Legislature(2015 - 2016)CAPITOL 106

03/01/2016 03:15 PM House HEALTH & SOCIAL SERVICES

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03:32:37 PM Start
03:33:04 PM HB344
05:16:46 PM Adjourn
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
-- Please Note Time Change --
*+ HB 344 DRUG PRESCRIPTION DATABASE TELECONFERENCED
Heard & Held
-- Public Testimony --
+= HB 227 MEDICAL ASSISTANCE REFORM TELECONFERENCED
Scheduled but Not Heard
+ Bills Previously Heard/Scheduled TELECONFERENCED
               HB 344-DRUG PRESCRIPTION DATABASE                                                                            
                                                                                                                                
3:33:04 PM                                                                                                                    
                                                                                                                                
CHAIR SEATON announced that the  first order of business would be                                                               
HOUSE BILL NO. 344, "An  Act relating to the controlled substance                                                               
prescription database; and providing for an effective date."                                                                    
                                                                                                                                
3:35:00 PM                                                                                                                    
                                                                                                                                
SUSIE EDWARDSON, Staff, Representative  Paul Seaton, Alaska State                                                               
Legislature, paraphrased  from a  prepared statement,  which read                                                               
[original punctuation provided]:                                                                                                
                                                                                                                                
     Talking points for HB 344                                                                                                
   · The point of HB 344 is to strengthen the existing                                                                          
     Prescription Drug Database into a tool that will                                                                           
     better assist providers with knowing and understanding                                                                     
     the status of their patients' prescriptions.                                                                               
   · It does this by:                                                                                                           
   o requiring near real time entry of information into the                                                                     
     database-to make sure the information is as up to date                                                                     
     as possible and to prevent excessive prescriptions                                                                         
     within a short time frame.                                                                                                 
   o allowing a pharmacist or practitioner to delegate                                                                          
     access and submittal authority to an authorized                                                                            
     employee or agent-  to remove some of the                                                                                  
     administrative burden from the practitioner in charge                                                                      
   o requiring that all practitioners who interact with                                                                         
     controlled substances shall register with the                                                                              
     database- to allow them to truly evaluate their                                                                            
     patient's information.                                                                                                     
   o Requiring that dispensers check the database prior to                                                                      
     dispensing.                                                                                                                
   o And by creating an automatic alert system within the                                                                       
     database, which will push unsolicited reports to                                                                           
     prescribers and pharmacists if a patient's dosage or                                                                       
     number of prescriptions reach a level of concern.                                                                          
   · HB 344 also allows database access to the Medicaid                                                                         
     Pharmacist and the Medicaid Drug Utilization Review                                                                        
     Committee, to allow them to review prescription drug                                                                       
     utilization rates under the program, and to the state                                                                      
     medical examiner for the purpose of investigating a                                                                        
     cause of death.                                                                                                            
   · De-identified data will be supplied to the Department                                                                      
     of Public Health to allow them to monitor overall                                                                          
     health trends in the state.                                                                                                
                                                                                                                                
3:37:59 PM                                                                                                                    
                                                                                                                                
MS. EDWARDSON further explained that:                                                                                           
                                                                                                                                
   · Our current prescription drug database is not as                                                                           
     strong as it could be.                                                                                                     
                                                                                                                                
   o Data is only required to be submitted on a monthly                                                                         
     basis, which can leave large gaps in the information                                                                       
     that would allow one patient to fill multiple                                                                              
     prescriptions without anyone knowing.  Some                                                                                
     pharmacists send in information more frequently than                                                                       
     this, but the database as a whole is only updated                                                                          
     monthly.                                                                                                                   
   o While all pharmacies are required to submit                                                                                
     prescription information, registration with the                                                                            
     database is not mandatory.  Today, approximately 40%                                                                       
     of dispensers and only 13.5% of prescribers are                                                                            
     registered.  The remaining 86.5% of prescribers have                                                                       
     no way of knowing if their patient is receiving                                                                            
     prescriptions from another prescriber or at what                                                                           
     dosage.                                                                                                                    
   o The Board of Pharmacy is in charge of the database.                                                                        
     They currently do sometimes send out unsolicited                                                                           
     reports, which can alert unsuspecting providers to                                                                         
     concerning behavior, but they do not expressly have                                                                        
     that authority.  HB 344 gives them that authority.                                                                         
                                                                                                                                
3:39:43 PM                                                                                                                    
                                                                                                                                
TANEEKA HANSEN, Staff, Representative Paul Seaton, Alaska State                                                                 
Legislature, paraphrased from the Sectional Analysis [included                                                                  
in members' packets], which read:                                                                                               
                                                                                                                                
     Section  1   (Pg  1,  Line   4)  This   section  allows                                                                    
     pharmacists  or  providers  delegate the  submittal  of                                                                    
     information to  the database to an  authorized employee                                                                    
     or agent.  This section also requires  that pharmacists                                                                    
     submit  data  in  near  real  time,  in  the  procedure                                                                    
     established by the Board of Pharmacy.                                                                                      
                                                                                                                                
     Section 2  (Pg 2, Line  20) This section  requires that                                                                    
     the  information in  the  database remain  confidential                                                                    
     and describes who is permitted  to access the database.                                                                    
     Under  this  bill,  a practitioner  or  pharmacist  may                                                                    
     delegate  access to  an authorized  agent or  employee.                                                                    
     Access is also granted  to the lead Medicaid pharmacist                                                                    
     and  the  Medicaid   Utilization  review  committee  to                                                                    
     review drug utilization in the  Medicaid program. It is                                                                    
     also  granted   to  the  State  Medical   Examiner  for                                                                    
     investigation  into  cause   of  death.  Finally,  this                                                                    
     section allows that authorized  employees of Health and                                                                    
     Social Services  may receive  de-identified information                                                                    
     from the database for public health.                                                                                       
                                                                                                                                
3:41:22 PM                                                                                                                    
                                                                                                                                
MS. HANSEN continued with the review of the Sectional Analysis,                                                                 
which read:                                                                                                                     
                                                                                                                                
     Section 3  (Pg 4, Line  5) AS 17.30.200 (e)  is amended                                                                    
     to  state  that  the  failure  of  the  pharmacists  or                                                                    
     providers  to register  or  submit  information to  the                                                                    
     database is grounds for the  board to take disciplinary                                                                    
     action.                                                                                                                    
                                                                                                                                
3:41:43 PM                                                                                                                    
                                                                                                                                
MS. HANSEN further explained the Sectional Analysis, which read:                                                                
                                                                                                                                
     Section  4 (Pg  4,  Line 11)  Deletes language  stating                                                                    
     that dispensers  or practitioners are not  obligated to                                                                    
     check the  database prior to dispensing,  to conform to                                                                    
     the requirement on dispensers in section 5.                                                                                
                                                                                                                                
3:42:01 PM                                                                                                                    
                                                                                                                                
MS. HANSEN moved on to the next section, which read:                                                                            
                                                                                                                                
     Section 5 (Pg 4, Line  20) This section requires that a                                                                    
     dispenser or  their authorized agent or  employee shall                                                                    
     check the  database prior to dispensing  and submit the                                                                    
     prescription information  to the database in  near real                                                                    
     time.                                                                                                                      
                                                                                                                                
3:42:30 PM                                                                                                                    
                                                                                                                                
MS. HANSEN discussed Section 6 of the proposed bill, which read:                                                                
                                                                                                                                
     Section  6  (Pg  5,  Line  6)  This  section  adds  new                                                                    
     subsections   that  include   in   subsection  (o)   an                                                                    
     exemption  made  for  practitioners or  pharmacist  who                                                                    
     cannot update  the database  in near  real time  due to                                                                    
     technological  barriers and  in subsection  (p) creates                                                                    
     an automatic  electronic alert system when  someone has                                                                    
     prescriptions  inconsistent   with  general  standards.                                                                    
     Subsection  (q) requires  all healthcare  providers who                                                                    
     prescribe,   dispense,  or   administer  a   controlled                                                                    
     substance  to  register   with  the  prescription  drug                                                                    
     database  and  subsection  (r)  directs  the  board  of                                                                    
     pharmacy to  notify the necessary medical  board when a                                                                    
     practitioner registers with the database.                                                                                  
                                                                                                                                
3:44:15 PM                                                                                                                    
                                                                                                                                
MS. HANSEN continued her discussion of the Sectional Analysis,                                                                  
which read:                                                                                                                     
                                                                                                                                
     Section  7 (Pg  5,  Line 27)  This  section allows  the                                                                    
     board of  pharmacy to  adopt the  regulations necessary                                                                    
     to implement this act.                                                                                                     
                                                                                                                                
     Section 8 (Pg 6, Line  2) This section directs that all                                                                    
     dispensers  and  prescribers  shall register  with  the                                                                    
     database within 180 of the  effective date of the bill,                                                                    
     allowing  additional time  to  register.  The board  of                                                                    
     pharmacy shall provide information to other boards on                                                                      
     how to register and comply with database.                                                                                  
                                                                                                                                
3:45:13 PM                                                                                                                    
                                                                                                                                
MS. HANSEN concluded the presentation  of the sectional analysis,                                                               
which read:                                                                                                                     
                                                                                                                                
       Section 9 (Pg 6, Line 12) The regulatory authority                                                                       
     under this act takes effect July 1, 2016.                                                                                  
                                                                                                                                
      Section 10 (Pg 6, Line 13) Except in section 9, the                                                                       
       changes created by this act take effect January 1,                                                                       
     2017.                                                                                                                      
                                                                                                                                
3:45:38 PM                                                                                                                    
                                                                                                                                
CHAIR SEATON asked about the proposed changes to the bill.                                                                      
                                                                                                                                
MS. HANSEN  replied that, although  currently there were  not any                                                               
draft amendments, there  were some concerns.   She explained that                                                               
in order to relieve the burden  of time demands from an emergency                                                               
room doctor or  the pharmacist in charge, it was  important to be                                                               
able  to  delegate  authority.    She pointed  out  that  it  was                                                               
important for delegation to be  to a state licensed or registered                                                               
employee, to allow  for enforcement action for the  proper use of                                                               
information,  and   that  language  to  change   this  was  being                                                               
considered.    The  delegation  would include  a  wide  range  of                                                               
providers  connected  with  the  state medical  boards,  such  as                                                               
certified nurse assistants and dental hygienists.                                                                               
                                                                                                                                
3:47:04 PM                                                                                                                    
                                                                                                                                
MS. HANSEN shared  that there were also concerns for  the cost of                                                               
the  near real  time requirement,  noting that  committee members                                                               
had  letters commenting  on this  issue.   She reported  that the                                                               
data base could be updated  weekly for a minimal additional cost,                                                               
and there was also investigation for  the ability and the cost to                                                               
update  on a  daily basis.   She  pointed out  that the  term for                                                               
"near real time" allowed some  flexibility, even while implying a                                                               
certain urgency.                                                                                                                
                                                                                                                                
3:47:48 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE   WOOL  asked   what   people,   other  than   the                                                               
pharmacist, were licensed in a pharmacy.                                                                                        
                                                                                                                                
MS. HANSEN,  in response, said that  "it would be more  than just                                                               
the lead  pharmacist."   She offered  her belief  that pharmacist                                                               
techs were also  registered with the state, and that  most of the                                                               
people in  the office  would be registered  or licensed  with the                                                               
state.   She  relayed  that  the current  law  required the  lead                                                               
pharmacist in charge to enter the information.                                                                                  
                                                                                                                                
REPRESENTATIVE WOOL asked for the  reasons to the requirement for                                                               
a license.                                                                                                                      
                                                                                                                                
MS.  HANSEN, in  response, stated  that registration  allowed for                                                               
disciplinary  action  and  sanctions  through  the  corresponding                                                               
board.                                                                                                                          
                                                                                                                                
CHAIR SEATON  pointed out  that it was  not only  the dispensers,                                                               
but also  the providers who  would delegate someone to  check the                                                               
database.     He  explained  that   there  were  "way   too  many                                                               
prescriptions  for way  too many  pills."   This had  allowed for                                                               
addictions,  and  he  noted  that there  were  more  deaths  from                                                               
overuse of  prescription drugs  than from  heroin.   He explained                                                               
that  the intent  for this  current  solution had  been to  "make                                                               
prescribers check and find out  if the person they're prescribing                                                               
has had more  than recommended filling the  prescriptions..."  He                                                               
allowed that  some prescribers  did not want  "to go  through the                                                               
bother,  but it's  a huge  problem in  the state."   He  declared                                                               
that,  as it  was necessary  for a  solution, this  had been  the                                                               
genesis of the proposed bill.   He pointed out that there was now                                                               
a proposed  change for both  the dispenser and the  prescriber to                                                               
update the database.                                                                                                            
                                                                                                                                
MS.  HANSEN  clarified that  currently  only  the pharmacist  was                                                               
required to submit information.   She acknowledged that there had                                                               
been  testimony  that a  prescription  could  be entered  in  the                                                               
database, but if the prescription  was not filled, there were not                                                               
any  "pills out  there  to be  concerned for  and  then it  might                                                               
actually  muddy  the  waters  of the  information"  as  a  higher                                                               
prescription amount would be reflected  for a patient who was not                                                               
actually  acting  on  the  prescription.    She  reiterated  that                                                               
currently  only  the  dispensers  were  required  to  submit  the                                                               
information,  although the  current proposed  bill version  would                                                               
require all  practitioners to  register with  the database.   She                                                               
shared that there  had been consideration for  a requirement that                                                               
the providers  check the database  prior to prescription,  but it                                                               
had been  decided to require  mandatory registration in  order to                                                               
"get people connected  with the data base as a  first step."  She                                                               
pointed  out that  a similar  proposed  bill, SB  74, included  a                                                               
component which required prescribers  to check the database prior                                                               
to a prescription.  She emphasized  that this was the crux of the                                                               
conversation.                                                                                                                   
                                                                                                                                
3:53:52 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE  TARR  directed  attention   to  the  fiscal  note                                                               
[included in members'  packets] and asked about a  return to fees                                                               
required  for the  pharmacists.   She pointed  out that  this had                                                               
been  considered  by  some  to   be  problematic  during  earlier                                                               
discussions,  and  she  questioned  if there  could  be  a  "more                                                               
holistic  sort  of  solution  to  accomplish  that."    She  also                                                               
questioned  whether  this  would  be better  served  through  the                                                               
Department of Health and Social Services.                                                                                       
                                                                                                                                
MS. HANSEN,  in response,  shared that  her office  had discussed                                                               
the issue of spreading the fees  over the other boards which were                                                               
registering,  although there  was not  yet a  proposed amendment.                                                               
She  offered  her belief  that  there  was  a federal  grant  for                                                               
funding  through the  Department of  Health and  Social Services,                                                               
although it was still under the  Alaska Board of Pharmacy as they                                                               
had   the  investigative   and  licensing   authority  over   the                                                               
dispensers.  She directed attention  to Section 6 of the proposed                                                               
bill, which  allowed access to the  Medicaid pharmacist, Medicaid                                                               
drug  utilization   review  committee,  and  the   state  medical                                                               
examiner,  and would  identify information  to the  Department of                                                               
Public Health.   She noted  that these were  suggestions received                                                               
from  the  controlled  substance  advisory group  and  that  DHSS                                                               
access would offer  a better idea of  prescription utilization in                                                               
the Medicaid program and for public health trends.                                                                              
                                                                                                                                
REPRESENTATIVE TARR mused that she  could not find any mention of                                                               
the Department of  Public Health.  She stated that  she wanted to                                                               
ensure that  this was not  only viewed  "from that lens,  but the                                                               
important health implications."                                                                                                 
                                                                                                                                
MS. HANSEN  pointed out that  the reference to the  Department of                                                               
Public Health was at the top of page four.                                                                                      
                                                                                                                                
3:58:51 PM                                                                                                                    
                                                                                                                                
CHAIR  SEATON asked  for a  comparison between  the two  proposed                                                               
bills [HB 344 and SB 74].                                                                                                       
                                                                                                                                
MS.  HANSEN  stated  that  SB  74 did  not  currently  allow  for                                                               
delegation of  the submittal  of information,  as was  allowed in                                                               
Section 1 of  proposed HB 344, although proposed SB  74 did allow                                                               
the delegation of access which proposed  HB 344 also allowed.  HB
344 required  submittal of prescription information  at near real                                                               
time,  whereas  SB  74  required   a  weekly  submittal  of  this                                                               
information.    HB 344  only  required  dispensers to  check  the                                                               
database  prior to  dispensing, although  it required  all health                                                               
care   practitioners  dealing   with  controlled   substances  to                                                               
register  with  the  data  base.   SB  74  required  everyone  to                                                               
register,  and   it  required  that  providers   check  prior  to                                                               
dispensing,  prescribing, or  administering a  drug.   She opined                                                               
that  the requirement  to  check  may be  amended  so  as to  not                                                               
interfere  with emergency  or trauma  care.   HB 344  provided an                                                               
exemption  for  pharmacists  who  were not  able  to  update  the                                                               
database  in  near  real  time  due  to  technological  barriers;                                                               
whereas, SB 74  did not contain this exemption.   Although HB 344                                                               
required  registration with  the  database, it  allowed 180  days                                                               
from the effective date to register,  whereas SB 74 did not allow                                                               
this delay in registration.                                                                                                     
                                                                                                                                
REPRESENTATIVE WOOL walked  through the sequence of  events as an                                                               
individual  brought a  controlled substance  prescription to  the                                                               
pharmacy:     the  pharmacist  would   check  the   database  for                                                               
permission to a determined threshold,  and, after dispensation of                                                               
the  prescription the  data would  be entered  into the  database                                                               
within 24 hours or so.                                                                                                          
                                                                                                                                
CHAIR SEATON asked about "the push notification."                                                                               
                                                                                                                                
MS. HANSEN  directed attention to  subsection (p),  which created                                                               
an  automatic  electronic  alert   system,  although  this  still                                                               
required the  dispenser check  the database for  the alert.   She                                                               
shared that the current threshold  was set for five prescriptions                                                               
from five providers and five pharmacies in three months.                                                                        
                                                                                                                                
CHAIR  SEATON  noted   that  the  Board  of   Pharmacy  could  be                                                               
questioned for whether this was the right threshold.                                                                            
                                                                                                                                
4:04:01 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE TARR pointed out that  the proposed bill used both                                                               
the terms  pharmacist and practitioner, even  though practitioner                                                               
was not  defined in  the proposed  bill.  She  asked if  this was                                                               
defined elsewhere in statute, or it was necessary to define.                                                                    
                                                                                                                                
MS. HANSEN  replied that she  was not sure  if it was  defined in                                                               
statute, although she opined that  the proposed bill was clear as                                                               
it  said,  "practitioners  that have  the  ability  to  dispense,                                                               
administer, or prescribe" and then  listed the schedule of drugs.                                                               
She stated  that, as sections of  the proposed bill did  refer to                                                               
health care providers who had  interactions with these controlled                                                               
substances, it  was "kind of  defined right there."   She offered                                                               
to check on the definition.                                                                                                     
                                                                                                                                
REPRESENTATIVE TARR  suggested to  provide anything that  was not                                                               
obvious, so there would not be an unintended consequence.                                                                       
                                                                                                                                
CHAIR SEATON pointed  out that there were  two different possible                                                               
scenarios  to  allow exemptions  for  emergency  care, one  where                                                               
review  is not  required prior  to administration  of medication,                                                               
and  the second  option  which  would say  that  nothing in  this                                                               
section prevents emergency care for taking priority.                                                                            
                                                                                                                                
4:06:04 PM                                                                                                                    
                                                                                                                                
CHAIR SEATON opened public testimony.                                                                                           
                                                                                                                                
4:06:57 PM                                                                                                                    
                                                                                                                                
JAY  BUTLER, MD,  Chief Medical  Officer/  DPH Director,  Central                                                               
Office,  Division  of Public  Health,  Department  of Health  and                                                               
Social Services, reflected on the  earlier discussions on opioids                                                               
and the  issues for  opioid and  heroin overdose,  which required                                                               
prevention, treatment, and reversal of  overdose.  He stated that                                                               
the current discussion  was for prevention, as it  was clear that                                                               
those  dependent on  opioid pain  relievers were  at much  higher                                                               
risk to  eventual use  of heroin  and the  associated conditions.                                                               
He  stated  that   proposed  HB  344  incorporated   all  of  the                                                               
recommendations of the  controlled substances advisory committee,                                                               
and he  offered a  brief overview  of the  group, which  had been                                                               
established in  1982 with a goal  to advise the governor  and the                                                               
board on controlled substances and  its regulation, evaluation of                                                               
enforcement   policies,    review   of   budget    requests   for                                                               
interventions, and  the effectiveness of treatment  programs.  He                                                               
opined that the group may never have  met prior to this year.  He                                                               
listed the  designees, which included  the Attorney  General, the                                                               
Commissioner  of Department  of Health  and Social  Services, and                                                               
the  Commissioner  of  Department  of  Public  Safety,  or  their                                                               
designees.    He reported  that  the  committee had  discussed  a                                                               
number of topics,  which included models for  state regulation of                                                               
controlled  substances,  prescription  opioid pain  reliever  and                                                               
heroin  abuse, and  discussion with  the Alaska  Criminal Justice                                                               
Commission.   He referenced the  white paper from  the controlled                                                               
substances  advisory  committee  [Included in  members'  packets]                                                               
which addressed the Alaska  prescription drug monitoring program,                                                               
one part  of which  addressed the  opioid issue.   He  listed the                                                               
nine  recommendations  from  the   committee,  which  included  a                                                               
requirement for all pharmacists  and prescribers to register with                                                               
the  Alaska prescription  drug  monitoring  program, as  evidence                                                               
showed  increased  utilization  resulted in  declining  rates  of                                                               
opioid use  and prescription; and,  to review the data  base when                                                               
prescribing or dispensing a controlled substance.                                                                               
                                                                                                                                
DR.  BUTLER offered  the third  recommendation, which  authorized                                                               
prescribers  and  pharmacists  to  delegate  database  access  to                                                               
supervised  employees or  clinical staff.   He  opined that  this                                                               
would make the  system more workable by removing  barriers to its                                                               
utilization.   He reported that  no providers he had  spoken with                                                               
had  any  reservations  for this  recommendation,  and  that  the                                                               
ability  for the  provider to  see the  information prior  to the                                                               
visit with the patient would be very helpful.                                                                                   
                                                                                                                                
DR. BUTLER  offered the  fourth recommendation,  which authorized                                                               
the  Board of  Pharmacy to  forward unsolicited  notifications to                                                               
prescribers  and  dispensers  about patients  possibly  obtaining                                                               
controlled  substances in  a manner  inconsistent with  generally                                                               
recognized standards  of care.   He referenced this as  the "push                                                               
notifications."     He   declared  that   this  was   a  powerful                                                               
communication tool supported by many of the providers.                                                                          
                                                                                                                                
DR.  BUTLER stated  the fifth  recommendation for  collecting the                                                               
dispensing  data and  updating the  database weekly.   He  shared                                                               
that  many  other  states  had weekly  or  more  often  reporting                                                               
requirements.    He  acknowledged the  difficulties  for  regular                                                               
reporting  by smaller  pharmacies in  remote areas,  particularly                                                               
with the challenges posed by  internet access.  He suggested that                                                               
the definition could be to update "at least weekly."                                                                            
                                                                                                                                
DR.  BUTLER  shared  the  sixth  recommendation  which  addressed                                                               
database access,  the Medicaid pharmacy program  and the Medicaid                                                               
drug  utilization review  committee.   He  stated  that the  only                                                               
current  visibility for  these  was with  regard  to opioids  for                                                               
which there was  a Medicaid claim.  He reported  that other state                                                               
investigations revealed that patients  could attain opioids under                                                               
the Medicaid program, and then sell  them on the street.  He said                                                               
the recommendation also included the  state medical examiner as a                                                               
source of  opioid use  information.  He  offered his  belief that                                                               
expanded  authority  was  an   appropriate  balance  between  the                                                               
guarantee  for patient  privacy and  the  need to  know by  those                                                               
responsible for  programs in  public health  in order  to address                                                               
this opioid challenge.                                                                                                          
                                                                                                                                
4:18:54 PM                                                                                                                    
                                                                                                                                
CHAIR SEATON  asked if there  were any problems  with restriction                                                               
for   delegation  of   database   use  to   those  licensed   for                                                               
registration.                                                                                                                   
                                                                                                                                
DR.  BUTLER   expressed  his  agreement  that   this  raised  the                                                               
questions  of appropriate  safeguards  for  patient privacy,  and                                                               
that  licensure should  be  under board  authority  to allow  for                                                               
disciplinary   action,   although   he   was   unclear   on   the                                                               
certification process.                                                                                                          
                                                                                                                                
CHAIR SEATON asked that more  information on the terms be offered                                                               
in any  testimony.   He asked  about a proposal  by the  State of                                                               
Maine  on a  3-day limitation  for  a prescription  on its  first                                                               
issuance.                                                                                                                       
                                                                                                                                
DR.  BUTLER,   in  response,  said   that  these   were  clinical                                                               
guidelines  and specific  issues  related to  maximum doses,  but                                                               
that these were  not directly linked to the database.   He stated                                                               
that the  database was not  intended to dictate practice  or tell                                                               
doctors  what  to do,  that  it  was intended  to  be  used as  a                                                               
communication tool  to provide visibility for  prescriptions to a                                                               
given patient or by a given  provider.  He shared that nationally                                                               
there  were some  draft chronic  pain management  guidelines with                                                               
the conversion  equivalent to  morphine.  He  stated that  two of                                                               
the  biggest risk  factors for  opioid  overdose were  escalating                                                               
dose  and co-administration  of benzodiazepine.   He  pointed out                                                               
that  a  value  of  the  database was  to  recognize  these  risk                                                               
factors,  as  a   single  provider  may  not  be   aware  of  the                                                               
prescriptions from another provider.                                                                                            
                                                                                                                                
CHAIR SEATON  stated that the  focus was for curing  the problem,                                                               
not  just   addressing  the  database.     He  stated   that  the                                                               
legislature was  alarmed, even  though he  was unsure  how active                                                               
the medical community was toward the opioid problem.                                                                            
                                                                                                                                
REPRESENTATIVE  TARR  reiterated  her  earlier  request  for  the                                                               
definition of practitioner.                                                                                                     
                                                                                                                                
DR.  BUTLER  replied that  the  general  intent was  for  persons                                                               
authorized  to   prescribe,  in   this  case,   specifically  for                                                               
controlled  substances.    He listed  physicians,  dentists,  and                                                               
advance practice registered nurses.                                                                                             
                                                                                                                                
REPRESENTATIVE  VAZQUEZ directed  attention to  AS 08.80.480(28),                                                               
the  definition  for  practitioner,  and read:    "an  individual                                                               
currently licensed,  registered or otherwise by  the jurisdiction                                                               
in  which the  individual practices  to prescribe  and administer                                                               
drugs in the  course of professional practice."   She stated that                                                               
there  was  also  a  definition for  a  pharmacy  technician,  "a                                                               
supportive   staff  member   who   works   under  the   immediate                                                               
supervision  of a  pharmacist."   She read  the definition  for a                                                               
pharmacist in  charge, "a  pharmacist who  accepts responsibility                                                               
for operation of  a pharmacy in a manner that  complies with laws                                                               
and regulations  applicable to the  practice of pharmacy  and the                                                               
distribution  of drugs  and who  is personally  in charge  of the                                                               
pharmacy  and the  pharmacy's personnel."   She  stated that  the                                                               
definition for pharmacist was  "the individual currently licensed                                                               
by the state to engage in the practice of pharmacy."                                                                            
                                                                                                                                
CHAIR  SEATON directed  attention  to  page 1,  line  10, of  the                                                               
proposed bill,  that the definition  of practitioner was  for the                                                               
person   who   directly   dispenses  the   scheduled   controlled                                                               
substances.    He questioned  whether  the  definition should  be                                                               
extended to  prescribers.  He  pointed out that  registration for                                                               
the database was predicated on  reading seven pages of very small                                                               
font, and asked if this  was stopping providers and practitioners                                                               
from registering.                                                                                                               
                                                                                                                                
DR. BUTLER offered  his support for the removal  of any obstacles                                                               
to registration.   He shared that it took him  about 7 minutes to                                                               
complete  the   on-line  form  for  the   database  registration,                                                               
including the search  time for his national provider  number.  He                                                               
opined that  it was a  bigger barrier  to have the  form printed,                                                               
notarized, and  mailed, which took  him 9 minutes.   He suggested                                                               
an option to link the  database registration with license renewal                                                               
and do  it all on-line.   He expressed  his hope that  this could                                                               
remove the need for notarization.                                                                                               
                                                                                                                                
4:32:43 PM                                                                                                                    
                                                                                                                                
JANEY  HOVENDEN, Director,  Division  of Corporations,  Business,                                                               
and Professional  Licensing, Department of Commerce,  Community &                                                               
Economic  Development, in  response to  the question  for linkage                                                               
with licensing  and use  of the database,  explained that  it had                                                               
not yet  been determined  if that was  possible, but,  she stated                                                               
that "would  be something that we  would always strive to  do and                                                               
always  look for  options  and  opportunities to  technologically                                                               
advance."                                                                                                                       
                                                                                                                                
CHAIR SEATON  asked if  renewal of  the license  and registration                                                               
for the data base could be combined.                                                                                            
                                                                                                                                
MS. HOVENDEN  replied that a reminder  or a link could  be easily                                                               
included with any documentation at renewal.                                                                                     
                                                                                                                                
CHAIR SEATON asked if the license renewal had to be notarized.                                                                  
                                                                                                                                
MS. HOVENDEN said that the division  had not yet explored the use                                                               
of My Alaska  as a signing option.  She  stated that the division                                                               
was always looking for ways  to streamline and make things easier                                                               
for the applicants and registrants.                                                                                             
                                                                                                                                
REPRESENTATIVE VAZQUEZ asked  how proposed HB 344  would apply to                                                               
registered pharmacies located outside the state.                                                                                
                                                                                                                                
MS.  HOVENDEN  stated that  these  licensed  pharmacies would  be                                                               
treated the same as those located in-state.                                                                                     
                                                                                                                                
CHAIR SEATON  asked if this  would include medical  providers and                                                               
telemedicine.                                                                                                                   
                                                                                                                                
MS. HOVENDEN deferred to the chair of the State Pharmacy Board.                                                                 
                                                                                                                                
REPRESENTATIVE TARR  directed attention to the  fiscal note which                                                               
included a  program manager position.   She asked about  the cost                                                               
for databases communicating.                                                                                                    
                                                                                                                                
MS.  HOVENDEN,  in response  to  Representative  Tarr, said  that                                                               
there was a  cost associated with the database vendor,  as it was                                                               
a  third party  software program  contract.   She explained  that                                                               
this  additional  expense  would   be  for  modification  to  the                                                               
existing database to make it easier for registrants.                                                                            
                                                                                                                                
CHAIR  SEATON asked  about an  estimate for  the weekly  database                                                               
updates.                                                                                                                        
                                                                                                                                
MS. HOVENDEN explained that the  vendor had given a cost estimate                                                               
of  $26,000 annually  for either  weekly or  daily updates.   She                                                               
replied to Chair  Seaton that she would clarify  whether that had                                                               
been included in the fiscal note.                                                                                               
                                                                                                                                
REPRESENTATIVE STUTES asked about  any problems with facilitating                                                               
this in a timely fashion.                                                                                                       
                                                                                                                                
MS. HOVENDEN said  that a program coordinator could  manage it on                                                               
behalf  of  the  Board  of  Pharmacy,  although  there  was  some                                                               
concern, as it was necessary that  the effective date be prior to                                                               
the requirement for registrants.                                                                                                
                                                                                                                                
4:42:47 PM                                                                                                                    
                                                                                                                                
BILL ALTLAND, Pharmacist,  Board of Pharmacy, stated  that he was                                                               
a pharmacist  practitioner from a  rural remote area.   He shared                                                               
that he had  been part of the workgroup studying  the idea of the                                                               
prescription  drug monitoring  program eight  years prior,  as it                                                               
was a  big problem  in the  state.   He offered  an example  as a                                                               
provider in  rural remote areas  for the concerns  and challenges                                                               
with  out  of  state  pharmacies,   and  licensed  pharmacies  or                                                               
practitioners,  especially in  the context  of tribal  providers.                                                               
He  referenced an  opinion  by the  state  attorney general  that                                                               
tribal  providers did  not have  to be  licensed in  Alaska.   He                                                               
expressed his concern for this  decision, sharing that he felt it                                                               
important for practitioners to be  licensed, as well as important                                                               
that any delegation  for access to the database be  to a licensed                                                               
technician.   He  asked  how  a prescriber  would  know what  the                                                               
leverage was to  get the not licensed providers  into the system.                                                               
He pointed out  that Seattle was a major health  provider hub for                                                               
southern Southeast Alaska.  He shared  that there was a system on                                                               
Prince  of  Wales  Island  to   talk  about  patients  with  pain                                                               
management issues.                                                                                                              
                                                                                                                                
REPRESENTATIVE VAZQUEZ read  from the statutes that  they did not                                                               
cover  "control  of  drugs in  the  federally  operated  hospital                                                               
institution."                                                                                                                   
                                                                                                                                
MR.  ALTLAND shared  that the  military was  a closed  system for                                                               
federal  beneficiaries, and  that Metlakatla  was a  reservation;                                                               
however,  there was  concern  for the  decisions  not to  include                                                               
tribal health care providers.                                                                                                   
                                                                                                                                
REPRESENTATIVE TARR  asked if  there had been  any scale  back in                                                               
prescriptions.                                                                                                                  
                                                                                                                                
MR.  ALTLAND  said there  had  been  difficult decisions  and  he                                                               
lauded the monitoring program, noting that it was needed.                                                                       
                                                                                                                                
4:54:37 PM                                                                                                                    
                                                                                                                                
SCOTT  WATTS, Pharmacist,  reported  that he  was an  independent                                                               
pharmacist.   He  lauded the  intent of  the proposed  bill.   He                                                               
expressed his concerns, which included  that real time submission                                                               
was  difficult for  many pharmacies,  although nightly  or weekly                                                               
submission would accomplish the intent  of the proposed bill.  He                                                               
reported  that it  was  most  important for  the  database to  be                                                               
checked when the prescription was  being written, that this would                                                               
cut down  the time involved for  all.  He opined  that people who                                                               
were  licensed and  registered had  more to  lose should  they do                                                               
something  incorrectly.     He  said  that  the   amount  of  the                                                               
prescription should start with the  prescriber.  He declared that                                                               
this was a very important,  worthwhile program, and expressed his                                                               
concern that  this was  not put  solely on  the shoulders  of the                                                               
pharmacists.                                                                                                                    
                                                                                                                                
REPRESENTATIVE TARR asked for a  comprehensive list of all of the                                                               
users.                                                                                                                          
                                                                                                                                
4:58:45 PM                                                                                                                    
                                                                                                                                
MATT  KEITH,  Vice President  of  Pharmacy,  Geneva Woods  Health                                                               
Care, stated his  support for the program, and noted  that he was                                                               
also a  pharmacist.   He acknowledged  the challenges  for opiate                                                               
use and controlled substances.   He expressed his support for the                                                               
database  and  the new  portal,  as  it  was quicker,  easier  to                                                               
access,  and more  flexible.   He  supported the  concept of  the                                                               
proposed bill, although  he shared a disconnect for  how it would                                                               
be accomplished.  He stated  that the requirement for a mandatory                                                               
review for every prescription of  all controlled substances would                                                               
be  logistically burdensome  and would  add cost.   He  expressed                                                               
agreement with  the licensure  of pharmacy  technicians, although                                                               
there was  not a  lot of capacity  to do these  extra tasks.   He                                                               
pointed to programs related to  prescription drugs which required                                                               
registration   of   patients   on   websites,   with   additional                                                               
information put  in prior to dispensing.   He pointed out  that a                                                               
review of the  database prior to every prescription  and prior to                                                               
its  dispensation  would  have  an  impact  on  the  service  and                                                               
response  level.   He echoed  the sentiment  that drug  abuse and                                                               
overdose would not happen if  the prescription was not written in                                                               
the first place, and, doctors  needed to look at this information                                                               
before writing a prescription.   This meant that pharmacists were                                                               
having  to  be  reactive.    He reported  that  there  were  some                                                               
disconnects between  the two proposed  bills, which needed  to be                                                               
ascertained, including the exemption  for the word, "administer,"                                                               
as  this was  not something  that pharmacists  did.   He directed                                                               
attention to the holistic oversight  for patients, especially for                                                               
those in a  chronic pain program, and he  described his company's                                                               
clinical practitioner  approach.   He asked whether  the proposed                                                               
bill  was to  address chronic  opiate use,  or all  forms of  all                                                               
controlled  substances,  as  the   proposed  bill  was  currently                                                               
written.                                                                                                                        
                                                                                                                                
CHAIR  SEATON  asked  what  schedules  of  controlled  substances                                                               
should be included.                                                                                                             
                                                                                                                                
MR.  KEITH replied  that a  proactive approach  with the  biggest                                                               
concern being for opiate overdose  should focus on the schedule 2                                                               
drugs.  However,  another factor with overdose  could include the                                                               
use of  other drugs.  He  pointed out that a  requirement for the                                                               
mandatory  review of  schedule  2 drugs  would  reveal any  other                                                               
currently prescribed drugs.  He  emphasized that the focus should                                                               
be on the patient not just on one drug.                                                                                         
                                                                                                                                
CHAIR  SEATON  asked  for   recommendations  by  pharmacists  for                                                               
necessary reporting, as  well as what schedule level  of drugs to                                                               
check prior to  prescription or dispensation, to  be forwarded to                                                               
his office.                                                                                                                     
                                                                                                                                
REPRESENTATIVE TARR asked about any  side effects from schedule 3                                                               
drugs, including suicidal tendencies,  and if the information was                                                               
being tracked elsewhere.                                                                                                        
                                                                                                                                
MR. KEITH relayed that he was  not sure about suicide.  He stated                                                               
that if  there were a  requirement to report on  scheduled drugs,                                                               
but  only mandatorily  review the  schedule 2  drugs for  opiates                                                               
with  a primary  concern for  opiate abuse,  then these  would be                                                               
seen.  He stated that it  was not necessary to mandatorily review                                                               
each and every  other class of drug prior to  dispensation.  This                                                               
would  reveal  the  targeted  population  for  opiate  abuse  and                                                               
overdose.  He declared that  "every anti-depressant on the market                                                               
has  been   associated  with  that  [suicide]   and  they're  not                                                               
controlled substances."  He pointed  out that it was important to                                                               
determine the target for improved outcomes.                                                                                     
                                                                                                                                
REPRESENTATIVE WOOL  asked what  other prescriptions  were listed                                                               
on  the database,  should  the  prescribers also  check  it.   He                                                               
opined that this  "would be going further upstream  to prevent or                                                               
reduce the amount of delays at the pharmacy."                                                                                   
                                                                                                                                
MR. KEITH  expressed his agreement, reminding  the committee that                                                               
the reporting of all controlled  substances would reveal them all                                                               
on the  database, including those  drugs with the added  risk for                                                               
negative  outcome.    He  acknowledged  that  it  was  much  more                                                               
proactive  for  the  doctor  to   check  the  database  prior  to                                                               
prescribing a drug.                                                                                                             
                                                                                                                                
CHAIR  SEATON  opined   that  this  was  the   intention  of  the                                                               
committee.                                                                                                                      
                                                                                                                                
5:09:13 PM                                                                                                                    
                                                                                                                                
DAN   NELSON,  Pharmacist,   echoed  what   the  other   pharmacy                                                               
representatives  had   testified.    He   added  that   the  time                                                               
requirement   for   checking   all   the   controlled   substance                                                               
prescriptions on the  database was onerous to  the pharmacies, as                                                               
some high  volume retail pharmacies  in Alaska were  filling more                                                               
than  1000 prescriptions  each  day, about  10  percent of  those                                                               
being controlled  substances.  He  said that although  each check                                                               
took  about two  minutes, any  interpretation of  the information                                                               
should  not  be  a  delegated  task, but  should  be  done  by  a                                                               
practitioner or a  pharmacist.  He declared that  this should all                                                               
be done by  a prescriber, prior to issuance  of the prescription.                                                               
He  offered  his  belief  that,  as  the  number  of  pharmacists                                                               
registering for the  database was vastly more than  the number of                                                               
prescribers, this  showed that pharmacists were  "very interested                                                               
in stemming  the prescription  drug abuse  epidemic."   He shared                                                               
that pharmacists  wanted to  play an active  role.   He applauded                                                               
the  committee   for  considering  this  issue.     He  suggested                                                               
consideration   of  mandatory   continuing  education   for  pain                                                               
management, in  order to improve some  of the pain outcomes.   He                                                               
reiterated that  this requirement  would be extremely  onerous on                                                               
pharmacies, noting  that it would  increase the work load  on his                                                               
pharmacy by two - three hours each day.                                                                                         
                                                                                                                                
CHAIR  SEATON asked  if there  was  agreement with  the idea  for                                                               
schedule  2  drugs  being  checked   by  providers,  and  not  by                                                               
pharmacists.                                                                                                                    
                                                                                                                                
MR.  NELSON replied  that this  would be  a good  starting point,                                                               
adding  that all  schedule  2  drugs were  not  opiates, as  some                                                               
opioids were  schedule 2,  3, 4,  and 5.   He  questioned whether                                                               
limiting the proposed bill to  schedule 2 drugs would effectively                                                               
capture the desired end.                                                                                                        
                                                                                                                                
CHAIR SEATON asked  for any suggestions of ways  for the proposed                                                               
bill to be written.                                                                                                             
                                                                                                                                
MR. NELSON, in response to  Representative Tarr, relayed that the                                                               
Centers  for Disease  Control and  Prevention (CDC)  had recently                                                               
issued some draft guidelines on other substances to consider.                                                                   
                                                                                                                                
[HB 344 was held over.]                                                                                                         

Document Name Date/Time Subjects
Hb 344 Version H.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Sponsor Statement.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Sectional.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Fiscal Note- DCCED-CBPL-02-27-16.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Background-PDMP Controlled Substance advisory_1-29-16.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Background_PDMP annaul report 2016.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Background_NCSL_telehealth, PDMP, licensure_1.23.2016.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Testimony_NACDS_3.1.2016.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Testimony Tara Ruffner.pdf HHSS 3/1/2016 3:15:00 PM
HB 344
HB 344 Testimony_CVS health.pdf HHSS 3/1/2016 3:15:00 PM
HB 344