Wisconsin Laws

Requirements for Licensure and Operations of Medications for Opioid Use Disorder Treatment

Question:

Does law address if an OTP is permitted take home dosages of medication?

Answer:
Yes
This answer is derived from 1 section of law
Citation:
  • citation 1: see full citation
    (11) Take-home medication practices.(a) 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the service physician shall determine if take-home doses are appropriate or if approval to take home doses should be rescinded.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:1. 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.2. 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.3. 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.4. 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.5. Service staff may not use the level of the daily dose to determine whether a patient receives take-home medication.(b) 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.(c) 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.(d) 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:1. The patient is not abusing substances, including alcohol.2. The patient keeps scheduled service appointments.3. The patient exhibits no serious behavioral problems at the service.4. The patient is not involved in criminal activity, such as drug dealing and selling take-home doses.5. The patient has a stable home environment and social relationships.6. The patient has met the following criteria for length of time in treatment starting from the date of admission:a. Three months in treatment before being allowed to take home doses for 2 days.b. Two years in treatment before being allowed to take home doses for 3 days.c. Three years in treatment before being allowed to take home doses for 6 days.7. The patient provides assurance that take-home medication will be safely stored in a locked metal box within the home.8. The rehabilitative benefit to the patient in decreasing the frequency of service attendance outweighs the potential risks of diversion.(e) 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.(f) 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.(g) 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:1. The patient is employed, attends school, is a homemaker or is disabled.2. The patient is not known to have used or abused substances, including alcohol, in the previous year.3. The patient is not known to have engaged in criminal activity in the previous year.(h) Observation requirement. 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.(i) Denial or rescinding of approval. A service shall deny or rescind approval for take-home privileges for any of the following reasons:1. Signs or symptoms of withdrawal.2. Continued illicit substance use.3. The absence of laboratory evidence of FDA-approved narcotic treatment in test samples, including serum levels.4. Potential complications from concurrent disorders.5. Ongoing or renewed criminal behavior.6. An unstable home environment.(j) Review.1. 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.2. 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.3. 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.4. 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.(k) Reduction of take-home privileges or requirement of more frequent visits to the service.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.2. 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.(L) Reinstatement. 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.(m) Clinical probation.1. 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.2. 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.(n) 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. see full law