Ensure that no patient may be approached to participate in the research unless the patient's participation is approved by the person responsible for the patient's treatment plan.
The medical director of a service is responsible for all of the following:
Ensuring that the service complies with all federal, state, and local statutes, ordinances and regulations regarding medical treatment of narcotic addiction.
Ensuring that evidence of current physiological or psychological dependence, length of history of addiction and exceptions as granted by the state methadone authority to criteria for admission are documented in the patient's case record before the initial dose is administered.
Ensuring that a medical evaluation including a medical history and a physical examination have been completed for a patient before the initial dose is administered.
Ensuring that appropriate laboratory studies have been performed and reviewed.
Signing or countersigning all medical orders as required by federal or state law, including all of the following:
Prescriptions for additional take-home medication for an emergency situation.
Reviewing and countersigning each treatment plan 4 times annually.
Ensuring that justification is recorded in the patient's case record for reducing the frequency of service visits for observed drug ingesting and providing additional take-home medication under exceptional circumstances or when there is physical disability, as well as when any medication is prescribed for physical health or psychiatric problems.
The amount of narcotic drug administered or dispensed, and for recording, signing and dating each change in the dosage schedule in a patient's case record.
A service physician is responsible for all of the following:
Determining the amount of the narcotic drug to be administered or dispensed and recording, signing and dating each change in a patient's dosage schedule in the patient's case record.
Ensuring that written justification is included in a patient's case record for a daily dose greater than 100 milligrams.
Approving, by signature and date, any request for an exception to the requirements under sub. (11)
relating to take-home medications.
Detoxification of a patient from narcotic drugs and administering the narcotic drug or authorizing an agent to administer it under physician supervision and physician orders in a manner that prevents the onset of withdrawal symptoms.
Making a clinical judgment that treatment is medically justified for a person who has resided in a penal or chronic care institution for one month or longer, under the following conditions:
The person is admitted to treatment within 14 days before release or discharge or within 6 months after release without documented evidence to support findings of physiological dependence.
The person would be eligible for admission if he or she were not incarcerated or institutionalized before eligibility was established.
The admitting service physician or service personnel supervised by the service physician records in the new patient's case record evidence of the person's prior residence in a penal or chronic care institution and evidence of all other findings of addiction.
The service physician signs and dates the recordings under subd. 5. c.
before the initial dose is administered to the patient or within 48 hours after administration of the initial dose to the patient.
A patient's history and physical examination shall support a judgment on the part of the service physician that the patient is a suitable candidate for narcotic addiction treatment.
A service shall provide narcotic addiction treatment to a patient for a maximum of 2 years from the date of the person's admission to the service, unless clear justification for longer service provision is documented in the treatment plan and progress notes. Clear justification for longer service shall include documentation of all of the following:
Continued treatment is medically necessary in the professional judgment of the service physician.
Because methadone and other FDA-approved narcotics are medications, the dose determination for a patient is a matter of clinical judgment by a physician in consultation with the patient and appropriate staff of the service.
The service physician who has examined a patient shall determine, on the basis of clinical judgment, the appropriate narcotic dose for the patient.
Any dose adjustment, either up or down, to sanction the patient, to reinforce the patient's behavior or for purposes of treatment contracting, is prohibited, except as provided in par. (h)
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.