Regulatory Focus™ > News Articles > Poor-Quality Medicines a 'Global Pandemic,' New Research Says

Poor-Quality Medicines a 'Global Pandemic,' New Research Says

Posted 21 April 2015 | By Michael Mezher 

Poor-Quality Medicines a 'Global Pandemic,' New Research Says

Poor-quality and falsified medicines are "potentially devastating" to global health, researchers and regulators said on Monday in a collection of articles posted in the American Journal of Tropical Medicine and Hygiene.

Background: Counterfeit Drugs

Not all poor-quality medicines are created equal. The authors of one of the articles break poor-quality medicines into three categories: falsified (including counterfeit), substandard and degraded. While each of these categories presents different challenges to regulators, they all pose a threat to global public health.

Counterfeit medicines are perhaps the most visible threat to the medicines supply chain. A 2014 study referenced in one of the articles estimates that counterfeit drugs generate approximately $75 billion annually. Between 2010 and 2014, Interpol says its anti-counterfeiting operations resulted in 1,400 arrests and the seizure of 500 tons of counterfeit medicines.

Despite attempts by regulators and law enforcement agencies to curtail the threat posed by counterfeit medicines, data from the Pharmaceutical Security Institute (PSI) showed that reported incidents of counterfeiting more than doubled between 2005 and 2010.

The threat of counterfeit medicines is not just limited to illicit or uncontrolled supply chains. Counterfeit drugs also enter the market through legitimate supply chains.

In one article, researchers conducted what may be the first analysis of counterfeit medicines infiltrating legitimate supply chains. The analysis relied on data from PSI's Counterfeit Incident System (CIS) which catalogs reports of counterfeit medicines from public and non-public sources. In total, the researchers looked at 1,510 reports of counterfeit drugs found in legitimate supply chains between 2009 and 2011.

The analysis found anti-infective and genitourinary (including erectile dysfunction drugs) to be the most commonly reported counterfeit drugs found in legitimate supply chains. While the researchers acknowledge limitations in the data due to underreporting and gaps in incident classification, the findings indicate a threat to consumers and highlight the need for stronger surveillance and reporting on counterfeit medicines found in legitimate supply chains.

Poor-Quality Drugs

Substandard, falsified and degraded medicines pose a significant threat to global health. The threat of these products goes far beyond the immediate potential for toxicity or contamination. Poor-quality medicines also contribute to the rise of drug-resistant diseases such as malaria and tuberculosis, making these illnesses even more difficult to treat with standard quality treatments.

The collection of articles featured seven studies that sampled drugs such as antimalarials and antibiotics for quality. These studies tested roughly 16,800 samples obtained from national surveys, "mystery shoppers," law enforcement seizures as well as overt and randomized samples. The studies found 9-41% of the samples did not meet quality requirements. One study that tested 291 samples of antimalarial drugs in Cambodia found 30% contained either too much or too little of the active ingredient. Interestingly, none of the products sampled in the Cambodian study were found to be falsified.

The numbers attributed to deaths caused by poor-quality drugs are staggering; the authors estimate that in 2013, 122,350 deaths in children under 5 in sub-Saharan Africa were attributable to poor-quality antimalarial drugs.


The American Journal of Tropical Medicine and Hygiene

Categories: Regulatory News

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