Legislature(2023 - 2024)DAVIS 106
03/23/2023 03:00 PM House HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| Confirmation Hearing(s): Department of Health, Commissioner|| Confirmation Hearing(s) | |
| HB112 | |
| HB60 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | TELECONFERENCED | ||
| *+ | HB 112 | TELECONFERENCED | |
| += | HB 60 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
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 of HB 112,
paraphrased the sponsor statement [copy included in the
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, gave the sectional analysis for HB 112 [copy included
in the committee packet], 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
(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
(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, gave a PowerPoint
presentation, titled "House bill 112: Profession of Pharmacy"
[hard copy included in the committee packet]. She explained the
mission of the Board of Pharmacy and its guiding principles. On
slide 2, she pointed out guiding principal 4, which addresses
the issues that HB 112 would effect. She stated that it would
help create a routine review of the effectiveness of regulations
and reduce barriers to licensure, while not compromising patient
health and safety, as seen under 4.1. She pointed out under
4.4, the proposed legislation would help in advocating for
legislation for the pharmacy profession as it evolves and new
opportunities for improvement patient safety arise. Pointing to
4.5, she stated that the proposed legislation would help
anticipate changes to the Drug Supply Chain Security Act,
allowing a proactive response.
MS. SCHABER moved to slide 3, which addressed the background of
HB 112. She stated that the proposed legislation is the result
of a multi-year, multi-chair review of statutes and regulations
to help ensure the Alaska Board of Pharmacy can continue to meet
its mission. She listed what HB 112 would accomplish, as
follows: streamline the licensure process while improving public
safety; maintain compliance with DSCSA; help alignment the
Pharmacy Board with other boards in Alaska and in other states;
clarify the role of pharmacists in epinephrine access; and
create a collaborative effort between the Alaska Board of
Pharmacy and the Alaska Pharmacists Association
4:15:53 PM
MS. SCHABER moved to slide 4 and discussed how the proposed
legislation would streamline the licensure process while
improving public safety. She stated that it would eliminate
unnecessary forms currently required in statute, clarify that
only pharmacists who dispense controlled substances are required
to register with PDMP, and add national criminal background
checks.
MS. SCHABER moved to slide 5 and discussed how the proposed
legislation would help with compliance with Drug Supply Chain
and Security Act. She explained that 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, and
pharmacy boards play a key role through appropriate licensing of
drug distributors and pharmacies. She stated that HB 112 would
ensure that the Alaska Board of Pharmacy powers and duties
support the DSCSA.
4:18:53 PM
MS. SCHABER moved to slide 6 and discussed how HB 112 would help
align the Pharmacy Board with other boards in Alaska and in
other states. It would do this by replacing one of the two
public member seats with a pharmacy technician seat, allow the
board to adopt language for retired pharmacist status, and
clarify the executive administrator's salary, as this would
allow a pharmacist to serve in this role in the future.
MS. SCHABER moved to slide 7 and discussed how HB 112 would help
the role of pharmacists in epinephrine access. She stated that
an epinephrine training program would be implemented, and a
clarification would be made which states a pharmacist can
administer epinephrine to a person or prescribe epinephrine auto
injectors to someone who has completed the training program.
she added that this would increases epinephrine access for
Alaskans with anaphylactic emergencies.
4:22:18 PM
MS. SCHABER concluded the presentation by requesting the
committee's support of HB 112, as this would allow for better
public health, safety, and welfare of Alaskans by the effective
control and regulation of the practice of pharmacy.
4:22:34 PM
REPRESENTATIVE FIELDS questioned whether [people on the board]
would have a financial interest in the healthcare industry.
MS. SCHABER answered that it is in statute that a person who is
a public member [of the board] would have no financial interest
in the healthcare industry. She said that this person would
bring a public consumer interest to the board.
REPRESENTATIVE FIELDS questioned the current board member
requirements.
MS. SCHABER deferred the question to the [Division of
Corporations, Business, and Professional Licensing]. She
reiterated that this is in statute and added that the biggest
change is a person having no financial interest. She said that
a willingness to attend quarterly meetings and a commitment to
the work 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 because of the time commitment, as well as low
willingness of the public to serve on a board for a profession
they might not know much about; therefore, HB 112 would change
one of the public seats to a technician position.
4:25:06 PM
REPRESENTATIVE FIELDS expressed appreciation for the idea. He
questioned the board's role in supporting the training of
pharmacy technicians.
REPRESENTATIVE RUFFRIDGE responded that during his time serving
on the Board of Pharmacy, this was an item of interest, and
regulations were passed to add a certified pharmacy technician
as an individual recognized in regulatory practice. For
example, 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. 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 would seem unnecessary to
have the executive director be a pharmacist. He asked why the
executive director is required to be a pharmacist.
REPRESENTATIVE RUFFRIDGE stated that he is a previous member of
the board and is a pharmacist and expressed the understanding
that an executive administrator of the Board of Pharmacy
performs many duties, and members are expected to have an in-
depth understanding of the department's licensing duties. He
pointed out that many licensing and professional questions are
directed to the executive administrator. He added that in many
states pharmacists serve in this role.
MS. SCHABER added that the five pharmacists on the Alaska Board
of Pharmacy are all volunteers and work full time and would not
have the time to address questions.
4:30:21 PM
REPRESENTATIVE MINA asked how out-of-state entities are being
regulated.
REPRESENTATIVE RUFFRIDGE answered that they are not being
regulated. He explained that they are required to register in
the state, but if the entity is dispensing or providing services
in the state, the Board of Pharmacy has no option to protect or
promote the safety and wellbeing of Alaska patients because the
entities are not licensed.
MS. SCHABER stated that HB 112 would give the board oversight.
She explained that currently only a registration acknowledges
out-of-state entities are providing services. She explained
that if there was a safety concern regarding an out-of-state
pharmacy, the board would have no oversight. In response to a
follow-up question concerning the prevalence of out-of-state
entities, she pointed out that mail-order pharmacies are an
example, and some are considered compounding pharmacies that
could provide either sterile or non-sterile compounds,
medications, eye drops, and injections to patients in Alaska.
4:33:01 PM
REPRESENTATIVE FIELDS asked how pharmacies are adapting to
fentanyl being present in adulterated drugs.
REPRESENTATIVE RUFFRIDGE answered that it is a very large
concern. 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 often sent through Internet pharmacies. He said
the proposed legislation would follow federal regulation.
MS. SCHABER added that the proposed legislation would address
giving the board oversight of Internet pharmacies.
4:35:33 PM
REPRESENTATIVE FIELDS expressed concern that gaps in primary
care could lead to expensive care for families. He asked if
there are opportunities for the board to work with other primary
healthcare providers in an effort to reduce such gaps.
REPRESENTATIVE RUFFRIDGE responded that there would be a more
detailed answer later, as there are opportunities for
pharmacists to fill gaps in care. He explained that during the
pandemic, pharmacies across the state had been able to fill
roles that historically they had not. He relayed that there is
a nationwide push for pharmacists to be given provider status,
something HB 112 would not do; however, the state has taken
steps to promote this ability. He alluded to a barrier in
pharmacy businesses, causing many to close across the state and
country.
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 ROBB, 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. In response to a follow-up question, she expressed
uncertainty about how many registered pharmacies are in the
state. She offered to report back to the committee.
4:42:18 PM
REPRESENTATIVE RUFFRIDGE thanked members for hearing the bill.
He said that the hearing has been a good start in promoting
changes that have been worked on for a long time.
REPRESENTATIVE FIELDS acknowledged Representative Ruffridge's
previous efforts. He suggested that some regulatory reforms
around staffing could help address "pharmacy deserts" in the
state. He asked if other reforms would bring more pharmacies to
unserved places.
REPRESENTATIVE RUFFRIDGE responded that pharmacies are closing
because of the high-barrier entry, namely in payroll costs. He
pointed out that some corporate pharmacies are reducing staff,
even as the number of prescriptions is rising. He elaborated
that many pharmacies operate as a net loss to large corporations
because this margin is small. He suggested that this could be
altered with the role pharmacy technicians play, as they could
be more of a manager while pharmacists provide clinical
oversight. He explained that tele-pharmacies allow a pharmacy
to operate in an urban setting. For example, downtown Anchorage
has three pharmacy technicians, as pharmacists are centrally
located in a larger facility, and technology is used to remotely
access the prescriptions. He explained that this option already
has a statute to govern it, and this is something the board has
changed to open the option now for pharmacy deserts; however,
pharmacies in the state need to adopt this change.
4:46:35 PM
CHAIR PRAX announced HB 112 was held over.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB 112 Sectional Analysis .pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 112 |
| HB 112 Sponsor Statement Version B.pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 112 |
| HB0112A.PDF |
HHSS 3/23/2023 3:00:00 PM |
HB 112 |
| Heidi Hedberg Resume 2023.pdf |
HHSS 3/23/2023 3:00:00 PM |
|
| HB112 HSS Hearing slides 3.23.23.pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 112 |
| HB 60 CS Version S.pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 60 |
| HB 60 Sectional Analysis (Version S) 3-23-23.pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 60 |
| HB 60 Explanation of Changes Version A to Verson S (3-23-23).pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 60 |
| HB 112 Support as of 3_21 Redacted.pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 112 |
| HB 112 Fiscal Note DCCED.pdf |
HHSS 3/23/2023 3:00:00 PM |
HB 112 |