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-.03 - Guidelines

(a) Multiple studies have shown that opioid addiction treatment with buprenorphine can be successfully integrated into office practice by physicians who are not addiction specialists. In such studies, patient outcomes are comparable to or better than outcomes of patients treated in specialized clinics. However, as in the treatment of any medical disorder, physicians who choose to offer addiction treatment need to understand the nature of the underlying disorder, the specific actions of each of the available medications (as well as any associated contraindications or cautions), and the importance of careful patient selection and monitoring.

(b) The Board has adopted the following guidelines for the treatment of opioid addiction in office-based settings. The guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of accepted professional practice.

(a) The diagnosis and medical management of opioid addiction should be based on current knowledge and research, and should encompass the use of both pharmacologic and nonpharmacologic treatment modalities. Thus, before beginning to treat patients for opioid addiction, the physician should become knowledgeable about opioid addiction and its treatment, including the use of approved pharmacologic therapies and evidence-based nonpharmacologic therapies.

(b) Physicians who wish to prescribe or dispense buprenorphine for the treatment of opioid addiction must meet the requirements of DATA 2000, which are that the physician must be licensed in the state, have a valid DEA controlled substances registration and identification number, comply with federal and state regulations applicable to controlled substances, and hold a current waiver.

(c) In addition to these requirements, DATA limits the number of patients that a physician is permitted to treat at any one time to 30 in the first year after obtaining a waiver, and to 100 patients thereafter. The physician who wishes to treat more than 30 patients after the first year must file an application with the DEA to extend his or her waivered capacity to do so.

(d) DATA 2000 also requires that a physician who wishes to treat opioid addiction with buprenorphine in an office setting must demonstrate a capacity to offer (or refer patients for) appropriate counseling and other ancillary services, and to recognize when those services are needed.

(e) Physicians are not permitted to delegate the prescribing of buprenorphine to non-physicians. Even physicians who hold DEA registrations to prescribe controlled substances for other conditions are not allowed to prescribe buprenorphine for the treatment of addiction unless they meet the DATA requirements and hold a waiver. However, non-physician professionals can play an active role in evaluating and monitoring patients and providing other elements of care, in accordance with state regulations and rules governing physician supervision and medical oversight.

(f) Physicians should consult federal regulations (21 CFR § 1301.28) and statutes (21 USC 823(g)); the resources available on the DEA's website (at www.deadiversion.usdoj.gov); and Board rules governing the issuance of prescriptions for controlled substances.

(a) The objectives of the patient assessment are to determine a given patient's eligibility for treatment, to provide the basis for a treatment plan, and to establish a baseline measure for use in evaluating a patient's response to treatment. Accordingly, the assessment should be designed to achieve the following:

(b) Assessment usually begins at the time of the patient's first office visit and continues throughout treatment. While the evidence is not conclusive, consensus opinion is that an initial patient assessment is of higher quality when it includes a medical and psychiatric history, a substance abuse history, and an evaluation of family and psychosocial supports, as well as a pregnancy test for all women of childbearing age. The physical examination, if performed during the initial assessment, can be focused on evaluating neurocognitive function, identifying sequelae of opioid addiction, and looking for evidence of severe hepatic dysfunction.

(c) As a general rule, a urine drug screen or other toxicologic screen should be part of the initial evaluation to confirm recent opioid use and to screen for unreported use of other drugs. Ideally, this drug screen should include all opioids commonly prescribed and/or misused in the local community, as well as illicit drugs that are available locally. It also is advisable to access the patient's prescription drug use history through the Alabama Department of Public Health Prescription Drug Monitoring Program (PDMP), both to confirm compliance in taking prescribed medications and to detect any unreported use of other prescription medications.

(d) Information from family members and significant others can provide useful additional perspectives on the patient's status, as can contact with or records from clinicians who have treated the patient in the past.

(a) There is an emerging consensus among addiction experts that treatment medications such as buprenorphine should be considered as an option for every opioid-addicted patient. However, the failure to offer medication-assisted treatment does not in itself constitute substandard care. No single treatment is appropriate for all persons at all times. Therefore, an individualized treatment plan is critical to the patient's ultimate success in returning to productive functioning.

(b) The treating physician should balance the risks and benefits of medication-assisted treatment in general -- and treatment with buprenorphine in particular -- against the risks associated with no treatment or treatment without medication. The various options include:

(c) If a decision is made to offer the patient treatment with buprenorphine, the risks associated with possible misuse and diversion are such that the combination buprenorphine/naloxone product is preferable for most patients. The monoproduct should be used only rarely except in pregnant women, for whom it is the preferred formulation.

(d) Psychosocial and other nonpharmacologic interventions often are useful components of treatment. Such interventions typically work best in conjunction with medication-assisted therapies; in fact, there is some evidence that the combination of pharmacologic and non-pharmacologic interventions may be more effective than either approach used alone. The ability to offer patients psychosocial supports, either on-site or through referral, is a requirement of the DATA 2000 legislation.

(a) Every patient to whom buprenorphine is prescribed should be cautioned to follow the directions exactly, particularly during the induction stage. Critical issues involve when to begin dosing, the frequency of subsequent doses, and the importance of avoiding the use of any other illicit or prescription opioid.

(b) Concurrent use of non-opioid sedating medications or over-the-counter products also should be discussed, and patients should be advised to avoid the use of alcohol.

(c) Patients should be cautioned about potential sedation or impairment of psychomotor function during the titration phase of induction with buprenorphine.

(d) Finally, because opioids can contribute to fatal overdoses in individuals who have lost their tolerance to opioids or in those who are opioid-naive (such as a child or other family member), proper and secure storage of the medication must be discussed. Particularly where there are young people in the patient's home, the subject of safe storage and use should be revisited periodically throughout the course of treatment, with the discussions documented in the patient record.

(a) Although agonist medications such as buprenorphine clearly are effective for the treatment of opioid dependence, they do entail a substitute dependence on the prescribed medication to replace the prior dependence on the misused opioid. This issue should be thoroughly discussed with the patient in terms of potential risks and benefits as part of the informed consent process. Patients and family members often are ambivalent about agonist treatment for this reason and their concerns may influence subsequent treatment choices. Possible topics of discussion include the difference between addiction and physical dependence (including an explanation of why agonist therapy is not simply "switching one addiction for another"), the likelihood of relapse with and without medication-assisted treatment, the projected duration of the treatment, the potential for successfully tapering from agonist therapy at some point in the future, and the role and importance of adjunctive therapies such as counseling and peer support. With the patient's consent, this conversation could include family members, significant other(s), or a guardian.

(b) A written informed consent document, discussed with and signed by the patient, can be helpful in reinforcing this information and establishing a set of "ground rules." The practitioner should document the informed consent in the patient's medical record.

(a) The terms of treatment agreements vary widely, but typical provisions include an acknowledgment of the potential benefits and risks of therapy and the goals of treatment; identification of one provider and one pharmacy from whom the patient will obtain prescriptions; authorization to communicate with all providers of care (and sometimes significant others) and to consult the PDMP; other treatments or consultations in which the patient is expected to participate, including recovery activities; avoidance of illicit substances; permission for drug screens (of blood, urine, saliva or hair/nails) and pill counts as appropriate; mechanisms for prescription renewals, including exclusion of early renewals; expected intervals between office visits; and specification of the conditions under which therapy will be continued or discontinued.

(b) The agreement also should include a statement instructing the patient to stop taking all other opioid medications unless explicitly told to continue. Such a statement reinforces the need to adhere to a single treatment regimen. Inclusion in the agreement of a pharmacy address and telephone number reinforces to the patient the importance of using one pharmacy to fill prescriptions.

(c) Finally, the treatment agreement should set forth the objectives that will be used to evaluate treatment success, such as freedom from intoxication, improved physical and psychosocial function, and adherence to the treatment regimen.

(d) Copies of the treatment agreement and informed consent should be provided to the patient and all other care providers, and filed in the patient's medical record. The agreement should be reviewed regularly and adjusted as needed.

(a) The goal of induction and stabilization is to find the lowest dose of buprenorphine at which the patient discontinues or markedly reduces the use of other opioids without experiencing withdrawal symptoms, significant side effects, or uncontrollable craving for the drug of abuse.

(b) The initial induction process requires a higher degree of attention and monitoring than the later maintenance phase. Particular attention should be given to the timing of the initial doses so as to minimize untoward outcomes. Withdrawal symptoms can occur if either too much or too little buprenorphine is administered (i.e., spontaneous withdrawal if too little buprenorphine is given, precipitated withdrawal if buprenorphine is administered while the opioid receptors are substantially occupied by an opioid agonist). Undermedication or overmedication can be avoided through a flexible approach to dosing, which sometimes requires higher doses of treatment medication than expected, and by taking into account patient-reported symptoms.

(c) The stabilization phase is focused on finding the right dose for an individual patient. A patient is stabilized when the dose allows him or her to conduct activities of daily living and to be aware of his or her surroundings without intoxication and without suffering withdrawal or distressing drug craving. Although there is no precise way to determine in advance what the optimal dose for a particular patient will be, most patients are likely to stabilize on eight to 16 mg. of buprenorphine per day, although some may need doses of up to 24 mg per day. As the dose of Buprenorphine increases, the board recognizes that the risk for diversion and abuse also increases. While the board recognizes that from time to time a patient may need a higher dose of Buprenorphine, it is expected that the clinical reasons for an increased dose be documented in the medical records, and that the clinician utilize available resources to be vigilant for risk of diversion regardless of dosage prescribed.

(d) Buprenorphine blood concentrations stabilize after approximately seven days of consistent dosing. If withdrawal symptoms subsequently emerge during any 24-hour dosing interval, the dose may be too low, or other factors may be involved. Medical factors that may cause a patient's dose requirements to change include (but are not limited to) starting, stopping. or changing the dose of other prescription medications; onset and progression of pregnancy; onset of menopause; progression of liver disease; and significant increase or decrease in weight.

(e) Dose adjustments generally can be made in increments of 2 mg/day. Because buprenorphine has a long plasma half-life and even longer duration of action at the mu opioid receptor, five days should be allowed between dose adjustments.

(f) Patient adherence to medication regimens and session appointments is associated with better treatment outcomes, and regular monitoring can help patients plan for possible obstacles and teach them ways to handle any problems that occur. Regular assessment of the patient's level of engagement in treatment and the strength of the therapeutic alliance allows for modification of the treatment plan and level of care in response to the patient's progress or lack thereof.

(g) Early in treatment, medications should be prescribed and follow-up visits scheduled commensurate with the patient's demonstrated stability. Until patients have shown the ability to be compliant with the treatment plan and responsible with their medication supplies, and have discontinued high-risk behaviors and associated diversion risks, they should be seen more frequently and given supplies of medication only as needed until the next visit. As patients demonstrate stability and the risk declines, they can be seen less often (typically once a month) and prescribed larger supplies of medication.

(h) Patient monitoring during follow-up visits should address the following points:

(i) The patient's compliance with regard to use of prescribed buprenorphine and avoidance of other opioids should be monitored through patient report, regular toxicologic analyses, reports from significant others, and regular checks of the PDMP.

(j) Individuals being treated with medication-assisted treatment often demonstrate dramatic improvement in addiction-related behaviors and psychosocial functioning. Such positive changes should be acknowledged and reinforced by the prescribing physician whenever possible. Reducing the frequency of monitoring visits, with their associated costs, and increasing the patient's responsibility for medications are examples of how positive, responsible behaviors can be reinforced.

(a) Treatment outcomes typically are positive for patients who remain in treatment with medication-assisted therapies such as buprenorphine. However, some patients struggle to discontinue their misuse of opioids or other drugs, are inconsistent in their compliance with treatment agreements, or succeed in achieving some therapeutic goals while not doing well with others.

(b) Behaviors that are not consistent with the treatment agreement should be taken seriously and used as an opportunity to further assess the patient and adapt the treatment plan as needed. In some cases, where the patient's behavior raises concerns about safety or diversion of controlled medications, there may be a need to refer the patient for treatment in a more structured environment (such as an OTP). However, behavior that violates the treatment agreement or a relapse to nonmedical drug use do not constitute grounds for automatic termination of treatment. Rather, they should be taken as a signal to reassess the patient's status, to implement changes in the treatment plan (as by intensifying the treatment structure or intensity of services), and to document such changes in the patient's medical record.

(c) Whenever the best clinical course is not clear, consultation with another practitioner may be helpful. The results of the consultation should be discussed with the patient and any written consultation reports added to the patient's record.

(d) Patients with more serious or persistent problems may benefit from referral to a specialist for additional evaluation and treatment. For example, the treatment of addiction in a patient with a comorbid psychiatric disorder may be best managed through consultation with or referral to a specialist in psychiatry or addiction psychiatry. In other instances, aberrant or dysfunctional behaviors may indicate the need for more vigorous engagement in peer support, counseling, or psychotherapies, or possibly referral to a more structured treatment setting.

(a) Relapse always should be ruled out as a reason for loss of stability. Relapse to drug use has been described as "an unfolding process in which the resumption of substance abuse is the last event in a long series of maladaptive responses to internal or external stressors or stimuli." It rarely is caused by any single factor; rather, it is a dynamic process in which the patient's readiness to change interacts with other external and internal factors. Patients in relapse vary in the quantity and frequency of their substance use, as well as the accompanying medical and psychosocial sequelae.

(b) Clinical strategies to prevent and address relapse generally encompass the following steps:

(c) It should be noted that lack of adherence to pharmacologic regimens occurs in a substantial portion of patients being treated for addiction, with some studies reporting that a majority of patients fail to follow the treatment plan at some point in their care. Retention in treatment is also a problem. This is no different from the challenges encountered in managing any chronic disease, such as diabetes, hypertension, epilepsy, and other potentially life-threatening disorders, and is not an indication to terminate treatment.

(d) Patients who continue to misuse opioids after sufficient exposure to buprenorphine and ancillary psychosocial services or who experience continued symptoms of withdrawal or craving at 32 mg of buprenorphine should be considered for therapy with methadone.

(a) Available evidence does not support routinely discontinuing medication-assisted treatment once it has been initiated and the patient stabilized. However, this possibility frequently is raised by patients or family members. When it is, the physician and patient should carefully weigh the potential benefits and risks of continuing medication-assisted treatment and determine whether buprenorphine therapy can be safely discontinued.

(b) Studies indicate that opioid-dependent patients are at high risk for relapse when medication-assisted treatment is discontinued, even after long periods of stable maintenance. Research also shows that longer duration of treatment is associated with better treatment outcomes. Such long-term treatment, which is common to many medical conditions, should not be seen as treatment failure, but rather as a cost-effective way of prolonging life and improving the quality of life by supporting the natural and long-term process of change and recovery. Therefore, the decision to discontinue treatment should be made only after serious consideration of the potential consequences.

(c) As with other disease processes, the continuation of medication-assisted treatment should be linked directly to the patient's response (for example, his or her attainment of treatment goals). Relapse risk is highest in the first six to 12 months after initiating abstinence, then diminishes gradually over a period of years. Therefore, it is reasonable to continue treatment for at least a year if the patient responds well.

(d) If buprenorphine is discontinued, the patient should be tapered off the medication through use of a safely structured regimen, and followed closely. It may be necessary to reinstate pharmacotherapy with buprenorphine or a different medication or other treatment services if relapse appears imminent or actually occurs. Such relapse poses a significant risk of overdose, which should be carefully explained to the patient. Patients also should be assured that relapse need not occur for them to be reinstated to medication-assisted treatment.

(a) Accurate and up-to-date medical records protect both the physician and the patient. In the event of a legal challenge, detailed medical records that document what was done and why are essential elements of the practitioner's defense.

(b) A written informed consent and a treatment agreement articulating measurable treatment goals are key documents. The treatment agreement should be updated as new information becomes available. Both the informed consent and treatment agreement should be carefully explained to the patient and signed by both the patient (or guardian) and the treating physician. The medical record should clearly reflect the decision-making process that resulted in any given treatment regimen.

(c) The patient's chart should contain a summary of the information needed to understand the treatment plan, even without a thorough knowledge of the patient. This includes some demographic data, the names of other practitioners caring for the patient, all diagnoses, therapies employed, and a list of all medications prescribed. The name, telephone number, and address of the patient's pharmacy also should be recorded to facilitate contact as needed.

(d) Other documents that should be part of the medical record, where available, include:

(e) The medical record also must include all prescription orders, whether written or telephoned. In addition, written instructions for the use of all medications should be given to the patient and documented in the record.

(f) Monitoring visits should be carefully documented in the medical record, along with any subsequent changes to the treatment plan. The patient's record also should contain documentation of steps taken to prevent the diversion of treatment medications, including any communications with other treating physicians and use of the PDMP to verify that all prescribed medicines have been obtained and that no other prescriptions for controlled drugs have been dispensed without the physician's knowledge.

(g) Records (including drug logs, if buprenorphine is dispensed in the office) should be up-to-date and maintained in an accessible manner, readily available for review. Good records demonstrate that a service was provided to the patient and establish that the service provided was medically necessary. Even if the outcome is less than optimal, thorough records protect the physician as well as the patient.

(h) Physicians who treat patients for addiction must observe the special confidentiality requirements of federal law found in 42 CFR, Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR §§2.1 through 2.67), which addresses the confidentiality of patients being treated for alcohol or drug addiction. Title 42 CFR, Part 2, includes a prohibition against release of records or other information without the patient's consent or a valid court order, or in cases of a bona fide medical emergency, or in the course of mandatory reporting of child abuse.