PRINTER'S NO. 2121
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
1349
Session of
2015
INTRODUCED BY YAW, TEPLITZ, VULAKOVICH, BREWSTER, SCAVELLO,
BAKER, ARGALL, COSTA, FOLMER, WHITE, RESCHENTHALER,
HUTCHINSON, YUDICHAK, BROWNE, RAFFERTY, STEFANO AND KILLION,
OCTOBER 12, 2016
REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE,
OCTOBER 12, 2016
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, in public safety, providing for
restrictions on prescribing opioids.
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
Sec.
5201. Definitions.
5202. Restrictions on prescribing opioids.
5203. Consent.
5204. Exception.
5205. Medical record.
§ 5201. Definitions.
The following words and phrases when used in this chapter
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shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Medical emergency." A situation that in a prescriber's
good faith medical judgment creates an immediate threat of
serious risk to the life or physical health of an individual.
"Medical professional." 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.
"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
agonist.
§ 5202. Restrictions on prescribing opioids.
(a) General rule.--A medical professional may not prescribe
to an individual more than a seven-day supply of a controlled
substance containing an opioid.
(b) Exceptions.--Notwithstanding subsection (a), a medical
professional may prescribe to an individual more than a seven-
day supply of a controlled substance containing an opioid if any
of the following apply:
(1) In the professional medical judgment of the medical
professional, more than a seven-day supply of a controlled
substance containing an opioid is required to stabilize the
individual's acute medical condition and the medical
professional:
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(i) documents the acute medical condition in the
individual's record; and
(ii) indicates the reason why a nonopioid
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.
(c) Medical professional requirements.--Except as provided
in section 5203 (relating to consent), before issuing an
individual the first prescription in a single course of
treatment for a controlled substance containing an opioid, a
medical professional shall:
(1) Assess whether the individual has taken or is
currently taking prescription drugs for treatment of a
substance abuse disorder.
(2) Discuss with the individual all of the following:
(i) The risks of addiction and overdose associated
with the controlled substance containing an opioid.
(ii) The dangers of taking a controlled substance
containing an opioid with benzodiazepines, alcohol or
other central nervous system depressants.
(iii) Any 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 §
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201.56(b)(1)).
(3) Obtain written consent for the prescription from the
individual.
§ 5203. Consent.
A medical professional shall record the consent required
under section 5202(c)(3) (relating to restrictions on
prescribing opioids) on a form prescribed by the Department of
Health. The form shall be separate from any other document the
medical professional uses to obtain informed consent for other
treatment provided to the individual. The form shall contain all
of the following:
(1) the name and quantity of the controlled substance
containing an opioid being prescribed and the amount of the
initial dose;
(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 medical professional
discussed the matters described in paragraph (2);
(4) the number of refills, if any, authorized by the
prescription; and
(5) the signature of the individual consenting to the
medical treatment and the date of signing.
§ 5204. Exception.
The requirements under section 5202(c) (relating to
restrictions on prescribing opioids) do not apply if the
treatment with a controlled substance containing an opioid meets
any of the following criteria:
(1) the treatment is associated with or incident to a
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medical emergency; or
(2) in the medical professional's judgment, fulfilling
the requirements of section 5202(c) with respect to the
treatment would be detrimental to the individual's health or
safety.
§ 5205. Medical record.
A signed consent form obtained under this chapter shall be
maintained in the individual's medical record.
Section 2. This act shall take effect in 60 days.
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