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PRIOR PRINTER'S NOS. 2073
PRINTER'S NO. 2093
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
1367
Session of
2015
INTRODUCED BY YAW, STEFANO, SCARNATI, RESCHENTHALER, McGARRIGLE,
ARGALL, MENSCH, GREENLEAF, TEPLITZ, GORDNER, BARTOLOTTA,
BAKER, COSTA, RAFFERTY, HUTCHINSON, WHITE, FOLMER, DINNIMAN,
YUDICHAK AND KILLION, SEPTEMBER 23, 2016
AS AMENDED ON SECOND CONSIDERATION, SEPTEMBER 27, 2016
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, in public safety, providing for
prescribing opioids to minors; imposing powers and duties on
certain Commonwealth agencies and on the Legislative
Reference Bureau; and imposing penalties.
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 in Part III to read:
CHAPTER 52
PRESCRIBING OPIOIDS TO MINORS
Sec.
5201. Definitions.
5202. Administration.
5203. Prohibition.
5204. Procedure.
5205. Penalties.
§ 5201. Definitions.
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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:
"Authorized adult." An adult to whom a minor's parent or
guardian has given written LEGAL authorization to consent to the
minor's medical treatment.
"Bureau." The Bureau of Professional and Occupational
Affairs.
"Controlled substance." A drug, substance or immediate
precursor included in Schedules I 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.
"Licensing agency BOARD ." A Commonwealth agency which
licenses, registers or certifies a prescriber.
"Medical emergency." A situation which, in a prescriber's
good faith professional judgment, creates an immediate threat of
serious risk to the life or physical health of a minor.
"Minor." An individual under 18 years of age. The term
excludes an individual who is emancipated by:
(1) marrying;
(2) entering the armed forces of the United States;
(3) being employed and self-sustaining; or
(4) otherwise being independent from the care and
control of the individual's parent, guardian or custodian.
"Opioid." Any of the following:
(1) A preparation or derivative of opium.
(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 opioid
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agonist.
"Prescriber." An individual who is authorized under the laws
of this Commonwealth to distribute, dispense or administer a
controlled substance containing an opioid in the course of
professional practice in this Commonwealth. The term does not
include a veterinarian.
§ 5202. Administration.
(a) Licensing agencies BOARDS .--A licensing agency may BOARD
SHALL administer this chapter as to prescribers under its
jurisdiction.
(b) Bureau.--
(1) The bureau shall, in cooperation with the licensing
agencies BOARDS , prescribe the form under section 5204(a)(3)
(relating to procedure).
(2) The bureau shall transmit notice of the availability
of the form to the Legislative Reference Bureau for
publication in the Pennsylvania Bulletin.
§ 5203. Prohibition.
(a) Proscription.--A prescriber may not do any of the
following:
(1) Prescribe to a minor a controlled substance
containing an opioid unless the prescriber complies with
section 5204 (relating to procedure).
(2) Except as set forth in subsection (b) and subject to
section 5204(c)(1), prescribe to a minor more than a seven-
day supply of a controlled substance containing an opioid.
(b) Exception.--Notwithstanding subsection (a)(1), a
prescriber may prescribe to a minor more than a seven-day supply
of a controlled substance containing an opioid if any of the
following apply:
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(1) In the professional medical judgment of the
prescriber, more than a seven-day supply of a controlled
substance containing an opioid is required to stabilize the
minor's acute medical condition. In order for this paragraph
to apply, the prescriber must:
(i) document the acute medical condition in the
minor's record with the prescriber; and
(ii) indicate the reason why a non-opioid
alternative is not appropriate to address the acute
medical condition.
(2) The prescription is for:
(i) management of pain associated with cancer;
(ii) use in palliative or hospice care; or
(iii) management of chronic pain not associated with
cancer.
§ 5204. Procedure.
(a) Requirements.--Except as set forth in subsection (b),
before issuing a minor the first prescription in a single course
of treatment for a controlled substance containing an opioid,
regardless of whether the dosage is modified during that course
of treatment, a prescriber shall do all of the following:
(1) Assess whether the minor :
(i) has ever suffered or is currently suffering from
a mental health or substance abuse disorder; and
(ii) has taken or is currently taking prescription
drugs for treatment of a SUBSTANCE ABUSE disorder under
subparagraph (i) .
(2) Discuss with the minor and the minor's parent or
guardian or with an authorized adult all of the following:
(i) The risks of addiction and overdose associated
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with the controlled substance containing an opioid.
(ii) The increased risk of addiction to controlled
substances to individuals suffering from mental or
substance abuse 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
drug and biological products described in § 201.56(b)
(1)).
(3) Obtain written consent for the prescription from
the minor's parent or guardian or from an authorized adult.
The prescriber shall record the consent on the form under
section 5202(b)(1) (relating to administration). The
following apply:
(i) The form must contain all of the following:
(A) The BRAND NAME OR GENERIC name and quantity
of the controlled substance containing an opioid
being prescribed and the amount of the initial dose.
(B) 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.
(C) A statement certifying that the prescriber
engaged in the discussion under paragraph (2).
(D) The number of refills authorized by the
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prescription UNDER SECTION 5203(B) (RELATING TO
PROHIBITION) .
(E) The signature of the minor's parent or
guardian or of an authorized adult and the date of
signing.
(ii) The form shall be maintained in the minor's
record with the prescriber.
(b) Exception.--Subsection (a) does not apply if the minor's
treatment with a controlled substance containing an opioid meets
any of the following criteria:
(1) The treatment is associated with or incident to a
medical emergency as documented in the minor's medical
record.
(2) In the prescriber's professional judgment, complying
with subsection (a) with respect to the minor's treatment
would be detrimental to the minor's health or safety. The
prescriber shall document in the minor's medical record the
factor or factors which the prescriber believed constituted
cause for not fulfilling the requirements of subsection (a).
(c) Limited prescription.--If the individual who signs the
consent form under subsection (a)(3) is an AUTHORIZED adult
authorized to consent to the minor's medical treatment , the
prescriber:
(1) may prescribe not more than a single, 72-hour
supply; and
(2) shall indicate on the prescription the quantity that
is to be dispensed pursuant to the prescription.
§ 5205. Penalties.
A violation of this chapter subjects a prescriber to
administrative sanctions by the provider's licensing agency
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BOARD under the applicable statute.
Section 2. This act shall take effect as follows:
(1) The following provisions shall take effect
immediately:
(i) The addition of 35 Pa.C.S. § 5201.
(ii) The addition of 35 Pa.C.S. § 5202.
(iii) This section.
(2) The remainder of this act shall take effect upon
publication of the notice under 35 Pa.C.S. § 5202(b)(2).
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