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New Approaches for Antiviral Medication Dispensing During a Pandemic:
Collaborations that utilizes the community pharmacist
Lisa Koonin MN, MPHCenters for Disease Control and Prevention
Anita Patel, PharmD, MSCenters for Disease Control and Prevention
Mitchel Rothholz, RPh, MBAAmerican Pharmacists Association
Gillian SteelFisher, PhD, MScHarvard 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.
Accreditation Information
The American Pharmacists Association is accredited by theAccreditation 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.
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
CDC’s Alternative Antiviral Drug Distribution and Dispensing Exploratory
Project
Lisa M. Koonin MN MPHLead, Pandemic Medical Care and
Countermeasures Task ForceInfluenza Coordination Unit
Centers for Disease Control and Prevention
Timely Antiviral Treatment During an Influenza Pandemic Depends Upon Success At Every Step
Antiviral susceptibility and effectiveness Supply Available EUA/Regulatory issues
Public acceptance
Pharmacists acceptability
Distribution from SNS/Commercial supply
chain
Provider Acceptability
Patient access to Rx
Access to medication
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
AntiviralManufacturers
SNS
LHD
SHD
Nursing Homes
Various
methods
Pharmaceutical Distributors
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 ClinicsTargeting
underserved 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?
Alternative AVD Distribution and Dispensing Plan Must be Feasible and Acceptable
New Approach drafted
Feasible? Acceptable? YESPossible 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, MSHealth Scientist
Division of Strategic National StockpileOffice of Public Health Preparedness and Response
Centers for Disease Control and Prevention
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
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Matt’s Medicine Store, Independence MOPharmacy Simulation 1: Independent pharmacy
March 11, 2012
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Walgreens, Chicago, ILPharmacy 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 filled
3. 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
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Exercise Objectives
• 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
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• 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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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
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VolunteersPatient 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
The Simulation Cell (SimCell)• Problems requiring a 3rd party to resolve were simulated by Controllers staffing phones at the SimCell
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• 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
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 served29 41 35 35
Number people picked up multiple scripts4 11 7 9
Throughput (number people serviced per hour) 20.7 27.3 23.3 23.3
Number scripts filled34 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 Name Medication
Dose/Strength Quantity Instructions
OverallCorrect 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%
• Overall high level accuracy observed
Objective 2b. Assessing Accuracy: Chicago, IL
Patient Name Medication
Dose/Strength Quantity Instructions
OverallCorrect 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. BottlenecksBoth drills
Objective 4. Quality of the dispensing experience for each pharmacy “patient” during the exercise
Independence, MO
Chicago, IL
• 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!
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Thanks to the Pharmacy Simulation Team!
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Harvard Opinion Research Program, February 24 - April 23, 2012
The Voice of Pharmacists: A Poll about Alternative Methods for Antiviral
Distribution 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 Opinion Research Program, February 24 - April 23, 2012
Methods Summary
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• 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 Opinion Research Program, February 24 - April 23, 2012
Key Research Questions
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• 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?
Harvard Opinion Research Program, February 24 - April 23, 2012
Overarching Reactions
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Harvard Opinion Research Program, February 24 - April 23, 2012
84%
85%
11%
7%
3%
5%
2%
3%
Good Neither Bad Don't Know
Pharmacists’ Reactions to Proposed Antiviral Distribution Effort
44
… a good or bad idea for the government to distribute antivirals through pharmacies in this way?
…a good or bad thing for the pharmacist profession?
Just based on the information so far, do you think it would be…
Harvard Opinion Research 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%
Strongly Agree Somewhat Agree
Relationships with your local public health department
Relationships with patients
Relationships with physicians
(93%)
(78%)
(84%)
(76%)
(96%)The role of pharmacists during public health emergencies
Relationships with your state public health department
Harvard Opinion Research Program, February 24 - April 23, 2012
Predictions about Pharmacist Participation
46
Harvard Opinion Research Program, February 24 - April 23, 2012
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81% 8% 6% 6%
Favor Neither 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 Opinion Research 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 likely
Somewhat likely
Not very likely
Not at all likely
Harvard Opinion Research Program, February 24 - April 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 received comp time for those shifts?
24%
67%
Very likely
Somewhat likely
49
91%
Harvard Opinion Research 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 comfortable would 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 Opinion Research Program, February 24 - April 23, 2012
Concerns
51
Harvard Opinion Research Program, February 24 - April 23, 2012
Pharmacists’ Worries About Participating
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Managing usual patients
Carrying influenza back to family
Personal exposure to influenza
Facing antiviral shortages
Managing antiviral 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 worried Somewhat worried
(71%)
(59%)
(59%)
(81%)
(57%)
(44%)
(45%)
(58%)
Harvard Opinion Research Program, February 24 - April 23, 2012
Experiences that Could Impact Participation
53
Harvard Opinion Research 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
<.05%
Harvard Opinion Research Program, February 24 - April 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 or more 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 Opinion Research 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?
56
68%
3%
2%
6%
5%
9%
None
2
3-5
6-10
More than 10
1
Harvard Opinion Research Program, February 24 - April 23, 2012
Predictions about Pharmacy Participation
57
Harvard Opinion Research Program, February 24 - April 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 Opinion Research Program, February 24 - April 23, 2012
79% 9% 4% 8%
Good Neither Bad Don't Know
Pharmacists’ Reactions to Proposed Antiviral Distribution Effort
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…good or bad for business in your pharmacy?
Just based on the information so far, do you think it would be…
Harvard Opinion Research 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 of which were antivirals, or do you think the pharmacy would not be able to do this [for 12 weeks]?
Yes, could handle increased volume
No, could not handle increased volume
Don’t Know
Harvard Opinion Research Program, February 24 - April 23, 2012
13%
72%
14%
13%
53%
34%
50%
100%
Pharmacies’ Abilities to Handle 2-3 Week Surge of Prescription Volume
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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%] more prescriptions--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 Opinion Research Program, February 24 - April 23, 2012
Pharmacy Features that Could Impact
Participation
62
Harvard Opinion Research Program, February 24 - April 23, 2012
Pharmacists’ Internet Access
63
While they work, do the pharmacists or pharmacy technicians have full access to the Internet, do they have restricted access to the Internet, do they have access to ONLY the company’s system software (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 to ONLY the company’s system software (intranet)
No Internet or intranet access at all
Harvard Opinion Research Program, February 24 - April 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 offer home 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 Opinion Research Program, February 24 - April 23, 2012
Key Take-Aways
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• 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 Opinion Research 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 supplies 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 also providing 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.
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
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/690213.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
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
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
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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