STATE OF MICHIGAN GRETCHEN WHITMER DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS ORLENE HAWKS GOVERNOR DIRECTOR LANSING MICHIGAN BOARD OF PHARMACY RULES COMMITTEE WORK GROUP MEETING MINUTES May 13, 2020 The Michigan Board of Pharmacy Rules Committee Work Group, met on May 13, 2020. The meeting was held via Zoom. CALL TO ORDER Andria Ditschman called the meeting to order at 1:02 p.m. ATTENDANCE Members Present: Charles Mollien, PharmD, JD Kathleen Pawlicki, MS, FASHP James Stevenson, PharmD (arrived 1:14 p.m.) Maria Young, R.Ph. Members Absent: None Staff Present: Andria Ditschman, Senior Policy Analyst, Boards and Committees Section Jacob Poynter, Analyst, Licensing Division Stephanie Wysack, Board Support, Boards and Committees Section Public Present: Rose Baran - Self Paige Fults - Michigan Health & Hospital Association Farah Jalloul – Michigan Pharmacists Association Joel Kurzman – National Association of Chain Drug Stores Pollyanne McKillop – Michigan Department of Agriculture & Rural Development (MDARD) Dwight McNally, DVM - Self Michele Schalow – Michigan Department of Agriculture & Rural Development (MDARD) WELCOME Ditschman explained how the meeting would be run. BUREAU OF PROFESSIONAL LICENSING 611 W. OTTAWA • P.O. BOX 30670 • LANSING, MICHIGAN 48909 www.michigan.gov/bpl • 517-241-0199 LARA is an equal opportunity employer/program Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes May 13, 2020 Page 2 of 8 RULES DISCUSSION Pharmacy – Animal Euthanasia and Sedation Rules (A copy of the draft rules, used during the meeting discussion, are attached) Ditschman stated that the draft included proposed modifications pursuant to the 2018 legislative changes dealing with shelters and Class B dealers. She stated that the rules should be easier to follow by separating them by animal euthanasia and animal sedation. Once the draft is complete, it will be forwarded to the Board of Veterinary Medicine, associations and shelters in order to get their input. R 338.3501 Definitions. Ditschman stated that the definition of animal control shelter and animal protection shelter will be modified. R 338.3502 Animal euthanasia; animal control shelters, animal protection shelters, class b dealers; authorization to apply for permit. Ditschman stated that this rule differentiates the types of permits available for each entity. Poynter stated that, the specific drugs that can be purchased are printed on the permits. McKillop stated that animal control shelters are regionally run by a municipality and animal protection shelters are operated by an entity that is not a municipality, such as the humane society or a nonprofit organization. Mollien asked if the rules were regurgitating what was already in statute. Ditschman stated that in some cases the rules copy some of the requirements in the statute. It was determined that the rules should not repeat the regulations in the statute. R 338.3503 Animal euthanasia; application for permit. Ditschman stated that this rule includes the application requirements. Subdivision (c): Ditschman will reevaluate the term “biographical data.” McKillop stated that the history of the need for the 2018 legislative changes stemmed from euthanasia being performed with a premix of sodium pentobarbital when the animal was in a state of unconsciousness. However, the shelters could not obtain ketamine this was not happening and euthanasia was being performed inhumanely. Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes May 13, 2020 Page 3 of 8 R 338.3504 Permit for animal euthanasia; form; non-transferable; change in responsible person. Ditschman stated that the permit is not transferable. The rule lists the information contained on the permit and includes the timeframe in which the shelter must notify the department of a change. R 338.3505 Registration with United States department of justice. Ditschman stated this rule includes the requirement to register with the United States Department of Justice. R 338.3506 Animal euthanasia; trained personnel; notification of changes; documentation of training. Subrule (2): Ditschman stated that this subrule gives the timeframe in which the Class B dealer or shelter must notify the Department when there is a change in the level of training by an individual in charge of the day-to-day operations or an employee. Mollien questioned why the proposed language referenced 10 days, when a pharmacy has 30 days to notify the department of a change in pharmacist-in-charge. There should be consistency. Ditschman will check if the 10-day language came from statute. If not, then she will change the language to 30 days. The Rules Committee agreed to the language change as proposed. Pawlicki asked about who was liable in the case of diversion. Poynter stated that the permit is issued to the facility, with a list of trained individuals. The individuals do not have a permit or a license. Therefore, the liability would be with the facility. Mollien stated that law enforcement could investigate. McKillop stated that the Drug Enforcement Agency (DEA) could investigate. R 338.3507 Animal euthanasia; training of personnel. Subrule (1): Ditschman stated that this subrule includes the training requirements until December 31, 2021. Subrule (2): Ditschman stated that this subrule includes the new training requirements. The law requires that the training requirements be approved by the state veterinarian. The state veterinarian issued a letter regarding the training effective July 13, 2018. Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes May 13, 2020 Page 4 of 8 Poynter asked if the words “until December 31, 2021” should be included in this subrule. Ditschman stated that the dates were covered at the beginning of the rule set but it could also be added here. Subdivision (2)(c): Pawlicki stated that clarification was needed. Poynter stated that the training is required but that does not allow the individual to perform euthanasia. Subdivision (2)(d): Ditschman stated that the language will be modified to remove everything after “state veterinarian.” Subdivision (1)(d): Schalow stated that language should be modified to state that the state veterinarian is reviewing programs based on the American Veterinary Medical Association (AVMA) Euthanasia Guidelines. Schalow also stated that “intracardial” should be used in place of “intercardial.” Ditschman stated that making changes to the language in subrule (1), that was approved in the previous rule, would affect individuals who have already completed the training. Ditschman stated that the language in subrule (2) had been approved by the state veterinarian. There may not be room for change as it complies with current AVMA Guidelines. Mollien asked if the rule needed to comply on an on-going basis which would make it more complicated. Ditschman stated that the statute requires the Board of Pharmacy to put the training in the rules in consultation with the state veterinarian. Mollien asked if the rule could state that that the Department recognizes what the AVMA adopts and leave out all the details. Schalow stated that the training programs are reviewed through the Michigan Department of Agriculture & Rural Development (MDARD). Mollien stated that the rule could require proof of the training without all the details of the training. Ditschman asked MDARD if that would be sufficient. Schalow stated that additional detail might not need to be added. Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes May 13, 2020 Page 5 of 8 Ditschman will contact the state veterinarian regarding this issue. The intent may be to leave the rule broad. Subdivision (1)(d): Pawlicki asked if a competency exam was required under this rule due to the wording “at the conclusion of the training.” Mollien stated that the competency evaluation is part of the training. McKillop stated that a lot of time is spent in the practicum in order to determine competency. Pawlicki stated that another body is determining the standards, so it is not needed in the rules. However, Michigan specific issues should be included in programs and should stay current and up to date. R 338.3508 Animal euthanasia; notification of completion of training; issuance of permit. Ditschman stated that this rule was rescinded as training is submitted with the request for a permit, so keeping it would be unnecessary. R 338.3510 Animal euthanasia; retention of records regarding dispensation of sodium pentobarbital. Ditschman stated that this rule was updated to include all the required drugs. R 338.3511 Storage of sodium pentobarbital. Ditschman stated that this rule was updated to include all the required drugs. R 338.3513 Animal sedation; authorization to apply for permit. Ditschman stated that this rule was updated to include all the required drugs as well as the requirements for training. Part 5. Animal Sedation Ditschman stated that the rules in this part were written similarly to those written in Part 2. The Rules Committee and public agreed to the proposed language unless otherwise noted. Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes May 13, 2020 Page 6 of 8 Centralized Prescription Processing Pharmacies (A copy of the draft rules, used during the meeting discussion, are attached) Ditschman asked the Board and public if there were any concerns or issues with the rules as written. Mollien asked why this set of rules was being worked on. Ditschman stated that the rules had not been updated since 2008 and references to the Code and in the rules need review and modification. Mollien stated that Meijer has no issues complying with the way the rules are currently written. Stevenson asked if this was strictly the centralized order verification process and not dispensing. Mollien stated that it is central fill pharmacy for dispensing. R 338.3051 Definitions Subdivision (1)(a): Stevenson suggested that this definition clarify central fill pharmacy as that is the term used in the industry. Mollien stated that the word dispensing should also be incorporated. Pawlicki asked who receives the prescription. Mollien stated that the prescription record is kept with the originating pharmacy.