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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 .
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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.
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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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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?
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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
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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
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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”
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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
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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
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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
a
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??
How to Obtain your CPE Credit
• Record Attendance Code provided during the webinar
• Please visit: http://www.pharmacist.com/live ‐activities
and select the Claim Credit link for this activity
• You will need a pharmacist.com username and
password
• Select Enroll Now or Add to Cart from the left
navigation and successfully complete the Assessment
(select correct attendance code), Learning Evaluation
and Activity Evaluation for access to your statement of
credit. You will need to provide your NABP e‐profile ID
number to access your statement of credit.