Did you know making counterfeit Viagra is up to 2,000 times more profitable than dealing hard drugs? In fact, a $1,000 investment in counterfeit prescription drugs can result in a $30,000 return, which is 10 times the profit rate of trafficking heroin. Pharmaceuticals are in high demand, and the punishment for fake pharmaceutical dealing is lower than for narcotics. It is no wonder the market for counterfeit pharmaceuticals continues to grow larger than many realize.

For example, Interpol’s flagship pharmaceutical investigation, Operation Pangea, reports it seized 2.4 million fake and illicit pills in 2011; in 2015, the total number of medications that officials seized jumped to 20.7 million.When hospitals and clinics experience a drug shortage, they often look outside of the regular supply chain, creating opportunities for criminals to push fake pharmaceuticals.

In 2012, hundreds of cancer patients took what they thought was Avastin, a monoclonal antibody cancer treatment, only to learn that the drug they obtained lacked the active ingredients. This past April, the U.S. Food and Drug Administration (FDA) received reports of fake Botox in clinics all over the country. With counterfeiting posing a constant threat, brands can turn to packaging manufacturers that specialize in anti-counterfeiting technologies and new innovations to keep products safe. Pharmaceutical professionals will be able to see these solutions and more at the Healthcare Packaging EXPO (Las Vegas Convention Center; Sept. 25–27), co-located with PACK EXPO Las Vegas 2017.

A GLOBAL ISSUE

Worldwide pharmaceutical sales reached $1.1 trillion in 2015, according to PMMI’s 2016 Pharmaceutical and Medical Devices trend report. Experts estimate that the global counterfeit drug market ranges from $75 to $200 billion and, in some instances, make up half of all drugs sold in some low-income countries. Because they often sell at a lower price, counterfeit drugs are a dangerous source of unfair competition and can cause financial harm to both branded and generic drug manufacturers. Counterfeit pharmaceuticals are one of the most commonly cited problems for U.S. pharmaceutical manufacturers trying to enter foreign markets. The prevalence of counterfeits requires legitimate manufacturers to dedicate considerable resources to ensuring the security of the supply chain for genuine drugs, ultimately raising the price of medicines for consumers.

Fake pharmaceuticals can be found all over the world. The Regulatory Affairs Professional Society cites Brazil, China, Guatemala, India, Indonesia, Lebanon, Peru and Russia as countries that are major players in producing, selling and distributing counterfeit drugs. In 2015, 90 percent of all counterfeit medicines were shipped from China, Hong Kong and Singapore. More than 40 countries have introduced track-and-trace laws to help regulate products as they pass through the supply chain, and by early 2018 more than 75% of the world’s prescription medicines will be legally protected, according to the PMMI report.

WHAT'S CAUSING THE PROBLEM?

Consumers may choose to purchase fake drugs online because they cannot afford to visit a doctor or get medicine from a pharmacy, but studies show that about 90 percent of drugs purchased online come from a different country than the claims made on the website. Other times, patients will purchase drugs from internet pharmacies, which often buy drugs from other countries with loose regulatory systems. PMMI’s 2016 Brand Protection and Product Traceability report found that medicines bought over the internet that conceal their physical address are counterfeit in more than half of cases.

The drug industry is a target for counterfeiting because pharmaceuticals have high value and high utilization, and because the complex development process means large amounts of chemicals cross borders. Many of those countries do not have the same regulatory requirements as the United States. The World Health Organization estimates that about 30 percent of countries worldwide do not have a functional drug regulation agency equivalent to the FDA.

Anomalies in cross-border drug pricing have created a market opportunity for fake pharmaceutical traffickers. For example, a drug may sell for $20 per vial in Brazil but $10 a vial in Argentina. Third-party traders will interrupt the supply chain, diverting the drugs from to Brazil to make an extra $10. This results in lost revenue for the pharmaceutical industry and means patients in Argentina need to find alternative means of getting their drugs, explained Gary Parish, President of Complete Inspection Systems Inc.  

PROTECTION IN PLAIN SIGHT

The first layer of protection pharmaceutical packaging professionals can implement is an overt anti-counterfeiting solution, which is easily visible. Examples of overt solutions include holograms, serial codes and barcodes. The problem with holograms is that counterfeiters easily duplicate them, but serial codes and barcodes offer more security. For instance, Complete Inspection Systems produces unique barcodes for pharmaceutical packages that can hold up to 50 percent more data than standard barcodes.

Another range of solutions from Multifeeder Technology  includes 1D, 2D and 3D barcodes that serve as both a database and an anti-counterfeiting measure. Neal Nordling, president at Multifeeder Technology explained that barcodes are important because of the information they carry. When pharmaceuticals are produced, the raw materials often come from one country, the product is produced in another country and then packaged in a third country. “Once the transportation starts, you have to have a good database and marking devices so that product integrity can be checked at the other end of the transportation,” said Nordling.

Pharmaceutical manufacturers can further increase security by layering anti-counterfeit solutions, combining overt solutions with covert ones. In contrast to overt technology, covert anti-counterfeiting measures are invisible to the naked eye. “The more layers of protection, the harder it is for counterfeiters to replicate,” said Peter Nordling, Director of Engineering at Multifeeder Technology.

HIDDEN FIGURES

Other printing and marking technologies are being utilized to hinder counterfeit drug trafficking. For example, the CD-3 is a handheld device invented by the FDA that emits ultraviolet and infrared light onto pills and their packaging to determine if they are genuine. The device is intuitive to use, relatively inexpensive at $1,000 per device and surprisingly effective.

“As print has become more sophisticated, a lot of covert features now are added into package artwork,” said Lon Johnson, vice president of pharmaceutical sales at Colbert Packaging, producers of a wide range of covert packaging security solutions, including holographic features, foil stamping, die cutting and specialty security inks. Johnson notes that his company uses special inks on packages that react to pens used in the over the counter (OTC) market. “Before checkout, stores check packages with a pen,” he said. He added that other examples of covert solutions include text-based codes, often used in developing countries. These codes, often hidden under a scratch-off film, allow the customer to see if the package has been tampered with. 

Legitimate drug manufacturers are starting to design packaging with scratch-off codes that a consumer texts to a special phone number. They then receive an automatic response confirming whether or not the drug is genuine. This has promising initial results—so far, Herrington said, no falsifier has been able to hack this system. But in the long term, experts agree, more must be done to strengthen the regulatory system.

STAYING TWO STEPS AHEAD

With estimates of counterfeit drugs representing between eight and 15 percent of all medicines sold worldwide, pharmaceutical manufacturers need to stay ahead of counterfeiters by constantly updating their security methods. Attendees at Healthcare Packaging EXPO will have the chance to explore state-of- the-art packaging technologies, equipment and materials up close and in person. Between PACK EXPO Las Vegas and the Healthcare Packaging EXPO, more than 2,000 exhibitors will offer solutions to improve security, protection and product integrity. To register, visit here.