Trial Engrossment of Amendment A00116 to Senate Bill 0112 P.N. 0057, Regular Session 2019-2020

A00116

THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

No.

112

Session of

2019

INTRODUCED BY YAW, SCAVELLO, LANGERHOLC, FOLMER, K. WARD,

STEFANO, BAKER, COSTA, KILLION, HAYWOOD, REGAN, YUDICHAK AND

BROWNE, JANUARY 23, 2019

REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE,

JANUARY 23, 2019

AN ACT

Amending Title 35 (Health and Safety) of the Pennsylvania

Consolidated Statutes, in prescribing opioids to minors,

providing for prescribing opioids to individuals and further

providing for definitions, for prohibition and for procedure;

and making editorial changes.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. The heading of Chapter 52A of Title 35 of the

Pennsylvania Consolidated Statutes is amended to read:

CHAPTER 52A

PRESCRIBING OPIOIDS TO [MINORS] INDIVIDUALS

Section 2. The definitions of "medical emergency" and

"minor" in section 52A01 of Title 35 are amended and the section

is amended by adding a definition to read:

§ 52A01. 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:

* * *

" Health care facility. " The term shall have the same meaning

as provided in section 103 of the act of July 19, 1979 (P.L.130,

No.48), known as the Health Care Facilities Act.

* * *

"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] an

individual.

"Minor." An individual under 18 years of age. The term

excludes [an individual] a minor 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.]:

(1) married or has been married;

(2) pregnant or has been pregnant;

(3) a member of the armed forces of the United States;

(4) legally emancipated.

* * *

Section 3. Section 52A03 of Title 35 is amended to read:

§ 52A03. Prohibition.

(a) Proscription.--A prescriber may not do any of the

following:

(1) Prescribe to [a minor] an individual a controlled

substance containing an opioid unless the prescriber complies

with section 52A04 (relating to procedure).

(2) Except as set forth in subsection (b) and subject to

A00116 - 2 -

section 52A04(c)(1), prescribe to [a minor] an individual

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] 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

prescriber, more than a seven-day supply of a controlled

substance containing an opioid is required to stabilize the

[minor's] individual's acute medical condition. In order for

this paragraph to apply, the prescriber must:

(i) document the acute medical condition in the

[minor's] individual'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.

Section 4. Section 52A04 of Title 35, amended October 24,

2018 (P.L.650, No.93), is amended to read:

§ 52A04. Procedure.

(a) Requirements.--Except as set forth in subsection (b),

before issuing [a minor] an individual 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

A00116 - 3 -

all of the following:

(1) Assess whether the [minor] individual has taken or

is currently taking prescription drugs for treatment of a

substance use disorder.

(2) Discuss with the [minor and] individual or, if the

individual is a minor, 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

with the controlled substance containing an opioid.

(ii) The increased risk of addiction to controlled

substances to individuals suffering from mental or

substance use 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))

deemed necessary by the prescriber.

(3) [Obtain] In the case of a minor, 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 52A02(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

A00116 - 4 -

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.

engaged in the discussion under paragraph (2).

(D) The number of refills authorized by the

prescription under section 52A03(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] individual'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] individual's

medical record.

(2) In the prescriber's professional judgment, complying

with subsection (a) with respect to the [minor's]

individual's treatment would be detrimental to the [minor's]

individual's health or safety. The prescriber shall document

in the [minor's] individual's medical record the factor or

factors which the prescriber believed constituted cause for

not fulfilling the requirements of subsection (a).

(3) The medical treatment is rendered while the [minor]

A00116 - 5 -

individual remains admitted to a licensed health care

facility or remains in observation status in a licensed

health care facility.

(4) The prescriber is continuing a treatment initiated

by another member of the prescriber's practice, the

prescriber who initiated the treatment followed the

procedures outlined in subsection (a) and the prescriber who

is continuing the treatment is not changing the therapy in

any way other than dosage.

consent form under subsection (a)(3) is an authorized adult, 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.

Section 5. This act shall take effect in 180 days.

A00116 - 6 -