Section I: Overview of the Public Problem

United States

A portion of the United States’ population is dependent on opiates and heroin. The United States’ current public problem with opiate dependence lies not only with the misuse of prescription or illicit drugs, but also with policies that affect dependency treatments.  This is especially true for treatments that use opiate-substitute medications such as methadone, Subutex, and Suboxone which “contain the active ingredient, buprenorphine hydrochloride, which works to reduce the symptoms of opiate dependence” (FDA, 2014). The National Institute on Drug Abuse (NIDA) states that “In 2011, 4.2 million Americans aged 12 or older had used heroin at least once in their lives” (NIDA, 2005), and The Substance Abuse and Mental Health Services Administration (SAMHSA) reports that, “681,000 Americans aged 12 and older used heroin in the past year. The data shows that 169,000 Americans age 12 and older used heroin for the first time in 2013… Overall, on an average day about 460 Americans use heroin for the first time” (SAMHSA, 2015). The Center for Disease Control’s (CDC) reports show that opioid overdose death rates are highest among persons aged 45- 54 years and higher among non-Hispanic whites and Native Americans/Alaska Natives (American Society of Addiction Medication [ASAM], 2013, p.4). This not only affects the lives and health of the people who become dependent on opiates, but it also affects the entire community.

The National Substance Abuse Institution (NIDA) states that drug abuse contributes to many of America’s current top social problems, such as drugged driving, violence, stress, and child abuse. Drug abuse affects all of us in the community by contributing to the majority of homelessness and crime. It affects education; children with prenatal substance exposure are 1.5 times more likely to need special education services at a cost of an estimated at $23 million per year. It also affects the workplace as illicit drug users are more likely to miss more days at work (NIDA, 2005).

Drug misuse in the United States can be traced back to the civil war, but was not recognized as a major dilemma until the 19th century when the United States participated in the International Opium Convention in 1912, designed to control the importation and distribution of opium and other narcotics. By the 1960s and 1970s the United States shifted toward an era of counterculture and drug experimentation and felt the magnitude of addiction and misuse first hand despite prior legislations created to eliminate distribution. In 1970, the Controlled Substances Act was passed by Congress and upheld by President Nixon, and created further regulations pertaining to addictive narcotics, including addictive prescription medication.  By 1971, President Nixon initiated the first significant federal funding of rehabilitation programs as part of his infamous “War on Drugs” which un-coincidentally followed the discovery of methadone as a viable heroin addiction treatment. Some state Medicaid programs stepped into medication assisted treatment (MAT) area first by offering coverage for MAT with methadone in Outpatient Treatment Programs (OTP). Since 1964 methadone has been used for the purpose of treatment of opioid dependence (ASAM, 2013).

England & Wales

The most comprehensive information regarding which populations experience heroin addiction come from treatment centers across England. Patients presenting with either primary or comorbid heroin use accounted for 62% of new patients, and while heroin use is seen across all ages, it is predominately skewed towards an older population (Public, 2013).

 

Table 1   Age and Primary Substance of New Presentations to Treatment in 2012-13
	18-24 n            %	25-29 n            %	30-34 n            %	35-39 n           %	40+ n           %	Total n            %
Opiates only	2,082    17	4,341    34	6,162    41	5,092    43	7,388    43	25,065   36
Opiates/Crack	1,454    12	3,159    25	4,533    30	3,828    32	4,907    29	17,881   26

Note. Adapted from Drug Statistics from the National Drug Treatment Monitoring System, p. 19, by Public Health England, 2013, London, UK: United Kingdom Focal Point at Public Health England.

 

The 2014 UK Focal Point on Drugs provides total overall estimated use for England. The estimated number of people, aged 15-64, with opioid specific use is 256,163, about 4.8% of the population. The estimated number of people, aged 15-64, with opioid and/or crack cocaine use is 293,879, about 5.5% of the population. Combined primary and comorbid heroin use accounts for 10% of the population (Public, 2014).

The most serious negative effects of heroin use are the risks associated with injecting the drug. While users who smoke or snort heroin are also subject to health risks, people who inject drugs (PWID) put themselves in greater danger, especially if they share needles. In 2013 “there were 112 new HIV diagnoses associated with injecting drug use reported in the UK” (Public, 2014, p.89). The rate of HIV among current and former English PWID is 1.2%. Hepatitis C infections are much more common in PWID. In the UK, 90% of Hepatitis C infections “will have been acquired through injecting drug use” (2014, p.90). Besides risks to their own health, heroin users can also cause emotional and financial damage to friends and family. Economically, in the 2013/14 fiscal year, England spent £572.3 million on overall drug misuse services for adults, and £75.6 million and services for young people. Overall this accounted for 24% of the total amount spent on public health (2014).

Meaningful regulation of opiates first occurred in the early twentieth century, despite opium being present in Britain since the tenth century. In 1920 the Dangerous Drugs Act was passed, giving doctors the authority to prescribe dangerous drugs for the treatment of medical conditions; this included prescribing drugs to addicts. While the Home Office was troubled with whether treating addicts by prescribing them drugs was considered proper medical treatment, The Rolleston Committee Report of 1926 stated that addiction was a legitimate medical disease and that prescribing heroin and morphine to addicts was a valid treatment as long as they met two requirements. These requirements were that the patient be receiving treatment under a method of gradual reduction, and that they were healthy enough to receive the drug long term. It was at this time that the standard of dealing with opiate addiction as a medical problem instead of one to be handled by law enforcement was established. It is believed that this method kept opiate addiction rates low, with as little as 290 addicts in the entire country in 1953 (Bennet, 1988).

In the 1960’s, increased drug misuse by adolescents and young adults became a topic of concern. In 1967 the Ministry of Health created plans to establish fifteen drug treatment clinics in London’s major teaching hospitals, as well as twenty-four others in additional parts of England and Wales (Bennet, 1988). The aim of these clinics was to, “contain the spread of heroin addiction by continuing to supply the drug in minimum quantities where this is necessary in the opinion of the doctor” (Strang, 2006, p.1228). The goal was to limit the amount of spare heroin so those who were less committed to using would stop. Treatment centered on injecting addicts with high doses of heroin over a long period of time. As a heroin epidemic swept across the UK in the late 1970’s, attitudes towards treatment shifted, and oral methadone became the primary treatment method with a focus on rapid reduction instead of prolonged maintenance (2006).

Section II: Overview of the Public Law

United States

Title XXXV- Waiver Authority for Physicians Who Dispense or Prescribe Certain Narcotic Drugs for Maintenance Treatment or Detoxification Treatment; commonly known as: Drug Addiction Treatment Act of 200DATA 2000 enables certain physicians to treat opioid addiction with schedule III, IV, and V narcotics approved by the FDA. Waived physicians may prescribe and allocate medications that comply with FDA regulations to patients outside of traditional Opioid Treatment Programs (OTP).

The goal of DATA 2000 is to provide treatment for areas that do not have OTP available and it also removes the element of stigma associated with getting treated at a methadone clinic. The objective is achieved through the regulations set by DATA 2000. OTP’s have regulations of their own such as: attaining valid accreditations, certifications, and registering with different organizations, programs, and branches of the government. The patients must also fit criteria in order to receive treatment through OTPs. The criteria is as follows: a person must have become addicted to an opioid drug at least one year prior to entering the program and it must be a voluntary act. People under the age of 18 had to have two medically assisted detoxification attempts that can be documented or treatment without assistive medication within a year. However, the physician has the ability to waive the requirements if the potential patient is released from a penal institution and has history with opioid addiction; as well as, if the patient is pregnant, and if the patient was previously treated at a facility. The maximum number of times a person can attempt this program is two. In some cases this is where DATA 2000 becomes important because the patient can go to a physician outside of OTPs and receive treatment.

In order for a physician to obtain a waiver for DATA he/she must possess an up-to-date State Medical License, valid DEA registration number, and specialty or subspecialty certification in addiction from ABMS, ASAM, or AOA. A second DEA number is given to physicians who qualify for the waiver and then once a waiver is attained he/she is able to treat up to thirty patients with a narcotic addiction. A 2006 amendment to DATA 2000 allows physicians to treat one hundred patients instead of thirty after the physician has had the waiver for a year or more.

DATA 2000 does not have specific provisions for a social program although; a majority of the patients who benefit from this law are poor and receive their treatment through Medicaid. Medicaid assistance for substance abuse varies depending on individual state’s regulations. Substance abuse treatment can be covered through Medicare if they conclude that it is a necessity and it is administered at an inpatient or outpatient center.

Depending on the way a person looks at this DATA 2000 can be seen as universal because any physician that meets the eligibility requirements can obtain a waiver. It is also seen as residual because of Medicaid’s part in paying for patients’ treatment. Thirty-four states have Medicaid coverage for methadone in narcotic treatment programs (NTPs), thirty-eight have coverage for Suboxone at physician clinics, and thirty states accept Medicaid coverage for Suboxone in NTPs, among other drugs. Some states that cover with Medicaid have time limits or limits on the dosage the drugs being administered to patients (Rinaldo, 2008).

England & Wales

Under Chapter 38 of the “Misuse of Drugs Act in 1971”, the British government set up the Advisory Council on the Misuse of Drugs, for the sole purpose of informing the government on rates of drug misuse and addiction, abuse (Misuse of Drugs Act 1971 c.38). This act was created as part of Britain’s harm reduction model to reduce crime associated with drug addiction and misuse. Opiates, whether prescription or illicit, are now controlled under this act.

Methadone and other opiate substitutes are legal under licensed providers and are controlled substances endorsed for the maintenance of heroin addiction under UK . The objective of using opiate-substitute drugs as viable opiate addiction treatment is to reduce the need for addicts to obtain their drug money or illicit drugs through criminal means, thus reducing crime and the need to share intravenous needles that also can reduce the transmission of HIV/AIDS. General Practitioners and clinics licensed through the state are the only legal providers of these treatments. The UK also provides various opioid addiction intervention treatments and they are provided on an individual basis.

Currently, the United Kingdom holds two main types of rehabilitation treatments: private and state-funded. Private rehabilitation may have abstinent or maintenance programs as well as psychosocial therapy and is often held in-house (Executive Rehab Guide). For most heroin  addicts, private rehabilitation may have too long of a waiting list or may be too expensive. The public National Health Services (NHS) in the UK also provides heroin treatment through general practitioners. The NHS, founded in 1948, receives its funding through taxation so the number of patients treated for heroin addiction is dependent on legislation and tax-paying population (NHS, 2015). Since maintenance treatment lies within national healthcare policies, maintenance treatment is universal and mode of receiving such care is on an individual basis.

The NHS spends most of its budget on treatment clinics such as those that offer methadone or Suboxone and no longer offers any of its budget towards inpatient rehabilitation (NHS Rehabs). From 2010 to 2012, the NHS shut down more than 90 inpatient rehabilitation centers in England alone, focusing instead on maintenance rather than recovery (UK Rehabs). The policies in place by the NHS are often criticized and referred to as “revolving door policies” in which addicts can be referred to a practitioner and can walk into clinics to receive their doses of opiate substitutes with little monitoring on their overall addiction or recovery goals. Addicts may also see different medical providers throughout their entire maintenance treatment or are rarely referred to other community-based organizations; each of these organizations’ eligibility requirements varies.

Section III: Policy Analysis

The current laws covering opioid agonist medication-assisted treatment (OA-MAT) have not been effective at reducing opioid addiction in the United States. Rates of opiate addiction continue to increase, from 634.1 per 100,000 people in 2003 to 891.8 per 100,000 in 2012 (Jones, Campopiano, Baldwin, & McCance-Katz, 2015, p.55). Overdose deaths due to opiates also increased, from 1.4 per 100,000 in 1999 to 5.4 per 100,000 in 2011 (Chen, Hedegaard, & Warner, 2014).

Opiate usage has declined in England & Wales, from 529.5 per 100,000 in 2004/2005 to 456.0 per 100,000 in 2011/2012 (Large, 2015; Burton, Thomson, Visintin, & Wright, 2014, p58). During this same period, the number of users in OA-MAT rose, from just under 100,000 to over 150,000, before leveling off in 2010 (Burton et al., 2014, p.84). Waiting times to start treatment improved between 2006/07 to 2012/13, from 87% to 98% of people receiving treatment in less than 3 weeks (Burton et al., 2014, 77). In spite of these promising facts, no progress was made on reducing overdose deaths. Opiates continue to be the most commonly found drug in overdose deaths (“Trends”, 2015, p.4). From 2005-2013, deaths due to opioid overdose varied, between 1,191-1,592 per year, a rate of under 3 per 100,000 (“Deaths related”, 2015, p.7; “Deaths related”, 2009, p.9).  However, the majority of those deaths were in individuals not currently in treatment (“Trends”, 2015, p.21), and this rate is almost half that of the United States. Opioid addiction continues to be a problem, but treatment in England has been more effective at reducing it.

Research has consistently found that, “OA-MAT with methadone or buprenorphine is the most effective treatment for opioid use disorder. OA-MAT has been shown to increase treatment retention and reduce opioid use, risk behaviors that transmit HIV and hepatitis, and mortality” (Jones et al., 2015, p.55). Outpatient medical treatment is the most efficient intervention for addicts, the “Australian Treatment Outcome Study showed that two-year opioid abstinence rates were projected to cost $5,000 in Australian dollars (AUD) for either buprenorphine or methadone maintenance, $11,000 AUD for residential rehabilitation and $52,000 AUD for prison (ASAM, 2013, p.66).” However, the United States currently lacks the capacity to treat all opioid addicts with OA-MAT. Thirty-seven states have at least 75% of their OTPs operating at greater than 80% capacity, and of those thirty-seven, thirteen have 100% of their OTPs operating at greater than 80% capacity (Jones et al., 2015). DATA-waived physicians are unable to fill this gap in treatment capacity. All states except Maine and Vermont have a maximum buprenophine treatment capacity lower than their opioid addiction rates (Jones et al., 2015). Without coverage expansion, addicts have limited options for OA-MAT and thus are more likely relapse or overdose.

The lack of OA-MAT providers limits the capacity for the treatment in the US. Lifting the patient limit in DATA 2000 would expand access to treatment. During the SAMSHA 2014 Buprenophrine Summit, experts indicated that patient limits were a major obstacle to expanding treatment coverage (“2014 Buprenophine”, pp. 6-10). These limits do not exist at OTPs, but those do not have the geographic coverage needed to treat the current population of addicts in the US. If we want to effectively treat opioid dependence and reduce overdose deaths, more people need to receive OA-MAT treatment.

PUBLIC LAW 106-310

OCT. 17, 2000

CHILDREN’S HEALTH ACT OF 2000

106 P.L. 310; 1101 Stat. 114; 2000 Enacted H.R. 4365; 106 Enacted H.R. 4365

TITLE XXXV—WAIVER AUTHORITY FOR PHYSICIANS WHO DISPENSE OR PRESCRIBE CERTAIN NARCOTIC DRUGS FOR MAINTENANCE TREATMENT OR DETOXIFICATION TREATMENT

SEC. 3502. AMENDMENT TO CONTROLLED SUBSTANCES ACT.

Section 303(g)(2)(B) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B))(iii)

The total of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30,except that unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number.”

• Section 303(g)(2)(B) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)) is amended in clause (iii) by striking “is 30, except” and all that follows through “of this subparagraph.” and inserting “shall be determined by the Secretary in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other substance abuse disorder professionals. The determination shall be guided by science.”

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