Medication Counterfeiting

All medications, powders, and solutions that arrive into and then leave the pharmacy contain their stated ingredients, right? Maybe not! There are situations where this is not the case. The US Food and Drug Administration routinely releases messages about drug recalls because the stated ingredients may be an unapproved drug, a filling error at the manufacturer, or an incorrect amount of drug or the wrong drug in each dosage form. The use of unapproved drugs is motivated by greed and tends to be focused on drugs related to sexual function and weight loss agents. The filling errors and incorrect amounts of drugs are generally errors in a system that is designed to minimize those types of problems or greed. The good news is that both of these events are generally infrequent compared to the entire scope of pharmaceutical products. However, there is still the issue of counterfeit drugs throughout the health care and medication distribution system, and there is no perfect solution for how to detect these counterfeit products, especially today.

A counterfeit product is one that is “deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product.”^1(p1) The frequency of counterfeit products in the United States and the world marketplace has been increasing over the last decade.^1–5 If this issue is not addressed, people’s lives and health will be negatively impacted, and the financial cost to patients, health plans, and governments will be large. In some locations, the presence of counterfeit drugs is no longer an isolated problem. In 2011, the frequency of counterfeit antimalarial drugs in Nigeria was estimated to be 64%.⁶ The World Health Organization estimates that at least 30% of the medicines sold in parts of Asia, Africa, and Latin American are counterfeit.^7,8 The types of drugs that are involved in most counterfeiting cases include chemotherapeutic agents, vaccines, sexual dysfunction agents, weight loss agents, hormones, antibiotics, antivirals, analgesics, steroids, antihistamines, and antianxiety agents.¹

There have been a number of approaches discussed over the last several decades for dealing with these drugs, but the global and multiple layered supply and manufacturing process makes some of these systems difficult to implement. The Drug Quality and Security Act that was signed into law by President Obama in November 2013 requires the implementation of a new national system designed to detect and discourage counterfeiting and is scheduled to be started in 2015 and implemented over a 10-year period. This law provides for a national track-and-trace system that includes product identification, product tracing, product verification, detection and response, notification, wholesaler licensing, and third-party logistics provider licensing.^9–11 Europe will require unique identifiers on all medicine packages starting in 2016.¹² One of the systems that mostly likely will be used is the inclusion of radio frequency identification (RFID) devices in the packaging. This will enable the tracking of a specific product throughout the manufacturing and supply system to the pharmacy.² Another means of tracking could be the use of a cold laser marking system on each tablet or capsule.¹³

Let’s hope these new processes and requirements will help reverse the tide of this serious health care problem. In the meantime, each of us need to help validate the legitimacy of each pharmaceutical product, especially pharmaceutical products that are experiencing supply shortages, and only work with those supplies that have documented procurement systems that are designed to prevent the introduction of counterfeit products within the supply chain. Patients and health care professionals should be discouraged from using supply sources (eg, Internet pharmacies, foreign sources), especially those that promise large financial savings, that cannot be validated (eg, Verified Internet Pharmacy Practice Sites), or are unwilling to provide assurance that they are using systems designed to prevent the introduction of counterfeited products into their supply chain.