Legislature(2017 - 2018)BARNES 124
04/10/2017 03:15 PM House LABOR & COMMERCE
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| Audio | Topic |
|---|---|
| Start | |
| HB9 | |
| HB38 | |
| HB124 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | HB 38 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | HB 9 | TELECONFERENCED | |
| += | HB 124 | TELECONFERENCED | |
HB 9-PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC
3:52:37 PM
CHAIR KITO announced that the first order of business would be
HOUSE BILL No. 9, "An Act relating to the Board of Pharmacy;
relating to the licensing and inspection of certain facilities
located outside the state; relating to drug supply chain
security; and creating a position of executive administrator for
the Board of Pharmacy." [Before the committee was the proposed
committee substitute (CS) for HB 9, Version 30-LS0131\J, Bruce,
4/6/17, adopted on 4/7/17 as the working document.]
CHAIR KITO opened the hearing with the continuation of invited
testimony.
3:53:28 PM
RICHARD HOLT, PharmD, Vice Chair, Board of Pharmacy, testified
in support of HB 9. He said the Board of Pharmacy is requesting
the authority to license and write regulations around that
statute to have the ability to oversee the pharmacy supply chain
of medication coming into Alaska. It is not uncommon for other
states to have similar legislation for the safety of their
patients, he pointed out. Only Alaska, Hawaii, Guam, Utah, and
Massachusetts don't have the ability to license these wholesale
distributors. The Board of Pharmacy is asking for the licensing
opportunity to take care of patients in Alaska and maintain
their safety.
DR. HOLT stated that the proposed executive administrator
position is really needed to assist the Board of Pharmacy in all
the regulations that the board is currently working on. He
noted that pharmacy continues to evolve very rapidly to things
that are being seen elsewhere in the country, but which haven't
begun to be touched upon in Alaska, which really impacts patient
safety. This legislation is very important to achieve, he said.
3:55:19 PM
REPRESENTATIVE KNOPP inquired whether he is correct in his
understanding that Alaska, Guam, and Hawaii have not set up
inspection programs.
DR. HOLT replied that the information he has from the National
Association of Boards of Pharmacy is that the last remaining
areas that have not [set up inspection programs] are Alaska,
Hawaii, Guam, Utah, and Massachusetts. He said he has been
informed that those other areas are actively working on
legislation, but the legislation is not finalized.
REPRESENTATIVE KNOPP stated it is a good bill in concept and he
is not opposed to it. However, he continued, he is reluctant to
create a position in the current fiscal climate because he is
not big on growing government. He asked why [the Board of
Pharmacy] doesn't think Alaska is adequately protected if [other
states] have an inspection process and verification of the
supply chain.
DR. HOLT responded that [the Board of Pharmacy] currently has
statutory authority to register out-of-state pharmacies and part
of that is reviewing out-of-state inspections. Some of the
inspections he has seen coming in from other states, he advised,
show him great cause to be alarmed. Some of them have little to
no detail at all, yet [the board] accepts them in that
circumstance. He noted that with professionals in this field,
licensed pharmacists, and two public members, [the board] feels
that it is its profession to protect the patients in Alaska, so
having the authority to do inspections is important.
DR. HOLT further advised that it must be kept in mind that even
if a facility has a great inspection and meets the adequacies
that [the Board of Pharmacy] would write regulations to, if
something happens [the board] still doesn't have the authority
over that wholesale distributor or other facility if there is
not this piece of legislation. He explained that if the
wholesaler shipped a drug and something happened to the patients
in Alaska, [the board] could not reprimand that facility because
the facility is out of the board's jurisdiction.
3:58:18 PM
REPRESENTATIVE WOOL noted that Massachusetts doesn't have a law
like this and it has a strong medical community. He inquired
why Massachusetts doesn't have a law like this.
DR. HOLT answered he doesn't know the current status, but he has
been told Massachusetts is working on this in light of the 2012
compounding situation in which the New England Compounding
Center was an unlicensed manufacturer of steroid medications.
Based on whether the medication was mislabeled or from
unsanitary contamination, the result was 64 people dying and 800
people sick with fungal meningitis from what this center shipped
across the country.
REPRESENTATIVE WOOL offered his understanding that HB 9 is
trying to solve a few problems, one of them being bad actors and
unclean conditions in compounding facilities, and the other
being pharmacists approached by midlevel distributors that are
often cheaper but without a way of knowing the source and
perhaps the medication being counterfeit. He recalled it was
the sourcing of the medication that was in question and not so
much the process. He said he shares Representative Knopp's
concern about having to hire someone to do more digging around
to verify these licenses. He asked whether it is possible to
avoid midlevel distributors and go with certified big
pharmaceutical distributors.
DR. HOLT replied that in his capacity with his retailer he
doesn't purchase directly. But, he advised, that would limit
the sources and options for the patients receiving those
medications, as well as impacting the economical side of a
business. The intention is not to limit business, but rather to
make sure that the sources of these compounded medications, the
wholesale distributors, and so forth are licensed. Whether it
is a clinic, hospital, or retail pharmacy, there is comfort in
knowing something about that business, he said. Right now [the
board] doesn't license them and it is unknown where things are
coming from, nothing has been looked at. He pointed out that
under HB 9 the executive administrator (EA) position would be
paid from the fees from these three licensing categories, not
just from wholesale distributors.
4:02:50 PM
CHAIR KITO closed public testimony on HB 9 after ascertaining no
one else wished to testify.
4:03:17 PM
REPRESENTATIVE JOSEPHSON commented he thinks HB 9 is a fine bill
and is a quintessential example of how the public doesn't
understand all the things that the State of Alaska does. The
bill, he continued, is a textbook example of what government
must do.
4:03:47 PM
REPRESENTATIVE WOOL moved to report CSHB 9, Version 30-LS0131\J,
Bruce, 4/6/17, out of committee with individual recommendations
and the accompanying fiscal notes. There being no objection,
CSHB 9(L&C) was reported from the House Labor and Commerce
Standing Committee.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB38 Supporting Document - 2017 Research Report 3.24.17.pdf |
HL&C 4/10/2017 3:15:00 PM |
HB 38 |
| HB0038 ver J 3.24.17.pdf |
HL&C 4/10/2017 3:15:00 PM |
HB 38 |
| HB038 Explanation of Changes version A to version J 4.10.17.pdf |
HL&C 4/10/2017 3:15:00 PM |
HB 38 |
| HB038 PowerPoint Presentation 4.10.2017.pdf |
HL&C 4/10/2017 3:15:00 PM |
HB 38 |
| HB038 ver J Sectional Analysis 4.10.2017.pdf |
HL&C 4/10/2017 3:15:00 PM |
HB 38 |
| HB038 ver J Side-by-side 4.10.2017.pdf |
HL&C 4/10/2017 3:15:00 PM |
HB 38 |