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 SEPTEMBER 23, 2020 The Michigan Board of Pharmacy Rules Committee Work Group, met on September 23, 2020. The meeting was held via Zoom. CALL TO ORDER Andria Ditschman called the meeting to order at 2:31 p.m. ATTENDANCE Members Present: Charles Mollien, PharmD, JD Michael Sleiman, R.Ph. Sandra Taylor, R.Ph. Members Absent: Cynthia Boston, BHS, R.Ph.T. 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 Farah Jalloul – Michigan Pharmacists Association Jonathan McLachlan – Alliance RX, Walgreens Prime Lisa Penny – Spectrum Health Christine Rainey – FernCare Free Clinic, Inc., Free Clinics of Michigan WELCOME Ditschman stated that holding a public meeting allows for the department to receive comments from the public 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 September 23, 2020 Page 2 of 11 RULES DISCUSSION Pharmacy – Controlled Substances (A copy of the draft rules, pursuant to today’s discussion, is attached) Ditschman stated that the definitions would remain unless otherwise defined in the statute. R 338.3102 Definitions; I to P. Subdivision (1)(f) “Patient identifier” Mollien stated that the word “Michigan” should be removed as identification should be recognized from any state. All zeros are used in the system currently when presented with an out of state identification. Both subdivision (1)(f)(i) and (ii) should reflect the acceptance from any state. Ditschman stated that she will copy that language into the Michigan Automated Prescription System (MAPS) part of the rules as well. Ditschman asked if all identification should include a photograph. Mollien and Sleiman stated it should. The Rules Committee agreed to the change in language to subdivision (1)(f)(i) and (ii). Subdivision (1)(f)(iv): Ditschman asked if a description of the animal should be required. Mollien stated that the patient profile is under the owner being used and that the pharmacy uses the requirements of the American Society for Automation in Pharmacy (ASAP). Ditschman stated that she would follow up with the Department as well as other veterinarian groups to find out what should be used in identifying the animal as the patient. Subdivision (2)(a): Ditschman stated that “medical institution” is defined in the pharmacy general rules. The pharmacy general rule is referenced in the controlled substance rule that defines “medical institution.” Part 2. Schedules Ditschman stated that the federal statute, legislative statute, and the administrative rules of the state are not the same. Scheduling drugs is the responsibility of the Board as part of the rule making process. As suggested previously, would referencing the federal schedule in the rules make its use easier, instead of listing each scheduled drug? Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes September 23, 2020 Page 3 of 11 Mollien stated that the stricter of the two, federal or state, must be followed, so referencing the federal would make sense and then the state would reference anything that made stricter, in the rules. Ditschman stated that referencing the federal schedule will require the use of a specific date of the federal list, which in turn would require a rule change when the federal list changes. Taylor stated that it becomes confusing to determine which schedule to reference and agreed with Mollien’s statement. Sleiman also agreed. Ditschman stated that she would update the rules to the most current date and anything new can be brought to the Board to be scheduled differently. McLachlan agreed and stated that it was a cleaner approach to scheduling. Baran stated that only one drug was scheduled differently than the federal schedule in the rules. She stated that ephedrine needed to be added to the rules. Ditschman stated that she would have a Department pharmacist or Board member check the accuracy of the drugs that are scheduled differently in Michigan and need to be listed in the rules. Baran asked if there was a way to eliminate scheduling of drugs from the Public Health Code. Mollien stated that the statute allowed for the Board to review newly scheduled drugs for scheduling purposes. What happens if the Board does not act in the allotted timeframe? Ditschman stated that the Board must address the drugs as being listed in a schedule is not automatic. R 338.3132 Activities requiring separate licenses. Ditschman stated that this rule outlines specific activities that require a license. What does the Rules Committee look for when determining if a license is required? Mollien stated that he looks at where the actual drug is located. Licensing should track where the drugs are located. Ditschman asked if both the location of the drug and the activities associated with the drug should be addressed for licensing. Mollien stated that the rules would need to define what “an activity” means. If there is no controlled substance on site, a controlled substance license should not be required. Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes September 23, 2020 Page 4 of 11 Ditschman asked if the activities and locations that trigger a license should be separated in this section. Taylor agreed with separating the activity and location. Poynter stated that the statute references activities so it can be confusing when determining if a license should be required. If a facility is storing, all activities should be covered except for prescribing. Ditschman asked Poynter about the confusion by licensees of subrules (2) and (4). Poynter stated that leaving subrule (3) would be clear enough. Poynter asked how “principal place of practice” is defined. Ditschman stated that it was where the main business of the practice is being handled, including billing, records, and invoicing. Mollien stated that it is different with chain pharmacies as they are each considered a principle place of business and licensed separately. Penny stated that federal guidelines provide a chart for clarification of activities and maybe that would help here. Mollien stated that could work if it clarified the activities. Ditschman stated she would work on putting a chart together as an option. Mollien stated that a lot of the rule could be removed which would help clarify as well. Subrule (5): Ditschman asked if this subrule needed clarification. Poynter and Mollien stated that it did not need to be changed. Leave it as is. Subrule (6): Ditschman asked if this subrule was here for nursing homes. Poynter stated that the pharmacy that owns the machine placed in the nursing home, holds the license. Each location, where a machine is located, must hold a license. If there is more than one machine at one location, only one license is needed. Subrules (6) and (7): Ditschman asked how these provisions differ. Poynter stated there is no difference. Ditschman stated that she will merge subrules (6) and (7) together. Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes September 23, 2020 Page 5 of 11 Penny asked what was the purpose of licensing the machine. Mollien stated that it is the pharmacy that is licensed, not the machine. Poynter stated that the license authorized the use of the machine at the nursing home. Poynter stated that the Drug Enforcement Agency (DEA) was registering hospital locations. Baran stated that the only exception in the rules for licensure is for nursing homes. Nursing homes also require a separate DEA registration. R 338.3135 Opioids and other controlled substances awareness training standards for prescribers and dispensers of controlled substances; requirements. Ditschman stated that the opioid rules were already written, they are just being incorporated into this set of controlled substance rules. The following should be noted: • The rule outlined that training is required for the individual who holds the controlled substance license as well as an individual that they may delegate to, allow by a practice agreement, or order the prescribing or dispensing of a controlled substance. • The rule has been broadened. • The application of the rule to Physician’s Assistants is clarified in the language. • Dates have been added to the rule so that it is clear when the training is required. Mollien stated that the rule made sense. We may want to add language to specify how long proof must be maintained. Five years may be a good marker. Ditschman suggested using the first cycle after initially renewing. Sleiman and Taylor also agreed that the rule made sense. R 338.3136 Information in applications. Ditschman asked if the addition for researchers and instructional activities was needed. Poynter stated that there was no language for chemical analysis previously. Poynter stated that subdivision (1)(e) could be removed. Mollien stated that the rule could be organized any way. Poynter suggested separating chemical analysis into a new subrule (3). Michigan Board of Pharmacy Rules Committee Work Group Meeting Minutes September 23, 2020 Page 6 of 11 Ditschman asked if the wording in subdivision (1)(d) was sufficient or should it be written like subrule (1). Poynter stated that it should be set up like subrule (1). The Rules Committee agreed with the proposed change. R 338.3137 Waiver of license requirement. Subdivision (1)(f): Ditschman stated that the Department was suggesting the language to clarify the rule. Mollien stated that if a controlled substance license is held to prescribe, a separate license is not needed to treat within a drug treatment program.