Legislature(2021 - 2022)BELTZ 105 (TSBldg)
05/02/2022 01:30 PM Senate LABOR & COMMERCE
Note: the audio ![]()
and video ![]()
recordings are distinct records and are obtained from different sources. As such there may be key differences between the two. The audio recordings are captured by our records offices as the official record of the meeting and will have more accurate timestamps. Use the icons to switch between them.
| Audio | Topic |
|---|---|
| Start | |
| Confirmation Hearing(s) | |
| HB265 | |
| HB306 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | TELECONFERENCED | ||
| *+ | HB 265 | TELECONFERENCED | |
| *+ | HB 306 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
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 Those provisions were repealed in 1955 and a new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.
| Document Name | Date/Time | Subjects |
|---|---|---|
| Jody Miller Application_Redacted.pdf |
SL&C 5/2/2022 1:30:00 PM |
GOVERNOR'S APPOINTEES |
| Hannah St. George Application_Redacted.pdf |
SL&C 5/2/2022 1:30:00 PM |
GOVERNOR'S APPOINTEES |
| HB 265 v. E.PDF |
SL&C 5/2/2022 1:30:00 PM |
HB 265 |
| HB 265 Sponsor Statement v. E.pdf |
SFIN 5/12/2022 1:00:00 PM SL&C 5/2/2022 1:30:00 PM |
HB 265 |
| HB 265 Sectional Analysis v. E.pdf |
SFIN 5/12/2022 1:00:00 PM SL&C 5/2/2022 1:30:00 PM |
HB 265 |
| HB 265 Explanation of Changes v. W to v. E.pdf |
SFIN 5/12/2022 1:00:00 PM SL&C 5/2/2022 1:30:00 PM |
HB 265 |
| HB 265 Presentation 04.28.22.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 265 |
| HB 265 Testimony Received as of 04.28.22.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 265 |
| HB 306 v. A.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 306 |
| HB 306 Sponsor Statement.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 306 |
| HB 306 Sectional Analysis v. A.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 306 |
| HB 306 Legislative Audit Division Sunset Review BOP 7.15.21.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 306 |
| HB 306 Letters of Support received as of 2.25.22.pdf |
SL&C 5/2/2022 1:30:00 PM |
HB 306 |
| HB 306 Fiscal Note 2360 - DCCED.PDF |
SL&C 5/2/2022 1:30:00 PM |
HB 306 |