Legislature(2017 - 2018)BELTZ 105 (TSBldg)

03/14/2017 01:30 PM LABOR & COMMERCE

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ SB 64 UNIFORM ENVIRONMENTAL COVENANTS ACT TELECONFERENCED
Heard & Held
-- Public Testimony --
*+ SB 79 OPIOIDS;PRESCRIPTIONS;DATABASE;LICENSES TELECONFERENCED
Heard & Held
-- Public Testimony --
*+ SB 37 PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC TELECONFERENCED
Heard & Held
-- Public Testimony --
Bills Previously Heard/Scheduled:
-- Public Testimony --
+= SB 4 NON-CHEMICAL BARBERING;HAIR BRAIDING TELECONFERENCED
Moved SSSB 4 Out of Committee
+= SB 16 FIDUCIARY ACCESS TO DIGITAL ASSETS TELECONFERENCED
Moved SB 16 Out of Committee
+= SB 32 PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS TELECONFERENCED
Moved SB 32 Out of Committee
         SB 37-PHARMA BD & EMPLOYEES; DRUG DIST/MANUFAC                                                                     
                                                                                                                                
3:01:47 PM                                                                                                                    
CHAIR COSTELLO  announced the consideration  of SB 37.  She noted                                                               
this  is the  first  hearing.  The intent  is  to  hear from  the                                                               
sponsor,  take members'  questions,  take  public testimony,  and                                                               
hold the bill for further consideration.                                                                                        
                                                                                                                                
3:02:40 PM                                                                                                                    
SENATOR CATHY  GIESSEL, Alaska State  Legislature, sponsor  of SB
37, said she appreciates teaming SB  79 with SB 37. She noted the                                                               
bill is at the request of the Board  of Pharmacy. It is not a new                                                               
issue; a similar bill was heard last session.                                                                                   
                                                                                                                                
She stated that SB 37 ensures  a more secure drug supply chain to                                                               
ensure    that    Alaskans   receive    safe,    non-counterfeit,                                                               
unadulterated medications.  In Alaska,  when a  pharmacy, doctor,                                                               
or  hospital orders  a supply  of prescription  medications, they                                                               
may order  from one  of the wholesale  distributors in  Alaska or                                                               
one in the  Lower 48. Alaska is  one of two states  that does not                                                               
license    out-of-state   wholesale    distributors.   In    2012                                                               
contaminated  medicines were  distributed  that  resulted in  the                                                               
death of  many people in the  Lower 48. To protect  Alaska, SB 37                                                               
would  ensure that  out-of-state  applicants  seek licensure  and                                                               
comply with  the same  regulations Alaska  wholesale distributors                                                               
comply with.                                                                                                                    
                                                                                                                                
She said  that SB 37  also brings  Alaska into compliance  with a                                                               
federal law  - the Drug Quality  Security Act of 2013  - and will                                                               
create a  new license  category under the  Board of  Pharmacy for                                                               
out-of-state    wholesale   distributors.    The   Division    of                                                               
Corporations,  Business,  and  Professional  Licensing  estimates                                                               
that  this will  equal about  400 new  licensees. Currently,  the                                                               
Alaska Board  of Pharmacy  has no  authority to  regulate out-of-                                                               
state wholesale  distributors and  SB 37  would provide  that. It                                                               
would require  certain guidelines  for the distributor:  obtain a                                                               
license  in Alaska,  authorize inspection  by a  designee of  the                                                               
Board, and  give the Board the  authority to appoint an  agent to                                                               
examine the distributor's facility.                                                                                             
                                                                                                                                
She highlighted the  definition section of the  bill, noting that                                                               
one  definition -  "outsourcing facility"  - is  a facility  that                                                               
compounds  sterile drugs.  It is  an  example of  an entity  that                                                               
would fall under SB 37.                                                                                                         
                                                                                                                                
3:05:55 PM                                                                                                                    
SENATOR  GIESSEL advised  that  the Board  of  Pharmacy is  being                                                               
asked  to take  on  more responsibilities.  Last  year under  the                                                               
Medicaid reform  bill the Prescription Drug  Monitoring [Program]                                                               
(PDMP) was  established, which puts more  responsibilities on the                                                               
Board.  SB  37  will  allow  the Board  to  create  an  executive                                                               
administrator position to implement  statutes and regulations and                                                               
manage the Board's new responsibilities.                                                                                        
                                                                                                                                
She noted a fiscal note for  SB 37 and that the services provided                                                               
are  all  receipt  services. Monies  will  be  recovered  through                                                               
wholesale license fees and  the executive administrative position                                                               
will be funded by licensees of the Board of Pharmacy.                                                                           
                                                                                                                                
CHAIR  COSTELLO noted  that Sara  Chambers from  the Division  of                                                               
Corporations,  Business, and  Professional Licensing,  Department                                                               
of Commerce, Community and Economic  Development was available to                                                               
answer questions.                                                                                                               
                                                                                                                                
3:07:45 PM                                                                                                                    
JANE  CONWAY,   Staff,  Senator   Cathy  Giessel,   Alaska  State                                                               
Legislature, presented the sectional analysis  of SB 37 on behalf                                                               
of the sponsor. She read the following:                                                                                         
                                                                                                                                
     Section 1: Amends AS 08.80.030(b)                                                                                        
                                                                                                                              
     (14): Amends  and allows  licensing and  inspection for                                                                  
     out-of-state   drug    distributors   and   outsourcing                                                                    
     facilities                                                                                                                 
     (15):   Establishes   qualifications  and   duties   of                                                                  
     executive  administrator.  Executive  administrator  is                                                                    
     delegated authority in order to conduct board business                                                                     
                                                                                                                                
     Section  2:  Amends  AS  08.80.030   by  adding  a  new                                                                  
     subsection:                                                                                                              
                                                                                                                              
     AS   08.80.030(c):   Specifications   for   facilities,                                                                  
     equipment,  personnel, and  procedures  for control  of                                                                    
     drugs in compliance with the  federal Drug Supply Chain                                                                    
     Security Act.                                                                                                              
                                                                                                                              
     Section  3:  Amends  AS  08.80.157   by  adding  a  new                                                                  
     subsection:                                                                                                                
     (k):  Applies   to  wholesale  drug   distributors  and                                                                  
     outsourcing  facilities  outside  the  state  under  AS                                                                    
     08.80.159, regarding licensing.                                                                                            
                                                                                                                                
     Section 4: Amends AS 08.80 by adding a new section:                                                                      
     Sec.   08.80.159:  Requires   that  a   wholesale  drug                                                                  
     distributor or  outsourcing facility have a  license in                                                                    
     Alaska   before   shipping,  mailing,   or   delivering                                                                    
     prescription  drugs  to  a licensee  in  the  state  or                                                                    
     before advertising in the state,  that an agent must be                                                                    
     appointed in  the state,  and a  designee of  the board                                                                    
     must authorize inspection of the facility.                                                                                 
                                                                                                                                
     An outsourcing facility, in  addition, must comply with                                                                    
     the  federal Drug  Quality and  Security  Act of  2013.                                                                    
     The  board  may  require an  inspection  of  facilities                                                                    
     located  outside of  the state,  approve a  designee to                                                                    
     inspect.   The  board   shall   adopt  regulations   to                                                                    
     implement this section.                                                                                                    
                                                                                                                                
3:09:53 PM                                                                                                                    
     Section 5:  Amends AS  08.80 by  adding new  section to                                                                  
     Article 2:                                                                                                               
                                                                                                                              
     Sec.  08.80.270:   Allows  the   Board  to   create  an                                                                  
     executive administrator  position. Defines the  role of                                                                    
     the executive administrator.                                                                                               
                                                                                                                                
     Section  6:  Amends  AS  08.80.480   by  adding  a  new                                                                  
     paragraph:                                                                                                               
                                                                                                                              
     AS 08.80.480(37): Defines "outsourcing facility"                                                                         
                                                                                                                                
3:10:26 PM                                                                                                                    
SENATOR  STEVENS  asked  if Alaska  wholesalers  receive  federal                                                               
inspections and inspections by other states.                                                                                    
                                                                                                                                
SENATOR  GIESSEL said  she  did not  know.  She suggested  asking                                                               
pharmacists.                                                                                                                    
                                                                                                                                
3:11:00 PM                                                                                                                    
SENATOR  GARDNER asked  about reciprocity  and  why Alaska  can't                                                               
rely on inspection  standards of other states  for wholesale drug                                                               
companies.                                                                                                                      
                                                                                                                                
3:11:33 PM                                                                                                                    
SENATOR GIESSEL said  she did not know. She  suggested asking the                                                               
pharmacists.  She said  one provision  in  the bill  is that  the                                                               
Board could  designate someone in  another state to  examine that                                                               
state's wholesaler.                                                                                                             
                                                                                                                                
SENATOR GARDNER asked how much  medication is brought into Alaska                                                               
by wholesalers and how many wholesalers are in Alaska.                                                                          
                                                                                                                                
SENATOR  GIESSEL  said  she  believes   there  is  one  wholesale                                                               
distributor in Alaska.                                                                                                          
                                                                                                                                
3:13:23 PM                                                                                                                    
CHAIR COSTELLO  opened public testimony  on SB 37.  She requested                                                               
that Mr. Christensen address members' questions.                                                                                
                                                                                                                                
BARRY  CHRISTENSEN,  Co-Chair,  Alaska  Pharmacists  Association,                                                               
testified in  support SB 37.  He deferred  to Mr. Holm  to answer                                                               
members' questions. He said the  bill is necessary to ensure that                                                               
Alaskans  are  receiving good  medications.  He  agreed that  the                                                               
Board of  Pharmacy has  been taxed with  doing more  with minimal                                                               
staffing. He  supported having an executive  administrator on the                                                               
Board.                                                                                                                          
                                                                                                                                
3:15:00 PM                                                                                                                    
LEIF HOLM, Chair,  Board of Pharmacy, testified in  support of SB
37. He reiterated the purpose of  the bill. He voiced support for                                                               
the executive  assistant position  due to the  increased workload                                                               
of the Board. He repeated  the funding mechanisms outlined in the                                                               
fiscal note.                                                                                                                    
                                                                                                                                
SENATOR  STEVENS  asked,  if   the  federal  government  inspects                                                               
wholesalers  in  Alaska,  why  there  is  a  need  for  an  extra                                                               
inspection. He also wondered whether  other states inspect Alaska                                                               
wholesalers.                                                                                                                    
                                                                                                                                
MR. HOLM clarified that the bill  is written so that Alaska "may"                                                               
do  an inspection.  He did  not  have information  on what  other                                                               
states do. He  added that there are 21 states  that recognize the                                                               
National  Association  of  the   Boards  of  Pharmacy's  Verified                                                               
Accredited  Wholesale  Distributor  Program (VAWD),  which  is  a                                                               
built-in inspection.  The Alaska  Board of Pharmacy  accepts that                                                               
as part of the licensure process.                                                                                               
                                                                                                                                
3:18:37 PM                                                                                                                    
CHAIR COSTELLO  asked if  the Board can  direct an  individual to                                                               
conduct the inspection. She asked  whether the VAWD fulfills that                                                               
requirement.                                                                                                                    
                                                                                                                                
MR. HOLM said he believes that would work.                                                                                      
                                                                                                                                
3:19:14 PM                                                                                                                    
SENATOR  GARDNER asked  if it  is  customary in  some places  for                                                               
pharmaceutical   wholesalers  to   be  licensed   to  hold   VAWD                                                               
accreditation.                                                                                                                  
                                                                                                                                
MR. HOLM  responded that four  states require  that accreditation                                                               
to do business in their state.                                                                                                  
                                                                                                                                
SENATOR  GARDNER asked  if  it  would make  sense  for Alaska  to                                                               
require VAWD certification.                                                                                                     
                                                                                                                                
MR. HOLM  said not at  this point.  Other states also  have other                                                               
extensive pharmacy  inspections that  Alaska accepts. He  did not                                                               
want to limit the drug supply, just insure its quality.                                                                         
                                                                                                                                
3:20:50 PM                                                                                                                    
SENATOR GARDNER asked  if passing SB 37 means that  if an Alaskan                                                               
pharmacist were  to purchase  drugs they would  have to  buy them                                                               
from  an Alaskan  wholesaler or  an outside  distributer with  an                                                               
Alaskan license and certificate of inspection.                                                                                  
                                                                                                                                
MR. HOLM  said he  believes they  would have  to have  an Alaskan                                                               
wholesale license.                                                                                                              
                                                                                                                                
3:22:07 PM                                                                                                                    
SENATOR HUGHES asked  Mr. Holms to explain the  current makeup of                                                               
the Board.  She wondered if  the new executive position  would be                                                               
covered by  outside license fees  and if pharmacist  license fees                                                               
will increase.  She also inquired whether  pharmacists support SB
37.                                                                                                                             
                                                                                                                                
3:23:08 PM                                                                                                                    
MR.  HOLM   related  that  the  Board's   licensing  examiner  is                                                               
backlogged with  work. The wholesale  license fee  is anticipated                                                               
to be $1,000  to $5,000, which should be more  than sufficient to                                                               
cover  the  cost  of  an  executive  administrator.  He  did  not                                                               
anticipate that pharmacist license fees will increase.                                                                          
                                                                                                                                
CHAIR  COSTELLO closed  public testimony  on SB  37 and  held the                                                               
bill in committee for further consideration.                                                                                    

Document Name Date/Time Subjects
SB 64 - Sponsor Statement.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Sectional Analysis Ver. J.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Fiscal Note DEC.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Fiscal Note DNR.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Support Background - Fact Sheet.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Support Background - Uniform Law Commission.PDF SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Support Letter - Cook Inlet Housing Auth..pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Supporting Document - DOD Response Memo.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 64 - Opposition Letter - DOD.pdf SL&C 3/14/2017 1:30:00 PM
SB 64
SB 79 - Sponsor Statement.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Sectional Analysis.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Fiscal Note DHSS.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 64.PDF SL&C 3/14/2017 1:30:00 PM
SB 64
SB 37.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 37 - Sponsor Statement.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 37 - Sectional Analysis.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 37 - Fiscal Note DCCED.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 37 - Support Letter - AKPhA.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 37 - Support Letter - Board of Pharmacy.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 37 - Supporting Background -DSCSA FDA.pdf SL&C 3/14/2017 1:30:00 PM
SB 37
SB 79 - Public Testimony.tif SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Supporting Background - Medicaid Reform PDMP Pharmacy FAQs.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 -Supporting Background - AKPDMP Report 29th Legislature.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 -Supporting Background - Medicaid Reform Controlled Substance Advisory Committee.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Support Background - Benefits and Harms of Opioids Guide from CDC.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Support Background - DHSS Bulletin.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Support Background - Guidelines for Prescribing Opioids from CDC.pdf SL&C 3/14/2017 1:30:00 PM
SB 79
SB 79 - Support Background - PDMP Guide from CDC.pdf SL&C 3/14/2017 1:30:00 PM
SB 79