Medication Management for Opioid Treatment Programs

Medication Management for Opioid Treatment Programs A. The medication used in the treatment of opioid addiction must at a minimum: 1. Be approved by the Food and Drug Administration; 2. Be administered only as authorized and directed by orders signed by the Medical Director; 3. Be dispensed according to product pharmaceutical label; and 4. Be appropriate to produce the desired response for the desired length of time. B. Urine drug screening must be included as one (1) source of information in making programmatic decisions, monitoring drug use, and making decisions regarding people’s capability to receive take-home medication. These screens must NOT be used as the sole criterion to discharge a person from treatment. C. The program must include methodology for conducting a urine drug screening in its policies and procedures that at a minimum, ensures the following: 1. Urine specimens are obtained in a treatment atmosphere of trust and safety, rather than of punishment and power; 2. Results of all drug testing shall be filed in the person’s record; 3. Urine testing shall be documented and performed by a laboratory certified by an independent, federally approved accreditation entity; 4. Specimen testing includes the same panel and cutoff concentrations as the baseline toxicology report; 5. Specimens are obtained randomly on the basis of the individual clinic visit schedule, but no less than twice a month for the first 30 days and a minimum of eight (8) times in any 12-month period; 6. People have signed a statement that they have been informed about how urine specimens are collected and of the responsibility to provide a specimen when asked (a signed statement must be maintained in the person’s record); 7. The bathroom used for collection is clean and always supplied with soap and toilet articles; 8. That specimens are collected in a manner that minimizes falsification; if using direct observation, the procedures must be carried out ethically and professionally; 9. That results of urine screens are communicated promptly to the person to facilitate rapid intervention with any drug that was disclosed or with possible diversion of methadone (or other treatment) as evidenced by lack thereof or its metabolites in the urine; and 10. The program will develop a specific, DMH-approved policy, requiring that blood serum testing will be done on a person if there is any reason for suspicion that the urine testing is incorrect or in any manner thought to be false. This policy must be developed and approved prior to opening the program. D. The program must have written policies and procedures that outline the documentation and implementation of standard procedures for addressing a failed urine drug screen, which is defined as positive toxicology results for illicit or non-prescribed drugs and/or negative results for drugs provided by the OTP in the course of opioid maintenance therapy. These implemented policies and procedures must include, but are not limited to the following: 1. Baseline toxicology testing results shall be discussed with the person and documentation of this discussion recorded as a progress note in the person’s record. 2. For new people who are within the first 90 days of treatment, a failed urine drug screen will be discussed by the therapist and the person during the next clinic visit to review the treatment plan and modify services as needed. 3. For people with take-home privileges: (a) The first failed urine drug test will result in the following: (1) Person will be placed on probation for 90 days; (2) Person will receive a minimum of two (2) random drug screens per month during the probationary period; and (3) Person must be required to meet with their primary therapist to discuss toxicology results and individual service plan. (b) The second failed urine drug test will result in the following: (1) Person will be transferred to a lower dosing phase; (2) Person will receive a minimum of two (2) random drug screens per month during the probationary period; and (3) Person must be required to participate in a clinical staffing with the treatment team to develop and implement a remedial plan. (c) The third and subsequent failed urine drug test will result in the following: (1) Complete re-assessment; (2) Complete medical re-evaluation of medication dosage, plasma levels, metabolic responses, and adjustment of dosage; (3) Assessment for co-occurring disorders and modifications to treatment protocol as needed; (4) Increase in counseling services, change in primary counselor, and/or family intervention as appropriate; and (5) Consideration of alternative opioid addiction treatment. (d) The sixth consecutive failed urine drug test will result in the person being informed that administrative withdrawal procedures will begin immediately, and a referral made to the appropriate level of care unless the Medical Director: (1) Provides objective clinical contraindications of the need for this action; and (2) Develops a written intervention plan in consultation with the person and the treatment team to detoxify from any substance not prescribed by the OTP and intensify counseling. E. When dispensing Methadone the program must: 1. Ensure that each medication administration and dosage change is ordered and signed by the program Medical Director; 2. Ensure that administration of each dose is documented in the person’s record; 3. Ensure that administration of each dose is documented in the medication sheets; 4. Document administration of the dose with signature or initials of the qualified person administering the medication; and 5. Document the exact number of milligrams of the medication dispensed with daily totals. F. The initial dose of methadone should be prescribed by the Medical Director based on standard medical practice and sound clinical judgment. For each new patient enrolled in a program, the initial dose of methadone shall not exceed 50 mg, and the total daily dose for the first day may not exceed 60 mg, unless the Medical Director documents in the person’s record that 60 mg did not suppress opioid abstinence symptoms. G. Subsequent doses of medication shall be: 1. Individually determined based upon the Medical Director’s evaluation of the history and present condition of the person. 2. Reviewed and updated according to the person’s treatment plan and in consideration of the following criteria: (a) Cessation of withdrawal symptoms. (b) Cessation of illicit opioid use as measured by: (1) Negative drug tests; and (2) Reduction of drug-seeking behavior. (c) Establishment of a blockade dose of an agonist. (d) Absence of problematic craving as measured by: (1) Subjective reports; and (2) Clinical observations. (e) Absence of signs and symptoms of too large an agonist dose after an interval adequate for the person to develop complete tolerance to the blocking dose. 3. Subject to a process which shall be established and implemented by the program to address people who are objectively intoxicated or who are experiencing other problems that would render the administration of methadone unsafe. H. The program shall have a written policy implemented for split dosing that must: 1. Include input from the Medical Director in consultation with the treatment team and the State Opioid Treatment Authority. 2. Accurately reflect that split dosing is guided by outcome criteria that shall include: (a) The person complains that the dosage level is not holding. (b) The person exhibits signs and symptoms of withdrawal. (c) The Medical Director employs peak and trough criteria for split dosing, if appropriate. (d) The Medical Director is unable to obtain a peak and trough ratio for 2.0 or lower, increasing intervals of dosing may be appropriate. (e) Addressing the failure of all avenues of stabilization. (f) Addressing stabilization failures with the person involving the Medical Director and the treatment team. 3. Include provisions for education of the person on the rationale for split dosing and take- home medication. I. The program shall develop, implement, maintain, and document implementation of dosing policies and procedures for the provision of medication to a guest person “Guest Dosing.” The Guest Dosing policies shall at a minimum specify: 1. The person must be enrolled in their home OTP for a minimum of 30 days before being eligible for a guest dose at another OTP unless approval is obtained by the State Opioid Treatment Authority prior to enrollment as a guest. 2. The receiving program must have evidence of two (2) consecutive successful urine drug screens within a 30-day period prior to a person being enrolled for guest dosing unless approval is obtained by the State Opioid Treatment Authority prior to enrollment as a guest. 3. The sending program’s responsibilities include, at a minimum: (a) Develop a document to utilize in transmitting all relevant person and dosing information to the receiving program to request guest dosing privileges; (b) Forward this document to the receiving program; (c) Provide the person with a copy of the document that was sent to the receiving program; (d) Verify receipt of the information sent to the receiving program; (e) Verify that the person understands all stipulations of the guest dosing process including, but not limited to, fees, receiving program contacts, dosing times, and procedures; (f) Accept the person upon return from guest dosing unless other arrangements have been made; and (g) Document all procedures implemented in the guest dosing process in each person’s record. 4. The receiving program’s responsibilities include, at a minimum: (a) Verify receipt of the sending service’s request for guest dosing privileges and acceptance or rejection of the person for guest medication within 48 hours of the request; (b) Communicate any requirements of the receiving program that have not been specified on the document submitted by the sending program; (c) Establish a process for medical personnel to verify dose prior to dosing; and (d) Document all procedures implemented in the guest dosing process in each person’s record. 5. If guest dosing exceeds 14 days, a drug screen shall be obtained. 6. Guest dosing shall not exceed 28 days. J. No dose of methadone in excess of 120 mg per day may be ordered or administered without the prior approval of the State Opioid Treatment Authority. K. Take-home privileges. The service must develop, implement, maintain, and document implementation of policies and procedures that govern the process utilized by the Medical Director and treatment team for determination of unsupervised consumption of medication, referred to as take-home privileges. All information utilized to determine take-home privileges must be documented in the person’s record, with documentation to include at a minimum, the following: 1. Absence of recent use of drugs and/or failed urine drug screens; 2. Regularity of clinic attendance; 3. No observed, reported, or otherwise known serious behavioral problems; 4. Absence of known recent criminal activity; 5. Stability of the person’s home environment and social relationships; 6. Length of time in treatment; 7. Assurance that take-home medication can be safely stored within the person’s home; 8. Personal possession of a secure locking storage device in order to receive the medication from the clinic (NO exceptions); and 9. Decisions and rationale for the approval of take-home privileges. L. The program will adhere to the following schedule of Treatment Phases based on the clinical judgment of the Medical Director and the treatment team's behavioral assessment of the person served. The quantity of take-home medication and frequency of urine drug screens must not be less restrictive than the following: 1. Phase 1 – During the first 90 days of treatment, people will successfully complete a minimum of two (2) urine drug screens per month but will NOT be eligible for any take-home medication. 2. Phase 2 – During days 91-180 of treatment, people will successfully complete one (1) urine drug screen per month to be eligible for two (2) doses per week of take-home medication. 3. Phase 3 – During days 181-270 of treatment, people will successfully complete one (1) urine drug screen per month to be eligible for three (3) doses per week of take-home medication. 4. Phase 4 – During days 271-365 of treatment, people will successfully complete one (1) urine drug screen per month to be eligible for six (6) doses per week of take-home medication. 5. Phase 5 – During the second continuous year of treatment, people will successfully complete one (1) urine drug screen per month to be eligible for 13 doses of take-home medication. 6. Phase 6 – During the third and subsequent continuous years of treatment, people will successfully complete one (1) urine drug screen per month to be eligible for a one (1) month supply of take-home medication. M. Temporary take-home medication for non-emergency: The program shall develop, implement, maintain, and document implementation of written policies and procedures for the process to allow for temporary take-home medication for exceptional circumstances which shall include at a minimum: 1. The need for temporary take-home medication shall be clearly documented with verifiable information in the person’s record; 2. The person must meet the minimum requirements for take-home privileges outlined in