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 March 7, 2021 Recent Drug Developments and Law Update 2021 University of Montana Skaggs School of Pharmacy
Disclosure The presenters declare no actual or potential conflict of interest in relation to this presentation.
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)
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
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
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 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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