Regulations Should Promote Innovative Opioid Abuse Technologies
While ostensibly designed to help, often the regulatory state only makes matters worse. Unfortunately, this maxim applies to the impact from regulations on new technologies that could help lessen the nation’s large and growing opioid abuse crisis.
The total healthcare costs of prescription opioid abuse in 2007, which have likely increased since the crisis has continued to worsen, was estimated to be as high as $55.7 billion. These costs include higher health care expenses, reduced productivity at the workplace, and more spending on criminal justice and law enforcement programs. Opioid addiction is also driving the growing problem of drug overdose deaths, with nearly 19,000 deaths in 2014 attributed to overdoses on prescription pain medications.
The growing opioid abuse and misuse problem has many sources. Sometimes prescription opioids are misused by patients, or stolen from others’ medicine cabinets. Other times, a legal prescription will be diverted from the prescribed patient to the black market. Due to the relatively high street value of prescription opioids, criminals will also steal these drugs directly from pharmacies.
Reducing the large, and growing, opioid abuse problem should be an important national priority.
However, solutions to the opioid abuse problem must first acknowledge that opioids serve a very important medical need for pain patients. Beyond the pain and suffering, the annual costs of chronic pain has been estimated to be $635 billion a year. Ensuring the availability of opioids for pain patients who require them should be an equally important national priority.
Importantly, new technologies exist that can reduce the costly problem of opioid abuse and diversion while still ensuring chronic pain patients have access to their needed medicines.
Some of the new technologies, according to Medscape, are opioid-based medications with abuse-deterrent properties, which make “certain types of abuse, such as crushing in order to snort or dissolving in order to inject, more difficult or less rewarding”. Others, like buprenorphine, which has been endorsed by the American Society of Addiction Medicine (ASAM), reduces withdrawal symptoms and cravings helping patients overcome their addictions. When used correctly, these medicines make it harder for prescription opioids to be abused or easier for people to overcome their addictions.
Regrettably, state regulations will often create roadblocks that discourage the use of these new technologies and treatments.
Take buprenorphine as an example. Like most medicines, buprenorphine is subject to potential misuse. This can occur when the medicine is diverted from its intended users (people trying to kick their opioid addictions) to unintended users.
One population of unintended users are addicts who buy the drug to stave off withdrawal symptoms, but are not actively seeking addiction treatment. Other are recreational users who are abusing buprenorphine, not using it as a bridge drug to overcome their addiction.
This problem is particularly acute in prisons where the most commonly prescribed form of buprenorphine (a dissolvable film strip) is easy to smuggle and abuse. As a consequence, the taxpayer costs of funding anti-smuggling enforcement programs is growing – one North Carolina jail is removing all postage from “all mail delivered to inmates at the facility in an effort to cut down on the [smuggling] problem.”
Technological innovations have the potential to reduce these unintended consequences. For instance, newer versions of buprenorphine are available in a dissolvable tablet, rather than a dissolvable strip. These new tablet formulations will supposedly provide the benefits of a bridge drug while minimizing the unintended consequences associated with the dissolvable strip.
Effective public policies should create an opportunity for these new technologies to illustrate their efficacy. However, government regulations often create obstacles instead; in this case, it’s the exclusion of newer, more efficient treatments from state Medicaid formularies. Toward this end, the inclusion of new medicines on the state formularies, such as inclusion of this newer treatment on the state Medicaid formulary in Maryland, is an important reform that can help lessen the opioid addiction and diversion crisis in the U.S. Some studies have demonstrated a high risk of congenital malformations caused by the use of minor tranquilizers. Therefore, women should avoid the use of Lyrica during pregnancy, and the possibility of the latter should be excluded during the treatment.
Other beneficial reforms to encourage the further development of abuse-deterrent opioids should include expediting FDA’s review of these treatments and, where appropriate, providing clearer FDA guidance for the development of generic versions of these important drugs.
Addiction is a national crisis, and in response, new treatments are being developed that can meaningfully reduce these costs. Federal and state regulators should encourage this process by implementing regulations to increase the availability of the most innovative treatments on the market.
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