HOUSE AMENDED
PRIOR PRINTER'S NOS. 2075, 2094, 2158
PRINTER'S NO. 2190
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
1368
Session of
2015
INTRODUCED BY KILLION, YAW, SCARNATI, CORMAN, AUMENT, BROWNE,
BARTOLOTTA, FOLMER, RAFFERTY, RESCHENTHALER, VULAKOVICH,
FONTANA, TEPLITZ, COSTA, HUTCHINSON, YUDICHAK, STEFANO,
MENSCH AND ARGALL, SEPTEMBER 23, 2016
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
OCTOBER 24, 2016
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, in public safety, providing for safe
opioid prescription AND FOR PATIENT VOLUNTARY NONOPIOID
DIRECTIVE and imposing powers and duties on certain
Commonwealth agencies.
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 CHAPTERS in Part III to
read:
CHAPTER 51
SAFE OPIOID PRESCRIPTION
Sec.
5101. Definitions.
5102. Safe opioid prescription education .
5103. Temporary regulations .
§ 5101. 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:
"College." Any of the following:
(1) A medical college.
(2) A medical training facility, including a school of
nursing and a school of optometry.
(3) A dental school.
(4) An osteopathic medical college or osteopathic
medical training facility.
"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.
"Licensing boards." The following:
(1) The State Board of Dentistry.
(2) The State Board of Medicine.
(3) The State Board of Nursing.
(4) The State Board of Optometry.
(5) The State Board of Osteopathic Medicine.
(6) The State Board of Podiatry.
"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.
§ 5102. Safe opioid prescription education.
(a) Curriculum. --Beginning August 1, 2017, the licensing
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boards shall, by joint regulation, implement a safe prescription
of a controlled substance containing an opioid curriculum. The
curriculum may be offered in colleges or by providers approved
by the licensing boards and shall include all of the following:
(1) Current, age-appropriate information relating to
pain management.
(2) Multimodal treatments for chronic pain that minimize
the use of a controlled substance containing an opioid.
(3) If a controlled substance containing an opioid is
indicated, instruction on safe methods of prescribing a
controlled substance containing an opioid that follow
guideline-based care.
(4) Identification of patients who have risk factors for
developing problems with prescription of a controlled
substance containing an opioid.
(5) Training on managing substance abuse USE disorders
as a chronic disease.
(b) Separation from standardized curriculum.-- The education
required under this chapter shall not be considered part of the
college's c urriculum necessary for graduation. THE EDUCATION
REQUIRED UNDER THIS CHAPTER SHALL NOT BE CONSIDERED TO BE A
MANDATE OF THE CURRICULUM NECESSARY FOR GRADUATION. NOTHING IN
THIS CHAPTER SHALL BE CONSTRUED TO PROHIBIT A COLLEGE FROM
REQUIRING SUCH CURRICULUM TO BE NECESSARY TO GRADUATE AFTER
AUGUST 1, 2017.
§ 5103. Temporary regulations.
In order to facilitate the prompt implementation of this
chapter, each licensing board may issue temporary regulations.
The following shall apply:
(1) The temporary regulations shall expire no later than
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two years after their issuance.
(2) The temporary regulations issued by each licensing
board shall not be subject to:
(i) Sections 201, 202 and 203 of the act of July 31,
1968 (P.L.769, No.240), referred to as the Commonwealth
Documents Law.
(ii) The act of June 25, 1982 (P.L.633, No.181),
known as the Regulatory Review Act.
CHAPTER 52
PATIENT VOLUNTARY NONOPIOID DIRECTIVE
SEC.
5201. SCOPE OF CHAPTER.
5202. DEFINITIONS.
5203. VOLUNTARY NONOPIOID DIRECTIVE.
5204. GUIDELINES.
5205. EXEMPTION FROM LIABILITY.
5206. LICENSING BOARDS.
§ 5201. SCOPE OF CHAPTER.
THIS CHAPTER RELATES TO PATIENT VOLUNTARY NONOPIOID
DIRECTIVES.
§ 5202. 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:
"CONTROLLED SUBSTANCE." AS DEFINED IN THE ACT OF APRIL 14,
1972 (P.L.233, NO.64), KNOWN AS THE CONTROLLED SUBSTANCE, DRUG,
DEVICE AND COSMETIC ACT.
"DEPARTMENT." THE DEPARTMENT OF HEALTH OF THE COMMONWEALTH.
"HEALTH CARE FACILITY." A HEALTH CARE FACILITY AS DEFINED IN
SECTION 103 OF THE ACT OF JULY 19, 1979 (P.L.130, NO.48), KNOWN
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AS THE HEALTH CARE FACILITIES ACT, OR ANY OTHER FACILITY OR
INSTITUTION LICENSED, REGISTERED OR OTHERWISE PERMITTED TO
DISTRIBUTE, DISPENSE, CONDUCT RESEARCH WITH OR PRESCRIBE OR
ADMINISTER A CONTROLLED SUBSTANCE CONTAINING AN OPIOID OR OTHER
CONTROLLED SUBSTANCE IN THE COURSE OF PROFESSIONAL PRACTICE OR
RESEARCH IN THIS COMMONWEALTH.
"LICENSING BOARD." THE TERM SHALL INCLUDE THE FOLLOWING:
(1) THE STATE BOARD OF MEDICINE AS SET FORTH IN THE ACT
OF DECEMBER 20, 1985 (P.L.457, NO.112), KNOWN AS THE MEDICAL
PRACTICE ACT OF 1985.
(2) THE STATE BOARD OF OSTEOPATHIC MEDICINE AS SET FORTH
IN THE ACT OF OCTOBER 5, 1978 (P.L.1109, NO.261), KNOWN AS
THE OSTEOPATHIC MEDICAL PRACTICE ACT.
(3) THE STATE BOARD OF NURSING AS SET FORTH IN THE ACT
OF MAY 22, 1951 (P.L.317, NO.69), KNOWN AS THE PROFESSIONAL
NURSING LAW.
(4) THE STATE BOARD OF PODIATRY AS SET FORTH IN THE ACT
OF MARCH 2, 1956 (1955 P.L.1206, NO.375), KNOWN AS THE
PODIATRY PRACTICE ACT.
(5) THE STATE BOARD OF DENTISTRY AS SET FORTH IN THE ACT
OF MAY 1, 1933 (P.L.216, NO.76), KNOWN AS THE DENTAL LAW.
"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.
"PATIENT." AN INDIVIDUAL WHO IS UNDER THE MEDICAL CARE OF A
PRACTITIONER.
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"PRACTITIONER." A HEALTH CARE PRACTITIONER AS DEFINED IN
SECTION 103 OF THE ACT OF JULY 19, 1979 (P.L.130, NO.48), KNOWN
AS THE HEALTH CARE FACILITIES ACT.
"SECRETARY." THE SECRETARY OF HEALTH OF THE COMMONWEALTH.
"SYSTEM." THE ACHIEVING BETTER CARE BY MONITORING ALL
PRESCRIPTIONS PROGRAM ELECTRONIC PRESCRIPTION MONITORING SYSTEM
WITH A DATABASE COMPONENT AS ESTABLISHED UNDER 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.
"VOLUNTARY NONOPIOID DIRECTIVE." A WRITTEN INSTRUCTION FORM
EXECUTED BY A PATIENT EVIDENCING THE NAMED PATIENT'S REQUEST NOT
TO HAVE A CONTROLLED SUBSTANCE CONTAINING AN OPIOID OFFERED,
SUPPLIED, PRESCRIBED OR OTHERWISE ADMINISTERED TO THE NAMED
PATIENT BY A PRACTITIONER.
§ 5203. VOLUNTARY NONOPIOID DIRECTIVE.
(A) DUTY OF DEPARTMENT.--
(1) IN CONSULTATION WITH A STATEWIDE PROFESSIONAL
ORGANIZATION REPRESENTING PHYSICIANS LICENSED TO PRACTICE
MEDICINE IN ALL ITS BRANCHES, STATEWIDE ORGANIZATIONS
REPRESENTING NURSING HOMES, REGISTERED PROFESSIONAL NURSES,
EMERGENCY MEDICAL SYSTEMS AND A STATEWIDE ORGANIZATION
REPRESENTING HEALTH CARE FACILITIES, THE DEPARTMENT SHALL
DEVELOP AND PUBLISH A UNIFORM VOLUNTARY NONOPIOID DIRECTIVE
FORM WHICH MAY BE USED BY A PATIENT TO DENY OR REFUSE THE
ADMINISTRATION OR PRESCRIBING OF A CONTROLLED SUBSTANCE
CONTAINING AN OPIOID BY A PRACTITIONER.
(2) THE VOLUNTARY NONOPIOID DIRECTIVE FORM DEVELOPED BY
THE DEPARTMENT IN ACCORDANCE WITH PARAGRAPH (1) SHALL
INDICATE TO ALL PRESCRIBING PRACTITIONERS AND HEALTH CARE
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FACILITIES THAT THE NAMED PATIENT SHALL NOT BE OFFERED,
PRESCRIBED, SUPPLIED WITH OR OTHERWISE ADMINISTERED A
CONTROLLED SUBSTANCE CONTAINING AN OPIOID .
(3) THE VOLUNTARY NONOPIOID DIRECTIVE FORM SHALL BE
POSTED IN A DOWNLOADABLE FORMAT ON THE DEPARTMENT'S PUBLICLY
ACCESSIBLE INTERNET WEBSITE.
(B) EXECUTION OF FORM.--THE FOLLOWING SHALL APPLY:
(1) A PATIENT MAY EXECUTE AND FILE A VOLUNTARY NONOPIOID
DIRECTIVE FORM WITH A PRACTITIONER OR OTHER AUTHORITY
AUTHORIZED BY THE SECRETARY TO ACCEPT THE VOLUNTARY NONOPIOID
DIRECTIVE FORM FOR FILING. EACH PRACTITIONER OR OTHER PERSON
AUTHORIZED BY THE SECRETARY TO ACCEPT A VOLUNTARY NONOPIOID
DIRECTIVE FORM FOR FILING SHALL DATE AND AFFIX HIS SIGNATURE
TO THE FORM IN THE PRESENCE OF THE PATIENT AS EVIDENCE OF
ACCEPTANCE AND SHALL PROVIDE A SIGNED COPY OF THE FORM TO THE
PATIENT.
(2) THE PATIENT EXECUTING AND FILING A VOLUNTARY
NONOPIOID DIRECTIVE FORM WITH A PRACTITIONER SHALL SIGN AND
DATE THE FORM IN THE PRESENCE OF THE PRACTITIONER, A DESIGNEE
OF THE PRACTITIONER OR OTHER PERSON AUTHORIZED BY THE
SECRETARY TO ACCEPT A VOLUNTARY NONOPIOID DIRECTIVE FORM FOR
FILING. IN THE CASE OF A PATIENT WHO IS UNABLE TO EXECUTE AND
FILE A VOLUNTARY NONOPIOID FORM, THE PATIENT MAY DESIGNATE A
DULY AUTHORIZED GUARDIAN OR HEALTH CARE PROXY TO EXECUTE AND
FILE THE FORM IN ACCORDANCE WITH PARAGRAPH (1).
(3) A PATIENT MAY REVOKE THE VOLUNTARY NONOPIOID
DIRECTIVE FORM FOR ANY REASON AND MAY DO SO BY WRITTEN OR
ORAL MEANS.
(4) NOTWITHSTANDING PARAGRAPH (1), BEFORE SIGNING A
VOLUNTARY NONOPIOID DIRECTIVE FORM A PRACTITIONER MAY, IF
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DEEMED APPROPRIATE, ASSESS THE PATIENT'S PERSONAL AND FAMILY
HISTORY OF ALCOHOL OR DRUG ABUSE AND EVALUATE THE PATIENT'S
RISK FOR MEDICATION MISUSE OR ABUSE. IN EVALUATING SUCH
RISKS, THE PRACTITIONER SHALL ACCESS THE SYSTEM TO DETERMINE
WHETHER AN UNUSUAL OR SUSPECT PATTERN FOR THE PRESCRIBING OF
CONTROLLED SUBSTANCES CONTAINING OPIOIDS TO THE PATIENT HAS
BEEN REPORTED TO THE SYSTEM. IF A PRACTITIONER REASONABLY
BELIEVES THAT A PATIENT IS AT RISK FOR SUBSTANCE MISUSE OR
ABUSE OR A PRACTITIONER BELIEVES IN THE PRACTITIONER'S EXPERT
MEDICAL OPINION THAT FOR ANY OTHER REASON THE NONOPIOID
DIRECTIVE IS APPROPRIATE, THE PRACTITIONER SHALL SIGN THE
FORM. THE PRACTITIONER SIGNING THE NONOPIOID DIRECTIVE FORM
SHALL NOTE DOING SO IN THE PATIENT'S MEDICAL RECORD.
§ 5204. GUIDELINES.
(A) ADOPTION OF GUIDELINES.--THE DEPARTMENT SHALL ADOPT AND
PUBLISH GUIDELINES FOR THE IMPLEMENTATION OF THE VOLUNTARY
NONOPIOID DIRECTIVE FORM. THE GUIDELINES SHALL INCLUDE, BUT NOT
BE LIMITED TO:
(1) A STANDARD FORM FOR THE RECORDING AND TRANSMISSION
OF THE VOLUNTARY NONOPIOID DIRECTIVE FORM, WHICH SHALL
INCLUDE VERIFICATION BY THE PATIENT'S PRACTITIONER AND WHICH
SHALL COMPLY WITH THE WRITTEN CONSENT REQUIREMENTS OF THE
PUBLIC HEALTH SERVICE ACT (58 STAT. 682, 42 U.S.C. § 290DD-
2(B)) AND 42 CFR PT. 2 (RELATING TO CONFIDENTIALITY OF
ALCOHOL AND DRUG ABUSE PATIENT RECORDS), PROVIDED THAT THE
VOLUNTARY NONOPIOID DIRECTIVE FORM SHALL ALSO PROVIDE THE
BASIC PROCEDURES NECESSARY TO REVOKE THE VOLUNTARY NONOPIOID
DIRECTIVE FORM.
(2) PROCEDURES TO RECORD THE VOLUNTARY NONOPIOID
DIRECTIVE FORM IN THE PATIENT'S MEDICAL RECORD OR, IF
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AVAILABLE, THE PATIENT'S INTEROPERABLE ELECTRONIC MEDICAL
RECORD AND IN THE SYSTEM.
(3) REQUIREMENTS AND PROCEDURES FOR A PATIENT TO APPOINT
A DULY AUTHORIZED GUARDIAN OR HEALTH CARE PROXY TO OVERRIDE A
PREVIOUSLY FILED VOLUNTARY NONOPIOID DIRECTIVE FORM AND
CIRCUMSTANCES UNDER WHICH AN ATTENDING PRACTITIONER MAY
OVERRIDE A PREVIOUSLY FILED VOLUNTARY NONOPIOID DIRECTIVE
FORM BASED ON DOCUMENTED MEDICAL JUDGMENT WHICH SHALL BE
RECORDED IN THE PATIENT'S MEDICAL RECORD.
(4) PROCEDURES TO ENSURE THAT ANY RECORDING, SHARING OR
DISTRIBUTING OF DATA RELATIVE TO THE VOLUNTARY NONOPIOID
DIRECTIVE FORM COMPLIES WITH ALL FEDERAL AND STATE
CONFIDENTIALITY LAWS.
(5) APPROPRIATE EXEMPTIONS FOR PRACTITIONERS AND OTHER
HEALTH CARE PROVIDERS AND EMERGENCY MEDICAL PERSONNEL TO
PRESCRIBE OR ADMINISTER A CONTROLLED SUBSTANCE CONTAINING AN
OPIOID WHEN, IN THEIR PROFESSIONAL MEDICAL JUDGMENT, A
CONTROLLED SUBSTANCE CONTAINING AN OPIOID IS NECESSARY.
(B) PUBLICATION.--THE DEPARTMENT SHALL PUBLISH THE
GUIDELINES IN THE PENNSYLVANIA BULLETIN AND ON ITS PUBLICLY
ACCESSIBLE INTERNET WEBSITE.
(C) WRITTEN PRESCRIPTIONS.--A WRITTEN PRESCRIPTION THAT IS
PRESENTED AT AN OUTPATIENT PHARMACY OR A PRESCRIPTION THAT IS
ELECTRONICALLY TRANSMITTED TO AN OUTPATIENT PHARMACY SHALL BE
PRESUMED TO BE VALID FOR THE PURPOSES OF THIS SECTION AND A
PHARMACIST IN AN OUTPATIENT SETTING SHALL NOT BE HELD IN
VIOLATION OF THIS SECTION FOR DISPENSING A CONTROLLED SUBSTANCE
CONTAINING AN OPIOID OR OTHER CONTROLLED SUBSTANCE IN
CONTRADICTION TO A VOLUNTARY NONOPIOID DIRECTIVE FORM, EXCEPT
UPON EVIDENCE THAT THE PHARMACIST ACTED KNOWINGLY AGAINST THE
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VOLUNTARY NONOPIOID DIRECTIVE FORM.
§ 5205. EXEMPTION FROM LIABILITY.
(A) PRACTITIONER EXEMPTION.--NO PRACTITIONER OR EMPLOYEE OF
A PRACTITIONER ACTING IN GOOD FAITH SHALL BE SUBJECT TO CRIMINAL
OR CIVIL LIABILITY OR BE CONSIDERED TO HAVE ENGAGED IN
UNPROFESSIONAL CONDUCT FOR FAILING TO OFFER OR ADMINISTER A
PRESCRIPTION OR MEDICATION ORDER FOR A CONTROLLED SUBSTANCE
CONTAINING AN OPIOID UNDER THE VOLUNTARY NONOPIOID DIRECTIVE
FORM.
(B) REPRESENTATIVE EXEMPTION.--NO PERSON ACTING AS A
REPRESENTATIVE OR AN AGENT UNDER A HEALTH CARE PROXY SHALL BE
SUBJECT TO CRIMINAL OR CIVIL LIABILITY FOR MAKING A DECISION
UNDER SECTION 5204(A)(3) (RELATING TO GUIDELINES) IN GOOD FAITH.
§ 5206. LICENSING BOARDS.
NOTWITHSTANDING ANY OTHER PROVISION OF LAW OR REGULATION, A
LICENSING BOARD MAY LIMIT, CONDITION OR SUSPEND THE LICENSE OF
OR ASSESS A FINE AGAINST A PRACTITIONER WHO RECKLESSLY OR
NEGLIGENTLY FAILS TO COMPLY WITH A PATIENT'S VOLUNTARY NONOPIOID
DIRECTIVE FORM.
Section 2. This act shall take effect immediately.
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