Ever since there have been products, there have been counterfeit products distracting the consumer from the originator. There is a small philosophical difference between an originator product and a counterfeit—and that difference mostly centers around the idea of intellectual property (IP). IP attorneys spend long days justifying the differences, or lack thereof, between an originator and a copy. Trillions of dollars are made on knock-off products, and while some are of decent quality, others endeavor to convince consumers that they’re equivalent to the original product and (woefully) are not by a long shot. Oftentimes this discrepancy will manifest in a defective product and consumer frustration, but in the pharmaceutical market, counterfeits can lead to serious adverse events (SAEs) and even death.

In pharmaceuticals, counterfeiting not only impacts IP of the originator molecule, but it undermines the safety of the public. Because unlike toys or gadgets, drug therapies go through a substantial demonstration of efficacy in clinical trials, so to intentionally develop inert, or hazardous, copies undermines the intent of the final product. This is where the ethical problems enter in the pharmaceutical counterfeiting market. Make no mistake: There is a tremendous incentive to counterfeit pharmaceutical products, as it is currently a scheme worth over $75 billion annually.¹

Techniques for anti-counterfeiting
Branded labels and logos exist to signal to consumers that what they have is the original product. Of course, the counterfeitors then need to duplicate each of these product-specific idiosyncracies.

There are many examples of anti-counterfeiting technology in pharmaceuticals that have been foiled: Manufacturer brand debossing on tablets can be copied; packages duplicated; tablet and capsule morphologies replicated; and containers cloned, or sourced from the same closure vendors. Those individuals most likely to be fooled by counterfeiting are first-time users of a drug therapy, because they have no mental baseline as a comparator. There are also a lot of first-time users of drug products. Think of the number of patients multiplied by the permutations of the number of marketed drug products.

It was only a couple decades ago that holograms on stickers and logos were the 21st century approach to anti-counterfeiting. These are now easily duplicated by counterfeitors. Drug forms that come in novel delivery devices such as auto-injector pens, transdermal patches, etc., offer some inherent resistance to counterfeiting. But first-time users wouldn’t know what to expect.

Now drugs that offer cutting-edge patient data tracking will provide some anti-counterfeiting comfort for the time being, until patients begin to refuse drug treatments that track compliance. Serialization allows for tracking and tracing to a certain degree across the supply chain and ensures greater chain of custody for the manufacturer, and as more pharmacies become a part of the serialization effort, the system gets more robust. But it does not demonstrate to patients that their prescription hasn’t been counterfeited.

Special consideration for regulators
This is a serious problem for the pharmaceutical industry, as it is for the technology sector, art, music, textiles, and virtually every other extant industry. Counterfeitors in the pharmaceutical sector, however, risk patients’ lives. There is a deep latent risk as well, and that comes in the form of post-marketing surveillance for safety reports. Knowing which reported adverse events (AEs) for a particular drug are from actual marketed drug or a counterfeit replacement is virtually impossible. Therefore knowing which post-marketing safety signals are false positives, which is already a difficult task, becomes more difficult when patients report adverse events and may have been taking a counterfeited prescription. It is therefore incumbent upon us as ambassadors for this industry to continue to seek methods to make counterfeiting more and more difficult. All patients who take a prescription and expect a certain beneficial effect, and at the same time a particular margin of safety, deserve the best products we can produce. CP

References and Further Reading

1. Moran, B. “Cracking Down on Counterfeit Drugs.” http://www.pbs.org/wgbh/nova/next/body/uncovering-counterfeit-medicines/
2. Davison, M. (2011). Pharmaceutical anti-counterfeiting: Combating the real danger from fake drugs. Hoboken, NJ: John Wiley & Sons, Inc.