The service shall delay administration of methadone to an objectively intoxicated patient until diminution of intoxication symptoms can be documented, or the patient shall be readmitted for observation for withdrawal symptoms while augmenting the patient's daily dose in a controlled, observable fashion.
The narcotic dose that a service provides to a patient shall be sufficient to produce the desired response in the patient for the desired duration of time.
A patient's initial dose shall be based on the service physician's evaluation of the history and present condition of the patient. The evaluation shall include knowledge of local conditions, such as the relative purity of available street drugs. The initial dose may not exceed 30 milligrams except that the total dose for the first day may not exceed 40 milligrams.
A service shall incorporate withdrawal planning as a goal in a patient's treatment plan, and shall begin to address it once the patient is stabilized. A service physician shall determine the rate of withdrawal to prevent relapse or withdrawal symptoms.
A service physician may order the withdrawal of a patient from medication for administrative reasons, such as extreme antisocial behavior or noncompliance with minimal service standards.
The process of withdrawal from medication for administrative reasons shall be conducted in a humane manner as determined by the service physician, and referral shall be made to other treatment services.
Granting take-home privileges.
During treatment, a patient may benefit from less frequent required visits for dosing. This shall be based on an assessment by the treatment staff. Time in treatment is not the sole consideration for granting take-home privileges. After consideration of treatment progress, the service physician shall determine if take-home doses are appropriate or if approval to take home doses should be rescinded. Federal requirements that shall be adhered to by the state methadone authority and the service are as follows:
Take-home doses are not allowed during the first 90 days of treatment. Patients shall be expected to attend the service daily, except Sundays, during the initial 90-day period with no exceptions granted.
Take-home doses may not be granted if the patient continues to use illicit drugs and if the primary counselor and the treatment team determine that the patient is not making progress in treatment and has continued drug use or legal problems.
Take-home doses shall only be provided when the patient is clearly adhering to the requirements of the service. The patient shall be expected to show responsibility for security and handling of take-home doses.
Service staff shall go over the requirements for take-home privileges with a patient before the take-home practice for self-dosing is implemented. The service staff shall require the patient to provide written acknowledgment that all the rules for self-dosing have been provided and understood at the time the review occurs.
Service staff may not use the level of the daily dose to determine whether a patient receives take-home medication.
Treatment team recommendation.
A treatment team of appropriate staff in consultation with a patient shall collect and evaluate the necessary information regarding a decision about take-home medication for the patient and make the recommendation to grant take-home privileges to the service physician.
Service physician review.
The rationale for approving, denying or rescinding take-home privileges shall be recorded in the patient's case record and the documentation shall be reviewed, signed and dated by the service physician.
Service physician determination.
The service physician shall consider and attest to all of the following in determining whether, in the service physician's reasonable clinical judgment, a patient is responsible in handling narcotic drugs and has made substantial progress in rehabilitation:
The patient is not involved in criminal activity, such as drug dealing and selling take-home doses.
The patient has met the following criteria for length of time in treatment starting from the date of admission:
Three months in treatment before being allowed to take home doses for 2 days.
Three years in treatment before being allowed to take home doses for 6 days.
The patient provides assurance that take-home medication will be safely stored in a locked metal box within the home.
The rehabilitative benefit to the patient in decreasing the frequency of service attendance outweighs the potential risks of diversion.
Time in treatment criteria.
The time in treatment criteria under par. (d) 6.
shall be the minimum time before take-home medications will be considered unless there are exceptional circumstances and the service applies for and receives approval from the FDA and the state methadone authority for a particular patient for a longer period of time.
Individual consideration of request.
A request for take-home privileges shall be considered on an individual basis. No request for take-home privileges may be granted automatically to any patient.
Additional criteria for 6-day take-homes.
When a patient is considered for 6-day take-homes, the patient shall meet the following additional criteria:
The patient is employed, attends school, is a homemaker or is disabled.
The patient is not known to have used or abused substances, including alcohol, in the previous year.
The patient is not known to have engaged in criminal activity in the previous year.
A patient receiving a daily dose of a narcotic medication above 100 milligrams is required to be under observation while ingesting the drug at least 6 days per week, irrespective of the length of time in treatment, unless the service has received prior approval from the designated federal agency, with concurrence by the state methadone authority, to waive this requirement.
Denial or rescinding of approval.
A service shall deny or rescind approval for take-home privileges for any of the following reasons:
The absence of laboratory evidence of FDA-approved narcotic treatment in test samples, including serum levels.
The service physician shall review the status of every patient provided with take-home medication at least every 90 days and more frequently if clinically indicated.
The service treatment team shall review the merits and detriments of continuing a patient's take-home privilege and shall make appropriate recommendations to the service physician as part of the service physician's 90-day review.
Service staff shall use biochemical monitoring to ensure that a patient with take-home privileges is not using illicit substances and is consuming the FDA-approved narcotic provided.
Service staff may not recommend denial or rescinding of a patient's take-home privilege to punish the patient for an action not related to meeting requirements for take-home privileges.
Reduction of take-home privileges or requirement of more frequent visits to the service. DHS 75.15(11)(k)1.
A service may reduce a patient's take-home privileges or may require more frequent visits to the service if the patient inexcusably misses a scheduled appointment with the service, including an appointment for dosing, counseling, a medical review or a psychosocial review or for an annual physical or an evaluation.
A service may reduce a patient's take-home privileges or may require more frequent visits to the service if the patient shows positive results in drug test analysis for morphine-like substances or substances of abuse or if the patient tests negative for the narcotic drug administered or dispensed by the service.
A service shall not reinstate take-home privileges that have been revoked until the patient has had at least 3 consecutive months of tests or analyses that are neither positive for morphine-like substances or substances of abuse or negative for the narcotic drug administered or dispensed by the service, and the service physician determines that the patient is responsible in handling narcotic drugs.
A patient receiving a 6-day supply of take-home medication who has a test or analysis that is confirmed to be positive for a substance of abuse or negative for the narcotic drug dispensed by the service shall be placed on clinical probation for 3 months.
A patient on 3-month clinical probation who has a test or analysis that is confirmed to be positive for a substance of abuse or negative for the narcotic drug administered or dispensed by the service shall be required to attend the service at least twice weekly for observation of the ingestion of medication, and may receive no more than a 3-day take-home supply of medication.
Employment-related exception to 6-day supply.
A patient who is employed and working on Saturdays may apply for an exception to the dosing requirements if dosing schedules of the service conflict with working hours of the patient. A service may give the patient an additional take-home dose after verification of work hours through pay slips or other reliable means, and following approval for the exception from the state methadone authority.
A service may grant an exception to certain take-home requirements for a particular patient if, in the reasonable clinical judgment of the program physician, any of the following conditions is met:
The patient has a physical disability that interferes with his or her ability to conform to the applicable mandatory schedule. The patient may be permitted a temporarily or permanently reduced schedule provided that she or he is found under par. (c)
to be responsible in handling narcotic drugs.
The patient, because of an exceptional circumstance such as illness, personal or family crisis, travel or other hardship, is unable to conform to the applicable mandatory schedule. The patient may be permitted a temporarily reduced schedule, provided that she or he is found under par. (c)
to be responsible in handling narcotic drugs.
The program physician or program personnel supervised by the program physician shall record the rationale for an exception to an applicable mandatory schedule in the patient's case record. If program personnel record the rationale, the physician shall review, countersign and date the rationale in the patient's record. A patient may not be given more than a 14-day supply of narcotic drugs at one time.
The service physician's judgment that a patient is responsible in handling narcotic drugs shall be supported by information in the patient's case file that the patient meets all of the following criteria:
Absence of recent abuse of narcotic or non-narcotic drugs including alcohol.
Stability of the patient's home environment and social relationships.
Assurance that take-home medication can be safely stored within the patient's home.
The rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of diversion.
Any exception to the take-home requirements exceeding 2 times the amount in that phase is subject to approval of the designated federal agency and the state methadone authority. The following is the amount of additional take-home doses needing approval: Phase 1 = 2 additional (excluding Sunday); phase 2 = 4 additional; phase 3 = 6 additional; phase 4 = 12 take-home doses required for approval.
Service staff on receipt of notices of approval or denial of a request for an extension from the state methadone authority and the designated federal agency shall place the notices in the patient's case record.
Service staff shall review an exception when the conditions of the request change or at the time of review of the treatment plan, whichever occurs first.
An exception shall remain in effect only as long as the conditions establishing the exception remain in effect.
A service shall use drug tests and analyses to determine the presence in a patient of opiates, methadone, amphetamines, cocaine or barbiturates. If any other drug has been determined by a service or the state methadone authority to be abused in that service's locality, a specimen shall also be analyzed for that drug. Any laboratory that performs the testing shall comply with 42 CFR Part 493
A service shall use the results of a drug test or analysis on a patient as a guide to review and modify treatment approaches and not as the sole criterion to discharge the patient from treatment.
A service's policies and procedures shall integrate testing and analysis into treatment planning and clinical practice.
Drawing blood for testing.
A service shall determine a patient's drug levels in plasma or serum at the time the person is admitted to the service to determine a baseline. The determinations shall also be made at 3 months, 6 months and annually subsequently. If a patient requests and receives doses above 100 milligrams, serum levels shall be drawn to evaluate peak and trough determinations after the patient's dose is stabilized.
Obtaining urine specimens.
A service shall obtain urine specimens for testing from a patient in a clinical atmosphere that respects the patient's confidentiality, as follows:
A urine specimen shall be collected upon each patient's service visit and specimens shall be tested on a random basis.
The patient shall be informed about how test specimens are collected and the responsibility of the patient to provide a specimen when asked.
The bathroom used for collection shall be clean and always supplied with soap and toilet articles.
Specimens shall be collected in a manner that minimizes the possibility of falsification.
When service staff must directly observe the collection of a urine sample, this task shall be done with respect for patient privacy.
Service staff shall discuss positive test results with the patient within one week after receipt of results and shall document them in the patient's case record with the patient's response noted.
The service shall provide counseling, casework, medical review and other interventions when continued use of substances is identified. Punishment is not appropriate.