Legislature(2023 - 2024)BELTZ 105 (TSBldg)

04/24/2023 01:30 PM Senate LABOR & COMMERCE

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+= HB 51 USE OF DESIGNATED REFRIGERANTS TELECONFERENCED
Heard & Held
-- Public Testimony <Time Limit May Be Set> --
+= SB 73 REGISTER INTERIOR DESIGNERS TELECONFERENCED
Heard & Held
+= SB 94 PROFESSION OF PHARMACY TELECONFERENCED
Heard & Held
*+ SB 108 DISCRIMINATION: GENDER ID.;SEXUAL ORIENT. TELECONFERENCED
Heard & Held
-- Invited & Public Testimony --
-- <Time Limit May Be Set> --
+ Bills Previously Heard/Scheduled TELECONFERENCED
**Streamed live on AKL.tv**
                  SB 94-PROFESSION OF PHARMACY                                                                              
                                                                                                                                
1:54:01 PM                                                                                                                    
CHAIR  BJORKMAN   reconvened  the   meeting  and   announced  the                                                               
consideration  of SENATE  BILL NO.  94  "An Act  relating to  the                                                               
Board  of  Pharmacy;  relating   to  the  practice  of  pharmacy;                                                               
relating   to   pharmacies;   relating   to   prescription   drug                                                               
manufacturers;   relating  to   prescriptions  for   epinephrine;                                                               
relating to the administration of  epinephrine; and providing for                                                               
an effective date."                                                                                                             
                                                                                                                                
He stated  that this is the  third hearing of the  bill and there                                                               
is  one friendly  amendment  for the  committee  to consider.  He                                                               
invited Ms. Conway to provide a recap of SB 94.                                                                                 
                                                                                                                                
1:54:59 PM                                                                                                                    
JANE  CONWAY,   Staff,  Senator   Cathy  Giessel,   Alaska  State                                                               
Legislature,  Juneau,  Alaska,  gave  a   recap  of  SB  94.  She                                                               
explained that SB  94 updates pharmacy statutes  by bringing them                                                               
into the modern era. She said  that the Board of Pharmacy and the                                                               
Alaska  Pharmacist Association  collaborated  for  months on  the                                                               
bill  which  covers  out-of-state  pharmacies,  wholesalers,  and                                                               
distribution centers  among other  areas. SB 94  clarifies powers                                                               
for  the  Board   of  Pharmacy  and  adds   a  national  criminal                                                               
background check for pharmacists.                                                                                               
                                                                                                                                
1:56:21 PM                                                                                                                    
CHAIR  BJORKMAN found  no  questions and  requested  a motion  to                                                               
adopt the proposed amendment.                                                                                                   
                                                                                                                                
1:56:35 PM                                                                                                                    
SENATOR GRAY-JACKSON moved  to adopt Amendment 1,  work order 33-                                                               
LS0293\U.1, for SB 94.                                                                                                          
                                                                                                                                
                                                 33-LS0293\U.1                                                                  
                                                     Bergerud                                                                   
                                                      4/21/23                                                                   
                                                                                                                                
                          AMENDMENT 1                                                                                       
                                                                                                                                
     OFFERED IN THE SENATE                                                                                                      
          TO:  SB 94                                                                                                            
                                                                                                                                
     Page 1, line 2, following "manufacturers;":                                                                              
         Insert "relating to licensing and registration                                                                       
     requirements for certain wholesale drug distributors;"                                                                   
                                                                                                                                
     Page 4, following line 11:                                                                                                 
         Insert a new bill section to read:                                                                                     
      "*Sec. 4. AS 08.80.157(h) is amended to read:                                                                         
              (h)  The board may suspend, revoke, deny, or                                                                      
          refuse  to  renew the  license  of  a facility  or                                                                    
          pharmacy on the following grounds:                                                                                    
                   (1)     the  finding  by   the  board  of                                                                    
          violations  of  a  federal, state,  or  local  law                                                                    
          relating  to   the  practice  of   pharmacy,  drug                                                                    
          samples,  wholesale  or   retail  drug  or  device                                                                    
          distribution,   or   distribution  of   controlled                                                                    
          substances;                                                                                                           
                   (2)   a felony conviction  under federal,                                                                    
          state, or  local law of  an owner of  the facility                                                                    
          or pharmacy or  of an employee of  the facility or                                                                    
          pharmacy;                                                                                                             
                   (3)      the  furnishing   of  false   or                                                                    
          fraudulent  material  in  an application  made  in                                                                    
          connection  with drug  or device  manufacturing or                                                                    
          distribution;                                                                                                         
                   (4)      suspension   or  revocation   by                                                                    
          federal, state,  or local government of  a license                                                                    
          currently or previously held  by the applicant for                                                                    
          the  manufacture  or   distribution  of  drugs  or                                                                    
          devices, including controlled substances;                                                                             
                   (5)    obtaining  remuneration by  fraud,                                                                    
          misrepresentation, or deception;                                                                                      
                   (6)   dealing with drugs  or devices that                                                                    
          are known or  should have been known  to be stolen                                                                    
          drugs or devices;                                                                                                     
                   (7)   dispensing or distributing drugs or                                                                    
          devices directly  to patients by a  wholesale drug                                                                    
          distributor other than a pharmacy unless                                                                          
                        (A)  the drug or device is a                                                                        
             dialysate, drug composed solely of fluids,                                                                     
             electrolytes, and sugars, or device that is                                                                    
                                (i)  necessary to perform                                                                   
                    home dialysis;                                                                                          
                                (ii)  approved by the United                                                                
                    States Food and  Drug Administration, as                                                                
                    required by federal law; and                                                                            
                                (iii)    delivered   in  its                                                                
                    original, sealed,  and labeled packaging                                                                
                    only upon  the receipt of  a physician's                                                                
                    order; and                                                                                              
                        (B)  the wholesale drug distributor                                                                 
                                (i)  delivers  the dialysate                                                                
                    drug  or device  directly  to a  patient                                                                
                    with end-stage renal  disease, or to the                                                                
                    patient's  designee,  for the  patient's                                                                
                    self-administration      of     dialysis                                                                
                    therapy;                                                                                                
                                (ii)     uses  a   bar  code                                                                
                    scanning    and   verification    system                                                                
                    confirming  that the  dialysate drug  or                                                                
                    device  selected  to fill  the  patient-                                                                
                    specific  order matches  the information                                                                
                    on the patient-specific label; and                                                                      
                                (iii)       has   additional                                                                
                    secondary  accuracy and  delivery checks                                                                
                    in place; and                                                                                           
                        (C)  a licensed pharmacist serves                                                                   
             as a consultant to the wholesale drug                                                                          
             distributor to                                                                                                 
                                (i)  conduct a retrospective                                                                
                    audit  of 10  percent  of the  dialysate                                                                
                    drug   and    device   orders   provided                                                                
                    directly  to patients  processed by  the                                                                
                    wholesale drug  distributor every month;                                                                
                    and                                                                                                     
                                (ii)  perform assessments at                                                                
                    least  twice monthly  to ensure  quality                                                                
                    of   product   storage,  handling,   and                                                                
                    distribution   by  the   wholesale  drug                                                                
                    distributor,   and  to   ensure  product                                                                
                    expiration  dates are  later than  three                                                                
                    months after the date of assessment;                                                                  
                   (8)  violation of this chapter or a                                                                          
          regulation adopted under this chapter."                                                                               
                                                                                                                                
     Renumber the following bill sections accordingly.                                                                          
                                                                                                                                
     Page 9, line 20:                                                                                                           
          Delete "sec. 18"                                                                                                      
          Insert "sec. 19"                                                                                                      
                                                                                                                                
     Page 9, line 21:                                                                                                           
          Delete "sec. 18"                                                                                                      
          Insert "sec. 19"                                                                                                      
                                                                                                                                
     Page 9, line 31:                                                                                                           
          Delete "Section 20"                                                                                                   
          Insert "Sections 4 and 21"                                                                                            
                                                                                                                                
     Page 10, line 1:                                                                                                           
          Delete "sec. 21"                                                                                                      
          Insert "sec. 22"                                                                                                      
                                                                                                                                
CHAIR BJORKMAN asked Ms. Conway to explain Amendment 1 to SB 94.                                                                
                                                                                                                                
1:56:51 PM                                                                                                                    
MS. CONWAY explained the following changes Amendment 1 would                                                                    
make to SB 94:                                                                                                                  
                                                                                                                                
[Original punctuation provided.]                                                                                                
                                                                                                                                
             Senate Bill 94 Profession of Pharmacy                                                                            
                                                                                                                              
       Explanation of Changes if Amendment LS0293\U.1 is                                                                      
                            adopted:                                                                                          
                                                                                                                                
     Amendment U.1  adds language to the  bill regarding the                                                                    
     direct  shipping   of  dialysate  and   other  dialysis                                                                    
     treatment  devices and  supplies to  the patient.  This                                                                    
     language comes  from CSHB 96  (Rep. Prax) and  is being                                                                    
     added to mirror  changes made in the  companion bill to                                                                    
     SB 94.                                                                                                                     
                                                                                                                                
     The amendment requires that  the dialysate and dialysis                                                                    
     devices and supplies                                                                                                       
                                                                                                                                
     • Must be approved by the FDA                                                                                              
                                                                                                                                
     •  Must arrive  in  a sealed  and  labeled package  and                                                                    
        ordered via a physician                                                                                                 
                                                                                                                                
     •  Must be directly sent to the patient (with end-stage                                                                    
        renal disease or acute kidney injury) or patient                                                                        
        designee. Currently there are 154 home-dialysis                                                                         
        patients (as of 2020 statistics)                                                                                        
                                                                                                                                
     •  Must be marked with a scannable  bar code matched to                                                                    
        the patient-specific label                                                                                              
                                                                                                                                
     •  A licensed pharmacist must serve as  a consultant to                                                                    
        ensure wholesale drug  distributors test  each month                                                                    
        the dialysate and devices sent to  patients AND they                                                                    
        must perform  quality  assessments  2X  a  month  to                                                                    
        ensure proper  storage,  handling and  distribution.                                                                    
        The dialysate must have  an expiration date  that is                                                                    
        good for 3 months following the assessment date.                                                                        
                                                                                                                                
     And because  of the provisions  set out in this  SB 94,                                                                    
     the   facility  would   be  licensed   and  under   the                                                                    
     jurisdiction of the AK Board of Pharmacy.                                                                                  
                                                                                                                                
     Currently  24 states  use this  model,  8 other  states                                                                    
     have something similar. There have  been no known cases                                                                    
     of harm reported. 2 states  have legislation pending to                                                                    
     allow this program.                                                                                                        
                                                                                                                                
     A  short  deck of  slides  is  attached for  additional                                                                    
     information for your review.                                                                                               
                                                                                                                                
2:01:19 PM                                                                                                                    
At ease.                                                                                                                        
                                                                                                                                
2:02:43 PM                                                                                                                    
CHAIR BJORKMAN reconvened the meeting and held SB 94 in                                                                         
committee with Amendment 1 pending.                                                                                             

Document Name Date/Time Subjects
SB 108 Ver A.PDF SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Sponsor Statement Ver A.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Sectional Analysis Ver A.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Presentation to SL&C 04.24.23.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Fiscal Note-GOV-HRC-04.21.23.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Supporting Document-Bostock Briefing Paper ASCHR July 2022.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Supporting Document-Williams Insitute 2015 Alaska Data.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 108 Public Testimony-Received by the Committee through 04.21.23.pdf SL&C 4/24/2023 1:30:00 PM
SB 108
SB 94 Draft Proposed Amendment U.1.pdf SL&C 4/24/2023 1:30:00 PM
SB 94
SB 94 Summary of Changes made by Amendment U.1 04.24.23.pdf SL&C 4/24/2023 1:30:00 PM
SB 94
SB 94 Supporting Documents-HB 96 Presentation Slides v.2 04.24.23.pdf SL&C 4/24/2023 1:30:00 PM
HB 96
SB 94
SB 94 Supporting Documents-CSHB96-Letter of Support_AK Board of Pharmacy 04.23.23.pdf SL&C 4/24/2023 1:30:00 PM
HB 96
SB 94