Counterfeit Medicines and Global Health Security

The American Journal of Tropical Medicine and Hygiene recently published a supplement titled “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,” which features pieces by Tim Mackey, Margaret Hamburg, Ramanan Laxminarayan, and numerous other drug policy experts. The supplement highlights the wide-ranging health, legal, economic, and technical challenges generated by the persistence of substandard medicines in both legitimate and illicit drug supply chains. For example, Dr. Mackey and his colleagues reported 1,799 different detections of counterfeit medicines in legitimate supply chains alone, over a 36-month period between 2009 and 2011. The biggest culprits? Anti-infectives, or “drugs used to treat diseases caused by infectious agents including antimicrobial drugs, antivirals, antifungals, and antiprotozoans.” Such drugs comprised an alarming 21.1% of the counterfeit drugs identified in Dr. Mackey’s study.

Without access to effective, life-saving drugs, populations across the world remain vulnerable to the threat of infectious diseases. The scale and nature of this problem thus equate to big challenges for global health security-strengthening efforts.  

Counterfeit medicines are difficult to track and test

There aren't many systems in place for detecting counterfeit medicines in global supply chains before they reach consumers. Ensuring drug quality might require regulators to use an assay to detect drugs with wrong or missing active pharmaceutical ingredients, APIs. Or, they might take a more quantitative approach, such as assessing tablet hardness and/or rates of disintegration and dissolution.[1] Regulators might also analyze drug packaging, serial numbers, and inserts to determine legitimacy. As a result, verifying the integrity of a given medicine is often a laborious process. Exhibit A: this flowchart, which illustrates the algorithms used by the Counterfeit Drug Forensic Investigation Network to detect and classify substandard drugs.

 

IOM

Markets for counterfeit medicines exacerbate existing disease burdens 

Fake antimalarials and antibiotics like artemisinin, penicillin, and Zithromax are among the most prevalent counterfeit drugs sold today, and have serious consequences for consumers. Conflict in Myanmar, for example, has led to dramatic increases in the number of malaria cases among civilians. Concurrently, the market for fake antimalarials containing little or no API has also exploded. As a result, many who fall sick are often unable to access effective treatment. And, because many medicines in Myanmar are easily obtained without a prescription, it’s even harder to stop counterfeits from reaching patients. Furthermore, drug makers in Myanmar who create and distribute fake medicines have become highly skilled at replicating the holographic stickers used to differentiate between real and phony antimalarials, thereby making it nearly impossible to track and eliminate these drugs from legitimate supply chains.

Sub-therapeutic doses of anti-infective medication can also lead to poorer patient outcomes, contribute to the emergence and spread of drug-resistant pathogens, and weaken health systems. Robust markets for counterfeit medicines have already contributed to spikes in antibiotic and antimalarial resistance in many parts of the world. Additionally, patients could experience adverse effects after taking phony drugs, or lose confidence in medical institutions lacking the means to deliver effective treatment.

Counterfeit medicines undermine epidemic and pandemic preparedness by contributing to shortages of effective drugs

Disease outbreaks of all sizes could potentially amplify the dangerous consequences of counterfeit medicine distribution and use. Without access to reliable supplies of medical countermeasures, health authorities could encounter challenges in treating cases of infectious disease and preventing additional spread. Counterfeit medicines could also hinder medical surge capabilities by penetrating legitimate supply chains and displacing authentic drugs. However, conducting surveillance for illicit drugs requires considerable time, money, and resources, all of which are typically in shorter supply during public health emergencies.

Eliminating counterfeit medicines will require considerable multisectoral efforts on the parts of policymakers, regulators, and health authorities. Furthermore, many counterfeit medicines are manufactured, financed, and distributed by organized crime outfits and terrorist organizations. Hezbollah, the Irish Republican Army, the Basque Homeland and Freedom Group, and various groups from Chechnya and North Africa, for example, have all been involved in counterfeiting medicines for profit.[2] Therefore, getting law enforcement and intelligence experts on board is also crucial.

Additionally, there are some precautionary steps that stakeholders around the world, at all levels of public health and healthcare practice, industry, and government might consider taking to lessen the impacts of counterfeit drugs on the market.

1)      Continue investing in systems to secure pharmaceutical supply chains and monitor them for phony products. Many government agencies worldwide, like the US Food & Drug Administration, are aware of the risks associated with counterfeit medicines, and have begun collaborating with other public- and private-sector agencies to secure their nations’ pharmaceutical supply chains. Countries with large counterfeit drug markets might benefit from learning best practices from those with more resilient drug supply chains.

2)      Disincentivize counterfeiting by encouraging stricter enforcement of anti-counterfeiting laws. Counterfeiting activities generally carry lighter penalties than drug trafficking. Collaborating with law enforcement officials to more proactively indict and prosecute offenders could help deter others from manufacturing phony drugs.

3)      Educate vulnerable populations about the dangers of consuming counterfeit medicines. Helping the public understand how to recognize potentially phony products, and informing them of whom to contact in the event they experience adverse reactions could go a long way in protecting the health of populations at risk of consuming potentially dangerous drugs

In the context of our post-SARS, post-H1N1, post-Ebola world, the questions of who can access medicines and who is most affected by the sociopolitical factors that drive counterfeiting are more important than ever. Though the problem of counterfeit medicines is an old one, its persistence makes it worth revisiting, especially in light of this renewed energy around global health security. Aggressively addressing the problem of counterfeit drugs is a step in the right direction to make the world safer from the threats of treatable infections and suboptimal healthcare.


[1] Countering the Problem of Falsified and Substandard Drugs. Institute of Medicine. http://www.iom.edu/Reports/2013/Countering-the-Problem-of-Falsified-and-Substandard-Drugs.aspx

[2] The Infiltration of Terrorist Organizations Into the Pharmaceutical Industry: Hezbollah as a Case Study. http://www.tandfonline.com/doi/abs/10.1080/1057610X.2013.813244