The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug treatment and abuse prevention legislation—the Federal Comprehensive Addiction and Recovery Act (CARA), Senate Bill 524—while two states—Massachusetts and Wisconsin—enacted legislation establishing new rules and procedures for the prescribing, use, and disposal of controlled substances. The Centers for Disease Control and Prevention (CDC), meanwhile, published the long-awaited CDC Guideline for Prescribing Opioids for Chronic Pain (the Guideline) to assist primary care clinicians in outpatient settings outside of end-of-life or palliative care. The interplay between these new legislative and regulatory actions and public attitudes about opioid addiction paint a complex picture of the future of pain care.
What has happened?
On March 10, CARA passed the Senate by a vote of 94 to 1. It provides a multi-pronged approach to tackling record levels of prescription drug addiction, from mandating the development of best practices for prescribing opioids to authorizing grants for drug education, prevention, and treatment programs. CARA directs the Secretary of the U.S. Department of Health and Human Services (HHS) to convene a Pain Management Best Practices Interagency Task Force—composed of representatives of HHS, the Department of Veterans Affairs, Drug Enforcement Administration, CDC, addiction treatment organizations, and other stakeholder communities—to review, modify, and update best practices for managing pain (including chronic pain) and prescribing pain medication. CARA authorizes HHS, in consultation with the President’s Office of National Drug Control Policy, to make grants to entities suffering from “drug crises” (those experiencing above average rates of drug abuse for extended periods or sudden spikes) to implement community-wide abuse prevention strategies. The law also would expand disposal sites for unwanted prescription medications, the availability of naloxone to law enforcement agencies and other first responders, educational efforts to prevent opioid and heroin abuse, and promote drug treatment and recovery.
CARA reflects strong public support for increased government spending on treatment programs. In a recent Harvard School of Public Health-Stat poll, 41% of American adults surveyed responded that the amount of money the government currently spends on such programs is too low.
Within a week of CARA’s passage, CDC published the Guideline, which sets forth 12 recommendations for determining when and how to initiate or continue opioid therapy for chronic pain. According to CDC Director Tom Frieden,
[t]he guideline is designed to help clinicians and patients together assess the risks and benefits of opioid use and identify the best treatment option . . . based on three key principles. First, non-opioid therapy is preferred for chronic pain outside of active cancer, palliative and end of life care. . . . Second, when opioids are used start low and go slow. . . . Third, always use caution when prescribing opioids and monitor every patient closely.
In addition to the Senate and CDC, state legislatures have focused on stemming the opioid health crisis locally. On March 9, Massachusetts lawmakers introduced House Bill No. 4056, entitled An Act relative to substance abuse, treatment, education and prevention. The Massachusetts House and Senate unanimously approved the first-in-the-nation bill, which was signed into law five days later on March 14.
The Massachusetts bill affects doctors, patients, public health agencies, and pharmaceutical manufacturers in different ways. First, and most notably, the bill prohibits “a practitioner [from] issu[ing] a prescription for more than a 7-day supply . . . [w]hen issuing a prescription for an opiate to an adult patient for outpatient use for the first time [or] to a minor,” the first such limitation legislatively imposed by any state. If, however,
in the professional medical judgment of a practitioner, more than a 7-day supply of an opiate is required to treat the adult or minor patient’s acute medical condition or is necessary for the treatment of chronic pain management . . . then the practitioner may issue a prescription for the quantity needed to treat such acute medical condition [or] chronic pain . . . .
To reduce the prevalence of unused medications, the Massachusetts bill requires that manufacturers of Schedule II or III controlled substances (including opioids) participate in a “drug stewardship program” to “collect, secure, transport and safely dispose of unwanted drugs.” Manufacturers must engage in public outreach and education about the program and pay the operational and administrative costs associated with it, which by law cannot be passed through to consumers. Participation is required for any manufacturer selling or distributing a “covered drug” in Massachusetts, directly or through a wholesaler or retailer. Retail pharmacies may but are not required to participate in the drug stewardship program, which takes effect January 1, 2017.
Eight days after Massachusetts made national headlines, Wisconsin’s governor signed into law eight pieces of legislation as part of his Heroin Opioid Prevention and Education (H.O.P.E.) tour. The H.O.P.E. laws require that, before prescribing any “monitored prescription drug,” i.e., any Schedule II, III, IV, or V controlled substance or other “drug identified by the board by rule as having a substantial potential for abuse,” Wis. Stat. § 961.385(1)(ag), dispensers report and review patient and dispensing information using the Wisconsin Prescription Drug Monitoring Program. To root out so-called “pill mills,” pain clinics and programs treating addiction with the use of narcotics, e.g., methadone, must register with and be certified by the Wisconsin Department of Health Services (WDHS).
Distinctions with a difference
Although they share some common characteristics, CARA, the Massachusetts law, the Wisconsin H.O.P.E. legislation, and the CDC Guideline highlight nuanced differences in strategy for combating a public health issue. CARA focuses on strengthening the network of community-based addiction prevention and treatment programs. Wisconsin has increased government oversight of potential sources of opioids, including by creating a state pain clinic registry. Massachusetts has charged manufacturers with collecting and disposing of unwanted and expired drugs to help avoid their diversion and misuse. The CDC Guideline contains recommendations for best practices for opioid therapy for chronic pain. CDC’s focus on prescriber conduct seems most in line with public opinion: nearly two in five adults believe doctors who inappropriately prescribe opioid pain relievers are “mainly responsible” for painkiller abuse. Similar proportions, 37%, blame opioid users, while only 10% fault pharmaceutical companies.
The extent to which recent state and federal measures aimed at curbing opioid abuse are successful remains to be seen. The prescription, use, and misuse of opioids will remain hot-button issues for the foreseeable future, however. Just a few days ago, in fact, the U.S. Food and Drug Administration (FDA) announced safety labeling changes for immediate-release opioid pain medications, including a new “boxed warning” (FDA’s strongest risk communication) regarding the risks of opioid addiction and overdose. Two days later, FDA published draft guidance for industry recommending studies to ensure that generic opioids are sufficiently deterrent to all potential routes of abuse. More is sure to come.