As a primary care doctor who cares for many patients with opioid-use disorder, I am invested in timely and effective strategies to curb our nation’s opioid epidemic. Because so many instances of opioid addiction and overdoses begin with or involve commonly prescribed opioids, we need multiple strategies that address the significant harms associated with prescription opioids.
I am skeptical of one strategy, however: The President’s Commission and the Food and Drug Administration are promoting development of abuse-deterrent prescription opioids as the solution to our opioid problem. These technologies target common methods of opioid abuse, such as crushing, snorting, dissolving or injecting prescription opioids. Currently, ten FDA-approved abuse-deterrent prescription opioids are available. Many of these new and expensive formulations incorporate physical and chemical barriers to make manipulation of the drug difficult or to decrease its subsequent effects. Other formulations combine the opioid with an opioid blocker that — if abused — may interfere with or reduce the opioid’s effect.
Making it more difficult to modify prescription opioids sounds like a simple, elegant answer to the opioid epidemic. And, shouldn’t pharmaceutical companies develop these kinds of safe prescription opioids anyway? The problem is, abuse-deterrent prescription opioids will not change the risks inherent to opioids, and will likely mislead patients and providers into thinking that they present safe alternatives.
The problematic origins of abuse-deterrent prescription opioids
Ironically, the first prescription opioid that was touted to have low abuse potential was Oxycontin. Purdue Pharma brought the original OxyContin to market in 1996. Shortly thereafter, its popularity soared in large part because of its FDA approved label – “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.” Though scientific evidence backing this claim was sparse, the pharmaceutical company aggressively promoted the prescription opioid and misrepresented the risk of addiction.
Purdue racked in billions of dollars and OxyContin became one of the most commonly abused prescription opioids in America. Patients who did not experience the marketed level of pain relief were encouraged to use the medication at higher doses, quantities, or frequency. Crushing and snorting or dissolving and injecting OxyContin, in fact, made it more powerful. Hence, the FDA approved the “abuse-deterrent” formulation of OxyContin in 2010.
Abuse-deterrent, not addiction-proof
The FDA cautions that “abuse-deterrent” does not mean “abuse- or addiction-proof.” As a doctor experienced in treating addiction, I know this means that formulating the prescription opioid to deter its manipulation will not actually prevent misuse or addiction. However, this concept is not intuitive for most patients and providers — and we should not expect it to be.
If there is anything we know about the opioid epidemic, it’s that the misuse of prescription opioids — taking medication in a manner or dose other than prescribed; taking someone else’s prescription; or taking a medication “to get high” — is quite common. In fact, more than 11 million Americans reported misuse of prescription opioids in 2016. Often, prescription opioids are misused when people take too many pills or take them too frequently above what is prescribed. For 20 to 30 percent of these people, opioid misuse escalates to an addiction. Therefore, even if abuse-deterrent prescription opioids make it harder to crush or dissolve the medication, they do not prevent the most common type of opioid misuse — by oral ingestion.
Even after its makeover, OxyContin illustrated how abuse-deterrent prescription opioids do not thwart addiction. One study found that while there was an immediate drop in OxyContin abuse after its reformulation, the effect was not far-reaching and opened the door to worse problems. For instance, many who abused the original OxyContin figured out how to bypass the new deterrent mechanism and continued to use the “abuse-deterrent” prescription opioid. Those who could not get what they sought from reformulated OxyContin simply moved onto cheaper — but illicit — drugs, such as heroin.
Abuse-deterrent formulations might have turned some away from one particular prescription opioid, but they did not address the underlying risk of addiction. Opioids can be addictive no matter how you package them – their biochemical effect on the human body is an inherent property, so that changing the coating or filling is just that.
Evidence and abuse-deterrence
The lack of real-world evidence for the effectiveness of abuse-deterrent prescription opioids is also problematic. FDA-required studies for these medications are conducted in the laboratory or controlled settings, but not where misuse or addiction occur. The FDA also requires pharmaceutical companies to study the real-world effects of abuse-deterrent prescription opioids after they become available on the market. However, data on real-world effects are not sufficient. Such data will likely remain inadequate because of the complexities and lack of incentives of studying real-world use.
While the real-world evidence is limited, what we do know is that abuse-deterrent prescription opioids are costly to the healthcare system. An analysis conducted by the Institute for Clinical and Economic Review (ICER) found that abuse-deterrent opioids, at their current prices, cost an additional $231,500 to prevent one new case of opioid abuse, and $1.36 billion to prevent one overdose death.
Abuse-deterrent prescription opioids also require doctors to spend more time addressing insurance red tape, which means time away from patients. Patients might also face increased out-of-pocket costs for expensive medications, or restricted access to older formulations. In the meantime, the high cost of getting these medications into the healthcare system drain resources away from valuable and effective strategies needed to curb the opioid epidemic.
Why newer prescription opioids won’t solve the epidemic
Clearly, abuse-deterrent prescription opioids aren’t “the” answer to curbing this epidemic. Instead, a systematic overhaul of our health care system can reduce the risks associated with prescription opioid use. Prescription opioids are powerful medications that help treat pain, and patients can benefit from using them in a tailored way for their medical or surgical condition. Whenever possible, non-opioid medications and treatments such as physical therapy, massage therapy, acupuncture, mindfulness, biofeedback should be tried first. Then, patients need to be educated about the risks of prescription opioid misuse, addiction, and overdose. Providers should be trained and held accountable to educating patients about prescription opioid benefits versus risks. Strategies to promote safe opioid prescribing also need to be adopted widely at the level of clinics, hospitals, pharmacies and regulatory agencies. Public health campaigns that empower patients to understand the pros and cons of prescription opioids are direly needed.
Educating patients, training providers, and implementing systems to promote safe opioid prescribing should be among our strategic priorities in combatting the opioid epidemic. Investing in the development of new, costly, and misleading abuse-deterrent opioid formulations is an unnecessary distraction from the focus of our precious resources in the fight to save lives.
Tiffany Lu is an internal medicine physician, Albert Einstein College of Medicine, Bronx, NY. She blogs at the Doctor’s Tablet.
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