Legislature(1995 - 1996)
04/25/1995 01:45 PM Senate L&C
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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
SB 158 PHARMACISTS AND PHARMACIES
SENATOR KELLY announced SB 158 to be up for consideration.
THERESA SAGER, Legislative Aide to Senator Mike Miller, said this
legislation was brought to their attention by the Alaska
Pharmaceutical Association. She said they worked with Mr. Chris
Coursey who would give them a brief overview.
CHRIS COURSEY, Alaska Board of Pharmacy, said they had been working
on this issue for four years. He noted that the committee had a
sectional analysis in their packets that he had prepared. The
pharmacy community, some years ago, recognized the need to revise
and update the statutes which, in general, are antiquated and
obsolete. Most of the statutes are dated from the 1930's through
the 1970's and do not reflect the current practice of pharmacy. In
addition, many of the statutes have been introduced in a piecemeal
fashion and are overly restrictive or specific and would be more
appropriate addressed in regulation.
For example, 08.80.350 requires pharmacies to have reference texts
which are no longer published, requires records to be kept for five
years, while federal regulations require records to be kept for two
years, and has a grading system and examination which is obsolete.
MR. COURSEY noted there are several major omissions in the existing
statutes. Nowhere is the practice of pharmacy defined, nor are
there any provisions for the use of support personnel. There is
existing, but very vague, language in the area of discipline or
unprofessional conduct.
In Section 2, line 12 - 19, people who engage in the practice of
pharmacy needs clarification, as well as the reference to
"distribution" other than dispensing, he advised.
Number 180
Section 16 on page 7, line 17, the intent of the Board of Pharmacy
is to apply to those facilities that are currently licensed by the
Board. There is no intent to license practitioner offices, medical
clinics, etc., that are not currently licensed.
SENATOR KELLY asked on page 10, line 24, if the standards of
immorality were being lowered. MR. COURSEY said that was not the
intent, but rather they are actually broadening the ability of the
Board to discipline or sanction a licensed person.
Number 290
SENATOR SALO was concerned with the elimination of #9 and #10 which
make a controlled substance available to a person, except upon
prescription, etc. She thought that would be one of the more
serious offenses in the pharmaceutical world. MR. COURSEY
explained that controlled substances are specifically addressed in
regulations with disciplinary guidelines.
SENATOR KELLY asked if they exist in regulation only because they
are authorized by #9 and #10. SENATOR SALO noted that she thought
MR. COURSEY explained the intent of section 20 was to cover
situations in which a disciplinary action or licensing action is
taking place, in case the owner of a pharmacy, for instance, isn't
a licensed pharmacist.
Number 324
SENATOR KELLY asked what the substitution of equivalent drug
products in section 21 meant. MR. COURSEY replied that the statute
is basically the same as what exists now except that some of this
is dealt with in regulation. There is no intent to weaken or
lessen this area.
SENATOR KELLY asked, once again, if the deleted the specific
language from statute, if the Board would have to address it all.
MR. COURSEY replied they wouldn't have to.
SENATOR SALO noted that they wanted a pharmacist to have the
ability to substitute generic drugs largely for cost reasons.
SENATOR KELLY said he would like to hear from the doctors whether
or not this language is sufficient. He was concerned that this
would not allow a pharmacy to stock a whole lot of drugs if they
could get away with just stocking generic drugs.
MR. COURSEY said when the existing statute was passed, medical
doctors were the only group of practitioners who were authorized to
prescribe and dispense. At this time, we have advanced nurse
practitioners, physicians' assistants, and dispensing opticians who
dispense. The advanced nurse practitioners have dispensing
regulations within the Board of Nursing which sets the same
standards for dispensing as a pharmacist is held to.
As for enforcement, MR. COURSEY said, the Board of Pharmacy would
not be enforcing action against another practitioner group. They
do believe the Board of Pharmacy should be the entity establishing
minimum standards for dispensing of drugs such as labeling and
record keeping.
Number 403
SENATOR KELLY asked if the Board is attempting to regulate outside
of Alaska. MR. COURSEY said under 08.80.158 they register
pharmacies located outside of the state. These are essentially
mail order pharmacies that do business within the state. The new
definition of pharmacy, by referring to pharmaceutical care
services, further refines and limits the definition to apply to a
pharmacy where a licensed pharmacist is present.
SENATOR SALO said the pharmacists in her home town like this bill
and she is likely to support it, but she questioned section 22, the
confidentiality section, which wasn't there before. She was
particularly concerned with number three saying that she thought
pharmaceutical records should be as confidential as medical records
are within a doctor's office or clinic. She asked why other
persons or government agencies might have access to them. MR.
COURSEY replied that meant other persons or agencies authorized by
law, for example, the Division of Occupational Licensing, in an
investigation of a physician or pharmacy or prescription records
subpoenaed by a court.
SENATOR SALO asked, regarding number two in the confidentiality
section, if that kind of availability of records was aimed at
someone who might be abusing prescription drugs by going to several
different places. She asked if there was an intention of sharing
information between pharmacies. MR. COURSEY said this legislation
was not too involved with a person who was abusing drugs,
necessarily, but for a patient, for example, who has prescriptions
issued by multiple prescribers who may not be aware of other drugs
being prescribed.
SENATOR TORGERSON was concerned that a Board member has the
authority to go into someone's business and red line a product he
believes may be misbranded. The Board consists of five pharmacists
and two people from the general public and he thought the
professionals should be specified for this action rather than just
any Board member and section b should have some sort of official
time line. MR. COURSEY responded that he didn't have any problem
with any of his suggestions.
Number 475
SENATOR TORGERSON asked if Section 2, Number 11, to seize all drugs
or related material found by the Board to constitute danger, meant
that the Board has the authority to say an FDA approved drug is not
allowed to be prescribed in Alaska. He commented that that seemed
like very broad authority for the Board.
Referring to language on page 7, line 29, SENATOR TORGERSON asked
for an example of what would not be in the public interest. MR.
COURSEY gave the example of a pharmacy owned by a non-pharmacist
whose pharmacy license is up for renewal, but he doesn't have any
licensed pharmacist employed. SENATOR TORGERSON said that, again,
he thought that was very broad based language and wasn't in the
best interests of the public.
Number 500
SENATOR KELLY asked his staff to get a list of the repealers in
section 32. He asked what the registration fee was for pharmacists
in Alaska. MR. COURSEY replied that it was $180 per license period
(two years).
SENATOR KELLY noted that the fiscal note says the request for an
executive secretary would drive the price up. MR. COURSEY replied
that they are not requesting a secretary at this time. SENATOR
KELLY asked if he would request higher dues before it is filled.
MR. COURSEY replied yes and that they believe the Board should be
self supporting.
CATHERINE REARDON, Director, Division of Occupational Licensing,
supported the general effort of the bill to update and make more
comprehensive the pharmacy statute, but believed work was needed to
get it into shape for passage. She also noted that the intent of
the bill is not to limit the dispensing authority of physicians'
assistants, nurse practitioners, doctors, and dispensing opticians,
but the actual wording of the bill does restrict them. Mr. Coursey
also made it clear that the intent is to only apply this bill to
drug stores, but the actual wording may be broader.
If fees were to be raised for hiring an executive secretary, they
would go up $283 bi-annually. MS. REARDON said they are not
comfortable with increasing fees that much. The other costs of the
bill are relatively miner, she said - contractual services for
printing new statute and regulation books. SENATOR KELLY wanted
clarification of the fiscal note. MS. REARDON explained that the
fiscal note was above and beyond the amount that is in the budget.
She clarified that the fee would be an increase of $283.
TAPE 95-19, SIDE B
Number 590
MS. REARDON said she thought the reason the executive secretary
language was in the bill was in case they wanted to request one
through the budget process at a later time. She thought this was
a misunderstanding. If the legislature desires to give them that
position and fund it, they could do it any time without this
language.
SENATOR KELLY asked her if she meant that the legislature could
fund another position and then the licensing fees would
automatically go up, because the Boards are self supporting. MS.
REARDON agreed that is basically what happens, although it wouldn't
be instantaneous, but would happen the next time the renewal period
came around.
SENATOR KELLY asked if the section were deleted, would that remove
the fiscal note from the bill. MS. REARDON said that would remove
everything except the reprinting of statutes and regulations which
they would have to consider absorbing.
MS. REARDON explained that the reason for having the executive
secretary in the fiscal note was to let the committee know how much
one would cost.
SENATOR KELLY asked who was currently doing the clerical support
for the Board. MS. REARDON replied within the Division of
Occupational Licensing there are quite a few licensing examiners
who are range 12 positions working here in Juneau.
Number 506
MS. REARDON thought the embargo and the sealing sections needed
more work in outlining the exact process.
In reference to Senator Torgerson's comment about the Board having
the authority to prohibit the sale of drugs that weren't FDA
approved, she said. Her understanding of current Alaska law is
that pharmacies may carry non-FDA-approved drugs, because
physicians may prescribe, with informed consent of the patient,
drugs that are not FDA-approved. So she thought some thought was
needed in that area as well.
The statute currently requires fluency in spoken and written
English as a requirement for a pharmacy license. This bill
maintains that requirement, she explained. It is an unusual
requirement, but the justification is that understanding and
communicating in English are necessary to properly dispense drugs.
However, in statute, we do not require that of physicians and other
health care providers of whom the same argument might be made.
Number 465
MS. REARDON pointed out that, in addition to the repealer, the new
section 08.81.40 replaces the current reciprocity statute and,
therefore, the existing statute should be repealed.
Finally, on page 6, line 25 under reciprocity we are requiring that
we look at the requirements that the person was subject to in their
other state, perhaps 10 years before, and compare them with the
state's requirements 10 years before, which would be fairly
difficult for them to do, so they request language instead that
says, "The qualifications necessary to be licensed in this state at
this time."
One more point MS. REARDON mentioned was in section 9, removal only
for cause of Board members. The reasons are set out on page 4,
line 29, she explained, and it is their position that occupational
boards should serve at the pleasure of the governor. The current
statute does say that Board members may be removed by the Governor
for cause. This is very unusual. The Medical Board and the
Nursing Board do not contain the "for cause" criteria. The Board
has a lot of power and they feel it is important that someone have
the ability to redirect boards and their policy decisions.
Number 446
SENATOR KELLY announced a recess from 2:45 - 2:55 p.m.
MAGGIE SARBER, Ketchikan, said she was testifying on behalf of Mary
Christianson, who was not able to attend the meeting. She said the
bill they have before them represents specific statute revisions
that pharmacists across the state have endorsed to better reflect
the current practice of pharmacy in Alaska. She supported SB 158
in its entirety.
RICHARD HOLM, North Pole pharmacist and past president of the
Alaska Pharmaceutical Association, supported SB 158. He added that
they would find very few doctors or pharmacists who would object to
making generic substitutions, because to a large extent they are
already doing it under Medicaid regulations. Regarding FDA
approval, he cautioned the committee to not use language referring
to FDA approval, because it is specific to mass-produced
manufactured drug items. Historically pharmacy and practitioner
prescriber have used many preparations that are not FDA approved,
nor would they ever be. He said that definitions they use in this
statute have to be broad in nature, because of the changes that are
coming over the pharmacy industry.
KENDAL KAIHAI, Fairbanks pharmacist, said this legislation is
important for pharmacists and patients they are dealing with. The
rules governing pharmacy now make for some very difficult
situations.
SENATOR KELLY said that the committee would work on this bill and
have it before them on Thursday.
TIM BOEHMER, pharmacist at Providence Hospital, clarified that the
removal for cause (of Board members) issue was national language
and the current language is acceptable.
SENATOR KELLY asked if, in using national language, he was
referring to a model that was enacted by the National Association
of Pharmacists. MR. BOEHMER answered that was correct; it was a
model practice act that was put forward by that Association.
With the executive secretary, they intended some modification of
the current licensing examiners position to accommodate someone who
could be clearly involved in dealing with an urgent situation, like
the case in New York where tylenol was adulterated with cyanide,
when the public needs to be protected quickly.
Number 291
JACKI WARREN, Director of Pharmacy at Providence Hospital, said SB
158 is important to Alaska. She has responsibilities related to
both inpatient practice and retail pharmacy and, she said, we need
to put our Board in the position of being able to provide guidance
on how support personnel should be addressed and give them further
language that will put them in line with the model.
Page 11, Section 21 Substitution of Equivalent Drug Products needed
more clarification. She explained the way a physician controls the
dispensing process is by checking "dispensed only as written" on
the prescription.
SENATOR KELLY asked if there was another law requiring the
dispensed only as written language or could the Board of Pharmacy
change the ability of the physician to check that box. MS. WARREN
replied that she thought the language on line 22 took care of that
concern.
Number 160
JACK HEESCH, Alaska Academy of Physicians' Assistants and the
Alaska Nurses Association, supported SB 158, because they believed
the pharmacy statutes are outdated and need revision. However,
they think some of the definitions may be over-reaching.
On page 2, line 12, for instance, the practice of pharmacy (page
16, line 16) means the interpretation, evaluation, and dispensing
of prescription drug orders and drug administration, etc. They
would like additional verbiage to cover the fact that there are
people out there practicing under their own licenses who are
allowed to dispense medications and clarify that the Board of
Pharmacy is not going to be regulating nurses or physicians'
assistants or dispensing opticians.
SENATOR KELLY asked if that was the status quo. MR. HEESCH said it
was in that regard. He said the other concern they have is
specifically on page 12, line 25 which they consider somewhat
onerous, because it might require record keeping well beyond the
bounds of necessity.
Number 222
ROBERT NEIBERT, President, Alaska Pharmaceutical Association, said
the Association supports the bill whole-heartedly. He assured the
committee that as long as a physician has the dispense only as
written authority, every pharmacist understands that, unless the
product is therapeutically equivalent, they aren't going to
substitute something that is inferior. Samples fall under federal
regulations and so does record keeping, he said. The Pharmacy
Practice Act, he thought, was to make sure no one would get in
trouble with the feds if there was a major drug recall and there
needed to be a way to identify the recalled product and get it back
to the manufacturer.
SENATOR SALO asked him if the confidentiality language was part of
the national model. MR. NEIBERT replied that is where it came
from, but in reality they are finding that medicaid patients
records available to anyone using their medicaid I.D. number.
There isn't much confidentiality, because the state is demanding it
in other areas.
SENATOR SALO asked if there were circumstances where it would be
useful to have information kept for longer than two years and if it
was that much of a problem to store with today's technology. MR.
NEIBERT said prescriptions are still hard copy and take up a lot of
room. A normal prescription is only valid for 12 months to begin
with; controlled substances are good for only six months. There is
no practical reason to keep records beyond even that. Two years is
reasonable.
SENATOR SALO asked what if you're dealing with thalidomide, for
instance, with ensuing litigation. MR. NEIBERT said an example of
this type of thing is with DES which they heard nothing about over
20 years. Even a five-year limitation wouldn't have helped that.
Number 64
URSULA GAHLER, Alaska Pharmaceutical Association, said she has been
frustrated with Alaska statutes which have not kept pace with
national trends and rapidly changing technology. For example, she
said, advances in technology have made it possible for computer
controlled delivery systems which didn't even exist when the
current statutes were written. New drugs have been created, she
said, that require special handling and equipment are not currently
addressed. Current statutes required her to purchase specific,
very expensive reference texts which are not useful to her. As
statutory requirements, the Pharmacy Board has no latitude to
update pharmacy requirements such as this without legislative
approval which is a waste of money and valuable legislators' time.
Because of restrictive statutes it has been difficult and costly
for some licensed practicing pharmacists from other states to be
licensed in Alaska which limits the ability to import experienced
professional pharmacists to the state. The new statutes empower
the Pharmacy Board with the ability to adjust and regulate rapidly
changing pharmacy practices.
She noted that the people who have worked on updating the statutes
have worked over a period of four years and are well respected
experts in the profession of pharmacy and have adopted
recommendations from the National Association of Boards of Pharmacy
to fit the unique needs of Alaska.
DAVE WILLIAMS, Director, Division of Medical Assistance,
complimented the Division of Occupational Licensing on the work
related to this bill. He didn't want to leave them with the
impression that at the point of sale a person's whole record would
be flashed before every pharmacist in the state. The intent is to
let them know if there is a refill time due so there aren't early
refills and to let them know if the patient is eligible and,
therefore, might pay their bill with medicaid.
MR. WILLIAMS said that he would like to check some issues with the
Division of Public Health regarding duties of the epidemiologist
and drugs that might be compromised.
SENATOR KELLY said he would work with the sponsor, state agencies,
the Alaska Pharmaceutical Association, and the Alaska Board of
Pharmacy to come up with a version of the bill that would receive
the legislature's approval.
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