
completed a 12-week conservative care management
treatment regimen, the prescriber shall refer the
individual to a conservative care management treatment
specialist to complete a 12-week conservative care
management treatment regimen before issuing a
prescription.
(ii) If the individual has completed a 12-week
conservative care management treatment regimen, the
prescriber shall consult with the individual's
conservative care management treatment specialist as soon
as practicable to determine if a prescription should be
issued. The reasons provided by the conservative care
management treatment specialist as to why a prescription
should be issued shall be documented by the prescriber.
(2) Discuss with the [minor and] individual or, if the
individual is a minor, with the minor's parent or guardian or
with an authorized adult, all of the following:
(i) The risks of addiction and overdose associated
with the controlled substance containing an opioid.
(ii) The increased risk of addiction to controlled
substances to individuals suffering from mental or
substance use disorders.
(iii) The dangers of taking a controlled substance
containing an opioid with benzodiazepines, alcohol or
other central nervous system depressants.
(iv) Other information in the patient counseling
information section of the labeling for controlled
substances containing an opioid required under 21 C.F.R.
201.57(c)(18) (relating to specific requirements on
content and format of labeling for human prescription
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