PRINTER'S NO. 1341
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 AND ZIMMERMAN, APRIL 9, 2019
REFERRED TO COMMITTEE ON HEALTH, APRIL 9, 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, for
establishment of program and for requirements for dispensers
and pharmacies; providing for requirements for first
responders; 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
prescription medication history, including, but not limited to,
any history of a drug overdose, through an electronic system
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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:
* * *
"First responder." A firefighter, law enforcement officer or
emergency medical services personnel.
* * *
"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 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
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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 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
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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.
(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 in identifying at-risk
individuals and referring them to drug addiction
treatment professionals and programs.
(v.1) Aid prescribers 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
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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
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
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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
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 6. Establishment of program.
* * *
(b) Program components.--The program shall:
* * *
(6) Establish a protocol for health care professionals
and first responders to ensure data submitted to the system
with respect to an opioid overdose is not duplicative.
* * *
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):
(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
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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
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
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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. The act is amended by adding 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.
(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
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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,
Device and Cosmetic Act, and in the manner determined
by the Pennsylvania Attorney General pursuant to 28
Pa. Code ยง 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,
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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 8. This act shall take effect in 60 days.
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