milligan.


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.


While the study appears to be available only to subscribers at the Journal, I found it available on the American Enterprise Institute website in its entirety at the link below:


Substandard and falsified anti-tuberculosis drugs: A preliminary field analysis

Roger Bate, Lorraine Mooney, Kimberly Hess, Julissa Milligan, Paul Jensen | The International Journal of Tuberculosis and Lung Disease


Roger Bate also authors a commentary that warns of the dangers of these drugs - published on Feb. 5th in the International Herald Tribune - called:


Feeding a Disease With Fake Drugs

Published: February 5, 2013

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