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, paraphrased the sponsor statement [included in 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, read the sectional analysis for HB 112, 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 2 (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 3 (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, began the PowerPoint presentation titled, "House bill 112: Profession of Pharmacy" [hardcover included in committee packet] on slide. She explained the mission of the Board of Pharmacy, and that HB 112 touches on goal 4.1 [shown under "strategies on slide 2] relating to regulation and enforcement, which read as follows [original punctuation provided]: Routinely review effectiveness of regulations that reduce barriers to licensure without compromising patient health and safety. MS. SCHABER also pointed to 4.4, which read as follows [original punctuation provided]: Advocate for legislation as the pharmacy profession evolves and new opportunities for improvement patient safety arise. MS. SCHABER further referenced the goal list, pointing to 4.5, which read as follows [original punctuation provided]: Anticipate changes to the Drug Supply Chain Security Act and respond proactively. MS. SCHABER read slide 3, which read as follows [original punctuation provided]: Background of HB 112 •Result of multi year, multi chair review of statutes and regulations to ensure the Alaska Board of Pharmacy can continue to meet its mission •HB 112 addresses changes by: •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 •Collaborative effort between the Alaska Board of Pharmacy and the Alaska Pharmacists Association 4:15:53 PM MS. SCHABER moved to slide 4, which read as follows [original punctuation provided]: Goal: Streamline licensure process while improving public safety •Eliminates unnecessary forms currently required in statute •Clarifies that only pharmacists who dispense controlled substances are required to register with the Prescription Drug Monitoring Program (PDMP) •Adds national criminal background check MS. SCHABER read slide 5, which read as follows [original punctuation provided]: Goal: Compliance with Drug Supply Chain and Security Act •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 •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 4:18:53 PM MS. SCHABER directed attention to slide 6, which read as follows [original punctuation provided]: Goal: Alignment •Replaces one of the two public member seats with a pharmacy technician seat •Allows the board to adopt language for retired pharmacist status •Clarifies the board executive administrator's salary, allowing flexibility for a pharmacist to serve in this role in the future MS. SCHABER showed slide 7, which read as follows [original punctuation provided]: Goal: Epinephrine Access •Adds epinephrine training program under Board of Pharmacy Oversight •Clarifies that a pharmacist can administer epinephrine to a person or prescribe epinephrine auto injectors to someone who has completed the training program •Increases epinephrine access for Alaskans with anaphylactic emergencies 4:22:18 PM MS. SCHABER concluded the presentation on slide 8, which read as follows [original punctuation provided]: Support •The Board of Pharmacy respectfully requests your support of HB 112, allowing us to further promote , preserve, and protect the public health, safety, and welfare of Alaskans by and through the effective control and regulation of the practice of pharmacy. •Thank you for your time! 4:22:34 PM REPRESENTATIVE FIELDS inquired as to what type of person is considered as someone that has a financial interest in the healthcare industry. MS. SCHABER answered that it is in statute, which is that it is a person that is a public member that has no financial interest in the healthcare industry. She said that such a person brings a public consumer interest to the board. REPRESENTATIVE FIELDS asked what the current board member requirements are, other than just being a member of the public. MS. SCHABER deferred the question to the division. She mentioned statute and said that no financial interest is the biggest change. She said that a willingness to attend quarterly meetings and a commitment to the work involved 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 due to the time commitment requirement, as well as low willingness from a member of the public to serve on a board for a profession they may not know much about; therefore, HB 112 would change one of the public seats to a technician position. 4:25:06 PM REPRESENTATIVE FIELDS commented that he likes the idea. He asked what Representative Ruffridge sees as the role of the board in supporting training for pharmacy technicians. REPRESENTATIVE RUFFRIDGE responded that, during his time serving on the Board of Pharmacy, that was an item of interest, and that regulations were passed to add a certified pharmacy technician as a specific individual recognized in regulatory practice. 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, as examples. 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 wouldn't seem necessary to have the executive director be a pharmacist. He asked why the executive director is required to be a pharmacist. REPRESENTATIVE RUFFRIDGE responded that, in his time as previous member of the Board of Pharmacy, as well as a pharmacist, there is a lot of work to be an executive administrator of the Board of Pharmacy, and members are expected to have a deep-level understanding of what the department does for licensing. He said that many licensing and professional questions are directed to the executive administrator, and there would be a disconnect if they had knowledge of the pharmacy profession since they would have to go to the board to answer every question. He added that a pharmacist serving in the role is current practice in many states. 4:29:23 PM MS. SCHABER added that the five pharmacists on the board are all volunteers and work full time, so they don't have the time to address the questions. 4:30:21 PM REPRESENTATIVE MINA asked how out-of-state entities are being regulated currently. REPRESENTATIVE RUFFRIDGE answered that they are not. He explained that they are required to register in the state, but the Board of Pharmacy if the entity is dispensing or providing services into the state has no option to protect or promote the safety and wellbeing of Alaska patients because the entities are not licensed. 4:31:17 PM MS. SCHABER elaborated that the change in HB 112 gives the board oversight. She explained that currently it is only a registration that acknowledges that they are providing services. She explained that if there was a safety concern regarding the out of state pharmacy, the board has no oversight. 4:32:11 PM REPRESENTATIVE MINA asked how prevalent out-of-state entities are and what kinds of businesses they are. MS. SCHABER pointed to mail-order pharmacies as an example, and that some of the out-of-state pharmacies are considered compounding pharmacies that provide either sterile or non- sterile compounds, medications, eye drops, and injections to patients in Alaska. 4:33:01 PM REPRESENTATIVE FIELDS asked about fentanyl being present in adulterated drugs, and how pharmacies are adapting to this. REPRESENTATIVE RUFFRIDGE answered that it is a very large concern and has always been a concern since fentanyl is one type of the adulterated/counterfeit medications that's been seen. 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 being sent to Alaska often through Internet pharmacies. He said the bill contains changes to comply with requirements within federal regulation. 4:35:00 PM MS. SCHABER added that the bill does address giving the board oversight of Internet pharmacies, and that access to naloxone is important. 4:35:33 PM REPRESENTATIVE FIELDS shared that he is a parent, and that when his kids get sick, it makes him think about how gaps in primary care could lead to expensive care. He asked if there are opportunities for the board to work with other primary healthcare providers in an effort to reduce such gaps. 4:36:22 PM REPRESENTATIVE RUFFRIDGE responded that there will be a more detailed answer from him later; there is an extensive number of opportunities for pharmacists to fill gaps in care. During the pandemic, pharmacies across the state filled in roles that they did not historically provide. He relayed that there is a nationwide push for pharmacists to be given provider status, something HB 112 does not do, but the state has taken steps to promote the ability of pharmacists to take such steps. He said there is a barrier in the fact that pharmacies are a difficult business to be in, with many across the state and country closing because there are many challenges. 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 ROB, 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. 4:41:10 PM REPRESENTATIVE SUMNER asked how many registered pharmacies there are. 4:41:33 PM MS. ROB answered that she doesn't know how many but would get that information to the committee. 4:42:18 PM REPRESENTATIVE RUFFRIDGE thanked members for hearing the bill. He said the hearing has been a good start in promoting changes that have been worked on for a long time. He shared that the chair before him would be proud that members are finally bringing to bear a process they started a number of years ago. 4:43:26 PM REPRESENTATIVE FIELDS shared that Representative Ruffridge had previously shared that some regulatory reforms around staffing could help address "pharmacy deserts" in the state. He asked if there are other reforms to be thinking about to help bring more pharmacies to places that are unserved. REPRESENTATIVE RUFFRIDGE responded that pharmacies closing is due to the high barrier entry, namely in payroll costs. He pointed out that some corporate pharmacies are going through staff reduction, even while the numbers of prescriptions being dispensed go up. He elaborated that a lot of pharmacies operate as a net loss to large corporations because there is a small margin; a big component in altering that is the role of pharmacy technicians becoming more of a manager while pharmacists act more as clinical oversight for a pharmacy. He explained that tele-pharmacies allow a pharmacy to operate in an urban setting; downtown Anchorage, as an example, has three pharmacy technicians with the pharmacists being more centrally located in a larger facility and using technology to remotely access the prescriptions that are being dispensed. He explained that this is an option that already has statute to govern it, and a barrier to it was changing regulations related to the pharmacy technician's capacity, something the board has changed, which opens the option now for pharmacy deserts. 4:46:35 PM CHAIR PRAX announced HB 112 was held over.