Take Home Dose Exceptions: Balancing Safety with Autonomy Take home doses are granted to the patient for unsupervised administration if/when they meet the following eight-point criteria, described in CRF 42 Part 8.12. 1. 2. 3. 4. 5. 6. 7. 8. Absence of recent illicit drug use including alcohol Regular clinic attendance No serious behavioral problems at clinic No criminal activity. Stable home environment and social relationships. Length of time in treatment. Take home medication can be safely stored Rehabilitative benefit to the patient outweighs the risks of diversion or misuse. If patients meet these criteria, no exception needs to be submitted. Exceptions are requested when the physician feels the patient should be allowed more take homes than permitted by the eight-point criteria. Any variation from usual treatment standards outlined by 42CRF 8.12 MUST be approved by the program physician, State Opioid Treatment Authority (SOTA), and federal authorities at CSAT. These are to be done online at the extranet website: http://otp-extranet.samhsa.gov Don’t dispense extra doses until these approvals are obtained. Things to think of before asking for extra take home doses: Consider the reason for the take home request o Family emergencies, medical problems/procedures, spending time in healthy activities with non-drug using family or friends, taking on important personal or family responsibilities, work activities. o Versus going on spring break or something similar o Medical issues: should be discussed and confirmed with the other physician(s). For example – pregnant patient says her doctor has commanded her to be on bed rest – I call the OB and discuss, request a written statement for the chart about the need for bed rest. Number of days requested o One or two days over what the patient currently qualifies for, unless marked extenuating circumstances o Versus two weeks with minimal justification If the patient is traveling, is there a clinic where it’s reasonable to guest dose, rather than give extra take homes? Current dose: will they be getting an extra 80mg per take home, or an extra 300mg? Type of medication: buprenorphine versus methadone o Buprenorphine less likely to cause overdose death, so it’s reasonable to be more lenient with take homes for this medication. o In North Carolina, still need to submit exception to the 8-point criteria for buprenorphine. We have guidelines with suggested timelines for take home levels for compliant patients. Continued positive urine drug screens: o Is the patient positive for marijuana, versus benzos/alcohol? Inclement weather exceptions – can be submitted as a blanket request. Difficult to predict since the exception should be requested 48 hours before the weather hits – one day to get the exception, next day to dispense the extra dose. Must judge danger of travel in bad weather versus overdose risk. Most programs open for 1-2 hours for patients unable to manage an extra dose. Bottom line: do you as the physician feel the patient will not be a danger to him/herself or others if granted the take home request? Please include this information on the exception request: On the request, please use this shorthand format: Tx:, Cur:, Max:, L:, where the TX stands for total time in treatment, CUR stands for current time of continuous compliance, Max stands for maximum time in continuous compliance, and L stands for present level. o For a patient who has been in treatment for a year and a half, now on level 1 but at one time had eight months of compliance, and now has only two months of compliance, the shorthand would read: Tx 1.5yr, CUR: 2mo, Max: 8mo, L=1 On the request, list the dates of the last three drug screens and their results, including specific drugs Date of last visit with program physician Results of most recent NC CSRS results – consider getting an updated report prior to asking for an exception. Exception requests should be discussed by staff with the program physician. The physician is ultimately responsible for what happens to the patients’ extra take home doses, and physician may need to meet with the patient before approving exception. ** I expect to know about all of the requests I see on the SAMHSA exception website. I’m not happy when I see requests that have not been discussed in advance** Most important: do not submit a request unless you agree with it. The program physician knows the patient better than the state & federal authorities. If you want to add information, put into one of the text boxes. By agreeing to submit the request, you are telling these authorities that you believe and endorse the request. Other reasons for requests: Entry into treatment of a patient who does not meet the one-year requirement for physiologic opioid addiction. Exception to the detoxification standards outlined in the regulations. Permission to split dose: usually need peak & trough blood levels, at least on nonpregnant patients. Probably best to get P&T on pregnant patients too.