Legislature(2023 - 2024)SENATE FINANCE 532
05/03/2023 01:30 PM Senate FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| SB94 | |
| SB122 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 94 | TELECONFERENCED | |
| += | SB 122 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | SB 53 | TELECONFERENCED | |
SENATE BILL NO. 94
"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."
1:35:34 PM
SENATOR CATHY GIESSEL, SPONSOR, explained that the bill was
related to the profession of pharmacy and the Board of
Pharmacy. She reminded that the goal of regulatory boards
was to protect the public. She relayed that the bill
proposed to update outdated statutes related to the
profession of pharmacy. She highlighted that the bill was a
multi-year collaboration between multiple board iterations
and multiple chairs of the Board of Pharmacy, working along
with the Alaska Pharmacists Association, students,
retirees, and the Alaska Tribal Health Organization. She
cited a great deal of change in the practice of pharmacy
over the previous 20 years. She described that during the
Covid-19 pandemic, pharmacists had played a critical role
in healthcare delivery and filling service gaps.
Senator Giessel relayed that SB 94 covered statute areas
including the boards composition; the prescribing of
epinephrine auto-injectors (epi-pens); and the licensing
and inspection of out-of-state pharmacies, internet
pharmacies, wholesalers and distribution centers. The bill
clarified board powers, added a national background check
for pharmacists and pharmacy technicians, and repealed
obsolete language from the statutes. She noted that her
staff would identify the changes to the bill made in the
Senate Labor and Commerce Committee. She discussed
additional invited testimony.
Co-Chair Olson asked about Senator Giessels reference to
epi-pens.
Senator Giessel clarified that the bill would allow a
pharmacist to prescribe the epi-pen.
Co-Chair Olson asked if pharmacists would be able to
dispense epi-pens.
Senator Giessel answered affirmatively and noted that there
would be a required education program prior to
authorization.
1:38:29 PM
JANE CONWAY, STAFF, SENATOR CATHY GIESSEL, addressed a
Sectional Analysis document (copy on file):
Section 1. Amends AS 08.80.010(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
to be an individual with no financial interest in the
healthcare industry.
Section 2. Amends AS 08.80.030(b) 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 list of entities to
be licensed and inspected.
(b)(17) Adds internet-based pharmacies to list of
entities to be licensed if they are servicing
Alaskans.
(b)(18) adds language allowing the board to adopt
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(h) Licensing of
facilities (7)(A) allows the direct shipping of
dialysate and supplies from a wholesale drug
distributor to home dialysis patients that are FDA-
approved and meet the guidelines to do so set out by
the AK Board of Pharmacy.
Section 5. Amends AS 08.80.157 Licensing and
inspection of facilities outside the state (k) this
adds out-of-state pharmacies and manufacturers to the
list of entities that must be licensed.
Section 6. 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.
Section 7. Amends AS 08.80.159 Licensing and
inspection of facilities outside the state (c) adds
pharmacies and manufacturers to list of those required
to be inspected to gain Alaska licensure.
Section 8. Amends AS 08.80.160 Fees (10) Removes the
word "registration" since the bill mandates licensure
of a facility.
Section 9. 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 an epinephrine auto-injector to
someone who has completed the epinephrine auto-
injector training.
1:42:08 PM
Ms. Conway continued to address the Sectional Analysis:
Section 10. 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 11. 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 12. 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 13. 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 autoinjector, and to
administer epinephrine shot 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 14. 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 15. 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 16. 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 17. 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 18. Amends AS 17.22.090 Definitions (3)
defines the "board" as the Board of Pharmacy
Section 19. Repealers
• Repeals 08.80.110(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, dentistry, 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 20. 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 21. TRANSITION: REGULATIONS Allows the Board
of Pharmacy and DCCED to adopt regulations to carry
out the changes laid out in this legislation.
Section 22. Sections 4 and 21 an immediate effective
date under AS 01.10.070(c)
Section 23: Effective date is set to coincide with the
Drug Supply Chain and Security Act that will go into
effect on November 26, 2023.
Senator Wilson referenced Section 2, page 3, line 21
relating to adopting regulations regarding retired
pharmacist status. He asked if the provision was intended
for retired pharmacists to be able to return to work. He
asked for more details.
Ms. Conway relayed that currently if a pharmacist retired,
the license lagged, while other professions typically had a
designated retirement status that provided more dignity,
importance, and recognition in the profession.
Co-Chair Olson asked if the retired pharmacists Drug
Enforcement Agency (DEA) number automatically expired.
Senator Giessel suggested that invited testimony could
address Co-Chair Olson's question.
1:48:26 PM
REPRESENTATIVE JUSTIN RUFFRIDGE, shared that he was the
previous chair of the Board of Pharmacy and had worked on
the bill in that role. He affirmed that the bill was a
multi-year effort for multiple boards and multiple chairs
of the board. He thought it was important to know that the
board chair had worked on right touch regulations at the
request of the governor to update and modernize the
regulatory framework across all boards and commissions. He
asserted that the board had taken the charge very seriously
and had found that there were items that could not be
changed without legislative action. He supported the bill.
Co-Chair Olson referenced working in Barrow and mentioned
that the pharmacist there had been working on the
legislation. He asked about retired pharmacists and the
expiration of DEA numbers. He asked about the necessary
steps for a pharmacist to come out of retirement.
Representative Ruffridge explained that pharmacists were
not allowed to hold a DEA registration, and a change of the
practice had been considered at the federal and state
level. He mentioned pharmacists being a part of medication-
assisted treatment for opioid addiction, which would
require a DEA number. The topic would not be outlined in
the bill.
1:51:28 PM
Co-Chair Olson understood there was a school of pharmacy
that was out of state but had a facility in Alaska. He
asked about an internship, and whether it was mandatory.
Representative Ruffridge was excited about the opportunity
for kids in the state to be educated as doctors in
pharmacy, and he thought that the program was the only
doctorate level medical degree that could be obtained in
the state. He cited that the program was a joint and
collaborative effort between the University of Alaska and
Idaho State University (ISU). He described modern
technology and distance delivery methods to have classes at
the University of Alaska Anchorage (UAA) and at ISU.
Representative Ruffridge described that the education
profile for pharmacy education was a four-year
undergraduate degree usually in science, and an additional
four years for a doctoral degree. During the four years,
students were allowed to work as a licensed pharmacy intern
in order to gain experience. A number of intern hours were
required to qualify for licensure and sit for the exam.
Alaska required 1,500 hours, and the number differed by
state. He continued that at the end of four years of
schooling, a pharmacy student could enter a one- or two-
year residency program in specialized pharmacy practice. He
estimated that it could be from 8 to 10 years to become
licensed, depending upon the specialty.
1:53:54 PM
Co-Chair Olson referenced Section 13 and training of
pharmacists to dispense epi-pens. He mentioned detrimental
effects of mis-application of epinephrine, and asked about
the required training. He mentioned the danger of
anaphylactic shock.
Representative Ruffridge relayed that the ability to
provide epinephrine in the case of anaphylaxis had always
been a pharmacy statute as part of pharmacists ability to
prescribe and give vaccinations. Pharmacists were permitted
to administer epinephrine in the case of anaphylaxis due to
a vaccination. He explained that the training referenced in
Section 13 of the bill referenced a program that already
existed in the state. The bill proposed to move the
training program from the Department of Health to under the
purview of the Board of Pharmacy. The training would be
open to the public and would provide a certificate after
one day, after which a person could be provided
epinephrine. He listed individuals such as camp counselors
and flight attendants as examples of people who might need
access to epi-pens.
Co-Chair Olson asked about the difference in training for
epinephrine and the training for naloxone.
Representative Ruffridge relayed that the model for
language in the bill was the same that was already in place
for naloxone.
1:57:05 PM
ASHLEY SCHABER, CHAIR, BOARD OF PHARMACY (via
teleconference), relayed that she became the chair of the
pharmacy board in December and had served on the board for
almost two years. She had practiced as a pharmacist in the
state for almost 16 years.
Ms. Schaber discussed a presentation entitled "Senate Bill
94: Profession of Pharmacy" (copy on file). She turned to
slide 2, which showed the Alaska Board of Pharmacy 2023
Strategic Plan. She read the mission of the Board of
Pharmacy. She highlighted that the bill had been in the
works for several years and cited goal 4 - to grow the
economy while promoting community health and safety. She
highlighted strategies listed under the strategic plan
including to routinely review effectiveness of regulations
that reduce barriers to licensure, advocating for
legislation, and anticipating changes relating to the Drug
Supply and Security Act. She reviewed board membership
positions.
Ms. Schaber advanced to slide 3, "Background of SB 94":
•Result of multi-year, multi-chair review of statutes
and regulations to ensure the Alaska Board of Pharmacy
can continue to meet its mission
•SB 94 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
Ms. Schaber referenced important access to critically
needed dialysis fluids.
1:59:44 PM
Ms. Schaber referenced slide 4, "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 mentioned moral affidavit forms in reference to
eliminating unnecessary forms. She discussed the addition
of the national background check, which was thought to be
an added measure of protection for Alaskans through the
licensure process and was in line with 30 other states.
Co-Chair Olson referenced Ms. Schabers mention of dialysis
fluids. He asked if the bill contemplated the shipping of
dialysis fluid to rural Alaska.
Ms. Schaber relayed that the changes to SB 94 addressed
some of the current statutory barriers to providing home
dialysis. It had been identified that there were some
changes that could eliminate the requirement for facilities
distributing the fluid to be registered as a pharmacy. The
board reviewed the changes and felt like the proposed
changes were a good balance to ensure there were no
barriers to provide service to all areas of the state while
maintaining the integrity of the process.
Co-Chair Olson asked if the proposed change only
encompassed peritoneal dialysis.
Ms. Schaber answered affirmatively.
Co-Chair Olson asked about hemodialysis.
Ms. Schaber understood that only the peritoneal dialysis
fluids for home dialysis would be impacted by the proposed
change.
2:03:23 PM
Ms. Schaber spoke to slide 5, "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
•SB 94 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
Ms. Schaber noted that when considering the statute change,
there had been very few mail-order pharmacies that were
shipping into the state, but the number had exponentially
grown in recent years. The change from registration to
licensure would give the board jurisdiction. She mentioned
that concern had been raised that patients were not
receiving the same medication counseling from mail-order
pharmacies as they would from an in-state pharmacy.
Ms. Schaber addressed slide 6, "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
larifies the board executive administrator's salary,
allowing flexibility for a pharmacist to serve in this
role in the future
Ms. Schaber relayed that the proposed change to board seats
would modernize the board. She discussed the language for
retired pharmacist status. She discussed the complexity of
pharmacy and regulation.
2:08:33 PM
Co-Chair Olson asked how many pharmacists were in the
state.
Ms. Schaber did not have the information at hand.
Co-Chair Olson asked Ms. Schaber to address the difference
between a pharmacist and a pharmacy technician.
Ms. Schaber explained that a pharmacist would go through
professional pharmacy school as Representative Ruffridge
had described. She continued that a pharmacy technician was
a licensed individual in the state that helped a pharmacist
within a pharmacy practice. She noted that pharmacy
technicians could have multiple different roles that
included inventory, ordering medications, working through
drug shortages, medication histories, and providing
immunizations. She noted that the role of pharmacy
technicians had grown in previous years.
Co-Chair Olson summarized that the bill did not propose to
increase membership on the board, but rather replaced a
public member seat with a pharmacy technician member.
Ms. Schaber answered in the affirmative and noted that the
bill proposed to replace one of the two public member seats
on the board. She explained that up until about one month
previously, both of the public member seats had been
vacant. She continued that historically the public member
seats had been challenging to fill, and she thought the
change would help fill the membership as well as bring the
technician perspective to the board.
2:10:52 PM
Ms. Schaber spoke to slide 7, "Goal: Epinephrine Access":
•Moves 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
Ms. Schaber commented that access to epinephrine was
peculiarly important in rural areas, where access to higher
level care might be more challenging. She spoke to the
access to dialysis fluids, which was in line with the goal
of increasing access. She mentioned the process of changes
to the CS and discussed patients receiving dialysis at
home.
Ms. Schaber highlighted slide 8, "Support":
•The Board of Pharmacy respectfully requests your
support of SB 94, 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!
Ms. Schaber thanked the committee for its time.
2:13:43 PM
BRANDY SEIGNEMARTIN, EXECUTIVE DIRECTOR, ALASKA PHARMACISTS
ASSOCIATION, testified in support of the bill. She was a
licensed pharmacist and was there to speak on behalf of the
Alaska Pharmacists Association. She asserted that some of
the provisions of greatest concern were related to patient
safety. She mentioned the proposed background checks for
all licensees coming into the state, which she thought
would protect Alaskans. She pointed out that licensing out-
of-state pharmacies, internet pharmacies, and other
entities would give the board direct oversight if
medication errors occurred. She mentioned that the drug
supply chain had been a target of attacks by criminals, and
without strong protections Alaskans could be at risk for
unsafe or counterfeit medications. She considered that by
giving full authority to the board to regulate the
entities, protections would be strengthened.
Ms. Seignemartin discussed epinephrine auto-injectors and
the ability of pharmacists to dispense them to qualified
individuals. She thought Representative Ruffridge had done
a good job in describing the training and requirements. She
discussed the importance of access to epi-pens in certain
circumstances and the importance of the drug in live-saving
care. She expressed appreciation for the change in allowing
a pharmacist to serve as the executive administrator of the
board, and adding a pharmacy technician to a seat on the
board. She mentioned and supported provisions related to
retired pharmacists.
2:17:43 PM
Co-Chair Olson OPENED public testimony.
2:17:48 PM
BARRY CHRISTIANSEN, CHAIR, ALASKA PHARMACISTS ASSOCIATION
(via teleconference), testified in support of the bill. He
relayed that he had been a practicing pharmacist for 35
years. He recognized that the bill represented years of
work by previous boards. He cited that there were currently
1,000 licensed pharmacists in the state.
Co-Chair Olson asked how many pharmacy technicians were
licensed in the state.
Mr. Christiansen estimated that there were perhaps four to
five times the number of technicians than pharmacists. He
offered to follow up with more information.
Co-Chair Olson asked what kind of improvements or additions
to the bill would create additional benefits to the end
user, including people in remote areas with limited access.
Mr. Christiansen thought the bill helped to modernize
pharmacies. He cited that there were a dozen graduates in
pharmacy per year in Anchorage. He thought having a modern
statute base with provisions like the epinephrine
prescribing program was important for getting pharmacists
where they were needed. He did not have additional ideas to
offer.
2:20:58 PM
DESIREE MOLINA, SELF, PALMER (via teleconference), spoke in
support of SB 94. She relayed that she was a fourth year
student in the UAA/ISU Doctor of Pharmacy program and a
recent graduate of a masters of business administration
program. She was employed as a pharmacist intern and was an
executive intern for the Alaska Pharmacists Association.
She thought the bill created efficiencies in licensing and
increased public safety. She planned to continue practicing
in Alaska after graduation. She supported increased access
to epinephrine.
2:23:12 PM
VINCE HANKS, BAXTER HEALTH CARE, ILLINOIS (via
teleconference), spoke in support of the bill and was
available for questions. He thought the bill was important
for all aspects of pharmacy in Alaska. He supported the
testimony of previous testifiers.
Co-Chair Olson asked about Mr. Hanks' knowledge of the
state.
Mr. Hanks relayed that he travelled to the state often and
had a distribution center in Anchorage.
Senator Merrick asked about the training courses for
administration of the epi-pen and if a person would have to
purchase the medication.
Senator Giessel suggested asking the question of Dr.
Schaber.
Ms. Schaber thought some insurance companies would pay for
the medication. She offered to follow up in greater detail
as to how other states handled the matter.
Senator Merrick recalled that Narcan was being supplied to
the public.
Ms. Schaber thought Naloxone was more widely available than
epinephrine, and recalled that there were various sites
around the state that provided the drug to have on hand.
She mentioned Project Hope, which was a program through the
state. She hoped the bill would increase access to
epinephrine.
Co-Chair Olson asked about the shelf life for an epi-pen.
Ms. Schaber replied usually a year or two, and noted that
the time varied by manufacturer.
2:27:04 PM
SYLVAN ROBB, DIRECTOR, DIVISION OF CORPORATIONS, BUSINESS
AND PROFESSIONAL LICENSING, DEPARTMENT OF COMMERCE,
COMMUNITY AND ECONOMIC DEVELOPMENT, cited that in FY 22,
there were 1,130 licensed pharmacists and 1,649 licensed
pharmacy technicians.
Ms. Robb addressed a new fiscal note from the Department of
Commerce, Community and Economic Development, OMB Component
2360. She cited a cost of $751,200 in FY 25 into the out
years, and noted that only $269,000 of the amount was
General Fund and was related to the addition of five staff
members. She listed the positions as one full-time
Administrative Assistant, one full-time Records and
Licensing Supervisor, two full-time Occupational Licensing
Examiners, and one full-time Investigator 3.
Ms. Robb discussed changes that were the source of the
additional cost. She noted that the bill proposed to move
out-of-state pharmacies from registering to being licensed,
and the previous year there were over 1,400 out-of-state
pharmacies. Additionally, the bill required internet
pharmacies to be licensed and inspected.
Co-Chair Olson asked if a patient in the state could send
out a prescription to an out-of-state pharmacy that would
send the prescription.
Ms. Robb informed that out-of-state pharmacies would have
to be licensed in Alaska in order to send medications to
Alaskans.
SB 94 was HEARD and HELD in committee for further
consideration.
2:29:27 PM
AT EASE
2:31:12 PM
RECONVENED
| Document Name | Date/Time | Subjects |
|---|---|---|
| SB 94 DCCED CBPL 042823.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 94 |
| SB 94 Sectional Analysis vsn R.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 94 |
| SB 94 23.04.27 ANHB to Senator Giessel re. SB 94 support Profession of Pharmacy - Final.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 94 |
| SB 94 Sectional Analysis vsn R.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 94 |
| SB 122 work draft version H.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 122 |
| SB 122 Summary of Changes version H.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 122 |
| SB 114 Opposition Letters 2.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 114 |
| SB 114 Support Letters 3.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 114 |
| SB 94 Responses to Questions SFIN 05-04-23.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 94 |
| SB 94 23.05.07 ANHB to Senator Giessel re. Support for SB94- Profession of Pharmacy.pdf |
SFIN 5/3/2023 1:30:00 PM |
SB 94 |