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AV Dist Methods

Aug 07, 2018

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  • 8/20/2019 AV Dist Methods

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    New Approaches for Antiviral Medication 

    Dispensing During a Pandemic:

    Collaborations that

     utilizes

     the

     community

     

    pharmacist

    Lisa Koonin MN, MPH

    Centers for Disease Control and Prevention

    Anita Patel, PharmD, MS

    Centers for Disease Control and Prevention

    Mitchel Rothholz, RPh, MBA

    American Pharmacists Association

    Gillian SteelFisher, PhD, MSc

    Harvard School of  Public Health

    Development and Support

    This webinar was developed by the American 

    Pharmacists Association and supported by a 

    Cooperative Agreement provided by the Centers for 

    Disease Control and Prevention (CDC). The opinions 

    expressed in this program do not represent the 

    viewpoints of  the CDC.

    Disclosures•   Mitch Rothholz, declares that his wife is an employee of  

    Merck and he serves on the advisory committee for 

    Merck and Pfizer.

    •   Gillian SteelFisher,  PhD, MSc, declares her husband is a 

    consultant for

     Eli

     Lilly.

     

    •   Lisa Koonin, MN, MPH, Anita Patel, PhamD, MS, and 

    APhA’s editorial staff  declares no conflicts of  interest or 

    financial interests in any product or service mentioned in 

    this activity, including grants, employment, gifts, stock 

    holdings, and honoraria. For complete staff  disclosures, 

    please see the Education and Accreditation Information 

    section at www.pharmacist.com/education . 

  • 8/20/2019 AV Dist Methods

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    Accreditation Information

    The American Pharmacists Association is accredited by the

    Accreditation Council

     for

     Pharmacy

     Education

     as

     a provider

     of 

     continuing

     pharmacy

     

    education (CPE). This activity, New Approaches During a Pandemic for Antiviral 

    Medication Dispensing‐ Collaboration that utilizes the community pharmacist , is 

    approved for 1.5 hours of  CPE credit (0.15 CEUs). The ACPE Universal Activity Number 

    assigned by the accredited provider is: 202‐000‐12‐248‐L04‐P.

    To obtain CPE credit for this activity, participants will be required to actively 

    participate in the entire webinar and complete an online evaluation and CPE recording 

    form located at www.pharmacist.com/education by September 28, 2012. 

    Target Audience: Pharmacists

    ACPE Activity Type: Knowledge‐Based

    Learning Level: 2

    Initial Release Date: September 19, 2012

    Learning Objectives

    •   Discuss the goals for an antiviral medication 

    distribution  program during a pandemic

    •   Describe the current model and proposed model for 

    distribution  of  antiviral medications and the various 

    providers within the system

    •   Articulate the value of  incorporating community 

    pharmacists within a new model of  antiviral 

    medication distribution/dispensing during a 

    pandemic event.

    Learning Objectives•   Discuss the learnings from pharmacy simulations 

    conducted by CDC that identified success factors for 

    the new model of  antiviral medication dispensing

    •   Identify strategies for overcoming barriers to the 

    implementation of 

     a collaborative

     practice

     

    agreement and discuss components of  a 

    collaborative practice agreement needed to 

    successfully implement the new model for patient 

    evaluation and antiviral medication dispensing

    •   Describe the learnings from a Harvard University 

    survey of  pharmacists and how the results informed 

    the proposed model of  care delivery.

  • 8/20/2019 AV Dist Methods

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    Self ‐Assessment Question #11. The purpose of  exploring a new method of  

    pandemic antiviral distribution and dispensing is 

    to:A. Improve access to antivirals during an influenza 

    pandemic

    B. Increase the burden on public health during a 

    public health emergency

    C. Provide antivirals for free to the public

    D. Ensure every American has a dose of  antivirals

    Self ‐Assessment Question #2

    2. CDC’s pharmacy simulation exercises provided 

    information that:

    A. Pharmacies can provide medicines during an 

    emergency

    B. Pharmacies can increase the number of  patients 

    served during a future pandemic

    C. Usual standards of  accuracy and quality control 

    can be maintained when dispensing antivirals 

    during a pandemic 

    D. All of 

     the

     above

    Self ‐Assessment Question #3

    3. Collaborative Drug Therapy Management 

    (CDTM) encompasses the following:

    A. It is a team approach

    B. May include,

     but

     is

     not

     limited

     to

     initiating,

     

    modifying, and monitoring a patient’s drug 

    therapy

    C. Can be utilized in non‐emergency and declared 

    influenza situations

    D. All of  the above

  • 8/20/2019 AV Dist Methods

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    CDC’s Alternative Antiviral Drug 

    Distribution and Dispensing Exploratory Project

    Lisa M. Koonin MN MPH

    Lead, Pandemic Medical Care and

    Countermeasures Task Force

    Influenza Coordination Unit

    Centers for Disease Control and

    Prevention

    Timely Antiviral Treatment During an Influenza Pandemic Depends Upon Success  At  Every  Step

     Antiv iral s uscep tibi lity and

    effectivenessSupply Available EUA/Regulatory issues

    Public acceptance

    Pharmacists acceptability

    Distribution from

    SNS/Commercial suppl y

    chain

    Provider Acceptability

    Patient access to Rx

     Access to med icatio n

    Timely administration

    CDC Antiviral Distribution and Dispensing Project

    •   AV Project Dates: May 2011  – May 2013

    •   AV Project Key Partners: ASTHO, NACCHO, American Pharmacists 

    Association, National Association of  Chain Drug Stores, National 

    Community Pharmacists Association, Rx Response

    •   AV Project Goal: To improve the availability and access to antivirals 

    during an influenza pandemic

    •   AV 

    Project 

    Key 

    Activities: 

    •   Explore the feasibility, acceptability,  cost, and impact of  leveraging 

    existing  systems by sending SNS antivirals to pharmaceutical 

    distributors and pharmacies to distribute and dispense

    •   Develop processes to align with usual commercial system 

    practices (inventory control, pharmacy ordering, tracking, billing)

    •   Explore innovative financing mechanisms:

     –  Explore how dispensing fees could be covered for 

    uninsured/underinsured

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     Antiv iralManufacturers

    SNS

    LHD

    SHD

    NursingHomes

    Various

    methods

    PharmaceuticalDistributors

    Med Offices /Clinics

    Pharmacies

    Hospitals

    PH Clinics

    CURRENT METHOD: Antiviral Distribution and Dispensing During 2009 H1N1 Pandemic

    Dispensing Locations

    Various

    methods

    SNS 

    LHDSHD

    Large Pharmacy

    Chains

    Hospitals

    Med Offices/Clinics

    Nursing Homes

    PH Clinics

    Targetingunderserved

    populationsX %

    Z %Distributor(s)

    Independent

    Pharmacies

    Dispensing Locations

    Chain, Big-Box,

    Grocery Pharmacies

    Timely Dispensing

    Tribal nations?Prisons?Other?

    PROPOSED METHOD FOR TESTING:Future Pandemic Antiviral Distribution and Dispensing

    Triggers for Release

    Amount of  Release

    Y %

    Key Areas of  Exploration

    •   What proportion of  SNS AVDs should be sent to SHDs and what proportion to distributors?

    •   Leveraging inherent strengths of  key participants: –   Public health’s unique reach to underserved  and 

    other populations

     –   Distributor and pharmacies reach 

     –  Specific uses for state/local  stockpiled antivirals?

     –   Distribution strategies: “prime the pump”, per‐capita, demand‐based, mixed model?

    •   Financing: –  How to assure that cost/payment is not a barrier?

    •   Acceptability, feasibility, cost, reliability? 

  • 8/20/2019 AV Dist Methods

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    Alternative AVD Distribution and Dispensing 

    Plan Must be Feasible and Acceptable

    New 

    Approach drafted

    Fea si bl e? A cc ep ta bl e?   YES

    Possible New 

    Policy

    NO

    Back to the 

    drawing 

    board!

    •  Learn from H1N1

    • Explore possible solutions

    • Feedback from PH and other partners

    • Legal barriers

    • Mathematical modeling > supply/demand

    • Commercial partner interest (RFI/RFP)

    • Retail pharmacy throughput/simulations

    • Reach to non‐pharmacy locations

    • Access for uninsured

    • Ability to track assets/information flow

    • Cost analysis

    • Public Health

    • Distributors

    • Pharmacy execs

    • Pharmacists 

    • Providers

    • Public

    Assumptions

    •   Rapid access to antiviral drugs is critical 

    •   Stockpiled assets will be the primary resource for AVDs in the US

    •   Public health continues to have a key role in AVD distribution and dispensing

    •   This system will be scalable

    •   System rules will be transparent and adapt as needed

    •   Information exchange is critical for all partners

    “Scripted Surge”: Preliminary Findings from 

    CDC’s Pharmacy Throughput Simulations

    American Pharmacists Association Webinar

    September 19, 2012

    Anita Patel, PharmD, MS

    Health Scientist

    Division of  Strategic National Stockpile

    Office of  Public Health Preparedness and Response

    Centers for Disease Control and Prevention

  • 8/20/2019 AV Dist Methods

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    Exercise Purpose

    •   Simulate a pandemic scenario at a pharmacy 

    to 

    assess 

    the 

    impact 

    of  

    dispensing 

    government provided antiviral medications in addition to normal pharmacy prescriptions during an emergency

     –  These drills will help to assess throughput in pharmacy surge situations and identify bottlenecks in the prescription drug dispensing process

    1

    Matt’s Medicine Store, 

    Independence MOPharmacy Simulation 1: 

    Independent pharmacy

    March 11, 2012

    2

    Walgreens, Chicago, IL

    Pharmacy Simulation 2:

    Traditional chain pharmacy

    June 24, 2012

    Scripted Surge: When and

    Where?

    1. Determine the average time required for a community 

    pharmacy to dispense prescription drugs in a pandemic surge 

    situation 

    2. Determine number of  patients served and scripts filled/hour 

    and 

    assess 

    accuracy 

    of  

    prescriptions 

    filled3. Identify specific “bottlenecks” in the dispensing process

    4. Examine the quality of  the dispensing experience for: 

     –    Each pharmacy “patient” during the exercise 

     –    Pharmacy staff  during the exercise

    2

    Exercise Objectives

  • 8/20/2019 AV Dist Methods

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    •   Use of  normal pharmacy processes, systems and materials 

    •   Dispensing under

     traditional

     pharmacy

     practice

     principles

     

    •   Pharmacy operating at anticipated  surge levels

    •   Mirror normal prescription environment –  How  prescriptions enter pharmacy

    »   Hardcopy, called, faxed, electronic

     –  Antiviral Rx plus regular Rx

     –  Ratio of  insurance related problems

     –  Estimates of  patient related problems

    •   2 run‐throughs –   Approximately 90 minutes in length each

    Exercise Design

    •   The US is at the peak of  the worst influenza pandemic in decades

    •   A new pandemic vaccine is still being made and is not yet available

    •   Antiviral drugs are the only treatment for the infection –  There are two antiviral drugs Tamiflu® and Relenza®

    •   Commercial supplies of  antiviral medications have been depleted

    •   A proportion of  the federal stockpile of  influenza antiviral medications has been distributed to local pharmacies to dispense to patients with a prescription  

    Setting the Stage 

    The Scenario

    What Happened?•   27 actors for each drill

    2

    • Each was given patient

    profile cards

    • “Personal”information

    • Information about

    their insurance, name

    of their doctor, and

    the medications they

    have been

    “prescribed”

  • 8/20/2019 AV Dist Methods

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    2

    Patient Profile Card

    Back of Card

    •   Along with ‘prescriptions', ‘patients’ handed one or more of  the following cards to pharmacy staff  to help present a more realistic scenario

     –   Green cards = Used for payment

     –   Blue cards = Insurance coverage

     –   Orange card =  Problem (affixed to green or blue cards)

     –   Red card = Timed actor

    •   Normal pharmacy prescription errors were also included for pharmacy staff  to catch as part of  normal dispensing processes –   Dosing errors, patient allergies, drug interactions

    2

    Volunteers

    Patient Cards

    What Happened? (cont.)•   Pharmacists filled “prescriptions” as on a normal, but busy day at peak 

    of  an influenza pandemic

    •   “Patients” presented with prescriptions and scenarios 

    •   Pharmacists filled all “prescriptions” and provided services as they 

    normally would

     –   Except NO REAL MEDICATIONS WERE  HANDLED OR USED

  • 8/20/2019 AV Dist Methods

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    The Simulation Cell (SimCell)•   Problems requiring a 3rd party to resolve were simulated 

    by Controllers staffing phones at the SimCell

    2

    • Problems with the patient insurance

    • Problems associated with the 

    method of  payment

    • Missing/incorrect 

    information on prescription 

    • Interactions with physicians 

    to verify prescriptions as 

    needed

    Timed randomly selected actors 

    at four different points in the 

    pharmacy

    1. entry to the pharmacy

    2. drop‐off  of  the prescription

    3. prescription pick‐up

    4. exiting the pharmacy

    Objective 1 ‐ Determine the average time required for a for community pharmacy to dispense 

    antiviral drugs during surge scenario

    Objective 1: Time Results Drop off  to  pick  up of  

     prescriptions 

    (Mean = 23.8 minutes)Time (minutes)

    25.4

    Independence, MO

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    Summary of  people served and prescriptions filled in both drills 

    (Run 1 and Run 2)

    Objective 2aDetermine number of  patients served and 

    scripts filled/hour

    MO Run 1 MO Run 2   CHI Run 1 CHI Run 2

    Duration of  run (minutes)   84 90   90 90

    Number people served  29 41 35 35

    Number people picked up multiple scripts  4 11   7 9

    Throughput (number people serviced per hour)  20.7 27.3   23.3 23.3

    Number scripts filled  34 55   44 45

    Throughput (number scripts filled per hour)  24.3 36.7   29.3 30.0

    •   Assessing accuracy

     –  Volunteers turned in prescriptions  to QA 

    evaluators after leaving the pharmacy

     –  Criteria examined

    •  Patient Name

    •  Medication

    •  Dose/Strength

    •  Quantity

    •   Instructions for drug use

    Objective 2b. Accuracy

    •   Overall high level accuracy observed

    Objective 2b. 

    Assessing Accuracy: Independence, MO

    Patient 

    N am e M edicat ion

    Dose/

    Strengt h Q ua nt it y I ns truct ions

    Overall

    Correct 

    Prescriptions   99% 98% 100% 99% 98%

    Run 1 (n=34)

    Correct 

    Prescriptions   100% 100% 100% 100% 97%

    Run 2 (n=55)

    Correct 

    Prescriptions   98% 96% 100% 98% 98%

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    •   Overall high level accuracy observed

    Objective 2b. 

    Assessing Accuracy: Chicago, IL

    Patient 

    Name   MedicationDose/

    Strength   Quantity Instructions

    Overall

    Correct 

    Prescriptions   99% 98% 99% 99% 96%

    Run 1 (n=34)

    Correct 

    Prescriptions   98% 98% 100% 98% 95%

    Run 2 (n=55)

    Correct 

    Prescriptions   100% 98% 98% 100% 96%

    Top bottlenecks perceived by pharmacy staff 

    1. Counseling 

    2. Inputting prescription  information into the 

    computer

    3. Taking doctor calls 

    4. Taking in prescriptions  from patients

    5. Other 

    •   Technology  – Printers, computers, register issues

    •   Attaining accurate prescriptions from prescribers

    Objective 3. Bottlenecks

    Both drills

    Objective 4. Quality of the dispensing experience for each pharmacy “patient” during

    the exercise

    Independence,

    MO

    Chicago, IL

  • 8/20/2019 AV Dist Methods

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    •   Pharmacies were able to dispense 1.5‐2.5x more scripts than normal script  peak  rate  –   Using normal surge staff 

    •   Solutions to bottlenecks may need to be implemented 

     –   Adjust normal

     practice

     •   Increase staff 

    •   Clarity on each staff  role

    •   Adjust flow of  patients  or script dispensing process

    •   Use of  advanced  technology (eScripts, novel ways of  processing Rx {tablets), video counseling) 

    •   Key artificialities/limitations  of  the exercise: –   Learning curve on disease and drugs could not be accounted  for in a one day 

    drill•   Ability to cope with surge may improve over time from start of  pandemic to peak—

    couldn’t replicate that in drill

    •   Familiarity with disease, drugs, dosage, contraindications, drug information will likely improve

    •   Pharmacy staff  need to implement appropriate infection control measures 

     –   Resilience of  staff  over time could not be accounted  for 

     –   Anxiety/fear of  staff  and patients  could not be simulated

    Key Preliminary Observations

     –  ASTHO/NACCHO/CDC

     –  IEM  Consulting, Inc. 

     –  Participating pharmacies

     –  National Association of  Chain Drug Stores

     –  National Community Pharmacists Association

     –  Rx  Response

     –  State and Local Health officials and Emergency Management officials

     –   Volunteers 

     –  Many 

    others!

    3

    Thanks to the Pharmacy 

    Simulation Team!

    3

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    The Voice of Pharmacists:

     A Pol l about Al ternative Methods for Antiv iralDistribution During a Pandemic Influenza

    September 19, 2012

    Gillian SteelFisher, Ph.D., M.Sc.

    Robert J. Blendon, Sc.D.

    Mandy Brule, M.A.

    Harvard School of Public Health

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Methods Summary

    41

    • Mail and online poll

    • Conducted February 24 to April 23, 2012

    • Nationally representative sample of 1,076 Pharmacists who work in

    community pharmacies (retail settings)

    • Quick summary statistics on sample:

    • 60% pharmacists; 38% managing pharmacists; 1% district managers

    • 67% full-time (35+ hours)

    • 73% staff (vs. float)

    • 54% male; 46% female

    • 81% married

    • 37% are parents of children 18 and under 

    • Questions after brief description of scenario & alternative delivery effort

    Technical note: Some summary statistics do not add to 100% or the sum of the subsets due to rounding and/or

    categories not shown (e.g., “refused/skipped”)

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Key Research Questions

    42

    • What do pharmacists think of this idea overall?

    • Will they participate?

    • What concerns might prevent them from participating?

    • Do they have relevant experience that might impact

    participation?

    • Do they think their pharmacies will participate?

    • Do they work in pharmacies that might impact their

    participation?

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    Overarching Reactions

    43

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    84%

    85%

    11%

    7%

    3%

    5%

    2%

    3%

    Go od Nei th er B ad Don 't Kn ow

    Pharmacists’ Reactions to

    Proposed Antiviral Distribution Effort

    44

    … a good or bad idea for the government to distribu te antivirals through

    pharmacies in this way?

    …a good or bad thing for th e pharmacist profession?

    Just based on the information so far, do you think it would be…

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Pharmacists’ Views on The Impact of This

    InitiativePlease indicate whether you agree or disagree with the following statements:

    Participating in this effort would strengthen…

    45

    28%

    40%

    46%

    65%

    78%

    49%

    38%

    37%

    28%

    18%

    St ron gly Agree So mewh at Agree

    Relationships with your local public health department

    Relationships with patients

    Relationships with physicians

    (93%)

    (78%)

    (84%)

    (76%)

    (96%)

    The role of pharmacists during publ ic health emergencies

    Relationships with your state public health department

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    Predictions about

    Pharmacist Participation

    46

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    47

    81%   8%  6% 6%

    Favor Nei ther Oppose Don 't Know

    Would you favor or oppose participating in such an effort personally?

    Do you think the other pharmacist(s) who work in your pharmacy would favor or oppose

    participating in such an effort?

    65%   4% 8% 2% 21%

    Favor Neither Oppose There no other pharmacists Don't Know

    Pharmacists’ Views on Pharmacist Participation

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Pharmacists’ Predictions: Coming to Work for

    Normal Shifts During a 12-Week Outbreak

    48

    How likely is it that you would come to work for your regular hours for all 12 WEEKS of the

    outbreak? (Assuming you are not sick yourself)

    1%

    1%

    6%

    91%

    Very li kely

    Somewhat likely

    Not very likely

    Not at all likely

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    Pharmacists’ Willingness to Come In for

    Extended or Additional Shifts

    33%

    46%

    Routine Pay

    Very likely

    Somewhat likely

    Higher Pay Rate/

    Comp Time

    79%

    In order to support the increased prescription volume, how likely is it that you would come to work

    for extended or additional shifts [at routine pay rates / if you received a higher pay rate or receivedcomp time for those shifts?

    24%

    67%

    Very likely

    Somewhat likely

    49

    91%

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Pharmacists’ Comfort Levels in Giving Antivirals

    Only to High-Risk Groups

    50

    In any emergency there is a chance that there would not be enough medicine at the time patients

    needed it. If there were a shortage of antivirals in your pharmacy and community, how comfortablewould you be with only filling prescriptions for those identified as high-risk – following CDC

    guidelines on high-risk groups?

    3%

    16%

    41%

    39%

    Very comfortable

    Somewhat comfortable

    Not very comfortable

    Not at all comfortable

    80%

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Concerns

    51

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    Pharmacists’ Worries About Participating

    52

    Managing usual

    patients

    Carrying influenzaback to family

    Personal exposure

    to influenza

    Facing antiviral

    shortages

    Managingantiviral patients

    Keeping order

    in the pharmacy

    New billing

    process

    Personal legal

    liability

    11%

    15%

    21%

    16%

    19%

    20%

    29%

    33%

    33%

    31%

    36%

    42%

    40%

    39%

    41%

    47%

    Very worr ied Somewhat worr ied

    (71%)

    (59%)

    (59%)

    (81%)

    (57%)

    (44%)

    (45%)

    (58%)

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Experiences that Could

    Impact Participation

    53

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Pharmacists’ Experience Compounding

    Medication

    54

    In the last five years, have you compounded medication to make them appropriate for children,

    adults with swallowing problems or those who need special dosing?

    22%

    78%

    Yes, I have

    No, I haven’t

    Don’t Know

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    Pharmacists’ Experience with

    “Collaborative Practice Agreements”Do you personally have any experience with a “collaborative practice agreement”? (“Collaborative

    practice agreement” means a written and signed agreement between a pharmacist and one ormore physicians for the purpose of medication therapy management (MTM) of patients, based on a

    protocol or protocols authorized by the physician(s).)

    3%

    2%

    58%

    37%

    55

    Yes

    No

    Don’t Know-I am unfamiliar with this term

    Don’t Know- Not sure if I’ve experienced this

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Frequency of Contact between Pharmacists and

    their State or Local Health DepartmentsIn the past year, in your capacity as a pharmacist, how many times have you had contact with any

    staff of your state or local public health department?

    5668%

    3%

    2%

    6%

    5%

    9%

    None

    2

    3-5

    6-10

    More than 10

    1

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Predictions about

    Pharmacy Participation

    57

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    16%

    1%

    82%

    58

    Do you think your pharmacy would participate in such a program if their really were a pandemic

    influenza outbreak?

    Pharmacists’ Views on Pharmacy Participation

    Yes, my pharmacy would participate

    No, my pharmacy would not participate

    Don’t Know

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    79%   9% 4% 8%

    Go od Nei th er B ad Don 't Kn ow

    Pharmacists’ Reactions to

    Proposed Antiviral Distribution Effort

    59

    …good or bad for business in your pharmacy?

    Just based on the information so far, do you think it would be…

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    10%

    27%

    63%

    Pharmacies’ Abilities to Handle 20% Increased

    Prescription Volume for 12 Weeks

    60

    If the pharmacy only had its routine number of pharmacists, student pharmacist interns and

    pharmacy technicians, do you think the pharmacy could handle 20% more prescriptions – all ofwhich were antivirals, or do you think the pharmacy would not be able to do this [for 12 weeks]?

    Yes, could handl e increased volume

    No, could not handle increased volume

    Don’t Know

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    13%

    72%

    14%

    13%

    53%

    34%

    50%

    100%

    Pharmacies’ Abilities to Handle 2-3 Week Surge

    of Prescription Volume

    61

    If the pharmacy had only its routine number of pharmacists, student pharmacist interns and

    pharmacy technicians, do you think the pharmacy could handle an increase of [50% or 100%] moreprescriptions--all of which were antivirals--for 2-3 weeks, or do you think it would not be able to do

    this?

    Yes, could handle surge

    No, could not handle surge

    Don’t Know

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Pharmacy Features

    that Could Impact

    Participation

    62

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Pharmacists’ Internet Access

    63

    While they work, do the pharmacists or pharmacy technicians have full access to the I nternet,

    do they have restricted access to the Internet, do they have access to ONLY the company’s systemsoftware (intranet), or do they have no Internet or intranet access at all?

    2%

    32%

    31%

    35%

    Full access to the Internet

    Restricted access to the Internet

     Access t o ONLY the company’s system soft ware (in tranet )

    No Internet or intr anet access at all

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    Harvard O inion ResearchPro ram,Februar 24- A ril 23, 2012

    Pharmacies’ Customer Service Options for

    Patients

    64

    Drive-thru window

    Does your pharmacy have a drive-thru

    window?

    Yes

    No

    8%

    26%

    34%

    Yes, would be

    willing to offerhome delivery

    Home Delivery

    In a pandemic, do you think your pharmacy

    would be willing to [continue to] offer home

    delivery?

    Yes, continue to offer 

    Yes, newly offer 

    61%

    38%

    Harvard OpinionResearch Program,February 24 - April 23, 2012

    Key Take-Aways

    65

    • Relatively high acceptability among pharmacists

    • Supportive of the effort overall

    • Willing to participate personally

    • Believe participation would strengthen public health role

    • Pharmacy participation seems logical

    • Important possible barriers to participation

    • Problems with antiviral supply

    • Insufficient protection for family/self 

    • Insufficient legal protection

    • Logistical challenges

    • Increasing number of staff 

    • Increasing Internet access

    • Opportunities

    • Building relationships with public health and physicians

    • Sharing more perspectives: other pharmacists; executives; the public

    Harvard OpinionResearch Program,February 24 - April 23, 2012

     Appendix:

    Fictional Scenario

    66

    Please imagine for a minute that there is an outbreak of pandemic flu, where the strain

    is much more severe than the 2009-2010 H1N1 outbreak, and a nationwide public

    health emergency has been declared. Antivirals are most effective against this strain if

    taken within 48 hours of symptoms. Commercial suppl ies are nearly exhausted and so

    the government’s stockpiles are the primary source of the medication.

    Unlike past outbreaks, when the government distributed antivirals mostly to public

    health departments, imagine that there is a new system where the government is alsoproviding antivirals directly to pharmaceutical distributors for distribution to pharmacies.

    Imagine further that your pharmacy agrees to receive shipments of antivirals and to

    dispense these antivirals for patients who have a prescription. Because the new flu

    virus is causing a lot of serious illness in many people, you would expect more patients

    to come to your pharmacy than usual. The antivirals will be in unit-of-use (unit-dose)

    packaging and will be provided to pharmacies for free from the government, but your

    pharmacy can charge patients a dispensing fee. The government has established a

    special claims submission process in order to ensure reimbursement for patients

    without insurance. Finally, depending on the severity of the pandemic, measures will

    be recommended to protect you and pharmacy staff from the virus that will reduce the

    chance you will get ill and thereby reduce the chance you will infect others.

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    Terminology•   Collaborative Drug Therapy 

    Management  (CDTM)1

     –   Collaborative practice under a 

    protocol

     –   Goal: provide patient care services 

    that achieve optimal medication 

    use and patient outcomes.

    •   Collaborative pharmacy 

    practice agreement (ID)

     –   Agreement between 1 or more 

    pharmacists and 1 or more 

    practitioners for the purpose of  

    conducting drug therapy 

    management  services

    •   Protocols / Standing 

    Orders

     –  Guides activities

     outlined within CDTM or 

    separate from CDTM 

    (like immunizations)

     –  Describes nature, scope, 

    communication and 

    procedures of  drug 

    therapy management or 

    patient care services

    1 Source: NABP Model Act

    Collaborative Drug Therapy 

    Management (CDTM)•   Team approach

    •   May include, but are not limited to:

     –  Initiating, modifying, and monitoring a patient’s drug 

    therapy;

     –  Ordering and performing laboratory and related tests; and

     –  Assessing patient response to therapy.

    •   Authority ranges from setting/patient restrictions  to broad 

    authority

     –  Non emergency

     –  Declared emergency

    •   States / Territories

     with

     no

     CDTM

     authority:

     AL,

     DC,

     

    DE, OK, PR,SC

    Public Health Emergency Laws

    •   In an emergency a state Governor can be 

    provided authority to issue an emergency 

    order to allow pharmacists to evaluate and 

    dispense antiviral

     medications

     –  Some states have existing law or are proposing 

    specific law

     –  Some states go by Governor emergency 

    declaration ability

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    Approaches to Gain Authorityideally  in non‐emergency  situation that  could  apply  to emergency  situation

    •   Health Department Advocacy

    •   State 

    Board 

    of  

    Pharmacy•   Washington State 

     –   Collaborative Drug Therapy Agreement for Antiviral 

    Medications for Treatment or Prophylaxis during an 

    Influenza Outbreak. 

    •  specifically authorizes pharmacists to prescribe antiviral medications and will only be effective when authorized by 

    public health officials. 

    •   Available at 

    http://www.doh.wa.gov/Portals/1/Documents/Pubs/69021

    3.pdf 

    CDTM

    •   For pharmacists to engage to the full extent in dispensing antiviral medications, CDTM laws 

    need to be structured to allow pharmacists to 

    evaluate a patient per a protocol and order an 

    antiviral medication for that patient. 

     –  Not to be confused with prescribing

    •   These medications have a time factor for 

    receiving maximum benefit

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    Broad  or  Open‐Ended  Language•   Use permissive language

    •   Types of  collaborative authority decisions, including:

     –   types of  diseases, drugs, or drug categories involved and the type of  

    collaborative authority authorized in each case; and

     –   procedures, decision criteria, or plans the pharmacists are to follow when 

    making therapeutic decisions, particularly when modification or initiation of  

    drug therapy is involved;

    •   Offers an opportunity for pharmacists to evaluate a patient per a 

    protocol and order an antiviral medication for patient seen under 

    the CDTM. 

    CDTM laws that may hinder ability of  

    pharmacists to order antiviral therapy

    •   Requirement   for  a Prescriber’s Initial  Diagnosis 

    of  the Patient 

    •   Requirement   for  a Physician Order   for  Therapy  

     for  a Specific Patient 

    •   Requirement  that  CDTM Take Place in a 

    Hospital  or  Similar  Facility 

    •   Requirement  that  the Pharmacy  Have a 

    Private Setting  for  CDTM

    Recap

    •   Be prepared before an event occurs

    •   Serve the public health needs of  communities

    •   Have 

    the 

    service 

    be 

    part 

    of  

    the 

    services 

    provided by  the pharmacy

     –  Time is essential for effectiveness  of  the therapy

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    Self ‐Assessment Question #11. The purpose of  exploring a new method of  

    pandemic antiviral distribution and dispensing is 

    to:A. Improve access to antivirals during an influenza 

    pandemic

    B. Increase the burden on public health during a 

    public health emergency

    C. Provide antivirals for free to the public

    D. Ensure every American has a dose of  antivirals

    Self ‐Assessment Question #2

    2. CDC’s pharmacy simulation exercises provided 

    information that:

    A. Pharmacies can provide medicines during an 

    emergency

    B. Pharmacies can increase the number of  patients 

    served during a future pandemic

    C. Usual standards of  accuracy and quality control 

    can be maintained when dispensing antivirals 

    during a pandemic 

    D. All of 

     the

     above

    Self ‐Assessment Question #3

    3. Collaborative Drug Therapy Management 

    (CDTM) encompasses the following:

    A. It is a team approach

    B. May

     include,

     but

     is

     not

     limited

     to

     initiating,

     

    modifying, and monitoring a patient’s drug therapy

    C. Can be utilized in non‐emergency and declared 

    influenza situations

    D. All of  the above

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    May, 2011  May, 2013

    9/19/2012

    Project Plan for CDC Alternative Antiviral Distribution and

    Dispensing Project

    If  the  proposed  strategy  is  feasible and  acceptable…

    Fall 2012

    •   CDC develops, issues, receives RFP s and evaluates them for 

    feasibility, suitability, practicality and acceptability

    •   CDC will finalize new approaches and award contract to entities

    •   CDC will develop SOPs, amend state planning guidance, and 

    working with ASTHO and NACCHO, disseminate final plans  to 

    SLTT partners

    Questions??

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