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A02397
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1005
Session of
2019
INTRODUCED BY COX, BERNSTINE, BROWN, IRVIN, KIRKLAND, MASSER,
MILLARD, MURT, NEILSON, PICKETT, PYLE, READSHAW, SAYLOR,
STRUZZI, ZIMMERMAN AND HEFFLEY, APRIL 9, 2019
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
JUNE 5, 2019
AN ACT
Amending the act of October 27, 2014 (P.L.2911, No.191),
entitled "An act providing for prescription drug monitoring;
creating the ABC-MAP Board; establishing the Achieving Better
Care by Monitoring All Prescriptions Program; and providing
for unlawful acts and penalties," further providing for
purpose, for definitions, for powers and duties of board, AND
for establishment of program and for requirements for
dispensers and pharmacies; AND providing for requirements for
first responders; and further providing for access to
prescription information. RESPONDER AGENCIES AND HOSPITAL
EMERGENCY DEPARTMENTS AND FOR REQUIREMENTS FOR CORONERS AND
MEDICAL EXAMINERS; and further providing for access to
prescription information.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 2 of 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, is amended
to read:
Section 2. Purpose.
This act is intended to increase the quality of patient care
by giving prescribers and dispensers access to a patient's
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prescription medication history, including, but not limited to,
any history of a drug overdose DRUG-RELATED OVERDOSE EVENT ,
through an electronic system that will alert medical
professionals to potential dangers for purposes of making
treatment determinations. The act further intends that patients
will have a thorough and easily obtainable record of their
prescriptions for purposes of making educated and thoughtful
health care decisions. Additionally, the act seeks to aid
regulatory and law enforcement agencies in the detection and
prevention of fraud, drug abuse and the criminal diversion of
controlled substances.
Section 2. Section 3 of the act is amended by adding
definitions to read:
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
* * *
"DRUG-RELATED OVERDOSE DEATH." AN INCIDENT WHERE AN OVER-
THE-COUNTER DRUG, PRESCRIPTION OR CONTROLLED SUBSTANCE OR
ILLEGAL SUBSTANCE IS THE PRIMARY OR SECONDARY CAUSE OF DEATH OF
AN INDIVIDUAL OR MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE
DEATH OF AN INDIVIDUAL.
"DRUG-RELATED OVERDOSE EVENT." AS FOLLOWS:
(1) AN INCIDENCE OF A PHYSICAL STATE RESULTING FROM
INTENTIONALLY OR UNINTENTIONALLY CONSUMING OR ADMINISTERING A
TOXIC OR OTHERWISE HARMFUL LEVEL OF AN OVER-THE-COUNTER DRUG,
PRESCRIPTION OR CONTROLLED SUBSTANCE OR ILLEGAL SUBSTANCE
THAT MAY BE SUSPECTED BY ANY OF THE FOLLOWING:
(I) AN OBSERVATION OF SYMPTOMS REQUIRING MEDICAL
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RESPONSE.
(II) A CLINICAL SUSPICION OF A DRUG OVERDOSE.
(III) A POSITIVE URINE TOXICOLOGY SCREEN FOR A
CONTROLLED SUBSTANCE OR A NEGATIVE URINE TOXICOLOGY
SCREEN IF THERE ARE NO OTHER CONDITIONS TO EXPLAIN THE
CLINICAL SYMPTOMS.
(2) THE TERM MAY INCLUDE, BUT IS NOT LIMITED TO, ANY OF
THE FOLLOWING EVENTS THAT RESULTED FROM CONSUMING DRUGS:
(I) CENTRAL NERVOUS SYSTEM DEPRESSION RESULTING IN A
DECREASED HEART RATE AND BREATHING, LOSS OF CONSCIOUSNESS
OR DEATH.
(II) STIMULANT EFFECTS RESULTING IN AN INCREASED OR
IRREGULAR HEART RATE, AGITATION OR HYPERTENSION.
(III) HALLUCINATIONS, SEIZURES OR UNRESPONSIVENESS.
"Drug-related overdose event." An incidence of a physical
state resulting from intentionally or unintentionally consuming
or administering a toxic or otherwise harmful level of
controlled prescription medication or illegal substance that may
be suspected by any of the following:
(1) An observation of symptoms requiring an emergent
medical response.
(2) A clinical suspicion of a drug overdose.
"First responder." A firefighter, law enforcement officer or
emergency medical services personnel. PROVIDER.
"FIRST RESPONDER AGENCY." A FEDERAL, STATE, LOCAL
GOVERNMENTAL OR NONGOVERNMENTAL AGENCY THAT EMPLOYS FIRST
RESPONDERS. THE TERM INCLUDES AN EMERGENCY MEDICAL SERVICES
AGENCY AS DEFINED IN 35 PA.C.S. § 8103 (RELATING TO
DEFINITIONS).
* * *
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"Single county authority." The agency designated to plan and
coordinate drug and alcohol prevention, intervention and
treatment services for a geographic area, which may consist of
one or more counties, and to administer the provisions of such
services funded through the agency.
* * *
"Opioid overdose agent." A medication approved by the Food
and Drug Administration to reverse the effects of an opioid
drug.
* * *
Section 3. Section 5 of the act is amended to read:
Section 3. Section 5(5)(v) of the act is amended and the
paragraph is amended by adding subparagraphs to read:
Section 5. Powers and duties of board.
The board shall have the following powers and duties:
(1) Evaluate and secure a vendor of an electronic
prescription monitoring system for the purpose of carrying
out the provisions of this act.
(2) Appoint an advisory group comprised of dispensers,
prescribers, law enforcement officials, addiction
specialists, patient and privacy advocates and individuals
with expertise considered important to the operation of the
program. All members shall have varying perspectives and will
provide input and recommendations to the board regarding the
establishment and maintenance of the program. The advisory
group shall not exceed 12 members.
(3) Create a written notice to be used by prescribers
and used or displayed by dispensers to provide notice to
patients that information regarding prescriptions for
controlled substances and opioid overdose agents D RUG-RELATED
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OVERDOSE EVENTS is being collected by the program and that
the patient has a right to review and correct the information
with the program. The notice must include all of the
following:
(i) The manner in which the patient may access the
patient's personal information. The notice shall state
that one-time quarterly patient access shall be at no
cost.
(ii) An explanation of the program and the program's
authorized users.
(iii) The program's record retention policies.
(iv) An explanation that prescription information is
confidential and is not subject to the act of February
14, 2008 (P.L.6, No.3), known as the Right-to-Know Law.
(v) Any cost associated with accessing the
information more than once during each calendar quarter.
(4) Phase in an enforcement process so that dispensers
and prescribers may transition and have adequate time to make
the necessary changes to their operating systems.
* * *
(5) Develop policies and procedures to:
(i) Require more frequent reporting of prescription
medication information under section 7 should technology
permit and so long as there is little or no fiscal impact
to the Commonwealth or those required to report. Any
change in the frequency of reporting shall be made in
collaboration with the Board of Pharmacy and the Board of
Pharmacy's members to ensure that a pharmacy is able to
accommodate the change.
(ii) Evaluate the information in the system.
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(iii) Allow for authorized department personnel to
conduct internal reviews, analyses and interpret the data
contained in the system.
(iv) Safeguard the release of information to
authorized users and department personnel and ensure the
privacy and confidentiality of patients and patient
information.
* * *
(v) Aid prescribers and first responders in
identifying at-risk individuals and referring them to
single county authorities, drug addiction treatment
professionals and programs.
(v.1) Aid prescribers and first responders in
identifying individuals with a history of drug overdoses
in order to provide alternative treatment options.
(vi) Establish professionally developed criteria,
with the advice of the advisory group, that generates
referrals of prescription monitoring information to the
appropriate licensing board in the Department of State. A
referral may only be generated when the system produces
an alert that there is a pattern of irregular data for a
dispenser or prescriber which appears to deviate from the
clinical standard.
(vii) Provide training to prescribers and dispensers
on the use of the system.
(viii) Assist professional organizations whose
members prescribe, monitor or treat patients or dispense
controlled substances to patients to develop educational
programs for those members relating to prescribing
practices, pharmacology, controlled substance abuse, the
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use and availability of opioid overdose agents and
clinical standards, including:
(A) identification of those at risk for
controlled substance abuse; and
(B) referral and treatment options for patients.
(ix) Permit individuals employed by prescribers,
pharmacies and dispensers to query the system as
designees so long as each individual designee has a
unique identifier when accessing the system and set
explicit standards to qualify individuals authorized to
query the system and to ensure the security of the system
when used by a designee.
(x) Keep pace with technological advances that
facilitate the interoperability of the system with other
states' prescription drug monitoring systems and
electronic health information systems.
(xi) Evaluate the costs and benefits of the program.
(xii) Convene the advisory group at least annually.
(xiii) Direct the department to operate and maintain
the program on a daily basis.
(xiv) Review the program for the purpose of
compiling statistics, research and educational materials
and outreach.
(xv) Identify any controlled substance that has been
shown to have limited or no potential for abuse and
therefore should not be reported to the program.
(xvi) Require and ensure registration of all
prescribers and dispensers with the program.
* * *
(xvii) Identify additional medications that could
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assist prescribers in making treatment options for
patients who are at risk for a substance use disorder.
Section 4. Section 6(b) of the act is amended by adding a
paragraph to read:
SECTION 4. SECTION 6(B)(1) OF THE ACT IS AMENDED AND THE
SECTION IS AMENDED BY ADDING PARAGRAPHS TO READ:
Section 6. Establishment of program.
* * *
(b) Program components.--The program shall:
(1) PROVIDE AN ELECTRONIC SYSTEM OF CONTROLLED
SUBSTANCES PRESCRIBED AND DISPENSED IN THIS COMMONWEALTH AND
OF DRUG-RELATED OVERDOSE EVENTS THAT OCCURRED IN THIS
COMMONWEALTH.
* * *
(6) Establish a protocol for health care professionals
HOSPITAL EMERGENCY DEPARTMENTS and first responders RESPONDER
AGENCIES to ensure data submitted to the system with respect
to an opioid overdose DRUG-RELATED OVERDOSE EVENTS is not
duplicative.
(7) PROVIDE DRUG-RELATED OVERDOSE DEATH EVENT
INFORMATION, INCLUDING ANY DRUGS THAT CONTRIBUTED TO THE
OVERDOSE, ON THE PATIENT'S PROGRAM RECORD.
* * *
Section 5. Section 7(b) and (c) of the act are amended and
the section is amended by adding a subsection to read:
Section 7. Requirements for dispensers and pharmacies.
* * *
(b) Data elements.--All of the following information shall
be provided by a dispenser or pharmacy, except as provided in
subsection (b.1):
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(1) The full name of the prescriber.
(2) The prescriber's Drug Enforcement Agency (DEA)
registration number.
(3) The date the prescription was written.
(4) The date the prescription was dispensed.
(5) The full name, date of birth, gender and address of
the person for whom the prescription was written and
dispensed.
(6) The National Drug Code.
(7) The quantity and days' supply.
(8) The DEA registration number and National Provider
Identifier of the dispenser or pharmacy.
(9) The method of payment for the prescription.
(b.1) Opioid overdose agent information.--With respect to an
opioid overdose agent, the following information shall be
provided by the treating health care practitioner after
administration of the opioid overdose agent in accordance with
section 13.7 of the act of April 14, 1972 (P.L.233, No.64),
known as The Controlled Substance, Drug, Device and Cosmetic
Act:
(1) The full name, date of birth, gender and address of
the person to whom the opioid overdose agent was
administered.
(2) The date the opioid overdose agent was administered.
(3) The brand name, if any, of the opioid overdose
agent.
(4) The National Drug Code.
(5) The DEA registration number and National Provider
Identifier of the dispenser or pharmacy.
(6) The method of administration of the opioid overdose
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agent.
(7) The amount of the opioid overdose agent necessary to
treat the person.
(c) Frequency.--
(1) A dispenser or pharmacy shall submit all information
required under subsection (b) to the system no later than the
close of the subsequent business day after dispensing a
controlled substance.
(2) Paragraph (1) shall not apply to the dispensing of
an opioid overdose agent either through prescription or as a
result of a standing order.
* * *
Section 6 5. The act is amended by adding a section SECTIONS
a section to read:
Section 7.1. Requirements for first responders.
(a) Submission.--A first responder shall, according to the
format determined by the board, electronically submit
information to the system regarding each opioid overdose agent
administered in the course of the first responder's professional
duties for any individual not transported to a hospital for
additional health care services.
(b) Data elements.--All of the following information shall
be provided by the first responder:
(1) The full name, date of birth, gender and address of
the person to whom the opioid overdose agent was
administered.
(2) The date the opioid overdose agent was administered.
(3) The brand name, if any, of the opioid overdose
agent.
(4) The National Drug Code.
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(5) The DEA registration number and National Provider
Identifier of the dispenser or pharmacy.
(6) The method of administration of the opioid overdose
agent.
(7) The amount of the opioid overdose agent necessary to
treat the person.
(c) Frequency.--A first responder shall submit all
information required under subsection (b) to the system not
later than 72 hours after administration of the opioid overdose
agent.
(d) First responder's designee.--A first responder may
designate an employee or agent of the first responder's
organization to submit the information required under subsection
(b) to the system according to standards established by the
board.
Section 7. Section 9(b)(3)(i) of the act is amended to read:
Section 9. Access to prescription information.
* * *
(b) Authorized users.--The following individuals may
query the system according to procedures determined by
the board and with the following limitations:
* * *
(3) (i) The Office of Attorney General shall query the
system on behalf of all law enforcement agencies,
including, but not limited to, the Office of the Attorney
General and Federal, State and local law enforcement
agencies for:
(A) Schedule II controlled substances as
indicated in the act of April 14, 1972 (P.L.233,
No.64), known as The Controlled Substance, Drug,
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Device and Cosmetic Act, and in the manner determined
by the Pennsylvania Attorney General pursuant to 28
Pa. Code § 25.131 (relating to every dispensing
practitioner); [and]
(B) all other schedules upon receipt of a court
order obtained by the requesting law enforcement
agency. Upon receipt of a motion under this clause,
the court may enter an ex parte order granting the
motion if the law enforcement agency has demonstrated
by a preponderance of the evidence that:
(I) the motion pertains to a person who is
the subject of an active criminal investigation
with a reasonable likelihood of securing an
arrest or prosecution in the foreseeable future;
and
(II) there is reasonable suspicion that a
criminal act has occurred[.]; and
(C) information with respect to the
administration of an opioid overdose agent shall not
be subject to a query by the Office of Attorney
General.
* * *
SECTION 7.1. REQUIREMENTS FOR FIRST RESPONDER AGENCIES AND
HOSPITAL EMERGENCY DEPARTMENTS.
(A) SUBMISSION.--A FIRST RESPONDER AGENCY OR HOSPITAL
EMERGENCY DEPARTMENT SHALL, IN THE FORMAT DETERMINED BY THE
DEPARTMENT, ELECTRONICALLY SUBMIT DRUG-RELATED OVERDOSE EVENT
INFORMATION TO THE DEPARTMENT.
(B) DATA ELEMENTS.--ALL OF THE FOLLOWING INFORMATION that is
available and reasonably able to be identified during a review
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of the individual's medical records SHALL BE PROVIDED BY A FIRST
RESPONDER AGENCY OR HOSPITAL EMERGENCY DEPARTMENT:
(1) THE FULL NAME, DATE OF BIRTH, GENDER AND ADDRESS OF
AN the INDIVIDUAL WHO EXPERIENCED A DRUG-RELATED OVERDOSE
EVENT.
(2) THE DATE AND TIME OF THE DRUG-RELATED OVERDOSE
EVENT.
(3) THE ADDRESS WHERE THE INDIVIDUAL WAS PICKED UP OR
WHERE THE DRUG-RELATED OVERDOSE EVENT TOOK PLACE.
(4) WHETHER AN EMERGENCY OPIOID ANTAGONIST WAS
ADMINISTERED TO THE INDIVIDUAL.
(5) THE LOCATION WHERE THE EMERGENCY OPIOID ANTAGONIST
WAS ADMINISTERED, IF AVAILABLE.
(6) THE AMOUNT OF EMERGENCY OPIOID ANTAGONIST
ADMINISTERED, IF AVAILABLE.
(7) WHETHER THE DRUG-RELATED OVERDOSE EVENT RESULTED IN
DEATH.
(8) THE SUSPECTED OR CONFIRMED DRUG INVOLVED IN THE
DRUG-RELATED OVERDOSE EVENT.
(C) FREQUENCY.--A FIRST RESPONDER AGENCY OR HOSPITAL
EMERGENCY DEPARTMENT SHALL SUBMIT ALL INFORMATION REQUIRED UNDER
SUBSECTION (B) TO THE PROGRAM NO LATER THAN 72 HOURS AFTER A
DRUG-RELATED OVERDOSE EVENT WAS REPORTED 14 days after the
completion of the acute episode of care .
(D) DEFINITION.--AS USED IN THIS SECTION, THE TERM
"EMERGENCY OPIOID ANTAGONIST" MEANS A MEDICATION APPROVED BY THE
UNITED STATES FOOD AND DRUG ADMINISTRATION TO REVERSE THE
EFFECTS OF AN OPIOID DRUG.
SECTION 7.2. REQUIREMENTS FOR CORONERS AND MEDICAL EXAMINERS.
(A) SUBMISSION.--A COUNTY CORONER OR MEDICAL EXAMINER IN
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THIS COMMONWEALTH SHALL ELECTRONICALLY SUBMIT DATA, IN THE
FORMAT PUBLISHED UNDER SUBSECTION (C), ON A DRUG-RELATED
OVERDOSE DEATH TO THE DEPARTMENT WITHIN FIVE BUSINESS DAYS OF
FINALIZING THE CAUSE AND MANNER OF THE DRUG-RELATED OVERDOSE
DEATH.
(B) CONTENTS OF DATA.--IN COMPLYING WITH SUBSECTION (A), A
COUNTY CORONER OR MEDICAL EXAMINER SHALL PROVIDE ALL OF THE
FOLLOWING INFORMATION TO THE DEPARTMENT:
(1) DEMOGRAPHIC INFORMATION OF THE DECEDENT, INCLUDING
BUT NOT LIMITED TO, THE FULL NAME, ADDRESS AND DATE OF BIRTH
OF THE DECEDENT.
(2) THE TOXICOLOGY REPORT.
(3) THE AUTOPSY REPORT.
(4) THE CIRCUMSTANCES OF THE DRUG-RELATED OVERDOSE
DEATH.
(C) PUBLICATION.--THE DEPARTMENT SHALL TRANSMIT A NOTICE OF
THE FORMAT FOR DATA SUBMISSION UNDER SUBSECTION (A) TO THE
LEGISLATIVE REFERENCE BUREAU FOR PUBLICATION IN THE PENNSYLVANIA
BULLETIN WITHIN 30 DAYS OF THE EFFECTIVE DATE OF THIS
SUBSECTION.
(D) PUBLIC REPORTS.--THE DEPARTMENT SHALL USE THE DATA
SUBMITTED UNDER SUBSECTION (A) TO COMPILE PUBLICLY AVAILABLE
REPORTS CONTAINING STATISTICS AND PATTERNS RELATING TO DRUG-
RELATED OVERDOSE DEATHS ON A QUARTERLY BASIS TO HELP IDENTIFY
THREATS TO PUBLIC HEALTH AND SAFETY.
(E) LIABILITY.--ANY INDIVIDUAL WHO, IN GOOD FAITH, PROVIDES
DATA TO THE DEPARTMENT UNDER THIS SECTION SHALL NOT BE SUBJECT
TO ANY CIVIL OR CRIMINAL LIABILITY AS A RESULT OF PROVIDING THE
DATA.
SECTION 6. SECTION 9 HEADING OF THE ACT IS AMENDED TO READ:
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Section 6. Section 9 heading and (b)(3) of the act are
amended and subsection (b) is amended by adding a paragraph to
read:
SECTION 9. ACCESS TO PRESCRIPTION INFORMATION AND DRUG-RELATED
OVERDOSE EVENT INFORMATION.
* * *
(b) Authorized users.--The following individuals may query
the system according to procedures determined by the board and
with the following limitations:
* * *
(3) (i) The Office of Attorney General shall query the
system on behalf of all law enforcement agencies,
including, but not limited to, the Office of the Attorney
General and Federal, State and local law enforcement
agencies for:
(A) Schedule II controlled substances as
indicated in the act of April 14, 1972 (P.L.233,
No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act, and in the manner determined
by the Pennsylvania Attorney General pursuant to 28
Pa. Code § 25.131 (relating to every dispensing
practitioner);
(B) all other schedules upon receipt of a court
order obtained by the requesting law enforcement
agency. Upon receipt of a motion under this clause,
the court may enter an ex parte order granting the
motion if the law enforcement agency has demonstrated
by a preponderance of the evidence that:
(I) the motion pertains to a person who is
the subject of an active criminal investigation
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with a reasonable likelihood of securing an
arrest or prosecution in the foreseeable future;
and
(II) there is reasonable suspicion that a
criminal act has occurred.
(ii) Data obtained by a law enforcement agency under
this paragraph shall only be used to establish probable
cause to obtain a search warrant or arrest warrant.
(iii) Requests made to the Office of Attorney
General to query the system under this paragraph shall be
made in a form or manner prescribed by the Office of
Attorney General and shall include the court order, when
applicable. Each individual designee of the Office of
Attorney General shall have a unique identifier when
accessing the system.
(iv) The Office of Attorney General shall not query
the system for information regarding a drug-related
overdose event.
* * *
(12) An authorized employee of a county or municipal
health department may query the system if the employee has a
unique identifier when accessing the system and the employee
accesses the system for any of the following purposes:
(i) Developing educational programs relating to
prescribing practices and controlled substance abuse.
(ii) Identifying at-risk individuals for the purpose
of connecting them with addiction treatment professionals
and programs, including single county authorities.
(iii) Compiling epidemiological data to ensure the
security of the system when an authorized employee of a
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county or municipal health department accesses the
system.
* * *
Section 8 7. This act shall take effect in 60 180 days.
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