Current through Register Vol. 54, No. 44, November 2, 2024
(a)
Prescriber requirements . Except as specified in subsection
(c), before issuing an individual the first prescription in a single course of
treatment for chronic pain with a controlled substance containing an opioid,
regardless of whether the dosage is modified during that course of treatment, a
prescriber shall:
(1) Assess whether the
individual has taken or is currently taking a prescription drug for treatment
of a substance use disorder.
(2)
Discuss with the individual:
(i) The risks of
addiction and overdose associated with the controlled substance containing an
opioid.
(ii) The increased risk of
addiction to a controlled substance if the individual suffers from a mental
disorder or substance use disorder.
(iii) The dangers of taking a controlled
substance containing an opioid with benzodiazepines, alcohol or other central
nervous system depressants.
(iv)
Other information deemed appropriate by the prescriber under
21 CFR
201.57(c)(18) (relating to
specific requirements on content and format of labeling for human prescription
drug and biological products described in § 201.56(b)(1)).
(v) The nonopioid treatment options available
for treating chronic noncancer pain, if applicable, that are consistent with
the best practices per the Pennsylvania Opioid Prescribing
Guidelines.
(3) Review
and sign a treatment agreement form that includes:
(i) The goals of the treatment.
(ii) The consent of the individual to a
targeted test in a circumstance where the physician or prescriber determines
that a targeted test is medically necessary. The treatment of chronic pain
shall be consistent with the Pennsylvania Opioid Prescribing
Guidelines.
(iii) The prescription
drug prescribing policies of the prescriber, which policies include:
(A) A requirement that the individual take
the medication as prescribed.
(B) A
prohibition on sharing the prescribed medication with other
individuals.
(iv) A
requirement that the individual inform the prescriber about any other
controlled substances prescribed or taken by the individual.
(v) Any reason why the opioid therapy may be
changed or discontinued by the prescriber.
(vi) Appropriate disposal methods for opioids
that are no longer being used by the individual as specified in a consultation
with the prescriber.
(vii) The
brand name or generic name, quantity and initial dose of the controlled
substance containing an opioid being prescribed.
(viii) A statement indicating that a
controlled substance is a drug or other substance that the United States Drug
Enforcement Administration has identified as having a potential for
abuse.
(ix) A statement certifying
that the prescriber engaged in the discussion under subsection
(a)(2).
(x) The signature of the
individual and the date of signing. The prescriber may utilize electronic
methods to obtain the signature of the individual and the date of
signing.
(4) Obtain
written consent for the prescription from the individual. The prescriber may
utilize electronic methods to obtain the written consent of the
individual.
(5) Record the consent
under subsection (a)(4) on the treatment agreement form in subsection
(a)(3).
(b) The treatment
agreement form under subsection (a)(3) shall be maintained by the prescriber in
the medical record of the individual.
(c)
Urine drug testing.
(1) A baseline test, periodic test or
targeted test shall be used to establish a general assessment for an individual
new to treatment for chronic pain and in monitoring adherence to an existing
individual treatment plan, as well as to detect the use of a nonprescribed
drug.
(2) A baseline test shall be
required prior to the issuance of the initial prescription for chronic pain and
shall include confirmatory or quantitative testing of presumptive positive drug
test results.
(3) An individual who
is treated for addiction or an individual who is considered moderate or high
risk by the prescriber shall be tested at least once annually or as frequently
as necessary to ensure therapeutic adherence.
(d)
Exception. Subsection
(c) shall not apply if the treatment of an individual with a controlled
substance containing an opioid is associated with or incident to:
(1) A medical emergency documented in the
medical record of the individual.
(2) The management of pain associated with
cancer.
(3) The use in palliative
or hospice care.
(4) The
professional judgment of the prescriber under subsections (a)(1) and
(2).
(e)
Documentation of exception. If subsection (d) applies, the
prescriber shall document in the individual's medical record the factor under
subsection (d) that the prescriber believes applies to the
individual.
(f) A prescriber may
terminate the treatment agreement form under subsection (a)(3) if the
prescriber has reasonable belief, based on standards of professional practice,
that the treatment agreement is no longer necessary.
(g) If a prescriber terminates a treatment
agreement under subsection (f), the prescriber shall:
(1) Document the reason for the termination
of the treatment agreement in the individual's medical record.
(2) Inform the individual of the termination
of the treatment agreement.
(3) If
necessary, work with the individual, to the fullest extent possible, to ensure
continuity of care as outlined under 49 Pa. Code §16.61(a)(17)
(relating to unprofessional and immoral conduct).
(h)
Urine testing exception
. If, because of a medical necessity, an individual is unable to produce urine
for the urine drug testing required herein, a different type of drug test may
be used that is at least equivalent in accuracy to a urine drug test approved
by the Food and Drug Administration. Alternative drug tests may not be
substituted for urine drug tests under any other circumstances.
