1Amending Title 44 (Law and Justice) of the Pennsylvania
2Consolidated Statutes, establishing the Pharmaceutical
3Accountability Monitoring System; abrogating a regulation;
4and imposing penalties.

5The General Assembly of the Commonwealth of Pennsylvania
6hereby enacts as follows:

7Section 1. Title 44 of the Pennsylvania Consolidated
8Statutes is amended by adding a chapter to read:

<-9CHAPTER 27

10PHARMACEUTICAL ACCOUNTABILITY MONITORING SYSTEM

11Sec.

122701. Short title of chapter.

132702. Purpose.

142703. Scope of chapter.

152704. Definitions.

162705. Advisory committee.

172706. Establishment of Pharmaceutical Accountability Monitoring

1System.

22707. Requirements for Pharmaceutical Accountability Monitoring
3System.

42708. Access to prescription information.

52709. Unlawful acts and penalties.

62710. Education and treatment.

72711. Immunity.

82712. Additional provisions.

92713. Use of money collected.

102714. Rules and regulations.

112715. Evaluation, data analysis and reporting.

122716. Concurrent jurisdiction.

132717. Nonapplicability.

142718. Expiration of chapter.

15§ 2701. Short title of chapter.

16This chapter shall be known and may be cited as the
17Pharmaceutical Accountability Monitoring System Act.

18§ 2702. Purpose.

19The purpose of this chapter is to reduce the abuse of
20controlled substances and fraud by providing a tool that will
21ensure that practitioners making prescribing decisions have
22complete and reliable information about what, if any, other
23prescription drugs have recently been prescribed to their
24patients. It is the purpose of this act to provide reporting
25mechanisms, with full confidentiality protections, in which
26dispensers report prescription information to a central
27repository, in order to identify ultimate user and practitioner
28behaviors that give rise to a reasonable suspicion that
29prescription drugs are being inappropriately obtained or
30prescribed, so that appropriate ameliorative and corrective

1action, including treatment for individuals suffering from drug
2and alcohol addiction, may be taken. This chapter is further
3intended to help detect, refer to law enforcement and regulatory
4agencies and deter prescription drug fraud and diversion.

5§ 2703. Scope of chapter.

6This chapter is intended to improve the Commonwealth's
7ability to enable informed and responsible prescribing and
8dispensing of controlled substances and to reduce diversion and
9misuse of such drugs in an efficient and cost-effective manner
10that will not impede the appropriate medical utilization of
11licit controlled substances.

12§ 2704. Definitions.

13The following words and phrases when used in this chapter
14shall have the meanings given to them in this section unless the
15context clearly indicates otherwise:

16"Active investigation." An investigation that is being
17conducted with a reasonable good faith belief that it could lead
18to the filing of administrative, civil or criminal proceedings,
19or that is ongoing and continuing and for which there is a
20reasonable good faith anticipation of securing an arrest or
21prosecution in the foreseeable future.

22"Alcohol and other drug addiction treatment program." Any
23facility or treatment program that is licensed by the
24Commonwealth to provide alcohol and other drug addiction
25treatment on a hospital, nonhospital residential or outpatient
26basis.

27"ASAP." The American Society for Automation in Pharmacy.

28"Controlled substance." A drug, substance or immediate
29precursor included in Schedule II, III, IV or V of the act of
30April 14, 1972 (P.L.233, No.64), known as The Controlled

1Substance, Drug, Device and Cosmetic Act, or the Controlled
2Substances Act (Public Law 91-513, 84 Stat. 1236).

3"Database." The Pharmaceutical Accountability Monitoring
4System established in section 2706 (relating to establishment of
5Pharmaceutical Accountability Monitoring System).

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

7"Dispense." To deliver a controlled substance, other drug or
8device to an ultimate user by or pursuant to the lawful order of
9a practitioner.

10"Dispenser." A practitioner who dispenses in this
11Commonwealth, including mail order and Internet sales of
12pharmaceuticals. The term does not include any of the following:

13(1) A licensed health care facility or long-term care
14pharmacy that distributes such substances for the purpose of
15inpatient hospital, long-term care facility administration or
16licensed life provider.

17(2) A practitioner or other authorized person who
18administers such a substance.

19(3) A wholesale distributor of a controlled substance.

20(4) A hospice care provider.

21(5) A medical practitioner at a health care facility
22licensed by this Commonwealth if the quantity of controlled
23substances dispensed is limited to an amount adequate to
24treat the patient for a maximum of 24 hours with not more
25than two 24-hour cycles within any 15-day period.

26"Dispensing veterinarian." A veterinarian who dispenses in
27this Commonwealth.

28"Internet pharmacy." A person, entity or Internet site,
29whether in the United States or abroad, that knowingly or
30intentionally delivers, distributes or dispenses, or offers or

1attempts to deliver, distribute or dispense, a controlled
2substance by means of the Internet, including a pharmacy.

3"Licensed health care facility." A health care facility that
4is licensed under Article X of the act of June 13, 1967 (P.L.
531, No.21), known as the Public Welfare Code, or the act of July
619, 1979 (P.L.130, No.48), known as the Health Care Facilities
7Act.

8"LIFE." The program of medical and supportive services known
9as Living Independently for Elders.

10"Mail-order pharmacy." A pharmacy that dispenses controlled
11substances using the United States Postal Service or any express
12delivery service.

13"NDC." The National Drug Code.

14"NPI." The National Provider Identifier.

15"PAMS." The Pharmaceutical Accountability Monitoring System
16established in section 2706 (relating to establishment of
17Pharmaceutical Accountability Monitoring System).

18"Practitioner." The term shall mean:

19(1) a physician, dentist, pharmacist, podiatrist,
20physician assistant, certified registered nurse practitioner,
21optometrist, dispensing veterinarian or other person
22licensed, registered or otherwise permitted to distribute,
23dispense or to administer a controlled substance, other drug
24or device in the course of professional practice or research
25in this Commonwealth; or

26(2) a pharmacy, hospital, clinic or other institution
27licensed, registered or otherwise permitted to distribute,
28dispense, conduct research with respect to or to administer a
29controlled substance, other drug or device in the course of
30professional practice or research in this Commonwealth.

1"Ultimate user." A person who lawfully possesses a
2controlled substance, other drug, device or cosmetic for his own
3use or for the use of a member of his household or for
4administering to an animal in his care.

5§ 2705. Advisory committee.

6(a) Establishment.--An advisory committee is established to
7provide input and advice to the department regarding the
8establishment and maintenance of PAMS, including, but not
9limited to:

10(1) Use of PAMS to improve patient care, to identify and
11address addiction and to facilitate the goal of reducing
12misuse, abuse, overdose, addiction to and diversion of
13controlled substances and drugs of concern.

14(2) Safeguards for the release of information to
15authorized users.

16(3) The confidentiality of prescription monitoring
17information and the integrity of the patient's relationship
18with the patient's health care provider.

19(4) Development of criteria for referring prescription
20monitoring information to a law enforcement or professional
21licensing agency.

22(5) Development of criteria for referring a prescriber,
23dispensing veterinarian or dispenser to a professional
24licensing agency or impaired professionals association.

25(6) The design and implementation of training, education
26or instruction.

27(7) The provision of assessment and referral to alcohol
28and other drug addiction treatment as part of any other
29requirements of this chapter.

30(8) Technical standards for electronic reporting of

1prescription monitoring information.

2(9) Technological improvements to facilitate the
3interoperability of PAMS with other State prescription drug
4monitoring programs and electronic health information systems
5and to facilitate prescribers' and dispensers' access to and
6use of PAMS.

7(10) Proper analysis and interpretation of prescription
8monitoring information.

9(11) Design and implementation of an evaluation
10component.

11(12) Recommended appointments to the advisory committee.

12(b) Confidentiality.--For the purpose of providing input and
13advice pursuant to subsection (a), no advisory committee member
14shall receive prescription monitoring information which
15identifies, or could reasonably be used to identify, the
16patient, prescriber, dispensing veterinarian, dispenser or other
17person who is the subject of the information.

18(c) Membership.--

19(1) The department shall establish an advisory committee
20comprised of the following:

21(i) A representative recommended by the Department
22of State representing the State Board of Medicine, the
23State Board of Nursing and the State Board of Veterinary
24Medicine.

25(ii) A representative recommended by the State Board
26of Pharmacy.

27(iii) A representative recommended by the Attorney
28General.

29(iv) Two physicians recommended by the Pennsylvania
30Medical Society, one of whom holds membership in the

1American Society of Addiction Medicine and the other who
2is a physician with expertise in chronic pain management
3and treatment.

4(v) A physician who is a member of the Pennsylvania
5Psychiatric Society specializing in addiction psychiatry.

6(vi) A representative recommended by the
7Pennsylvania District Attorneys Association.

8(vii) A representative recommended by the
9Pennsylvania Coroners Association.

10(viii) A representative recommended by the Drug and
11Alcohol Service Providers Organization of Pennsylvania.

12(ix) A representative of chronic pain patients
13recommended by a physician with expertise in chronic pain
14management.

15(x) A representative of veterinary medicine with
16dispensing practice recommended by the Pennsylvania
17Veterinary Medical Association.

18(xi) A representative of pharmacies recommended by
19the Pennsylvania Association of Chain Drug Stores.

20(xii) A representative of pharmacies recommended by
21the Pennsylvania Pharmacists' Association.

22(2) The department may also appoint persons with
23recognized expertise, knowledge and experience in the
24establishment and maintenance of prescription monitoring
25programs, skills and expertise in alcohol and other drug
26addiction assessment and referral to addiction treatment or
27issues involving the misuse, abuse or diversion of, or the
28addiction to, controlled substances or drugs of concern.

29(d) Quorum.--Nine members of the advisory committee shall
30constitute a quorum for the transaction of all business. The

1members shall elect a chairman and such other officers as deemed
2necessary whose duties shall be established by the advisory
3committee. The department shall convene the advisory committee
4at least quarterly using telecommunication whenever possible.

5(e) Staff assistance.--The department shall provide the
6advisory committee with any staff services which may be
7necessary for the advisory committee to carry out its duties
8under this chapter.

9§ 2706. Establishment of Pharmaceutical Accountability
10Monitoring System.

11(a) General rule.--The department shall establish and
12administer the Pharmaceutical Accountability Monitoring System
13(PAMS) for monitoring all controlled substances that are
14dispensed within this Commonwealth by all practitioners,
15dispensing veterinarians or dispensers, including, but not
16limited to, a practitioner, dispensing veterinarian or dispenser
17that dispenses to a person or ships to an address within this
18Commonwealth.

19(b) Disclosure.--Each practitioner shall disclose to all
20persons receiving a controlled substance that the identifying
21prescription information will be entered into the PAMS and may
22be accessed for limited purposes by specified individuals.

23(c) Data compliance.--Data required by this section shall be
24submitted in compliance with this section to the department by
25the pharmacy or other dispensing entity.

26(d) Registration.--Each dispenser, practitioner and designee
27dispensing or prescribing controlled substances shall register
28with and establish a user name and personal identification
29number that permits access to the secure website housing PAMS
30established by this chapter.

1§ 2707. Requirements for Pharmaceutical Accountability
2Monitoring System.

3(a) Submission.--The dispenser shall, regarding each
4controlled substance dispensed, submit by electronic means,
5using the most current version of the ASAP prescription
6monitoring program web service standard, to the department the
7following information using methods of transmission protocols
8and in a format established by the department:

9(1) Full name of the prescribing practitioner.

10(2) Prescriber Drug Enforcement Agency (DEA)
11registration number.

12(3) Date the prescription was written.

13(4) Date the prescription was dispensed.

14(5) Full name, date of birth, gender and address of the
15person for whom the prescription was written and dispensed.

16(6) The NDC.

17(7) Dosage quantity and days' supply.

18(8) Name of the pharmacy or other entity dispensing the
19controlled substance.

20(9) Dispensing entity's DEA registration number and NPI.

21(10) Source of payment for the prescription.

22(b) Veterinary dispensers.--The dispensing veterinarian
23shall, regarding each controlled substance dispensed, submit
24by electronic mail to the department the following
25information:

26(1) Pet's name.

27(2) Owner's name.

28(3) Pet's or owner's address.

29(4) Practice's name.

30(5) Dispensing veterinarian's name.

1(6) DEA license number.

2(7) Date the prescription was written.

3(8) Date the prescription was dispensed.

4(9) Name of the controlled substance.

5(10) Quantity and strength of the medication.

6(11) Dosage and frequency of the medication.

7(c) Frequency.--

8(1) Each dispenser shall submit the information required
9by this chapter not later than seventy-two hours after the
10dispensing of a controlled substance monitored by PAMS. The
11department shall implement a real-time reporting requirement
12as expeditiously as possible.

13(2) Each dispensing veterinarian shall submit the
14information required by this chapter within six months of
15dispensing a controlled substance monitored by PAMS to the
16department.

17(d) Maintenance.--The department shall maintain PAMS in an
18electronic file or by other means established by the department
19to facilitate use of the database.

20(e) Recordkeeping.--The department shall maintain a record
21of PAMS queries for reference, including:

22(1) Identification of each person who requests or
23receives information from PAMS.

24(2) The information provided to each person.

25(3) The date and time the information is requested and
26provided.

27(f) Expungement.--The department shall remove from PAMS all
28identifying information more than six years old from the date of
29collection. Such information shall then be destroyed unless a
30law enforcement agency or a professional licensing or

1certification agency or board for prescribers or dispensers has
2submitted a written request to the department for retention of
3specific information. All requests shall comply with procedures
4adopted by the department.

5§ 2708. Access to prescription information.

6(a) General rule.--Except as set forth in subsection (c),
7prescription information submitted to the department and records
8of requests to query the data shall be confidential and not
9subject to disclosure under the act of February 14, 2008 (P.L.6,
10No.3), known as the Right-to-Know Law.

11(b) Privacy procedures.--The department shall maintain
12procedures to ensure that the privacy and confidentiality of
13patients and patient information collected, recorded,
14transmitted and maintained is not disclosed to persons except
15those enumerated in subsection (d).

16(c) Queries.--

17(1) A practitioner may query the data for an existing
18patient.

19(2) A practitioner may query the data for prescriptions
20written using his or her own DEA number.

21(3) Upon request of a Federal or State law enforcement
22official, information from PAMS related to a controlled
23substance on Schedule II of the act of April 14, 1972
24(P.L.233, No.64), known as The Controlled Substance, Drug,
25Device and Cosmetic Act, shall be provided by the department.

26(4) A Federal or State law enforcement official whose
27duties include enforcing laws relating to controlled
28substances and prescription drugs shall be provided access to
29the information from PAMS relating to the person who is the
30subject of an active investigation of a drug abuse offense,

1including, but not limited to, violations of The Controlled
2Substance, Drug, Device and Cosmetic Act, insurance fraud,
3medicare fraud or medicaid fraud pursuant to an active
4investigation.

5(d) Limited availability.--The department shall make
6information in PAMS available only to the following persons and
7in accordance with department regulations:

8(1) Personnel of the department specifically assigned to
9conduct internal reviews related to controlled substances
10laws under the jurisdiction of the department.

11(2) Authorized department personnel engaged in analysis
12of controlled substance prescription information as a part of
13the assigned duties and responsibilities of their employment.

14(3) Qualified personnel for the purpose of bona fide
15research or education. Data elements that would reasonably
16identify a specific recipient, prescriber, dispensing
17veterinarian or dispenser shall be deleted or redacted from
18such information prior to disclosure. Release of the
19information shall only be made pursuant to a written
20agreement between such qualified personnel and the department
21in order to ensure compliance with this chapter.

22(4) A practitioner, dispensing veterinarian or one
23representative employed by the practitioner, designated by
24the practitioner pursuant to criteria established by the
25department, having authority to prescribe controlled
26substances, to the extent that the information relates to a
27current patient of the practitioner or dispensing
28veterinarian to whom the practitioner or dispensing
29veterinarian is prescribing or considering prescribing any
30controlled substance.

1(5) A pharmacist, or one designee employed by the
2pharmacy, designated by the pharmacist pursuant to criteria
3established by the department, having authority to dispense
4controlled substances to the extent the information relates
5specifically to a current patient to whom that pharmacist is
6dispensing or considering dispensing any controlled
7substance.

8(6) A designated representative from the Commonwealth or
9out-of-State agency or board responsible for licensing or
10certifying prescribers, dispensing veterinarians or
11dispensers who is involved in a bona fide investigation of a
12prescriber, dispensing veterinarian or dispenser whose
13professional practice was or is regulated by that agency or
14board.

15(7) A medical examiner or county coroner for the purpose
16of investigating the death of an individual.

17(8) A designated prescription monitoring official of a
18state with which this Commonwealth has an interoperability
19agreement may access prescription monitoring information in
20accordance with the provisions of this chapter and procedures
21adopted by the department.

22(9) An individual who is the recipient of a controlled
23substance prescription entered into PAMS upon providing
24evidence satisfactory to the PAMS manager that the individual
25requesting the information is in fact the person about whom
26the data entry was made. In the case where law enforcement
27has accessed the data for an active investigation, the
28information about that query shall be withheld from the
29individual for a period of six months.

30(10) The Office of Attorney General of Pennsylvania or

1the equivalent law enforcement officer of another state may
2access information from the PAMS for an active investigation
3of a criminal violation of law governing controlled
4substances.

5(11) A grand jury may access information from the PAMS
6for an active investigation of a criminal violation of law
7governing controlled substances.

8(12) Authorized personnel of the Department of Public
9Welfare engaged in the administration of the medical
10assistance program, and authorized personnel of the Insurance
11Department engaged in the administration of the Children's
12Health Insurance Program (CHIP).

13(e) Dispenser access.--No person shall knowingly hinder a
14pharmacist, dispensing veterinarian or practitioner who
15dispenses who is eligible to receive information from PAMS from
16requesting and receiving such information in a timely fashion.

17§ 2709. Unlawful acts and penalties.

18(a) Knowing, intentional or negligent release or use.--A
19person may not knowingly, intentionally or negligently use,
20release, publish or otherwise make available any information
21obtained from PAMS for any purpose other than those specified in
22section 2708(c) (relating to access to prescription
23information). A person who does knowingly, negligently or
24intentionally release or use information from PAMS that is not
25authorized in section 2708 commits a felony of the third degree
26and is subject to a civil penalty of not less than $5,000, or
27shall be sentenced to imprisonment of not more than 90 days, or
28both, for each offense.

29(b) Misrepresentation or fraud.--Any person who obtains or
30attempts to obtain information from PAMS by misrepresentation or

1fraud commits a felony of the third degree.

2(c) Unauthorized purpose.--Any person who obtains or
3attempts to obtain information from PAMS for a purpose other
4than a purpose authorized by this chapter or by department
5regulations commits a felony of the third degree.

6(d) Civil violation.--The procedure for determining a civil
7violation of this subsection shall be in accordance with
8department regulations. Civil penalties assessed under this
9subsection shall be deposited in the General Fund, appropriated
10to the department and dedicated to PAMS operations.

11(e) Failure to submit.--The failure of a dispenser or
12dispensing veterinarian to submit information to PAMS as
13required under this section, after the department has submitted
14a specific written request for the information or when the
15department determines the individual has a demonstrable pattern
16of knowing that failure to submit the information as required,
17is grounds for the appropriate licensing board to take the
18following action in accordance with the appropriate licensing
19act:

20(1) Prohibit an Internet pharmacy from conducting
21business in this Commonwealth.

22(2) Refuse to issue a license to the individual.

23(3) Refuse to renew the individual's license.

24(4) Revoke, suspend, restrict or place on probation the
25license.

26(5) Issue a public or private reprimand to the
27individual.

28(6) Issue a cease and desist order.

29(7) Impose a civil penalty of not more than $1,000 for
30each failure to submit information required by this act.

1(f) Medical record.--Nothing in this section shall prohibit
2a practitioner from maintaining a PAMS patient report as part of
3the patient's medical record.

4§ 2710. Education and treatment.

5(a) General rule.--With the input and advice of the advisory
6committee, the department shall:

7(1) assist the appropriate agency, board or association
8for each category of authorized user in this act to
9incorporate the appropriate information regarding PAMS into
10the training, education or instruction provided to each
11category of authorized user;

12(2) assist the State or regional chapter of the American
13Society of Addiction Medicine, the Pennsylvania Medical
14Society, the Pennsylvania Psychiatric Society, the
15Pennsylvania Veterinary Medical Association, the Pennsylvania
16Academy of Family Physicians and the Pennsylvania Coalition
17of Nurse Practitioners to develop a continuing education
18course for health care professionals on prescribing
19practices, pharmacology and identification, referral and
20treatment of patients addicted to or abusing controlled
21substances monitored by PAMS; and

22(3) implement, or assist other appropriate agencies to
23implement, an educational program to inform the public about
24the use, diversion and abuse of, addiction to and treatment
25for the addiction to the controlled substances monitored by
26PAMS, including the nature and scope of PAMS.

27(b) Referral.--With the input and advice of the advisory
28committee, the department shall refer prescribers, dispensing
29veterinarians and dispensers it has reason to believe may be
30impaired to the appropriate professional licensing or

1certification agency, and to the appropriate impaired
2professionals associations, to provide intervention, assessment
3and referral to alcohol and other drug addiction treatment
4programs, and ongoing monitoring and follow-up.

5(c) Identification.--With the input and advice of the
6advisory committee, the department shall work with the patient's
7individual practitioner and the appropriate alcohol and other
8drug addiction treatment professionals to provide that patients
9identified through PAMS as potentially addicted to a controlled
10substance are assessed and referred to alcohol and other drug
11addiction treatment programs.

12§ 2711. Immunity.

13An individual who has submitted to or received information
14from PAMS in accordance with section 2706 (relating to
15establishment of Pharmaceutical Accountability Monitoring
16System) may not be held civilly liable or disciplined in a
17licensing board action for having submitted the information or
18for not seeking or obtaining information from the prescription
19monitoring program prior to prescribing or dispensing a
20controlled substance to an ultimate user.

21§ 2712. Additional provisions.

22(a) Funding.--A practitioner or a pharmacist shall not be
23required to pay a fee or tax specifically dedicated to
24establishment, operation or maintenance of the system.

25(b) Costs.--All costs associated with recording and
26submitting data as required in this section shall be assumed by
27the submitting dispenser.

28(c) Use of data.--Except as provided in subsection (d), data
29provided to, maintained in or accessed from PAMS that may be
30identified to, or with, a particular person is not subject to

1discovery, subpoena or similar compulsory process in any civil,
2judicial, administrative or legislative proceeding, nor shall
3any individual or organization with lawful access to the data be
4compelled to testify with regard to the data.

5(d) Exceptions.--The restrictions in subsection (c) do not
6apply to:

7(1) A criminal proceeding.

8(2) A civil, judicial or administrative action brought
9to enforce the provisions of this section.

10§ 2713. Use of money collected.

11(a) General rule.--The department may use the moneys
12deposited in the General Fund and appropriated to the department
13for the following purposes:

14(1) Maintenance and replacement of PAMS equipment,
15including hardware and software.

16(2) Training of staff.

17(3) Pursuit of grants and matching funds.

18(b) Collections.--The department may collect any penalty
19imposed under section 2709 (relating to unlawful acts and
20penalties) and which is not paid by bringing an action in the
21court of common pleas of the county in which the person owing
22the debt resides or in the county where the department is
23located.

24(c) Legal assistance.--The department may seek legal
25assistance from the Attorney General or the county or district
26attorney of the county in which the action is brought to collect
27the fine.

28(d) Attorney fees and costs.--The court shall award
29reasonable attorney fees and costs to the department for
30successful collection actions under section 2709.

1§ 2714. Rules and regulations.

2The department shall promulgate rules and regulations setting
3forth the procedures and methods for implementing this chapter.
4At a minimum, the rules and regulations shall include the
5following:

6(1) Effectively enforce the limitations on access to
7PAMS prescribed in section 2708 (relating to access to
8prescription information).

9(2) Establish standards and procedures to ensure
10accurate identification of individuals requesting information
11or receiving information from PAMS.

12(3) Allow adequate time following implementation of this
13chapter for dispensers, dispensing veterinarians and
14practitioners to make the changes to their operational
15systems necessary to comply with this chapter.

16(4) Allow for dispensers and dispensing veterinarians to
17have ease of transition to comply with the requirements of
18the Pharmaceutical Accountability Monitoring System.

19(5) Not place an undue burden on law enforcement seeking
20information related to an investigation.

21(6) Dispensers, dispensing veterinarians and
22practitioners licensed to practice in this Commonwealth shall
23not be held liable for failure to comply with PAMS
24requirements until all changes are fully operational and
25dispensers, dispensing veterinarians and practitioners have
26had adequate time to make necessary adjustments to operating
27systems and to receive training to fully accommodate such
28changes upon promulgation of the regulations, but not later
29than one year after the effective date of this chapter.

30(7) Dispensers and dispensing veterinarians who can show

1good cause for not submitting data electronically may be
2authorized to submit data manually if they lack Internet
3access.

4§ 2715. Evaluation, data analysis and reporting.

5(a) General rule.--The department shall design and implement
6an evaluation component to identify:

7(1) cost benefits of PAMS;

8(2) the impact on efforts to reduce misuse, abuse,
9overdose and diversion of, or addiction to, controlled
10substances;

11(3) the impact on prescribing practices for controlled
12substances;

13(4) the number of ultimate users identified through PAMS
14as potentially addicted to a controlled substance that were
15assessed for alcohol and other drug addictions;

16(5) the number of ultimate users in paragraph (4) that
17received alcohol and other drug addiction treatment and the
18names of the licensed alcohol and other drug addiction
19treatment facilities in which the ultimate users were
20treated;

21(6) the progress made in implementing real-time
22reporting; and

23(7) other information relevant to policy, research and
24education involving controlled substances and drugs of
25concern monitored by PAMS.

26(b) Annual report.--The department shall annually report the
27information specified in subsection (a) to the Public Health and
28Welfare Committee of the Senate, the Human Services Committee of
29the House of Representatives, the United States Department of
30Justice, the Substance Abuse and Mental Health Services

1Administration of the Office of National Drug Control Policy and
2members of Pennsylvania's United States Congressional
3delegation. Additionally, the department shall make the annual
4report available to the public on its publicly accessible
5Internet website.

6(c) Evaluation.--Within six years of the effective date of
7this act, the department shall submit to the chairman and
8minority chairman of the Public Health and Welfare Committee of
9the Senate and the chairman and minority chairman of the Human
10Services Committee of the House of Representatives, a written
11report containing information regarding the collection of data
12within PAMS. The report must include, but need not be limited
13to, the following information pertaining to the data collected
14within PAMS since its inception:

15(1) The number of times information from PAMS has been
16illegally accessed.

17(2) The number of times a patient's privacy or
18confidentiality was compromised through use of the system.

19(3) The number of times the security of the PAMS
20database has been breached by hackers operating under
21malicious purposes.

22(4) A comparison of the rate of death by accidental
23overdose before the implementation of PAMS and the rate of
24death by accidental overdose after the implementation of
25PAMS.

26(5) The rate by which doctors are utilizing PAMS to
27query patients identified as being potentially addicted to a
28controlled substance through PAMS for referral to alcohol and
29other drug addiction treatment programs.

30(6) The cost effectiveness of the frequency of data

1submission.

2(7) Any impact on efforts to reduce misuse, abuse,
3overdose and diversion of, or addiction to, controlled
4substances.

5(8) Any impact on prescribing practices for controlled
6substances.

7(9) The number of patients that were referred for
8alcohol and other drug addiction treatment.

9(10) The effectiveness of the interoperability with
10other states.

11§ 2716. Concurrent jurisdiction.

12The Attorney General shall have concurrent prosecutorial
13jurisdiction with the county district attorney for violations of
14this chapter. No person charged with a violation of this chapter
15by the Attorney General shall have standing to challenge the
16authority of the Attorney General to prosecute the case and, if
17any such challenge is made, the challenge shall be dismissed and
18no relief shall be available in the courts of this Commonwealth
19to the person making the challenge.

20§ 2717. Nonapplicability.

21The requirements of this chapter shall not apply to:

22(1) the direct administration of a controlled substance
23to the body of an ultimate user; or

24(2) the administration or dispensing of a controlled
25substance that is otherwise exempted as determined by the
26Federal Secretary of Health and Human Services under the
27National All Schedules Prescription Electronic Reporting Act
28of 2005 (Public Law 109-60, 119 Stat. 1979).

29§ 2718. Expiration of chapter.

30This chapter shall expire seven years after the date of the

1enactment of this chapter.

2Section 2. The regulation of the Department of Health in 28
3Pa. Code § 25.131 (relating to every dispensing practitioner) is
4abrogated.

5Section 3. Upon the full operation of PAMS, the Department
6of Drug and Alcohol Programs shall transmit notice to the
7Legislative Reference Bureau for publication in the Pennsylvania
8Bulletin.

9Section 4. The provisions of this act are severable. If any
10provision of this act or its application to any person or
11circumstance is held invalid, the invalidity shall not affect
12other provisions or applications of this act which can be given
13effect without the invalid provision or application.

14Section 5. This act shall take effect as follows:

15(1) Section 2 shall take effect 90 days after
16publication of the notice under section 3 of this act.

17(2) This section shall take effect immediately.

18(3) The remainder of this act shall take effect in 60
19days.

<-20CHAPTER 27

21PHARMACEUTICAL ACCOUNTABILITY MONITORING SYSTEM

22Sec.

232701. Short title of chapter.

242702. Purpose.

252703. Scope of chapter.

262704. Definitions.

272705. Advisory committee.

282706. Establishment of Pharmaceutical Accountability Monitoring
29System.

302707. Requirements for Pharmaceutical Accountability Monitoring

1System.

22708. Access to PAMS information.

32709. Unlawful acts, penalties and private right of action.

42710. Education and treatment.

52711. Immunity.

62712. Additional provisions.

72713. Use of money collected.

82714. Rules and regulations.

92715. Evaluation, data analysis and reporting.

102716. Concurrent jurisdiction.

112717. Nonapplicability.

122718. Expiration of chapter and expungement.

13§ 2701. Short title of chapter.

14This chapter shall be known and may be cited as the
15Pharmaceutical Accountability Monitoring System Act.

16§ 2702. Purpose.

17The purpose of this chapter is to reduce the abuse of
18controlled substances and fraud by providing a tool that will
19ensure that practitioners making prescribing decisions have
20complete and reliable information about what, if any, other
21prescription drugs have recently been prescribed to their
22patients. It is the purpose of this act to provide reporting
23mechanisms, with full confidentiality protections, in which
24dispensers report prescription information to a central
25repository, in order to identify ultimate user and practitioner
26behaviors that give rise to a reasonable suspicion that
27prescription drugs are being inappropriately obtained or
28prescribed, so that appropriate ameliorative and corrective
29action, including treatment for individuals suffering from drug
30and alcohol addiction, may be taken. This chapter is further

1intended to help detect, refer to regulatory agencies and deter
2prescription drug fraud and diversion.

3§ 2703. Scope of chapter.

4This chapter is intended to improve the Commonwealth's
5ability to enable informed and responsible prescribing and
6dispensing of controlled substances and to reduce diversion and
7misuse of such drugs in an efficient and cost-effective manner
8that will not impede the appropriate medical utilization of
9licit controlled substances.

10§ 2704. Definitions.

11The following words and phrases when used in this chapter
12shall have the meanings given to them in this section unless the
13context clearly indicates otherwise:

14"Active investigation." An investigation that is being
15conducted with a reasonable suspicion that it could lead to the
16filing of administrative, civil or criminal proceedings, or that
17is ongoing and continuing and for which there is a reasonable
18suspicion of securing an arrest or prosecution in the
19foreseeable future.

20"ASAP." The American Society for Automation in Pharmacy.

21"Controlled substance." A drug, substance or immediate
22precursor included in Schedule II, III, IV or V of the act of
23April 14, 1972 (P.L.233, No.64), known as The Controlled
24Substance, Drug, Device and Cosmetic Act, or the Controlled
25Substances Act (Public Law 91-513, 84 Stat. 1236). The term
26shall not include a drug, substance or immediate precursor
27included in Schedule V of the Controlled Substances Act provided
28that it has been identified in 21 CFR § 1308.15(e) (relating to
29Schedule V).

30"Continuing care provider." A facility licensed by the

1Department of Insurance under the act of June 18, 1984 (P.L.391,
2No.82), known as the Continuing-Care Provider Registration and
3Disclosure Act.

4"Database." The Pharmaceutical Accountability Monitoring
5System established in section 2706 (relating to establishment of
6Pharmaceutical Accountability Monitoring System).

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

8"Dispense." To deliver a controlled substance, other drug or
9device to an ultimate user by or pursuant to the lawful order of
10a practitioner.

11"Dispenser." A practitioner who dispenses in this
12Commonwealth, including mail order and Internet sales of
13pharmaceuticals. The term does not include any of the following:

14(1) The use of such substances on the order of a
15practitioner for the purpose of treating patients who are
16inpatient at a licensed hospital, a licensed ambulatory care
17facility, a continuing care provider or a licensed long-term
18care nursing facility.

19(2) A licensed provider under the LIFE program.

20(3) A licensed health care facility or long-term care
21pharmacy that distributes such substances for the purpose of
22inpatient hospital or long-term care facility administration.

23(4) A practitioner or other authorized person who
24administers such a substance.

25(5) A wholesale distributor of a controlled substance.

26(6) A hospice care provider in the course of providing
27hospice care.

28(7) A medical practitioner at a health care facility
29licensed by this Commonwealth if the quantity of controlled
30substances dispensed is limited to an amount adequate to

1treat the patient for a maximum of 24 hours with not more
2than two 24-hour cycles within any 15-day period.

3"Dispensing veterinarian." A veterinarian who dispenses in
4this Commonwealth.

5"Internet pharmacy." A person, entity or Internet site,
6whether in the United States or abroad, that knowingly or
7intentionally delivers, distributes or dispenses, or offers or
8attempts to deliver, distribute or dispense a controlled
9substance by means of the Internet, including a pharmacy.

10"Licensed addiction treatment program." An alcohol and other
11drug addiction treatment program licensed by the department.

12"Licensed health care facility." A health care facility that
13is licensed under the act of July 19, 1979 (P.L.130, No.48),
14known as the Health Care Facilities Act, or a personal care home
15or assisted living residence that is licensed under Article X of
16the act of June 13, 1967 (P.L.31, No.21), known as the Public
17Welfare Code.

18"LIFE." The program of medical and supportive services known
19as Living Independently for Elders.

20"Mail-order pharmacy." A pharmacy that dispenses controlled
21substances using the United States Postal Service or any express
22delivery service.

23"NDC." The National Drug Code.

24"NPI." The National Provider Identifier.

25"PAMS." The Pharmaceutical Accountability Monitoring System
26established in section 2706 (relating to establishment of
27Pharmaceutical Accountability Monitoring System) or its
28successor.

29"Practitioner." The term shall mean:

30(1) a physician, dentist, pharmacist, podiatrist,

1physician assistant, certified registered nurse practitioner,
2optometrist, dispensing veterinarian or other person
3licensed, registered or otherwise permitted to distribute,
4dispense or to administer a controlled substance, other drug
5or device in the course of professional practice or research
6in this Commonwealth; or

7(2) a pharmacy, hospital, clinic or other institution
8licensed, registered or otherwise permitted to distribute,
9dispense, conduct research with respect to or to administer a
10controlled substance, other drug or device in the course of
11professional practice or research in this Commonwealth.

12"Ultimate user." A person who lawfully possesses a
13controlled substance, other drug, device or cosmetic for his own
14use or for the use of a member of his household or for
15administering to an animal in his care.

16§ 2705. Advisory committee.

17(a) Establishment.--An advisory committee is established to
18provide input and advice to the department regarding the
19establishment and maintenance of PAMS, including, but not
20limited to:

21(1) The use of PAMS to improve patient care, to identify
22and address addiction and to facilitate the goal of reducing
23misuse, abuse, overdose, addiction to and diversion of
24controlled substances and drugs of concern.

25(2) Safeguards for the release of information to persons
26authorized to access PAMS in accordance with section 2708
27(relating to access to PAMS information).

28(3) The confidentiality of prescription monitoring
29information and the integrity of the patient's relationship
30with the patient's health care provider.

1(4) The development of criteria for referring
2prescription monitoring information to a professional
3licensing agency.

4(5) The development of criteria for referring a
5practitioner to a professional licensing agency or impaired
6professionals association.

7(6) The design and implementation of training, education
8or instruction.

9(7) The provision of assessment and referral to alcohol
10and other drug addiction treatment as part of any other
11requirements of this chapter.

12(8) The development of technical standards for
13electronic reporting of prescription monitoring information.

14(9) The maintenance of technological improvements to
15facilitate the interoperability of PAMS with other State
16prescription drug monitoring programs and electronic health
17information systems and to facilitate practitioners' access
18to and use of PAMS.

19(10) The proper analysis and interpretation of
20prescription monitoring information.

21(11) The design and implementation of an evaluation
22component.

23(12) Recommended appointments to the advisory committee.

24(b) Confidentiality.--For the purpose of providing input and
25advice pursuant to subsection (a), no advisory committee member
26shall receive prescription monitoring information which
27identifies, or could reasonably be used to identify, the
28ultimate use or practitioner who is the subject of the
29information. Notwithstanding any other law to the contrary, any
30and all meetings of the PAMS advisory committee are to be

1considered confidential and closed to the public. Members and
2staff shall maintain strict standards of confidentiality in the
3handling of all matters before the advisory committee. In
4addition, all relevant Federal and State laws regarding patient
5privacy and confidentiality will be adhered to. All material and
6information, regardless of form, medium or method of
7communication provided to or acquired by an advisory committee
8member or staff in the course of the advisory committee's work,
9shall be regarded as confidential information, shall not be
10disclosed and are not public records. In addition, all material
11and information, regardless of form, medium or method of
12communication, made or generated by a member of department staff
13in the course of the advisory committee's work, shall be
14regarded as confidential information and shall not be disclosed
15and are deemed not to be a public record. All necessary steps
16shall be taken by members and staff to safeguard the
17confidentiality of such material or information in conformance
18with Federal and State law.

19(c) Membership.--

20(1) The department shall establish an advisory committee
21comprised of the following:

22(i) A representative recommended by the Department
23of State representing the State Board of Medicine, the
24State Board of Nursing and the State Board of Veterinary
25Medicine.

26(ii) A representative recommended by the State Board
27of Pharmacy.

28(iii) A representative recommended by the Attorney
29General.

30(iv) Two physicians recommended by the Pennsylvania

1Medical Society, one of whom holds membership in the
2American Society of Addiction Medicine and the other who
3is a physician with expertise in chronic pain management
4and treatment.

5(v) A physician who is a member of the Pennsylvania
6Psychiatric Society specializing in addiction psychiatry.

7(vi) A representative recommended by the
8Pennsylvania District Attorneys Association.

9(vii) A representative recommended by the
10Pennsylvania Coroners Association.

11(viii) A representative recommended by the Drug and
12Alcohol Service Providers Organization of Pennsylvania.

13(ix) A representative of chronic pain patients
14recommended by a physician with expertise in chronic pain
15management.

16(x) A representative of veterinary medicine with
17dispensing practice recommended by the Pennsylvania
18Veterinary Medical Association.

19(xi) A representative of pharmacies recommended by
20the Pennsylvania Association of Chain Drug Stores.

21(xii) A representative of pharmacies recommended by
22the Pennsylvania Pharmacists' Association.

23(xiii) A representative recommended by the
24Pennsylvania State Nurses Association.

25(2) The department may also seek input from persons with
26recognized expertise, knowledge and experience in the
27establishment and maintenance of prescription monitoring
28programs, skills and expertise in alcohol and other drug
29addiction assessment and referral to addiction treatment or
30issues involving the misuse, abuse or diversion of, or the

1addiction to, controlled substances.

2(d) Quorum.--Nine members of the advisory committee shall
3constitute a quorum for the transaction of all business. The
4members shall elect a chairman and such other officers as deemed
5necessary whose duties shall be established by the advisory
6committee. The department shall convene the advisory committee
7at least quarterly using telecommunication whenever possible.

8(e) Staff assistance.--The department shall provide the
9advisory committee with any staff services which may be
10necessary for the advisory committee to carry out its duties
11under this chapter.

12§ 2706. Establishment of Pharmaceutical Accountability
13Monitoring System.

14(a) General rule.--With the input and advice of the advisory
15committee, the department shall establish and administer the
16Pharmaceutical Accountability Monitoring System (PAMS) for
17monitoring all controlled substances that are dispensed by
18dispensers or dispensing veterinarians within this Commonwealth,
19including, but not limited to, those dispensed to a person or
20shipped to an address within this Commonwealth. The system shall
21comply with the Health Insurance Portability and Accountability
22Act of 1996 (Public Law 104-191, 110 Stat. 1936) as it pertains
23to protected health information(PHI) and electronic protected
24health information (EPHI), as well as all other relevant Federal
25and State privacy and security laws and regulations.

26(b) Disclosure.--Each practitioner shall disclose to all
27persons for whom a controlled substance is prescribed that the
28identifying prescription information will be entered into the
29PAMS when the controlled substance is dispensed and may be
30accessed only for limited purposes by specified individuals.

1(c) Data compliance.--Data required by this section shall be
2submitted in compliance with this section to the department by
3the pharmacy or other dispensing entity.

4(d) Registration.--Each dispenser, practitioner and person
5designated by each dispenser and practitioner in accordance with
6section 2707(d) (relating to requirements for Pharmaceutical
7Accountability Monitoring System) shall register with and
8establish a user name and personal identification number that
9permits access to the secure website housing PAMS established by
10this chapter.

11§ 2707. Requirements for Pharmaceutical Accountability
12Monitoring System.

13(a) Submission.--The dispenser shall, regarding each
14controlled substance dispensed, submit by electronic means,
15using the most current version of the ASAP prescription
16monitoring program web service standard, to the department the
17following information using methods of transmission protocols
18and in a format established by the department:

19(1) Full name of the prescribing practitioner.

20(2) Prescriber Drug Enforcement Agency (DEA)
21registration number.

22(3) Date the prescription was written.

23(4) Date the prescription was dispensed.

24(5) Full name, date of birth, gender and address of the
25patient for whom the prescription was written and dispensed.

26(6) The NDC.

27(7) Quantity and days' supply.

28(8) Name of the pharmacy or other entity dispensing the
29controlled substance.

30(9) Dispensing entity's DEA registration number and NPI.

1(10) Source of payment for the prescription.

2At the start up of the program, the most current version of the
3ASAP prescription monitoring program standard shall be used and
4updates are only required when substantive changes are made to
5the standard.

6(b) Veterinary dispensers.--The dispensing veterinarian
7shall, regarding each controlled substance dispensed, submit
8by electronic mail to the department the following
9information:

10(1) Pet's name.

11(2) Owner's name.

12(3) Pet's or owner's address.

13(4) Practice's name.

14(5) Dispensing veterinarian's name.

15(6) DEA license number.

16(7) Date the prescription was written.

17(8) Date the prescription was dispensed.

18(9) Name of the controlled substance.

19(10) Quantity and strength of the medication.

20(11) Dosage and frequency of the medication.

21(c) Frequency.--

22(1) Each dispenser shall submit the information required
23by this chapter not later than seventy-two hours after the
24dispensing of a controlled substance monitored by PAMS. The
25department shall implement a real-time reporting requirement
26as expeditiously as possible.

27(2) Each dispensing veterinarian shall submit the
28information required by this chapter within six months of
29dispensing a controlled substance monitored by PAMS to the
30department.

1(d) Maintenance.--The department shall maintain PAMS in an
2electronic file or by other means established by the department
3to facilitate use of the database.

4(e) Recordkeeping.--The department shall maintain a record
5of PAMS queries for reference, including:

6(1) Identification of each person who requests or
7receives information from PAMS.

8(2) The information provided to each person.

9(3) The date and time the information is requested and
10provided.

11(4) In the event that a request was made by the Office
12of Attorney General on behalf of Federal or State law
13enforcement officials, the name shall be listed as "OAG" so
14the names of law enforcement officials remain confidential.

15(f) Expungement.--The department shall remove from PAMS all
16information identifying the ultimate user or practitioner more
17than six years old from the date of collection. Such information
18shall then be destroyed unless a law enforcement agency or a
19professional licensing or certification agency or board for
20prescribers or dispensers has submitted a written request to the
21department for retention of specific information. All requests
22shall comply with procedures adopted by the department.

23§ 2708. Access to PAMS information.

24(a) General rule.--All information entered into the database
25or otherwise submitted to the department and records of requests
26to query the data shall be confidential and not subject to
27disclosure under the act of February 14, 2008 (P.L.6, No.3),
28known as the Right-to-Know Law.

29(b) Privacy procedures.--

30(1) The department shall maintain procedures to ensure

1that the privacy and confidentiality of patients and patient
2information collected, recorded, entered, transmitted and
3maintained is not disclosed to persons except those
4enumerated in subsections (e) and (f).

5(2) All transmissions of data under this section shall
6comply with relevant Federal and State privacy and security
7laws and regulations.

8(c) Investigations.--The department shall not disclose the
9existence of an active investigation.

10(d) Database queries.--In addition to the department:

11(1) A practitioner may query the database for the
12following information about an existing patient:

13(i) A practitioner or one person employed,
14designated and supervised by a practitioner pursuant to
15criteria established by the department to the extent that
16the information relates to a current patient of the
17practitioner or dispensing veterinarian to whom the
18practitioner or dispensing veterinarian is prescribing or
19considering prescribing any controlled substance.

20(ii) A pharmacist or designated pharmacy associate
21under the supervision of the pharmacist, designated by
22the pharmacist pursuant to criteria established by the
23department, having authority to dispense controlled
24substances to the extent the information relates
25specifically to a current patient to whom that pharmacist
26is dispensing or considering dispensing any controlled
27substance.

28(2) A practitioner may query the database for
29prescriptions written using his or her own Drug Enforcement
30Agency number.

1(e) Information.--Upon written request, in the manner and
2form required by the department, information contained in PAMS
3shall be made available by the department only to the following
4persons and in accordance with department regulations:

5(1) Authorized personnel of the department who are 
6specifically assigned to conduct internal reviews related to 
7controlled substances laws under the jurisdiction of the 
8department.

9(2) Authorized personnel of the department who are
10engaged in analysis of controlled substance prescription
11information as a part of the assigned duties and
12responsibilities of their employment.

13(3) Researchers for the purpose of bona fide research or
14education. All information that would identify the ultimate
15user or practitioner shall be deleted or redacted from such
16information prior to disclosure. Release of the information
17shall only be made pursuant to a written agreement between
18such researcher and the department in order to ensure
19compliance with this chapter.

20(4) A designated representative from the Commonwealth or
21out-of-State agency or board responsible for licensing or
22certifying practitioners who is involved in a bona fide
23investigation of a prescriber, dispensing veterinarian or
24dispenser whose professional practice was or is regulated by
25that agency or board.

26(5) A coroner for the purpose of investigating the death
27of an individual.

28(6) A designated prescription monitoring official of a
29state with which this Commonwealth has an interoperability
30agreement may access prescription monitoring information in

1accordance with the provisions of this chapter.

2(7) An individual about whom information has been
3entered into PAMS upon providing evidence satisfactory to the
4department that the individual requesting the information is
5in fact the person about whom the data entry was made.

6(8) Authorized personnel of the Department of Public
7Welfare engaged in the administration of the medical
8assistance program, authorized personnel of the Insurance
9Department engaged in the administration of the Children's
10Health Insurance Program (CHIP) and authorized personnel of
11the Department of Aging engaged in the administration of the
12Pharmaceutical Assistance Contract for the Elderly program.

13(f) Dispenser access.--No person shall knowingly hinder a
14practitioner who is eligible to receive information from PAMS
15from requesting and receiving such information in a timely
16fashion.

17(g) Law enforcement access.--

18(1) The Office of Attorney General shall submit requests
19for information from PAMS to the department on behalf of all
20law enforcement agencies, including, but not limited to, the
21Office of Attorney General and Federal, State and local law
22enforcement agencies, as well as an Attorney General or
23similar official from another state. The department shall
24provide the Office of Attorney General access to information
25as follows:

26(i) Pursuant to a valid search warrant, the
27department shall provide information from PAMS in
28relation to a controlled substance on Schedule II of the
29act of April 14, 1972 (P.L.233, No.64), known as The 
30Controlled Substance, Drug, Device and Cosmetic Act.

1(ii) If the Attorney General determines that
2information in PAMS is relevant to an active
3investigation, upon request of the Office of Attorney
4General, the department shall provide the office access
5to information from PAMS in relation to a controlled
6substance on Schedules III, IV and V of The Controlled
7Substance, Drug, Device and Cosmetic Act only as it
8relates to persons who are the subject of the active
9investigation.

10(2) The department may provide access to information
11from PAMS to a grand jury empaneled to investigate a criminal
12violation of a law governing controlled substances,
13including, but not limited to, violations of The Controlled
14Substance, Drug, Device and Cosmetic Act, and to investigate
15insurance, Medicare or Medicaid fraud.

16(3) Law enforcement officials may only use PAMS data to
17aid in establishing probable cause in order to obtain a
18search or arrest warrant.

19§ 2709. Unlawful acts, penalties and private right of action.

20(a) Unlawful acts.--A person commits an offense when the
21person:

22(1) Knowingly, intentionally or negligently uses,
23releases, publishes or otherwise makes available any
24information obtained from PAMS for any purpose other than
25those specified in section 2708 (relating to access to PAMS
26information).

27(2) Obtains or attempts to obtain information from PAMS
28by misrepresentation or fraud.

29(3) Obtains or attempts to obtain information from PAMS
30for a purpose other than a purpose authorized by this chapter

1or by department regulations.

2(b) Grading.--A person who violates subsection (a)(1), (2)
3or (3) commits a felony of the third degree and shall, upon
4conviction, be sentenced to pay a fine of not less than $5,000
5or to imprisonment for not more than 90 days, or both.

6(c) Civil violation.--The procedure for determining a civil
7violation of this subsection shall be in accordance with
8department regulations. Civil penalties assessed under this
9subsection shall be deposited in the General Fund, appropriated
10to the department and dedicated to PAMS operations.

11(d) Failure to submit.--The failure of a dispenser or
12dispensing veterinarian to submit information to PAMS as
13required under this section, after the department has submitted
14a specific written request for the information or when the
15department determines the individual has a demonstrable pattern
16of failure to submit the information as required, is grounds for
17the appropriate licensing board to take the following action in
18accordance with the appropriate licensing act:

19(1) Prohibit an Internet pharmacy from conducting
20business in this Commonwealth.

21(2) Refuse to issue a license to the individual.

22(3) Refuse to renew the individual's license.

23(4) Revoke or suspend the license.

24(5) Restrict or place on probation the licensee.

25(6) Issue a public or private reprimand to the
26individual.

27(7) Issue a cease and desist order.

28(8) Impose a civil penalty of not more than $1,000 for
29each failure to submit information required by this act.

30(9) Authorize any other action under the appropriate

1licensing act.

2(e) Medical record.--Nothing in this section shall prohibit
3a practitioner from maintaining a PAMS patient report as part of
4the patient's medical record.

5(f) Private right of action.--

6(1) Any person whose private personal or medical
7information from PAMS is knowingly, intentionally or
8negligently released, obtained through fraud or
9misrepresentation or used for a purpose other than a purpose
10authorized by this section or department regulations and
11thereby suffers any ascertainable loss of privacy or
12reputation as a result of an act by any person declared
13unlawful by subsection (a), may bring a private action to
14recover actual damages or $1,000, whichever is greater. The
15court may, in its discretion, award up to three times the
16actual damages sustained, but not less than $1,000, and may
17provide such additional relief as it deems necessary or
18proper. The court shall award to the plaintiff, in addition
19to other relief provided in this section, costs and
20reasonable attorney fees.

21(2) Any permanent injunction, judgment or order of the
22court made under subsection (a) shall be prima facie evidence
23in an action brought under paragraph (1) that the defendant
24engaged in activity declared unlawful by subsection (a).

25§ 2710. Education and treatment.

26(a) General rule.--With the input and advice of the advisory
27committee, the department shall:

28(1) assist the appropriate agency, board or association
29for each category of person authorized to contribute or
30access information from PAMS to incorporate the appropriate

1information regarding PAMS into the training, education or
2instruction provided to each category of authorized user;

3(2) assist the State or regional chapter of the American
4Society of Addiction Medicine, the Pennsylvania Medical
5Society, the Pennsylvania Psychiatric Society, the
6Pennsylvania Veterinary Medical Association, the Pennsylvania
7Academy of Family Physicians and the Pennsylvania Coalition
8of Nurse Practitioners to develop a continuing education
9course for health care professionals on prescribing
10practices, pharmacology and identification, referral and
11treatment of patients addicted to or abusing controlled
12substances monitored by PAMS; and

13(3) implement, or assist other appropriate agencies to
14implement, an educational program to inform the public about
15the use, diversion and abuse of, addiction to and treatment
16for the addiction to the controlled substances monitored by
17PAMS, including the nature and scope of PAMS.

18(b) Referral and notification.--In accordance with criteria
19established by the advisory committee in section 2705(a)
20(relating to advisory committee), the department shall:

21(1) Refer a practitioner it has reasonable suspicion to
22believe may be impaired to the appropriate impaired
23professionals associations to provide intervention,
24assessment and referral to alcohol and other drug addiction
25treatment programs, including ongoing monitoring and follow-
26up.

27(2) Notify the appropriate licensing agency or board.

28(c) Identification.--With the input and advice of the
29advisory committee, the department shall work with the patient's
30individual practitioner and the appropriate alcohol and other

1drug addiction treatment professionals to provide that patients
2identified through PAMS as potentially addicted to a controlled
3substance are assessed and referred to a licensed addiction
4treatment program.

5§ 2711. Immunity.

6An individual who has submitted to or received information
7from PAMS in accordance with section 2706 (relating to
8establishment of Pharmaceutical Accountability Monitoring
9System) may not be held civilly liable or disciplined in a
10licensing board action for having submitted the information or
11for not seeking or obtaining information from the prescription
12monitoring program prior to prescribing or dispensing a
13controlled substance to an ultimate user except as otherwise
14determined by a licensing agency or board or as set forth in
15this chapter.

16§ 2712. Additional provisions.

17(a) Funding.--A practitioner or a pharmacist shall not be
18required to pay a fee or tax specifically dedicated to
19establishment, operation or maintenance of the system.

20(b) Costs.--All internal costs associated with recording and
21submitting data as required in this section shall be assumed by
22the submitting dispenser.

23(c) Use of data.--Except as provided in subsection (d), data
24provided to, maintained in or accessed from PAMS that may be
25identified to, or with, a particular person is not subject to
26discovery, subpoena or similar compulsory process in any civil,
27criminal, judicial, administrative or legislative proceeding,
28nor shall any individual or organization with lawful access to
29the data be compelled to testify with regard to the data.

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

1apply to a civil, judicial or administrative action brought to
2enforce the provisions of this chapter.

3§ 2713. Use of money collected.

4(a) General rule.--The department may use the moneys
5deposited in the General Fund and appropriated to the department
6for the following purposes:

7(1) Maintenance and replacement of PAMS equipment,
8including hardware and software.

9(2) Training of staff.

10(3) Pursuit of grants and matching funds.

11(4) Implementing and complying with the provisions of
12this chapter.

13(b) Collections.--The department may collect any penalty
14imposed under section 2709 (relating to unlawful acts, penalties
15and private right of action) and which is not paid by bringing
16an action in the court of common pleas of the county in which
17the person owing the debt resides or in the county where the
18department is located.

19(c) Legal assistance.--The department may seek legal
20assistance from the Attorney General or district attorney of the
21county in which the action is brought to collect the fine.

22(d) Attorney fees and costs.--The court shall award
23reasonable attorney fees and costs to the department, the
24Attorney General or the district attorney of the county in which
25the action is brought to collect the fine for successful
26collection actions under section 2709.

27§ 2714. Rules and regulations.

28With input and advice from the advisory committee, the
29department shall promulgate rules and regulations setting forth
30the procedures and methods for implementing this chapter. At a

1minimum, the rules and regulations shall include the following:

2(1) Effectively enforce the limitations on access to
3PAMS prescribed in section 2708 (relating to access to
4prescription information).

5(2) Establish standards and procedures to ensure
6accurate identification of individuals requesting information
7or receiving information from PAMS.

8(3) Allow adequate time following implementation of this
9chapter for dispensers, dispensing veterinarians and
10practitioners to make the changes to their operational
11systems necessary to comply with this chapter.

12(4) Allow for dispensers and dispensing veterinarians to
13have ease of transition to comply with the requirements of
14the Pharmaceutical Accountability Monitoring System.

15(5) Not place an undue burden on law enforcement seeking
16information related to an investigation.

17(6) Practitioners shall not be held liable for failure
18to comply with PAMS requirements until all changes are fully
19operational and practitioners have had adequate time to make
20necessary adjustments to operating systems and to receive
21training to fully accommodate such changes upon promulgation
22of the regulations, but not later than one year after the
23effective date of this chapter.

24(7) Dispensers and dispensing veterinarians who can show
25good cause for not submitting data electronically may be
26authorized to submit data manually if they lack Internet
27access.

28§ 2715. Evaluation, data analysis and reporting.

29(a) General rule.--With input and advice from the advisory
30committee, the department shall design and implement an

1evaluation component to identify:

2(1) cost benefits of PAMS;

3(2) the impact on efforts to reduce misuse, abuse,
4overdose and diversion of, and addiction to, controlled
5substances;

6(3) the impact on prescribing practices for controlled
7substances;

8(4) the number of individuals identified through PAMS as
9potentially addicted to a controlled substance that were
10assessed for alcohol and other drug addictions;

11(5) the number of individuals in paragraph (4) that were
12referred for alcohol and other drug addiction treatment and
13the names of the licensed addiction treatment programs in
14which the individuals were treated;

15(6) the progress made in implementing real-time
16reporting; and

17(7) other information relevant to policy, research and
18education involving controlled substances and drugs of
19concern monitored by PAMS.

20(b) Annual report.--The department shall annually report the
21information specified in subsection (a) to the Public Health and
22Welfare Committee of the Senate, the Human Services Committee of
23the House of Representatives, the United States Department of
24Justice, the Substance Abuse and Mental Health Services
25Administration of the Office of National Drug Control Policy and
26members of Pennsylvania's United States Congressional
27delegation. Additionally, the department shall make the annual
28report available to the public on its publicly accessible
29Internet website.

30(c) Evaluation.--Within six years of the effective date of

1this act, the department shall submit to the chairman and
2minority chairman of the Public Health and Welfare Committee of
3the Senate and the chairman and minority chairman of the Human
4Services Committee of the House of Representatives, a written
5report containing information regarding the collection of data
6within PAMS. The report must include, but need not be limited
7to, the following information pertaining to the data collected
8within PAMS since its inception:

9(1) The number of times information from PAMS has been
10illegally accessed.

11(2) The number of times a patient's privacy or
12confidentiality was compromised through use of the system.

13(3) The number of times the security of the PAMS
14database has been breached by hackers operating under
15malicious purposes.

16(4) A comparison of the rate of death by accidental
17overdose before the implementation of PAMS and the rate of
18death by accidental overdose after the implementation of
19PAMS.

20(5) The rate by which practitioners are utilizing PAMS
21to query patients identified as being potentially addicted to
22a controlled substance through PAMS for referral to alcohol
23and other drug addiction treatment programs.

24(6) The cost effectiveness of the frequency of data
25submission.

26(7) Any impact on efforts to reduce misuse, abuse,
27overdose and diversion of, or addiction to, controlled
28substances.

29(8) Any impact on prescribing practices for controlled
30substances.

1(9) The number of patients that were referred for
2alcohol and other drug addiction treatment.

3(10) The effectiveness of the interoperability with
4other states.

5(11) Recommendations for updates and improvements to
6this chapter or other law.

7§ 2716. Concurrent jurisdiction.

8The Attorney General shall have concurrent prosecutorial
9jurisdiction with the county district attorney for violations of
10this chapter. No person charged with a violation of this chapter
11by the Attorney General shall have standing to challenge the
12authority of the Attorney General to prosecute the case and, if
13any such challenge is made, the challenge shall be dismissed and
14no relief shall be available in the courts of this Commonwealth
15to the person making the challenge.

16§ 2717. Nonapplicability.

17The requirements of this chapter shall not apply to:

18(1) the direct administration of a controlled substance
19to the body of an ultimate user; or

20(2) the administration or dispensing of a controlled
21substance that is otherwise exempted as determined by the
22United States Secretary of Health and Human Services under
23the National All Schedules Prescription Electronic Reporting
24Act of 2005 (Public Law 109-60, 119 Stat. 1979).

25§ 2718. Expiration of chapter and expungement.

26This chapter shall expire seven years after the date of the
27enactment of this chapter. All information in PAMS shall be
28expunged upon the expiration of this chapter.

29Section 2. The regulation of the Department of Health in 28
30Pa. Code § 25.131 (relating to every dispensing practitioner) is

1abrogated.

2Section 3. Upon the full operation of PAMS, the Department
3of Drug and Alcohol Programs shall transmit notice to the
4Legislative Reference Bureau for publication in the Pennsylvania
5Bulletin.

6Section 4. The provisions of this act are severable. If any
7provision of this act or its application to any person or
8circumstance is held invalid, the invalidity shall not affect
9other provisions or applications of this act which can be given
10effect without the invalid provision or application.

11Section 5. This act shall take effect as follows:

12(1) Section 2 shall take effect 90 days after
13publication of the notice under section 3 of this act.

14(2) This section shall take effect immediately.

15(3) The remainder of this act shall take effect in 60
16days.