Unregulated Drug Market Hurting TB Public Health Efforts

(FDA.gov)

The campaign against tuberculosis is generally considered a public health responsibility, but a new study indicates that private, unregulated TB drug sales may be hurting rather than helping those efforts. Results of the study appear in the new issue of the journal PLoS ONE.

The research, conducted by the organization TB Alliance and health care market research company IMS Health, examines private TB drug markets in 10 countries with significant numbers of TB cases: Bangladesh, China, India, Indonesia, Pakistan, Philippines, Russian Federation, South Africa, Thailand, and Viet Nam. These countries represent about 60 percent of the world’s TB burden.

TB Alliance says the disease requires lengthy, supervised treatment to maximize cure rates and minimize the development of drug resistance. In low-income countries, this task often falls on public health authorities rather than private treatment facilities, which are largely unregulated and fragmented.

Across the 10 high-burden countries studies, the study found as much TB drug volume in the private sector as in the public sector. The results also show at least one-third of all private sector dosages of first-line TB drugs fall outside of national and international treatment recommendations.

For example, the study detected 111 different first-line TB drug dosages and combinations, compared to the 14 deemed necessary by the Stop TB Partnership’s Global Drug Facility. Misuse of these drugs could lead to treatment failures and encourage multidrug-resistant TB (MDR-TB), which further worsens the TB epidemic.

The size of the private TB drug market varies among the 10 countries. However, four of the largest countries studied —  India, Indonesia, Pakistan, and Philippines — had among the largest private markets.  Enough TB drugs are sold in these private markets to treat all, or nearly all, TB patients with a full TB drug regimen, despite the 60 to 80 percent of the current TB cases in those countries already treated by public agencies.

The study also suggests that neither the private nor public drug markets are treating large percentages of patients with MDR-TB. In three of the 10 countries studied, private markets were not treating any MDR-TB patients. In the remainder, the highest rate of private MDR-TB coverage reached only 10 percent of the patients.

Commenting on the findings, Mario Raviglione, Director of the Stop TB Department at the World Health Organization says, “Private providers following best practices should be supported through accreditation and access to free TB drugs from the public sector, while those not doing so should be regulated.” Raviglione adds, “Greater government and international support is needed for these efforts and also for improved regulatory oversight and quality assurance of TB drugs.”

Read more: Database to Track Substandard, Counterfeit Medicines

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