HB 323-EXTEND: BOARD OF PHARMACY  [Contains discussion of SB 37] [Contains discussion of HB 9]   3:16:58 PM CHAIR KITO announced that the first order of business would be HOUSE BILL NO. 323, "An Act extending the termination date of the Board of Pharmacy; and providing for an effective date." 3:17:24 PM REPRESENTATIVE COLLEEN SULLIVAN-LEONARD, Alaska State Legislature, presented HB 323 as prime sponsor. She paraphrased the sponsor statement, which reads as follows [original punctuation provided]: House Bill 323 extends the termination date for the Board of Pharmacy to June 30, 2022. Pursuant to A.S.?08.03.010( c)(16), this Board is scheduled to sunset on June 30th, 2018 if the legislature does not pass legislation extending it. Legislative Audit reviewed the Board's operations and determined that it is in the best interest of the state to extend this Board considering recent statutory changes that expand the Board's responsibilities in relation to the controlled substance prescription database. Therefore, recommendation is made to extend this Board for 4 years or through June 30, 2022. The Board of Pharmacy is composed of 7 members; 5 licensed pharmacists actively engaged in the practice of pharmacy in the State for a period of 3 years immediately preceding their appointments and 2 members of the public. The Board also regulates admission into the practice of pharmacy, establishes and enforces compliance with professional standards and adopts regulations. It also establishes and maintains a controlled substance prescription database and establishes standards for the independent administration by a pharmacist of vaccines, related emergency medications and opioid overdose drugs. The Board also oversees licensing for pharmacists, pharmacy interns, pharmacy technicians, pharmacies, wholesale drug distributors located inside the state, licenses drug rooms located inside institutional facilities and also registers pharmacies located outside of the State if a pharmacy ships, mails or delivers prescription drugs to consumers of that state. These regulations control various aspects of the field, including but not limited to controlling and regulating the practice of pharmacy in Alaska. A.S.?08.80.005 mandates that effective control and regulation is necessary to promote, preserve and protect the public's health, safety and welfare. 3:21:08 PM KRIS CURTIS, Legislative Auditor, Legislative Audit Division, Legislative Agencies and Offices, reported August 2017 sunset audit findings related to HB 323. She stated the board was licensing effectively and was conducting its meetings in accordance with the laws. She underlined the board was also amending regulations to improve the industry. She informed the board had 3,747 active licenses in March 2017 for a 33 percent increase in licensees since the previous audit in 2009. The board had a surplus of just over [$]275 thousand and management within DCBPL had communicated that it would be performing a fee analysis at the end of 2017. She explained the division recommended only a 4-year extension in recognition of recent statutory changes that expand the board's responsibilities in relation to the controlled substance prescription database (CSPD). MS. CURTIS described the 2008 bill [Senate Bill 196] establishing the database. She paraphrased the audit document, entitled "A Sunset Review of the Department of Commerce, Community, and Economic Development, Board of Pharmacy (board)" [included in committee packet], which reads as follows [original punctuation provided]: The statute requires each dispenser submit to the board, by electronic means, information regarding each prescription dispensed for a controlled substance. The database electronically collects information from in- state and out-of-state pharmacies as well as other dispensers of controlled substance prescriptions. The database allows pharmacists and practitioners to review prescription history prior to prescribing or dispensing a controlled substance. The database is also to be used to: • monitor prescribing practices and patterns of prescribing or dispensing; • identify practitioners who prescribe controlled substances in an unprofessional or unlawful manner; • identify individuals who may be abusing controlled substances; and • identify individuals who present forgeries or otherwise false or altered prescriptions to a pharmacy. 3:23:40 PM MS. CURTIS identified that there were many problems with the 2008 statute, including that it did not provide the ability to identify all dispensers that must submit information so DCBPL staff could not monitor completeness or identify which specific dispensers were not submitting the required information. She added that regulations required monthly reporting of information; however, monthly reporting was not effective for monitoring prescription practices. MS. CURTIS presented that the second issue with the 2008 legislation was that there was no requirement that a dispenser or practitioner check the database prior to dispensing, prescribing, or administering medication. She added that according to DCBPL staff, information in the database was not analyzed by the board and forwarded to practitioners or pharmacists because the Department of Law advised that the law did not allow the agency or board to provide unsolicited reports. MS. CURTIS described how the law had been changed so that currently pharmacists who dispense and practitioners who prescribe, administer, or dispense controlled substances are required to register with the database and the board must notify the applicable occupational boards when practitioners register with the database, thereby allowing a check for completeness and the ability to identify noncompliance. She underlined failure to register is grounds for disciplinary action and dispensers are required to report weekly and this requirement was subsequently changed to report daily. MS. CURTIS stated that access to the database was expanded to include dispensers, dispenser delegates, and other persons or entities with a valid business need and the board was authorized to provide unsolicited notification 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. She added unsolicited reports may also be issued to a practitioner's licensing board and new performance measures must be reported to the legislature annually including measures regarding the impact of the database. She stated dispensers and practitioners are now required to check the database prior to dispensing, prescribing, or administering medication, with specific exclusions. MS. CURTIS said the audit states that with the changes, the board was empowered to serve the public interest; however, DCBPL does not believe this board should be proactively analyzing the database as it is not traditionally the role of an occupational board. She added that DCCED had stated additional resources would be needed if the legislature intends for the board to analyze the data. 3:26:30 PM MS. CURTIS presented the two recommendations. She said the first recommendation was that DCBPL's chief investigator should work with the director to improve the timeliness of investigations, and the second was that DCBPL's director should improve procedures to ensure required licensure documentation is appropriately obtained and retained. MS. CURTIS informed the Office of the Governor agreed with the 4-year extension but had not commented on the database concerns; the department agreed with both recommendations and had indicated it had implemented new procedures to ensure timeliness of investigations and did state that additional resources would be required; and the board chair had agreed with both recommendations. 3:29:10 PM REPRESENTATIVE KNOPP asked when the previous audit had been carried out. MS. CURTIS answered the previous audit had been carried out in 2009. She pointed to a timeline in the audit document. She added there are new reporting requirements on the status of the database. REPRESENTATIVE KNOPP surmised it would be four years before the next report on the database. MS. CURTIS answered it would probably be in 2021. 3:30:44 PM REPRESENTATIVE BIRCH remarked pharmacies do not have a way to be compensated for their expertise and said he thought that in other places pharmacies could be paid for some level of medical support services. He asked whether it would be appropriate to solicit the board for recommendations for advancement of the pharmacy profession. MS. CURTIS answered the type of audit was unique in that the 11 criteria used were set out in statute. She added unless there are specific complaints heard at a board meeting or news article, other issues would not be addressed in the audit. 3:33:53 PM LEIF HOLM, Chair, Board of Pharmacy, Division of Corporations, Business and Professional Licensing (DCBPL), Department of Commerce, Community, and Economic Development (DCCED), testified in support of HB 323. He testified the board concurred with the 4-year board extension as it was understood that the board's duties were expanding further. REPRESENTATIVE BIRCH said he supported the bill proposal but had concerns regarding pharmacists receiving compensation for their expertise. He asked where the board chairman would turn to remedy the situation for pharmacists in the state. MR. HOLM answered it was a complicated question and underlined the board tries to stay away from matters of financial interest. He emphasized he does not speak as a board member when speaking to PBMs and auditing practices. He said he knows there is an active push for pharmacies to get provider status at the federal level to receive payment for their services. He stated the interest of the board is patient safety. 3:37:08 PM REPRESENTATIVE KNOPP spoke to the board's database responsibilities and asked how the board could maintain the database with no part- or full-time employees. MR. HOLM answered it had not been working well, and the board has not had the time or manpower. He added the board had been actively pursuing a bill to license out-of-state wholesalers in the state and had attached an executive administrator position but had not been able to get the bill passed. He added that with Senate Bill 74, the board was allowed to hire an administrator for the Prescription Drug Monitoring Program (PDMP) as well as a board assistant, but he surmised that the position would be solely focused on the PDMP. 3:39:10 PM CHAIR KITO spoke to concerns about implementing the PDMP and asked for Mr. Holm's thoughts regarding how the legislature could assist the board. MR. HOLM testified that since the board hired someone to work on the PDMP progress was being made. 3:41:05 PM CHAIR KITO opened public testimony on HB 323. 3:41:18 PM RICHARD HOLT, Vice Chair, Board of Pharmacy, Division of Corporations, Business and Professional Licensing (DCBPL), Department of Commerce, Community, and Economic Development (DCCED), testified in support of HB 323. He said he concurred with what Mr. Holm had stated in his testimony regarding the legislative audit. He mentioned other legislation would aid the board in its duties, such as SB 37 and HB 9. CHAIR KITO held over HB 323.