Take Home Dose Exceptions

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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.
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