Full Summaries Sorted

Medicalizing the Opioid Epidemic in the U.S. in the Era of Health Care Refo...

The problem

The surge in prescription narcotic and subsequent heroin addiction has prompted the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) to declare abuse of pre- scription opioids an ever-expanding epidemic in the United States (CDC 2015a; HHS 2015). Between 2002 and 2013, drug overdose rates quadrupled (CDC 2015b), exceeding overdose deaths from heroin and cocaine (Volkow et al. 2014). Heroin overdose deaths are increasing as patients shift to cheaper and more accessible heroin from the opioids that their physicians prescribe less frequently, due to increased awareness and education about the potential abuses of opioid prescriptions (Volkow 2014). The Food & Drug Administration (FDA) has increased awareness of its Risk Evaluation and Mitigation Strategy (REMS) to provide a tool for managing medication risks (FDA 2016a).

However, a CDC study found that drug overdoses have propelled mortality rates of White young adults while remaining relatively flat for minorities, especially African Americans and Latinos/Hispanics. Prescription opioids are more readily prescribed to White, middle-class, paying patients, accounting for the surge in opioid and heroin addiction in this formerly less affected segment of the population (CDC 2015b). In August 2015, the Office on


Received 26 October 2016 Revised 15 January 2017 Accepted 20 January 2017


Affordable Care Act; heroin; opiates; opioid epidemic; parity; prescription drug misuse

National Drug Control Policy (ONDCP) announced that it would allocate funds to hire coordinators for New England and four other regions to develop plans for treating, rather than punishing, addicts (Shear 2015).

The medicalization of the opioid epidemic is com- plicated by the fact that the line between legal and illicit narcotics has become blurred. Fentanyl, a very powerful opioid used for acute severe pain, has long been a problem in addicted health professionals, particularly anesthesiologists. Now, however, diversion from legal sources into the drug culture is being complicated by manufacture in clandestine labs with fentanyl analogs, i.e., its chemical derivatives. When used to adulterate heroin or prescription narcotics, overdoses and other adverse reactions have surged in new user populations. Many of these clandestine synthetic products are more potent than the user expects.

Carfentanil, for example, was developed as an elephant/ large animal tranquilizer, and is making its way into North America. First synthesized in 1974, it is marketed under a variety of street names in the Midwest and has been recently linked to over 200 overdoses in Pennsylvania and Ohio. One hundred times more powerful than fentanyl (NCBI 2016), 4000 times more powerful than heroin, and 10,000 times more powerful than morphine, carfentanil is


CONTACT David E. Smith David E. Smith MD & Associates, 856 Stanyan Street, San Francisco, CA 94117, USA. © 2017 Taylor & Francis Group, LLC

96 D. E. SMITH

extremely toxic with a wide therapeutic index (DEA 2016). As a result, carfentanil overdose requires significantly more than the usual doses of the opioid antagonist naloxone to reverse its effects (Hawkins 2016). Because of this potency, fentanyl derivatives have been classified as a specific occu- pational hazard for DEA agents involved in seizing clandes- tine labs, due to dermal and inhalation exposure (DEA 2016).

The demographics of heroin addiction have changed dramatically in the last 50 years, when I began treating opiate addicts in San Francisco. Then, heroin addiction was an inner-city issue affecting minorities and indivi- duals with a history of criminal justice involvement. Now, however, it has a much wider geographic distri- bution, with White, middle-class men and women in their twenties, living outside large urban areas, who are the largest number of users. Most new heroin users previously abused prescription opioids, as well as other drugs, starting in adolescence (Cicero et al. 2014; DuPont 2016; Jones 2013).

The nexus of spread of the current opioid epidemic originates from the medical system and the demo- graphics of the new addict population (Cicero et al. 2014). Increased acceptance of prescribing strong, nar- cotic-based painkillers for injury-related pain, in com- bination with a lack of education and awareness on the part of the medical community and patients of the potential addictiveness of these painkillers, has led to use of these powerful medications far beyond their original intended use for cancer pain and acute pain associated with specific medical conditions, such as trauma or myocardial infarction. This prescribing dilemma is aggravated by the fact that many physicians prescribe opioids with benzodiazepines, a combination that affects overdose and dependence (Quest 2016). There are appropriate indications for this drug combi- nation with acute pain, anxiety, and insomnia in asso- ciation with specific medical conditions, including PTSD and panic disorder. However, the number of patients prescribed this combination increased 41% from 2002 to 2014, and the overdose rate in emergency rooms from this drug combination almost tripled between 2004 and 2011 (FDA 2016b). In 2016, noting these changes, the FDA advised that it will require a black box warningproviding information about the serious risks associated with using these medications. Management of pain with opioids is a complex strategy since most patients who use them for pain do not misuse their medications. However, a minority of about 10% can develop serious, life-threatening addic- tive disease. The National Pain Strategy (Clark 2016; NIH Pain Consortium 2015) has outlined four key guidelines to achieve balance:

(1) What is the long-term effectiveness of opioids for treating chronic pain?

(2) What are the potential risks of opioid treat- ment in patients with chronic pain?

(3) What are the effects of different opioid man- agement strategies on outcomes related to addiction, abuse, misuse, pain, and quality of life?

(4) What is the effectiveness of risk mitigation strategies for opioid treatment?

This changing dynamic has put pressure on the medical profession, which has become oriented to pre- scribing pain medication rather than preventing and treating addiction, to become more aware of these medicationspotential for addiction and to screen for potential misuse and abuse. Shifting the system to be less of the problem and more of the solution with addictive disease is a policy initiative that the U.S. government and professional associations are beginning to address (CDC 2015a, 2015b; Shear 2015).

Prior to the introduction of Oxycontin®, physicians were reluctant to prescribe opioids for pain because of fear of addiction, but with Purdues aggressive market- ing program using well-paid physicians, the medical tide turned. Between 1999 and 2011, the use of opioids for chronic non-malignant pain tripled, overdoses quadrupled, and the number of patients seeking treat- ment for opioid addiction rose 900%, with four out of five current heroin addicts reporting that their addic- tion started with prescription opioids (Podolin 2016).

The legal response

David Musto, in his classic The American Disease (1999), described a high incidence of opiate depen- dence in mainstream society in the late nineteenth and early twentieth centuries, centered on patent- based medicines containing opium used for a variety of medical complaints, particularly by women. In 1914, however, the Harrison Narcotics Tax Act regulated and taxed opiates and cocaine products.

The Harrison Narcotics Act, which declared it illegal to prescribe narcotics to addicts in ambulatory care, regardless of the good faith of the doctor,was upheld by the U.S. Supreme Court, both in Webb v. U.S. (1919) and in U.S. v. Behrman in 1922 (Bonnie et al. 2004). This decision redefined the addicts status from patient to criminal and doctors were prosecuted as aiding criminals from 1915 into the 1960s. The demographics of opiate addiction passed from mainstream society to the underground culture (Kennedy 1920; Musto 1999).

With the opiate epidemic in the late 1960s associated with the Vietnam War and described in graphic detail in such movies as American Gangster, the U.S. government mounted a legal response that became known as the War on Drugs(Bentel and Smith 1971a, 1971b; Sheppard, Gay, and Smith 1971; Smith, Gay, and Shepherd 1974). At its peak, the U.S., with 5% of the worlds population, held 25% of the incarcerated population.

These drug laws, with harsh sentencing require- ments, had a disproportionate impact on people of color. For the same drug offense, African Americans and Latinos are far more likely to be criminalized than a White, middle-class person, leading to widespread disrespect for the unequal application of the law. At the end of 2013, almost 500,000 people were behind bars for a drug law violation on any given night in the United States10 times the total in 1980 (Fellner 2009; SAMHSA 2014). With the growing awareness that addiction is a brain disease, coupled with the passage of the Wellstone-Domenici Act, there has been a shift from the overcrowded criminal justice system toward diversion into treatment. Stressing the need for diver- sion to treatment from the criminal justice system, U.S. Attorney General Eric Holder expressed support for reducing sentences for all non-violent drug offenders in 2014 (Appuzo 2014; Samuels 2016).

DuPont (2016) stresses that law enforcement plays a critical role in both supply reduction and demand, as more addicts enter the criminal justice system. Diversion to carefully monitored addiction treatment, associated with drug testing and appropriate consequences for positive drug tests in violation of a monitoring contract, is a key part of this strategy. DuPont uses his analysis of opioid-addicted health professionals as an example of long-term opioid treatment strategies that have long- term success (DuPont 2016; DuPont et al. 2009a, 2009b).

The medical response

The National Pain Strategy calls for reducing the over- reliance on prescription opioid medication. This con- cern dates back to the introduction of these medications in the mid-1990s, when the AMA and American Pain Society established pain as the fifth vital sign, fueling a surge in the prescription of opioids. Warnings were issued by the Agency for Health Care Policy and Research, noting that potential misuse/ dependence and other side effects had been reported in up to 35% of patients. Oxycontin had been intro- duced shortly before this (Podolin 2016).

In November 2016, the Surgeon General released the first-ever report on addiction—“Facing Addiction in America: The Surgeon Generals Report on Alcohol,

Drugs, and Health.The report describes evidence- based prevention program approaches to screening, brief intervention, referral, and treatment (SBIRT), and the role of physicians and other health care provi- ders have in delivery of services:

Much of the current emphasis on addiction services stems from medical research showing that individuals with untreated drug and alcohol disorders are among the heaviest users of the health care system, contribut- ing to a substantial share of rising Medicaid, Medicare and private health care spending. Mounting evidence also shows physical health care costs decline dramati- cally when people with substance addictions get treat- ment. The longer they maintain sobriety, the lower their medical bills are. (Vestal 2015, p. 8)

Previous research from the California Alcohol and Drug Program and numerous studies from the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) have demonstrated the cost-effectiveness of treatment for substance use disor- ders, serving as the basis for integration of addiction services into the mainstream medical system under health care reform and parity. Every dollar spent on treatment can save up to seven dollars in criminal- justice-related costs, and up to $12 when health care costs are included (National Research Council 2014; NIDA 2012; Reuter 2013; Walmsley 2013). Effective student education and prevention programs can save as much as $15 to $18 in costs (Miller and Hendrie 2008). The economic and social benefits of bringing this previously excluded population into the main- stream system will be substantial, with changes in three major areas that will:

  1. (1) include mental health and substance abuse ser- vices in essential health plans;

  2. (2) apply parity protection to all insurance plans; and

  3. (3) provide substance abuse and mental health ser- vices to more Americans.

As described by Vestal (2015), the key issue is for the insurance exchanges under health care reform to pro- vide adequate funding for comprehensive addiction treatment. Of the 18 million adults potentially eligible for Medicaid in all 50 states, at least 2.5 million have substance abuse disorders. Of the 19 million uninsured adults with slightly higher incomes who are eligible for subsidized exchange insurance, an estimated 2.8 million struggle with substance abuse, according to a recent national survey by SAMHSA (Vestal 2015).

The increased prevalence of prescription opioid use disorders and related mortality has prompted more


98 D. E. SMITH

specific guidelines for clinical management of opioid use disorder for the primary care medical system, in addition to the practice parameters that have long existed in the specialty addiction literature. The Journal of the American Medical Association (JAMA) clinical guidelines synopsis make the following recommendations:

  1. (1) Opiod withdrawal alone is not recommended for treatment of opioid use disorders because of increased risk of overdose death and associated comorbidity such as infectious disease.

  2. (2) In the absence of medical contraindications, supervised opioid agonist treatment should be offered to patients with buprenorphine/naltrex- one, the preferred front line treatment.

    (1) Psychosocial support tailored to the patients needs should be offered as an adjunct to medical treatment (Dunlap and Cifu 2016).

Addiction medicine has described this as medication- assisted treatment (MAT), combining medication and psychosocial support. The importance of long-term psy- chosocial strategies, such as 12-Step programs like Narcotics Anonymous and therapeutic communities sup- plementing medication strategies designed to prevent overdose and relapse, based on the principle that addic- tion is a chronic disease with acute manifestations, is increasingly recognized (DuPont 2016; Galanter, Seppala, and Klein 2016; HHS 2016).

The addiction medicine response

In 2016, Congress passed the Comprehensive Addiction and Recovery Act (CARA). Included in this legislation are grants to increase the availability of life- saving opioid antagonists such as naloxone, and fund- ing for medically based MAT programs for previously underserved populations (U.S. Congress 2016).

A major medical advance in combating the opioid epidemic has been through demand reduction via pre- vention and treatment as a result of health care reform and parity legislation in the form of the Wellstone- Domenici Mental Health and Addiction Equity Act of 2007 and the Patient Protection and Affordable Care Act (PPACA) (2008; U.S. Congress 2010), also popu- larly known as the Affordable Care Act (ACA) or Obamacare.Addiction is now defined as a chronic disease to be covered by health insurance in a manner similar to other chronic diseases like diabetes and heart disease (Smith, Lee, and Davidson 2010).

The response to these policies to medicalize, rather than criminalize, the opiate epidemic has produced innovative programs at the national, state, and local levels, such as the ANGEL program in Gloucester, Massachusetts, where law enforcement and the treat- ment community work cooperatively to steer addicts to care (Gloucester Police Department 2015).

Faced with a surging opiate epidemic in the north- eastern states in 2015, the ONDCP has funded a series of grants to facilitate collaboration between public health and public safety officials, emphasizing an inte- grated approach at the community level. The governor of Vermont, who accepted expanded Medicaid funding under the ACA, called for more treatment facilities using MAT to improve opiate treatment and capacity (Volkow et al. 2014). In contrast, the governor of Maine, who opposes the ACA, rejected the expanded Medicaid funding needed for non-profit addiction facilities. As a result, one large treatment program in the state closed, while the other closed a satellite facil- ity. This decline in state government support for evi- dence-based solutions to the addiction problem in Maine is reducing the states treatment capacity.

This dramatic contrast between the policies of Vermont and Massachusetts, which have a treatment- focused approach, and Maine, which has an enforce- ment/supply reduction emphasis, will allow measures to determine which policy is more effective in dealing with the opioid epidemic. Future efforts in other states can be evidence based to determine whether more funding becomes available to expand treatment capa- city for opioid addicts.

Medicaid, which provides health care to low-income people, is administered state by state. Under the ACA, progressive states such as California implemented the Medicaid waiver, which expanded the availability of buprenorphrine to opioid addicts. In California, use of the Medicaid waiver, in conjunction with CARA funding, has brought a large number of lower-income patients into MAT programs. States that did not expand treatment with the Medicaid waiver saw a sig- nificant reduction in treatment capacity. With the 2017 Republican Congressional majority and the newly elected Trump Administration, the waiver program is likely to face further reductions in treatment capacity.

The health care reform legislation which is crucial to an expanded, integrated health care approach to the opioid epidemic is also at risk from a Republican- controlled Congress and executive branch. The U.S. Supreme Court upheld the tax subsidies of the Affordable Care Act (Liptak 2015; Sherman 2015), including mandated access to addiction treatment, which gave an estimated 32 million people access to

substance abuse treatment. However, new legislation can negate these gains. The ACA (U.S. Congress 2010) aug- ments the Wellstone-Dominici Mental Health Parity and Addiction Act of 2007 (Wellstone-Dominici) (U.S. Congress 2008), which extends federal parity protections to 62 million Americans (Beronio et al. 2013). Wellstone-Dominici provides that mental and beha- vioral health coverage must be comparable to that for medical and surgical services, which expands health care options for individuals previously uninsured, uninsur- able, and previously excluded from the mainstream health care system. Just as individuals with chronic medical conditions such as diabetes or high blood pres- sure are not limited in the number of doctor visits or treatments, those needing mental health care, including those with substance use disorders, will not be restricted in their care. Approximately 42 million Americans lack health insurance (Smith and Medalia 2014), and it is estimated that 25% of the uninsured have substance and/or mental health conditions (Beronio et al. 2013). The ACA extends availability of coverage to more indi- viduals, has provisions for making insurance coverage more affordable, and offers providers reimbursement for mental health services (Beronio et al. 2013).

ACA and addiction medicine

Addiction treatment has come a long way, but demand for the treatment of addiction and substance abuse is still a major problem. Armed with the new financial resources that the ACA offers, it is hoped that more patients will get the care and treatment they need. Addicts, by the nature of their disease, will avoid treat- ment until they face serious health issues, incarceration, or death. Traditionally, it was ultimately lack of access to treatment facilities or funds, or a combination of both, that prevented treatment. Political compromise of the ACA is a serious threat to the medical response to the opioid epidemic (Clark 2016).

Because addiction medicine is still a relatively new medical specialty, many primary care physicians and other clinicians are not trained to interact with the patients and programs of the addiction treatment system and new medications (Leshner 1999). They may hesitate to refer patients to appropriate treatment programs. Many depend on pharmaceutical marketing information rather than keeping up with new academic research. Many psychiatrists dont accept health insurance, relying instead on private pay.Managed care systems have finally adapted to the Wellstone-Dominici legislation, sometimes court-mandated through fines, to provide services and develop programs to cover substance misuse and mental health services.

While high incarceration levels have forced federal, state, and local governments to look for alternatives, the answer has existed all along in the form of treatment, education, training for clinicians, and public awareness. The missing key to this solution has been funding. Armed with the new funding of the ACA and the mandates of managed care, access and treatment on demand have increased, while, in recent years, incar- ceration levels are starting to decrease as substance abusers are increasingly redirected to such programs as pre-trial diversion, drug courts, treatment programs, and re-entry support (ONDCP 2014).

Early intervention in the primary care medical system and expanded adolescent addiction treatment is crucial, since most current treatment is adult oriented. This inte- gration of services is mandated by the Wellstone-Dominici parity legislation and the ACA (Beronio et al. 2013), and is being implemented in many community-based programs, such as HealthRIGHT 360 in San Francisco (www.

In 2008, NIDA reported, The total costs of drug abuse addiction due to use of tobacco, alcohol and illegal drugs are estimated at $524 billion a year. Illicit drug use alone counts for $181 billion in health care, productivity loss, crime, incarceration and drug enforcement(NIDA 2008). While affordable care and parity reforms prompt some to ask how we can afford these treatments and services for substance abuse, to continue on our current path is many times more expensive. Health care reform and parity pro- vide solutions to the growing economic, social, legal, and health impacts of substance abuse.

The current overuse of opioids, which has become the leading cause of death of young adults in many areas of the country, has both medical components to its causa- tion and medical components to its solution. The death toll of AIDS in the 1980s rivals that of this still-expanding opioid epidemic. A national public health policy strategy, similar to that mounted in addressing the AIDS epi- demic, would be well-advised. As Surgeon General Vivek Murthy has stated, We, as clinicians, are uniquely positioned to turn the tide on the opioid epidemic.It falls to us to pick up this challenge.

DMU Timestamp: February 07, 2020 23:04

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