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

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."

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.)

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."

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.

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.

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.

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.

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.

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.