Alabama Administrative Code › Title 540 - ALABAMA BOARD OF MEDICAL EXAMINERS › Chapter 540-X-21 - POLICY ON DATA 2000: GUIDELINES FOR THE TREATMENT OF OPIOID ADDICTION IN THE MEDICAL OFFICE[1] › Section 540-X-21-.04 - Definitions

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Accurate use of
			 terminology is essential to understanding office-based treatment of opioid
			 addiction. However, terminology in this area is changing. For many years, the
			 most commonly used terms have been "drug abuse" and "drug dependence," with the
			 latter indicating a severe condition considered synonymous with the term
			 "addiction" (the chronic brain disease). The terms "abuse" and "dependence," in
			 use since the third edition of the
Diagnostic and Statistical Manual of
			 Mental Disorders
, were replaced in the fifth edition by the term
			 "substance use disorder." Other new terms include "opioid use" for the activity
			 of using opioids benignly or pathologically, and "opioid use disorder" for the
			 disease associated with compulsive, out-of-control use of opioids.
(2) For the purposes of Chapter 540-X-21, the
			 following terms are defined as shown.
(a)
			 Abuse. The definition of "abuse" varies widely, depending on the context in
			 which it is used and who is supplying the definition. For example, in the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
			 Text Revision
(DSM-IV-T), the American Psychiatric Association defines
			 drug abuse as "a maladaptive pattern of substance use, leading to clinically
			 significant impairment or distress, as manifested by one or more behaviors."
			 The
Diagnostic and Statistical Manual of Mental Disorders,
			 Fifth
Edition (DSM-V), published in May 2013, replaces the term
			 "abuse" with "misuse."
(b)
			 Addiction.
1. Addiction is widely defined as
			 a primary, chronic, neurobiologic disease, with genetic, psychosocial, and
			 environmental factors influencing its development and manifestations. It is
			 characterized by behaviors that include the following: impaired control over
			 drug use, craving, compulsive use, and continued use despite harm. (As
			 discussed below, physical dependence and tolerance are normal physiological
			 consequences of extended opioid therapy and are not the same as
			 addiction.)
2. A recent definition
			 of addiction, adopted by the American Society of Addiction Medicine in 2011,
			 reads as follows: "Addiction is a primary, chronic disease of brain reward,
			 motivation, memory and related circuitry. Dysfunction in these circuits leads
			 to characteristic biological, psychological, social and spiritual
			 manifestations. This is reflected in an individual pathologically pursuing
			 reward and/or relief by substance use and other behaviors. Addiction is
			 characterized by inability to consistently abstain, impairment in behavioral
			 control, craving, diminished recognition of significant problems with one's
			 behaviors and interpersonal relationships, and a dysfunctional emotional
			 response. Like other chronic diseases, addiction often involves cycles of
			 relapse and remission. Without treatment or engagement in recovery activities,
			 addiction is progressive and can result in disability or premature
			 death."
(c) Controlled
			 Substance.
1. A controlled substance is a drug
			 that is subject to special requirements under the CSA, which is designed to
			 ensure both the availability and control of regulated substances. Under the
			 CSA, availability of regulated drugs is accomplished through a system that
			 establishes quotas for drug production and a distribution system that closely
			 monitors the importation, manufacture, distribution, prescribing, dispensing,
			 administering, and possession of controlled drugs. Civil and criminal sanctions
			 for serious violations of the statute are part of the government's drug control
			 apparatus. Title 21, Chapter II of the Code of Federal Regulations (21 CFR.
			 §§1300-1399) implements the CSA.
2. The CSA confers the responsibility for
			 scheduling controlled substances on the FDA and the DEA. In granting regulatory
			 authority to these agencies, the Congress noted that both public health and
			 public safety needs are important and that neither takes primacy over the
			 other, but that both are necessary to ensure the public welfare. To accomplish
			 this, the Congress provided guidance in the form of factors that must be
			 considered by the FDA and DEA when assessing public health and safety issues
			 related to a new drug or one that is being considered for rescheduling or
			 removal from control.
3. Most
			 opioids are classified as Schedule II or III drugs under the CSA, indicating
			 that they have a high potential for abuse and a currently accepted medical use
			 in treatment in the U.S., and that abuse of the drug may lead to psychological
			 or physical dependence. (Although the scheduling system provides a rough guide
			 to abuse potential, it should be recognized that all controlled substances have
			 some potential for abuse.)
(d) Dependence.
1. Physical dependence is a state of biologic
			 adaptation that is evidenced by a class-specific withdrawal syndrome when the
			 drug is abruptly discontinued or the dose rapidly reduced, and/or by the
			 administration of an antagonist. It is important to distinguish addiction from
			 the type of physical dependence that can and does occur within the context of
			 good medical care, as when a patient on long-term opioid analgesics for pain
			 becomes physically dependent on the analgesic. The distinction is reflected in
			 the two primary diagnostic classification systems used by health care
			 professionals: the
International Classification of Mental and
			 Behavioural Disorders, 10th Edition
(ICD-10) of the World Health Organization (WHO), and the
Diagnostic and
			 Statistical Manual
of the American Psychiatric Association. In the
			 DSM-IV-TR, a diagnosis of "substance dependence" meant addiction. In the DSM V,
			 the term dependence is reestablished in its original meaning of physiological
			 dependence; when symptoms are sufficient to meet criteria for substance misuse
			 or addiction, the term "substance use disorder" is used, accompanied by
			 severity ratings.
2. It may be
			 important to clarify this distinction during the informed consent process, so
			 that the patient understands that physical dependence and tolerance are likely
			 to occur if opioids are taken regularly for a period of time, but the risk of
			 addiction is relatively low unless the patient has additional risk factors.
			 According to the World Health Organization, "The development of tolerance and
			 physical dependence denote normal physiologic adaptations of the body to the
			 presence of an opioid."
(e) Detoxification.
1. Detoxification (also termed "medically
			 supervised withdrawal") refers to a gradual reduction, or tapering, of a
			 medication dose over time, under the supervision of a physician, to achieve the
			 elimination of tolerance and physical dependence.
2. "Detoxification" is a legal and regulatory
			 term that has fallen into disfavor with some in the medical community; indeed,
			 some experts view "detoxification" as a misnomer because many abusable drugs
			 are not toxic when administered in proper doses in a medical
			 environment.
(f)
			 Diversion.
1. The CSA establishes a closed
			 system of distribution for drugs that are classified as controlled substances.
			 Records must be kept from the time a drug is manufactured to the time it is
			 dispensed. Health care professionals who are authorized to prescribe, dispense,
			 and otherwise control access to such drugs are required to register with the
			 DEA.
2. Pharmaceuticals that make
			 their way outside this closed system are said to have been "diverted" from the
			 system, and the individuals responsible for the diversion (including patients)
			 are in violation of the law. The degree to which a prescribed medication is
			 misused depends in large part on how easily it is redirected (diverted) from
			 the legitimate distribution system.
(g) Maintenance Treatment. Maintenance
			 treatment involves the dispensing or administration of an opioid medication
			 (such as methadone or buprenorphine) at a stable dose and over a period of 21
			 days or more, for the treatment of opioid addiction. When maintenance treatment
			 involves the use of methadone, such treatment must be delivered in an OTP.
			 However, maintenance treatment with buprenorphine may be delivered in either an
			 OTP or a medical office by a properly credentialed physician.
(h) Medication-Assisted Treatment (MAT). MAT
			 is any treatment for opioid addiction that includes a medication (such as
			 methadone, buprenorphine, or naltrexone) that is approved by the FDA for opioid
			 detoxification or maintenance treatment. MAT may be provided in a specialized
			 OTP, or, for buprenorphine or naltrexone, in a physician's office or other
			 health care setting.
(i) Misuse.
			 The term misuse (also termed non-medical use) incorporates all uses of a
			 prescription medication other than those that are directed by a physician and
			 used by a patient within the law and the requirements of good medical
			 practice.
(j) Opioid.
1. An opioid is any compound that binds to an
			 opioid receptor. The class includes both naturally occurring and synthetic or
			 semi-synthetic opioid drugs or medications, as well as endogenous opioid
			 peptides. Most physicians use the terms "opiate" and "opioid" interchangeably,
			 but toxicologists (who perform and interpret drug tests) make a clear
			 distinction between them. "Opioid" is the broader, more appropriate term
			 because it includes the entire class of agents that act as opioid receptors in
			 the nervous system, whereas "opiates" refers to natural compounds derived from
			 the opium plant but not semisynthetic opioid derivatives of opiates or
			 completely synthetic agents. Thus, drug tests that are "positive for opiates"
			 have detected one of these compounds or a metabolite of heroin, 6-monoacetyl
			 morphine (MAM). Drug tests that are "negative for opiates" have found no
			 detectable levels of opiates in the sample, even though other opioids that were
			 not tested for, including the most common currently used and misused
			 prescription opioids, may well be present in the sample that was
			 analyzed.
2.
Opioid
			 agonists
are compounds that bind to the mu opioid receptors in the
			 brain, producing a response that is similar in effect to the natural ligand
			 that would activate it. With full mu opioid agonists, increasing the dose
			 produces a more intense opioid effect. Most opioids that are misused, such as
			 morphine and heroin, are full mu opioid agonists, as is methadone.
3.
Opioid partial agonists
occupy and activate the opioid receptors, but the activation they produce
			 reaches a plateau, beyond which additional opioid doses do not produce a
			 greater effect. It should be noted that the plateau (or "ceiling effect") may
			 limit a partial agonist's therapeutic activity as well as its toxicity.
			 Buprenorphine is a partial mu opioid agonist.
4.
Opioid antagonists
bind
			 to and block the opioid receptors and prevent them from being activated by an
			 opioid agonist or partial agonist. Naltrexone and naloxone both are opioid
			 antagonists, and both can block the effect of opioid drugs.
(k) Opioid Treatment Program
			 (OTP). (Sometimes referred to as a "methadone clinic" or "narcotic treatment
			 program"). An OTP is any treatment program certified by SAMHSA in conformance
			 with 42 CFR, Part 8, Certification of Opioid Treatment Programs (42 CFR
			 §§8.1 through
			 8.34),
			 to provide supervised assessment and medication-assisted treatment of patients
			 who are addicted to opioids. An OTP can exist in a number of settings,
			 including intensive outpatient, residential, and hospital facilities.
			 Treatments offered by OTPs include medication-assisted treatment with
			 methadone, buprenorphine or naltrexone, as well as medically supervised
			 withdrawal or detoxification, accompanied by varying levels of medical and
			 psychosocial services and other types of care. Some OTPs also can provide
			 treatment for co-occurring mental disorders.
(l) Recovery. A process of change through
			 which individuals improve their health and wellness, live a self-directed life,
			 and strive to reach their full potential. As used in the ASAM
[not
			 mentioned/defined elsewhere, spell out?]
Patient Placement Criteria,
			 "recovery" refers to the overall goal of helping a patient achieve overall
			 health and well-being. SAMHSA's 10 guiding principles recognize that recovery:
1. Emerges from hope;
2. Is person-driven;
3. Occurs via many pathways;
4. Is holistic;
5. Is supported by peers and
			 allies;
6. Is supported through
			 relationship and social networks;
7. Is culturally-based and
			 influenced;
8. Is supported by
			 addressing trauma;
9. Involves
			 individual, family and community strengths and responsibility; and
10. Is based on respect.
(m) Relapse.
1. Relapse has been variously defined as "a
			 breakdown or setback in a person's attempt to change or modify any target
			 behavior" and as "an unfolding process in which the resumption of substance
			 misuse is the last event in a long series of maladaptive responses to internal
			 or external stressors or stimuli." Relapse rarely is caused by any single
			 factor and often is the result of an interaction of physiologic and
			 environmental factors.
2. The term
lapse
(often referred to as a
slip
) refers to
			 a brief episode of drug use after a period of abstinence. A lapse usually is
			 unexpected, of short duration, with relatively minor consequences, and marked
			 by the patient's desire to return to abstinence. However, a lapse can also
			 progress to a full-blown relapse, marked by sustained loss of
			 control.
(n) Tolerance.
1. Tolerance is a state of physiologic
			 adaptation in which exposure to a drug induces changes that result in
			 diminution of one or more of the drug's effects over time. Tolerance may occur
			 both to an opioid's analgesic effects and to its unwanted side effects, such as
			 respiratory depression, sedation, or nausea. Most investigators agree that
			 absolute tolerance to the analgesic effects of opioids does not occur. In
			 general, tolerance to the side effects of opioids develops more rapidly than
			 does tolerance to the drug's analgesic effects.
2. Tolerance may or may not be evident during
			 treatment with opioids and is not the same as addiction.
(o) Trial Period. A period of time, which can
			 last weeks or even months, during which the efficacy of a medication or other
			 therapy for the treatment of addiction is tested to determine whether the
			 treatment goals can be met. If the goals are not met, the trial should be
			 discontinued and an alternative approach (i.e, a different medication or
			 non-pharmacologic therapy) adopted.
(p) Waiver. A documented authorization from
			 the Secretary of Health and Human Services, issued by SAMHSA under the DATA
			 2000 regulations, that exempts a qualified physician from the rules applied to
			 OTPs and allows him or her to use buprenorphine for the treatment of addiction
			 in office-based practice.