Legislature(2001 - 2002)
01/30/2001 09:37 AM House ARR
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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
ALASKA STATE LEGISLATURE
JOINT COMMITTEE ON
ADMINISTRATIVE REGULATION REVIEW
January 30, 2001
9:37 a.m.
HOUSE MEMBERS PRESENT
Representative Lesil McGuire, Chair
Representative Jeannette James
Representative Joe Hayes
HOUSE MEMBERS ABSENT
All House members present
SENATE MEMBERS PRESENT
Senator Georgianna Lincoln
SENATE MEMBERS ABSENT
Senator Robin Taylor, Vice Chair
Senator Lyda Green
OTHER LEGISLATORS PRESENT
Representative Gretchen Guess
COMMITTEE CALENDAR
Overview of Committee by Chair, Rep. Lesil McGuire
Tam Cook Legislative Legal, Review of Cmte Powers
Deborah Behr Dept of Law, Law's Review of Regulations
Board of Pharmacy Review
PREVIOUS ACTION
No previous action to record
WITNESS REGISTER
TAMARA COOK, Director
Legal and Research Services
Legislative Affairs Agency
Alaska State Legislature
Capitol Building
Juneau, Alaska 99801
POSITION STATEMENT: Reviewed the powers of the committee.
DEBORAH BEHR, Assistant Attorney General
Legislation & Regulations Section
Civil Division(Juneau)
Department of Law
PO Box 110300
Juneau, Alaska 99811-0300
POSITION STATEMENT: Presented the Department of Law's review of
regulations.
CATHERINE REARDON, Director
Division of Occupational Licensing
Department of Community & Economic Development
PO Box 110806
Juneau, Alaska 99811-0806
POSITION STATEMENT: Reviewed the Board of Pharmacy regulations.
DR. COLLEEN MURPHY
(No address provided.)
POSITION STATEMENT: Expressed her interest in [collaborative
agreements with pharmacists] proceeding.
LIS MERTEN
National Association of Chain Drug Stores
(No address provided.)
POSITION STATEMENT: Testified in support of the Board of
Pharmacy regulations.
ROD SHAFER, Executive Director
Washington State Pharmacist Association
1501 Taylor Avenue SW
Renton, Washington
POSITION STATEMENT: Reviewed Washington's experience with
collaborative agreements involving pharmacists.
MARK BOHRER, Pharmacist
Member, Board of Pharmacy
19725 Highland Ridge Drive
Eagle River, Alaska 99577
POSITION STATEMENT: Offered additional information.
SHIRLEY CORSEY, Consultant Pharmacist
in Geriatrics
Providence Hospital
25740 Berryhill Road
Eagle River, Alaska 99577
POSITION STATEMENT: Offered additional information.
GARY GIVENS, President
Alaska Pharmaceutical Association
Pharmacy Director, Alaska Native Medical Center
19638 Delphin Circle
Eagle River, Alaska 99577
POSITION STATEMENT: Offered additional information.
BARRY CHRISTENSEN, Pharmacist
3526 Tongass Avenue
Ketchikan, Alaska 99901
POSITION STATEMENT: Discussed collaborative agreements.
ACTION NARRATIVE
TAPE 01-1, SIDE A
Number 001
CHAIR LESIL McGUIRE called the Joint Committee on Administrative
Regulation Review to order at 9:37 a.m. Representatives
McGuire, James, and Hayes were present at the call to order.
Senator Lincoln arrived as the meeting was in progress.
Representative Guess was also in attendance. Chair McGuire
invited Ms. Cook to begin her review.
REVIEW OF COMMITTEE POWERS
Number 0057
TAMARA COOK, Director, Legal and Research Services, Legislative
Affairs Agency, Alaska State Legislature, began by saying that
the Joint Committee on Administrative Regulation Review (ARR) is
a permanent interim committee of the legislature that has been
established in statute. The general powers of ARR is set out in
AS 24.20.460. She explained that the committee was formed to
review the adoption of regulations by the executive branch and
consider them in terms of whether or not those regulations
accomplish legislative intent. Ms. Cook noted that paragraph
(4) AS 24.20.460 provides the committee the authority to
consider proposed regulations. The committee is not limited to
review of regulations that are adopted and filed. The committee
can get involved earlier in [the regulation-making/adoption]
process.
Number 0187
MS. COOK emphasized the importance of the Supreme Court's ruling
in 1980, which restricted the power of ARR with respect to some
of the statutory provisions. Those statutes have never been
amended or repealed subsequent to that ruling. Ms. Cook
explained:
Essentially, the Administrative Regulation Review
Committee, by statute, has the authority to recommend
to the full legislature that they consider the
annulment of a regulation by resolution. ...the
mechanism whereby the legislature can exercise the
legislative veto of a regulation was held
unconstitutional in the case State v. A.L.I.V.E.
Voluntary. So, it doesn't do either the committee or
the legislature any good to submit such a
recommendation now, to the full legislature. In
addition, the same case, I think, makes it fairly
clear that the power of suspension that appears in the
statutes for the [Administrative] Regulation Review
Committee at [AS] 24.20.445 is not going to be upheld
by a court, if you attempted to exercise it. Now,
that provision essentially ... purports to give the
committee the power to suspend the effectiveness of a
regulation that it has objections to. And it seems to
me, quite clear, that the committee cannot act to that
level. Essentially, the court, in State v. A.L.I.V.E.
held that if the legislature wishes to take an action
that has binding legal effect ... on others, a third
party's, that it must act by using the enactment
procedures that are set out in the state constitution.
That is, it must pass a law. There must be three
readings, there must be a required vote separately by
each house. The subject must be reflected in the bill
and above all, a piece of legislation is, of course,
subject to veto by the governor, subject to being
overridden by the legislature. So, it is those
provisions that our court held define the scope of the
power of the legislature to effect the rights of third
parties (indisc.). So, I think it is important to
bear in mind that while the committee cannot make a
recommendation that the legislature effectively use
its legislative veto authority through the use of a
resolution, there is nothing that prevents the
legislature from doing what it has always done and
that is enacting laws.
MS. COOK continued:
A regulation is essentially a legislative power that
is exercised by the executive branch of government
pursuant to a delegation by the legislature itself.
The legislature can always withdraw a delegation ...
to a certain extent. So, one of the things that ...
the committee can certainly do in response to concerns
about a regulation is to look at the underlying
legislation and consider modifying the legislation in
a way that meets the concerns of the committee. The
committee has the right to introduce legislation
through the Rules committee. So, that ... course of
action is always available to the legislature and to
the committee to pursue and remains, probably, its
most potent tool. That and, I would say,
participation in the regulation process at the
proposal stage is potent.
Number 0454
MS. COOK said:
The other thing that I would like to draw the
attention of some of the members of this committee to
is the fact that not every regulation, a fair number
of them now, ... is adopted under the Administrative
Procedure Act [APA]. There are a great many
regulations in areas, where the legislature has itself
made the policy determination that they were going to
give a particular agency or, in the case of the
railroad, a public corporation the ability to adopt
regulations without complying with the APA. Now,
obviously, they comply with some sorts of due process
requirements attached, but they're not necessarily
Administrative Procedure Act regulations. And, I
think a lot of people do not understand this. There's
nothing that prevents this committee from getting
involved in those sorts of regulations as well, even
though they're not subject to the same kind of process
that you see. Now, ... the APA actually has a
provision that says that proposed regulations are
going to be delivered to the committee for its review.
Some of the other provisions where you see a statute
that says an agency may adopt regulations it does not
have to follow the APA, it also goes on to say that
those regulations shall be submitted to the committee
for its review. In many cases, there's such ... an
independent statement, but not in all. Nevertheless,
I think it's quite clear that this committee could
consider regulations from sources where the adopting
agency is not required to comply with the APA. And
so, that was a point that I thought I ought to make.
MS. COOK offered to answer questions from the committee.
Number 0584
CHAIR McGUIRE related her belief that there is actually a lot of
misconception about what ARR can and cannot do. She noted that
the committee packet includes Ms. Cook's overview of the
committee's power.
REPRESENTATIVE JAMES commented that ARR has, in the past, been
successful in negotiating [changes] with the agency during the
writing of the regulations. She emphasized that this committee
can make a difference without introducing legislation.
Department of Law's Review of Regulations
Number 0713
DEBORAH BEHR, Assistant Attorney General, Legislation &
Regulations Section, Civil Division(Juneau), Department of Law
(DOL), informed the committee that she is the person who signs-
off on all the aforementioned APA regulations. Ms. Behr noted
that Steve Weaver, also in the Legislation & Regulations
Section, is available to answer regulatory questions on
particular projects. She noted that the committee packet should
include the current "Administrative Drafting Manual for
Regulations." "All state agencies that are required to comply
with the APA must meet this," she said. This manual, which can
also be found on the Department of Law's home page, highlights
all the different steps in the regulatory process. She offered
to give the committee or its staff a separate briefing on the
manual. The committee packet should also contain a document
labeled, "Exhibit 1," which is the Alaska Administrative Code
(AAC) contacts for the executive branch. She explained that the
governor adopted an Administrative Order, which requires that
each department have an administrative [regulatory] contact.
She identified this contact person as "one stop shopping" for
that particular department and although this person may not know
all the details, he/she will know how to obtain them.
Number 0878
MS. BEHR turned to two recent statutory provisions. She first
addressed the statutory provision requiring that administrative
regulations be posted on the online public notices [site]. She
directed the committee to the document entitled, "Exhibit 2."
The online public notice system is running and all the state
agencies are using it. She pointed out that the site has a copy
of the notice for the regulations, which specifies when and
where the hearings are. Furthermore, if regulations have been
adopted, it provides a summary of those regulations. Ms. Behr
then addressed the statutory provision regarding e-mail to
legislators and the need for legislators to receive e-mail as
fast as possible. She related her understanding that this is
being implemented by all agencies that have to do APA
regulations. She said that she has heard that has been quite
successful.
Number 0966
MS. BEHR announced that she would now focus on a pared down
presentation regarding how DOL reviews regulations. She again
offered to provide the committee or its staff with a separate
briefing on this matter. Ms. Behr directed the committee's
attention to a document entitled, "Exhibit 3," which is a
checklist that DOL uses to review regulations. She emphasized
that DOL's statutory duties to review APA regulations is a legal
review not a policy review. This review is a two-level review
in which an agency attorney is assigned to every project and
thus each project will include someone who deals with the
particular area of law on a daily basis. Then the review moves
up to Ms. Behr's level where [the project] is reviewed on the
basis of whether it complies with the statutes and the
constitution. She noted that APA establishes the requirements
for the timeframes regarding how long regulations should be
available for public comment and when the regulations can be
adopted, the types of hearings required, and the types of
documents required. Ms. Behr said that she reviews all that
information and the procedure followed.
MS. BEHR remarked that the committee is probably most
interested in her legal review of the substance [of the
regulations]. She explained that first she reviews whether the
state agency has regulation-writing authority. Next, she would
review whether the regulation is consistent with the statutes.
She noted that she would also review whether the regulation
meets the legal requirement to be reasonably necessary to carry
out the statute for which she generally defers to boards,
commissions, and commissioners. She pointed out that she would
question [a regulation] if it looked like it is outside the
range of what a court would approve. Finally, Ms. Behr reviews
whether the regulations meet the state and federal
constitutions, which she remarked to often be the most difficult
part of the review.
Number 1229
MS. BEHR turned to the issue of how long it takes to do a
project, to which she said it depends. However, once a
regulation is approved for filing by the lieutenant governor, it
goes to the lieutenant governor who now has limited review
authority. The legislature gave the lieutenant governor the
ability to review "nonboard" regulations on the basis of failing
to faithfully execute the laws and give the agency more time to
respond to specific issues raised by ARR. The committee has the
opportunity to submit comments during the public comment period
and the lieutenant governor can review whether those comments
were responded to appropriately. Ms. Behr echoed Ms. Cook's
comment about the committee commenting during the public comment
period. She offered to answer any questions.
Board of Pharmacy Review
CHAIR McGUIRE announced that the committee would now hear the
review of the Board of Pharmacy.
Number 1363
CATHERINE REARDON, Director, Division of Occupational Licensing,
Department of Community & Economic Development, informed the
committee that her division oversees the Board of Pharmacy,
which adopted regulations on January 12, 2001. These
regulations authorize collaborative agreements between
pharmacists and physicians or other prescribing health care
professionals. She pointed out that these regulations have not
yet been approved by DOL and that process may take several
months. If these regulations were approved by DOL, Ms. Reardon
projected the results of these regulations would be evident in
the summer. She noted that the regulations should be in the
committee packet.
MS. REARDON referred to page 2 of the regulations, which inserts
a new section entitled, "Pharmacist Collaborative Practice
Authority." She noted that she would refer to physicians for
purposes of discussion, although this collaborative agreement
could be with any practitioner authorized to prescribe drugs
under AS 08. She reviewed what the regulations required in the
protocol as specified in the new section 12 AAC 52.240 (b) (1)-
(7). She pointed out that this [collaborative agreement] would
be restricted to legend drugs, nonnarcotics. Furthermore, this
written agreement must be submitted to the Board of Pharmacy,
who must approve it before the relationship is established.
Number 1573
MS. REARDON referred to the final section of regulations
entitled "Monitoring of Drug Therapy By Pharmacists." This
section would allow a physician to establish an agreement with a
pharmacist. For example, the monitoring may be such that when
an asthma patient comes in each month for refills, the
pharmacist tests this patient to determine the amount of air the
patient can breath and depending upon the results the pharmacist
can either renew the prescription or call the physician.
MS. REARDON emphasized that [these regulations] deal with the
Board of Pharmacy. [These regulations] would allow pharmacists
to enter into these [collaborative] agreements under the
specific conditions. However, the Medical, Nursing, and Dental
boards would retain their ability to govern how their
professionals behave. Therefore, those boards could choose to
write their own regulations. Furthermore, the Medical Board
retains the ability to establish the rules for doctors and thus
can make these rules more restrictive than the pharmacy
regulations, if the Medical Board wanted to engage in a
regulation project. The case would be the same for the Nursing
and Dental boards as well. Ms. Reardon explained that she
mentioned this due to the concern surrounding the broadness of
the regulations. The broadness of the regulations may be
advantageous to the other boards because each profession can
tailor [its regulations] or perhaps choose not to engage in
[collaborative agreements]. Ms. Reardon also emphasized that
these agreements are voluntary and optional. Furthermore, these
collaborative agreements could be focused such that it refers to
a specific patient or board such that it refers to a class of
people. She noted that the Board of Pharmacy did discuss these
regulations at five different meetings; this has been a two year
process.
Number 1789
MS. REARDON informed the committee that an Anchorage physician
had asked whether the agreement she is contemplating with local
pharmacists to provide emergency contraception would conform to
Medical Board standards. On January 19 the Medical Board wrote
that this physician could enter into an agreement for the
emergency contraceptive care after the pharmacy regulations take
effect, as long as the physician ensures the pharmacist has
appropriate education and training. She emphasized that this
collaborative agreement is not specifically directed at
emergency contraceptives.
MS. REARDON concluded by reminding the committee to keep in mind
the current realities of health care. She related her
impression that some of these collaborative relationships
between pharmacists and physicians may be occurring now. For
example, in a hospital physicians may be delegating certain
responsibilities to pharmacists. She also posed the possibility
that physicians may [already] be requesting that pharmacists
refill all their patients' prescriptions once during the
physician's absence. Therefore, perhaps these regulations would
provide some form and documentation of the collaborative
relationships [that already exist].
MS. REARDON addressed the issue of fragmentation of care. She
posed an example in which an individual obtains a flu shot from
a pharmacist who has an agreement to administer the flu shot,
but the agreement is not with that individual's physician. In
such a case, there is concern regarding how that individual's
physician would know that he/she had that treatment.
Number 1978
DR. COLLEEN MURPHY testified via teleconference. She emphasized
the importance of passing these regulations in order to cover
the current practice of medicine and pharmacy. She pointed out
that the majority of Anchorage hospitals currently have
pharmacists working in collaborative relationships with
physicians. Furthermore, pharmacists and physicians are working
collaboratively as Ms. Reardon stated earlier. Dr. Murphy
informed the committee of a physician who had signed a
collaborative agreement with a local pharmacy in order to
provide the flu vaccine and the nuemococol(ph) vaccine under his
prescriptive authority.
DR. MURPHY turned to the issue of fragmentation of health care
and stated, "it's not really fragmentation, it depends on how
you choose to work with your health professional colleagues."
She said that she would like to think that [health professionals
would work] collaboratively. Dr. Murphy expressed the need for
any collaborative practice agreement to have the option for the
patient to request for the encounter provided through the
pharmacist to be faxed to the primary care physician.
Therefore, the fragmentation could be easily overcome. Dr.
Murphy mentioned that other states with collaborative agreements
have demonstrated that some patients don't want their primary
care physician to know about the care sought outside their
office. In conclusion, Dr. Murphy expressed her interest in
[collaborative agreements with pharmacists] proceeding.
REPRESENTATIVE JAMES related her understanding that in many
cases, the pharmacist may be more familiar with certain
medications than a physician. She asked what emergency
contraception is.
CHAIR McGUIRE, upon determining that Dr. Murphy was not online,
announced that Representative James' question would be held
until Dr. Murphy was back online.
Number 2156
LIS MERTEN, National Association of Chain Drug Stores, testified
via teleconference. Although she said that she was mainly
interested in listening to the hearing, she noted support of the
regulations being discussed. Ms. Merten echoed Ms. Reardon's
earlier statement that these [collaborative] arrangements are
voluntary.
SENATOR LINCOLN noted that Washington has had collaborative
agreements for some time and thus she asked if there have been
any problems. She also asked if Alaska's regulations are
similar to Washington's regulations.
MS. MERTEN deferred to Rod Shafer.
Number 2232
ROD SHAFER, Executive Director, Washington State Pharmacist
Association, noted that he has provided the committee with a
packet of information of which one side includes information
provided at the National Conference of State Legislators. That
information includes studies that document the value pharmacists
bring to the health care arena, that is value in patient
outcomes and dollars saved. The second portion of the
information addresses pharmacists' contributions in
collaborative practice arrangements. He said that information
reviews what collaborative practice arrangements are and the
advantages of such. He noted that the committee should also
have information regarding medication use in the U.S. There is
also a section that addresses the potential dollars that
pharmacists' services in collaborative arrangements could save
Medicaid.
MR. SHAFER then turned to the Power Point presentation that
reviews what has happened in Washington. In 1979 Washington
enacted the [collaborative practice agreement] laws and in 1980
the rules were promulgated and subsequently approved in 1981.
Therefore, Washington has about 20 years of experience with
[collaborative agreements]. He referred the committee to a
document entitled, "1993-1999 Survey Goals" that measured the
satisfaction from the pharmacist and the prescriber, the
frequency of use of these arrangements, and defined the impact,
and determined whether the Board of Pharmacy should promote
these arrangements as an effective way of promoting health care.
In 1999 "we" reviewed what quality insurance measures were
included in these collaborative practice agreements as well as
what type of data was collected. He informed the committee of
the following information [that was obtained from the surveys].
In 1993 there were 57 protocols on file with the State of
Washington, the majority of which were with hospitals and HMOs
(health maintenance organizations). Of those 57 protocols, 44
responded. He indicated that 135 prescribers and 84 pharmacists
responded as well. Mr. Shafer directed attention to the
following information: "utilization with seven pharmacists and
27 physicians per protocol." He remarked that many of these
protocols had to do with group practices, which results in the
skewed numbers. In 1999 the number of protocols has grown to
358, which doesn't include the 153 protocols for the provisions
of emergency contraception ...
TAPE 01-1, SIDE B
MR. SHAFER indicated that 88 of those participating responded,
of which "double the amount of pharmacists and physicians ...
sent in their surveys." He specified that the type of
prescriptive authority being looked at is the initiation of
therapy, the modification of [therapy], and the continuation [of
therapy]. He explained that the initiation could be as simple
as someone requesting a flu shot, which the pharmacist gives.
Or, the initiation could be such that a physician writes an
order and sends a patient to the pharmacy-based pain clinic.
The order could instruct the pharmacist to control the patient's
pain per protocol. Modification of therapy would be in the case
of a patient who is already on some protocol and the pharmacist
reviews the protocol [in case] there are extenuating
circumstances that prevent compliance with the treatment
protocol. Mr. Shafer reminded the committee that today there
are over 10,000 drugs available. Furthermore, the treatment
modalities are very complex and someone needs "to hold their
hand through that process and we think the pharmacy plays a huge
role in that." He indicated the need for the physician and
pharmacist to work together in order to have the results desired
by the physician, pharmacist, and patient. The continuation [of
therapy] is similar to the aforementioned example of [a
physician] being gone and requesting that [a pharmacist] refill
the patient's prescription [based on the agreement].
MR. SHAFER emphasized that in Washington today 35 percent of all
protocols are in chain pharmacies, 26 percent of the protocols
are independent and 20 percent of the protocols are in medical.
Therefore, about 78 percent of these protocols are occurring in
ambulatory care settings not in institutional settings. This
illustrates that more care is moved into the community where
people are. Mr. Shafer identified "the next great 'Aha' in
health care" as occuring when there is the realization that when
health care is where people are, they will access it. He
continued, "When we make it difficult for them to access health
care, then they don't and we end up with people who are very
sick when they finally get to our doorstep." This is
exemplified with immunizations such as that for the flu shot.
Pharmacists in the State of Washington provided over 135,000 flu
shots last year.
Number 2272
CHAIR McGUIRE asked if there have been any lawsuits that
resulted from [collaborative agreements]. She noted discussions
that she has had regarding whether physicians in Alaska can
delegate any of their healing authority. She inquired as to the
liability for the physician, if those authorities are delegated
at the various stages.
MR. SHAFER answered, "After 20 years we've had no complaints, no
lawsuits, no incidence of a patient who has been harmed. Not
one."
MR. SHAFER continued with the results of these protocols after
20 years. In 1993 there was a 98 percent satisfaction rate from
physicians involved with these. He did note that there was one
physician and one pharmacist who were unhappy with their
protocol, however, it didn't result in anything bad happening to
patients. In 1999 there was a 95 percent satisfaction rate
[from physicians involved with these protocols] and pharmacists
were also satisfied. He turned to the quality assurance
measures and noted that in 50 percent of the cases, there was
case review by the pharmacist and the physician. He noted other
quality assurance measures, such as chart audits, [the
collection of data in regard to] adverse drug reactions, and
complaints. He said that there is no review 34 percent of the
time. Mr. Shafer informed the committee that the Washington
Medical Association has a policy that says it is not opposed to
collaborative practice agreements between physicians and
pharmacists and other health care providers as long as it is on
a one-to-one basis. In most cases, [the Washington State
Pharmacists Association] agrees with that. He could think of
two cases, emergency contraception and immunizations, that would
need a broader base protocol. In fact, the Washington Medical
Association has a resolution that endorses the provision of
emergency contraception and immunization by pharmacists.
Number 2097
MR. SHAFER turned to the outcome data collected. In regard to
whether the set goals were being achieved, 48 percent of the
time [the goals were met]. He noted that 44 percent of the time
patient satisfaction and quality of life issues were reviewed.
Eighteen percent of the time access to care was being reviewed.
He indicated that these collaborative agreements do improve
access to care because the most accessible health care
professional is the pharmacist. The equivalent of the U.S.
population walks through a pharmacy once a month, which provides
huge opportunities for education and "hand holding." He noted
the collection of data regarding adverse events.
MR. SHAFER moved on to the perceived impacts from the
prescribers on the patient. He commented on the physicians'
[perception that these collaborative agreements] increased
patient convenience, decreased costs, and increased the quality
of care. The pharmacists' perception was a bit higher. With
regard to the [Washington] Board of Pharmacy's recommendation
regarding whether pharmacists should promote collaborative drug
therapy management as a method of improving patient outcomes, 76
percent of prescribers responded in the affirmative. Of course,
pharmacists had a higher approval rating. No one expressed the
need to discourage this type of collaboration. Mr. Shafer
reminded the committee that health care is based on protocols.
Number 1976
MR. SHAFER informed the committee that "we" didn't survey the
153 emergency contraception protocols that are in place. He
explained that RU486 is not available to pharmacists nor do
pharmacists want to have the ability to handle that drug in the
situations it would be used. However, the emergency
contraception provision - the morning after pill - is merely a
doubling of the dose of a standard birth control pill that must
be taken within 72 hours of unprotected intercourse. Most
importantly, if the egg is fertilized and implanted, the woman
is pregnant and the emergency contraception product can do
nothing. He stated, "If you are pregnant, you are pregnant."
However, if the egg is not implanted, the emergency
contraception product may slow the [implantation] process.
Currently, there are two products available, one of which is
referred to as Plan B. Mr. Shafer emphasized that "this" is
nothing new as it has been known for 20 years and has been
available in physician's offices. Planned Parenthood has been
providing this [emergency contraception] for a number of years
in every state. In the State of Washington "they" provide about
5,000 interventions for women in a year. The first year that
pharmacists began to provide this [which includes an assessment
and counseling] to women that came in, the pharmacist did
12,000. He attributed that increase to making [emergency
contraception] more accessible to people. He noted that this is
on track in the second year with additional federal funding to
expand into rural Washington, which he estimated would increase
the interventions to about 24,000. Mr. Shafer informed the
committee that the State of Washington spends about $100
million, during conception to birth, on unintended pregnancies.
Number 1855
SENATOR LINCOLN referred to the correspondence from the Alaska
State Medical Board and the Alaska Board of Dental Examiners,
one of which is reluctant to proceed with the collaborative
agreement and the other is opposed to it. She asked if, 20
years ago, the State of Washington faced those same concerns.
If so, she asked how Washington was able to overcome the fears.
MR. SHAFER pointed out that 30 states currently have
collaborative drug therapy management. The remaining states are
in the same situation as Alaska. He remarked that
[collaboration] is generally accepted as good medical practice.
The difference between Washington in 1979 and Alaska now is that
in 1979 everyone was making money. However, today the issue
seems to be about "turf" and whether such arrangements would
take money and patients away from certain groups. He said there
seems to be two levels of rhetoric. Mr. Shafer also pointed out
that the American Medical Association has passed an ordinance
that "the provision of emergency contraception should be over-
the-counter. How you leap over having the pharmacist provide
and give an assessment to actually just anybody can walk in off
the shelf, is an interesting jump for me."
SENATOR LINCOLN returned to the topic of the morning after pill.
She related her understanding that if the egg is fertilized, the
morning after pill won't help. Furthermore, the literature in
the packet says that if the egg is fertilized and the morning
after pill is taken, it won't damage the fetus or harm the
mother. She indicated the need for Mr. Shafer to expand on
that.
MR. SHAFER explained that an egg can be fertilized and not
implanted. In such a case, the morning after pill will prevent
implantation. However, if the egg is fertilized and implanted -
the woman is clinically pregnant - it does nothing to abort that
nor does it do any harm to the fetus.
Number 1658
REPRESENTATIVE JAMES related her experience with her own
pregnancy in which her [egg] was not attached well enough.
Therefore, she questioned what would happen [if the woman took
the morning after pill] in a situation such as hers.
MR. SHAFER answered, "If the fertilized egg is implanted in any
manner, there is no way that this morning after pill is going to
dislodge that and that becomes a ... medical issue that needs to
be dealt with by your physician."
REPRESENTATIVE JAMES remarked that if these contraceptives are
currently only given by prescription and this can be given
without prescription, it would seem that it should be over-the-
counter. If this is serious and needs a prescription, then it
would seem that not having a prescription is problematic. In
response to Chair McGuire, Representative James said that Mr.
Shafer had answered her question [and thus hearing from Dr.
Murphy wasn't necessary]. Representative James remarked that
"emergency contraception" seems to be a misnomer.
MR. SHAFER noted that his card was included in the committee
packet if the members need further information.
ERIN CAREY BYRNE, Alaska Pharmaceutical Association, announced
that she would cede her time to a panel of folks that have come
down from Anchorage. She introduced the panel members: Shirley
Corsey, Gary Givens, and Mark Bohrer. All three of these
pharmacists are involved in some form of a collaborative care
arrangement.
MARK BOHRER, Pharmacist; Member, Board of Pharmacy, addressed
the [aforementioned suggestion] of the danger of emergency
contraception being over-the-counter. Mr. Bohrer said, "I think
having a health care professional involved is the potential to
counsel them or refer them to a physician for future
contraceptive needs so they don't have to rely on this method as
a form of contraception; to get it back in the loop of
providers."
REPRESENTATIVE JAMES asked, "The morning after pill -- does that
mean that this person ... does not have a prescription for birth
control pills or is this in addition to the birth control pills
that they maybe are taking .... What is the connection between
doing that and taking a regular dosage?"
SHIRLEY CORSEY, Consultant Pharmacist in Geriatrics, Providence
Hospital, answered that the protocol is the connection. She
explained that within the collaborative agreement, the physician
has written specific guidelines for a patient that fits [a
certain] criteria. This would be similar to a person meeting
the criteria to receive a flu vaccination.
REPRESENTATIVE JAMES asked if [the protocol] would be per
individual or in general.
MS. CORSEY explained that [the protocol] would be specific to
the physician and how the physician writes the criteria for the
collaborative agreement.
REPRESENTATIVE JAMES asked, then, if the patient has to be a
patient of that [physician].
MS. CORSEY replied no. She explained that the physician would
write a protocol that would delegate his authority for persons
meeting the criteria [specified in the protocol].
(UNIDENTIFIED SPEAKER) interjected that [the protocol] could be
restricted to the physician's patients.
REPRESENTATIVE JAMES expressed concern with a doctor delegating
his authority to do something for someone who has never been his
patient.
Number 1376
GARY GIVENS, President, Alaska Pharmaceutical Association;
Pharmacy Director, Alaska Native Medical Center, said that he
thinks this refers to the issue of the independent prescribing
authority. He explained that physicians have independent
prescribing authority that they can give to someone else, who
would have dependent prescribing authority.
REPRESENTATIVE JAMES asked how these patients are given this
care or counseling; is there a separate office?
MR. BOHRER informed the committee that he works in the Wasilla
Fred Meyer that has a closed room that is used for consultation.
He emphasized that he does not discuss health matters when
someone is standing in line, especially with something as
delicate as [emergency contraception]. In further response to
Representative James, Mr. Bohrer said that the drug product is
the cost. Currently, emergency contraception is not [provided
at the pharmacy level] in Alaska. With the vaccines, there is a
$10 charge.
REPRESENTATIVE JAMES clarified that she is interested in how
pharmacists are paid for everything -- for treating diabetics,
reading lab tests, et cetera.
MS. CORSEY explained that if the [treatment] is directed by a
physician as part of a collaborative agreement, then a Health
Care Financing Administration (HCFA) form can be completed for
Medicaid reimbursement.
REPRESENTATIVE JAMES asked if there is a schedule of charges.
MS. CORSEY answered that Medicaid would determine that.
MR. GIVENS said that it would depend on Medicaid or private
insurance for which there are different reimbursements set for
each. He recalled that 40 of the states have passed regulations
for insurance to reimburse for collaborative care.
Number 1207
MS. SHIRLEY expressed the need for Dr. Murphy or Mr. Shafer to
speak to what the prevention of an unintended pregnancy would do
to the abortion rate.
DR. MURPHY mentioned that she is a member of the American
Society of Emergency Contraception and that she attended the
society's national meeting last October. She said that the
mechanism of action is being researched as "we" are always
looking for more effective ways of "contracepting" women to
prevent unintended pregnancy. She informed the committee that
"currently the only scientific data around the mechanism of
action for emergency contraception appears to be related to
delaying the release of the egg." She specified that there is
no data to support the theories that [emergency contraception]
would interfere with fertilization, the transfer of the egg and
sperm, or change the lining of the uterus to interfere with
implantation. She expressed the importance of realizing that a
huge amount of fertilized eggs never successfully implant. Dr.
Murphy discussed results of the experience with birth control
pills in early pregnancy.
Number 1055
CHAIR McGUIRE returned to the consultation process. She related
her understanding that when prescribing contraceptive pills, the
woman must undergo an examination from which she is screened for
various tendencies. Therefore, she inquired as to what the
procedure would be [from the pharmacist]. She asked, "Is the
woman going through a full examination that screens her for any
of those potential problems? ...if you aren't, why is it
important to do it when prescribing regular oral contraceptives
that you take on a regular basis but not the 72-hour pill?"
DR. MURPHY pointed out that unintended pregnancy, cervical
cancer, and sexually transmitted diseases (STDs) are three
different issues and thus getting pregnant doesn't necessarily
cause cervical cancer or [STDs]. Therefore, part of the problem
of linking contraception with some of these evaluations is that
many women are deterred from coming to a doctor's office because
they can't afford the complete evaluation. She noted that some
providers are providing "hormone with optional pelvic exam,"
which means that a history is taken to determine that the
patient doesn't have cardiovascular disease, hypertension, or a
history of hyper coagulation themselves or in their family and
then the birth control is prescribed. The pelvic exam would be
done at a later date. Dr. Murphy informed the committee that
basically, the doses of medicine in the current forms of
emergency contraception are equivalent to three days of birth
control pills. Furthermore, [the 72-hour pill] does not have
the same contraindications that a more complex decision for a
long-term prescription for birth control pills. She noted that
[the 72-hour pill] does not cause blood clots. She said,
"Ironically, it's the women that would have high risk
pregnancies that emergency contraception might actually best
serve."
CHAIR McGUIRE said that she is aware of the distinctions that
Dr. Murphy outlined. However, she pointed out, "There is a
public policy decision that we're making that removes patients
from regular screening with their physicians and that is a
concern to recognize. Oftentimes, that might be the only reason
that a woman goes in to see her regular physician for the year
to get her oral contraceptions or things like that and it might
be that one screening that turns up cervical cancer."
Number 0877
MS. CORSEY clarified that the criteria is only for the morning
after [pill] not for the long-term use of oral contraceptives.
Furthermore, the screening is part of the criteria for the
collaborative practice agreement and thus the pharmacist is
going over the series of screening questions related to
hypertension, et cetera. The woman must meet that criteria.
With regard to the long-term relationship with a physician, the
State of Washington found that often the woman in need of the
morning after pill, which must be taken within 72 hours, needs
it after regular business hours or during the weekend.
Therefore, access has been such an issue for [the morning after
pill]. Furthermore, sometimes people are uncomfortable making
an appointment with their physician for this. Ms. Corsey
requested that Dr. Murphy or Mr. Shafer speak to the fact that
the availability of the morning after pill causes the abortion
rate to decrease.
CHAIR McGUIRE commented that she thinks [the committee] has
gotten that message. Chair McGuire announced that she didn't
mean to make emergency contraception the focus because she felt
that the important issue is the relationship between pharmacists
and physicians with respect to a variety of drugs. Chair
McGuire noticed that the regulations include a procedure for the
physician to provide records to the pharmacist. Therefore, she
asked if there is a procedure in place by which the records
would be forwarded to the primary caregiver [from the
pharmacist].
MS. CORSEY replied yes and emphasized that the feedback loop is
important.
Number 0729
REPRESENTATIVE JAMES announced that she supports contraceptives.
However, her aforementioned concerns regarding contraceptives
[would also be relevant] to all the treatments. Therefore, she
expressed the need for those questions to be sufficiently
addressed in regulation in order for her to know "that those
issues of the treatment of a patient with a doctor will be
maintained."
MR. BOHRER referred the committee to 12 AAC 52.240(b)(7), which
reads: "a plan for providing the prescribing practitioner(s)
with all patient records created under the collaborative
practice agreement."
CHAIR McGUIRE indicated the need to take testimony from others
present. She announced that she didn't plan for this to be the
end of the discussion. She also expressed the hope that the
committee's concerns would be taken into account.
Number 0599
CINDY AUDET, Member, Alaska Pharmaceutical Association Board,
informed the committee that she also works as a hospital
pharmacist in Juneau. She noted her support of inserting
language to the professional regulations such that physicians
and pharmacists are allowed to have collaborative agreements.
REPRESENTATIVE HAYES related his understanding that these
collaborative agreements are being done now without specific
[authorizing] language in the regulations.
MR. AUDET informed the committee that she has mainly worked in
hospital settings for the past 20 years. In hospital practice,
there has been some form of collaborative practice with
physicians for as long as she has been involved, although the
nature has changed a bit. She explained that what can be
delegated [to pharmacists] has evolved from a medical staff
decision to the decision of individual practitioners.
REPRESENTATIVE HAYES noted the committee's suggestion that the
proposed regulations are too broad. He asked if Ms. Audet felt
that the current practice [with collaborative agreements] is
broad in scope or narrow.
MS. AUDET replied that it is used in a narrow scope and is based
on individual comfort levels and needs.
Number 0441
REPRESENTATIVE HAYES related his understanding from Ms. Reardon
that although the [pharmacists] may want a broad scope [with
collaborative agreements], the other groups can make their scope
as broad or narrow as they like. He asked if that would address
some of the committee's concerns.
MS. REARDON answered that she believes those other licensing
boards could decide to initiate regulations that would address
their concerns, which may in turn address some of the
committee's concerns. Ms. Reardon emphasized that although the
regulations allow a wide range of [things to be covered with]
collaborative agreements, the individual physician still
determines what he/she will specifically authorize the
pharmacist to do.
REPRESENTATIVE HAYES also related his understanding that the
regulations place the onus on the physician to ensure that the
pharmacist, with whom the physician is going to have an
agreement, has a certain level of education or training.
MS. REARDON clarified that is the view of the [Alaska State]
Medical Board. She interpreted the medical board's statement to
warn physicians that they will have to report to the board if
they are not careful in their relationships.
Number 0258
REPRESENTATIVE JAMES asked if the Dental Board and the [Alaska
State] Medical Board would have to pass similar regulations in
order to make this [collaborative agreement with pharmacists]
work.
MS. REARDON related her belief that if the [Alaska State]
Medical Board and the Dental Board are quiet, then these
agreements could go forward. If these other entities do take
action, they may choose to limit what their professionals can
do.
MS. BEHR noted that she had not reviewed the regulations.
However, she pointed out that there is always the ability to
monitor for professional misconduct. If [pharmacists] didn't
use their license appropriately, the board can always sanction
them for inappropriate professional conduct, which the board
must define. "So, there's two pieces to this. One is: the go
forth for the future and then the second is: if you don't have
a regulation in action, can the board take action on their
existing regs for someone acting inappropriately outside the
scope of their license?"
CHAIR McGUIRE pointed out that the Alaska Medical Association
takes the position that it doesn't have the statutory authority
to adopt these regulations.
MS. REARDON explained that DOL will review whether this
regulation has the statutory authority to allow [the
collaborative agreement] to go forward. Ms. Reardon suspected
that DOL would review whether the statutes for pharmacists,
dentists, and doctors allow [collaborative agreements]. She
surmised that [DOL would also review] whether this collaborative
agreement would amount to a delegation of the practice of
medicine or dentistry. Ms. Reardon said that in her view that
it wasn't clear that [a collaborative agreement] is a delegation
of the practice of dentistry or medicine.
TAPE 01-2, SIDE A
Number 0030
REPRESENTATIVE JAMES said that it seems that there is going to
be some decision-making that will be done by the pharmacist and
thus would seem to be a delegation of decision-making. She
didn't believe that [as many people] would get the flu shot if
they had to go to the doctor to do so. However, she expressed
concern with treating diabetics. She expected that the protocol
for diabetic treatment at a pharmacy would be specific to that
diabetic. This could be the case in other treatments, such as
the monitoring of blood work, cholesterol, et cetera. However,
she didn't expect that this would give a pharmacist a "blank
check." Therefore, Representative James wanted to be sure that
the regulations don't allow a physician to spread his disliked
cases to the pharmacist. She emphasized the need to ensure that
everyone in Alaska receives the best medical care possible.
Number 0266
MS. REARDON remarked that she could imagine a reading of these
regulations that said [the collaborative agreement] isn't a
delegation because the protocol could be perceived as a
prescription. It could be said that the pharmacist is
administering or distributing the physician's prescription.
REPRESENTATIVE JAMES commented that she could support that.
CHAIR McGUIRE noted her support of that also. However, she
pointed out that pharmacists have dependent prescriptive
authority and thus there could be a legal challenge.
REPRESENTATIVE HAYES reiterated that although there are no
[collaborative agreement] regulations, this is the current
practice and there has yet to be a lawsuit.
MS. REARDON agreed, but pointed out that "sometimes you think
more when it gets on top of the table." What people are doing
will be written down [in the regulations] and may lead to
questions.
Number 0416
BARRY CHRISTENSEN, Pharmacist, testified via teleconference. He
informed the committee that he was the president of the Alaska
Pharmaceutical Association when the last Pharmacy Practice Act
statutes were revised in 1996/1997. He remarked that those
statutes were modeled after the National Association of Boards
and Pharmacy Statute Guidelines. Alaska's statutes mirror the
statutes of most of the other states, specifically the 30 states
that have protocol-type agreements. Thus, Mr. Christensen
expressed concern that [without these collaborative agreement
regulations] Alaskan pharmacists are not the same as pharmacists
in other states.
MR. CHRISTENSEN informed the committee of a management agreement
that is occurring on a national level. This management
agreement deals with a drug for treating patients that are
resistant to typical schizophrenic drugs. This drug requires
that the patient have his/her white blood count taken every one
to two weeks in order to ensure that the drug isn't adversely
affecting the body's ability to produce white blood cells. The
drug is dispensed with an agreement between the pharmacist, the
physician, and the drug manufacturer that the pharmacist will
have the lab values from the patient's last blood draw in order
to ensure that the patient's white blood count is over the
acceptable level in order for the pharmacist to dispense the
drug. Mr. Christensen stated that this is an example of [a
collaborative agreement] that is already occurring and would be
validated by the adoption of the proposed regulations.
CHAIR McGUIRE said that she would appreciate continued contact
with Mr. Christensen on the aforementioned management agreement.
ADJOURNMENT
There being no further business before the committee, the Joint
Committee on Administrative Regulation Review meeting was
adjourned at 11:21 a.m.
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