Brief Description: The Board of Pharmacy proposes to update the regulations relating to prescription drug monitoring program controlled substance prescription database (PDMP) in accordance with AS 08.80.030 and AS 17.30.200, including registration, access and condition for use of the database, requirements for pharmacists and practitioners, waiver of electronic submission requirements by pharmacist or practitioner, reports, purging database records, grounds for discipline, disciplinary guidelines, and definitions, to implement amendments to AS 08.80 and AS 17.30 enacted under Chapter 25, SLA 2016 (SB 74) and Chapter 2, SSSLA 2017 (HB 159).
The Board of Pharmacy (Board) proposes to adopt regulation changes in Title 12, Chapter 52, of the Alaska Administrative Code including the following:
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12 AAC 52.855. Registration with the prescription drug monitoring program controlled substance prescription database, is proposed to be changed to update the requirements for registration with the prescription drug monitoring program’s controlled substance prescription database for pharmacists or practitioners.
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12 AAC 52.860. Access to and conditions for use of the prescription drug monitoring program database, is proposed to be changed to clarify who may access the controlled substance prescription database under AS 17.30.200.
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12 AAC 52.865. Reporting and reviewing PDMP information, is proposed to be amended to update the requirements for pharmacists and practitioners to report, and for practitioners to review, the controlled substance prescription database.
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12 AAC 52.870. Waiver of electronic submission requirement by pharmacist or practitioner, is proposed to be changed to clarify who may utilize a waiver of the PDMP’s electronic submission requirements, and how.
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12 AAC 52.880. Reports, is proposed to be changed to correct a citation and amend the information maintained about requests from non-registered persons.
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12 AAC 52.885. Purge database records, is a proposed new section that specifies what information will be purged from the PDMP and the timeline for each purge.
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12 AAC 52.890. Grounds for discipline, is proposed to be changed to amend grounds for discipline and the reporting of violations related to the PDMP.
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12 AAC 52.920. Disciplinary guidelines, is proposed to be changed to add a provision to include a violation of law relating to the PDMP.
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12 AAC 52.995. Definitions, is proposed to be changed to specify the definition of practitioner in the PDMP regulations.
You may comment on the proposed regulation changes, including the potential costs to private persons of complying with the proposed changes, by submitting written comments to Jun Maiquis, Regulations Specialist, Division of Corporations, Business and Professional Licensing, P.O. Box 110806, Juneau, AK 99811-0806. Additionally, the Board will accept comments by facsimile at (907) 465-2974 and by electronic mail at RegulationsAndPublicComment@alaska.gov. Comments may also be submitted through the Alaska Online Public Notice System by accessing this notice on the system at http://notice.alaska.gov/188354, and using the comment link. The comments must be received not later than 5:00 p.m. on February 15, 2018. Comments received after this deadline will not be considered by the Board.
You may submit written questions relevant to the proposed action to Jun Maiquis, Regulations Specialist, Division of Corporations, Business and Professional Licensing, P.O. Box 110806, Juneau, AK 99811-0806 or by e-mail at RegulationsAndPublicComment@alaska.gov. The questions must be received at least 10 days before the end of the public comment period. The Board will aggregate its response to substantially similar questions and make the questions and responses available on the Alaska Online Public Notice System and on the Board’s website at https://www.commerce.alaska.gov/web/cbpl/ProfessionalLicensing/BoardofPharmacy.aspx. The Board may, but is not required to, answer written questions received after the 10-day cut-off date and before the end of the comment period.
If you are a person with a disability who needs a special accommodation in order to participate in this process, please contact Jun Maiquis at (907) 465-2537 or RegulationsAndPublicComment@alaska.gov not later than February 8, 2018 to ensure that any necessary accommodation can be provided.
A copy of the proposed regulation changes is available on the Alaska Online Public Notice System and by contacting Jun Maiquis at (907) 465-2537 or RegulationsAndPublicComment@alaska.gov, or go to https://www.commerce.alaska.gov/web/portals/5/pub/PHA-1217-PDMP.pdf.
After the public comment period ends, the Board will either adopt the proposed regulation changes or other provisions dealing with the same subject, without further notice, or decide to take no action. The language of the final regulation may be different from that of the proposed regulation. You should comment during the time allowed if your interests could be affected. Written comments and questions received are public records and are subject to public inspection.
Statutory Authority: AS 08.01.075; AS 08.80.005; AS 08.80.030; AS 08.80.157; AS 08.80.261; AS 08.80.315; AS 08.80.460; AS 11.71.900; AS 17.30.200
Statutes Being Implemented, Interpreted, or Made Specific: AS 08.01.075; AS 08.80.005; AS 08.80.030; AS 08.80.157; AS 08.80.261; AS 08.80.315; AS 08.80.460; AS 11.71.900; AS 17.30.200
Fiscal Information: The proposed regulation changes are not expected to require an increased appropriation.
DATE: 1/10/18
Jun Maiquis, Regulations Specialist Division of Corporations, Business and Professional Licensing
For each occupation regulated under the Division of Corporations, Business and Professional Licensing, the Division keeps a list of individuals or organizations who are interested in the regulations of that occupation. The Division automatically sends a Notice of Proposed Regulations to the parties on the appropriate list each time there is a proposed change in an occupation's regulations in Title 12 of the Alaska Administrative Code. If you would like your address added to or removed from such a list, send your request to the Division at the address above, giving your name, either your e-mail address or mailing address (as you prefer for receiving notices), and the occupational area in which you are interested.
ADDITIONAL REGULATION NOTICE INFORMATION
(AS 44.62.190(d))
1. Adopting agency: Board of Pharmacy – Department of Commerce, Community, and Economic Development, Division of Corporations, Business and Professional Licensing.
2. General subject of regulation: Registration, access and condition for use of the database, requirements for pharmacists and practitioners, waiver of electronic submission requirements by pharmacist or practitioner, reports, purging database records, grounds for discipline, disciplinary guidelines, and definitions.
3. Citation of regulation: 12 AAC 52.855, 12 AAC 52.860, 12 AAC 52.865, 12 AAC 52.870, 12 AAC 52.880, 12 AAC 52.885, 12 AAC 52.890, 12 AAC 52.920, and 12 AAC 52.995.
4. Department of Law file number: To be assigned.
5. Reason for the proposed action: Compliance with new state statute, Chapter 25 SLA 2016 (SB 74) and Chapter 2, SSSLA 2017 (HB 159); Update and clarification of current regulations.
6. Appropriation/Allocation: Corporations, Business and Professional Licensing – #2360.
7. Estimated annual cost to comply with the proposed action to:
A private person: $50 PDMP initial registration; $50 PDMP registration renewal.
Another state agency: None known.
A municipality: None known.
8. Cost of implementation to the state agency and available funding (in thousands of dollars):
No costs are expected in FY 2018 or in subsequent years.
9. The name of the contact person for the regulation:
Laura Carrillo, Records and Licensing Supervisor
Alaska Board of Pharmacy
Division of Corporations, Business and Professional Licensing
Department of Commerce, Community, and Economic Development
Telephone: (907) 465-1039
E-mail: laura.carrillo@alaska.gov
10. The origin of the proposed action: Board of Pharmacy.
11. Date: 1/10/18
Prepared by: Jun Maiquis
Regulations Specialist
(907) 465-2537