How to make our counterfeit product problem worse

By Dr. John Hertig

Chair and Associate Professor of Pharmacy Practice in the Butler University College of Pharmacy and Health Sciences and President of ASOP Global’s board

 

On paper, the notion of importing cheap drugs from foreign countries like Canada, France, or the United Kingdom to address our domestic prescription drug pricing concerns is an appealing one. Six states have already put the wheels in motion on drug importation programs. Others, including Indiana, have seen legislative efforts in recent years to do the same.

Having spent years as a pharmacist and researching patient safety, administration, and health policy, I can say that not only is wholesale drug importation – even from seemingly safe and friendly nations – a bad idea, it’s an extremely dangerous one.

The politicians pushing drug importation as a quick and easy solution to provide financial relief to U.S. patients at the pharmacy counter tend to omit some important facts. Customs and Border Protection is already on track to break records this year – likely seizing more counterfeit drugs and other products in Indianapolis than ever before. We are currently experiencing a flood of counterfeit items crossing our borders. In our region alone, recent events prove the prevalence and dangers of counterfeit drugs and products. For instance, in the beginning months of the COVID-19 pandemic, U.S. Customs and Border Patrol intercepted 4,650 fake test kits intended for Indianapolis citizens. These bad actors were taking advantage of panicked people wanting any testing products they could lay their hands on and were attempting to sell them merchandise not approved by the FDA. Then, earlier this year, customs agents in Cincinnati seized over $750,000 worth of illegally imported prescription drugs and food products ticketed for Indiana and Kentucky. These food products included jellies and honey laced with the chemical ingredients found in Viagra. Over a six-month period, customs officials in Indianapolis have seen a 117 percent increase in seizures of contraband items, including over 700 shipments of illegal and counterfeit drugs.

Even if legislators claim we can safely import from nations like  Canada, it is important to remember that Canada doesn’t manufacture most any of its medicines domestically. They have to import their prescription drugs and experience frequent shortages. To protect its own citizenry, the Canadian government has enacted laws barring its licensed wholesalers from sending medications into our country.

So, that means any Canadian vendors offering to sell medicine to the US may lack access to Canada’s drug supply, instead buying from unvetted merchants operating unregulated in China or India. Pharmacists, the profession on the vanguard of drug safety, know this. In November 2020, after Florida became the first state to propose a drug importation plan from Canada, I helped conduct a survey of pharmacists about the policy. Less than 12 percent of the respondents stated that they would trust the safety and quality of imported medicines, and nearly 60 percent believed that there would not be adequate monitoring and safety of medicines imported from Canada. Additionally, 70 percent expressed concerns regarding the changes they would need to make in pharmacy operations to increase safety. Pharmacists are the last line of defense against unsafe and low-quality medications. If they have concerns, we should all have concerns.

In short, there are plenty of reasons to rethink proposals that would allow for wholesale foreign drug importation. Regardless of the country we plan to import from, U.S. patients will be left at the mercy of less-than-reputable sellers and the high likelihood of adulterated or substandard products.

There are better approaches to making prescription drugs more affordable in this country. Government officials are becoming more aware of the role played by pharmacy benefit managers, the middlemen in the prescription drug chain that negotiate discounts, but then pocket them and leave consumers paying full list price. Quite simply, policymakers should be focused on ways to reduce out-of-pocket costs at the pharmacy counter without putting patient and consumer health and safety at unnecessary risk.

The global counterfeit drug and medical product crisis is already endangering Indiana residents. We should not delude ourselves that we can safely import medicines.