Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Summit: Wisconsin Raj Naik, MD Department of Pediatrics Childhood Immunization Champion Gundersen Health System

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Objectives Learn how to counsel vaccine-hesitant families using the CASE-based approach Demonstrate the ability to use the CASE-based approach to dispel the ten most common HPV vaccine concerns

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Communication Style Matters Multiple studies have demonstrated that health care provider recommendation and attitude regarding childhood vaccines matters Discuss the vaccines as part of the routine not as an a optional activity Focus on cancer prevention Present the discussion with a positive attitude If there is hesitancy, try to set the table for a discussion

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. *A new model for talking to parents *A mnemonic to organize a rapid, useful response *Draws from Aristotelian teaching on rhetoric *Created by Alison Singer, MD -President, Autism Science Foundation -As taught by Dr. Robert Jacobson, MD Mayo Clinic CASE

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Corroborate About Me Science Explain/Advise The CASE Acronym

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Corroborate: – Acknowledge the parents’ concern and find some point on which you can agree; set the tone for a respectful, successful talk About Me: – Describe what you have done to build your knowledge base and expertise Science: – Relate what the science says Explain/Advise: – Explain your advice to patient, based on the science The CASE Approach

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Acknowledge the parents’ concern and find some point on which you can agree; set the tone for a respectful, successful talk “What is your main concern?” Don’t permit a vague refusal Make the parent get specific Then: “That's a valid concern” “When I heard that, I sought out answers myself” “We both want your child to be free of illness and injury” “We both want to avoid unnecessary medications and their side effects” Corroborate

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Describe what you have done to build your knowledge base and expertise “I’m committed to your child’s health, and I’ve dedicated my career to that work” “I’ve been studying medicine and pediatrics now for X years” “One of the areas where I read a great deal is about infections, immunity, and vaccination” “Vaccinations represent a major part of my professional effort as your child’s pediatrician” About Me:

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Science: Relate what the science says “Vaccines are better studied than any other medicine I prescribe or test I order” “Each vaccine is safer than any medicine I prescribe” “Vaccines are not fool‐proof but they are the most effective means to prevent certain injuries and illnesses” “The decision what to give when is based on the vaccine’s effectiveness, safety, and specific need for the child at that particular age” Science

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Explain/Advise: Explain your advice to patient, based on the science “That’s why I am recommending this vaccine” “If this were my child, I would be vaccinating her today” “I got this vaccine” “I made sure my children got these vaccines” “That’s why if I were you, I would be getting these vaccines for your child” Explain/Advise

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. C-A-S-E Practice Scenarios

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #1 Parental Concern: HPV Vaccine is too new

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Vaccine Myth HPV is too new – Licensed in 2006 – Pre-licensure studies for several years prior >20,000 study participants 33 countries – >187 million doses in >130 countries – Post-licensure surveillance (passive and active)

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #2 Parental Concern: We are giving too many shots

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Addressing Parents’ Concerns: Do Multiple Vaccines Overwhelm or Weaken the Infant’s Immune System? Offit PA, Quarles J et al. PEDIATRICS Vol. 109 No. 1 January 2002, pp – Studies on diversity of antigen receptors in the immune system reveal the ability to respond to extremely large numbers of antigens – Theoretically 10 9 to different antibody specificities – Limited by the number of circulating B cells How many vaccines could a child respond to at one time considering circulating B-cells, antibody production, receptors, and antigenic load of vaccines? – 10,000 + vaccines Immune Overload Theory

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Immune Overload Theory: (Offit et al)

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #3 Parental concern: The aluminum in HPV vaccine is toxic

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Vaccine Preservatives and Adjuvants Preservatives used in multi-dose vaccine vials to prevent bacterial contamination or to help present the antigens to the immune system (adjuvants) Aluminum is used as an adjuvant in a number of vaccines Source for information on aluminum: education-center/vaccine-ingredients/aluminum#.VrjwnOZFZ4s

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Vaccine Preservatives and Adjuvants Aluminum is the third most abundant element making up almost 9 percent of the earth's crust. Aluminum is found in plants, soil, water and air. Aluminum is used extensively and ingested: – Aluminum is found in numerous foods and beverages including fruits and vegetables, beer and wine, seasonings, flour, cereals, nuts, dairy products, baby formulas, and honey. – Aluminum is found in health products including antacids, buffered aspirin, antiperspirants and some vaccines. – Typically, adults ingest 7 to 9 milligrams of aluminum per day.

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Vaccine Preservatives and Adjuvants Vaccines containing adjuvants are tested extensively in clinical trials before being licensed. Aluminum salts and a detoxified bacterial component called monophosphoryl lipid A are the only materials that can be used as adjuvants in the United States. While infants receive about 4.4 milligrams of aluminum in the first six months of life from vaccines, they receive more than that in their diet.

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #4 Parental Concern: It’s too early to give HPV vaccine

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Vaccine Myth – Immune response is more robust earlier in adolescence – The vaccine is preventative only and will not work to treat those who are already infected – Protection has been long-lasting (>10 years) We will learn about the need for a booster from active surveillance and post-licensure studies

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #5 Parental Concern: Giving HPV vaccine to pre- teens at age years will result in teens having more sex

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Vaccine Myth Giving HPV vaccine at an early age will lead to more promiscuous behavior. False!!!

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #6 Parental Concern: HPV vaccine causes _____ – Infertility – MS or other neurological disease – Cancer – Death – miscellaneous

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Vaccine Safety Pre-licensure studies – >20,000 Passive surveillance (VAERS) Active surveillance (VSD) – 60,000

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Vaccine Safety Fainting and local injection site pain – Fainting preventable with lying down for 15 min after injection No significant difference in death, 200 categories of illness, ER visits or hospitalizations after receipt of HPV vaccine compared to baseline population

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #7 Parental Concern: HPV vaccine can cause HPV or make pre-existing disease worse

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #8 Parental Concern: Boys/men do not get cervical cancer so they should not get the vaccine

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. New Cancers Caused by HPV per Year United States CDC, United States Cancer Statistics (USCS), Women (n = 17,600) Anus n=2,600 15% Cervix n=10,400 59% Vagina n=600 3% Vulva n=2,200 13% Oropharynx n=1,800 10% Men (n = 9,300) Anus n=1,400 15% Oropharynx n=7,200 77% Penis n=700 8%

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #9 Parental concern: Isn’t it better to get immunity naturally?

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd.

HPV Infection ´ Most females and males will be infected with at least one type of mucosal HPV at some point in their lives ´ Most people will never know that they have been infected ´ A majority clear infection, but there is a significant percentage of people who don’t clear infection and end up with clinical disease Jemal A et al. J Natl Cancer Inst 2013;105:

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Without vaccination, annual burden of genital HPV-related disease in U.S. females: American Cancer Society. 2008; Schiffman Arch Pathol Lab Med. 2003; Koshiol Sex Transm Dis. 2004; Insinga, Pharmacoeconomics, ,000 cervical cancer deaths 10,846 new cases of cervical cancer 330,000 new cases of HSIL: CIN2/3 (high grade cervical dysplasia) 1.4 million new cases of LSIL: CIN1 (low grade cervical dysplasia) 1 million new cases of genital warts 3 million cases and $7 billion

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Example #10 Parental Concern: I heard HPV vaccine is not that effective

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV Vaccine Efficacy Immunogenicity - over 99% of girls studied developed antibodies after vaccination 4vHPV Efficacy - Clinical trials showed close to 100% protection against pre-cancers and genital warts Since 2006, >60% reduction in HPV infections among teen girls in the US

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd.

HPV Vaccine Counseling: How to get to Yes What you do and say as a HCP matters! The more you know about HPV disease, HPV vaccine, and HPV vaccine myths, the easier it will be for you to effectively counsel your patients. Use the CASE-based approach as a tool to help you counsel vaccine-hesitant families.

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. HPV VACCINE IS CANCER PREVENTION And YOU are the key! #WeCanStopHPV

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Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. ScEd3M Another Approach to Counseling The Vaccine-Hesitant Parent

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Billing & Coding H:\2016 CME\Vaccine Counseling Coding.pdf

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd HPV Projects Centralized Electronic Alerts and Reminders – >1 year since initiation

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd.

* HPV 9 (now the standard) is made using the same VLP technology

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd.

Efficacy of 9vHPV Vaccine 96% efficacy against infection with the 5 new HPV types 96.7% efficacy for prevention of female cancers or pre- cancers Antibody titers were non-inferior for the 4 original types >99% sero-converted to all nine HPV types Antibody titers were significantly higher in adolescents age 9 to 15 than for females age 16 to 26

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Updated ACIP Recommendations Age ´ Routine vaccination at age 11 or 12 years* ´ Vaccination recommended through age 26 for females and males not previously vaccinated Formulation by gender (assuming availability) 53 *vaccination series can be started at 9 years of age MMWR 2015;64: vHPV4vHPV2vHPV Females ✔✔✔ Males ✔✔

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Updated ACIP Recommendations: Interchangeability If vaccination providers do not know, or do not have available the HPV vaccine product previously administered, or are in settings transitioning to 9vHPV: For protection against HPV 16 and 18, ´ Females: Any HPV vaccine product may be used to continue or complete the series ´ Males: 4vHPV or 9vHPV may be used to continue or complete the series 54 MMWR 2015;64:300-4

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. ACIP Recommendations: Timing of the Series ´ 2vHPV, 4vHPV and 9vHPV are each administered in a 3-dose schedule ´ Interval between doses 1 → 2: ~6 weeks (1-2 months) ´ Interval between doses 1 → 3: 6 months Routine dosing intervals are recommended ´ If the vaccine schedule is interrupted, the series does not need to be restarted 55 MMWR 2015;64:300-4

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. GHS HPV Vaccine Data How are we doing at GHS?

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. Gundersen Health System: HPV Rates and NIS Benchmark Data GHS Data Patient Data Extraction Grand Total Female Patients ≥1 dose ≥2 doses ≥3 doses Male Patients ≥1 dose ≥2 doses ≥3 doses Grand Total NIS Benchmark Datahttp:// Females ≥1 dose51.1 (±4.1)56.6 (±3.9)61.0 (±4.3)¶¶64.4 (±4.1)¶¶66.5 (±4.4)¶¶60.0 (±1.9)¶ ≥2 doses40.1 (±4.0)46.4 (±4.0)¶¶51.6 (±4.3)¶¶55.7 (±4.2)¶¶57.6 (±4.7)¶¶50.3 (±1.9)¶ ≥3 doses26.2 (±3.6)35.9 (±3.9)¶¶41.2 (±4.2)¶¶43.8 (±4.1)¶¶51.0 (±4.7)¶¶39.7 (±1.9)¶ Males ≥1 dose38.9 (±4.2)42.6 (±4.0)45.7 (±4.1)¶¶40.0 (±4.0)41.8 (±4.1)41.7 (±1.8)¶ ≥2 doses27.1 (±3.9)30.9 (±3.8)35.8 (±4.1)¶¶31.2 (±3.8)32.6 (±4.0)31.4 (±1.7)¶ ≥3 doses16.2 (±3.3)20.9 (±3.5)24.9 (±4.0)¶¶22.9 (±3.5)¶¶23.3 (±3.7)¶¶21.6 (±1.6)¶

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd.

How To Improve HPV Vaccination Rates Health Care Provider education and training Public education Centralized alerts and reminders Scheduling of subsequent doses with 1 st dose administration Elimination of missed opportunities Using less traditional sites for delivery of vaccine (non-clinic based)

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. How To Improve HPV Vaccination Rates Health Care Provider education and training Public education Centralized alerts and reminders Scheduling of subsequent doses with 1 st dose administration Elimination of missed opportunities Using less traditional sites for delivery of vaccine (non-clinic based)

Gundersen Lutheran Medical Center, Inc. | Gundersen Clinic, Ltd. How To Improve HPV Vaccination Rates Health Care Provider education and training Public education Centralized alerts and reminders Scheduling of subsequent doses with 1 st dose administration Elimination of missed opportunities – Check Health Maintenance at every visit – Use acute care visits as an opportunity to immunize Using less traditional sites for delivery of vaccine (non-clinic based)