HOUSE BILL NO. 112 "An Act relating to the Board of Pharmacy; relating to the practice of pharmacy; relating to pharmacies; relating to prescription drug manufacturers; relating to prescriptions for epinephrine; relating to the administration of epinephrine; and providing for an effective date." 3:17:20 PM REPRESENTATIVE JUSTIN RUFFRIDGE, SPONSOR, introduced HB 112. He explained that the bill came about after being discussed for multiple years by the Alaska Board of Pharmacy. The board was tasked with regulation changes by the administration, and it thoroughly examined the regulations of the profession of pharmacy. The regulation changes were referred to as "right touch" regulations and modernized the profession as it had changed immensely over the past 25 years. The board started keeping a list of the items that would need to be changed in statute in order to implement the right touch regulations. The bill was a collection of the statute changes to help modernize the profession and it would also give the board the authority to continue the regulatory process. He relayed that the chair of the board would offer a presentation to explain the bill in more detail. DR. ASHLEY SCHABER, CHAIR, ALASKA BOARD OF PHARMACY (via teleconference), introduced the PowerPoint presentation "House Bill 112: Profession of Pharmacy" dated May 8, 2023 (copy on file). She began on slide 2 which detailed the board's 2023 strategic plan. There had been a cumulative effort over the last several years to ensure that the board had statute changes that would allow it to meet its mission. She highlighted that one of the board's four goals [listed on the slide] was to grow the economy while promoting community health and safety. Many of the changes related to the aforementioned goal, particularly to routinely review the effectiveness of regulations that reduced the barrier to licensure without compromising patient health and safety. She relayed that the board currently had seven members, five of whom were pharmacists and two of whom were public members. Dr. Schaber continued to slide 3 and offered some background information on HB 112. She explained that the bill would address necessary changes by doing the following: • Streamlining licensure process while improving public safety • Compliance with the Drug Supply Chain and Security Act • Alignment with other professional boards in Alaska and pharmacy boards in other states • Clarification of pharmacists' roles in epinephrine access Dr. Schaber indicated that the bill was a collaborative effort between the board and the Alaska Pharmacists Association. Dr. Schaber continued on slide 4. The first goal was to streamline the licensure process while improving public safety. The bill eliminated unnecessary forms currently required in statute. The forms were redundant and included information that was already part of the licensure process. The elimination of the forms would reduce the burden on the applicant and on the board. It also clarified that only pharmacists who dispensed controlled substances would be required to register with the Prescription Drug Monitoring Program (PDMP). It would also add a national criminal background check for all applicants, which would add another layer of protection. The background check was required in 30 other states and was a statutory requirement for nursing and other professions. 3:23:48 PM Representative Hannan asked what details were included in the national background check when it was returned to the board. She asked if included specific information or simply showed whether an applicant had committed a criminal violation. Dr. Schaber responded that she did not know which details were included in the background check. She thought that the background check acted as a flag to prompt additional review. Representative Ruffridge responded that the application for licensure currently had a "self-selection" response, which meant that the application asked whether an individual had been convicted of a crime or was currently under investigation for a crime. Applicants were able to select "no" on the application even if the true answer was "yes," and there would be no follow-up. During his time on the board, there were at least a few cases in which the answer checked on the application was no, but the actual answer was yes. The reason for the request was to ensure that applicants were answering truthfully on their applications. If a person were to lie, there would be reason to deny the individual a license. Representative Hannan noted that the committee spent time in the prior week talking about background checks for cannabis convictions that were no longer convictions under the law and how the process should be changed. She could see a problematic situation occurring in which a pharmacist applicant had a cannabis conviction in another state, but it was not considered a criminal offense in Alaska. She was hoping that there would be more detail than a yes or no as the answer was often more complicated. She did not think answering yes should be an automatic denial, but she was unsure if federal law would allow nuances to be considered. Representative Ruffridge responded that marijuana was still considered an illicit substance because it was federally illegal. A violation with a controlled drug of any type would be a flag to prompt additional review of an application. The board considered it an issue in its hiring process even though marijuana was legal at the state level because pharmacists would have access to controlled substances. Representative Coulombe asked Representative Ruffridge to put his credentials on the record. Representative Ruffridge responded that he was the previous chair of the Board of Pharmacy. He had a doctorate in pharmacy and had been a licensed pharmacist in the state since 2008. 3:29:31 PM Dr. Schaber continued on slide 5. The next goal was to be compliant with the Drug Supply Chain and Security Act (DSCSA). She read from the slide as follows: • The federal Drug Supply Chain and Security Act (DSCSA) further secures the U.S. drug supply through a system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter, and enable rapid response when such drugs are found. o Boards of Pharmacy play a key role in this process through appropriate licensing of drug distributors and pharmacies • HB 112 ensures the AK Board of Pharmacy powers and duties support the DSCSA related to manufacturers, out-of-state pharmacies, and internet pharmacies to ensure Alaskans receive safe medications Dr. Schaber explained that the change would be a modernization to the process. Currently, out-of-state pharmacies were required to register based on a statute put in place in 1992. The drug supply chain and pharmacy in general had changed significantly since 1992 when the original statute was put in place. She relayed that compliance with DSCSA would give the board jurisdiction over out-of-state pharmacies. There was a concern that out- of-state pharmacies that were mailing prescriptions into the state might not be providing the same kind of counseling that the in-state pharmacies were required to provide. The concern had been raised many times over the years in the form of public comment. Dr. Schaber continued on slide 6 and the next goal, which was alignment. To achieve the goal, the bill would replace one of the two public member seats with a pharmacy technician seat. As the field of pharmacy had changed over the years, the role of pharmacy technicians had changed with it. Both public member seats had been vacant for about a year and adding the pharmacy technician seat would allow for an additional perspective. The board also hoped that it would help fill the vacancy. The next change would be to allow the board to adopt language to create a retired pharmacist status. It would align the board with pharmacy boards in other states and with other professional boards in the state. The last change associated with the goal of compliance was to clarify the board executive administrator's salary which would allow the required flexibility for a pharmacist to serve in the role in the future. The salary was currently not flexible enough to allow a pharmacist to apply for the position. The board did not want to require that a pharmacist serve in the position because applicants with other credentials were able to serve also, but it wanted to allow for the possibility. 3:34:02 PM Dr. Schaber continued on slide 7 which detailed the goal of epinephrine access. The changes in the bill would move the epinephrine training program from the authority of the Department of Health (DOH) to be overseen by the board. It also clarified that a pharmacist could administer epinephrine or prescribe epinephrine auto-injectors to an individual who had completed the training program. It would ultimately increase epinephrine access for Alaskans with anaphylactic emergencies or those who might not know they were at risk for anaphylactic emergencies. She added that access was especially important in the rural areas of the state. Some of the changes in the bill also increased access by decreasing barriers to dialysis fluids, which was also important for Alaskans living in rural areas on home dialysis by allowing patients to receive the treatment at home. Dr. Schaber concluded her presentation on slide 8 and thanked the committee for its time. She urged the committee's support of the bill. Co-Chair Foster asked for clarity on the uses of situations in which epinephrine would be used. Dr. Schaber responded that epinephrine was an emergency medication used for allergic reactions, such as eggs, bee stings, or peanuts. Some individuals were aware that they had anaphylaxis, and some were not aware until they were exposed to the substance that causes a reaction. Representative Hannan asked about the board executive administrator's salary detailed in Section 10 of the bill. She asked how many other professional boards allowed for similar flexibility in salary. She wondered if there was a salary classification for pharmacists in the state pay schedules. 3:37:10 PM SYLVAN ROBB, DIRECTOR, DIVISION OF CORPORATIONS BUSINESS AND PROFESSIONAL LICENSING, DEPARTMENT OF COMMERCE COMMUNITY AND ECONOMIC DEVELOPMENT, responded that there were other pharmacists that worked for the state and there were pay schedules in place. The pay ranged depending on duties: for example, there was a pharmacist employed in the Alaska Psychiatric Institute (API) as well as DOH pharmacists in for Medicaid purposes with salary ranges from 24 through range 27. Relating to executive administrator of other boards, six of the boards had an executive administrator positions and one other board had a similar position with a different title. Only the Board of Nursing had required qualifications for the executive administrator role as it required that the individual was a registered nurse (RN). Representative Hannan asked if the nursing board members were paid on the RN pay schedule. Ms. Robb responded that the members were not paid as nurses. The executive administrator positions were considered partially exempt and the salary for the position was not specified in statute; however, it was the highest paid position because it required that the individual be a licensed professional and have a master's degree, it was the highest paid of the executive administrator positions and was a range 25. Representative Hannan asked if the phrasing for the pharmacy board's executive administrator was unique or if other boards had similar required competencies. She wondered if the administrators were adequately compensated based on the advanced requirements. Ms. Robb responded that not all heath care boards had executive administrators. The nursing board was the only board requiring the administrator to be a member of the nursing profession. The pay for the executive administrator positions ranged depending on the workload and on whether the pay was dictated in statute. The executive administrator position for the pharmacy board was currently not filled by a pharmacist. If the board hired a pharmacist for the position, it wanted the ability to pay the individual fairly based on the advanced requirements. Representative Hannan asked what the range increase would be in order to pay the executive administrator as a pharmacist. Ms. Robb replied that the other pharmacists that worked for the state were range 24 through range 27 depending on their duties. The board would have to work with classification to determine which other state pharmacist position the executive administrator was most similar to in order to determine the range. 3:41:53 PM Representative Josephson asked if the licensees of board paid for the executive administrator positions. Ms. Robb responded in the affirmative and noted that the divisions were funded through receipt-supported services. The cost of all staff for a particular board were paid by the licensees for that particular profession. The Division of Corporations Business and Professional Licensing (DCBPL) conducted time keeping in order to allow staff to indicate which program they were working on to ensure that the charges were allocated appropriately. Representative Josephson understood that the boards were providing services "out of the kindness of their hearts." He was not aware that some boards had an executive administrator apart from the Medical Board. He asked if the state would pick up the extra costs if a board chose not to hire an administrator. Ms. Robb responded that all were paid by the licensees of a board, and it would not matter whether the board had an executive administrator. Representative Josephson asked why each board would not want their own executive administrator. Ms. Robb responded that it depended on the scope and complexity of the program. The Board of Nursing was a team of 10 individuals that oversaw 28,000 licensees and it made sense for the board to employ an executive administrator. There were some boards with more complex licensing than others and needed more employees. Boards with fewer licensees and less complex licensing processes had less of a need for an executive administrator. 3:44:36 PM Representative Coulombe understood that out-of-state pharmacies had to be registered but did not have to be licensed. She asked if her understanding was correct. Representative Ruffridge responded in the affirmative. Representative Coulombe wanted to ensure that adding the licensing requirement would not be too much of a hinderance. She relayed that there were many individuals who relied on online pharmacies. She asked what licensing would be like for an out-of-state pharmacy. Representative Ruffridge responded that under the current process, registering with the Board of Pharmacy simply indicated that a pharmacist existed and may or may not send for medications with the state. There was no jurisdiction by the board of the medications that entered the state to ensure that counseling had been provided to the individuals receiving medications. There was no ability for the board to maintain safety measures. Over the years, mail order pharmacies had become more popular and regulations had not kept up with the changes. The change would not be overly burdensome to companies that already mailed a significant amount of medications into multiple states and would simply put Alaska in alignment with many other states in the nation. Representative Coulombe asked if there were new fees associated with registration or licensing. Representative Ruffridge responded that there were fees associated with licensing and registration, but the board had gone through multiple iterations of fee reductions over the last few years. He argued that the fee for pharmacy technicians was essentially nonexistent. Technicians were simply required to pay an initial $25 fee to become registered and licensed, which was reduced from a fee of $150. Co-Chair Foster suggested that Representative Ruffridge make closing comments. Representative Ruffridge thanked the committee for its time. The bill had been well vetted and had been overseen by three different chairs of the pharmacy board. He thought that the support for the bill was encouraging and that the bill represented the desires of the profession of pharmacy as a whole. He welcomed the support of the committee and was happy to answer any other questions. HB 112 was HEARD and HELD in committee for further consideration. Co-Chair Foster reviewed the agenda for the following day's meeting.