Legislature(2015 - 2016)CAPITOL 106
03/15/2016 03:00 PM House HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| HB260 | |
| HB262 | |
| HB344 | |
| HB234 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | HB 344 | TELECONFERENCED | |
| += | HB 260 | TELECONFERENCED | |
| *+ | HB 234 | TELECONFERENCED | |
| += | HB 237 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | HB 262 | TELECONFERENCED | |
HB 344-DRUG PRESCRIPTION DATABASE
3:48:31 PM
CHAIR SEATON announced that the next order of business would be
HOUSE BILL NO. 344, "An Act relating to the controlled substance
prescription database; and providing for an effective date."
3:48:48 PM
REPRESENTATIVE VAZQUEZ moved to adopt the proposed committee
substitute (CS) for HB 344, labeled 29-LS1378\N, Bruce, 3/14/16,
as the working draft.
CHAIR SEATON objected for discussion.
3:49:25 PM
TANEEKA HANSEN, Staff, Representative Paul Seaton, Alaska State
Legislature, stated that this version added a seven day limit to
initial opiate prescriptions; it limited the prescription drug
monitoring program to only Schedule II, III, and IV drugs;
changed the reporting requirement for the database from "near
real time" to "at least weekly;" changed the mandatory review of
the database from only dispensers to include dispensing,
prescribing, or administering of controlled substances, with
some exceptions; restricted the delegation of authority or
access or the ability to submit information to the database to
only licensed or registered employees; directed the Department
of Commerce, Community & Economic Development to establish
registration fees to cover the costs of data base operation, if
no federal grants are established; and changed transition
language to give regulatory authority to the Department of
Commerce, Community & Economic Development, with a more
immediate effective date. She paraphrased from the "Summary of
Changes: Version H to Version N" [included in members' packets],
which read:
Title
On lines 2- 4 the title has been expanded to include
'relating to the prescription f opiates; relating to
the practice of dentistry; relating to the practice of
medicine; relating to the practice of nursing;
relating to the practice of optometry; relating to the
practice of veterinary medicine' to reflect the
inclusion of seven day prescription restriction.
Section 1-12
New sections 1-12 were added to limit opiate
prescriptions under the following boards; dentistry,
medicine, nursing, and optometry. Under each board, an
initial opiate prescription is limited to seven days
unless the practitioner documents a logistical or
medical need for a longer supply, and prescriptions in
excess of the dosage without documented reasons can be
grounds for disciplinary action. Additional language
was added to section 1 (Board of Dental Examiners),
section 7 (Board of Nursing), and section 10 (Board of
Optometry) allowing disciplinary action if drugs are
dispensed, prescribed or sold drugs in violation of
law regardless of whether there has been criminal
actions. This mirrors existing language in the State
Medical Board (section 4).
3:53:32 PM
REPRESENTATIVE WOOL asked why the Board of Veterinary Medicine
had been included.
MS. HANSEN explained that the adult seven day limit had not been
added to Board of Veterinary Examiners, although the
disciplinary language had been added because, as all
practitioners were required to submit information on controlled
substances to the boards, this included the Board of Veterinary
Examiners as they are able to provide opiates. She relayed an
anecdote about the increase in opiates being prescribed for
animals.
CHAIR SEATON referenced the maximum dosage and asked whether
this was for the number of pills prescribed or for a milligram
limitation.
MS. HANSEN replied that the limitation was for the number of
pills, and not for the dosage level.
CHAIR SEATON reported that, although some states had limited the
milligrams per pill as recommended by the CDC, the focus of the
proposed bill was a concern for opioid addiction and the
duration of the prescriptions.
3:56:54 PM
MS. HANSEN moved on to address Section 13 and Section 14, which
read:
Section 13
This new section adds language to the Board of
Veterinary Examiners allowing disciplinary action if
drugs are dispensed, prescribed or sold drugs in
violation of law regardless of whether there has been
criminal actions. This mirrors existing language in
the State Medical Board (section 4).
Section 14
Language referencing the state controlled substance
schedules and federal schedules I and V has been
removed; this will limit the database to only drugs in
the federal schedules II, III, and IV. Language
regarding the Department of Commerce, Community, and
Economic Development assisting the board of pharmacy
with implementing the database has been moved to a
later section.
3:57:44 PM
MS. HANSEN discussed Section 15 and Section 16, which read:
Section 15
Language referencing the state controlled substance
schedules and federal schedules I and V has been
removed; this means the database will only be accessed
for drugs in the federal schedule II, III, and IV. The
reporting requirement in this section has changed,
from near-real-time to at least weekly.
Section 16
AS 17.30.200(d)(3) has been amended to state that a
licensed or registered practitioner with prescription
authority is allowed access to the database. This is
intended to capture practitioners in federal
facilities that are not required to be licensed with
the state but that may be registered.
3:59:04 PM
MS. HANSEN addressed Section 19, which read:
Section 19
Language directing dispensers to access the database
prior to dispensing and to report the prescription at
near real time has been deleted and replaced with
subsections k (3), k (4), and k (5) requiring all
practitioners to check the database prior to
dispensing, prescribing, or administering schedule II,
III, or IV controlled substances but creating
exemptions for emergent situations, surgery or medical
procedures. This section also creates alternate
procedures for practitioners with technological
barriers, previously included in a later section.
4:00:36 PM
MS. HANSEN directed attention to Section 20, which read:
Section 20
The language previously in subsection (o), creating a
technology exemption, has been moved to section 18.
The remaining subsections have been reordered.
Subsection (p) (previously subsection q) has been
amended to reflect that the database has been limited
to only schedule II, III, or IV controlled substances.
A new subsection (q) has been added to state that a
practitioner may only delegate database access or
information submittal to an agent or employee who is
who is licensed or registered in the state.
Subsection (r) directs the Department of Commerce,
Community, and Economic Development to notify each
board when a practitioner registers with the database
(previously required of the Board of Pharmacy). The
Board of Veterinary Examiners was added to assist the
Board of Pharmacy in implementing this section,
language that was previously under AS 17.30.200(a).
Additionally, the department shall establish
regulations for registration with the database, which
will cover the cost of the database minus all federal
funds.
4:02:01 PM
MS. HANSEN discussed Section 21, which read:
Section 21
The transition regulatory authority has been expanded
from just the Board of Pharmacy to now include the
Department of Commerce, Community, and Economic
Development and each board whose licensees will be
required to register.
4:02:24 PM
MS. HANSEN paraphrased Section 22, the new Subsection 23, and
Section 24, which read:
Section 22
The transition language has been amended to require
the Board of Pharmacy to provide information and
training on this act to the other boards. Subsection
(b) has been deleted.
New Subsection 23
New subsection 23 has been added which will enact AS
17.30.200(r) in September 1, 2016. This is the section
the Department to establish registration fees.
Section 24
The effective date (relating to transition language)
has been amended to take effect immediately.
4:03:42 PM
MS. HANSEN concluded with Section 25, which read:
Section 25
The effective date of the bill has been amended to
July 1, 2017.
MS. HANSEN, in response to Representative Wool, said that
previously all state and federally controlled substances were
included, whereas now it was limited to Schedule II, III, and IV
drugs of the federal schedule. She stated that all the drugs in
the federal Schedule I were illegal, and Schedule V drugs
included cough medicine and Tylenol with Codeine.
CHAIR SEATON relayed that Schedule IV included benzodiazepine,
whereas Ritalin was a Schedule II drug.
REPRESENTATIVE WOOL asked for clarification that benzodiazepine
was previously on the database requirement, pointing out that
earlier testimony had indicated that it, in combination with
opiates, "was a very bad combination." He asked if many of
these drugs would fall into the category for an initial 7-day
limit to the prescriptions.
MS. HANSEN relayed that the 7-day limit was specific to opiates;
however, reporting to the database included all controlled
substance in Schedules II, III, or IV. She pointed out that the
7-day limit would not apply to any refill for a chronic illness.
REPRESENTATIVE VAZQUEZ asked how the 7-day limit would work in
the rural villages.
MS. HANSEN directed attention to Section 2 of the proposed CS,
Version N, which described the maximum dosage for opiate
prescriptions. Pointing to page 3, line 27, she read:
a patient who is unable to access a practitioner
within the time necessary for a refill of the seven-
day supply because of a logistical or travel barrier;
the licensee may write a prescription for an opiate
for the quantity needed to treat the patient for the
time that the patient is unable to access a
practitioner.
MS. HANSEN relayed that, for an adult, this would just apply to
the initial prescription, and if diagnosed with a chronic issue
requiring a longer prescription, the refills would not have this
same requirement.
4:09:01 PM
SUSIE EDWARDSON, Staff, Representative Paul Seaton, Alaska State
Legislature, reported on the recommendations from Centers for
Disease Control and Prevention (CDC), which included that 3 days
or less was sufficient for opiate prescriptions, while more than
7-days would rarely be necessary. She shared that a recent bill
in Massachusetts limited initial opioid prescriptions to a 7-day
supply, while also requiring practitioners to check the database
for drugs which have a high potential for abuse, and that Maine
was working on a similar bill which would set a 3-day limit.
She stated that another CDC recommendation was for clinicians to
review a patient's history for controlled substance
prescriptions. She noted that a CDC recommendation not included
in the proposed bill was to limit dosage to 5 morphine milligram
equivalent (MME) daily, while limiting any increase of dosage to
90 MME.
CHAIR SEATON pointed out that, although CDC had also recommended
that any dosage over 90 MME should be noted on the prescription,
the proposed bill did not include this recommendation.
REPRESENTATIVE WOOL suggested that the prescription for a horse
may exceed this.
CHAIR SEATON added that federal practitioners were not required
to be licensed in Alaska, hence the addition of "registered" to
the proposed bill.
4:12:54 PM
CHAIR SEATON removed his objection.
There being no further objection, the proposed committee
substitute Version N was adopted as the working draft.
4:13:45 PM
CHAIR SEATON moved to adopt proposed Amendment 1, labeled 29-
LS1378\N.1, Bruce, 3/14/16, which read:
Page 13, lines 18 - 19:
Delete "database at least weekly [BOARD]"
Insert "board, at least weekly"
Page 13, line 20:
Delete "[FOR INCLUSION IN THE DATABASE]"
Insert "for inclusion in the database"
Page 18, following line 3:
Insert a new subsection to read:
"(s) The board shall, on a weekly basis, update
the database with the information submitted to the
board under (b) of this section."
REPRESENTATIVE VAZQUEZ objected for discussion.
4:13:59 PM
MS. HANSEN explained the proposed amendment, stating that it
clarified that practitioners and dispensers would submit
information to the board at least weekly, and that the board was
required to update the database with the submitted information
at least weekly.
4:15:10 PM
The committee took an at-ease from 4:15 p.m. to 4:17 p.m.
4:17:11 PM
REPRESENTATIVE VAZQUEZ removed her objection. There being no
further objection, Amendment 1, labeled 29-LS1378\N.1, Bruce,
3/14/16, was adopted.
MS. HANSEN explained that some of the written testimony had
mentioned that the requirement for a mandatory review for all
controlled substances could be onerous for some practitioners.
There had been a suggestion to limit the review of Schedule IV
to just benzodiazepine because of its aforementioned interaction
with other drugs, although further review had indicated that
other Schedule IV drugs had adverse interactions with opiates.
CHAIR SEATON declared that he wanted to ensure that the public
comments had been considered. He offered his belief that it was
better, and less confusing, to include all the Schedule II, III,
and IV drugs.
REPRESENTATIVE WOOL asked to hear from the Alaska Pharmacists
Association, noting that some of the drugs in and of themselves
were not dangerous. He expressed the need for a database for
opiates.
CHAIR SEATON said that public testimony would be opened up
again. He stated that he wanted to get the issues on the record
for consideration prior to public testimony.
MS. HANSEN suggested that the proposed bill state that the
database must be reviewed prior to dispensing, prescribing, or
administering a controlled substance. The regulation must
provide that the practitioner is not required to review the
information in the database before dispensing, prescribing, or
administering a controlled substance for less than a 3-day
supply. She stated that this would include all controlled
substances, and should alleviate some of the concerns for the
burden.
CHAIR SEATON reflected that a 3-day supply was enough for most
people, and asked whether doctors would prescribe the lesser
amount. He offered his belief that the issue was a result of
too long a course for opioid prescriptions. He asked for input
from the committee.
REPRESENTATIVE WOOL mused that some drugs were stronger than
others, and, as not all drugs were measured in MME, it was
difficult to micromanage the prescriptions.
CHAIR SEATON pointed out that this was an exception and, by
controlling the initial prescription, was an attempt to limit
opioid addiction in the state.
REPRESENTATIVE VAZQUEZ asked for testimony from Dr. Butler.
4:28:16 PM
JAY BUTLER, MD, Chief Medical Officer/DPH Director, Central
Office, Division of Public Health, Department of Health and
Social Services, opined that it was a difficult issue to
maintain access to appropriate care for pain yet prevent misuse
of the drugs, with the unintentional risk for overdose. He
suggested an additional exemption for a supply of less than x
number of days, pointing out that the CDC guidelines for 3-days
or less were often sufficient, whereas more than 7-days was
rarely needed. This exemption for less than 7-days could be
more acceptable to many providers, while not creating any
unintentional barriers to the treatment of pain.
CHAIR SEATON mused that the proposed bill stated that the
initial prescription could not be longer than 7-days, and asked
if anything under 7-days should be exempt.
DR. BUTLER relayed that he was speaking specifically to the
requirement for the review of the database. He acknowledged
that this could be for a shorter time frame, although he was
trying to strike a balance for not being overly burdensome or
creating barriers to treatment for acute pain. He said that it
was not entirely clear for prescriptions to outpatient
procedures in advance of the procedure.
CHAIR SEATON suggested that this would be covered under a less
than 3-day exemption.
REPRESENTATIVE VAZQUEZ asked for clarification, was this less
than 3 days, or 3 days or less.
DR. BUTLER replied that there was nothing really magic in
either, that the reference had been to the CDC guidelines, which
read, 3 days or less will often be sufficient in treatment of
acute pain.
CHAIR SEATON pointed out that this only applied to the initial
prescription for 7-days, not to renewals. He reported that the
prescriptions for 3-days or less without refills could also be
an issue. He stated that the exemption was not intended to
allow for open ended prescription refills of 3-days or less.
REPRESENTATIVE WOOL asked whether to include Schedule IV drugs
for the mandatory database review.
DR. BUTLER reminded the committee that there was an increased
risk of fatal overdose when opioids and benzodiazepine were co-
administered. He shared that many prescribers had stated they
prescribed Schedule IV drugs more frequently than Schedule II
drugs. He reported that the 2015 annual report had listed
238,000 prescriptions for Schedule II and III drugs, with
429,000 for Schedules II, III, and IV in the Prescription Drug
Monitoring Program (PDMP), even as the PDMP was fairly
incomplete.
CHAIR SEATON asked for clarification that the medical
recommendations was for Schedules II, III, and IV.
DR. BUTLER stated that this was a difficult question. If the
outcome were solely to reduce the risk of overdose, including
the Schedule IV drugs made a lot of sense; however, in looking
at the practicality of what could actually be done and what
providers would adopt and do, there were some reservations for
this.
REPRESENTATIVE WOOL asked if all the Schedule IV drugs, such as
Robitussin for a cough or Tylenol with codeine, would have to be
entered into the database. He asked whether it would be best to
include all of them, or limit it to select drugs, in order to
decrease the possible burden.
DR. BUTLER clarified that Robitussin was a Schedule V drug, as
was gabapentin which was used for chronic pain syndrome as it
had a very low abuse potential, and both of these were excluded.
CHAIR SEATON questioned whether 3-days or less, without refills
and exempt from the requirements, would be beneficial to the
practice of medicine. He asked about the risk for overdoses.
DR. BUTLER replied that this would be less burdensome on
providers. He stated that a situation where a very small
quantity was prescribed had a lower risk for overdose or
addiction.
4:42:00 PM
CHAIR SEATON opened public testimony.
4:42:17 PM
BARRY CHRISTENSEN, Pharmacist, Alaska Pharmacists Association,
reported that he was also the co-chair of the Legislative
committee for the Alaska Pharmacists Association. He said the
association represented over 200 pharmacists and pharmacy
technicians in the state. He declared that proposed HB 344 was
a "step in the right direction for helping opiate abuse and
prescription drug abuse in the State of Alaska." He applauded
the change from real time to weekly down loads as being more
cost effective and technologically available. He expressed
agreement that all users of the database should be licensed,
pointing out that all the pharmacy technicians working around
medications were licensed. He expressed concern that the
requirement for both prescribers and pharmacists to check the
database prior to every controlled substance prescription was
duplicative and time consuming. He pointed out that the PDMP
was only one tool used by pharmacists when trying to rule out
possible narcotic abuse. He pointed out that this would have a
big impact. He reported that real time prescription insurance
data checks were performed when processing prescriptions, as
almost 90 percent of prescriptions were done through insurance.
He stated that the 3-day prescription may have some merit.
REPRESENTATIVE WOOL asked for clarification for the statement
that it was duplicative for both the prescriber and the
dispenser to check the PDMP database. He offered his belief
that this was a good safe guard.
MR. CHRISTENSEN replied that the pharmacists have been using the
database since its onset, but that the best time to utilize the
database was before a prescription was written. He acknowledged
that there were instances when both should be checking the
database, but that professional judgement should dictate when.
REPRESENTATIVE WOOL asked which end of the database check to
make optional.
MR. CHRISTENSEN offered his belief that the pharmacist end
should be optional, as "it makes sense that it be dealt with
before the prescription is written rather than after in terms of
checking for potential abuse by the patient." He allowed that
it should be possible for pharmacists to double check when "we
do have warning flags come up."
CHAIR SEATON asked if the option for the pharmacist to delegate
the database check would alleviate the situation.
MR. CHRISTENSEN expressed appreciation for the option, and
although it did help the situation, it still affected work flow.
REPRESENTATIVE VAZQUEZ asked when it made sense for the
pharmacist to review the database.
MR. CHRISTENSEN replied that there were several times, including
when there was a new patient, multiple prescriptions for
narcotics, or a large quantity of narcotics. He added that
patient refusal to use insurance also raised concerns.
CHAIR SEATON shared the concern that availability of the
database, without any requirement to check it, had not been
sufficient to stop the availability of many prescription
medications. He reported that the proposed bill was also an
attempt to include the prescribers.
REPRESENTATIVE VAZQUEZ asked for his opinion about the 3-day or
less exemption.
MR. CHRISTENSEN relayed that, although this would ease the
burden "on a certain number of prescriptions," he was unsure for
how much it would decrease the work load. He pointed out that
they would most likely have not looked at the database for those
prescriptions anyway.
REPRESENTATIVE WOOL asked if the aforementioned "flags" were in
the database.
MR. CHRISTENSEN replied that most flags were through the
insurance system, reiterating that almost 90 percent of the
prescriptions were processed on-line at the time of dispensing.
He agreed that those flags would also show up on the PDMP
database.
4:54:59 PM
JERRY BROWN, Pharmacist, echoed some of the earlier comments,
including the removal of pharmacists for the mandatory
requirement to check the database for every narcotic
prescription. He offered his belief that it was not necessary
to be checked every time. He stated that he had problems with
the 7-day and the 3-day quantity, as prescribers would not check
the database. He suggested to use a 5-day supply instead. He
declared that there would always be a flag when checking the
data base because of the limited initial prescription amount,
and that additional time would be spent making a determination
for whether this was overprescribing or a restriction on the
prescription. He reported that, under Medicaid, the first
pharmacist was paid a dispensing fee for the first prescription,
but a second pharmacy did not receive any dispensing fee,
thereby being placed at a greater financial disadvantage. He
pointed to the difficulties presented by shorter initial
prescriptions when living in a remote area. He suggested that
5-day prescriptions were not so onerous for the patient.
MR. BROWN said that exempting emergency rooms and the
prescribers for a 3-day or 5-day supply would remove the
database checks. He stated that the proposed bill was micro
managing the professions of medicine and pharmacy, but it did
not help for the actual problem, the writing of the
prescription. He stated that the proposed bill actually
exempted that group from compliance for checking the database,
which was its purpose.
5:02:31 PM
DANIEL NELSON, President, Alaska Pharmacists Association, Tanana
Chiefs Conference, echoed the earlier comments, stating that the
requirement for mandatory PDMP queries by pharmacists and
prescribers was overly onerous and micro managing the practice
of medicine and pharmacy. He recommended that the language be
removed from the proposed bill. He stated that this was a
duplicative process, and there was not any rationale for the
pharmacist to check after the prescriber had done so. He stated
that 10 - 12 percent of prescriptions written were for
controlled substances. He estimated that it would take two to
three minutes per query, which was 3 - 4.5 hours daily in his
pharmacy. He reported that Alaska had one of the lowest per
capita prescriptions of opioids in the United States.
5:05:49 PM
CHAIR SEATON closed public testimony on HB 344 after
ascertaining no one further wished to testify.
[HB 344 was held over.]