HB 112-PROFESSION OF PHARMACY  4:03:06 PM CHAIR PRAX announced that the next order of business would be 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." 4:03:34 PM REPRESENTATIVE RUFFRIDGE, as prime sponsor of HB 112, paraphrased the sponsor statement [copy included in the committee packet], which read as follows [original punctuation provided]: Pharmacists and pharmacies are an integral part of Alaska' healthcare system. It is important that the Alaska statutes that guide them are updated and reflect the services provided by modern-day pharmacies. House Bill 112 clarifies the Alaska Board of Pharmacy's powers and duties to align with the federal Drug Supply Chain and Security Act (DSCSA) related to licensing and oversight of manufacturers, out-of-state pharmacies, outsourcing facilities, and internet pharmacies who conduct business in Alaska. In doing so, these out-of-state entities will be held to the same high standard as those operating in the state of Alaska, helping to ensure Alaskans have access to medications that are safe, no matter where they originate. HB 112 aligns Alaska's pharmacy board statutes with similar boards in other states. It allows for it to meaningfully recognize retired pharmacists and their contributions. Stressing the importance of public safety, HB 112 would allow the board to institute a national criminal background check for Alaska pharmacists and pharmacy technicians. This would align the Alaska Board of Pharmacy with the National Association of Boards and Pharmacy Model State Pharmacy Act. The Executive Administrator plays a critical role in the smooth functioning of the board and requires a high degree of competency and understanding of the complexities of pharmacy-related regulations and issues. This bill gives Alaska's Division of Professional Licensing flexibility to hire a qualified pharmacist for this administrative role should one apply. The changes proposed in House Bill 112 reflect a dedicated collaboration between the Alaska Board of Pharmacy and the Alaska Pharmacists Association (AKPhA) to modernize pharmacy practice statutes. 4:05:33 PM BRAEDAN GARRET, Staff, Representative Justin Ruffridge, Alaska State Legislature, on behalf of Representative Ruffridge, prime sponsor, gave the sectional analysis for HB 112 [copy included in the committee packet], which read as follows [original punctuation provided]: Section 1. Amends AS 08.08.010(a) Creation and  membership of board; officers  Alters composition of the seven-member Board of Pharmacy by designating one member to be a licensed pharmacy technician, and one being an individual with no financial interest in the healthcare industry Section 2. Amends AS 08.80.030 Powers and Duties of  Board  (b)(10) Separates out the licensing/regulating entities relating to manufacturing and distributing of drugs and devices by use of the word "or" (b)(12) adds an epinephrine auto-injector training program (b)(14) Clarifies that only pharmacists who dispense federally scheduled controlled substances be required to register with the Prescription Drug Monitoring Program (PDMP) (b)(16) Adds pharmacies and manufacturers from out-of- state to the list of entities to be licensed and inspected (b)(17) Adds internet-based pharmacies to the list of entities to be licensed if they are servicing Alaskans (b)(18) adds language adopting regulations pertaining to retired pharmacist status Section 3. Amends 08.80.145 Reciprocity; license  transfer  (3) removes character requirement - "of good moral character" (4) removes internship details this is a national standard among schools of pharmacy Renumbering of statute items Section 4. Amends AS 08.80.157 Licensing of facilities  (k) this adds out-of-state pharmacies and manufacturers to the list of entities that must be licensed and inspected Section 5. Amends AS 08.80.159 Licensing and  inspection of facilities outside the state  (a) Adds "distributor, pharmacy, manufacturer" to those out-of-state entities that must be licensed and inspected, under the Drug Supply Chain and Security Act Section 6. Amends AS 08.80.159 Licensing and  inspection of facilities outside the state  (c) adds "pharmacy and manufacturer" to list that may be inspected if located outside the state Section 7. Amends AS 08.80.160 Fees  (10) Removes the word "registration" since the bill mandates licensure of a facility Section 8. Amends 08.80.168 and adds a new subsection   Administration of vaccines and related emergencies  (e) Allows a pharmacist to administer epinephrine to a person or prescribe epinephrine auto-injectors to someone who has completed the epinephrine auto- injector training program Section 9. Amends AS 08.80.270 Executive administrator  of the board  (a) Adds an additional salary range option for the executive administrator, allowing flexibility for the Division to select a pharmacist for the role Section 10. Amends AS 08.80.420 Certain advertising  prohibited  (a) adds the term "apothecary" to list of those that cannot be used in media or advertising unless the store employs a licensed pharmacist with regular hours Section 11. Amends AS 12.62.400 National criminal  history record check  (a)(23) adds pharmacist and pharmacy technician to list of professions where a background check is required. Aligns with State of Alaska's nursing requirements and pharmacy requirements typical in other states. This adds a national level background check Section 12. Amends AS 17.22.010 Prescription,  purchase, administration of epinephrine by a trained  individual  Allows anyone over 18 to purchase or be prescribed an epinephrine auto-injector, and to administer epinephrine in an emergency to another person if they have completed an epinephrine auto-injector training program approved by the board. It removes very outdated language from this section Section 13. Amends AS 17.22.020(a) Approval of  training programs  (a) Allows the board, rather than the department, to adopt standards for the epinephrine auto-injector training program and deletes outdated language Section 14. Amends AS 17.22.020(b) Approval of  training programs  (b) Allows the board, rather than the department, to approve an epinephrine auto-injector training program that meets the board's standards Section 15. Amends AS 17.22.030 Applicability  States that this chapter does not apply to someone currently authorized under another law to administer epinephrine, such as a nurse or doctor, or some other authorized professional Section 16. Amends AS 17.22.040 Liability of certified  individual  Outlines that a person may not be sued who administers epinephrine to another in an emergency, and in good faith, if he or she has completed the epinephrine auto-injector training program approved by the board Section 17. Amends AS 17.22.090 Definitions  (3) defines the "board" as the Board of Pharmacy 4 Section 18. Repeals AS 08.80.110(2) Qualifications for  licensure by examination  • Repeals (2) furnish the board with at least two affidavits from reputable citizens that the applicant has known for at least one year attesting to the applicant's good moral character. This is not required in medical board, dental or nursing statutes. • Repeals 08.80.158 Registration of pharmacies located outside the state since this bill would now require licensure • Repeals AS 17.22.020(c) which is the Department's epinephrine auto-injector training program • Repeals AS 17.22.090(1) that defines the department as the Dept of Health, since it will no longer be the approving entity of the epinephrine auto-injector training program Section 19. TRANSITION LANGUAGE for currently  registered pharmacies  A new section that would allow pharmacies previously registered to continue to ship, mail or deliver prescription drugs to its customers in Alaska until their registration expires. At that time, they will then have to apply for licensure. Section 20. TRANSITION: REGULATIONS  Allows the Board of Pharmacy and DCCED to adopt regulations to carry out the changes laid out in this legislation. Section 21. Section 20 has an immediate effective date under AS 01.10.070(c) Section 22: Effective date is set to coincide with the Drug Supply Chain and Security Act that will go into effect on November 26, 2023. 4:13:37 PM ASHLEY SCHABER, Chair, Board of Pharmacy, gave a PowerPoint presentation, titled "House bill 112: Profession of Pharmacy" [hard copy included in the committee packet]. She explained the mission of the Board of Pharmacy and its guiding principles. On slide 2, she pointed out guiding principal 4, which addresses the issues that HB 112 would effect. She stated that it would help create a routine review of the effectiveness of regulations and reduce barriers to licensure, while not compromising patient health and safety, as seen under 4.1. She pointed out under 4.4, the proposed legislation would help in advocating for legislation for the pharmacy profession as it evolves and new opportunities for improvement patient safety arise. Pointing to 4.5, she stated that the proposed legislation would help anticipate changes to the Drug Supply Chain Security Act, allowing a proactive response. MS. SCHABER moved to slide 3, which addressed the background of HB 112. She stated that the proposed legislation is the result of a multi-year, multi-chair review of statutes and regulations to help ensure the Alaska Board of Pharmacy can continue to meet its mission. She listed what HB 112 would accomplish, as follows: streamline the licensure process while improving public safety; maintain compliance with DSCSA; help alignment the Pharmacy Board with other boards in Alaska and in other states; clarify the role of pharmacists in epinephrine access; and create a collaborative effort between the Alaska Board of Pharmacy and the Alaska Pharmacists Association 4:15:53 PM MS. SCHABER moved to slide 4 and discussed how the proposed legislation would streamline the licensure process while improving public safety. She stated that it would eliminate unnecessary forms currently required in statute, clarify that only pharmacists who dispense controlled substances are required to register with PDMP, and add national criminal background checks. MS. SCHABER moved to slide 5 and discussed how the proposed legislation would help with compliance with Drug Supply Chain and Security Act. She explained that 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, and pharmacy boards play a key role through appropriate licensing of drug distributors and pharmacies. She stated that HB 112 would ensure that the Alaska Board of Pharmacy powers and duties support the DSCSA. 4:18:53 PM MS. SCHABER moved to slide 6 and discussed how HB 112 would help align the Pharmacy Board with other boards in Alaska and in other states. It would do this by replacing one of the two public member seats with a pharmacy technician seat, allow the board to adopt language for retired pharmacist status, and clarify the executive administrator's salary, as this would allow a pharmacist to serve in this role in the future. MS. SCHABER moved to slide 7 and discussed how HB 112 would help the role of pharmacists in epinephrine access. She stated that an epinephrine training program would be implemented, and a clarification would be made which states a pharmacist can administer epinephrine to a person or prescribe epinephrine auto injectors to someone who has completed the training program. she added that this would increases epinephrine access for Alaskans with anaphylactic emergencies. 4:22:18 PM MS. SCHABER concluded the presentation by requesting the committee's support of HB 112, as this would allow for better public health, safety, and welfare of Alaskans by the effective control and regulation of the practice of pharmacy. 4:22:34 PM REPRESENTATIVE FIELDS questioned whether [people on the board] would have a financial interest in the healthcare industry. MS. SCHABER answered that it is in statute that a person who is a public member [of the board] would have no financial interest in the healthcare industry. She said that this person would bring a public consumer interest to the board. REPRESENTATIVE FIELDS questioned the current board member requirements. MS. SCHABER deferred the question to the [Division of Corporations, Business, and Professional Licensing]. She reiterated that this is in statute and added that the biggest change is a person having no financial interest. She said that a willingness to attend quarterly meetings and a commitment to the work is required. 4:24:14 PM REPRESENTATIVE RUFFRIDGE added that there are currently two public member positions on the board, with only one recently filled. He stated that it has been difficult to get public members to serve because of the time commitment, as well as low willingness of the public to serve on a board for a profession they might not know much about; therefore, HB 112 would change one of the public seats to a technician position. 4:25:06 PM REPRESENTATIVE FIELDS expressed appreciation for the idea. He questioned the board's role in supporting the training of pharmacy technicians. REPRESENTATIVE RUFFRIDGE responded that during his time serving on the Board of Pharmacy, this was an item of interest, and regulations were passed to add a certified pharmacy technician as an individual recognized in regulatory practice. For example, he explained that certified pharmacy technicians in Alaska currently have the ability to do final checks on prescriptions, if the prescription had a drug utilization review done by a pharmacist and administer vaccinations. He stressed that there is an effort in the industry to promote pharmacy technicians as being a "middle step." 4:26:54 PM REPRESENTATIVE SADDLER observed that if there are four pharmacists on the board right now, it would seem unnecessary to have the executive director be a pharmacist. He asked why the executive director is required to be a pharmacist. REPRESENTATIVE RUFFRIDGE stated that he is a previous member of the board and is a pharmacist and expressed the understanding that an executive administrator of the Board of Pharmacy performs many duties, and members are expected to have an in- depth understanding of the department's licensing duties. He pointed out that many licensing and professional questions are directed to the executive administrator. He added that in many states pharmacists serve in this role. MS. SCHABER added that the five pharmacists on the Alaska Board of Pharmacy are all volunteers and work full time and would not have the time to address questions. 4:30:21 PM REPRESENTATIVE MINA asked how out-of-state entities are being regulated. REPRESENTATIVE RUFFRIDGE answered that they are not being regulated. He explained that they are required to register in the state, but if the entity is dispensing or providing services in the state, the Board of Pharmacy has no option to protect or promote the safety and wellbeing of Alaska patients because the entities are not licensed. MS. SCHABER stated that HB 112 would give the board oversight. She explained that currently only a registration acknowledges out-of-state entities are providing services. She explained that if there was a safety concern regarding an out-of-state pharmacy, the board would have no oversight. In response to a follow-up question concerning the prevalence of out-of-state entities, she pointed out that mail-order pharmacies are an example, and some are considered compounding pharmacies that could provide either sterile or non-sterile compounds, medications, eye drops, and injections to patients in Alaska. 4:33:01 PM REPRESENTATIVE FIELDS asked how pharmacies are adapting to fentanyl being present in adulterated drugs. REPRESENTATIVE RUFFRIDGE answered that it is a very large concern. He explained that getting a clearer picture of what the drug supply chain looks like was one of the reasons why the Drug Supply Chain Act is at the federal level, as adulterated medications are often sent through Internet pharmacies. He said the proposed legislation would follow federal regulation. MS. SCHABER added that the proposed legislation would address giving the board oversight of Internet pharmacies. 4:35:33 PM REPRESENTATIVE FIELDS expressed concern that gaps in primary care could lead to expensive care for families. He asked if there are opportunities for the board to work with other primary healthcare providers in an effort to reduce such gaps. REPRESENTATIVE RUFFRIDGE responded that there would be a more detailed answer later, as there are opportunities for pharmacists to fill gaps in care. He explained that during the pandemic, pharmacies across the state had been able to fill roles that historically they had not. He relayed that there is a nationwide push for pharmacists to be given provider status, something HB 112 would not do; however, the state has taken steps to promote this ability. He alluded to a barrier in pharmacy businesses, causing many to close across the state and country. 4:38:53 PM REPRESENTATIVE SADDLER asked for the number of licensed pharmacists in Alaska. MS. SCHABER deferred the question to the division. She shared that there has been a challenge in ensuring that licenses are processed quickly. 4:40:42 PM SYLVAN ROBB, Director, Division of Corporations, Business, and Professional Licensing, Department of Commerce, Community, and Economic Development, answered that, as of today, there are 1,049 licensed pharmacists and 1,206 licensed pharmacy technicians. In response to a follow-up question, she expressed uncertainty about how many registered pharmacies are in the state. She offered to report back to the committee. 4:42:18 PM REPRESENTATIVE RUFFRIDGE thanked members for hearing the bill. He said that the hearing has been a good start in promoting changes that have been worked on for a long time. REPRESENTATIVE FIELDS acknowledged Representative Ruffridge's previous efforts. He suggested that some regulatory reforms around staffing could help address "pharmacy deserts" in the state. He asked if other reforms would bring more pharmacies to unserved places. REPRESENTATIVE RUFFRIDGE responded that pharmacies are closing because of the high-barrier entry, namely in payroll costs. He pointed out that some corporate pharmacies are reducing staff, even as the number of prescriptions is rising. He elaborated that many pharmacies operate as a net loss to large corporations because this margin is small. He suggested that this could be altered with the role pharmacy technicians play, as they could be more of a manager while pharmacists provide clinical oversight. He explained that tele-pharmacies allow a pharmacy to operate in an urban setting. For example, downtown Anchorage has three pharmacy technicians, as pharmacists are centrally located in a larger facility, and technology is used to remotely access the prescriptions. He explained that this option already has a statute to govern it, and this is something the board has changed to open the option now for pharmacy deserts; however, pharmacies in the state need to adopt this change. 4:46:35 PM CHAIR PRAX announced HB 112 was held over.