Inside the pharmacy of Brigham and Women’s Hospital, a pharmacist counts what the industry calls abuse-deterrent OxyContin. It’s harder to crush and snort than regular OxyContin, based on a formula the US Food and Drug Administration approved in 2010. Dr. Mohammed Issa, medical director of Brigham and Women’s Faulkner Pain Management Clinic, says these kinds of drugs could be part of a solution to the opioid crisis.
If Issa had the option of prescribing one opioid that might be abuse-prone and another that is an abuse-deterrent, he said the choice is clear. And not just to protect his own patients.
“At least 50 percent have taken those opioids from family or friends,” Issa said. “So it means that if someone comes in on a prescribed opiate there is a very big chance — one out of two, that this will end up in someone else's hands.”
Over the past few years, pharmaceutical companies like Purdue Pharma, Pfizer and others have been working to develop different kinds of abuse-deterrent formulas — or ADFs. The FDA has approved a total of 10 formulas — nine in the last three years. Some of the abuse-deterrent pills turn into a gel so they can’t be snorted or injected. Another formula developed by Purdue Pharma called Targiniq, will release naloxone, putting a user into withdrawal if it is injected.
It’s too early to know what kind of impact all these ADFs will have on the opioid crisis, but a 2015 study published in JAMA showed that the reformulated OxyContin led to a decline in abuse of the painkiller, but caused a spike in heroin use. A 2017 study attributed 80 percent of the increase in heroin deaths since 2010 to the abuse-deterrent formula.
Still, Bertha Madras, a Harvard professor and psychobiologist who specializes in addiction at McLean Hospital, said it doesn’t take much to get high off ADFs.
“Anybody who has an abuse-deterrent opioid can still swallow multiple pills and die of an overdose or become addicted to it,” Madras said.
Madras recently wrapped up work on the President’s Commission on Combating Drug Addiction and the Opioid Crisis and says there are other technologies that need to be considered, starting with something as simple as numbering every pill so that if they're sold on the street, law enforcement could track where they originated.
“There are ways of identifying these pills,” she said. “And at a submicroscopic level we can code every single one and know what the source is.”
As the FDA pushes for more abuse-deterrent formulas, the question remains as to how tamper-resistant these drugs are. Online chatrooms and forums all over the web are devoted to figuring out how to hack ADFs to get high. Another sticking point is cost.
“Some of the newer drugs that may have less potential for abuse can be up to about $100 plus, maybe $150 even," Issa said. "I’ve had patients who said they had to pay $300, $400 dollars per month.”
With the typical copayment for oxycodone around $3 — a 10,000 percent markup on a painkiller that does the same exact thing — ADFs can be a tough sell. In 2014, Massachusetts became the first state to pass legislation that requires insurers to cover abuse-deterrent drugs. The high cost of these drugs, however, can still come with a hefty co-payment, depending on one’s insurance policy. And although the FDA in November issued guidance on developing generic ADFs, it will be some time until those make it onto the market.
Dr. Issa sees the value in abuse-deterrents, but he said it’s just one piece of the puzzle. He’s hopeful about other future technologies, like biometric smart pill dispensers that notify your doctor when you’ve taken your pill. In the meantime, he wants to make sure everyone understands how abuse-deterrent opioids work.
“It’s extremely important to educate prescribers to educate patients and make them understand that these drugs [sic] still have the potential for addiction," he said. "All they do is they prevent people from taking them in a way that was not intended.”
