Take Home Regulation Page 4098

Page 4098

Federal Register

Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

(i) Unsupervised or “take-home” use.

To limit the potential for diversion of opioid agonist treatment medications to the illicit market, opioid agonist treatment medications dispensed to patients for unsupervised use shall be subject to the following requirements.

(1) Any patient in comprehensive maintenance treatment may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and State and Federal holidays.

(2) Treatment program decisions on dispensing opioid treatment medications to patients for unsupervised use beyond that set forth in paragraph (i)(1) of this section, shall be determined by the medical director.

1. Absence of recent abuse of drugs (opioid or nonnarcotic),including alcohol;
2. Regularity of clinic attendance;
3. Absence of serious behavioral problems at the clinic;
4. Absence of known recent criminal activity, e.g., drug dealing;
5. Stability of the patient’s home environment and social relationships;
6. Length of time in comprehensive maintenance treatment;
7. Assurance that take-home medication can be safely stored within the patient’s home; and
8. Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion.

(3) Such determinations and the basis for such determinations consistent with the criteria outlined in paragraph (i)(2) of this section shall be documented in the patient’s medical record. If it is determined that a patient is responsible in handling opioid drugs, the following restrictions apply:

1. During the first 90 days of treatment, the take-home Supply (beyond that of paragraph (i)(1) of this section) is limited to a single dose each week and the patient shall ingest all other doses under appropriate supervision as provided for under the regulations in this subpart.
2. In the second 90 days of treatment, the take-home Supply (beyond that of paragraph (i)(1) of this section) is two doses per week.
3. In the third 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is three doses per week.
4. In the remaining months of the first year, a patient may be given a maximum 6-day supply of take-home medication.
5. After 1 year of continuous treatment, a patient may be given a maximum 2-week supply of take-home medication.
6. After 2 years of continuous treatment, a patient may be given a maximum one-month supply of take-home medication, but must make monthly visits.

(4) No medications shall be dispensed to patients in short-term detoxification treatment (with or without commercial detox products like THC detox shampoos) or interim maintenance treatment for unsupervised or take-home use.