Substandard drugs and the fight against TB: The challenge and the opportunity


Doctor Marion Aritonang (L) checks the lungs of a newly diagnosed tuberculosis patient at the Indonesian Union Against Tuberculosis clinic in Jakarta, April 4, 2011.

Article Highlights

  • Shoddy medicines accelerate drug resistance and dramatically alter the course of epidemics

    Tweet This

  • Tuberculosis cases claimed 1.4 million lives in 2011—more than any other infectious disease except HIV/AIDS

    Tweet This

  • About 10% of TB pills sampled failed basic quality assessments, being either substandard or fake

    Tweet This

  • Rwanda has taken action to ensure the quality of its pharmaceutical supply chain

    Tweet This

  • Between 2000 and 2011, deaths from TB in Rwanda plummeted by 77 percent

    Tweet This

  • A global treaty that uses regulatory and financial means to prevent fake and substandard medicines is urgently needed

    Tweet This

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.

Also Visit
AEIdeas Blog The American Magazine
About the Author



What's new on AEI

AEI Election Watch 2014: What will happen and why it matters
image A nation divided by marriage
image Teaching reform
image Socialist party pushing $20 minimum wage defends $13-an-hour job listing
AEI on Facebook
Events Calendar
  • 20
  • 21
  • 22
  • 23
  • 24
Monday, October 20, 2014 | 2:00 p.m. – 3:30 p.m.
Warfare beneath the waves: The undersea domain in Asia

We welcome you to join us for a panel discussion of the undersea military competition occurring in Asia and what it means for the United States and its allies.

Tuesday, October 21, 2014 | 8:30 a.m. – 10:00 a.m.
AEI Election Watch 2014: What will happen and why it matters

AEI’s Election Watch is back! Please join us for two sessions of the longest-running election program in Washington, DC. 

Event Registration is Closed
Wednesday, October 22, 2014 | 1:00 p.m. – 2:30 p.m.
What now for the Common Core?

We welcome you to join us at AEI for a discussion of what’s next for the Common Core.

Thursday, October 23, 2014 | 10:00 a.m. – 11:00 a.m.
Brazil’s presidential election: Real challenges, real choices

Please join AEI for a discussion examining each candidate’s platform and prospects for victory and the impact that a possible shift toward free-market policies in Brazil might have on South America as a whole.

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.