Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 26 - OPIOID TREATMENT AGREEMENTS-TEMPORARY REGULATIONS › Section 26.4 - Procedures

Current through Register Vol. 54, No. 28, July 13, 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).