1 The Federation of State Medical Boards 2013 Model Guidelines for Opioid Addiction Treatment in the Medical Office Adopted April 2013 for Consideration by State Medical Boards
2 2002 FSMB Model Guidelines for Opioid Addiction Treatment in the Medical Office I. Preamble II. Guidelines Compliance with Controlled Substances Laws and Regulations Evaluation of the patient Treatment plan Informed consent and Agreement for Treatment Periodic Patient Evaluation Consultation Medical Records III. Definitions Total length: 5 pages (plus 2 pages of definitions)
3 Revisions to 2002 FSMB Model Guidelines for Opioid Addiction Treatment in the Medical Office I. Preamble: Introduction added with updated references to dose forms and risks of diversion and overdose. II. Guidelines More on physician qualifications and knowledge expectations Addition of option to increase from 30 to 100 patients. Expanded comments on role of non physician professionals Evaluation of the patient More detailed plus additional elements (eg: drug screens, CSRS) Treatment plan Stronger statements regarding benefits of agonist therapy and consideration of therapeutic options. Roles of mono and combo products. Added section on Educating the Patient: Pediatric risk
4 Revisions to 2002 FSMB Model Guidelines for Opioid Addiction Treatment in the Medical Office Informed Consent and Agreement for Treatment More attention to adequate informed consent in setting of agonist substitute dependence. More detail on Treatment Agreements Periodic Patient Evaluation Consultation Expanded into additional sections: Induction, Stabilization Adjusting Treatment Plan Preventing and Managing Relapse Duration of Treatment Medical Records III. Definitions More detailed and specific expectations.
5 2013 FSMB Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office Introduction I. Preamble II. Guidelines Physician Qualifications Patient Assessment Treatment Planning Educating the Patient Informed Consent Treatment Agreement Induction, Stabilization and Follow up Adjusting the Treatment Plan Preventing and Managing Relapse Duration of Treatment Medical Records III. Definitions Total length: 10 pages (plus 4 pages of definitions)
6 Introduction: Background and rationale unchanged. Added comments: New formulations noted: Preference for combo over mono product: Added emphasis: Whenever the mono product is used, extra attention should be given to the risks of misuse and diversion. Overdose potential does exist, particularly with sedatives. Significant risk for non tolerant, particularly children. Potential for misuse and diversion. Repeats claims regarding tablet safety compared to film.
7 Section I. Preamble: Federal Requirements: DATA 2000 Essentially unchanged: State license, DEA license, DEA waiver qualifications Prescription Requirements (unchanged but added to guidelines): Identifying information for patient Drug/dose/form/directions/quantity Dated as of and signed on day issued Regular DEA and X numbers on prescription
8 State Medical Board Requirements: Essentially unchanged:..board will determine the appropriateness of a particular physician's prescribing practices on the basis of that physician s overall treatment.....goal is to provide appropriate treatment of the patient's opioid addiction (either directly or through referral), while adequately addressing other aspects of the patient s functioning, including co occurring medical and psychiatric conditions
9 Section II: Guidelines: 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.
10 Physician Qualifications physician should become knowledgeable about opioid addiction and its treatment, including the use of approved pharmacologic therapies and evidence based nonpharmacologic therapies physician is permitted to treat at any one time to 30 in the first year after obtaining a waiver, and to 100 patients thereafter must file application with DEA demonstrate a capacity to offer (or refer patients for) appropriate counseling and other ancillary services, and to recognize when those services are needed Same: Physicians are not permitted to delegate the prescribing of buprenorphine to non physicians. Added: non physician professionals can play an active role in evaluating and monitoring patients and providing other elements of care
11 Patient Assessment Old: New: Complete medical history and physical exam must be documented in medical record evaluate underlying or coexisting conditions document suitablility based on diagnostic criteria (DSM IV TR). Objectives of assessment are to determine eligibility for treatment, a basis for a treatment plan, and establish a baseline for use in evaluating response to treatment. The assessment should: 1. Establish the diagnosis of opiate addiction, including the duration, pattern, etc. 2. Current withdrawal status. 3. Document use of other substances, including alcohol and other drugs of abuse. 4. Identify co morbid medical and psychiatric conditions 5. Screen for communicable diseases and address them as needed. 6. Evaluate level of physical, psychological and social functioning or impairment; 7. Assess access to social supports, employment, housing, finances and legal problems. 8. Determine the patient s readiness to participate in treatment.
12 Patient Assessment 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. As a general rule, a urine drug screen or other toxicologic screen should be part of the initial evaluation...drug screen should include all opioids commonly prescribed and/or misused in the local community, as well as illicit drugs that are available locally...advisable to access the patient s prescription drug use history through the state s prescription drug monitoring program.
13 Treatment Planning Old: Written treatment agreement stating objectives to determine treatment success. Further diagnostic evaluations or ancillary services needed. Involve significant others when available. Outline contingencies for treatment failure or non compliance.
14 Treatment Planning 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. Physician should balance the risks and benefits of treatment with buprenorphine against the risks associated with no treatment or treatment without medication. Options include: Simple detoxification and no other treatment; Detoxification followed by antagonist therapy; Counseling and/or peer support without medication assisted therapy; Referral to short or long term residential treatment; Referral to an OTP for methadone maintenance; or Treatment with buprenorphine or buprenorphine/naloxone in an office based setting. If a decision is made to offer the patient treatment with buprenorphine 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.
15 Educating the Patient 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. 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.
16 Informed Consent agonist medications 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 difference between addiction and physical dependence switching one addiction for another potential for successfully tapering from agonist thereapy likelihood of relapse with and without medication assisted treatment, importance of adjunctive therapies such as counseling and peer support.
17 Treatment Agreement The terms of treatment agreements vary widely potential benefits and risks and the goals of treatment identification of one provider and one pharmacy authorization to communicate with all providers (and sometimes significant others) need to consult the state's Prescription Drug Monitoring Program treatments or consultations expected for participation permission for drug screens and pill counts policy for prescription renewals, including exclusion of early renewals expected intervals between office visits conditions under which therapy will be continued or discontinued Copies 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.
18 Induction, Stabilization and Follow up Old: Patients should be seen at reasonable intervals (at least weekly during initial treatment) Once stable less frequent visits may be initiated (monthly may be reasonable ) New: 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.
19 Induction, Stabilization and Follow up: Continued The initial induction process requires a higher degree of attention and monitoring than the later maintenance phase Under medication or overmedication can be avoided through a flexible approach to dosing and by taking into account patient reported symptoms most patients are likely to stabilize on eight to 24 mg of buprenorphine per day. 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 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. Compliance should be monitored through patient report, regular toxicologic analyses, reports from significant others, and regular checks of the state's PDMP.
20 Adjusting the Treatment Plan Old: Continuation or modification of therapy should depend on the physician s evaluation of progress toward stated objectives If goals are not being achieved, the physician should re evaluate the appropriateness of continued treatment.
21 Adjusting the Treatment Plan New: Behaviors not consistent with the treatment agreement should be taken seriously further assess the patient and adapt the treatment plan as needed behavior that violates the treatment agreement or a relapse to nonmedical drug use do not constitute grounds for automatic termination of treatment they should be taken as a signal to reassess the patient's status to implement changes in the treatment plan 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).
22 Preventing and Managing Relapse Clinical strategies to prevent and address relapse: Identify environmental cues stressors relapse triggers. Help patients develop skills to cope or manage negative emotional states; Help toward a more balanced lifestyle. Help understand and manage craving. Identify and interrupt lapses and relapses. Develop a recovery support system. Families are more likely to provide such support if they are engaged in tx. process 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
23 Duration of Treatment 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. the decision to discontinue treatment should be made only after serious consideration of the potential consequences. If buprenorphine is discontinued, the patient should be tapered off the medication through use of a safely structured regimen, and followed closely...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 therapy.
24 Medical Records 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. The first page of 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..
25 Medical Records 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. 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, where available, use of the state's prescription drug monitoring program
26 Medical Records Higher level of confidentiality required: Physicians who treat patients for addiction must observe the special confidentiality requirements of federal law 42 CFR, Part 2, which addresses the confidentiality of patients being treated for alcohol or drug addiction. 42 CFR 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.
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