Report of the Task Force on Prescription Monitoring Program Standards

Report of the Task Force on Prescription Monitoring Program Standards Members Present: Gay Dodson (TX), chairperson; John Dorvee (ME); Danna Droz (OH); Allen F. Dulwick (OR); William Fitzpatrick (MO); Elizabeth I. Gregg (OH); Frederick Rick Karsten (GA); Richard Mick Markuson (ID); Edward G. McGinley (NJ); Lawrence Larry H. Mokhiber (NY); William Bill Prather (GA). Others Present: Gregory Braylock Sr, Executive Committee liaison; Carmen A. Catizone, Robert Cowan, Melissa Madigan, Eileen Lewalski, Chris Siwik, Deborah Zak, NABP staff. Ex Officio Members: Jennifer Fan, Substance Abuse and Mental Health Services Administration; Cathy Gallagher, Drug Enforcement Administration. Guests: Jim Giglio, Alliance of States with Prescription Drug Monitoring Programs; Kevin Nicholson, National Association of Chain Drug Stores; Ralph Orr, National Association of State Controlled Substances Authorities. Introduction: The Task Force on Prescription Monitoring Program Standards met October 28-29, 2009 at the Hilton Northbrook in Northbrook, IL. This task force was established in response to Resolution 105-6-09, Develop a Task Force to Research Various PMP Programs and Recommend Standards or Model Rules, which was approved by the NABP membership at the Association s 105 th Annual Meeting in May 2009. Review of the Task Force Charge: Task force members reviewed their charge and accepted it as follows: 1. Review and identify variations in existing prescription monitoring programs as compared to the Model Prescription Monitoring Act found in the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act). 2. Recommend revisions, if necessary, to the NABP Model Act addressing this issue. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net

Recommendation 1: NABP Should Work with Appropriate Entities and Individuals to Ensure that the Purposes of Prescription Monitoring Programs (PMPs) Are Being Served The task force recommends that NABP work with the state boards of pharmacy, PMP programs, pharmacists, prescribers, and other interested stakeholders to ensure that PMP programs serve two critical purposes: 1. assist the pharmacist and prescriber in assessing patient information and providing appropriate patient care, and; 2. assist law enforcement efforts in identifying and acting in regard to instances of drug abuse and diversion. Task force guests and ex officio members presented the task force with information pertaining to their various affiliations and agencies, including current endeavors involving PMPs such as the pending revision of the Alliance of States with Prescription Drug Monitoring Programs Model Act. Members determined through subsequent discussion that the main issues and areas of concern of PMPs involved user authentication, inappropriate access and inappropriate use of information, interoperability between states and the ability to accommodate each state s unique data requirements. The task force concluded that the existence of the two previously mentioned critical purposes should be the impetus for any new or revised PMP model act or state program. Recommendation 2: NABP Should Work with Prescriber Organizations to Emphasize Value of PMPs as a Tool for Prescribers The task force recommends that NABP work with prescriber organizations to emphasize the value of PMPs as a tool to assist prescribers in managing patient care and determining appropriate medication therapy. Task force members discussed the importance of prescribers utilizing PMP data to assist them in determining which patients may be doctor shopping or in need of intervention. Members stated that, although the pharmacist has a corresponding responsibility when dispensing controlled substances and has, historically, been the gatekeeper for prescription medications, the burden to ensure that appropriate drug therapy is ordered rests on the individual prescriber. The task force guest participants provided information to the members regarding the positive effects that unsolicited reports sent to prescribers may have in their decision to decrease prescribing of controlled substances and other drugs of abuse if necessary. Members provided feedback on these reports stating prescribers were continually shocked as to the number of doctor shoppers on the reports and how these reports provided prescribers and pharmacists with a tool to manage individual patients and identify those at risk for abuse, and allowed them to intervene in problematic cases. The members agreed that it was crucial to work with prescribers regarding their utilization of these reports to decrease the incidence of drug abuse and diversion. Recommendation 3: NABP Should Strongly Encourage PMPs to Require Reporting of All Controlled Substance Prescriptions in Schedules II through V and Other Prescription Drugs of Concern NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 2

The task force recommends that PMPs require reporting of all controlled substance prescriptions in Schedules II through V and other drugs of concern that are dispensed pursuant to a prescription. Task force members discussed the national drug abuse epidemic and the impact PMPs can have in the reduction of abuse and diversion. Members unanimously agreed that for PMPs to play a major role in reducing drug abuse and diversion, PMPs should require reporting of all controlled substances prescriptions in Schedules II through V, as well as prescriptions for other jurisdictionally determined drugs of concern. It was noted that some PMPs only require reporting of Schedule II controlled substance prescriptions, even though statistics indicate that hydrocodone, a Schedule III controlled substance, is the number one prescribed medication in the United States. The task force concluded that the Model Act should be revised and that future PMPs and existing PMPs should require the reporting of prescriptions in Schedules II through V. Recommendation 4: NABP Should Amend the Model Act and Work with the Alliance of States with Prescription Drug Monitoring Programs to Develop One Model The task force recommends the following changes to the Model Act, including changes to Appendix G Model Prescription Monitoring Act. The revisions recommended by the task force are denoted by underlines and strikethroughs. The task force also recommends that NABP work collaboratively with the Alliance of States with Prescription Drug Monitoring Programs (Alliance) to develop one Model Act that can be utilized by the states. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy --- Appendix G Model Prescription Monitoring Program Act Section 1. Short Title. This Act shall be known and may be cited as the Model Prescription Monitoring Program Act. Section 2. Legislative Findings. (Insert State-appropriate mission/purposes.) Section 3. Purpose. (Insert State-appropriate mission/purposes.) Section 4. Definitions. (a) Advisory Board means the advisory board established under Section 6 of this Act. (ab) Dispenser means a person authorized in this State to distribute to the ultimate user a substance monitored by the Prescription Monitoring Program, but does not include: NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 3

(b) (c) (cd) (de) (1) a licensed hospital or institutional facility Pharmacy that distributes such substances for the purposes of inpatient hospital care or the dispensing of prescriptions for controlled substances at the time of discharge from such a facility; (2) a licensed nurse or medication aide who administers such a substance at the direction of a licensed physician.; or (3) a Wholesale Distributor of a substance monitored by the Prescription Monitoring Program. Drug of Concern means any prescription or over-the-counter medication that demonstrates a potential for abuse, particularly those identified by Boards of Pharmacy, law enforcement, and addiction treatment professionals. Prescriber means a licensed health care professional with prescriptive authority Prescription Monitoring Program Information means information submitted to and maintained by the Prescription Monitoring Program. Prescription Monitoring Program (PMP) means a program established under Section 5 of this Act. Section 5. Establishment Of A Prescription Monitoring Program. (a) The Board of Pharmacy (or designated State agency or entity) shall establish and maintain, with the consultation of the Advisory Board, an electronic system for monitoring all controlled substances in Schedules II through V, all State-specified controlled substances in Schedules II through V, and State-specified Drugs of Concern the following substances dispensed in the State: (insert all or any combination of the following: Federally controlled substances, additional State-specified controlled substances, and Drugs of concern documented to demonstrate a potential for abuse, particularly those identified by law enforcement and addiction treatment professionals). (b) The Board of Pharmacy (or designated State agency or entity) may contract with a vendor to establish and maintain the electronic monitoring system pursuant to guidelines, which the Board of Pharmacy (or designated State agency or entity) shall promulgate. Section 6. Advisory Board. (a) The Advisory Board shall have the following members: (1) (insert appropriate designees of State health, law enforcement, and prosecutorial agencies) (2) (insert appropriate designees of occupational licensing, certification, and regulatory entities) (3) (insert appropriate designees of impaired professionals programs) (4) (insert appropriate pain management and addiction treatment representatives) (5) (insert appropriate patient rights advocates) (6) (insert appropriate recovering community advocates) (7) (insert appropriate community leaders) (b) The Board of Pharmacy (or designated State agency or entity) shall seek, and the Advisory Board shall provide, input and advice regarding the development and operations of the electronic monitoring system, including but not limited to: (1) which State controlled substances should be monitored, (2) which Drugs of concern demonstrate a potential for abuse and should be monitored, (3) the design and implementation of educational courses identified in Section 9, (4) proper analysis and interpretation of Prescription Monitoring Information, (5) the design and implementation of an evaluation component, and (6) potential nominees to the Advisory Board. Section 67. Reporting Of Prescription Monitoring Program Information. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 4

(a) (b) (bc) Each Dispenser shall submit to the Board of Pharmacy (or designated State agency or entity), by electronic means, or other format specified in a waiver granted by the Board of Pharmacy (or designated State agency or entity), at a minimum of every seven days, information specified by the Board of Pharmacy (or designated State agency or entity), including: (1) Drug Enforcement Administration Registration Number of Dispenser, (2) Drug Enforcement Administration Registration Number and name of the practitioner who prescribed the drug, (3) Name, address and telephone number of the ultimate user, (4) Identification of the drug by a national drug code number, (5) Quantity dispensed, (6) Number of days supplied, (7) Number of refills ordered, (8) Whether drug was dispensed as a refill or as a new prescription, (9) Date of dispensing, (10) Date of the original prescription; and (11) Such other information as may be required by State law. (1) a patient identifier, (2) the Drug Dispensed, (3) the date of the Dispensing, (4) the quantity Dispensed, (5) the Prescriber, and (6) the Dispenser. Each Dispenser shall submit the required information as frequently as specified by the Board of Pharmacy (or designated State agency). The Board of Pharmacy (or designated State agency or entity) may grant a waiver of electronic submission to any Dispenser for good cause, including financial hardship, as determined by the Board of Pharmacy (or designed State agency or entity). The waiver shall state the format and frequency with which the Dispenser shall submit the required information. Section 78. Access To Prescription Monitoring Program Information/Confidentiality. (a) Except as indicated in paragraphs (b), (c), and (d) of this Section 78, Prescription Monitoring Program Information submitted to the Board of Pharmacy (or designated State agency or entity) shall be considered Protected Health Information and not subject to public or open records laws. (b) The Board of Pharmacy (or designated State agency or entity) shall review the Prescription Monitoring Program Information. If there is reasonable cause to believe a violation of law (or breach of occupational standards) may have occurred, the Board (or designated State agency or entity) shall notify the appropriate law enforcement and occupational licensing, certification, or regulatory agency or entity, and provide Prescription Monitoring Program Information required for an investigation. (c) The Board of Pharmacy (or designated State agency or entity) may provide Prescription Monitoring Program Information for public research, policy, or education purposes, to the extent all information has been De-identified. (d) The following persons, after successful completion of the educational courses identified in Section 9(a), may access the Prescription Monitoring Program Information in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar Protected Health Information under federal and State law and regulation:. (1) (insert Prescribers) (2) (insert Dispensers) (3) (insert all appropriate law enforcement personnel) NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 5

(e) (4) (insert all appropriate occupational licensing, certification, and regulatory personnel) (5) (insert all appropriate judicial authorities) (6) (insert all appropriate personnel of the designated State agency or vendor/contractor establishing and maintaining the prescription monitoring program) (1) Practitioners (or the agents thereof) who certify, under the procedures determined by the State, that the requested information is for the purpose of providing medical or pharmaceutical treatment or evaluating the need for such treatment to a bona fide current patient; (2) Dispensers; (3) Boards of Pharmacy or vendors/contractors establishing and maintaining the prescription monitoring program; (4) State licensing, certification, or regulatory agencies that license, certify, or regulate health care professionals authorized to dispense controlled substances; (5) local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authorities, who certify, under the procedures determined by the State, that the requested information is related to an individual investigation or proceeding involving the unlawful diversion or misuse of a Schedule II through V substance, and such information will further the purpose of the investigation or assist in the proceeding; (6) other appropriate entities as determined by the Board of Pharmacy; and (7) patients who certify, under the procedures determined by the State, that the requested information is for the purpose of obtaining and reviewing their own records. The Board of Pharmacy (or designated State agency or entity) shall be immune from civil liability arising from inaccuracy of any of the information submitted to the Board of Pharmacy (or designated State agency or entity) pursuant to this Act. Section 9. Education And Treatment. (a) The Board of Pharmacy (or designated State agency or entity) shall, in consultation with the Advisory Board, implement the following education courses: (1) An orientation course during the implementation phase of the PMP. (2) A course for persons who are authorized to access the Prescription Monitoring Information but who did not participate in the orientation course. (3) A course for persons who are authorized to access the Prescription Monitoring Information but who have violated laws or breached occupational standards involving Dispensing, prescribing and use of substances monitored by the PMP. (4) A continuing education course for health care professionals developed by the American Society of Addiction Medicine and the State medical society on prescribing practices, pharmacology and identification, treatment, and referral of patients addicted to or abusing substances monitored by the PMP. When appropriate, the Board of Pharmacy (or designated State agency or entity), in consultation with the Advisory Board, shall develop the content of the education courses described in paragraphs (1) (3). (b) The Board of Pharmacy (or designated State agency or entity), in consultation with the Advisory Board, shall strongly recommend the application of a course to inform the public about use, diversion and abuse of, and addiction to substances monitored by the PMP. (c) The Board of Pharmacy (or designated State agency or entity), in consultation with the Advisory Board, shall, when appropriate: (1) work with associations for impaired professionals to ensure intervention, treatment, and outgoing monitoring and follow-up; and (2) ensure that individual patients who are identified and who have become addicted to substances monitored by the PMP receive addiction treatment. Section 810. Unlawful Acts And Penalties. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 6

(a) (b) (cb) (dc) A Dispenser who knowingly fails to submit Prescription Monitoring Program Information to the Board of Pharmacy (or designated State agency or entity) as required by this Act shall be subject to (insert appropriate administrative, civil, or criminal penalty). A person who knowingly accesses or uses Prescription Monitoring Program Information without authorization in violation of this Act shall be subject to (insert appropriate administrative, civil, or criminal penalty). A person authorized to have Prescription Monitoring Program Information pursuant to this Act who knowingly discloses such information in violation of this Act shall be subject to (insert appropriate administrative, civil, or criminal penalty). A person authorized to have Prescription Monitoring Program Information pursuant to this Act who uses such information in a manner or for a purpose in violation of this Act shall be subject to (insert appropriate administrative, civil, or criminal penalty). Section 911. Evaluation, Data Analysis, And Reporting. (a) The Board of Pharmacy (or designated State agency) shall, in consultation with the Advisory Board, design and implement an evaluation component to identify cost benefits of the Prescription Monitoring Program, and other information relevant to policy, research, and education involving substances monitored by the PMP. (b) The Board of Pharmacy (or designated State agency) shall report to the (insert appropriate State decision makers, eg, legislature) on a periodic basis, no less than annually, about the cost-benefits and other information noted in paragraph (a). Section 1012. Rules And Regulations. The Board of Pharmacy (or designated State agency) shall promulgate rules and regulations necessary to implement the provisions of this Act. Section 1113. Severability. If any provision of this Act or application thereof to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of the Act which can be given effect without the invalid provisions or applications, and to this end the provisions of this Act are severable. Section 1214. Effective Date. This Act shall be effective on (insert specific date or reference to normal State method of determination of the effective date). Comments Section 7(b). Comment This section is intended to allow boards of pharmacy to evaluate PMP information and determine appropriate information to provide to law enforcement entities. It is not intended to allow law enforcement officials open access to all data. Section 78(d)(5). Comment. It is recommended that appropriate entities include drug courts, district attorneys offices, or other similar entities, and only for the purpose of ensuring appropriate patient treatment, as opposed to efforts to search for information without knowledge of whether such information exists. Patients have several traditional means other than a Prescription Monitoring Program to access their medical information. However, some NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 7

States existing laws will require that patients have access to their prescription information, which is maintained by a monitoring program. Those States will, therefore, need to include patients as a category of individuals able to access the Prescription Monitoring Information under this section. Task force members discussed the timeframes involved in revising the Model Act and the Alliance s Model Act. Members agreed that NABP s Model Act should be revised as soon as possible so that NABP can work with the Alliance to address the primary concern of the task force patient, prescriber, dispenser, and law enforcement authority access to data. Members also agreed that the Model Act be revised to address the following issues: 1) authentication processes to allow access to data; and 2) the ability of PMPs to send and receive data to each other (interoperability). The task force acknowledged that a PMP should act as the gatekeeper for access to the PMP data and that it was important to determine appropriate types or levels of access. The members reviewed the National All Schedules Prescription Electronic Reporting Act of 2005 and agreed that some of its language should be included in the Model Act, specifically the language on reporting requirements and access to PMP data. The task force also agreed that the Model Act should be revised to indicate that boards of pharmacy should be the entities responsible for overseeing state PMPs. It was acknowledged that, although a myriad of state agencies administer PMPs (other than boards of pharmacy), this revision was aimed at providing guidance, particularly to those states that have yet to implement PMPs. The task force also decided that the sections pertaining to an advisory board and education and treatment should be removed based on lack of relevancy. Recommendation 5: NABP Should Encourage States to Adopt A Uniform Data Transmission Standard and Should Work with the American Society for Automation in Pharmacy (ASAP) to Revise Existing Standard The task force recommends that all states adopt a uniform standard for transmission of data from dispensers to PMPs and that NABP work with ASAP to revise and update its existing data reporting standard. The task force discussed the importance of establishing program elements with corresponding data transmission fields that all states should require in their PMPs, as well as the importance of discouraging states from requiring elements and data fields that would impede interoperability among PMPs. Members noted that various versions of the ASAP standards (from 1995 to 2007) are currently utilized across the country and could ultimately impede the ability of PMPs to share data. Recommendation 6: NABP Should Encourage States to Grant PMPs the Authority to Electronically Transmit Data to Other PMPs The task force recommends that states grant PMPs the authority to electronically transmit data to each other. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 8

In line with the task force s previous recommendation, members reiterated that interoperability is crucial for PMPs to be effective, particularly for states that boarder one another. As an example, a member noted that Kentucky, which has experienced significant controlled substance abuse and diversion issues, boarders seven other states and if all eight PMPs are unable to work collectively, drug abuse and diversion will remain an issue. Members concurred that all states must grant PMPs the authority to share PMP data. Recommendation 7: NABP Should Work with PMPs to Ensure that Law Enforcement Agencies Have Access to PMP Data and to Assist Them in Defining Safeguards to Prevent Unauthorized and Inappropriate Access The task force recommends that PMPs must provide law enforcement agencies access to PMP data but recognizes that such access must have defined controls and audit trails to prevent unauthorized and inappropriate access to PMP data. Members voiced concern that appropriate certification standards must be in place to prevent unauthorized and inappropriate access, otherwise known as fishing expeditions, of PMP data. It was agreed that PMP data must be made available to law enforcement, but that the PMP ultimately should be the gatekeeper for access to the material through regulation. Recommendation 8: NABP Should Assist State Boards of Pharmacy in Working with Law Enforcement Agencies to Provide PMPs with Information Regarding Outcomes of Investigations Resulting from Access to PMP Data The task force recommends that NABP assist state boards of pharmacy in working with local, state, and federal law enforcement agencies to develop a system of communication between the state agency operating the PMP and the enforcement agency that takes action on a case regarding the outcome of an investigation. Task force members discussed how this type of information would benefit PMPs by providing research data to evaluate the effectiveness of the PMP and as a means to suggest improvements to the program. Recommendation 9: NABP PMP Standards Task Force Member Should Participate in the Committee on Law Enforcement/Legislation The task force recommends that a member of the PMP Standards Task Force participate in the Committee on Law Enforcement/Legislation meeting to serve as a resource during the Model Act revisions discussion. Task force members were informed that any Model Act revisions they recommended would then be reviewed by the Committee on Law Enforcement/Legislation in January 2010. To ensure that the spirit of the revisions remained intact, it was decided that a member of the task force should participate as a resource for background information to the committee. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/391-4406 (F) 847/391-4502 www.nabp.net 9