PRINTER'S NO. 2353
THE GENERAL ASSEMBLY OF PENNSYLVANIA
INTRODUCED BY BAKER, TURZAI, DiGIROLAMO, RAPP, JAMES, HEFFLEY, SCHLOSSBERG, WATSON, HACKETT, GROVE, C. HARRIS, CLYMER, COHEN, GINGRICH, MAHONEY AND KRIEGER, SEPTEMBER 23, 2013
REFERRED TO COMMITTEE ON HUMAN SERVICES, SEPTEMBER 23, 2013
10PHARMACEUTICAL ACCOUNTABILITY MONITORING SYSTEM
122701. Short title of chapter.
142703. Scope of chapter.
162705. Advisory committee.
32708. Access to prescription information.
42709. Unlawful acts and penalties.
52710. Education and treatment.
72712. Additional provisions.
82713. Use of money collected.
92714. Rules and regulations.
102715. Evaluation, data analysis and reporting.
112716. Concurrent jurisdiction.
132718. Expiration of chapter.
14§ 2701. Short title of chapter.
17§ 2702. Purpose.
18The purpose of this chapter is to reduce the abuse of
19controlled substances and fraud by providing a tool that will
20ensure that practitioners making prescribing decisions have
21complete and reliable information about what, if any, other
22prescription drugs have recently been prescribed to their
23patients. It is the purpose of this act to provide reporting
24mechanisms, with full confidentiality protections, in which
25dispensers report prescription information to a central
26repository, in order to identify ultimate user and practitioner
27behaviors that give rise to a reasonable suspicion that
28prescription drugs are being inappropriately obtained or
29prescribed, so that appropriate ameliorative and corrective
30action, including treatment for individuals suffering from drug
4§ 2703. Scope of chapter.
5This chapter is intended to improve the Commonwealth's
6ability to enable informed and responsible prescribing and
7dispensing of controlled substances and to reduce diversion and
8misuse of such drugs in an efficient and cost-effective manner
9that will not impede the appropriate medical utilization of
10licit controlled substances.
11§ 2704. Definitions.
15"Active investigation." An investigation that is being
16conducted with a reasonable good faith belief that it could lead
17to the filing of administrative, civil or criminal proceedings,
18or that is ongoing and continuing and for which there is a
19reasonable good faith anticipation of securing an arrest or
20prosecution in the foreseeable future.
21"Alcohol and other drug addiction treatment program." Any
22facility or treatment program that is licensed by the
23Commonwealth to provide alcohol and other drug addiction
24treatment on a hospital, nonhospital residential or outpatient
26"ASAP." The American Society for Automation in Pharmacy.
27"Controlled substance." A drug, substance or immediate
28precursor included in Schedule II, III, IV or V of the act of
29April 14, 1972 (P.L.233, No.64), known as The Controlled
30Substance, Drug, Device and Cosmetic Act, or the Controlled
1Substances Act (Public Law 91-513, 84 Stat. 1236).
5"Department." The Department of Drug and Alcohol Programs.
12(1) A licensed health care facility or long-term care
13pharmacy that distributes such substances for the purpose of
14inpatient hospital, long-term care facility administration or
15licensed life provider.
18(3) A wholesale distributor of a controlled substance.
19(4) A hospice care provider.
20(5) A medical practitioner at a health care facility
21licensed by this Commonwealth if the quantity of controlled
22substances dispensed is limited to an amount adequate to
23treat the patient for a maximum of 24 hours with not more
24than two 24-hour cycles within any 15-day period.
27"Internet pharmacy." A person, entity or Internet site,
28whether in the United States or abroad, that knowingly or
29intentionally delivers, distributes or dispenses, or offers or
30attempts to deliver, distribute or dispense, a controlled
1substance by means of the Internet, including a pharmacy.
2"Licensed health care facility." A health care facility that
3is licensed under Article X of the act of June 13, 1967 (P.L.
431, No.21), known as the Public Welfare Code, or the act of July
519, 1979 (P.L.130, No.48), known as the Health Care Facilities
12"NDC." The National Drug Code.
13"NPI." The National Provider Identifier.
17"Practitioner." The term shall mean:
18(1) a physician, dentist, pharmacist, podiatrist,
19physician assistant, certified registered nurse practitioner,
20optometrist, dispensing veterinarian or other person
21licensed, registered or otherwise permitted to distribute,
22dispense or to administer a controlled substance, other drug
23or device in the course of professional practice or research
24in this Commonwealth; or
25(2) a pharmacy, hospital, clinic or other institution
26licensed, registered or otherwise permitted to distribute,
27dispense, conduct research with respect to or to administer a
28controlled substance, other drug or device in the course of
29professional practice or research in this Commonwealth.
30"Ultimate user." A person who lawfully possesses a
4§ 2705. Advisory committee.
9(1) Use of PAMS to improve patient care, to identify and
10address addiction and to facilitate the goal of reducing
11misuse, abuse, overdose, addiction to and diversion of
12controlled substances and drugs of concern.
1(9) Technological improvements to facilitate the
2interoperability of PAMS with other State prescription drug
3monitoring programs and electronic health information systems
4and to facilitate prescribers' and dispensers' access to and
5use of PAMS.
10(12) Recommended appointments to the advisory committee.
11(b) Confidentiality.--For the purpose of providing input and
12advice pursuant to subsection (a), no advisory committee member
13shall receive prescription monitoring information which
14identifies, or could reasonably be used to identify, the
15patient, prescriber, dispensing veterinarian, dispenser or other
16person who is the subject of the information.
21(2) The department may also appoint persons with
22recognized expertise, knowledge and experience in the
23establishment and maintenance of prescription monitoring
24programs, skills and expertise in alcohol and other drug
25addiction assessment and referral to addiction treatment or
26issues involving the misuse, abuse or diversion of, or the
27addiction to, controlled substances or drugs of concern.
10(a) General rule.--The department shall establish and
11administer the Pharmaceutical Accountability Monitoring System
12(PAMS) for monitoring all controlled substances that are
13dispensed within this Commonwealth by all practitioners,
14dispensing veterinarians or dispensers, including, but not
15limited to, a practitioner, dispensing veterinarian or dispenser
16that dispenses to a person or ships to an address within this
18(b) Disclosure.--Each practitioner shall disclose to all
19persons receiving a controlled substance that the identifying
20prescription information will be entered into the PAMS and may
21be accessed for limited purposes by specified individuals.
25(d) Registration.--Each dispenser, practitioner and designee
26dispensing or prescribing controlled substances shall register
27with and establish a user name and personal identification
28number that permits access to the secure website housing PAMS
29established by this chapter.
30§ 2707. Requirements for Pharmaceutical Accountability
2(a) Submission.--The dispenser shall, regarding each
3controlled substance dispensed, submit by electronic means,
4using the most current version of the ASAP prescription
5monitoring program web service standard, to the department the
6following information using methods of transmission protocols
7and in a format established by the department:
8(1) Full name of the prescribing practitioner.
11(3) Date the prescription was written.
12(4) Date the prescription was dispensed.
15(6) The NDC.
16(7) Dosage quantity and days' supply.
19(9) Dispensing entity's DEA registration number and NPI.
20(10) Source of payment for the prescription.
25(1) Pet's name.
26(2) Owner's name.
27(3) Pet's or owner's address.
28(4) Practice's name.
29(5) Dispensing veterinarian's name.
30(6) DEA license number.
1(7) Date the prescription was written.
2(8) Date the prescription was dispensed.
3(9) Name of the controlled substance.
4(10) Quantity and strength of the medication.
5(11) Dosage and frequency of the medication.
7(1) Each dispenser shall submit the information required
8by this chapter not later than seventy-two hours after the
9dispensing of a controlled substance monitored by PAMS. The
10department shall implement a real-time reporting requirement
11as expeditiously as possible.
23(2) The information provided to each person.
26(f) Expungement.--The department shall remove from PAMS all
27identifying information more than six years old from the date of
28collection. Such information shall then be destroyed unless a
29law enforcement agency or a professional licensing or
30certification agency or board for prescribers or dispensers has
4§ 2708. Access to prescription information.
5(a) General rule.--Except as set forth in subsection (c),
6prescription information submitted to the department and records
7of requests to query the data shall be confidential and not
8subject to disclosure under the act of February 14, 2008 (P.L.6,
9No.3), known as the Right-to-Know Law.
10(b) Privacy procedures.--The department shall maintain
11procedures to ensure that the privacy and confidentiality of
12patients and patient information collected, recorded,
13transmitted and maintained is not disclosed to persons except
14those enumerated in subsection (d).
20(3) Upon request of a Federal or State law enforcement
21official, information from PAMS related to a controlled
22substance on Schedule II of the act of April 14, 1972
23(P.L.233, No.64), known as The Controlled Substance, Drug,
24Device and Cosmetic Act, shall be provided by the department.
25(4) A Federal or State law enforcement official whose
26duties include enforcing laws relating to controlled
27substances and prescription drugs shall be provided access to
28the information from PAMS relating to the person who is the
29subject of an active investigation of a drug abuse offense,
30including, but not limited to, violations of The Controlled
13(3) Qualified personnel for the purpose of bona fide
14research or education. Data elements that would reasonably
15identify a specific recipient, prescriber, dispensing
16veterinarian or dispenser shall be deleted or redacted from
17such information prior to disclosure. Release of the
18information shall only be made pursuant to a written
19agreement between such qualified personnel and the department
20in order to ensure compliance with this chapter.
21(4) A practitioner, dispensing veterinarian or one
22representative employed by the practitioner, designated by
23the practitioner pursuant to criteria established by the
24department, having authority to prescribe controlled
25substances, to the extent that the information relates to a
26current patient of the practitioner or dispensing
27veterinarian to whom the practitioner or dispensing
28veterinarian is prescribing or considering prescribing any
30(5) A pharmacist, or one designee employed by the
1pharmacy, designated by the pharmacist pursuant to criteria
2established by the department, having authority to dispense
3controlled substances to the extent the information relates
4specifically to a current patient to whom that pharmacist is
5dispensing or considering dispensing any controlled
7(6) A designated representative from the Commonwealth or
8out-of-State agency or board responsible for licensing or
9certifying prescribers, dispensing veterinarians or
10dispensers who is involved in a bona fide investigation of a
11prescriber, dispensing veterinarian or dispenser whose
12professional practice was or is regulated by that agency or
16(8) A designated prescription monitoring official of a
17state with which this Commonwealth has an interoperability
18agreement may access prescription monitoring information in
19accordance with the provisions of this chapter and procedures
20adopted by the department.
21(9) An individual who is the recipient of a controlled
22substance prescription entered into PAMS upon providing
23evidence satisfactory to the PAMS manager that the individual
24requesting the information is in fact the person about whom
25the data entry was made. In the case where law enforcement
26has accessed the data for an active investigation, the
27information about that query shall be withheld from the
28individual for a period of six months.
7(12) Authorized personnel of the Department of Public
8Welfare engaged in the administration of the medical
9assistance program, and authorized personnel of the Insurance
10Department engaged in the administration of the Children's
11Health Insurance Program (CHIP).
12(e) Dispenser access.--No person shall knowingly hinder a
13pharmacist, dispensing veterinarian or practitioner who
14dispenses who is eligible to receive information from PAMS from
15requesting and receiving such information in a timely fashion.
16§ 2709. Unlawful acts and penalties.
17(a) Knowing, intentional or negligent release or use.--A
18person may not knowingly, intentionally or negligently use,
19release, publish or otherwise make available any information
20obtained from PAMS for any purpose other than those specified in
21section 2708(c) (relating to access to prescription
22information). A person who does knowingly, negligently or
23intentionally release or use information from PAMS that is not
24authorized in section 2708 commits a felony of the third degree
25and is subject to a civil penalty of not less than $5,000, or
26shall be sentenced to imprisonment of not more than 90 days, or
27both, for each offense.
1(c) Unauthorized purpose.--Any person who obtains or
2attempts to obtain information from PAMS for a purpose other
3than a purpose authorized by this chapter or by department
4regulations commits a felony of the third degree.
5(d) Civil violation.--The procedure for determining a civil
6violation of this subsection shall be in accordance with
7department regulations. Civil penalties assessed under this
8subsection shall be deposited in the General Fund, appropriated
9to the department and dedicated to PAMS operations.
10(e) Failure to submit.--The failure of a dispenser or
11dispensing veterinarian to submit information to PAMS as
12required under this section, after the department has submitted
13a specific written request for the information or when the
14department determines the individual has a demonstrable pattern
15of knowing that failure to submit the information as required,
16is grounds for the appropriate licensing board to take the
17following action in accordance with the appropriate licensing
21(2) Refuse to issue a license to the individual.
22(3) Refuse to renew the individual's license.
27(6) Issue a cease and desist order.
30(f) Medical record.--Nothing in this section shall prohibit
3§ 2710. Education and treatment.
6(1) assist the appropriate agency, board or association
7for each category of authorized user in this act to
8incorporate the appropriate information regarding PAMS into
9the training, education or instruction provided to each
10category of authorized user;
11(2) assist the State or regional chapter of the American
12Society of Addiction Medicine, the Pennsylvania Medical
13Society, the Pennsylvania Psychiatric Society, the
14Pennsylvania Veterinary Medical Association, the Pennsylvania
15Academy of Family Physicians and the Pennsylvania Coalition
16of Nurse Practitioners to develop a continuing education
17course for health care professionals on prescribing
18practices, pharmacology and identification, referral and
19treatment of patients addicted to or abusing controlled
20substances monitored by PAMS; and
21(3) implement, or assist other appropriate agencies to
22implement, an educational program to inform the public about
23the use, diversion and abuse of, addiction to and treatment
24for the addiction to the controlled substances monitored by
25PAMS, including the nature and scope of PAMS.
26(b) Referral.--With the input and advice of the advisory
27committee, the department shall refer prescribers, dispensing
28veterinarians and dispensers it has reason to believe may be
29impaired to the appropriate professional licensing or
30certification agency, and to the appropriate impaired
4(c) Identification.--With the input and advice of the
5advisory committee, the department shall work with the patient's
6individual practitioner and the appropriate alcohol and other
7drug addiction treatment professionals to provide that patients
8identified through PAMS as potentially addicted to a controlled
9substance are assessed and referred to alcohol and other drug
10addiction treatment programs.
11§ 2711. Immunity.
12An individual who has submitted to or received information
13from PAMS in accordance with section 2706 (relating to
14establishment of Pharmaceutical Accountability Monitoring
15System) may not be held civilly liable or disciplined in a
16licensing board action for having submitted the information or
17for not seeking or obtaining information from the prescription
18monitoring program prior to prescribing or dispensing a
19controlled substance to an ultimate user.
20§ 2712. Additional provisions.
27(c) Use of data.--Except as provided in subsection (d), data
28provided to, maintained in or accessed from PAMS that may be
29identified to, or with, a particular person is not subject to
30discovery, subpoena or similar compulsory process in any civil,
6(1) A criminal proceeding.
9§ 2713. Use of money collected.
15(2) Training of staff.
16(3) Pursuit of grants and matching funds.
17(b) Collections.--The department may collect any penalty
18imposed under section 2709 (relating to unlawful acts and
19penalties) and which is not paid by bringing an action in the
20court of common pleas of the county in which the person owing
21the debt resides or in the county where the department is
30§ 2714. Rules and regulations.
11(3) Allow adequate time following implementation of this
12chapter for dispensers, dispensing veterinarians and
13practitioners to make the changes to their operational
14systems necessary to comply with this chapter.
20(6) Dispensers, dispensing veterinarians and
21practitioners licensed to practice in this Commonwealth shall
22not be held liable for failure to comply with PAMS
23requirements until all changes are fully operational and
24dispensers, dispensing veterinarians and practitioners have
25had adequate time to make necessary adjustments to operating
26systems and to receive training to fully accommodate such
27changes upon promulgation of the regulations, but not later
28than one year after the effective date of this chapter.
3§ 2715. Evaluation, data analysis and reporting.
6(1) cost benefits of PAMS;
15(5) the number of ultimate users in paragraph (4) that
16received alcohol and other drug addiction treatment and the
17names of the licensed alcohol and other drug addiction
18treatment facilities in which the ultimate users were
25(b) Annual report.--The department shall annually report the
26information specified in subsection (a) to the Public Health and
27Welfare Committee of the Senate, the Human Services Committee of
28the House of Representatives, the United States Department of
29Justice, the Substance Abuse and Mental Health Services
30Administration of the Office of National Drug Control Policy and
5(c) Evaluation.--Within six years of the effective date of
6this act, the department shall submit to the chairman and
7minority chairman of the Public Health and Welfare Committee of
8the Senate and the chairman and minority chairman of the Human
9Services Committee of the House of Representatives, a written
10report containing information regarding the collection of data
11within PAMS. The report must include, but need not be limited
12to, the following information pertaining to the data collected
13within PAMS since its inception:
25(5) The rate by which doctors are utilizing PAMS to
26query patients identified as being potentially addicted to a
27controlled substance through PAMS for referral to alcohol and
28other drug addiction treatment programs.
10§ 2716. Concurrent jurisdiction.
11The Attorney General shall have concurrent prosecutorial
12jurisdiction with the county district attorney for violations of
13this chapter. No person charged with a violation of this chapter
14by the Attorney General shall have standing to challenge the
15authority of the Attorney General to prosecute the case and, if
16any such challenge is made, the challenge shall be dismissed and
17no relief shall be available in the courts of this Commonwealth
18to the person making the challenge.
19§ 2717. Nonapplicability.
20The requirements of this chapter shall not apply to:
23(2) the administration or dispensing of a controlled
24substance that is otherwise exempted as determined by the
25Federal Secretary of Health and Human Services under the
26National All Schedules Prescription Electronic Reporting Act
27of 2005 (Public Law 109-60, 119 Stat. 1979).
28§ 2718. Expiration of chapter.
8Section 4. The provisions of this act are severable. If any
9provision of this act or its application to any person or
10circumstance is held invalid, the invalidity shall not affect
11other provisions or applications of this act which can be given
12effect without the invalid provision or application.
13Section 5. This act shall take effect as follows:
16(2) This section shall take effect immediately.