Legislature(2017 - 2018)BARNES 124

04/10/2017 03:15 PM LABOR & COMMERCE

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
-- Delayed to 3:45 PM --
Moved CSHB 38(L&C) Out of Committee
-- Public Testimony --
+ Bills Previously Heard/Scheduled TELECONFERENCED
Moved CSHB 9(L&C) Out of Committee
-- Public Testimony --
Moved CSHB 124(L&C) Out of Committee
-- Public Testimony --
          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                                                               
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