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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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Page 1: Development and Support - elearning.pharmacist.comelearning.pharmacist.com/Portal/Files/LearningProducts...Mitchel Rothholz, RPh, MBA American Pharmacists Association Gillian SteelFisher,

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. 

Page 2: Development and Support - elearning.pharmacist.comelearning.pharmacist.com/Portal/Files/LearningProducts...Mitchel Rothholz, RPh, MBA American Pharmacists Association Gillian SteelFisher,

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.

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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 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

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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? 

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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

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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

19

Matt’s Medicine Store, Independence MOPharmacy Simulation 1: Independent pharmacy

March 11, 2012

20

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

21

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

24

• 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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25

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

26

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

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The Simulation Cell (SimCell)• Problems requiring a 3rd party to resolve were simulated by Controllers staffing phones at the SimCell

28

• 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 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%

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• 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

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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!

38

Thanks to the Pharmacy Simulation Team!

39

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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

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 Opinion Research 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 Opinion Research Program, February 24 - April 23, 2012

Overarching Reactions

43

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

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Harvard Opinion Research Program, February 24 - April 23, 2012

Predictions about Pharmacist Participation

46

Harvard Opinion Research Program, February 24 - April 23, 2012

47

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

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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

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Harvard Opinion Research Program, February 24 - April 23, 2012

Pharmacists’ Worries About Participating

52

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%

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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

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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

59

…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

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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

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%] 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

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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

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 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.

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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/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

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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‐activitiesand 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.