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Abuse of prescription opioids is an increasing national concern. Recent reports point to growing rates of overdose, addiction, emergency department visits, and death attributable to nonmedical use of prescription pain medications.1,2
Opioid misuse and addiction has an especially important impact on Medicaid programs; rates of drug abuse among covered individuals exceed those of other insured populations.3 Opioid agonist treatment with methadone hydrochloride or buprenorphine hydrochloride is the most effective way to treat opioid addiction.4 Medicaid programs in most states cover methadone treatment and in all states cover buprenorphine, but there is concern that either medication can be abused. As a consequence, daily on-site dosing is required for most patients who are prescribed methadone. Buprenorphine carries a lower risk of sedation and overdose; it can more safely be dispensed for unsupervised use at home. Prescriptions for the leading sublingual buprenorphine hydrochloride–naloxone hydrochloride product (Suboxone; Reckitt-Benckiser) have risen sharply since 2002, when the US Food and Drug Administration (FDA) approved its use for treatment of opioid addiction. At present, more than 20 000 physicians are certified to prescribe buprenorphine. Patients filled an estimated 9 million prescriptions for buprenorphine in 2012. For a typical patient, the medication costs about $325 a month.
Reported increases in buprenorphine diversion have raised concern about unsupervised and nonmedical use. Emergency department visits involving buprenorphine increased almost 10-fold from 2005 to 2010; half of the 30 135 emergency department visits in 2010 were for nonmedical use.2 Of particular note are case reports of accidental ingestion by children, including some deaths.5
Citing concerns about safety and costs, several states have implemented stricter controls on the use of buprenorphine in their Medicaid programs. Almost all states now require prior authorization before buprenorphine is prescribed; some impose additional restrictions. Eleven states now impose lifetime limits on the duration of buprenorphine therapy, which range from 12 to 36 months. States with these stringent restrictions include Arkansas, Delaware, Illinois, Maine, Michigan, Mississippi, Montana, Utah, Virginia, Washington, and Wyoming. Patients who cannot continue to take buprenorphine could theoretically be treated with methadone or without medication. Unfortunately, access to methadone maintenance programs is severely limited in many locations, and the requirement for on-site dosing creates challenges for work and family life. In addition, compared with opioid agonist treatment, drug-free treatment has higher relapse rates, higher costs, poorer treatment retention, and higher mortality.4,6
Given typical patterns of opioid addiction and recovery, lifetime limits on buprenorphine treatment may make opioid addiction worse. Most people make repeated treatment attempts before achieving sustained recovery. When not in treatment, they face a substantially greater risk of overdose and death. Medication-assisted treatment has saved many lives since its introduction, yet it is still not widely accepted by the public, or even by some physicians. Oversimplified views that treatment with medications is not effective because it does not immediately end drug dependence or because it substitutes one opioid for another may be appealing. And there are examples of people who quit using opioids on their own. But for most people, choosing drug-free opioid treatment increases their risk of relapse and death.4,6 From a policy perspective, severe restrictions on buprenorphine place patients at substantial risk.
A more sensible approach to the availability of buprenorphine would weigh the potential harm from diversion against the consequences of forcing patients to end treatment arbitrarily or to switch to less effective alternatives. Compared with methadone and many commonly used drugs, buprenorphine is relatively safe. Poison centers and emergency departments report that, among adults, fewer emergency visits related to buprenorphine reflect life-threatening situations and result in hospital admission than visits related to the use of heroin, methadone, or oxycodone.7 Accidental ingestion by children is more dangerous but less common.7 Despite the increase in emergency department visits, deaths associated with buprenorphine are rare.2,7
One study8 found that having limited access to buprenorphine treatment was the strongest predictor of using buprenorphine that had been diverted by another patient. Although some individuals report abusing it, buprenorphine is not the drug of choice for most recreational users or addicts. Sources of diverted buprenorphine vary, but those with legitimate prescriptions seem to supply about half of the drugs used illicitly. This suggests that they receive prescribed doses high enough to avoid withdrawal themselves and to share or sell a portion of their supply.9 Diversion has increased in proportion to the growing supply of buprenorphine.9 Necessary measures are careful screening of patients to document opioid addiction, clinical evaluations to ensure that minimum effective doses are used, monitoring with counts of the pill or film forms of the drug, and toxicology screens. These measures may reduce the supply of buprenorphine available for diversion, without restricting access or the duration of treatment.
Reformulation of buprenorphine products may also improve safety and reduce diversion, although this has yet to be demonstrated. In 2010, Reckitt-Benckiser began supplying an individually packaged sublingual film version of buprenorphine-naloxone in an effort to reduce pediatric exposure. The packaged film may also make it more difficult to divide doses for illicit distribution. Although Reckitt-Benckiser began curtailing supplies of buprenorphine pills in March 2013, 2 companies (Actavis and Amneal) began supplying a generic pill version at about the same time. A time-release implantable formulation of buprenorphine has also been developed (Probuphine; Titan Pharmaceuticals); however, the FDA has yet to approve it for prescription sales.
Although the cost and consequences of buprenorphine diversion should be further studied, the personal and societal costs of not treating opioid addiction and inadequate treatment include overdoses, deaths, and crimes related to substance use. Fortunately, many states continue to take a balanced approach to managing buprenorphine. Dose-based prior authorization policies, such as in Massachusetts, place tighter controls on high doses while making recommended doses available to patients with addiction. The American Society for Addiction Medicine recently announced its support for medication-assisted treatment and its opposition to measures that arbitrarily limit doses or duration of treatment.10 Dose-based prior authorization aims to meet patients’ need for treatment, without unduly contributing to diversion. Although additional evaluation is needed, as well as research on the therapeutic effects of various buprenorphine doses, careful monitoring and control of high-dose prescriptions are promising approaches.
Rather than overreacting to reports of buprenorphine diversion, policymakers should consider the actual harms that diversion may cause. Placing buprenorphine in the same category with more addictive and risky opioids distorts public policy and impedes effective treatment. Better education of prescribers and patients about the dangers of accidental ingestion by children, continued improvements in packaging and formulation of buprenorphine, and careful monitoring by prescribers and policymakers are all essential. Buprenorphine can and does cause harm, but those harms are outweighed by the serious health consequences and fatalities associated with opioid addiction itself.
Corresponding Author: Robin E. Clark, PhD, Center for Health Policy and Research, 333 South St, Shrewsbury, MA 01545 (firstname.lastname@example.org).
Published Online: July 22, 2013. doi:10.1001/jamainternmed.2013.9059.
Conflict of Interest Disclosures: None reported.
Clark RE, Baxter JD. Responses of State Medicaid Programs to Buprenorphine Diversion: Doing More Harm Than Good? JAMA Intern Med. 2013;173(17):1571–1572. doi:10.1001/jamainternmed.2013.9059
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