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hensive approaches to chronic pain into their scope of services.

Health care systems can in- corporate nonjudgmental screen- ing, brief intervention, and refer- rals for further assessment and treatment of addiction into all clinical settings where opioids are prescribed. Conversely, addiction- treatment providers can screen patients for pain, recognizing that inadequately treated pain is a risk factor for relapse.

Payers, including Medicare and state Medicaid programs, can use data-analysis tools to spot the red flags of inappropriate prescribing and refer prescribers to medical boards or other state agencies for further review, education, and oversight. Prescription-drug mon- itoring programs can also identi- fy prescribers in need of assis- tance. Coherent, evidence-based review of clinical practice can be

conducted with the aim of supporting high-quality care

for both chronic pain and addic- tion — and avoiding the unin- tended consequence of deterring physicians from caring for pa- tients with complex needs.

Public and private insurers can provide as generous coverage for treatment of opioid-use disorder as they do for management of chronic pain. This standard is infrequently met — for example,

it is long past time for Medicare to begin covering the effective care provided in opioid-treatment programs.

It is also time for the FDA to address the intertwining of chron- ic pain and addiction farther up- stream in the drug-development cycle. The agency might consider creating a pathway for develop- ment and review of new products and indications for simultaneous treatment of chronic pain and opioid-use disorder. Building on its own work to advance the sci- ence of abuse-deterrent formula- tions, the FDA should also re- quire that prescription opioids meet basic deterrent standards and should facilitate the gradual reformulation of existing products to meet such standards. In declin- ing to apply such a standard to Zo- hydro, the agency noted that ex- isting deterrent mechanisms have had minimal impact by them- selves. However, even modest safeguards have been shown to reduce the potential for inappro- priate use.5 As part of a compre- hensive strategy, a set of reason- able requirements for opioid medications is well in line with the FDA’s public health mission. Taking such action will deter others with less expertise from filling a perceived void.

In the end, pointing the finger at Zohydro is not going to resolve

the tension that exists today be- tween chronic pain and addiction. All concerned about the treatment of chronic pain and all responding to the rise in overdose deaths need to come together to promote high- quality and effective prevention and treatment for both conditions.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

From the Institutes for Behavior Resources (Y.O.) and the Maryland Department of Health and Mental Hygiene ( J.M.S.) — both in Baltimore.

This article was published on April 23, 2014, at NEJM.org.

1. Public health grand rounds — prescrip- tion drug overdoses: an American epidemic. Atlanta: Centers for Disease Control and Pre- vention, February 18, 2011 (http://www.cdc .gov/about/grand-rounds/archives/2011/ 01-February.htm). 2. Policy impact: prescription painkiller overdoses. Atlanta: Centers for Disease Con- trol and Prevention, July 2, 2013 (http:// www.cdc.gov/HomeandRecreationalSafety/ pdf/PolicyImpact-PrescriptionPainkillerOD .pdf ). 3. FDA Commissioner Margaret A. Ham- burg statement on prescription opioid abuse. Silver Spring, MD: Food and Drug Administration, April 3, 2014 (http://www .fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm391590.htm). 4. Federation of State Medical Boards of the United States. Pain management policies: board by board overview. February 2014 (http://www.fsmb.org/pdf/GRPOL_Pain_ Management.pdf ). 5. Severtson SG, Bartelson BB, Davis JM, et al. Reduced abuse, therapeutic errors, and diversion following reformulation of extend- ed-release oxycodone in 2010. J Pain 2013; 14:1122-30.

DOI: 10.1056/NEJMp1404181

Chronic Pain, Addiction, and Zohydro

Medication-Assisted Therapies — Tackling the Opioid- Overdose Epidemic Nora D. Volkow, M.D., Thomas R. Frieden, M.D., M.P.H., Pamela S. Hyde, J.D., and Stephen S. Cha, M.D.

The rate of death from over-doses of prescription opioids in the United States more than quadrupled between 1999 and

2010 (see graph), far exceeding the combined death toll from co- caine and heroin overdoses.1 In 2010 alone, prescription opioids

were involved in 16,651 overdose deaths, whereas heroin was im- plicated in 3036. Some 82% of the deaths due to prescription

An audio interview with Dr. Olsen

is available at NEJM.org

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opioids and 92% of those due to heroin were classified as unin- tentional, with the remainder be- ing attributed predominantly to suicide or “undetermined intent.”

Rates of emergency department visits and substance-abuse treat- ment admissions related to pre- scription opioids have also in- creased markedly. In 2007, prescription-opioid abuse cost in- surers an estimated $72.5 billion — a substantial increase over previous years.2 These health and economic costs are similar to those associated with other chron- ic diseases such as asthma and HIV infection.

These alarming trends led the Department of Health and Hu- man Services (HHS) to deem pre- scription-opioid overdose deaths an epidemic and prompted multi- ple federal, state, and local ac- tions.2 The HHS efforts aim to si- multaneously reduce opioid abuse

and safeguard legitimate and appropriate access to these med- ications. HHS agencies are im- plementing a coordinated, com- prehensive effort addressing the key risks involved in prescription- drug abuse, particularly opioid- related overdoses and deaths. These efforts focus on four main objectives: providing prescribers with the knowledge to improve their prescribing decisions and the ability to identify patients’ prob- lems related to opioid abuse, re- ducing inappropriate access to opioids, increasing access to effec- tive overdose treatment, and pro- viding substance-abuse treatment to persons addicted to opioids.

A key driver of the overdose epidemic is underlying substance- use disorder. Consequently, ex- panding access to addiction- treatment services is an essential component of a comprehensive response.2 Like other chronic dis-

eases such as diabetes and hyper- tension, addiction is generally refractory to cure, but effective treatment and functional recov- ery are possible. Fortunately, cli- nicians have three types of medi- cation-assisted therapies (MATs) for treating patients with opioid addiction: methadone, buprenor- phine, and naltrexone (see table). Yet these medications are mark- edly underutilized. Of the 2.5 mil- lion Americans 12 years of age or older who abused or were depen- dent on opioids in 2012 (according to the National Survey on Drug Use and Health conducted by the Substance Abuse and Mental Health Services Administration [SAMHSA]), fewer than 1 million received MAT.

When prescribed and moni- tored properly, MATs have proved effective in helping patients re- cover. Moreover, they have been shown to be safe and cost-effec- tive and to reduce the risk of over- dose. A study of heroin-overdose deaths in Baltimore between 1995 and 2009 found an association between the increasing availabil- ity of methadone and buprenor- phine and an approximately 50% decrease in the number of fatal overdoses.3 In addition, some MATs increase patients’ retention in treatment, and they all improve social functioning as well as re- duce the risks of infectious-disease transmission and of engagement in criminal activities. Nevertheless, MATs have been adopted in less than half of private-sector treat- ment programs, and even in pro- grams that do offer MATs, only 34.4% of patients receive them.4

A number of barriers contrib- ute to low access to and utilization of MATs, including a paucity of trained prescribers and negative attitudes and misunderstandings

Tackling the Opioid-Overdose Epidemic

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Opioid Sales, Admissions for Opioid-Abuse Treatment, and Deaths Due to Opioid Overdose in the United States, 1999–2010.

Data are from the National Vital Statistics System of the Centers for Disease Control and Prevention, the Treatment Episode Data Set of the Substance Abuse and Mental Health Services Administration, and the Automation of Reports and Consolidated Orders System of the Drug Enforcement Administration.

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Tackling the Opioid-Overdose Epidemic

about addiction medications held by the public, providers, and pa- tients. For decades, a common concern has been that MATs merely replace one addiction with another. Many treatment-facility managers and staff favor an ab- stinence model, and provider skepticism may contribute to low adoption of MATs.4 Systematic prescription of inadequate doses further reinforces the lack of faith in MATs, since the resulting return to opioid use perpetuates a belief in their ineffectiveness.

Policy and regulatory barriers are another concern. A recent re- port from the American Society of Addiction Medicine describing public and private insurance cov- erage for MATs highlights several policy-related obstacles that war- rant closer scrutiny. These barri- ers include utilization-manage- ment techniques such as limits on dosages prescribed, annual or lifetime medication limits, initial authorization and reauthorization

requirements, minimal counsel- ing coverage, and “fail first” cri- teria requiring that other thera- pies be attempted first (www.asam .org/docs/advocacy/Implications -for-Opioid-Addiction-Treatment). Although these policies may be intended to ensure that MAT is the best course of treatment, they may hinder access and appropriate care. For example, maintenance MAT has been shown to prevent relapse and death but is strongly discouraged by lifetime limits.5

In addition, although Medicaid covers buprenorphine and metha- done in every state, some Medic- aid programs or their managed- care organizations apply the utilization-management policies described above. Most commer- cial insurance plans also cover some opioid-addiction medications — most commonly buprenorphine — but coverage is generally lim- ited by similar policies, and ac- cess to care may be limited to in-network providers. Few private

insurance plans provide coverage for the depot injection formula- tion of naltrexone, and most do not cover methadone provided through opioid treatment pro- grams.

Implementation of the Afford- able Care Act (ACA) will increase access to care for many Ameri- cans, including persons with ad- diction. This expansion builds on the Mental Health Parity and Ad- diction Equity Act, which re- quires insurance plans that offer coverage for mental health or substance-use disorders to pro- vide the same level of benefits that they do for general medical treatment. The ACA significantly extends the reach of the parity law’s requirements, ensuring that more Americans have coverage for mental health and substance- use disorders and that coverage complies with the federal parity requirements. These reforms pre- sent new opportunities for reduc- ing prescription-opioid abuse and

Characteristics of Medications for Opioid-Addiction Treatment.

Characteristic Methadone Buprenorphine Naltrexone

Brand names Dolophine, Methadose Subutex, Suboxone, Zubsolv Depade, ReVia, Vivitrol

Class Agonist (fully activates opioid re- ceptors)

Partial agonist (activates opioid recep- tors but produces a diminished re- sponse even with full occupancy)

Antagonist (blocks the opioid receptors and interferes with the rewarding and analgesic effects of opioids)

Use and effects Taken once per day orally to reduce opioid cravings and withdrawal symptoms

Taken orally or sublingually (usually once a day) to relieve opioid crav- ings and withdrawal symptoms

Taken orally or by injection to diminish the reinforcing effects of opioids (potentially extinguishing the asso- ciation between conditioned stimuli and opioid use)

Advantages High strength and efficacy as long as oral dosing (which slows brain uptake and reduces euphoria) is adhered to; excellent option for patients who have no response to other medications

Eligible to be prescribed by certified physicians, which eliminates the need to visit specialized treatment clinics and thus widens availability

Not addictive or sedating and does not result in physical dependence; a re- cently approved depot injection for- mulation, Vivitrol, eliminates need for daily dosing

Disadvantages Mostly available through approved outpatient treatment programs, which patients must visit daily

Subutex has measurable abuse liability; Suboxone diminishes this risk by in- cluding naloxone, an antagonist that induces withdrawal if the drug is injected

Poor patient compliance (but Vivitrol should improve compliance); initi- ation requires attaining prolonged (e.g., 7-day) abstinence, during which withdrawal, relapse, and early dropout may occur

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its consequences by expanding the number of high-risk people who receive MATs through either public or private insurance. The importance of access to MATs and other treatment services for substance-use disorder is under- scored by the recent recognition of increased heroin use; what may be less widely recognized is that the majority of these new heroin users initially abused pre- scription opioids before shifting to heroin.

HHS agencies are actively col- laborating with public and private stakeholders in efforts to expand access to and improve utilization of MATs, in tandem with other targeted approaches to reducing opioid overdoses.2 For example, the National Institute on Drug Abuse (NIDA) is funding research to improve delivery of MATs to vulnerable populations, includ- ing those in the criminal justice system. NIDA is also working to develop new pharmacologic treat- ments for opioid addiction and helping to fund “user friendly” delivery systems for naloxone (i.e., intranasal rather than injection). SAMHSA is encouraging MAT use in its state funding of sub- stance-abuse treatment programs through the Substance Abuse Prevention and Treatment Block Grant and regulatory oversight of methadone and buprenorphine for opioid addiction. Furthermore,

SAMHSA supports production and dissemination of educational resources to MAT prescribers, as well as an “Opioid Overdose Tool- kit” to educate first responders, treatment providers, and patients about ways to prevent and inter- vene in opioid-overdose cases.

The Centers for Disease Con- trol and Prevention is working to empower states to implement com- prehensive strategies, including MATs, for preventing prescrip- tion-drug overdoses. These strat-

egies focus primarily on address- ing the overdose epidemic through enhanced surveillance, effective policies, and clinical practices that establish statewide prescribing norms. Such efforts can be en- hanced by using data sources to identify and intervene in cases of patients or providers who fall out- side those norms. And the Centers for Medicare and Medicaid Ser- vices is working to enhance access to MATs by Medicaid programs through improved benefit design and application of the Mental Health Parity and Addiction Equi- ty Act. But to be successful, all these initiatives require the active engagement and participation of the medical community.

The epidemic of prescription- opioid overdose is complex. Ex- panding access to MATs is a crucial component of the effort to help patients recover. It is also necessary, however, to implement

primary prevention policies that curb the inappropriate prescrib- ing of opioid analgesics — the key upstream driver of the epi- demic — while avoiding jeopar- dizing critical or even lifesaving opioid treatment when it is need- ed. Essential steps for physicians will be to reduce unnecessary or excessive opioid prescribing, routinely check data from pre- scription-drug–monitoring pro- grams to identify patients who may be misusing opioids, and take full advantage of effective MATs for people with opioid ad- diction.

Disclosure forms provided by the au- thors are available with the full text of this article at NEJM.org.

From the National Institute on Drug Abuse, National Institutes of Health, Bethesda (N.D.V.), the Substance Abuse and Mental Health Services Administration, Rockville (P.S.H.), and the Center for Medicaid and CHIP Services, Centers for Medicare and Medicaid Services, Baltimore (S.S.C.) — all in Maryland; and the Centers for Disease Control and Prevention, Atlanta (T.R.F.).

This article was published on April 23, 2014, and updated on May 1, 2014, at NEJM.org.

1. Jones CM, Mack KA, Paulozzi LJ. Pharma- ceutical overdose deaths, United States, 2010. JAMA 2013;309:657-9. 2. Addressing prescription drug abuse in the United States: current activities and future opportunities. Atlanta: Centers for Disease Control and Prevention, 2013 (http://www .cdc.gov/homeandrecreationalsafety/ overdose/hhs_rx_abuse.html). 3. Schwartz RP, Gryczynski J, O’Grady KE, et al. Opioid agonist treatments and heroin overdose deaths in Baltimore, Maryland, 1995-2009. Am J Public Health 2013;103:917- 22. 4. Knudsen HK, Abraham AJ, Roman PM. Adoption and implementation of medica- tions in addiction treatment programs. J Ad- dict Med 2011;5:21-7. 5. Clark RE, Baxter JD. Responses of state Medicaid programs to buprenorphine diver- sion: doing more harm than good? JAMA In- tern Med 2013;173:1571-2.

Tackling the Opioid-Overdose Epidemic

A key driver of the overdose epidemic is underlying substance-use disorder. Consequently, expanding access to

addiction-treatment services is an essential component of a comprehensive response.

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