2018 Montana Law Update

TONY KING, PharmD

MONTANA BOARD OF PHARMACY

Disclosure

I have no actual or potential conflict of

interest in relation to this presentation

Objectives

1. Describe law and regulatory updates related to the Montana Board of Pharmacy and the 2017 Legislative Session

2. Discuss Montana Prescriptive Drug Registry (MPDR) program activities

3. Identify two current federal legislative proposals

Pre-test questions:1. What does SB 68, the wholesaler bill, allow the Board to do?

a. Comply with federal law

b. Create 4 license types from the current wholesale drug distributor license

c. Individually license outsourcing facilities

d. A and B

e. All of the above

2. What do the naloxone bills HB 323 and HB 333 do?

a. Reclassify naloxone to be available as an OTC without a prescription

b. Identify a school, police/fire department, and other facilities as a patient

c. Allow “Eligible Recipient” facilities to purchase naloxone from a wholesaler

d. Removes existing pharmacist/prescriber collaborative practice authority

e. None of the above

3. Which two of the following are federal initiatives for the pharmacy profession?a. Regulating Justin Beiber songs

b. USP 800

c. Pharmacist Provider Status

d. Banning opioid reveral agents

e. A and B

f. B and C

g. All of the above

h. None of the above

Montana Board of Pharmacy Members

• Starla Blank, Pharmacist, President

• Rebekah Matovich, Certified Pharmacy Technician, Vice-President

• Marian Jensen, Public Member, Secretary

• Charmell Owens, Pubic Member

• Paul Brand, Pharmacist

• Mike Bertagnolli, Pharmacist

• Tony King, Pharmacist

Licensee Statistics As of April 2017

Individuals

– Pharmacists: 2,034• Clinical Pharmacist Practitioner

Endorsements: 22 (16 in June 2017)

– Interns: 359

– Certified Pharmacy Technicians: 1,244

– Technicians-in-Training: 351

– Dangerous Drug Researchers: 13

Facilities

– Community Pharmacies: 264• Telepharmacy Endorsements: 17

– Institutional Pharmacies: 97

– Mail Order Pharmacies: 623

– Limited Service Pharmacies: 5

– Outpatient Surgical Centers: 19

– Wholesale Drug Distributors: 1,367 (102 in-state)

2017 Legislative SessionHome page: http://leg.mt.gov

https://mopa.memberclicks.net/assets/docs/mpa%20preference%20list%20052217.pdf

Board Bill: SB 56Revise sunset dates related to funding of the prescription drug registry (Montana Prescription Drug Registry (MPDR))

• Extends authority for the Board to collect a $30 MPDR fee from licensees authorized to prescribe or dispense controlled substances until June 30, 2019

• Fees are collected at time of license renewals for all boards

• Timeline12/15 Introduced1/5 Senate Business Labor Hearing1/6 Passed Committee1/12 Passed Senate1/23 House Business Labor Hearing1/27 Passed Committee2/2 Passed House2/13 Signed by Governor

Board Bill: SB 56 (continued)Revise sunset dates related to funding of the prescription drug registry (MPDR)

• Next steps for implementation – Already implemented in 2015 to collect $30 from licensees at time of

license renewal– Continue to have attestation statement to self-identify if the fee does not

apply to an individual. – Expect to collect about $230,000 from fees in Fiscal Year 2017– Licensees who pay the fee include:

• Pharmacists• Physicians• Physician Assistants• Dentists• Optometrists• Podiatrists• Naturopathic Physicians• Advanced Practice Registered Nurses (APRN) with prescriptive authority

Board Bill: SB 68Revise drug distribution license through Board of Pharmacy (wholesalers)

• Provides authority to comply with federal law and implement Food and Drug Administration (FDA) requirements for security and safety of the drug supply chain– 2013 P.L. 113-54, Drug Quality and Security Act (DQSA)

– Includes Title I, Drug Compounding Act; Title II, Drug Supply Chain Security Act (DSCSA)

• Revises the current single wholesale drug distributor (WDD) license type to 4 separate license types – Wholesale distributor, third-party logistics provider (3PL), repackager, and

manufacturer

– Rulemaking will include additional guidance from FDA

– Existing WDD licensees will self-identify to be switched to other license type

Board Bill: SB 68 (continued)Revise drug distribution license through Board of Pharmacy (wholesalers)

• Adds definitions for product track and trace requirements

• Defines outsourcing facilities engaged in sterile compounding– Through rule, will add an endorsement on facility licenses engaged in sterile

compounding or identified as an outsourcing facility registered with FDA

• Timeline12/15 Introduced 1/11 Senate Business Labor Hearing1/11 Passed Committee1/17 Passed Senate2/2 House Business Labor Hearing2/7 Passed Committee 2/9 Passed House2/17 Signed by Governor

Board Bill: SB 68 (continued)Revise drug distribution license through Board of Pharmacy (wholesalers)

• Next steps for implementation– Draft rules to separate 1 wholesale drug distributor license type to 4

separate license types: wholesale distributors, 3PLs, repackagers, and manufacturers

– Integrate information from the Food and Drug Administration (FDA) regarding guidance and proposed rules, etc., as we await final rule for wholesaler and 3PL national licensing standards

– Consider best options for current licensees to self-identify license type – Create endorsements for existing licenses types to identity facilities that

are 503A sterile compounding or a 503B outsourcing facility

• STERILE COMPOUNDING: Consider steps for greater inspection procedures, enforcement, and rule changes regarding sterile compounding pursuant to implementation and requirements of DQSA and USP 797

Department Bills• Senate Resolution 13, confirm Governor’s appointee to health-related

boards– Governor’s Office resolution confirms appointments of Mike Bertagnolli and Tony King to the

Board – 2/14 Resolution adopted

• HB 141, to provide licensing boards with active supervision in antitrust liability cases– Department bill to clarify oversight and active supervision regarding actions of all boards

pursuant to a U.S. Supreme Court decision– 5/4 Signed by Governor– Implementation: continue what Department of Labor & Industry has been doing with regard to

oversight, strengthen policies and procedures, etc.

• SB 312, revise laws related to prescription drug use– Department bill regarding drug formularies for Workers Compensation program within

Employment Relations Division– 5/22 Signed by Governor

Naloxone Bills• HB 333, adopt the Help Save Lives from Overdose Act

– Defines “Eligible Recipient” and provides authority for facilities such as police/fire departments, crime lab, investigators, harm reduction coalitions, etc., to be identified as a patient for purposes of a prescription

– Allows for state-wide standing order through Department of Public Health and Human Services (DPHHS) in addition to existing prescription and collaborative practice authority

– Addresses liability issues

– Naloxone is still a prescription product – it is NOT available without a prescription or as an OTC…

– 5/4 Signed by Governor

– Implementation will involve coordination with DPHHS on development of standing order, education materials, and communication to pharmacists on how this will work

• HB 323, authorize emergency use of opioid antagonist in a school setting – Identifies the school as a patient for naloxone (similar to 2013 epinephrine law (SB 165)

– 4/4 Signed by Governor

Pharmacy Bills• HB 177, revise administration of immunization laws

– Clarifies the list of immunization that pharmacists can independently prescribe/administer without a collaborative practice agreement – allows for any pneumococcal vaccine (37-7-105, MCA)

– 2/22 Signed by Governor

• HB 276, revise reimbursement for pharmacies (PBMs)– Montana Pharmacy Association (MPA) bill that directs pharmacy benefit

managers (PBMs) to provide greater price transparency when claims are less than acquisition cost of a drug

– 3/31 Signed by Governor

– Implementation does not impact Board

MPA Update: Implementation and next steps

Pharmacy Bills (continued)

• SB 31, require Medicaid reimbursement for drug therapy management – Allows for Medicaid to reimburse pharmacists with a Clinical Pharmacist

Practitioner endorsement. – Tabled in Committee, will be implemented through rulemaking by July 2017

per agreement of the sponsor, MPA and DPHHS

Medicaid issued proposed rule notice on 4/28, comments were due 5/10. – Proposed rule adds:

• Clinical Pharmacist Practitioner (CPP) to the definition of health professional in ARM 37.86.4401.

• New rule defining collaborative practice drug therapy management (CDTM) – refers back to the Board’s definitions

• New rule for CDTM requirements and eligibility – refers to CPP and the use of CDTM as outlined in Board rule

• New rule outlining reimbursement to the medical practitioner or facility

MPA Update

Pharmacy Bills (continued)

• HB 233, establish the Montana drug product selection act (biosimilars)– Provides definitions for biologic interchangeable products as approved by FDA

– Includes post-dispensing communication requirements

– 2/22 Signed by Governor

• HB 195, revise laws related to pharmacies and prescription drugs (generic substitution) – Aims to clarify generic substitution communication to patients regarding less than A

or AB rated drugs

– Passed House, 3/10 tabled in Senate

– Consider clarifying in Board rule

Pharmacy Bills and Others

• HB 409, restrict opioid prescriptions– Restricts opioid dispensing to 7 days except for certain conditions and would require

patient identification at the pharmacy

– Passed House Human Services Committee, passed 2nd reading House, Failed 3rd and final reading House

• SB 228, exempting needle and syringe exchange providers from drug paraphernalia laws– 3/23 Signed by Governor

• SB 120, generally revise dental hygiene laws– Adds limited prescriptive authority for dental hygienists for certain oral health

medications under general supervisions of a dentist

– 5/4 Signed by Governor

Board Rulemaking• MPDR Fee Collection

– Proposed rule issued 3/10, MT Administrative Register Notice (MAR) 24-174-68– Aligns MPDR fee collection rule with 2015 and 2017 legislative action

• Reflects the $30 fee currently being collected• Clarifies fee collected at time of license renewal and is considered a renewal fee• Adds who is not required to pay the fee

– Board to finalize at next meeting

• Pharmacist Intern Licensing– Board approved issuing proposed rules to amend intern licensing:

• Issue an intern license after first day of school – rather than waiting current 30 days (ARM 24.174.602)

• Revise pharmacist foreign graduate intern requirements to align with amended pharmacist licensure requirements for foreign graduates (ARM 24.174.605)

• Meal/Rest Breaks– Board reviewed potential changes to pharmacist meal/rest break, ARM 24.174.411– Further review/consideration required due to legal concerns

Board Rulemaking• Fee Reduction for Applications and Renewals

– Majority of Board income is received through application and renewal fees

– Limited by statute to cash on hand of two times appropriation

– Pharmacy continues to have too much cash even with 50% fee abatement on renewal fees

– Board is required to reduce fees to bring budget in compliance

– Proposal for Board consideration: • Reduce all application and renewal fees of the primary license for individuals and

facilities by same percentage

• Endorsement fees on a primary license may or may not be reduced – the Board will see income generated from each and could decide to make changes to an endorsement type

• Endorsements related to dangerous drugs, medical gas, technician utilization plans, and CPPs

MPDR Home Page: www.mpdr.mt.gov

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Montana Prescription Drug Registry (MPDR)• Online tool that provides a list of controlled substances prescriptions

dispensed to patients and permits authorized users access to the information for the purposes of improving patient safety.

• MPDR information may also be a tool to identify potential misuse, abuse, and/or diversion of controlled substances

• Funded through federal grant support from the Montana Board of Crime Control and $30 fee collection from Montana licensees integrated into license renewal process

• Statistics as of May 31, 2017: • Over 10.9 million prescriptions in database

• Over 25,500 patient history searches in May (over 5,000 by Delegates); over 758,000 searches since 2012

• 3,606 licensees registered which is 34% of all eligible providers and 48% of those located in Montana

MPDR Projects• Interstate Data Sharing: Launched February 2017 and allows Montana to share

and receive information from other participating states – currently sharing with 10 states

– Alaska, Arizona, Idaho, Kansas, Nevada, New Mexico, North Dakota, Oklahoma, South Dakota, Texas

– Access requirements for each state determine shared access

• Delegate Access: Launched April 2016 and allows registered users to delegate search authority to an authorized agent (delegate)– Delegates must register and use own login credentials and must identify who they are

searching for with each search

– Pharmacists can only delegate to pharmacist interns or certified technicians

• Working on RFP process to look at other vendor options

• Other focus areas: data destruction, de-identification of data, statistical analysis for meeting grant reporting requirements, etc.

MPDR Interstate Data Sharing

MPDR In-State Registrations

MPDR First Time Users

Board Web Page: www.pharmacy.mt.gov

Board Newsletter Goes Electronic Only

• Newsletter will be electronic only after June 2017 issue

• All newsletters are posted on the Board’s Web page at www.pharmacy.mt.gov, click on Newsletter Information to link to NABP hosting page

• Subscribe to electronic notification on above NABP page (www.nabp.pharmacy – click on Boards of Pharmacy, then Montana)

Future Board Meetings

• 1/26/2018

• 4/13/2018

• 7/13/2018

• Location and time: Department of Labor & Industry, 301 S. Park Avenue, Helena, MT, 9:00 A.M.

• Screening Panel day prior at 1:00 P.M.; Adjudication Panel day of 8:00 A.M.

• No January 2018 meeting in conjunction with Montana Pharmacy Association winter meeting at Big Sky

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License Renewals

• Renewal fees abated 50%

• Individual renewal May – June– Deadline: June 30, 2017

– Renewal online: https://ebiz.mt.gov/pol

– Call Unit A at 406-444-6880 for assistance with online login information

• Facility renewal October-November

• Rule change to reduce application and renewal fees implemented October 2017

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Board of Pharmacy Contact Information

Marcie Bough, PharmD, Executive Officer

406-841-2371, mbough@mt.gov

Bill Sybrant, RRh, Board Inspector

406-439-6015. bsybrant@mt.gov

John Douglas, RPh, Board Inspector

406-431-1952, jdouglas@mt.gov

Donna Peterson, Program Manager Montana Prescription Drug Registry (MPDR)

406-841-2240, dlibsmpdr@mt.gov

Licensing Unit AFor renewals, license verification, address changes, and name changes406-444-5773, UnitA@mt.gov

Licensing Unit BFor technicians, community/hospital pharmacies, and intern applications406-444-5711, UnitB@mt.gov

Licensing Unit C For pharmacists, interns, wholesalers, and mail-order pharmacies406-444-6880, UnitC@mt.gov

Audit Unit For CE requests and audits406-444-5696, Audit@mt.gov

Tips from the field

• Bill Sybrant – Board Inspector • John Douglass – Board Inspector

Federal Initiatives

• CDC Mandated Prescribing

• DEA mandated opioid manufacturing reduction

• Pharmacists as providers

• Change in Medicare Part D

• Opioid overdose medication availability

• Prescription Drug Shortages

• EU manufacturing inspections

• Drug importation

• USP 800

• Technician levels

• NABP report

Post-test questions:1. What does SB 68, the wholesaler bill, allow the Board to do?

a. Comply with federal law

b. Create 4 license types from the current wholesale drug distributor license

c. Individually license outsourcing facilities

d. A and B

e. All of the above

2. What do the naloxone bills HB 323 and HB 333 do?

a. Reclassify naloxone to be available as an OTC without a prescription

b. Identify a school, police/fire department, and other facilities as a patient

c. Allow “Eligible Recipient” facilities to purchase naloxone from a wholesaler

d. Removes existing pharmacist/prescriber collaborative practice authority

e. None of the above

3. Which two of the following are federal initiatives for the pharmacy profession?

a. Regulating Justin Beiber songsb. USP 800

c. Pharmacist Provider Status

d. Banning opioid reveral agentse. A and B

f. B and C

g. All of the aboveh. None of the above

Thank You Answers: 1.d, 2. b, 3. f