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Pharmacy-based Immunizations: Current Best Practices and Novel Strategies to Increase Vaccination Rates

Joy Fakhouri, Pharm.D.Pharmacy Team Leader

Meijer PharmacyLivonia, MI

Joe Fava, Pharm.D.Clinical Assistant Professor

Wayne State UniversityDetroit, MI

An application-based continuing education program

Friday February 23, 2018

Michigan Pharmacists Association2018 Annual Convention & Exposition

Learning Objectives: Pharmacists

1. Understand the most up-to-date evidence on the safety, efficacy, and indications for current influenza, pneumococcal, herpes zoster, and tetanus/diphtheria/pertussis vaccines in adolescents and adults.

2. Evaluate patient vaccination status and make strong vaccine recommendations using efficient communication skills and electronic resources

3. Create a comprehensive annual vaccination plan that engages multiple stakeholders, starting with your pharmacy staff and including pharmacy students, community leaders, and public health representatives.

Learning Objectives: Technicians

1. Understand the indications and vaccine schedules of current influenza, pneumococcal, herpes zoster, and tetanus/diphtheria/pertussis vaccines in adolescents and adults.

2. Apply patient communication methods that are both efficient and effective - to recruit eligible patients for vaccinations.

3. Create a comprehensive annual vaccination plan that engages multiple stakeholders, starting with your pharmacy staff and including pharmacy students, community leaders, and public health representatives.

At your table

Presentation summary (one-page Key Points) and references

During-presentation active learning case studies

2017* ACIP/CDC Immunization Schedules

Listing of Influenza Vaccine Products for 2017-2018 Season

CDC MMWR August 2017

Adult Pneumococcal Vaccination Clinical Reference Chart Courtesy of California Department of Public Health (CDPH)

Immunization Update – Early 2018

Influenza Pneumococcal

Herpes ZosterTetanus,

Diphtheria & Pertussis

https://www.cdc.gov/flu/images/influenza-virus-fulltext.jpg

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Influenza Viruses: Four Types A: human, drifter + shifter, capable of pandemics or epidemics

Subtypes: based on surface proteins Hemagglutinin (H) 18 different (H1-H18)

Neuraminidase (N) 11 different (N1-N11)

Strains H1N1, H3N2

B: not divided into subtypes, does NOT shift Yamagata or Victoria lineage

C: mild, usually not associated w/ epidemics D: cattle, not known to infect humans

https://www.cdc.gov/flu/about/viruses/types.htm

Influenza: This Season

https://www.cdc.gov/flu/weekly/index.htm

Vaccine Efficacy Good match: 40-60% efficacy overall 2016-2017: 39% (32% against H3N2)

2017-2018: preliminary estimate against H3N2 in Australia: 10% U.S. vaccines have same composition (chosen September 2016 for release Summer 2017)

Hypotheses for poor vaccine efficacy Prior influenza exposure variable vaccine response Egg adaptation (changes in surface proteins during replication) Intra- or Inter-season drift

Vaccine Benefit Prevention of severe illness and decreased QOL in elderly

Decreases risk for flu-associated death by 65% in children

Influenza Vaccine: This Season

http://www.nejm.org/doi/full/10.1056/NEJMp1714916https://shotofprevention.com/2017/12/11/flu-vaccine-benefits-go-beyond-effectiveness-of-one-strain/?blm_aid=18693

Influenza VaccinationEligibility ALL patients aged 6 months and older*

INCLUDES: pregnant, immunosuppressed, and egg-allergic patients!!!

Formulations • Trivalent (IIV3) A types: H1N1 and H3N2, B type: Victoria lineage• Quadrivalent (IIV4) additional B type: Yamagata lineage

• Recombinant (RIV3 and RIV4) EGG-FREE• Cell culture-based (ccIIV4)

• Adjuvanted (aIIV3)• High dose (IIV3)

High Risk Groups (9)3-age4-disease states2-residence/race

Adverse Events • Injection-site reactions (soreness, redness, swelling) Up to 65%• Systemic flu-like symptoms (headache, fever, nausea, muscle aches) similar to placebo

Precautions (2)

Contraindications (1)

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5908a1.htmGrohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season. MMWR Recomm Rep 2017;66(No. RR-2):1–20. DOI: http://dx.doi.org/10.15585/mmwr.rr6602a1.

• < 5 years• > 50 years• < 18 years on ASA or salicylate-containing meds• Chronic pulmonary, CV**, renal, hepatic,

neurologic, hematologic, or metabolic disorders

• Immunocompromised• Pregnancy• BMI > 40 kg/m2

• Nursing Home/Long Term Care Residents• American Indians/Alaska Natives

• Moderate-to-severe acute illness w/ or w/out fever• History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine

• History of severe allergic reaction to any component of the vaccine or after previous dose of any influenza vaccine

Influenza Vaccination: Age 6 months – 8 years

Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season. MMWR Recomm Rep 2017;66(No. RR-2):1–20. DOI: http://dx.doi.org/10.15585/mmwr.rr6602a1.

Influenza Vaccination: Egg Allergy

https://www.cdc.gov/flu/protect/vaccine/egg-allergies.htm

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Influenza: Vaccine Product SelectionPatient Appropriate Vaccine

73 YOWM

32 YOAAF with latex allergy12 YOWF with egg allergy (hives)

28 YOAAF who is 20 weeks pregnant

Any age-appropriate IIV3/IIV4 EXCEPT Fluvirin®

High Dose IIV3 (Fluzone® HD) or aIIV3 (FluadTM)*

Any AGE-APPROPRIATE IIV3 or IIV4 Why not RIV3/4?

Any age-appropriate IIV3/IIV4Pregnancy Category B: Fluzone® Quadrivalent (ID and IM), Flucelvax Quadrivalent®, Afluria® Trivalent, Fluvirin® TrivalentNo Pregnancy Category: Afluria® Quadrivalent, Fluarix® Quadrivalent, Flulaval® Quadrivalent

CDC NOTES: • Less experience with IIV4 and ccIIV4 formulations• Data for RIV3/4 very limited**

Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season. MMWR Recomm Rep 2017;66(No. RR-2):1–20. DOI: http://dx.doi.org/10.15585/mmwr.rr6602a1.Highlights of Prescribing Information for all influenza vaccines listed above. Accessed 1 Feb 2018 – URLs available upon request.

Immunization Update – Early 2018

Influenza Pneumococcal

Herpes ZosterTetanus,

Diphtheria & Pertussis

Pneumococcal Disease Etiology: Streptococcus pneumoniae

90 different serotypes

10 common types cause 62% of invasive disease

Not just pneumonia! Two major clinical syndromes: bacteremia and meningitis

Pneumonia is most common disease caused by S. pneumoniae 25-30% will get bacteremia

Vaccines Pneumovax®23 (PPSV23)

Serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F

Prevnar 13® (PCV13) Serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

http://www.immunize.org/askexperts/experts_pneumococcal_vaccines.asphttps://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdfhttp://labeling.pfizer.com/showlabeling.aspx?id=501

Pneumococcal Vaccination

Case Study 1DL is a 67 YOWF who comes to your

pharmacy asking for a pneumonia ‘booster.’ Her MCIR profile shows she received one dose of PPSV23 at age 63 years. What are your recommendations?

Pneumococcal Vaccination

From “Pneumococcal Vaccine Timing – For Adults.” California Department of Public Health; Immunization Branch – September 2015

Pneumococcal Disease

Case Study 1 DL is a 67 YOWF who comes to your pharmacy asking for a pneumonia

‘booster.’ Her MCIR profile shows she received one dose of Pneumovax®23 (PPSV23) at age 63 years. What are your recommendations? PMH: T2DM, HTN

Case Study 1 Answer: Prevnar 13® (PCV13) today

Pneumovax®23 (PPSV23) 1 year later (5 total years since last PPSV23)

What if you’re < 65 YO?

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Pneumococcal Vaccination

From “Pneumococcal Vaccine Timing – For Adults.” California Department of Public Health; Immunization Branch – September 2015

Pneumococcal Vaccination Safety and Efficacy

Prevnar 13® Pneumovax®23

Efficacy • Against CAP: 45%*• Against Invasive Pneumococcal

Disease: 75%*

• Against invasive infection: 57%*; • 75%* in immunocompetent patients > 65

YO

Adverse Events (in adults)

• Injection site reactions (pain in >50%, redness and swelling in >10%)

• Fatigue (>30%)• Headache, muscle pain (>20%)• Joint pain, ↓ appetite, limitation of

arm movement (>10%)• vomiting, fever, chills, rash (>5%)

• Injection-site pain/soreness/tenderness (60.0%)

• Injection-site swelling/induration (20.3%) • Headache (17.6%)• Injection-site erythema (16.4%)• Asthenia and fatigue (13.2%)• Myalgia (11.9%)

https://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdfhttp://labeling.pfizer.com/showlabeling.aspx?id=501

*Against vaccine-type pneumococcal disease (serotypes contained in vaccine)

Immunization Update – Early 2018

Influenza Pneumococcal

Herpes ZosterTetanus,

Diphtheria & Pertussis

Herpes Zoster

http://www.nejm.org/doi/full/10.1056/NEJMct066061

Herpes Zoster

http://www.nejm.org/doi/full/10.1056/NEJMct066061

Herpes ZosterZostavax® (ZVL) SHINGRIX (RZV)

Vaccine Type • Live-attenuated• Oka/Merck strain VZV

• Inactive, recombinant, adjuvanted• VZV surface glycoprotein E antigen

component + AS01B adjuvant

How Supplied • Single-dose vial of lyophilized vaccine (powder)

• Separate package of diluent (clear)

• Single-dose vial of lyophilized vaccine (powder)

• Accompanying vial adjuvant suspension component (opalescent, colorless to pale brown)

Dosing and route of administration

• 0.65 ml (reconstituted) subcutaneously(1 dose)

• *Within 30 minutes of reconstitution

• 0.5 ml (reconstituted) IM at 0 and 2-6 months (2 doses)

• Administer immediately or store refrigerated and use w/in 6 hours

Storage and Handling

• Protect From light• Vaccine: frozen (-58oF to 5oF) • Diluent: Room temperature or

refrigerated (36oF to 46oF)

• Protect From light• Lyophylized gE antigen component AND

adjuvant suspension: (36oF to 46oF)

https://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi2.pdfhttps://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF

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Herpes ZosterZostavax® (ZVL) SHINGRIX (RZV)

Schedule (FDA/ACIP)

• FDA: 1 dose in > 50 YO• ACIP: 1 dose in > 60 YO

• FDA and ACIP: 2 doses (0 and 2-6 months) in > 50 YO

Efficacy • Overall: 51.3%• 50-59 YO: 69.8%• 60-69 YO: 63.9%• 70+ YO: 37.6%

• 50+ YO: 97.2%• 70+ YO: 89.8%

Adverse Effects Local:• Pain (34.3-53.9%)• Erythema (35.6-48.1%)• Swelling (26.1-40.4%)• Pruritus (6.9-11.3%), warmth (1.6-3.7%),

hematoma (1.6%), induration (1.1%)

Systemic: headache (1.4-9.4%), pain in extremity (1.3%)

Local• Pain (78%)• Erythema (38.1%)• Swelling (25.9%)

Systemic: myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), gastrointestinal symptoms (17.3%)

Pricing • ~$250-300• Medicare Part D Benefit w/ variable copays

• ~$280 for two doses• Coverage?

https://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi2.pdfhttps://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF

• Reduces PHN by 66.5%

Oxman, et al. NEJM 2005 352(22):2271-84 Cunningham et al. NEJM 2016;375(11):1019-32Schmader, et al. CID 2012;54(7):922-8 Chlibek et al. Vaccine 2016;34(6):863-8Lal et al. NEJM 2015;372(22):2087-96

• 88.8-91.2% effective against PHN

Herpes Zoster

https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/shingrix/pi/acip.html

Herpes Zoster New Recommendations: Key Reminders

Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR Morb Mortal Wkly Rep 2018;67:103–108. DOI: http://dx.doi.org/10.15585/mmwr.mm6703a5

Can you give SHINGRIX to patients who are immunosuppressed?

Can you give SHINGRIX to patients w/ history of Shingles?

Can you give SHINGRIX to someone who previously received Zostavax®?

How long do I have to wait after someone has gotten Zostavax to give SHINGRIX?

Can I give SHINGRIX at the same time as other vaccines?

NO (not yet: no data, studies ongoing)

YES

YES

When acute phase of illness is over and no symptoms present

Only available data: > 5 yearsExpert opinion: > 2 months

Fluarix Quadrivalent: data says YESPPSV23, TdAP: studies ongoing but CDC says YES*

Immunization Update – Early 2018

Influenza Pneumococcal

Herpes ZosterTetanus,

Diphtheria & Pertussis

Tetanus, Diphtheria, & Pertussis

Children: DTaP at 2, 4, 6, and 15-18 months, followed by last dose at 4-6 years

https://www.cdc.gov/vaccines/schedules/index.html

Adults: Tdap ONCE, Td every 10 years

Pregnancy: Tdap with EVERY pregnancy – ideally early in gestational weeks 27-36

Tetanus, Diphtheria, & Pertussis Case Study 2

GQ is a 68 YOAAM at your pharmacy requesting a tetanus shot booster. You check his MCIR and reveal that his last tetanus shot was in 2004 and he received TdaP. You check your vaccine stock for Td and notice you only have Boostrix® (TdaP) in stock. GQ has two infant grandchildren. What should you do?

A) Give him nothing. His caught up on his tetanus shots.

B) Give 1 dose of Boostrix® (Tdap) today

C) Refer him to another pharmacy or provider for the Td vaccine

D) Order Tenivac (Td) and tell him to come back when it arrives

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Tetanus, Diphtheria, & Pertussis Immunity to pertussis from vaccination is estimated to last only ~4-7 years

Can vary from person to person

Intervals of 5 and 10 years between TdaP vaccinations have been shown to be well-tolerated and immunogenic in adolescents and adults

Per Immunization Action Coalition panel of experts: If a person who previously received Tdap needs a Td booster and Td is not available it IS

acceptable to administer Tdap

Kilgore PE et al. Clin Microbiol Rev. 2016;29(3):449-86. van Twillert I et al. Pathogens and disease. 2015;73(8):ftv071.

McGirr A etl al. Pediatrics. 2015;135(2):331-43. Halperin SA et al. Vaccine. 2011;29(46):8459-65.

Halperin SA,et al. Vaccine. 2012;30(5):974-82. Epub 2011/11/26. doi: 10.1016/j.vaccine.2011.11.035. PubMed PMID: 22115634.http://www.immunize.org/askexperts/experts_per.asp

Tetanus, Diphtheria, & Pertussis

Case Study 2 GQ is a 68 YOAAM at your pharmacy requesting a tetanus shot booster. You

check his MCIR and reveal that his last tetanus shot was in 2004 and he received TdAP. You check your vaccine stock and notice you only have Boostrix® in stock. GQ has two infant grandchildren. What should you do?

A) Give him nothing. His caught up on his tetanus shots.

B) Give 1 dose of Boostrix® today

C) Refer him to another pharmacy or provider for the Td vaccine

D) Order Tenivac (Td) and tell him to come back when it arrives

Check your CPA first!

Novel Strategies to Boost your Immunization Numbers

Education

Annual education for both pharmacists and technicians

CEBloodborne PathogensCPR/AED TrainingReview Immunization SchedulesUnderstand State laws and Collaborative

Agreements and Protocols

Education

Flu + 1 or 2Use a state immunization registry (MCIR)

Check before giving flu shots to see which other vaccines are indicated.

Adult records complete??Educate technicians on who to offer certain

vaccines

“Flu + 1” Triggers

Vaccine TriggerPneumonia Age >65

Metformin/Insulin prescriptionAlbuterol inhalersNicotine replacement therapyNitroglycerinImmunosuppressive injectables

Shingles Age >50Medicare Part D.

Tdap Prenatal vitaminsPregnant patients, spouses, and grandparents

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Case #3

Overcoming Barriers

Myths/Misconceptions“I am sick. I can’t get my flu shot.”“I have an egg allergy.”“The flu shot will give me the flu. ““I never get the flu.”“I don’t want to be injected with Mercury.”

Overcoming Barriers

Fear of NeedlesTell patients side effects (local reactions)

upfront. Children- having suckers/stickers, distraction,

help from parentsHow to handle syncope

Overcoming Barriers

Financial Barriers

Financial Barriers Indigent patientsHigh copays

Pharmacy Barriers

Staffing- call offs during winter months

Busiest time of the year

Let’s take advantage of our increased volume to make a bigger impact in our community!

Making a Strong Recommendation

Research indicates that most adults believe that vaccines are important and are likely to get them if recommended by their healthcare professionals. “My pharmacist strongly recommends getting

your flu shot.” “My pharmacist recommends that all diabetics

get their pneumonia vaccine.”

https://www.hhs.gov/blog/2017/11/07/healthcare-providers-strong-vaccination-recommendation-can-be-game-changer-this-flu-season.html

Making a Strong Recommendation

1. Tailor reasons to that individual.2. Discuss how vaccination prevents illness.3. Outline the consequences of getting sick.4. Explain how vaccines work.5. Answer questions with compassion.

https://www.hhs.gov/blog/2017/11/07/healthcare-providers-strong-vaccination-recommendation-can-be-game-changer-this-flu-season.html

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Motivational Interviewing

Roll with resistance

1Express empathy

2Avoid argumentation

3Develop discrepancy

4Support self-efficacy

5

SHARE

SHARE the tailored reasons why the recommended vaccine is right for the patient

HIGHTLIGHT positive experiences with vaccines

ADDRESS patient questions and any concerns about the vaccine, including side effects, safety, and vaccine effectiveness

REMIND patients that vaccines protect them and their loved ones from many common and serious diseases

EXPLAIN the potential costs of getting the disease, including serious health effects, time lost

https://www.cdc.gov/vaccines/hcp/adults/downloads/standards-immz-practice-recommendation.pdf

Creating a Plan

Having a game plan in early summer will be a great help.

Stock up on supplies at beginning of season. Don’t have to worry about basic supplies

going on back order. Adequate supply of vaccines and

checking stock on a weekly basis.Epi-pens on hand and in date?

Creating a Plan

SpacePrivate area for vaccination in

case clothing needs to be removed

Clean area clutter and food free.

Avoid patient information disclosures.

Incorporating into the Workflow

Technicians and Pharmacist offering vaccines at every patient interaction!

Technicians collecting patient information via screening questionnaire. Calling PCP if MCIR incomplete. Checking personal immunization card.

Incorporating into the Workflow

Bill vaccines while patient shops/waits for their prescription.Triage as “Urgent” to increase

convenience. Tech provides vaccine in basket for

pharmacist to check, allowing vaccine to warm up.

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Use your Interns!

Lessen the labor burden.• Pharmacist

stays in workflow.

• Hours charged off.

Technician education about vaccines/how to

overcome patient barriers

Part of their

Education

Increasing Visibility Sending letters with pre-filled questionnaires to patients

that you gave flu shots the year before.

In-store advertisementsSigns, overhead announcements, greeters giving

flyers to customers.Setting up a table or having a technician on the

busiest entrance of the store to offer/advertise.

Off-site clinicsBusinesses with >100 employeesChurches, Schools, Community health fairs/events

Motivating Your Team

Ask at every patient interaction Weekly or monthly competitions Games Poster that shows progress Create a theme for your pharmacy Rewarding via gift cards/food

Geographical OutbreaksHepatitis A

Outbreak from August 2016. Michigan has 677 current cases and had 22 deaths as of Jan 12,

2018. Shortage of Hep A vaccine Prevention:

HAVRIX (HepA Vaccine) given at 0 and 6-12 monthsVAQTA® (HepA Vaccine) given at 0 and 6-18 monthsTWINRIX (HepA + HepB Vaccine) given at 0, 1, and 6 months

Childhood vaccine but most adults have not received yet.http://www.michigan.gov/mdhhs/0,5885,7-339-71550_2955_2976_82305_82310-447907--,00.html

https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Havrix/pdf/HAVRIX.PDFhttps://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110079.pdf

Geographical Outbreaks

Pertussis Vaccine-preventable disease Rise in cases in Michigan, peaking in 2010 with

over 1,500 cases reported. 2014- over 1,400 cases reported. Target pregnant patients 27-36 weeks and

those who are in close contact with a newborn.

http://www.michigan.gov/mdhhs/0,5885,7-339-73971_4911_4914-240419--,00.html

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More ways to increase vaccination rates

CMRs

Asses vaccination status during every CMR encounter.

MCIR patients

Travel Vaccines

Azithromycin or Metronidazole prn diarrhea.

Yellow Book Foreign

population?

Back-to-School Vaccines

11 year old vaccines-Tdap, HPV, and MenACWY

College Freshman

Flu shot

Follow-up Reminders Notify patients due for their boosters.

Ex. Run reports of Prevnar 13 given more than a year ago.

Others- SHRINGRIX HPV Hep A and B

More ways to increase vaccination rates

Why Vaccinate?

Protecting your community (herd immunity) Convenience of pharmacy hours and no

appointments needed. Doctors are too busy to assess vaccination status

and often do not stock all vaccines. Economic Benefit

Less work-days missed, hospitalizations, inappropriate prescribing of antibiotics, etc.

Why Vaccinate?

Increased profitability when reimbursement rates are low.

Building up your business! Annual Flu Vaccine is part of Medicare Part C

star ratings.Will pharmacies be measured by their rate of

vaccinations next?

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-10-12.html

Make it Fun! It’s our time to shine. Just have a plan and start

early. Team building and competition Increases our patient contact

Offer more services Show that Pharmacists do more than prepare

prescriptions.