Opiate Dependence Treatment Rules
EMERGENCY RULES - In effect until January 28, 2012
- Medication Assisted Therapy for Opioid Dependence Rules Rev. 04/21/11
PROPOSED RULES
PRIOR RULES - NO LONGER IN EFFECT:
Authority, Purpose, And Essential Requirements
I. Authority
These rules are established under authority of 18 VSA Chapter 92, which authorizes the Department of Health to establish comprehensive guidelines, by rule, for a regional system of opiate addiction treatment.
II. Purpose
These rules constitute guidelines for a regional system of opiate addiction treatment and were developed by the Department of Health in collaboration with the Opiate Addiction Treatment Advisory Committee described at 18 VSA § 4703.
III. Requirements
Prior to operating, opiate addiction treatment programs must receive written authorization by the Vermont Department of Health. Any program seeking approval to provide opiate addiction treatment must comply with the following essential requirements:
A. Behavioral Therapy
Patients must receive appropriate, comprehensive behavioral therapy.
B. Buprenorphine Use
If pharmacological treatment is medically appropriate, a medical assessment must be conducted for the appropriateness of treatment with buprenorphine, once it is Federally approved for opiate addiction treatment, prior to prescribing methadone.
C. Continuation and Cessation of Pharmacological Treatment
A routine medical assessment of the appropriateness for the patient of continued pharmacological treatment based on protocols designed to encourage cessation of pharmacological treatment must be made as soon as medically appropriate for the individual treatment needs of the patient.
D. Dispensing of Pharmacological Treatments
Federally approved pharmacological treatments for opiate addiction must be dispensed only by authorized treatment programs.
E. Education and Training Requirements
Comprehensive education and training requirements must be established, including relevant aspects of behavioral therapy and pharmacological treatment, for physicians, pharmacists, and certified or licensed alcohol and drug abuse counselors affiliated with an approved treatment program.
F. Rules of Conduct
Rules of conduct for patients must be established in writing, violation of which may result in discharge from the treatment program. These rules must include required urinalysis at such times as the program may direct, and restrictions on medication dispensing designed to prevent diversion of medications and to diminish the potential for patient relapse.
G. Location in Medical Hospitals or Medical School Facilities
Opiate addiction treatment that includes the prescription of pharmacological therapy must be operated only through treatment programs located in medical hospitals or medical school facilities, that have agreed to provide such treatment, in geographically well-suited locations in this state.
Opiate Treatment Approval Guidelines
These rules are based on the Center for Substance Abuse Treatment (CSAT) Guidelines for the Accreditation of Opiate Treatment Programs and have been written to comply with Vermont statute.
Introduction
Treatment Considerations Related to the Natural History of the Disease
The clinical assessment of all patients should take into account the natural history of opiate addiction as altered by time and treatment. Patients normally proceed from one stage of treatment to the next, or move back and forth among the naturally occurring stages.
The stages of pharmacological treatment therapy are listed below. It is important at all stages that psychosocial, as well as medical treatment, be of sufficient intensity and duration to be effective.
1. Initial treatment: consisting of intensive assessment and intervention, from 3 to 7 days in duration.
2. Early stabilization: from the third to seventh day of treatment through 8 weeks
3. Long-term treatment: from the end of early stabilization for an indefinite period of time.
4. Medically supervised withdrawal with continuing care, if and when appropriate.
The patient’s response to treatment determines her or his progression through the stages of treatment. Some patients may sometimes remain in one stage for a considerable period of time while, in contrast, others may progress very quickly. It is not uncommon for a patient to relapse.
I. Administrative Organization and Responsibilities
Pharmacological treatment for opiate addiction must be based in a medical hospital or the medical school facility. This is to ensure the ability to provide daily dosing and integration with medical services, among other things.
Administrative responsibilities, both for organizations and individual practitioners, are adequate to ensure quality patient care and to meet the requirements of the laws and regulations of the U.S. Department of Health and Human Services, Drug Enforcement Administration, and the State of Vermont.
A. Goals
Each treatment program shall have a written statement of its goals for patient care.
B. Human Resources Management
Each treatment program has a written plan approved by the Vermont Department of Health to ensure that staffing patterns are appropriate and adequate for the needs of the patients being served.
II. Management of Facility and Clinical Environment
Each treatment facility:
1. Has sufficient space and adequate equipment for the provision of all specified services including diagnosis, evaluation, and treatment of other medical, psychiatric, and behavioral disorders if they are to be carried out on site.
2. Maintains documentation that it meets all local and state safety and environmental codes.
3. Ensures protection of confidentiality including the use of locked files and the availability of private individual offices for counseling.
4. Provides a warm and welcoming atmosphere in a therapeutic environment that is "conducive to rehabilitation.... and conveys a sense of dignity and trust between program and patients" (Treatment Improvement Protocol (TIP) 1, State Methadone Treatment Guidelines, page 33).
5. Will provide services during hours that meet the needs of the overwhelming majority of patients, including hours before and/or after the traditional 8:00 a.m. to 5:00 p.m. working day, when possible.
III. Risk Management and Continuous Quality Improvement
A. Legal Issues
1. Obtains voluntary, written, program-specific informed consent to treatment from each patient at admission.
2. Informs each patient about all treatment procedures, services, and other policies and regulations throughout the course of treatment.
3. Obtains voluntary, written, informed consent to the prescribed pharmacotherapy from each patient before dosing begins.
4. Informs each patient of the following:
a. That the natural history of opiate addiction is altered by time and history;
b. That the goals of pharmacological medication therapy are stabilization of functioning, and, when medically appropriate, cessation of pharmacological treatment.
c. That at periodic intervals, in full consultation with the patient, the provider will discuss present level of functioning, course of treatment, and future goals.
5. Informs each patient at admission about State-specific requirements and program policies regarding the report of suspected child and elder abuse and neglect as well as other forms of abuse (e.g. violence against women).
6. Adheres to all requirements of the Federal confidentiality regulations (42 CFR Part 2).
7. Promulgates and makes available a written description of patients rights and responsibilities.
8. Follows written due process procedures for any involuntary terminations of patients.
9. Develops credentialing procedures to ensure that all staff maintains current credentials for performing their assigned job responsibilities.
B. Life Safety Issues
Each treatment program:
1. Develops procedures to ensure that the correct dose of medication(s) is administered and that appropriate actions are taken if an error is made, including a mechanism for reporting untoward incidents to appropriate program staff.
2. Provides 24-hour, 7-day per week access to designated program staff, so that patient emergencies may be addressed and dosage levels may be verified. Displays in facility offices and waiting areas and provides to patients the names and telephone numbers of who should be contacted in case of an emergency.
3. Ensures that there are appropriately trained staff on duty who are trained and proficient in CPR, management of opiate overdose, and other techniques as appropriate.
4. Develops and maintains an up-to-date disaster plan that specifies emergency evacuation procedures, fire drills, and maintenance of fire extinguishers.
5. Establishes policies and procedures that address safety and security issues for patients and staff, including training for staff to handle physical or verbal threats, acts of violence, inappropriate behavior, loitering, or other escalating and potentially dangerous situations, with emphasis on when security guards or police need to be summoned.
C. Continuous Quality Improvement Policies
Each treatment program
1. Provides regular and continuous staff education.
2. Maintains staff development plans.
3. Reviews and recertifies program policies and procedures at least annually.
4. Elicits ongoing input from patients in the development of program policies and procedures.
5. Develops and implements periodic patient satisfaction surveys.
6. Adheres to universal infection control precautions promulgated by the U.S. Centers for Disease Control and Prevention (CDC), and Vermont Occupational Safety and Health Administration (VOSHA) requirements.
7. Measures and monitors treatment outcomes and processes such as:
a. Reducing or eliminating the use of illicit opiates, illicit drugs, and the problematic use of licit drugs.
b. Reducing or eliminating associated criminal activities.
c. Reducing behaviors contributing to the spread of infectious diseases.
d. Improving quality of life by restoration of physical and mental health and functional status.
8. Develops a diversion control plan that covers both staff and patient conduct and that demonstrates accountability to the community.
D. Adverse Events
1. Establishes written procedures to prevent adverse events that could negatively impact patients and their family members, the program, or staff.
2. Establishes procedures, in case a specified or unanticipated adverse event occurs, to ensure
a. Full documentation of the adverse event
b. Prompt investigation and review of the situation surrounding the event
c. Implementation of timely and appropriate corrective action(s)
d. Ongoing monitoring of any corrective actions until their effectiveness is established.
IV. Professional Staff Credentials and Development
A. Each treatment program shall ensure:
1. Doctors, nurses, and other licensed professional care providers must maintain their current license and comply with the credentialing requirements of their own professions. Specific credentialing by any formal body for work in addictions is desirable but not essential.
2. Addiction counselors must meet the qualifications outlined by the employing program and the State of Vermont.
3. All staff receive initial education specific to the pharmacotherapies and corresponding behavioral therapies to be used and tailored to the patient populations to be served.
4. All staff receive continuing education.
5. An individual annual training plan is implemented.
6. Detailed job descriptions are developed for credentialed and non credentialed staff which clearly define the qualifications and competencies needed to provide specific services.
7. Records are kept of staff training events, including the qualifications of educators, outline of content, description of methods, and attendees; records of staff training events should be kept in personnel files.
8. Access to resources for problem solving and troubleshooting.
V. Patient Admission Criteria
A. Evidence of Current Physiological Dependence and Opiate Addiction
1. Program physician must document that treatment is medically necessary.
2. Criteria for admission should be based on DSM IV definition of opiate dependence.
3. Behavior supportive of a diagnosis of addiction includes:
a. Continuing use of the opiate despite known adverse consequences to self, family or society
b. Obtaining illicit opiates
c. Using prescribed opiates inappropriately.
d. One or more unsuccessful attempts at gradual removal of physical dependence on opiates (detoxification) using methadone. This is also called medically supervised withdrawal (MSW). An unsuccessful attempt at MSW is evidenced by uncontrollable drug craving (or actual use) caused by insufficient methadone dose during an admission for detoxification or MSW. There should be no artificial barrier created nor should there be a set amount of time that separates the transfer from an unsuccessful attempt at detoxification or MSW directly into the early phase of pharmacological maintenance treatment.
4. There may be individuals in special populations who have a history of opiate use but who are not currently physiologically dependent. The absence of physiological dependence should not be an exclusion criterion, and admission is clinically justified. This is because individuals in these populations are susceptible to relapse to opiate addiction leading to high-risk behaviors with potentially life threatening consequences. These populations include the following:
a. Persons released from a penal institution within the past 60 days
b. Persons recently discharged from a chronic care facility
c. Pregnant patients
d. Previously treated patients.
e. Adolescents
B. Avoiding Multiple Program Enrollments
Reasonable measures are taken to prevent patients from enrolling in treatment provided by more than one clinic or individual practitioner. These measures are commensurate with the severity of the problem and its documented consequences.
Programs will participate in a central registry designed and implemented by the Vermont Department of Health. All patients will be given an individual patient identifier.
VI. Patient Medical and Psycho-social Assessment
The purpose of an assessment is to determine treatment eligibility, develop a treatment plan, and establish a measure for the response to treatment. For all applicants initially deemed eligible for opiate therapy, a comprehensive physical examination, laboratory work up as indicated, psycho-social assessment, preliminary treatment plan, and patient orientation is completed during the initial treatment stage.
If pharmacological therapy is medically appropriate, a medical assessment shall be conducted for the appropriateness of treatment with bupenorphine, once it is federally approved for opiate addiction, prior to prescribing methadone. Such decisions regarding the appropriate medication to be prescribed shall be made in consultation between the patient and the medical director.
A. Levels of Assessments/Evaluations
Assessments generally comprise an intake screening assessment and an intensive initial evaluation. The screening is conducted to determine whether the patient may appropriately receive pharmacological treatment therapy. The intensive evaluation includes medical and health history, and physical examination to determine initial dosage and placement of the patient into the appropriate level of treatment. Upon completion of proper patient consent, the program seeks medical records from other health care providers. The health history is used to determine the length of dependence for placement purposes and to identify other chronic or acute medical conditions that affect the patient’s health.
Each program:
1. Determines current physical dependence and addiction. History, examination, and screening are used to determine the patient’s current degree of dependence on narcotics and, to the extent possible, the length of time the patient has been dependent on opiates. This assessment includes a physical examination for the presence of clinical signs of addiction, such as old and fresh needle marks, constricted or dilated pupils, and/or an eroded or perforated nasal septum and a state of sedation or withdrawal. The examination evaluates the observable and reported presence of withdrawal signs and symptoms, such as yawning, rhinorrhea, lacrimation, chills, restlessness, irritability, perspiration, piloerection, nausea, and diarrhea.
2. Documents medical and family history. A complete medical history, including but not limited to chronic or acute medical conditions, such as diabetes, renal diseases, hepatitis B, C, and delta, HIV, tuberculosis (TB), sexually transmitted diseases (STDs), other infectious diseases, pregnancy (including past history of pregnancy and current involvement in prenatal care), and chronic cardiopulmonary diseases is documented. Programs complete a full medical evaluation within 7 days of treatment initiation.
3. Completes a psychiatric history and mental status examination with DSM-IV categorization as part of a general medical evaluation.
4. Completes information on the patient’s family, including sex and date of birth of children, whether children are living with parents, and family medical and drug use histories.
5. Employs a multi-disciplinary evaluation approach. Such an approach may be conducted by multi disciplinary team members. As an alternative, this evaluation may be conducted by one or more individuals, but must evaluate the following areas—medical, psycho-social, vocational, educational, behavioral, marital, financial, legal, health and self-care needs of patient. This evaluation should be conducted within approximately 30 days of initiation of patient treatment. Assessment updates and treatment plan updates should be conducted quarterly for the first year of continuous treatment and semiannually for subsequent years.
B. Medical Laboratory Evaluation/Diagnostic Criteria
1. Required tests
a. TB skin test and chest x-ray if skin test is positive (including consideration for anergy), and,
b. Screening test for STDs.
2. Recommended tests and assessments. Based on an individual’s history and physical examination, programs investigate the possibility of infectious disease, pulmonary, cardiac abnormalities, dermatologic sequelae of addiction and possible concurrent surgical and other problems by conducting,
a. Complete blood count (CBC)
b. EKG, chest x-ray, Pap smear, screening for sickle cell disease
c. Hepatitis B surface antigen (HbsAG) and Hepatitis B surface antibody (Anti-HBs)
d. HIV testing (and counseling)
3. Urine drug-screening tests must be analyzed for opiates, methadone, amphetamines, cocaine, marijuana, and barbiturates. Urine testing for other drug use should be determined by community drug use patterns or individual medical indications.
4. Other considerations include the following:
a. Financial problems, transportation to referral sites, stress, and poor mental and physical well being may be barriers to comprehensive laboratory testing upon admission. Other tests may be deferred until the patient has stabilized.
b. Patients are usually in poor physical health and require other health care. Three months after admission is the optimal deadline for completing needed health-related procedures.
VII. Guidelines for Therapeutic Dosage
A. General Dosage Principles
1. The dose of pharmacological maintenance medication is individually determined on the basis of clinical judgment after review by a physician or other professional practitioner with prescribing privileges who is knowledgeable about, and experienced in, addiction medicine including pharmacological therapy.
2. Pharmacological maintenance medication doses are sufficient to produce the desired response in the patient for the desired duration of time, with allowance for a margin of effectiveness and safety.
3. Pharmacological therapy has three desired clinical effects, which are, in ascending importance:
a. Preventing the onset of subjective and/or objective signs of opiate abstinence syndrome for 24 hours or more
b. Reducing or eliminating the drug hunger or craving routinely experienced by the opiate-addicted individual when not in treatment
c. Blocking the effects of any illicitly acquired, self-administered opiates without inducing persistent euphoric or other undesirable effects that are experienced by the patient or noticed by other observers.
B. Maintenance Therapy
1. A documented history and physical examination supports the judgment by the physician that the patient is a suitable candidate for pharmacological therapy.
2. The initial full day dose of methadone is based on the physician’s evaluation of the history and present condition of the patient, with added knowledge of such local conditions as the relative purity of available street drugs.
3. The usual initial dose of pharmacological treatment should be from 20-30 milligrams. Reasons for exceeding an initial dose of 30 mg. need to be carefully documented in the clinical chart and should not exceed 40 mg., unless the physician documents in the patients’ record that 40 mg. did not suppress opiate abstinence symptoms after a 3 hour period of observation. Addicted patients abusing diverted medical opiates alone may require a lower initial dose of methadone, and should have the initial dose of methadone based on standard dose conversion tables and their recent amount of opiate intake.
4. Initial dosing of Levo-Alpha Acetyc Methadol (LAAM) and other approved medications should be based on the package insert. Deviations from this must be documented by the physician.
5. Induction and maintenance dosages follow the principles defined in CSAT’s, State Methadone Treatment Guidelines, with particular attention to steady-state pharmacokinetics with accumulation during the induction process.
6. The maintenance dose is individually determined with careful and caring attention to the essential information provided by the patient; the dose should be determined by a physician experienced in addiction treatment and should be adequate to achieve the desired effects for 24 hours or more with allowance for day-to-day fluctuations and elimination patterns.
7. The ordering physician shall insure that the justification for daily doses of methadone above 100 mg. are documented in the patient’s record.
8. The total dose of methadone and the interval between doses may require adjustments for patients who have atypical metabolism patterns or are prescribed other concurrent medications, which alter rates of methadone metabolism.
9. Pharmacological treatment is medication: Manipulating doses to reinforce positive behavior or to punish negative behavior is prohibited.
10. Doses of methadone and LAAM or other approved medications are adjusted as needed if a program switches from one generic formulation to another and differences in effective dose cause clinically relevant complaints.
11. The program should have the capability of obtaining medication blood levels when clinically indicated.
12. Cessation of pharmacological treatment shall be encouraged as soon as clinically appropriate.
C. Medical Withdrawal from Pharmacological treatment
Medical withdrawal refers to a medically supervised, gradual reduction or tapering of dose over time to achieve the elimination of tolerance and physical dependence to methadone or LAAM.
1. A plan for voluntary withdrawal from pharmacological therapy—as distinct from involuntary withdrawal and administrative withdrawal and other types of withdrawal discussed in section X. is developed in partnership between the patient and physician.
2. If medical withdrawal is initiated, dosages of methadone or LAAM are reduced at a rate that is well tolerated by the patient and also in accordance with sound medical practices.
3. For women of childbearing potential, the results of a pregnancy test are reviewed before initiating medical withdrawal of methadone or LAAM.
4. Pharmacological therapy is resumed in the event of impending relapse.
D. Pain Management in Maintenance Patients
1. Management of chronic pain in the methadone-maintained patient includes consultation with a specialist in pain medicine when possible and appropriate.
2. Management of acute pain in the methadone-maintained patient entails
a. Continuation of the regularly scheduled methadone dose
b. Additionally prescribing adequate doses of appropriate medications, including short-acting pharmacological medications is addressed in more detail later in this document.
VIII. Treatment Planning, Evaluation of Patient Progress in Treatment, and Continuous Clinical Assessment
A. Intensity and Duration of Treatment
1. In general, a greater intensity of services is desirable at the beginning of treatment.
2. Many patients often need psychosocial services for an extended period of time due to the multiplicity of their problems.
3. For long-term opiate addiction treatment, many patients need continuing medication with or without psycho-social services as outlined in TIP 20, Matching Treatment to Patient Needs in Opiate Substitution Therapy.
B. Retention in Treatment
1. Treatment programs make every effort to retain patients in treatment only as long as clinically appropriate and medically necessary.
2. Appropriate therapeutic measures are taken to address the other problems identified in the treatment plan.
C. Relapse Prevention
1. Psychosocial treatment continues for patients electing to discontinue pharmacotherapy.
2. If possible, hospital-based treatment programs track patients and reinstitute pharmacotherapy at the first sign of relapse or impending relapse
3. Some patients during their treatment no longer need psychosocial services. If the need for psychosocial services reemerges, however, programs provide the opportunity to return to full services.
D. Involvement of Family and Significant Others in Treatment
Treatment programs provide opportunities for family involvement in therapy.
IX. Testing for Drug Use
A. Urine drug screening (as well as other adequately tested toxicological testing procedures) is used as an aid in monitoring and evaluating a patient’s progress in treatment within a context that assesses a variety of outcome measures.
B. All treatment personnel in a pharmacological therapy program understand the benefits and the limitations of urine screening and other toxicological testing procedures.
C. Programs collect all urine or other toxicological specimens in a therapeutic context that suggests trust, respect and minimizes falsification. Reliance on direct observation, video camera monitoring, or one-way mirrors, although necessary for some patients, is neither necessary nor appropriate for all patients. Temperature testing is minimally intrusive and highly effective in identifying "counterfeit" or altered urine specimens.
D. Programs test urine samples for opiates, methadone, amphetamines, marijuana, cocaine, and barbiturates at the minimum. Any additional testing is based on individual patient need and local drug using conditions and trends. Treatment programs should make their laboratories aware of the fact that workplace testing standards for urine testing are not appropriate in the treatment context.
E. Program staff addresses results of urine screens promptly with patients to facilitate rapid intervention with any drug taking that was disclosed or possible diversion of methadone as evidenced by lack of methadone or its metabolites in the urine.
F. Programs conduct an initial urine or other toxicology test as part of the admission process. Thereafter, the frequency of urine screens or other toxicological testing is determined by the clinical appropriateness for each individual patient and related to the stage of treatment. Patients in the initial phases of treatment may require more frequent testing. During later phases of treatment, the testing schedule is reduced, but structured to ensure a rapid response to the possibility of relapse.
G. Programs document both the results of urine tests and follow-up therapeutic actions in the patient record.
H. Treatment programs establish procedures for addressing potentially false positive and false negative urine or other toxicology test results following principles outlined in TIP 1, State Methadone Guidelines.
X. Withdrawal and Discharge
Programs provide two types of withdrawal procedures: medical/therapeutic and administrative withdrawal. Medical/therapeutic is a voluntary, patient/physician-initiated withdrawal. In contrast, administrative withdrawal is usually involuntary. However, in those cases where a patient must be administratively discharged from pharmacotherapy, the program offers a humane withdrawal schedule. The person’s condition during medical or administrative withdrawal is periodically recorded in the patient’s record.
A. Administrative Withdrawal
1. Administrative withdrawal may result from disruptive conduct or behavior considered to have an adverse effect on the program, staff, or patient population of such gravity as to justify the involuntary withdrawal and discharge of a patient despite an extremely poor prognosis. Such behaviors include violence, threat of violence, dealing drugs, repeated loitering, flagrant non-compliance resulting in an observable, negative impact on the program, staff, and other patients.
2. In order to receive approval, programs are required to develop detailed written rules of conduct that include, but are not limited to, requirements for program participation, loitering, urinalysis, and use of other drugs (including alcohol) or medications.
B. Medical Withdrawal
Medical withdrawal occurs
1. As a voluntary and therapeutic withdrawal agreed upon by physician and patient, or
2. In response to the request of the patient against the advice of the physician, counselor, and other staff; that is, Against Medical Advice (AMA).
C. Support of Medical Withdrawal
The following program policies and procedures promote successful medical withdrawal whether conducted with or against medical advice:
1. Dose reduction occurs at a rate well tolerated by the patient.
2. A variety of supportive options are available to improve chances of a successful withdrawal.
3. Increased counseling is available prior to discharge.
4. Participants are encouraged to attend a self-help program that is sensitive to the needs of pharmacological therapy patients.
D. Additional Considerations for Medical Withdrawal Against Medical Advice (AMA)
1. The patient has the right to leave treatment when he or she chooses to do so.The program explains the risks of leaving treatment.
2. The physician, in consultation with the patient, determines the schedule for withdrawal from pharmacological therapy.
3. In the case of a patient who leaves a program abruptly, the program may readmit the patient within 30 days without a formal reassessment procedure.
4. The program documents the issue that caused the patient to seek discharge, and provides a full documentation of steps taken to avoid discharge.
E. Continuing Care
1. Continuing care is considered an essential part of treatment and includes discharge planning and relapse prevention.
2. Continuing care also includes procedures that address patients’ physical and mental health problems following withdrawal from pharmacological therapy, including the need for counseling and appropriate medication to help with sleep disorders, depression, and other problems.
3. Provisions are made for continuing care following the last dose of medication and for re-entry to maintenance treatment if relapse occurs.
XI. Management of Concurrent Alcohol and Polysubstance Abuse
A. Concurrent abuse of other drugs is managed within the context of the pharmacological therapy effort following principles described in TIP 10, Assessment and Treatment of Cocaine-Abusing Methadone-Maintained Patients, and TAP 7, Treatment of Opiate Addiction with Methadone.
B. Program staff are knowledgeable about current, effective strategies for treating alcohol, cocaine, and other drug abuse.
C. Ongoing multi-drug use is not necessarily a reason for discharge unless the patient refuses recommended, more intensive levels of care. Patients engaging in such multi-drug use must be carefully evaluated to determine the most therapeutic course of treatment.
D. When possible, comorbidities are concurrently managed on-site. This includes management of multiple drug use problems as well as psychiatric and medical disorders. Coexisting conditions are most effectively treated at a single site.
XII. Concurrent Services
A. Orientation to Treatment
Patients receive orientation to treatment initially and receive education on an ongoing basis about
1. Signs and symptoms of overdose and when to seek emergency assistance
2. The medication they are taking, including side-effects and common myths about the medication or modality of treatment
3. The nature of addictive disorders
4. The benefits of treatment and nature of the recovery process
5. Clinic guidelines, rules, and regulations, including the requirement to sign a formal agreement of informed consent
6. Noncompliance and discharge procedures, including administrative medication withdrawal
7. Patient’s rights
8. Confidentiality
9. Drug-screening and urinalysis procedures
10. Dispensing of medication
11. HIV and other infectious diseases
12. Potential drug interactions.
B. Substance Abuse Counseling
Appropriately trained, experienced, and licensed substance abuse counselors provide services of the intensity and duration required to meet the individual needs of each person. Staffing patterns are determined by the characteristics and needs of a particular patient population. Likewise, patient-staff ratios are sufficient to ensure reasonable and prompt access to counselors by patients and to provide the frequency and intensity of counseling services required.
C. Self-Help Groups
The use of self-help groups is encouraged but not required in pharmacotherapy. Traditional self-help groups are sometimes unfamiliar with maintenance patients. Programs can establish their own self-help programs or identify those groups that are accepting of maintenance pharmacotherapy.
D. Counseling on HIV Disease
1. Programs provide counseling on HIV disease and other infectious diseases and their prevention for every patient.
2. Programs provide risk reduction education to patients.
3. Patients are referred to HIV/AIDS services in their community and/or are connected with the Vermont Department of Health HIV/AIDS Program.
E. Medical Services
1. Providing basic primary care on-site is highly recommended, but not required. Referrals for medical and psychiatric treatment shall be made when indicated. Coordination of care should also be provided and those staff responsible for making linkages should be knowledgeable about pharmacotherapy treatment (e.g., drug interactions, acute withdrawal, and overdose). Medications which have their effectiveness enhanced by directly observed therapy (DOT)--such as tuberculosis medications, and psychiatric medications—can be effectively dispensed with the daily opiate dose. Likewise, psychotropic medications, which are indicated but subject to abuse, may be given through DOT.
2. Programs train staff to respond to medical emergencies within the clinic or office environment and ensure that needed supplies are available.
XIII. Special Considerations
A. Care of Patients: Cultural Competency
1. Programs develop and implement written, non-discrimination policies to ensure equal access to treatment for all persons in need regardless of race, ethnicity, gender, age (with specific reference to policies for minors) and sexual orientation.
2. Programs are sensitive to the culture and values of the persons being treated.
3. Programs ensure that persons in positions of authority are professionally and culturally competent (for example, that these persons are able to work effectively with the local community and/or receive input from advisors or committee members in the local community in terms of gender, ethnicity and language or are representative of it).
4. Unbiased language is used in print materials, electronic media, and course offerings.
5. Co-occurring mental health issues will not exclude persons from pharmacological treatment.
B. Care of Patients with Mental Health Needs
1. Programs ensure that patients with mental health needs are identified through the evaluation process and referred to appropriate treatment.
2. Program discharge procedures ensure that patients are monitored during withdrawal for emergence of symptoms of mental illness.
3. Programs establish and use linkages with mental health providers in the community.
4. Programs establish a mechanism to evaluate mental health medication jointly with the mental health provider. If possible and indicated, programs may dispense such medications in conjunction with the daily methadone dose in the hospital setting.
C. HIV Testing and Care of HIV-Positive Patients
1. Programs develop and implement a plan for educating patients about HIV/AIDS, testing procedures, confidentiality, reporting, and follow-up care, counseling, safer-sex, and not sharing intravenous equipment.
2. Programs offer HIV-positive patients options to receive pharmacological therapy and HIV/AIDS care and treatment.
3. Programs establish and use linkages with HIV/AIDS treatment programs in their communities and/or the Department of Health HIV/AIDS Program.
D. Patients with Chronic Pain
1. Programs shall make careful diagnostic distinctions between the physical dependence associated with chronic administration of opiates for relief of pain and the disease of opiate addiction. Apparent drug-seeking behaviors, typically associated with the disease of chronic opiate addiction, may occur as a response to inadequately treated or prolonged pain ("pseudo-addiction"). The physical dependence and tolerance to opiates seen in some chronic pain patients is an expected physiological response to pharmacological therapy and does not support a diagnosis of active opiate addiction.
2. Four of the seven criteria for "Substance Dependence" are useful in differentiating chronic pain patients with opiate dependency problems who are most appropriate candidates for methadone/LAAM therapy. The relevant criteria are:
a. Unsuccessful efforts to control use (loss of control)
b. Large amounts of time spent in activities to obtain or recover from effects; that is, compulsion (except as necessary to obtain pain relief)
c. Giving up or reducing important social, occupational, or recreational activities
d. Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance (DSM-IV, p. 181).
E. Emergencies
1. Programs maintain a 24-hour telephone answering capability to respond to facility and patient emergencies. A roster of patients and a log of medication dosages are accessible to the staff person on call for verification purposes.
F. Voluntary and Involuntary Closure
1. Authorized programs shall establish a plan to ensure continuity of care for patients in the event of voluntary or involuntary closure of program, that includes steps for the orderly transfer of patients, records, and assets to other programs.
2. Programs develop a plan to ensure that patient records from programs that are closing are secured and maintained in accordance with State and Federal regulations for a specified period of time.
G. Adolescents
1. A person under 18 is required to have had two documented attempts at short-term medically supervised withdrawal (detoxification) or drug free treatment to be eligible for maintenance treatment. The program physician shall document in the patient’s record that the patient continues to be or is again physiologically dependent on narcotic drugs. No person under 18 years of age, except an "emancipated minor", may be admitted to a maintenance treatment program unless a parent, legal guardian, or responsible adult completes and signs consent form, Form FDA 2635 "Consent to Methadone Treatment."
2. Programs tailor assessments to the developmental stage of the patient.
3. Programs develop and implement policies to ensure that adolescents are not harassed or exploited by older patients or staff.
H. Criminal Justice
1. Programs establish agreements and develop procedures to coordinate with agents of the criminal justice system on behalf of patients.
XIV. Care of Women in Treatment
A. General Principles
1. The policies and procedures of each treatment program reflect the specific needs of female patients.
2. Treatment programs make provisions to provide for respectful and safe treatment of women.
3. All staff receive training in the specific characteristics and needs of women participating in their particular treatment program.
4. Program policies ensure appropriate clinical flexibility in assigning female patients to counselors who are sensitive to and trained to address their individual needs (e.g., domestic violence, sexual abuse).
5. Program policies and procedures ensure that the option of same gender groups is available to all patients, as needed.
B. Pregnant and Postpartum Patients
1. Priority is given to pregnant women who seek treatment; the reasons for denying admission to any pregnant applicant are documented on an intake log.
2. It is strongly suggested that appropriate prenatal care, in consultation with an OB/GYN physician be provided on-site or by referral. Vermont Department of Health District Offices can assist with referrals. If a pregnant patient is referred elsewhere, the treatment program has agreements in place, including informed consent procedures, that ensure reciprocity in the exchange of pertinent clinical information regarding compliance with the recommended course of medical care.
3. If a pregnant patient refuses direct prenatal services or appropriate referral for such care, the treating physician in the pharmacological therapy program may use informed consent procedures to have the patient formally acknowledge in writing that these services were offered but refused.
4. With respect to pharmacotherapy for opiate-addicted pregnant women in pharmacological therapy, the program
a. Maintains patients who become pregnant during treatment on the pre-pregnancy dosage, if effective, and applies the same dosing principles as used with any other non-pregnant patient.
b. Ensures that the initial methadone dose for a newly admitted pregnant patient and the subsequent induction and maintenance dosing strategy reflect the same effective dosing protocols used for all other patients.
c. Monitors the methadone dose carefully, especially during the third trimester when pregnancy induced changes in the rate at which methadone is metabolized or eliminated from the system may necessitate either an increased or split dose.
d. Ensures that if a pregnant patient elects to withdraw from methadone, a physician experienced in addiction medicine supervises the withdrawal process, regular fetal assessments as appropriate for gestational age are part of the withdrawal process, and withdrawal is not initiated before 14 weeks or after 32 weeks gestation.
5. The program encourages breast-feeding during pharmacological therapy unless medically contraindicated, e.g., by the presence of HIV or HTLV I and II infection in the mother.
6. The treatment program establishes and implements policies and procedures, including informed consent, to ensure appropriate follow-up primary care of the new mother and well baby care for the infant.
7. If a pregnant patient is discharged, the program will identify the physician to whom the person served is being discharged. The name, address and telephone number of the physician should be recorded in the record of the person served.
C. Concurrent Pregnancy and HIV Infection
1. Pregnant women in pharmacological therapy with concomitant HIV infection are subject to the same policies and procedures established for all HIV-infected patients in treatment and receive the same services.
2. A treatment team approach provides OB/GYN and HIV care along with drug addiction treatment to pregnant patients with HIV/AIDS.
3. Treatment programs ensure that all pregnant patients with concurrent HIV infection are (1) informed that AZT is currently recommended to reduce perinatal transmission, and (2) provided with appropriate referrals and case management for this treatment.
D. Family Needs
1. The treatment program either offers on-site education and training for all male and female parenting patients, or refers patients to appropriate parenting skills services, and makes appropriate child care services available.
2. Program services include reproductive health education for all patients and appropriate referrals, as needed, for contraceptive services.
XV. Patients’ Rights
A. Principles
1. Patients receiving pharmacological treatment for opiate addiction are entitled to the rights provided in 18 VSA Chapter 42.
B. Confidentiality
1. Disclosure of patient records maintained by an opiate treatment program is governed by the provisions of 42 CFR Part 2, and every program must comply with that part and with all other applicable Federal and State confidentiality requirements.
C. Grievances
1. Patients have the right to initiate grievance procedures in accordance with 18 VSA §1852.
XVI. Record Keeping and Documentation
All records shall be retained for a minimum of ten years.
A. Patient Records
Patient records are confidential and updated in a timely manner. They contain legible entries, and are organized in a manner that facilitates access to specific elements of the record as well as measurement of individual patient treatment outcomes. Programs should have record retention policies and safeguards for the destruction of old containers, labels, printouts, and clinic records. Programs’ procedures should ensure security of electronic transfers and protection of confidential data stored in the computer.
Individual records maintained for each patient contain the following:
1. Identifying and basic demographic data and results of screening process. All information should be accessible and understandable to appropriate authorities.
2. Documentation of compliance with the Department of Health’s central registry system.
3. The initial assessment report.
4. An assessment of each person must be completed by the third visit.
5. Medical reports, including results of physical examination, past and family medical history; review of systems; nursing notes; laboratory reports, including results of regular toxicology screens; and progress notes, including documentation of current dose and other dosage data. Information in the medical record entered is by physicians and other licensed health professionals.
6. Dated case entries of all significant contacts with patients, including a record of each counseling session in chronological order.
7. Dates and results of case conferences for patients.
8. The treatment plan, and any amendments to it; quarterly reviews and updates of the assessment and treatment plan for the first year of continuous treatment; semiannual assessment and treatment plan updates for subsequent years; and, in subsequent years, a semiannual summary by the counselor which includes an evaluation of the existing treatment plan and the patient’s response to treatment.
9. Documentation that all services listed in the treatment plan are available and have actually been provided.
10. A written report of the process and factors considered in decisions impacting patient treatment or any other significant change in treatment, both positive and negative.
11. A record of correspondence with patient, family members, and other individuals, and a record of each referral for service and its results.
12. Documentation that the patient was provided with a copy of the program’s rules and regulations and a statement of patient’s rights and responsibilities, and that these items were discussed with her/him.
13. Consent forms, release(s) of information, prescription documentation, travel, employment, etc.
14. A closing summary, including reasons for discharge and any referral. In the case of death, the cause of death is documented.
B. Records of Storage, Dispensing, and Administering Methadone/LAAM
1. Each program has policies and procedures consistent with current DEA, other Federal, and State statutes and regulations.
2. Each medication order and dosage change is written on an acceptable order sheet signed by the physician.
a. Each dosage dispensed, prepared or received is recorded and accounted for by written signed notation in a manner which creates a perpetual and accurate inventory of all methadone in stock at all times.
b. Every dose is recorded on an administration sheet at the time that the dose is administered or dispensed and also on the patient’s individual medication dose history.
c. The qualified person administering or dispensing signs his or her name or initials at each notation.
d. If initials are used, the full signature of the qualified person administering or dispensing appears at the end of each page of the medication sheet.
e. The substance is totaled in milligrams daily.
3. Programs have a procedure for calibrating medication dispensing instruments consistent with manufacturers’ recommendations to ensure accurate patient dosing and substance tracking.
C. Other Records
1. Programs maintain individualized personnel files as a record of employment. These files contain employment and credentialing data deemed appropriate by the employer. It is recommended that they contain employment application data and date of employment, updated licensing and credentialing data, detailed job descriptions, performance evaluations, and appropriate training records.
2. Programs develop and implement procedures to avoid duplication of information gathering.
XVII. Diversion Control
Each program shall have a diversion control plan that demonstrates accountability and efficient use of personnel and other resources to achieve the highest quality of patient care while reducing possibilities for diversion of controlled substances from legitimate treatment to illicit use. The plan shall include the following:
A. A mechanism for continuous monitoring of clinical and administrative activities, to reduce the risk of medication diversion.
B. A mechanism for problem identification and correction, and for prevention of related diversion problems.
XVIII. Participation in Opiate (pharmacological) Therapy Research Activities
A. Patients have the right to give informed consent prior to being involved in research projects, and the right to retain a copy of the informed consent form.
B. Patients have the right to full disclosure of information about treatment and medication, including accommodation for those who do not speak English, or who are otherwise unable to read an informed consent form.
C. Programs are encouraged to participate in research activities as long as they do not compromise the integrity of the treatment process.
D. Research conducted in the treatment program does not compromise the integrity of the treatment process.
E. The director of the treatment program has the authority to consider participation in proposed research or study that is based on sound scientific principles.
F. All research involving human subjects is conducted in accordance with accepted Federal human subject protection standards.
G. Treatment and other services are not jeopardized for any patient who refuses to participate in research activities.
REFERENCES
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: Fourth Edition; DSM-IV. Washington, DC: American Psychiatric Association, 1994. Center for Drug Evaluation and Research of the Food and Drug Administration and the National Institute on Drug Abuse.
Guidance on the Use of Methadone in Maintenance and Detoxification Treatment of Narcotic Addicts. Rockville, MD, March, 1989. Center for Substance Abuse Treatment. State Methadone Treatment Guidelines. Treatment Improvement Protocol (TIP) 1. Rockville, MD: US Department of Health and Human Services, 1993 , DHHS Publication No. (SMA) 93-1991.
Technical Assistance Publications (TAPs) are publications, manuals, and guides developed by the Center for Substance Abuse Treatment (CSAT) to offer practical responses to emerging issues and concerns in the substance abuse treatment field. Each TAP is developed by an expert who has had firsthand experience with the topic. Treatment Improvement Protocols (TIPs) are best practice guidelines for the treatment of substance abuse. CSAT’s Office of Evaluation, Scientific Analysis, and Synthesis draws on the experience and knowledge of clinical, research, and administrative experts to produce the TIPs.
CSAT is part of the Substance Abuse and Mental Health Services Administration (SAMHSA) which is an agency of the U.S. Department of Health and Human Services. SAMHSA’s Office of Communications may be reached at (301) 443-8956.
NOTE:
These Department of Health's Opiate Addiction Treatment Rules were adopted effective May 21, 2001. Section III.G of the Rules repeats the language of 18 VSA § 4702(b)(7) that opiate addiction treatment that includes the prescription of pharmacological therapy shall be operated only through treatment programs located in medical hospitals or medical school facilities, that have agreed to provide such treatment, in geographically well-suited locations in this state.
On June 16, 2001, Governor Howard Dean signed Act 63 (2002) into law. Section 115a(a) of Act 63, which supplements the Opiate Addiction Treatment statutes and rules, reads as follows:
(a) Notwithstanding the provisions of 18 V.S.A. § 4702(b)(7), the commissioner of health may approve up to five opiate addiction treatment programs operated by, and located outside of a hospital or medical school, after consideration of the space requirements and space availability at the hospital or medical school, provided that the program is located in a multi-use building, so that the purpose for which a person is entering or leaving the building is not obvious. Programs approved by the commissioner shall be located in close proximity to other medical and social services and shall not be geographically located in isolated community settings.
Section 115a(a) of Act 63 should be viewed as supplementing 18 VSA Chapter 92 and the rules established under this Chapter's authority.