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 | |
| 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, paraphrased the
sponsor statement [included in 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, read the sectional analysis for HB 112, 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
2
(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
3
(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, began the PowerPoint
presentation titled, "House bill 112: Profession of Pharmacy"
[hardcover included in committee packet] on slide. She
explained the mission of the Board of Pharmacy, and that HB 112
touches on goal 4.1 [shown under "strategies on slide 2]
relating to regulation and enforcement, which read as follows
[original punctuation provided]:
Routinely review effectiveness of regulations that
reduce barriers to licensure without compromising
patient health and safety.
MS. SCHABER also pointed to 4.4, which read as follows [original
punctuation provided]:
Advocate for legislation as the pharmacy profession
evolves and new opportunities for improvement patient
safety arise.
MS. SCHABER further referenced the goal list, pointing to
4.5, which read as follows [original punctuation provided]:
Anticipate changes to the Drug Supply Chain Security
Act and respond proactively.
MS. SCHABER read slide 3, which read as follows [original
punctuation provided]:
Background of HB 112
•Result of multi year, multi chair review of statutes
and regulations to ensure the Alaska Board of Pharmacy
can continue to meet its mission
•HB 112 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
4:15:53 PM
MS. SCHABER moved to slide 4, which read as follows [original
punctuation provided]:
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 read slide 5, which read as follows [original
punctuation provided]:
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
•HB 112 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
4:18:53 PM
MS. SCHABER directed attention to slide 6, which read as follows
[original punctuation provided]:
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
•Clarifies the board executive administrator's salary,
allowing flexibility for a pharmacist to serve in this
role in the future
MS. SCHABER showed slide 7, which read as follows [original
punctuation provided]:
Goal: Epinephrine Access
•Adds 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
4:22:18 PM
MS. SCHABER concluded the presentation on slide 8, which read as
follows [original punctuation provided]:
Support
•The Board of Pharmacy respectfully requests your
support of HB 112, 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!
4:22:34 PM
REPRESENTATIVE FIELDS inquired as to what type of person is
considered as someone that has a financial interest in the
healthcare industry.
MS. SCHABER answered that it is in statute, which is that it is
a person that is a public member that has no financial interest
in the healthcare industry. She said that such a person brings
a public consumer interest to the board.
REPRESENTATIVE FIELDS asked what the current board member
requirements are, other than just being a member of the public.
MS. SCHABER deferred the question to the division. She
mentioned statute and said that no financial interest is the
biggest change. She said that a willingness to attend quarterly
meetings and a commitment to the work involved 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 due to the time commitment requirement, as well
as low willingness from a member of the public to serve on a
board for a profession they may not know much about; therefore,
HB 112 would change one of the public seats to a technician
position.
4:25:06 PM
REPRESENTATIVE FIELDS commented that he likes the idea. He
asked what Representative Ruffridge sees as the role of the
board in supporting training for pharmacy technicians.
REPRESENTATIVE RUFFRIDGE responded that, during his time serving
on the Board of Pharmacy, that was an item of interest, and that
regulations were passed to add a certified pharmacy technician
as a specific individual recognized in regulatory practice. 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, as examples. 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 wouldn't seem necessary
to have the executive director be a pharmacist. He asked why
the executive director is required to be a pharmacist.
REPRESENTATIVE RUFFRIDGE responded that, in his time as previous
member of the Board of Pharmacy, as well as a pharmacist, there
is a lot of work to be an executive administrator of the Board
of Pharmacy, and members are expected to have a deep-level
understanding of what the department does for licensing. He
said that many licensing and professional questions are directed
to the executive administrator, and there would be a disconnect
if they had knowledge of the pharmacy profession since they
would have to go to the board to answer every question. He
added that a pharmacist serving in the role is current practice
in many states.
4:29:23 PM
MS. SCHABER added that the five pharmacists on the board are all
volunteers and work full time, so they don't have the time to
address the questions.
4:30:21 PM
REPRESENTATIVE MINA asked how out-of-state entities are being
regulated currently.
REPRESENTATIVE RUFFRIDGE answered that they are not. He
explained that they are required to register in the state, but
the Board of Pharmacy if the entity is dispensing or providing
services into the state has no option to protect or promote
the safety and wellbeing of Alaska patients because the entities
are not licensed.
4:31:17 PM
MS. SCHABER elaborated that the change in HB 112 gives the board
oversight. She explained that currently it is only a
registration that acknowledges that they are providing services.
She explained that if there was a safety concern regarding the
out of state pharmacy, the board has no oversight.
4:32:11 PM
REPRESENTATIVE MINA asked how prevalent out-of-state entities
are and what kinds of businesses they are.
MS. SCHABER pointed to mail-order pharmacies as an example, and
that some of the out-of-state pharmacies are considered
compounding pharmacies that provide either sterile or non-
sterile compounds, medications, eye drops, and injections to
patients in Alaska.
4:33:01 PM
REPRESENTATIVE FIELDS asked about fentanyl being present in
adulterated drugs, and how pharmacies are adapting to this.
REPRESENTATIVE RUFFRIDGE answered that it is a very large
concern and has always been a concern since fentanyl is one type
of the adulterated/counterfeit medications that's been seen. 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 being sent to Alaska often through Internet pharmacies. He
said the bill contains changes to comply with requirements
within federal regulation.
4:35:00 PM
MS. SCHABER added that the bill does address giving the board
oversight of Internet pharmacies, and that access to naloxone is
important.
4:35:33 PM
REPRESENTATIVE FIELDS shared that he is a parent, and that when
his kids get sick, it makes him think about how gaps in primary
care could lead to expensive care. He asked if there are
opportunities for the board to work with other primary
healthcare providers in an effort to reduce such gaps.
4:36:22 PM
REPRESENTATIVE RUFFRIDGE responded that there will be a more
detailed answer from him later; there is an extensive number of
opportunities for pharmacists to fill gaps in care. During the
pandemic, pharmacies across the state filled in roles that they
did not historically provide. He relayed that there is a
nationwide push for pharmacists to be given provider status,
something HB 112 does not do, but the state has taken steps to
promote the ability of pharmacists to take such steps. He said
there is a barrier in the fact that pharmacies are a difficult
business to be in, with many across the state and country
closing because there are many challenges.
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 ROB, 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.
4:41:10 PM
REPRESENTATIVE SUMNER asked how many registered pharmacies there
are.
4:41:33 PM
MS. ROB answered that she doesn't know how many but would get
that information to the committee.
4:42:18 PM
REPRESENTATIVE RUFFRIDGE thanked members for hearing the bill.
He said the hearing has been a good start in promoting changes
that have been worked on for a long time. He shared that the
chair before him would be proud that members are finally
bringing to bear a process they started a number of years ago.
4:43:26 PM
REPRESENTATIVE FIELDS shared that Representative Ruffridge had
previously shared that some regulatory reforms around staffing
could help address "pharmacy deserts" in the state. He asked if
there are other reforms to be thinking about to help bring more
pharmacies to places that are unserved.
REPRESENTATIVE RUFFRIDGE responded that pharmacies closing is
due to the high barrier entry, namely in payroll costs. He
pointed out that some corporate pharmacies are going through
staff reduction, even while the numbers of prescriptions being
dispensed go up. He elaborated that a lot of pharmacies operate
as a net loss to large corporations because there is a small
margin; a big component in altering that is the role of pharmacy
technicians becoming more of a manager while pharmacists act
more as clinical oversight for a pharmacy. He explained that
tele-pharmacies allow a pharmacy to operate in an urban setting;
downtown Anchorage, as an example, has three pharmacy
technicians with the pharmacists being more centrally located in
a larger facility and using technology to remotely access the
prescriptions that are being dispensed. He explained that this
is an option that already has statute to govern it, and a
barrier to it was changing regulations related to the pharmacy
technician's capacity, something the board has changed, which
opens the option now for pharmacy deserts.
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 |