LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...

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LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
Law and MPDR Updates 2021

MARCIE BOUGH, PharmD
EXECUTIVE OFFICER

NIKKI GRIFFIS, PharmD
MPDR Program Manager

March 7, 2021
Recent Drug Developments and Law Update 2021
University of Montana Skaggs School of Pharmacy
LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
Disclosure

The presenters declare no actual or potential conflict
of interest in relation to this presentation.
LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
Objectives

1. Review legislative and regulatory updates related to the
   practice of pharmacy in Montana

2. Understand changes to the new Montana Prescription
   Drug Registry (MPDR)
LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
Questions
When does MCA 37-7-1515, mandatory MPDR use for prescribers of
opioids and benzodiazepines go into effect?
   A.   1/1/2022
   B.   7/1/2021
   C.   It went into effect on 10/1/2019
   D.   12/1/2021

Which state did the MPDR most recently connect with for Interstate
Data Sharing?
   A.   Wyoming
   B.   California
   C.   Texas
   D.   Alaska
LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
Board of Pharmacy Members

Tony King, Pharmacist, President

Starla Blank, Pharmacist, Vice-President

Marian Jensen, Public Member, Secretary

Courtney Bahny, Certified Pharmacy Technician

Paul Brand, Pharmacist

Jeff Nikolaisen, Pharmacist

Charmell Owens, Public Member
LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
Board of Pharmacy
            Contact Information and Meetings
                                            General Contact Information
Marcie Bough, PharmD, Executive Officer
                                            Emails:
406-841-2371, mbough@mt.gov
                                            dlibsdpha@mt.gov
                                            dlibsdmpdr@mt.gov
Mark Klawitter, RPh, Board Inspector
406-459-8847, mark.klawitter@mt.gov
                                            Websites:
                                            www.pharmacy.mt.gov
Genine Pitts, PharmD, Board Inspector       www.mpdr.mt.gov
406-431-1952, gennine.pitts@mt.gov
                                            Phone Numbers:
Nikki Griffis, PharmD, Program Manager      Office: 406-841-2300
Montana Prescription Drug Registry (MPDR)   Customer Service: 406-444-6880
406-841-2240, nikki.griffis@mt.gov
dlibsdmpdr@mt.gov
                                            2021 Board Meetings
                                            March 12
                                            June 18
                                            September 24
                                            December 3
LAW AND MPDR UPDATES 2021 - MARCIE BOUGH, PHARMD EXECUTIVE OFFICER NIKKI GRIFFIS, PHARMD MPDR PROGRAM MANAGER - UNIVERSITY ...
New Webpage: www.pharmacy.mt.gov
Law Updates 2021
                 House Bill (HB)
                 Senate Bill (SB)
              Senate Resolution (SR)

        Montana Code Annotated (MCA)
      Administrative Rules of Montana (ARM)

                      Access at:
https://boards.bsd.dli.mt.gov/pharmacy/regulations/
Montana Legislature: https://leg.mt.gov
HB 250, Revise Immunization Requirements for
                   Pharmacists
Sponsor: Rep. Casey Knudsen (R-Malta)
Status: 2/9/21 hearing; 2/22/21 amended in Committee but vote failed; tabled
in Committee

• Goal was to:
    –   Expand patient access to vaccines from pharmacists/interns
    –   Add new immunization authority for pharmacy technicians
    –   Clarify education and training requirements
    –   Expand type and age range of immunization provided
    –   Revise documentation and communication requirements
    –   Align with current federal COVID-19 immunization authority

• Current status of pharmacist immunization authority remains as
  outlined in 37-7-105, MCA, in addition to current federal COVID-19
  authority
Other Bills of Interest
• SB 357, Generally revise requirements related to telehealth
  Sen. Jen Gross (D-Helena)
    – Amends the term “Practice telepharmacy” to “Practice pharmacy by means
      of telehealth” as referenced in 37-7-101(39) and 37-7-201(2)(l)(iv)
    – Does not impact community pharmacy telepharmacy licensing authority
    – 2/26/21 hearing, passed; 3/2/21 passed Senate, transmitted to House

• SR 71. Confirm Governor’s appointees to various health-related boards
  Rep. David Howard (R-Park City)
    – Includes Board of Pharmacy appointments and timeline of terms:
          –   Tony King (2025)
          –   Starla Blank (2024)
          –   Paul Brand (2024)
          –   Jeff Nikolaisen (2025)
    – 2/10/21 hearing, adopted; 2/20/21 Senate adopted; 2/26/21 Filed with
      Secretary of State
Other Topics of Interest
•   Scope of Practice
     –   Proposed changes to healthcare licensing scope of practice laws and rules would be reviewed
         by Board of Medical Examiners.

•   Physician/Prescriber Dispensing
     –   Create new dispensing authority for physicians, other prescribers, and naturopathic physicians;
         similar to North Dakota authority.

•   Insulin Access
     –   Establish insulin safety net program providing 30-day supply one-time/year; similar to
         Minnesota program.

•   Drug Price Transparency
     –   SB 137 and HB 345 tabled in committees.

•   PBM licensure/reform
     –   Montana Pharmacy Association: Working with the State Auditor’s office on licensing PBMs and
         enforcing current laws.

     NOTE: PBM issues generally relate to drug price transparency, reimbursement, and/or other
     pharmacy business issues that are not related to Board of Pharmacy activity or authority. Contact
     the Montana Pharmacy Association.
Future Rule Topics
Next Proposed Rule
•   New device license type, medical gas, prescription transfers, continuing
    education programs, drug kits, drug distribution institutional facilities,
    definitions, listing of controlled substances, and collaborative practice

Future Rule Topics
•   Wholesale drug distributors, third-party logistics providers, repackagers, and
    manufacturers
•   Facility requirements, endorsements, and inspections
•   Compounding, outsourcing facilities, documentation/record keeping, limited
    service pharmacies, and others

Subcommittee Topics
•   Automated dispensing systems/machines
•   Technicians
THANK YOU
Page 15

    Questions
    When does MCA 37-7-1515, mandatory MPDR use for prescribers of
    opioids and benzodiazepines go into effect?
          A.   1/1/2022
          B.   7/1/2021
          C.   It went into effect on 10/1/2019
          D.   12/1/2021

    Which state did the MPDR most recently connect with for Interstate
    Data Sharing?
          A.   Wyoming
          B.   California
          C.   Texas
          D.   Alaska
Page 16

    Questions
    When does MCA 37-7-1515, mandatory MPDR use for prescribers of
    opioids and benzodiazepines go into effect?
          A.   1/1/2022
          B.   7/1/2021
          C.   It went into effect on 10/1/2019
          D.   12/1/2021

    Which state did the MPDR most recently connect with for Interstate
    Data Sharing?
          A.   Wyoming
          B.   California
          C.   Texas
          D.   Alaska
Montana Prescription Drug
Registry (MPDR) Updates 2021

• MPDR Accomplishments
• MPDR Stats
• New Software Vendor
• Next Steps
MPDR Next Steps - Accomplished from 2020

✓   Hire new pharmacist position for MPDR Program Manager

✓   Issue Request for Proposal for a new MPDR system vendor and
    migrate to a new online platform
    – Improve functionality, provide integration and new clinical tools for
      frontline users, increase use, and improve administrative procedures
    – Mandatory Use Statute MCA 37-7-1515 effective July 1, 2021.

✓   Collaborate with boards, state agencies, associations, and other
    stakeholders on outreach/education

✓   Continue to implement recommendations from Legislative Audit and
    engage MPDR Advisory Group

✓   Continue to collaborate on MPDR data research with Department of
    Public Health and Human Services and other stakeholders
MPDR New Software Vendor Appriss

• Appriss Clearinghouse- Software for prescription
 dispensation data reported by pharmacies

• PMP AWARxE- Software application for searching patient
 prescription history

• NarxCare- Clinical tools available on patient history reports

• Gateway- Integration platform
MPDR Enhancements
• Patient Profile Matching- Both automated and manual way of
 consolidating patient profiles (i.e. Robert Jones, Bobby Jones, Robby Jones)

• Data Integrity through Appriss Clearinghouse- Ensuring
 prescription information is valid and pharmacy compliance.

• Batch Searching- By manual entry of a patients or upload of spreadsheet

• NarxCare Scores and Graphs

• Patient Clinical Alerts
NarxCare
NarxCare – Narx Scores
• The last digit of each score represents the number of active
 prescriptions of that type. For example, a Narx Score of 504 indicates
 the patient should have four active narcotic prescriptions according to
 dispensation information in the PMP.
• The scores correspond to the number of literature-based risk factors
 that exist within the PMP data. These risk factors include:
  • The number of prescribers, pharmacies, amount of medication dispensed (often
    measured in milligram equivalencies) and the number of times prescriptions of a
    similar type overlap from different prescribers
  • The time elapsed for any risk factor serves to decrease its contribution to the score. For
    example, 1000 MME dispensed within the last month will elevate the score more than
    1000 MME dispensed one year ago.

• The distribution of Narx Scores for patients on controlled substance drug
 therapy is approximated as follows:
  •   35% score less than 200
  •   55% score between 200 and 500
  •   10% score more than 500
  •   1% score more than 650
NarxCare – Narx Scores cont.

 • The Narx Scores were designed such that:

   • Patients who use small amounts of medication with limited provider
     and pharmacy usage will have low scores.
   • Patients who use large amounts of medications in accordance with
     recommended guidelines (single provider, single pharmacy, etc.) will
     have mid-range scores.
   • Patients who use large amounts of medications while using many
     providers and pharmacies, and with frequently overlapping
     prescriptions, will have high scores.
NarxCare- Overdose Risk Score

                •   The number of pharmacies visited per unit
                    time
                •   Maximum morphine milligram equivalency
                    (MME) in the last year
                •   The number of prescribers in the last two years
                •   Various slopes of opioid and sedative use
                •   Various slopes of prescriber usage
NarxCare – RX Graph
Clinical Patient Alerts
Clinical Patient Alerts
• Prescriber & Dispenser Thresholds
   • Four or more prescribers and four or more pharmacies in 60 days.

• Daily Morphine Milligram Equivalent (MME) Threshold
  • ≥90 MME/Day
  • Excludes treatment drugs

• Concurrent Opioid and Benzodiazepine Prescriptions
MPDR Next Steps

•   Feedback on new software system- Users and MPDR Advisory Group

•   Integration through Gateway coming soon
     •   Electronic Health Records, Health Information Exchange, and
         pharmacy dispensing systems
     •   Veteran Affairs and Military Health Systems
     •   DPHHS considering potential funding with federal grant dollars
     •   Mandatory Use Statute MCA 37-7-1515 effective July 1, 2021.

•   Continued Outreach and Education to MPDR Users and Data Submitters
     •   Increase registration, pharmacy compliance auditing, and statistics
Resources

Webpage: www.mpdr.mt.gov
        MPDR PMP AWARxE Registered User Guide- includes NarxCare
        information
        MPDR Clearinghouse Data Submission Guide for Dispensers
        Montana Statutes and Rules

Contact Information:
        Nikki Griffis, PharmD
        Program Manager, Montana Prescription Drug Registry
        Montana Board of Pharmacy
        dlibsdmpdr@mt.gov
        406-841-2240
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