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Substandard Drugs And The Fight Against TB: The Challenge And The Opportunity



April 15th, 2013

Poorly manufactured and fraudulent medicines kill thousands of people around the world each year. For infectious diseases like malaria and HIV, shoddy medicines also accelerate drug resistance and dramatically alter the course of epidemics. With few new drugs under development, recent progress against these major killers in the poorest countries is precarious.

Bad drugs have become a big problem for one major infectious disease in particular: tuberculosis. If we don’t solve this issue, we may see the gains we’ve made against TB slip away.

According to the World Health Organization, global TB cases continued on a slow downward trend in 2011. While this is good news, the disease still claimed 1.4 million lives that year—more than any other infectious disease except HIV/AIDS. Meanwhile, multidrug-resistant TB cases rose to 630,000 worldwide. Resistant TB is deadly and costs significantly more to treat. For example, curing a single case of it in the United States can cost more than $200,000. Treatment takes two years, and the side effects can be severe, including nausea, vomiting, joint pain, and even hearing loss.

The rise in drug resistance is a complicated issue. One key driver is poor adherence to treatment and improper use of medicines. Patients with TB are typically put on a cocktail of drugs for six months, and even completing this regimen is often a challenge. In some countries, most notably India, TB drugs are readily available through private providers, where they’re over-prescribed and improperly used. For example, a 2010 study asked 106 private-sector physicians in Mumbai to write a prescription to treat TB. Only six wrote a correct prescription; most prescribed too many drugs for too long.

The Role Of Substandard Medications In Creating Drug Resistance

Medicines that have too little active ingredient can also create resistance. A report on substandard and fake drugs released last month by the U.S. Institute of Medicine states that this is a well-known problem for malaria control—and a growing concern for TB.

This is underscored by a recent peer-reviewed study, which found that there are high levels of fake and substandard TB drugs across 17 emerging markets.  Roughly one in ten TB pills sampled failed basic quality assessments, including thin-layer chromatography and disintegration tests, with half likely to be poorly manufactured and the other half being fake. Across African countries, one in six pills failed quality tests.

The Exceptional Case Of Rwanda

However, Rwanda stood out as a notable exception, where no fakes and only one substandard pill were found. This is largely because of specific actions that the Rwandan Government and its partners have taken to ensure the quality of drugs in its supply chain. For example, the Rwandan government provides free TB treatment and prohibits the sale of TB drugs in the private sector—though accredited facilities can provide them to patients free of charge using public sector supply chains.

Rwanda’s drug quality control strategy not only depends on its health system, but also on law enforcement and the judiciary—and not only for TB control, but also across all public health programs. For instance, drug contracts awarded by the Ministry of Health must go to manufacturers with current certificates of Good Manufacturing Practices certified by the World Health Organization. This process involves site visits by the World Health Organization and a thorough review of the organization’s facilities, production, and management practices. Imported medicine batches are quality-tested using High-Performance Liquid Chromatography. Where falsified medicines are found, authorities collaborate with the national police force and Interpol to quickly prosecute responsible parties.

Approved medicines are distributed by a dedicated, climate controlled supply chain—crucial to keeping medicines from degrading before they reach patients. More than 2,400 health workers throughout the country have been trained to identify and respond to drug quality problems, which are reported to the Ministry of Health, according to internal data collected by the ministry.

These actions have contributed to a steep drop in the burden of TB. The same internal study showed that, between 2000 and 2011, deaths from TB in Rwanda plummeted by 77 percent while new cases dropped by 71 percent.

Rwanda also participates in the recently launched Medicines Regulatory Harmonization Initiative for the East African Community, and the government is helping to draft a law against falsified medicines for the regional bloc (which includes its neighbors Kenya, Uganda, Tanzania, and Burundi). These steps will ensure that other countries can benefit from each other’s experiences and from stronger partnerships to protect drug quality and improve public health.

The Path Forward

But if we’re going to win the global fight against TB, we must take additional steps. First and foremost, a global treaty on fake and substandard medicines is urgently needed. A treaty would deploy international regulatory, technical, legal and financial mechanisms against bad drugs in a concerted manner. We have a treaty to guard against trafficking in counterfeit currency, which has been effectively enforced and has successfully limited the scope of this criminal activity. We have another for cigarettes, which has sharply constrained tobacco advertising in emerging markets. So why shouldn’t we have one for medicines?

Earlier this month, a patient with an extremely difficult to treat airborne form of resistant TB was detained in the United States after traveling through more than a dozen countries. Unless we are prepared for this scenario to become increasingly common, we must push for global leadership by WHO to initiate a drug quality treaty. We have a moral, epidemiological, and economic imperative to take action today.

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1 Response to “Substandard Drugs And The Fight Against TB: The Challenge And The Opportunity”

  1. cadyharen Says:

    The problem of fake drugs has been an issue for long. I am surprised by the case in Rwanda because in the third world you expect the problem to be more rampant. I agree that WHO should take a harder stand when it comes to drug quality because millions die every year due to consuming fake drugs or substandard or expired medications.

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