ACCREDITATION Pharmacy

Transcription

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2 FACULTY Michael D. Hogue, PharmD, FAPhA, FNAP Associate Dean, Center for Faith and Health Samford University College of Health Sciences Professor, Pharmacy Samford University McWhorter School of Pharmacy Birmingham, Alabama No (other) speakers, authors, planners or content reviewers have any relevant financial relationships to disclose. Content review confirmed that the content was developed in a fair, balanced manner free from commercial bias. Disclosure of a relationship is not intended to suggest or condone commercial bias in any presentation, but it is made to provide participants with information that might be of potential importance to their evaluation of a presentation.

3 ACCREDITATION Pharmacy The University of Kentucky College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider for continuing pharmacy education. This application-based activity has been assigned UAN L01-P and will award 1.00 contact hour/0.100 CEU of continuing pharmacy education credit in states that recognize ACPE providers. Statements of participation will indicate hours and CEUs based on participation and will be issued online at the conclusion of the activity. Successful completion includes signing in at registration, attending the entire session for which credit is claimed, completing the activity evaluation and requesting credit online at conclusion of the activity. Credit will be uploaded to CPE Monitor, and participants may print a statement of credit or transcript from their NABP e-profile. The College complies with the Accreditation Standards for Continuing Pharmacy Education.

4 Get Credit Instructions At the conclusion of the activity: 1. Go to 2. In the box marked Activity Code, enter PLN and click 'Search' 3. The appropriate activity details will display; click Proceed to Credit on the right hand side. 4. If you are not signed into CECentral.com, you will either need to login or create an account (free of charge) 5. Check all of the sessions for which you are requesting credit, check the certification statement, and click Submit 6. Complete the Evaluation and click Submit 7. Your certificate will display; you can print it or view it later by clicking Transcript in the blue bar at the top of the page The deadline to claim credit online is May 13, 2017

5 Educational Need Minimizing the burden of seasonal influenza requires improved vaccination rates and early use of antiviral medications in those at risk of complications. When selecting a vaccine, healthcare providers must be aware that not all influenza vaccines are alike. ACIP has specific recommendations for the type of vaccine that is appropriate based on age, immune status, and other patient factors. The immune response to live-attenuated vaccine versus inactivated vaccine can vary considerably and must be considered when selecting the optimal vaccine based on patient factors. Quadrivalent influenza vaccines have been made available since the influenza season and may help reduce the number of influenza infections in the US by providing broader coverage of virus strains.

6 Practice Gap Guidelines from ACIP recommend the flu vaccine for all individuals over the age of 6 months. However, data from the CDC reveal that: Only about half of the children from 6 months-17 years of age receive the flu vaccine Only about one-third of adults from years of age receive the flu vaccine In one study over five seasons at a large tertiary referral hospital, over 60% of patients admitted who were unvaccinated for influenza refused the vaccine while hospitalized. The most common reason given was believed not to be at risk. Though vaccination of healthcare providers (HCPs) is critical in preventing infection in vulnerable patients, nearly 1 in 4 HCPs are not vaccinated The availability of new vaccines can add to the complexity of selecting the most appropriate vaccine for each patient type. This complexity and confusion can augment barriers of improving vaccination rates within healthcare institutions.

7 Learning Objectives Upon completion of this educational activity, participants will be able to: Differentiate among the currently available influenza vaccines and select an appropriate vaccine based on patient factors and preferences. Apply strategies aimed to increase influenza vaccination rates and improve acceptance of immunization by patients in various clinical settings. Identify patients at risk of influenza-associated complications and mortality and appropriately initiate antiviral therapy to minimize the burden of disease.

8 Expected Outcome Evaluate the impact of this educational intervention on closing the identified practice gap. Improvement in learners competence and skills in preventing and treating influenza.

9 CDC Image. Available at cdc.gov/flu.

10 Influenza is No Laughing Matter The virus is carried on respiratory droplets up to six feet away from the person carrying the virus. A person with the flu can infect others for 1 day before having symptoms of their own, and for as long as a week after getting sick. People with COPD, diabetes, heart disease, neurologic conditions, asthma, and those who are pregnant can have serious complications: Pneumonia, bronchitis, sinus and ear infections Worsening of underlying chronic conditions (heart failure, COPD and asthma patients are at particular risk) Miscarriage or premature birth Death Centers for Disease Control and Prevention. Available at:

11 Flu Season Available at cdc.gov/flu/weekly/fluviewinteractive.htm.

12 Flu Season to date Available at cdc.gov/flu/weekly/fluviewinteractive.htm.

13 Impact of Vaccines Vaccines are one of the most important tools we have to protect the health of our nation's most vulnerable citizens, our children. (also adults, especially older adults) In the last 100 years, lifespan of Americans has doubled; largely as a result of vaccines and sanitation. Poland GA, Jacobson RM. N Engl J Med. 2011;364:97-9.

14 Centers for Disease Control and Prevention.

15 INFLUENZA VACCINE Reduction in Hospitalizations for Cardiac Disease and Strokes Observational studies of large cohorts (140,000; 146,000), AND 99-00, 3 HMOs, age 65 Vaccination against influenza associated with reduction in hospitalization for : Cardiac disease (19% both seasons) Cerebrovascular disease (16%; 23%) Pneumonia and influenza (32%; 29%) All-cause death (48%; 50%) Possible mechanisms: infection cause alterations in clotting factors, platelet aggregation, amount of inflammatory- response cytokines which enhance thrombosis Similar findings of more recent study* Nichol KL, et al. N Engl J Med. 2003;348: *Udell JA, et al. JAMA. 2013;310:

16 Adults who get Flu Vaccine Help Protect the Elderly People >65 years were less likely to have serious influenza-illness when 1/3 of younger adults within their communities were immunized. Cases of influenza-related illness in the elderly could have been prevented if more non-elderly adults had received the flu vaccine. Taksler GB, et al. Clin Infect Dis. 2015;61:

17 Vaccination Coverage is Lacking CDC. Available at:

18 Barriers to Vaccination Busy Practice Costly Inventory Storage and Handling Concerns Frequently Changing Practice Guidelines Lack of System-wide Documentation Inconsistent Reimbursement Patient Objections/Myths

19 Vaccines: Very High Benefit/Risk Ratio All vaccines have possible adverse effects, most are mild, rarely severe The risk of disease far outweighs the risk of vaccine MESSAGE: Vaccines are effective Safe Need to recommend

20 Determining Influenza Vaccine Composition Determined by World Health Organization Occurs annually, typically around mid-late February for vaccines to be used in the northern hemisphere Based on anticipated strains Trivalent vaccines offer protection against 2 influenza type A and 1 influenza type B strains Quadrivalent vaccines offer protection against 2 influenza A and 2 influenza B strains WHO. Accessed 2/7/2016.

21 US Influenza Vaccine Composition Trivalent Includes: A/California/7/2009 (H1N1) A/Switzerland/ /2013 (H3N2) B/Brisbane/60/2008-like virus (Victoria-lineage) Quadrivalent adds: B/Phuket/3073/2013-like virus (Yamagata-lineage) CDC. Accessed 2/7/2016.

22 Influenza Vaccine Abundant Choices for the Clinician ( )* IIV4, Standard Dose Fluarix ( 3 y.o.) Flulaval ( 3 y.o.) Fluzone ( 6 months) IIV4, Standard Dose, Intradermal Fluzone Intradermal (18-64 y.o.) cciiv4, Standard Dose Flucelvax ( 4 y.o.) IIV3, Standard Dose Afluria ( 9 y.o.) Fluvirin ( 4 y.o.) aiiv3, Standard Dose Fluad ( 65 y.o.) IIV3, High Dose Fluzone High-Dose ( 65 y.o.) RIV3 Flublok ( 18 y.o.) LAIV4** FluMist (2 to 49 y.o.) *MMWR. 2016; 65(5):1-54. Fluarix and Flulaval (GlaxoSmithKline); Fluzone, Fluzone Intradermal, Fluzone High-Dose (Sanofi Pasteur); Flucelvax, Afluria, Fluvirin, Fluad (Seqirus); Flublok (Protein Sciences); FluMist (MedImmune). **Flumist, while approved by the FDA, was not CDC recommended or available on the market for the season.

23 ACIP on Influenza Vaccine Routine annual influenza vaccine of all persons 6 months of age without contraindications. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is otherwise appropriate LAIV should not be used (although it is still FDA-licensed) Egg allergy concerns are minimal. CDC. Accessed 2/7/2017.

24 Influenza Vaccine Regular Dose IIV3 or IIV4: Killed, injectable 6 months and older Trivalent (IIV3) or Quadrivalent (IIV4) FDA-indicated ages may vary by manufacturer: Practically speaking, these vaccines are for anyone who doesn t have a contraindication to influenza vaccine IIV4 Intradermal (Fluzone Intradermal) FDA approval for years Manufacturer-supplied injection device (includes needle) 90% smaller needle; 9 mcg of each antigen (compared to 15 mcg of standard dose in IIV4) Quadrivalent IIV, Inactivated Influenza vaccine Fluzone Intradermal Quadrivalent (Influenza Vaccine) Prescribing Information. Sanofi Pasteur Inc., Swiftwater, PA. June 2016.

25 Influenza Vaccine High Dose IIV3, high-dose (Fluzone High-Dose) Contains 60 mcg each of the 3 influenza antigens (compared to 15 mcg each for regular IIV3) Slightly higher rate of MILD reactions Indications: Patients 65 years. Clinical trial had shown high-dose vaccine was 24.2% more effective in preventing influenza in adults 65 than the standard vaccine. Fluzone High-Dose (Influenza Vaccine) Prescribing Information. Sanofi Pasteur Inc. Swiftwater, PA. June DiazGranados CA, et al. N Engl J Med. 2014;371:

26 Should I Give High-Dose Flu Shots to Folks Older than 65? Phase IIIb-IV, multicenter, randomized, double-blind, active-controlled trial among adults 65 years and older 32,000 patients over 2 seasons Compared IIV3 high-dose vs. regular IIV3 Results: 1.4% vs. 1.9% infection rate in favor of high-dose Estimated absolute efficacy increased from 50% (with IIV3) to 62% (with high-dose) Similar to the level of protection in younger adults Caveats: only studied 2 influenza seasons (circulating strains didn t match well to vaccine in one year) Showed efficacy in both seasons anyway 2 episodes of possible neurological adverse effect with high-dose DiazGranados CA, et al. N Engl J Med. 2014;371:

27 Influenza Vaccine Adjuvanted Vaccine aiiv3, adjuvanted vaccine (Fluad ) Trivalent inactivated influenza vaccine plus a proprietary adjuvant that is proposed to recruit immune cells at the site of injection and enhance antigen uptake Results in potentially greater immunogenic response in elderly patients Indication: Patients 65 years. Clinical trials show non-inferiority with IIV3 based on seroconversion and geometric mean titers No data yet available that demonstrate decrease in influenza disease Fluad (influenza vaccine, adjuvanted) Prescribing Information. Sequiris, Inc., Holly Springs, NC. March 2016.

28 Influenza Vaccine in Egg Allergies Cell-Cultured and Recombinant Vaccines cciiv4 (Flucelvax Quadrivalent) In place of chicken eggs, uses animal cells (Canine Kidney) as host (reference strain obtained from virus originally grown in eggs); quadrivalent Approved for ages 4 years RIV3 (Flublok ) Recombinant vaccine egg-free hemagglutinin influenza vaccine produced by recombinant DNA technology using a baculovirus (a virus that infects insects) that produces virus-like particles, hemagglutinin (vaccine of choice for true egg allergy) Approved for ages >18; only 16-week shelf-life; trivalent Adverse events similar to other inactive vaccines Flucelvax Quadrivalent (influenza vaccine) Prescribing Information. Sequiris, Inc., Holly Springs, NC. April Flublok (influenza vaccine) Prescribing Information. Protein Sciences Corp., Meriden, CT. September 2016.

29 Influenza Nuts and Bolts 1 Vaccination season: Soon as available to ~April Influenza season unpredictable can start in October Immunity will last for almost all patients (no concern for waning immunity for most patients) Late season vaccination important and underutilized Egg allergy NO LONGER contraindication 3 Anaphylaxis is EXCEEDINGLY rare [<10 documented cases] Flublok if concern OK to give egg-based if no history of severe anaphylaxis If vaccinated, should be observed ~30 minutes in office DO NOT defer vaccination if the ideal vaccine is not available when another suitable vaccine is available 1. Centers for Disease Control and Prevention. Inactivated Influenza Vaccine Available at: 2. Talbot TR, et al. Infect Control Hosp Epidemiol. 2010;31: Kelso JM, Wang J. UpToDate Available at:

30 Influenza and Pregnancy *Zaman K, et al. N Engl J Med. 2008;359: Pregnant women are at high risk for severe complications and death Cellular immune response diminished Maternal influenza associated with increased* Maternal hospitalization Fetal malformation Other illnesses Prevention is best approach Newborns are at high risk for severe complications Several reports of 2 nd MRSA infection No approved vaccine for infants <6 months of age All caregivers need to be free from possible transmission to this vulnerable population

31 Case Exercise 1 Which vaccine for: A 67-year-old man with type 2 diabetes mellitus an no history of egg allergy? 1. IIV3, standard 2. IIV3 high-dose (Fluzone High-Dose) 3. IIV4, intradermal (Fluzone Intradermal) 4. cciiv4 (Flucelvax) 5. Any of the above 6. A and B only

32 Case Exercise 2 Which vaccine for: A 27-year-old woman during second trimester of pregnancy, hiveform reaction to eggs? 1. No vaccine 2. IIV4, standard 3. aiiv3 (Fluad) 4. RIV3 (Flublok) 5. B, C, or D 6. B or D only

33 Case Exercise 3 Which vaccine for: A 17-year-old with history of severe allergic reaction (i.e., respiratory distress) to eggs? 1. IIV4, standard 2. aiiv3 (Fluad) 3. RIV3 (Flublok) 4. cciiv4 (Flucelvax) 5. No vaccine/refer to specialist 6. C or D only

34 77% of Influenza is Asymptomatic Flu Watch Study 1 Course of influenza over 5 cohorts ( ) Serology; PCR; Weekly assessment for RTI Findings 77 % appeared to be asymptomatic Only 17% of PCR-confirmed infection sought medical attention A large number of well individuals in the community make a substantial contribution to transmission Hayward AC, et al. Lancet Resp Med. 2014;2: Horby PW. Lancet Resp Med. 2014;2:430-1.

35 Benefits/Obligations of Influenza Vaccine for Healthcare Providers As HCW we all have an obligation to protect our patients Transmission may occur without illness May be asymptomatic carriers Infectious prior to onset of symptoms Studies show reduced transmission after vaccination Protection from acute illness For H1N1 greatest morbidity and mortality is in healthy individuals aged years. Protection of family members (especially if very young or with medical conditions) Mandatory immunization of all HCW implemented at healthcare institutions 1. Centers for Disease Control and Prevention. Available at: 2. Hayward AC, et al. Lancet Resp Med. 2014;2:

36 When Influenza Strikes: Preventing Its Spread and Impact When influenza is confirmed or suspected: Ensure all close contacts are vaccinated Can be vulnerable up to 2 weeks following immunization Special precautions for household members at high risk Infants/young children Elderly Immunocompromised/comorbidities Consider utilizing antivirals in certain situations Grohskopf L, et al. MMWR. 2016;65(5):1-54. Available at:

37 Antiviral Medications to Combat Influenza CDC recommends antivirals for any patient with confirmed or suspected influenza who is: Hospitalized Has severe, complicated, or progressive illness At higher risk for influenza complications Higher risk individuals include those 65 years and older, have comorbidities, immunosuppressed, or residents of nursing homes or other chronic care facilities Most effective when given within 48 hours of infection, but can provide benefits even 4-5 days after infection Treatment can shorten duration of fever and symptoms, reduce risk of complications, and shorten duration of hospitalization (in children) Centers for Disease Control and Prevention. Influenza Antiviral Medications: Summary for Clinicians. Available at:

38 Approved Antiviral Medications for Influenza Neuramidase inhibitors (effective against influenza A and B strains) Oseltamivir (Tamiflu, generic) oral Zanamivir (Relenza ) inhaled Peramivir (Rapivab ) intravenous Adamantanes (effective against influenza A only) Amantadine Rimantadine High levels of resistance to both agents observed by influenza A H3N2 and H1N1 viruses; thus, not recommended for treatment or chemoprophylaxis of currently circulating influenza A viruses Centers for Disease Control and Prevention. Influenza Antiviral Medications: Summary for Clinicians. Available at:

39 Chemoprophylaxis with Antivirals Routine use of antivirals for chemoprophylaxis not recommended Certain situations may warrant use: Individuals at high risk of complications during the first 2 weeks following vaccination after exposure to an infectious person Individuals with severe immune deficiencies who might not respond to influenza vaccination High-risk individuals who cannot receive vaccination due to a contraindication after exposure to an infectious person Residents of institutions, such as LTCFs, during an influenza outbreak Centers for Disease Control and Prevention. Influenza Antiviral Medications: Summary for Clinicians. Available at:

40 Annual vaccination is the best way to prevent influenza

41 Need to Improve Vaccine Uptake Clear and unambiguous message to public, patients, providers High benefit/risk ratio SAFE Low rates lead to outbreaks and death Anti-vaccine movement is harmful to public health Poland GA, Jacobson RM. N Engl J Med. 2011;364:97-99.

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43 New Standards for Adult Vaccination ASSESS vaccination status of all patients in every clinical encounter Strongly RECOMMEND vaccines that patients need ADMINISTER needed vaccines or REFER to a provider who can vaccinate DOCUMENT vaccines received by your patients Centers for Disease Control and Prevention. Standards for adult immunization practice: Overview. cdc.gov/vaccines/hcp/patient-ed/adults/for-practice/standards/index.html. Accessed 2/7/2017.

44 Provider-Patient Miscommunication National Foundation for Infectious Diseases. Surveys of consumers and physicians, 2010.

45 The Communications Breakdown Recommendation You need to get this vaccine. OR I want you to get this vaccine. Vaccine- Motivated Patient Not a Recommendation Do you want this vaccine? OR Think about getting the vaccine. Vaccine- Ambivalent Patient

46 Document Vaccines Received by Your Patients DOCUMENT vaccines received by your patients 1 In a 2012 Survey of 352 general internists and 255 family physicians, ~8% of general internists and ~36% of family physicians reported recording vaccination information in a registry 2,a Documenting the vaccination status of your patients can decrease missed opportunities to vaccinate. 1 a Mail and internet-based survey conducted from March to June 2012 using a sample of general internists (n=352) and family physicians (n=255) in the United States. 1. Centers for Disease Control and Prevention. Standards for adult immunization practice: Vaccine documentation. cdc.gov/vaccines/hcp/patient-ed/adults/for-practice/standards/index.html. Accessed July 1, Hurley LP et al. Ann Intern Med. 2014;160:

47 Summary Influenza is a major source of morbidity and mortality, particularly in high-risk individuals Selection of an influenza vaccine can be individualized to maximize safety and effectiveness Antiviral medications are appropriate and effective in the treatment and prevention of influenza in certain situations Pharmacists can play an essential role in improving vaccination rates and reducing the burden of influenza

48 Open Forum: Q and A