BOARD OF PHARMACY- REGULATORY UPDATE. Kimberly Grinston, J.D., Executive Director

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2 BOARD OF PHARMACY- REGULATORY UPDATE Kimberly Grinston, J.D., Executive Director

3 Disclosure and Conflict of Interest I declare no conflicts of interest, real or apparent, and no financial interest in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings and honoraria.

4 Pharmacist Objectives At the conclusion of this program, the pharmacist will be able to: 1. Identify new rule/legislative compliance requirements 2. Develop needed compliance policies and procedures 3. Identify new inspection/compliance resources

5 Technician Objectives At the conclusion of this program, the technician will be able to: 1. Identify new legislative changes 2. Identify recent rule changes 3. Identify applicable Board resources

6 Pre-Test Questions All vaccines must comply with CDC guidelines TRUE FALSE Pharmacists can dispense epinephrine auto-injectors to any county parks department TRUE FALSE Pharmacists are required to notify the Board before dispensing naloxone under the standing order and complete all training requirements TRUE FALSE

7 Missouri Board of Pharmacy Regulatory Update

8 Legislative Changes (2017) SB 50 SB 139 SB 501

9 SB 501 Immunization Changes Epinephrine Sales Hospital Pharmacy Drug Take Back Program Naloxone Dispensing

10 SB 501 (Vaccines & CDC Compliance) Vaccines administered by protocol must comply with CDC guidelines Vaccines administered by medical prescription order must comply with CDC guidelines or manufacturer guidelines Effective August 28, 2017

11 SB 139 (Epinephrine Dispensing) Allows pharmacies to dispense epinephrine to an authorized entity with an Rx in the name of the entity [Sec ] Authorized Entity : Any entity or organization at or in connection with which allergens capable of causing anaphylaxis may be present including, but not limited to, restaurants, recreation camps, youth sports leagues, amusement parks, and sports arenas.

12 SB 139 (Epinephrine Dispensing) Similar to current law for nurses & school districts Rx can only be issued by a Missouri licensed physician & not a APRN or PA/AP. Rx must be in the name of the authorized entity [Sec ] Required 2-line format

13 SB 139 (Epinephrine Dispensing) Treated the same as a non-controlled Rx (Valid for 1-year, refills/quantity limits as prescribed)

14 SB 139 (Epinephrine Dispensing) Mandatory Training for expected auto-injector users Does not apply to pharmacists normally dispensing from regular inventory No additional pharmacist training required unless the medication was received based on a Rx issued to the pharmacy under

15 SB 139 (Epinephrine Dispensing) Can pharmacists provide the required training? Expected epinephrine auto-injector users [must] receive training in recognizing symptoms of severe allergic reactions including anaphylaxis and the use of epinephrine auto-injectors from a nationally recognized organization experienced in training laypersons in emergency health treatment or another entity or person approved by the department of health and senior services. Contact Department of Health

16 SB 501/SB 50 (Hospital Pharmacy) Missouri hospitals deemed in compliance with Chapter 197 licensing requirements if they comply with the Medicare conditions of participation [Sec ] Preempts designated hospital licensure rules that duplicate or conflict with Medicare COPs. DHSS reviewing the impact on hospital pharmacies [July 1, 2018 effective date]

17 SB 501 (Drug Take-Back Program) Authorizes the Board to develop and fund a drug take-back program with DHSS. Specifically includes Schedule II & III Updates provided in the future

18 SB 501 (Naloxone Dispensing) Allows pharmacists to dispense naloxone under a statewide protocol without a Rx Statewide protocol signed by DHSS Director Effective August 28, 2017

19 SB 501 (Naloxone Dispensing) See August Newsletter for complete information Naloxone Webinar September 12, 2017

20 SB 501 (Naloxone Dispensing) Any Missouri licensed pharmacist can participate in the standing order Standing order is a prewritten medication order that authorizes healthcare practitioners to perform designated activities. Standing order issued by DHSS Director, Dr. Randall Williams, M.D. No Rx needed

21 SB 501 (Naloxone Dispensing) No additional pharmacist training or certification required Notification/Registration not required Physician protocol is optional

22 SB 501 (Naloxone Dispensing) Standing Order allows dispensing to any eligible candidate Anyone who voluntarily requests naloxone or is at risk of an overdose or in a position to assist someone at risk

23 SB 501 (Naloxone Dispensing) Quantity Limits defined in the Standing Order Patient Education Mandatory Can be treated as an Rx or as a distribution Does not currently include Evzio

24 SB 501 (Naloxone Dispensing) If an Rx, comply with all Rx requirements If a distribution, patient name recommended but not required.

25 SB 501 (Naloxone Dispensing) Distribution: The transaction date Product name, strength & dosage form Quantity Distribution records 2 years; Rx records 5 years

26 SB 501 (Naloxone Dispensing) Insurance questions Depends on the plan MoHealthNet may allow reimbursement

27 SB 139 (Rx Cares for Missouri) Program) Authorizes the Board to establish a program to promote medication safety and to prevent prescription drug abuse, misuse, and diversion in Missouri Collaboration with DHSS Allows private and public funding

28 RULE CHANGES

29 Rule Review Executive Order Requires state agencies to review all rules Board has held 3 open meetings; Next meetings September & October 2017

30 Rule Review Board initiated its own comprehensive rule review in 2016 Revising and Updating Rules

31 Rule Review Topic: Remote Technician Supervision/Final Product Verification Automated Dispensing Systems (including patient self-service machines) Automated Distribution Models Drug Utilization Review

32 Rule Review Topic: Technology Usage Decreasing Paperwork Licensee Identification Other Patient Safety Proposals

33 Rule Changes Class-J Shared Services Rule (20 CSR ) Emergency Rule Effective August 6, 2-17 Proposed Rule Pending

34 20 CSR (Class-J) Caution! The emergency exemption does not exempt entities from all Board licensure. The emergency rule only exempts licensed Missouri pharmacies from having an additional Class J designation.

35 20 CSR (Class-J) What is administration? Applying or introducing medication to the body of a patient, whether by injection, infusion, inhalation, ingestion or other means.

36 Additional Exemption Requirements Receiving pharmacy documentation: Name and address of pharmacy providing medication Date of receipt of medication Patient name

37 Examples A pharmacy located within an infusion center Patient assistance programs Specialty drugs Restricted access drugs A community pharmacy administering to patients by medical prescription order Long acting injectable antipsychotics Specialty drugs

38 Additional Exemption Requirements If additional compounding or manipulation required by receiving pharmacy: Need valid prescription or medication order Must dispense as if its own prescription Must follow Board s requirements for; a. Prescriptions/medication orders b. Record keeping c. Compounding d. Labeling

39 Additional Exemption Requirements Patient counseling Receiving pharmacy responsible for patient counseling requirements Pharmacist administration by medical order 20 CSR Need separate medical order to administer Cannot rely on order from other pharmacy

40 Post Test: Question #1 Pharmacists can dispense epinephrine auto-injectors to any county parks department TRUE FALSE

41 Post Test: Question #1 Pharmacists can dispense epinephrine auto-injectors to any county parks department FALSE- Need a Rx

42 Post Test: Question #1 Pharmacists can dispense epinephrine auto-injectors to any county parks department FALSE- Need a Rx

43 Post Test: Question #2 Pharmacist administered vaccines must comply with CDC guidelines TRUE FALSE

44 Post Test: Question #2 Pharmacist administered vaccines must comply with CDC guidelines FALSE- CDC or Manufacturer s Guidelines if Administering by Rx Order

45 Post Test: Question #3 Pharmacists are required to notify the Board before dispensing naloxone under the standing order and complete all training requirements TRUE FALSE

46 Post Test: Question #3 Pharmacists are required to notify the Board before dispensing naloxone under the standing order and complete all training requirements FALSE Any licensed pharmacist can sell/dispense naloxone under the Standing Order

47 Take Home Points 1. New laws effective Pharmacists have options for dispensing/selling naloxone 3. Monitor the Board s website for new & proposed rules

48 Resources & References 1) August Newsletter 2) Board s Website (Rules & 2017 Legislation) 3) Naloxone Resource Center

49 Speaker Contact Information Kimberly Grinston Missouri Bd. of Pharmacy (573)