THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY DiGIROLAMO, COHEN, BAKER, BISHOP, BOYD, BRENNAN, R. BROWN, CALTAGIRONE, CLYMER, DAVIS, J. EVANS, GEIST, GINGRICH, GROVE, HAHN, HARHAI, HARKINS, HEFFLEY, HELM, HENNESSEY, HESS, HORNAMAN, KILLION, KOTIK, KULA, MANN, MICOZZIE, MURPHY, MURT, MYERS, PYLE, QUINN, REICHLEY, SAYLOR, SCAVELLO, CULVER, K. SMITH, TAYLOR, THOMAS AND VULAKOVICH, JUNE 8, 2011

REFERRED TO COMMITTEE ON HUMAN SERVICES, JUNE 8, 2011  

AN ACT

Amending Title 44 (Law and Justice) of the Pennsylvania

Consolidated Statutes, establishing the Pharmaceutical

Accountability Monitoring System; and imposing penalties.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Title 44 of the Pennsylvania Consolidated

Statutes is amended by adding a chapter to read:

CHAPTER 27

PHARMACEUTICAL ACCOUNTABILITY MONITORING SYSTEM

Sec.

2701.  Short title of chapter.

2702.  Scope of chapter.

2703.  Definitions.

2704.  Establishment of Pharmaceutical Accountability Monitoring

System.

2705.  Requirements for Pharmaceutical Accountability Monitoring

System.

2706.  Access to prescription information.

2707.  Unlawful acts and penalties.

2708.  Education and treatment.

2709.  Immunity.

2710.  Additional provisions.

2711.  Use of money collected.

2712.  Rules and regulations.

2713.  Evaluation, data analysis and reporting.

2714.  Severability.

§ 2701.  Short title of chapter.

This chapter shall be known and may be cited as the

Pharmaceutical Accountability Monitoring System Act.

§ 2702.  Scope of chapter.

This chapter is intended to improve the Commonwealth's

ability to enable informed and responsible prescribing and

dispensing of controlled substances and to reduce diversion and

misuse of such drugs in an efficient and cost-effective manner

that will not impede the appropriate medical utilization of

licit controlled substances.

§ 2703.  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:

"Alcohol and other drug addiction treatment program."  Any

facility or treatment program that is licensed, certified or

approved by the Commonwealth to provide alcohol and other drug

addiction treatment on a hospital, nonhospital, residential or

outpatient basis.

"Controlled substance."  A drug, substance or immediate

precursor included in Schedule II, III, IV or V of the act of

April 14, 1972 (P.L.233, No.64), known as The Controlled

Substance, Drug, Device and Cosmetic Act, or the Controlled

Substances Act (Public Law 91-513, 84 Stat. 1236).

"Database."  The Pharmaceutical Accountability Monitoring

System established in section 2704 (relating to establishment of

Pharmaceutical Accountability Monitoring System).

"Department."  The Department of Drug and Alcohol Programs.

"Dispenser."  A provider who dispenses a scheduled drug to a

patient in this Commonwealth but does not include any of the

following:

(1)  A licensed health care facility or long-term care

pharmacy that distributes such substances for the purpose of

inpatient hospital or long-term care facility administration.

(2)  A practitioner or other authorized person who

administers such a substance.

(3)  A wholesale distributor of a scheduled drug.

(4)  A hospice care provider.

"Licensed health care facility."  A health care facility that

is licensed under Article X of the act of June 13, 1967 (P.L.

31, No.21), known as the Public Welfare Code, or the act of July

19, 1979 (P.L.130, No.48), known as the Health Care Facilities

Act.

"PAMS."  The Pharmaceutical Accountability Monitoring System

established in section 2704.

"Patient."  The person who has lawfully obtained and who

possesses any scheduled drug for the person's own use.

"Practitioner."  The term shall mean:

(1)  a physician, osteopath, dentist, veterinarian,

pharmacist, podiatrist, nurse, scientific investigator or

other person licensed, registered or otherwise permitted to

distribute, dispense, conduct research with respect to or to

administer a controlled substance, other drug or device in

the course of professional practice or research in this

Commonwealth; or

(2)  a pharmacy, hospital, clinic or other institution

licensed, registered or otherwise permitted to distribute,

dispense, conduct research with respect to or to administer a

controlled substance, other drug or device in the course of

professional practice or research in this Commonwealth.

§ 2704.  Establishment of Pharmaceutical Accountability

Monitoring System.

(a)  General rule.--The department shall establish and

maintain an electronic system for monitoring all scheduled drugs

that are dispensed within this Commonwealth by all professionals

licensed to prescribe or dispense such substances in this

Commonwealth, including, but not limited to, a practitioner or

pharmacist or dispensed to an address within this Commonwealth

by a pharmacy that has obtained a license, permit or other

authorization to operate by the Pennsylvania Board of Pharmacy.

(b)  Duties of department.--The department shall administer

PAMS.

(c)  Purpose.--The purpose of PAMS is to contain data as

described in this section regarding every prescription for a

controlled substance dispensed in this Commonwealth to any

person other than an inpatient in a licensed health care

facility or by a hospice care provider.

(d)  Data compliance.--Data required by this section shall be

submitted in compliance with this section to the department by

the pharmacy or other dispensing entity.

(e)  Data input.--A dispenser shall input data as required by

the department.

(f)  Queries.--A practitioner may query such data.

(g)  Registration.--Each dispenser and practitioner licensed

to practice in this Commonwealth shall register with and

establish a user name and personal identification number that

permits access to the secure website housing PAMS established by

this act.

(h)  Dispenser access.--Each dispenser required to report

electronically pursuant to this act shall have online access to

PAMS at all times when the dispenser provides pharmaceutical

care to a patient potentially receiving a controlled substance.

§ 2705.  Requirements for Pharmaceutical Accountability

Monitoring System.

(a)  Submission.--The dispenser shall, regarding each

controlled substance dispensed, submit by electronic means to

the department the following information by transmission

methods, protocols and in a format established by the

department:

(1)  Full name of the prescribing practitioner.

(2)  Prescriber Drug Enforcement Agency (DEA)

registration number.

(3)  Date the prescription was written.

(4)  Date the prescription was dispensed.

(5)  Patient information of the person for whom the

prescription was written and dispensed, including full name,

date of birth, gender and address.

(6)  Positive identification of the person receiving the

prescription, including the type of identification.

(7)  Name of the controlled substance.

(8)  Quantity of the controlled substance prescribed.

(9)  Strength of the controlled substance.

(10)  Quantity of the controlled substance dispensed.

(11)  Dosage quantity and frequency prescribed.

(12)  Name of the pharmacy or other entity dispensing the

controlled substance.

(13)  Name of the pharmacist dispensing the controlled

substance.

(14)  Dispensing entity's DEA registration number and

NPI.

(15)  Source of payment for the prescription.

(16)  Other relevant information as established by

department regulations.

(b)  Frequency.--Each dispenser shall submit the information

required by this act as frequently as specified by the

department, but not later than two days after the dispensing of

a controlled substance monitored by PAMS. The department shall

implement a real-time reporting requirement as expeditiously as

possible.

(c)  Maintenance.--The department shall maintain PAMS in an

electronic file or by other means established by the department

to facilitate use of the database for identification of:

(1)  Prescribing and dispensing practices and patterns

for controlled substances.

(2)  An individual patient's patterns of obtaining

controlled substances from licensed practitioners and who

subsequently obtain dispensed controlled substances from a

drug outlet in quantities or with a frequency inconsistent

with generally recognized standards of dosage for that

controlled substance.

(3)  Individuals presenting forged or otherwise false or

altered prescriptions for controlled substances to a

pharmacy.

(d)  Recordkeeping.--The department shall maintain a record

of PAMS queries for reference, including:

(1)  Identification of each person who requests or

receives information from PAMS.

(2)  The information provided to each person.

(3)  The date and time the information is requested or

provided.

§ 2706.  Access to prescription information.

(a)  General rule.--Except as set forth in subsection (c),

prescription information submitted to the department shall be

confidential and not subject to disclosure under the act of

February 14, 2008 (P.L.6, No.3), known as the Right-to-Know Law.  

(b)  Privacy procedures.--The department shall maintain

procedures to ensure that the privacy and confidentiality of

patients and patient information collected, recorded,

transmitted and maintained is not disclosed to persons except

those enumerated in subsection (c).

(c)  Limited availability.--The manager of PAMS shall make

information in PAMS available only to the following persons and

in accordance with the limitations stated in the department

regulations:

(1)  Personnel of the department specifically assigned to

conduct investigations related to controlled substances laws

under the jurisdiction of the department.

(2)  Authorized department personnel engaged in analysis

of controlled substance prescription information as a part of

the assigned duties and responsibilities of their employment.

(3)  Qualified personnel for the purpose of bona fide

research or education. Data elements that would reasonably

identify a specific recipient, prescriber or dispenser shall

be deleted or redacted from such information prior to

disclosure. Release of the information shall only be made

pursuant to a written agreement between such qualified

personnel and the department in order to ensure compliance

with this chapter.

(4)  A licensed practitioner, or a representative

employed by the practitioner, designated by the practitioner

pursuant to criteria established by the department, having

authority to prescribe controlled substances, to the extent

of one of the following:

(i)  The information relates to a current patient of

the practitioner to whom the practitioner is prescribing

or considering prescribing any controlled substance.

(ii)  The information relates specifically to an

individual who has access to the practitioner's DEA

number, and the practitioner suspects that the individual

may use the practitioner's DEA identification number to

fraudulently acquire or prescribe controlled substances.

(iii)  The information relates to the practitioner's

own prescribing practices, except when specifically

prohibited by department regulations.

(5)  A licensed pharmacist, or a designee employed by the

pharmacist, designated by the pharmacist pursuant to criteria

established by the department, having authority to dispense

controlled substances to the extent the information relates

specifically to a current patient to whom that pharmacist is

dispensing or considering dispensing any controlled

substance.

(6)  Federal or State law enforcement authorities engaged

in the administration, investigation or enforcement of the

laws governing controlled substances and who are involved in

one of the following:

(i)  A bona fide specific drug-related investigation

involving a designated person.

(ii)  Investigating insurance fraud, Medicaid fraud

or Medicare fraud.

(7)  A designated representative from the Commonwealth or

out-of-State agency or board responsible for licensing or

certifying prescribers or dispensers who is involved in a

bona fide investigation of a prescriber or dispenser whose

professional practice was or is regulated by that agency or

board.

(8)  A medical examiner or county coroner for the purpose

of investigating the death of an individual.

(9)  A designated prescription monitoring official of a

state with which this Commonwealth has an interoperability

agreement may access prescription monitoring information in

accordance with procedures adopted by the department.

(10)  An individual who is the recipient of a controlled

substance prescription entered into PAMS upon providing

evidence satisfactory to the PAMS manager that the individual

requesting the information is in fact the person about whom

the data entry was made.

(11)  A judicial authority under grand jury subpoena or

court order or equivalent judicial process for investigation

of a criminal violation of law governing controlled

substances may access prescription monitoring information.

§ 2707.  Unlawful acts and penalties.

(a)  Knowing and intentional release.--Any person who

knowingly and intentionally releases any information in PAMS in

violation of the limitations under section 2706(c) (relating to

access to prescription information) commits a felony of the

third degree.

(b)  Misrepresentation or fraud.--Any person who obtains or

attempts to obtain information from PAMS by misrepresentation or

fraud commits a felony of the third degree.

(c)  Unauthorized purpose.--Any person who obtains or

attempts to obtain information from PAMS for a purpose other

than a purpose authorized by this section or by department

regulations commits a felony of the third degree.

(d)  Other person.--A person may not knowingly and

intentionally use, release, publish or otherwise make available

to any other person or entity any information obtained from PAMS

for any purpose other than those specified in section 2706(c).

Each separate violation of this subsection is a felony of the

third degree and is subject to a civil penalty not to exceed

$5,000.

(e)  Civil violation.--The procedure for determining a civil

violation of this subsection shall be in accordance with

department regulations. Civil penalties assessed under this

subsection shall be deposited in the General Fund, appropriated

to the department and dedicated to the controlled substance PAMS

operations.

(f)  Failure to submit.--The failure of a dispenser to submit

information to PAMS as required under this section, after the

department has submitted a specific written request for the

information or when the department determines the individual has

a demonstrable pattern of knowing that failure to submit the

information as required, is grounds for the pharmacy board to

take the following action in accordance with the act of

September 27, 1961 (P.L.1700, No.699), known as the Pharmacy

Act.

(1)  Refuse to issue a license to the individual.

(2)  Refuse to renew the individual's license.

(3)  Revoke, suspend, restrict or place on probation the

license.

(4)  Issue a public or private reprimand to the

individual.

(5)  Issue a cease and desist order.

(6)  Impose a civil penalty of not more than $1,000 for

each dispensed prescription for which the required

information was not submitted.

(g)  A person authorized to have prescription monitoring

information under this act who knowingly uses such information

in violation of this act shall, upon conviction, be fined not

less than $5,000, be sentenced to imprisonment of not more than

90 days, or both, for each offense.

§ 2708.  Education and treatment.

(a)  General rule.--The department shall:

(1)  assist the appropriate agency, board or association

for each category of authorized user in this act to

incorporate the appropriate information regarding PAMS into

the training, education or instruction provided to each

category of authorized user;

(2)  assist the State or regional chapter of the American

Society of Addiction Medicine, or comparable association in

this Commonwealth, and the medical society to develop a

continuing education course for health care professionals on

prescribing practices, pharmacology and identification,

referral and treatment of patients addicted to or abusing

controlled substances monitored by PAMS; and

(3)  implement, or assist other appropriate agencies to

implement, an educational program to inform the public about

the use, diversion and abuse of, addiction to and treatment

for the addiction to the controlled substances monitored by

PAMS.

(b)  Referral.--The department shall refer prescribers and

dispensers it has reason to believe may be impaired to the

appropriate professional licensing or certification agency, and

to the appropriate impaired professionals associations, to

provide intervention, assessment and referral to alcohol and

other drug addiction treatment programs, and ongoing monitoring

and follow-up.

(c)  Identification.--The department shall work with the

appropriate alcohol and other drug addiction treatment

professionals to provide that patients identified through PAMS

as potentially addicted to a controlled substance are assessed

and referred to alcohol and other drug addiction treatment

programs.

§ 2709.  Immunity.

An individual who has submitted information to PAMS in

accordance with this section may not be held civilly liable for

having submitted the information.

§ 2710.  Additional provisions.

(a)  Funding.--A practitioner or a pharmacist shall not be

required to pay a fee or tax specifically dedicated to

establishment, operation or maintenance of the system.

(b)  Costs.--All costs associated with recording and

submitting data as required in this section shall be assumed by

the submitting pharmacy.

(c)  Use of data.--Except as provided in subsection (d), data

provided to, maintained in or accessed from PAMS that may be

identified to, or with, a particular person is not subject to

discovery, subpoena or similar compulsory process in any civil,

judicial, administrative or legislative proceeding, nor shall

any individual or organization with lawful access to the data be

compelled to testify with regard to the data.

(d)  Exceptions.--The restrictions in subsection (c) do not

apply to:

(1)  A criminal proceeding.

(2)  A civil, judicial or administrative action brought

to enforce the provisions of this section.

§ 2711.  Use of money collected.

(a)  General rule.--The department may use the moneys

deposited in the General Fund and appropriated to the department

for the following purposes:

(1)  Maintenance and replacement of PAMS equipment,

including hardware and software.

(2)  Training of staff.

(3)  Pursuit of grants and matching funds.

(b)  Collections.--The department may collect any penalty

imposed under section 2707 (relating to unlawful acts and

penalties) and which is not paid by bringing an action in the

court of common pleas of the county in which the person owing

the debt resides or in the county where the department is

located.

(c)  Legal assistance.--The department may seek legal

assistance from the Attorney General or the county or district

attorney of the county in which the action is brought to collect

the fine.

(d)  Attorney fees and costs.--The court shall award

reasonable attorney fees and costs to the department for

successful collection actions under section 2707.

§ 2712.  Rules and regulations.

The department shall promulgate rules and regulations setting

forth the procedures and methods for implementing this chapter.

At a minimum, the rules and regulations shall include the

following:

(1)  Effectively enforce the limitations on access to

PAMS prescribed in section 2706 (relating to access to

prescription information).

(2)  Establish standards and procedures to ensure

accurate identification of individuals requesting information

or receiving information from PAMS.

§ 2713.  Evaluation, data analysis and reporting.

(a)  General rule.--The department shall design and implement

an evaluation component to identify:

(1)  cost benefits of PAMS;

(2)  the impact on efforts to reduce misuse, abuse,

overdose and diversion of, or addiction to, controlled

substances;

(3)  the impact on prescribing practices for controlled

substances;

(4)  the number of patients identified through PAMS as

potentially addicted to a controlled substance that were

assessed for alcohol and other drug addictions;

(5)  the number of patients in paragraph (4) that

received alcohol and other drug addiction treatment and the

names of the licensed, certified or approved alcohol and

other drug addiction treatment facilities in which the

patients were treated;

(6)  the progress made in implementing real-time

reporting; and

(7)  other information relevant to policy, research and

education involving controlled substances and drugs of

concern monitored by PAMS.

(b)  Annual report.--The department shall annually report the

information specified in subsection (a) to the Public Health and

Welfare Committee of the Senate, the Human Services Committee of

the House of Representatives, the United States Department of

Justice, the Substance Abuse and Mental Health Services

Administration of the Office of National Drug Control Policy and

members of Pennsylvania's United States Congressional

delegation. Additionally, the department shall make the annual

report available to the public on its publicly accessible

Internet website.

§ 2714.  Severability.

The provisions of this act are severable. If any provision of

this act or its application to any person or circumstance is

held invalid, the invalidity shall not affect other provisions

or applications of this act which can be given effect without

the invalid provision or application.

Section 2.  This act shall take effect in 60 days.