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A03315
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
572
Session of
2019
INTRODUCED BY AUMENT, KILLION, FOLMER, MENSCH, HUTCHINSON,
MARTIN, BROWNE AND YAW, APRIL 18, 2019
AS AMENDED ON THIRD CONSIDERATION, JUNE 17, 2019
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, in public safety, providing for opioid
treatment agreements.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Title 35 of the Pennsylvania Consolidated
Statutes is amended by adding a chapter to read:
CHAPTER 52B
OPIOID TREATMENT AGREEMENTS
Sec.
52B01. Definitions.
52B02. Procedure.
52B03. Regulations.
52B04. Penalties.
§ 52B01. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
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"Acute pain." The sudden onset of pain in response to a
specific injury that responds to medical treatment.
"Baseline test." The initial assessment through a urine drug
test to:
(1) identify the presence of an illegal substance prior
to prescribing a controlled substance; or
(2) confirm assess the presence or absence of a
prescribed drug or drug class.
"Chronic pain." Pain that persists or progresses over a
period of time that may be related to another medical condition
and is resistant to medical treatment. The term does not include
acute pain.
"Controlled substance." A drug, substance or immediate
precursor included in Schedules II through V of section 4 of the
act of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act.
"Definitive drug test." A qualitative or quantitative ur ine
drug test used to identify specific drugs, specific drug
concentrations and associated metabolites.
"Department." The Department of Health of the Commonwealth.
"Individual." An individual who is at least 18 years of age.
"Medical emergency." A situation that, in the good faith
professional judgment of the prescriber, creates an immediate
threat of serious risk to the life or physical health of a
person. The term includes treatment received in an emergency
department or urgent care center under the act of November 2,
2016 (P.L.976, No.122), known as the Safe Emergency Prescribing
Act.
"Opioid." Any of the following:
(1) A preparation or derivative of opium.
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(2) A synthetic narcotic that has opiate-like effects
but is not derived from opium.
(3) A group of naturally occurring peptides that bind at
or otherwise influence opiate receptors, including an opioid
agonist.
"Periodic test." A random urine drug test that screens for a
random selection of drugs.
"Prescriber." As defined in the act of October 27, 2014
(P.L.2911, No.191), known as the Achieving Better Care by
Monitoring All Prescriptions Program (ABC-MAP) Act.
"Presumptive positive drug test." A urine drug test that is
used to identify suspected possible use or non-use of drugs or a
drug class that may be followed by a definitive test to
specifically identify drugs or metabolites.
"Targeted test." A urine drug test ordered at the discretion
of a clinician prescriber , based on observation of the clinician
prescriber and related circumstances that enhance clinical
decision making.
"Treatment agreement." A document signed by a prescriber and
individual that contains a statement to ensure that the
individual understands:
(1) Treatment responsibilities.
(2) The conditions of medication use.
(3) The conditions under which the treatment of the
individual may be terminated.
(4) The responsibilities of the prescriber.
§ 52B02. Procedure.
(a) Prescriber requirements.--Except as specified in
subsection (d), before issuing an individual the first
prescription in a single course of treatment for chronic pain
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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 determines
that a targeted test is medically necessary. The
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treatment of chronic pain shall be consistent with the
Centers for Disease Control and Prevention guidelines, as
they relate to a baseline test and periodic test as
warranted for treatment. 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.
(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 paragraph (4) on the
treatment agreement form under paragraph (3).
(b) Treatment agreement form requirements.--The treatment
agreement form under subsection (a)(3) shall be maintained by
the prescriber in the medical record of the individual and
include:
(1) The brand name or generic name, quantity and initial
dose of the controlled substance containing an opioid being
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prescribed.
(2) 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.
(3) A statement certifying that the prescriber engaged
in the discussion under subsection (a)(2).
(4) 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.
(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) A prescriber may not issue a prescription opioid
drug for the treatment of chronic pain without first
obtaining a confirmatory or quantitative testing for
presumptive positive drug test results prior to the initial
issuance of a prescription under paragraph (1).
(4) (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.
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(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
subsection (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.
§ 52B03. Regulations.
(a) Promulgation.--The department shall promulgate temporary
regulations within 30 90 days of the effective date of this
subsection. The temporary regulations shall not be subject to:
(1) Sections 201, 202, 203, 204 and 205 of the act of
July 31, 1968 (P.L.769, No.240), referred to as the
Commonwealth Documents Law.
(2) Sections 204(b) and 301(10) of the act of October
15, 1980 (P.L.950, No.164), known as the Commonwealth
Attorneys Act.
(3) The act of June 25, 1982 (P.L.633, No.181), known as
the Regulatory Review Act.
(b) Expiration.--The temporary regulations under subsection
(a) shall expire on the promulgation of final-form regulations,
or two years following the effective date of this section,
whichever is later.
§ 52B04. Penalties.
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A violation of this chapter by a prescriber shall be subject
to sanctions under the prescriber's professional practice act
and by the appropriate licensing board.
Section 2. This act shall take effect immediately.
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