By The Editors
Treatment with poor quality medicines — substandard and falsified (fake) medicines — is a significant cause of harm to human populations worldwide.
According to a report released on February 13, 2013, by the Institute of Medicine of the National Academies “Falsified and substandard medicines provide little protection from disease and, worse, can expose consumers to major harm. Bad drugs pose potential threats around the world, but the nature of the risk varies by country, with higher risk in countries with minimal or non-existent regulatory oversight. While developed countries are not immune, – negligent production at a Massachusetts compounding pharmacy killed 44 people from September 2012 to January 2013 – the vast majority of problems occur in developing countries where underpowered and unsafe medicines affect millions.”
What is the difference between substandard and falsified medicines? Oxfam International explains the difference as follows: “Substandard medicines may contain the wrong type or concentration of active ingredient, or they may have deteriorated during distribution in the supply chain and thus become ineffective or dangerous. Falsified medicines are intentionally misrepresented to consumers. They may be fake in terms of composition or they may be falsely labelled, meaning that the information provided about the product is inaccurate.”
In an essay published in the scientific journal PLOS Medicine on July 2, 2013, Agnes Binagwaho and colleagues discuss the widespread problem posed by substandard and falsified anti-tuberculosis drugs available in low- and middle-income countries and describe Rwanda’s successful efforts to ensure drug quality.
According to the World Health Organization, tuberculosis is second only to HIV/AIDS as the greatest killer worldwide due to a single infectious agent. In 2011, 8.7 million people fell ill with tuberculosis and 1.4 million died from it. Two basic antibiotics used to treat tuberculosis are isoniazid and rifampicin.
Some of the authors of the PLOS Medicine essay recently published a study in The International Journal of Tuberculosis and Lung Disease, showing that ”Among 713 samples of isoniazid and rifampicin purchased at community pharmacies in 19 cities of 17 countries, 65 (9.1%) of the samples had insufficient active pharmaceutical ingredient (API) and failed basic quality control tests. Of those samples 18 (of 65, or 27.7%) were definitely falsified, since they had zero API and obviously fake packaging. The remaining products with insufficient API (47 of 65, or 72.3%) were either substandard or falsified.”
The countries involved in the study were Angola, Brazil, China, Democratic Republic of Congo, Egypt, Ethiopia, Ghana, India, Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, United Republic of Tanzania and Zambia. Rwanda was the only African nation whose samples did not include any falsified products.
According to Agnes Binagwaho and colleagues “There are two probable reasons for this success: first, the government of Rwanda has taken concrete legal and technical steps to ensure the quality of its drug supply chain; second, Rwanda was able to do that because it brought tuberculosis control into the publicly funded health system to a greater extent than many countries, which often rely on unregulated treatment in larger private sectors.”
On the basis of Rwanda’s success story, Agnes Binagwaho and colleagues present a “Time for Action” at the end of the PLOS Medicine essay — “We propose that a global treaty is now needed to guarantee sustainable progress towards higher quality medicines by bringing regulatory, technical, legal, and financial mechanisms to bear together. Such a treaty will be possible only with visionary and transparent leadership from WHO on behalf of its member states. As the dangers of drug-resistant tuberculosis fed by poor quality medicines illustrate all too well, the world loses ground with each passing day that WHO delays.”