Ala. Admin. Code r. 540-X-21-.04

Current through Register Vol. 43, No. 1, October 31, 2024

Section 540-X-21-.04 - Definitions

(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, 10^th 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.

Ala. Admin. Code r. 540-X-21-.04

Adopted by Alabama Administrative Monthly Volume XXXIII, Issue No. 06, March 31, 2015, eff. 4/23/2015.

Author: Alabama Board of Medical Examiners

Statutory Authority:Code of Ala. 1975, §§ 34-24-53.