HB 306-EXTEND BOARD OF PHARMACY  2:46:30 PM CHAIR COSTELLO announced the consideration of HOUSE BILL NO. 306 "An Act extending the termination date of the Board of Pharmacy; and providing for an effective date." She noted that this was the first hearing and the intention was to hear the introduction, take invited and public testimony, and look to the will of the committee. 2:46:49 PM REPRESENTATIVE ANDI STORY, Alaska State Legislature, Juneau, Alaska, sponsor of HB 306, introduced the legislation paraphrasing the following sponsor statement: House Bill 306 extends the termination date of the Board of Pharmacy until June 30, 2028. The current sunset date is June 30, 2022. The first Alaska Board of Pharmacy was created in 1913. Those provisions were repealed in 1955 and a new board was enacted with many of the same functions. The Board of Pharmacy benefits Alaskans by regulating pharmacies, pharmacists, pharmacy technicians, and pharmacy interns, and ensuring the practice of pharmacy is done safely and within the bounds of state law. Allowing the board to terminate would not be in the best interest of the state. The Division of Legislative Audit (DLA) found in their 2021 audit of the Board of Pharmacy that the "board served the public's interest by effectively conducting its meetings and actively amending regulations; however, improvements over the board's licensing functions are needed." DLA recommended the extension of the board for six years to reflect "the need for more timely oversight of the board's evolving role in combating the public health opioid crisis." REPRESENTATIVE STORY relayed that the Board of Pharmacy has seven members, five of which must be licensed pharmacists who have been actively engaged in the practice of pharmacy in Alaska for three years immediately preceding their appointment. The remaining two positions are public members who must not have a direct financial investment in the health care industry. 2:48:53 PM REPRESENTATIVE STORY stated that the legislative auditor made five recommendations. CHAIR COSTELLO pointed out that the auditor was in the room and available to discuss the audit. REPRESENTATIVE STORY responded that she wanted to talk about the recommendations to improve the monitoring and enforcement of the Prescription Drug Monitoring Program (PDMP) because it was a topic during the House committee process. She explained that while the PDMP is housed in the Board of Pharmacy, it is just one of six licensing boards that is responsible for monitoring and enforcing the requirements related to the PDMP. REPRESENTATIVE STORY reported that the audit found that at the time of the audit only the Board of Pharmacy was effectively monitoring both registration and reporting to the PDMP. She assured the committee that steps were taken to improve compliance with the PDMP. The chairs of the six boards and division staff now meet twice monthly to discuss the ongoing efforts to improve the shortcomings in the program. She highlighted that the Department of Health intends to use federal opioid grant funds to hire a contractor to evaluate the suggested improvements to the PDMP, which will help the chairs of the six licensing boards. She said it's important to extend the Board of Pharmacy so it can continue to protect the health and safety of Alaska. CHAIR COSTELLO asked Kris Curtis to present the overview of the sunset audit for the Board of Pharmacy. 2:52:19 PM KRIS CURTIS, Legislative Auditor, Legislative Audit Division, Alaska State Legislature, Juneau, Alaska, stated that the audit concluded that the Board of Pharmacy was serving the public's interest by effectively conducting meetings and actively amending regulations, but improvements are needed in the licensing functions. The audit further concluded that the Division of Corporations, Business, and Professional Licensing (DCBPL) staff actively worked to implement the new requirements of the PDMP database. However, at the time of the audit the occupational boards were not enforcing or monitoring the requirement. The audit recommended a six year extension. This is two years less than the maximum extension, which is a reflection of the need for more timely oversight of the board's evolving role in helping the public combat the public health opioid crisis. 2:53:17 PM MS. CURTIS directed attention to Exhibit 4 on page 13 that shows that there were 4,280 active licenses. This includes both facility and individual licenses and reflects a 14 percent increase since the last sunset audit in 2017. The increase is due to three new facility license types. The board's schedule of revenues and expenditures on page 15 shows a surplus of nearly $800,000 as of January 2021. During the February meeting, the board discussed, but decided against, reducing licensing fees because it planned to add a new licensing examiner position. There was also concern that establishing a disciplinary matrix of all noncompliance with the controlled substance prescription database (CSPD) likely would result in increased investigation expenditures. The schedule of fees appears on page 14. MS. CURTIS stated that much of the audit was dedicated to evaluating the board's changing role in administering the CSPD. The sunset audit in 2017 concluded that changes in the laws governing the database would give the board a more active role in combating the misuse of controlled substances. That audit recommended just a four year extension to allow the legislature time to review the board's progress in administering the new laws. 2:54:56 PM MS. CURTIS reviewed the information in the audit about the controlled substance prescription database (CSPD). She paraphrased the first paragraph on page 5: Senate Bill 196, passed in 2008, required the Board of 3 Pharmacy (board) to establish and maintain a CSPD. The law was passed with the intent to improve patient care and foster the goal of reducing misuse, abuse, and diversion of controlled substances. The statute requires each dispenser submit to the board, by electronic means, information regarding each prescription dispensed for a controlled substance. The CSPD electronically collects information from in-state pharmacies, as well as other dispensers of controlled substance prescriptions. MS. CURTIS advised that it soon became clear that the 2008 legislation lacked important authority that prevented the CSPD from meeting its intent. The law was significantly amended in 2017 and 2018 and those changes affected how the board administers the database. 2:55:56 PM MS. CURTIS turned to the report conclusions that begin on page 16. The changes to the database included that licensees from the six occupational boards that dispense controlled substances are required to register with the CSPD. Regulations were updated to require daily reporting of prescription data, and review is required. In general, the audit concluded that the changes made the database more capable of combatting opioid abuse. Implementing the laws requires the coordination of six occupational boards. The Board of Pharmacy administers the database and provides information to the other occupational boards, but each board is required to enforce and monitor the requirements for their respective licensees. As of January 2021, each board had started implementing the requirements, but none were fully enforcing the requirements. Exhibit 7 on page 17 summarizes the progress each board had made to monitor the requirement to register and report to the database. Only the Board of Pharmacy was monitoring compliance with both the registration and reporting requirements. Regarding reviewing the database prior to dispensing, prescribing, and administering controlled substances, the audit concluded that none of the boards were monitoring individual licensee compliance with this requirement. The Board of Pharmacy Prescription Drug Monitoring Program (PDMP) coordinator does provide summary information regarding the percent of the prescribers checking the database for the respective boards but the summary does not show individual licensee compliance. MS. CURTIS directed attention to Exhibit 8 on page 18 that shows that according to a 2021 legislative report of the Alaska Prescription Drug Monitoring Program, a majority of practitioners were not checking the CSPD. The audit also found that enforcement was limited by inadequate enforcement matrices, which guide a board's resolution of cases. Board disciplinary matrices did not cover noncompliance with the CSPD requirements during the audit period. Exhibit 9 on page 20 summarizes the status of the disciplinary matrices as of January 31, 2021. Several board matrices covered the failure to register, but not failure to report to the board or failure to review the database. 2:58:49 PM MS. CURTIS reviewed the provision of unsolicited reports, paraphrasing the text on pages 20-21: Statutes authorize the Board of Pharmacy to provide unsolicited notifications to a pharmacist or practitioner if a patient has received one or more prescriptions for controlled substances inconsistent with generally recognized standards of safe practice. The term "generally recognized standards of safe practice" must be defined by the respective boards. At the time of the audit, the standards had not been fully defined. Only two of the applicable boards set prescription limitations in regulation. The State Medical Board set a limitation of 50 morphine milligram equivalents (MME) for initial opioid prescriptions only and the Board of Dental Examiners set a limitation of 60 MME. (See Recommendation 3) The Board of Pharmacy may, but is not required to, send patient-specific utilization notifications to pharmacists and practitioners. Instead of sending patient-specific notifications, the PDMP coordinator provided summary data to applicable occupational boards as part of standard board reports and to practitioners as part of prescriber report cards. The following three metrics, referred to as "clinical alerts," were provided: 1. Number of patients treated with over 90 and 120 MME; 2. Number of patients treated with dangerous combinations; and 3. Number of patients who received controlled substances from five prescribers, at five pharmacies, over a three month period. The process of sending board reports evolved during the audit period. Not all boards were sent reports on a routine basis and not all board reports included the three metrics. Exhibit 10 on page 21 that summarizes the number of board reports issued during the audit period and the number of reports that included one or more of the three clinical alert metrics. 3:00:42 PM MS. CURTIS described the prescriber report cards, paraphrasing the text on page 22: Beginning FY 18, CSPD information, referred to as Prescriber Report Cards, was provided to prescribing practitioners. The report cards were intended to give practitioners the ability to review their prescribing activity and compare the activity to other practitioners within the same occupation and within a specific specialty. Quarterly report cards included: • the three clinical alerts; • the prescriber's current prescribing controlled substance volumes and duration, including comparison to peers; • the top three prescribed controlled substances; and • the number of patients searched in the CSPD. Exhibit 11 illustrates the number of practitioners who received a prescriber report card by occupational board. MS. CURTIS moved to the findings and recommendations starting on page 25: Recommendation No. 1: The board chair and DCBPL's director should improve procedures and training to ensure applicants meet requirements prior to licensure. MS. CURTIS said the audit found that 20 percent of the 25 facility licenses it tested did not include required regulatory documentation. By statute, a board may deny a license if an applicant has been convicted of a crime or has acted in a way that does not conform to professional standards. To help evaluate an applicant's professional fitness, the application asks a series of questions. Division policy is that a supervisor must review and approve applications of applicants who answered "yes" to the professional fitness questions. This usually involves referral to the board's investigative section for follow up. Three facility applicants answered "yes" to professional fitness questions, but there was no evidence that a supervisor either reviewed or referred the application to the investigative arm for follow up prior to the issuance of the license. DCBOL management attributed the facility license errors to turnover in the licensing examiner position, a lack of training, and human error. 3:03:08 PM Recommendation No. 2: The board should adopt regulations for renewing outsourcing facilities and third-party logistics provider licenses. MS. CURTIS explained that the renewal regulations weren't changed to reflect the addition when these two new facility license types were added, so the fix shouldn't be difficult. Recommendation No. 3: Applicable occupational boards and DCBPL's director should continue to coordinate efforts to improve the monitoring and enforcement of CSPD requirements. Recommendation No. 4: The Department of Commerce, Community, and Economic Development's (DCCED) commissioner should allocate sufficient resources to ensure licensees holding a Drug Enforcement Administration (DEA) registration number are consistently recorded in DCBPL's licensing database. MS. CURTIS explained that this is important to ensure the ability to electronically monitor the requirement to register with the CSPD. Recommendation No. 5: DCCED's commissioner should allocate sufficient resources to ensure the CSPD requirements are enforced. MS. CURTIS noted that the audit found that cases weren't investigated because of insufficient resources. 3:04:13 PM MS. CURTIS directed attention to management's response to the audit on page 47. The DCCED commissioner generally agreed with the conclusions and recommendations and reported that corrective action was taken to address several of the deficiencies. She indicated that training had been provided and procedures instituted regarding recording the DEA number in the licensing database. The response from the Board of Pharmacy is on page 51. The board chair agreed with the recommendations and said the board had taken action to address the regulatory deficiency and forwarded the suggested regulations to DCBPL. The chair also stated that being able to use the controlled substance prescription database to identify issues, promote better prescribing practices, and investigate those who fall outside guidelines requires people and process, both of which are in short supply. The chair stated that the board will continue to request resources be dedicated to the database to combat opioid abuse. CHAIR COSTELLO asked Board of Pharmacy chair Justin Ruffridge to comment on the audit. 3:05:44 PM JUSTIN RUFFRIDGE, Chair, State Board of Pharmacy, Department of Commerce, Community and Economic Development (DCCED), Soldotna, Alaska, stated that he agreed with the audit findings, many of which had been addressed. Processes and people were a work in progress, but the division was working hard to find and train personnel. Since the 2017 audit the board has been working to overhaul outdated regulations and that package had been delivered to the regulatory specialists for processing. He reported that the board worked through the pandemic to ensure that licensing was accessible, that there was emergency access to medications, and that patients had access to care. The board has also continued to serve the public by restarting onsite inspections, reducing license fees, and working on regulations to support changes in the field of pharmacy. MR. RUFFRIDGE stated that he was proud of the work the Board of Pharmacy had done the last few years and he fully supports the suggested board extension. CHAIR COSTELLO asked if he had found the Division of Corporations, Business, and Professional Licensing to be responsive to the board's needs. MR. RUFFRIDGE replied that the division is working hard and it tries to be responsive but it is plagued by budgetary constraints and hiring difficulties, so the response is slow. CHAIR COSTELLO expressed appreciation for the candor. 3:08:51 PM CHAIR COSTELLO opened public testimony on HB 306. 3:09:08 PM RENEE ROBINSON, President, Alaska Pharmaceutical Association, Anchorage, Alaska, stated that she had been a practicing pharmacist in the state for more than 14 years and she supported HB 306 to extend the Board of Pharmacy. She opined that the board had done an excellent job the last couple of years to make significant changes in the profession. She urged the committee to support HB 306 to keep the board from sunsetting for the next six years. 3:09:57 PM CHAIR COSTELLO closed public testimony on HB 306. She found no questions and solicited a motion. 3:10:04 PM SENATOR STEVENS moved to report HB 306, work order 32-LS1434\A, from committee with individual recommendations and attached fiscal note(s). CHAIR COSTELLO found no objection and HB 306 was reported from the Senate Labor and Commerce Standing Committee.