The Global Threat of Substandard and Falsified Medicines
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.”
Many US patients also fall victim to falsified and substandard medicine because they import their medicine to avoid paying the higher costs in the pharmacy chains in US. People think that it is safe to import drugs from Canada, but the medicine they get are usually imported from developing countries like India, China, or Bangladesh. Some patients buy directly from countries like India. For example, 30 day supply of Onglyza (a new medicine for type 2 diabetes) costs close to $275 without insurance in the US while it could be purchased for around $40 from India. When you purchase from outside the country, the medicines are not monitored by FDA and your risk of receiving falsified medicine rise. The FDA recently tested the so called “generic versions” of Viagra, Lipitor, and Ambien bought from a Canadian online pharmacy. All three do not have an approved generic and were declared falsified after testing.
Patients worldwide should continuously be advised to avoid invalidated internet pharmacies and to be suspicious of companies offering ‘prescription only’ medication without a prescription or at substantial discounts. These patients should also be reminded that it is the quality (effectiveness) of the drug and not the quantity (price) that matters.
These companies producing falsified drugs are committing a serious criminal act and can be labeled as potential murderers. Even when a medicine only contains an ineffective substance, this can weaken immunity in people even more and can result in them dying because they think they are fighting their illness with a real drug. Thus, making every falsified drug sold and produced to be a premeditated massacre.
One of the main routes of these falsified drugs sold by some of the online pharmacies is being shut down by shipping companies in the US. UPS has taken the initiative in stopping all shipments from online pharmacies that are not certified by the Drug Enforcement Administration. Although taking a big hit on the revenue generated by the shipping of the illegal pharmacies, UPS has taken the responsibility of reducing the distribution of the falsified drugs. This results in a huge reduction of risk involved for the patients and improves the public health in the US.
Falsified and substandard medicines are not only a threat to global health but also a threat to international security. Substandard and falsified medicines are major global health challenges that cause unnecessary morbidity and mortality around the world and threaten to undermine recent progress against infectious diseases by facilitating the emergence of drug resistance. To help change this problem other countries should follow in behind Rwanda an put forth effort to ban the sale of monotherapies, ensure that private sellers of important medicines are qualified, and prioritize the prevention of falsified medicines entering the country.