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Delivering Vaccines in your Practice

Delivering Vaccines in your Practice . Immunization Education For OB/GYN Physicians and their Staff. Clinical, Operational, and Financial Issues. 2014. Acknowledgements. Joint Program of: Georgia OB/ Gyn Society Georgia Chapter – American Academy of Pediatrics

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Delivering Vaccines in your Practice

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  1. Delivering Vaccines in your Practice Immunization Education For OB/GYN Physicians and their Staff Clinical, Operational, and Financial Issues 2014

  2. Acknowledgements Joint Program of: Georgia OB/Gyn Society Georgia Chapter – American Academy of Pediatrics Program & Content Advisors: Clinical: John Hill, MD – OB/Gyn, Athens Edmund Kim, MD – Gyn, Lawrenceville Alan Sievert, MD, MPH – Vice-Chairman of the EPIC Advisory Committee Operational/Financial: Bob Chalmers – Physicians’ Alliance Sandra Yarn, RN, BSN, CHES – EPIC Program Director

  3. Faculty Disclosure Information In accordance with ACCME* Standards, all faculty members are required to disclose to the program audience any real or apparent conflict of interest to the content of their presentation.  This presentation will include a discussion of some ACIP recommendations for the use of vaccines that have not currently been approved by the FDA. *Accreditation Council for Continuing Medical Education

  4. Objectives At the end of this presentation, attendees will be able to: Discuss three reasons why it is important to provide vaccines at an OB/Gyn practice Interpret the Adult Immunization Schedule Recall the most recent CDC recommendations for storage and handling of vaccines State a plan to incorporate vaccines into the workflow of the practice

  5. Vaccines Live, Attenuated Measles,Mumps & Rubella (MMR) Varicella LAIV Rotavirus Herpes Zoster Inactivated Toxoids (DTaP, Td, Tdap) Whole (Hepatitis A, IPV) Split (Influenza - IIV) Recombinant vaccines (Hepatitis B, HPV4, HPV2) Polysaccharide vaccines (PPSV23, MPSV4) Conjugated vaccines (Hib, PCV13, MCV4) Vaccine - A product that interacts with the immune system to produce active immunity against a disease without the risk of the disease and its potential complications. Ref: Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th Edition, May 2012

  6. Advisory Committee on Immunization Practices (ACIP) • ACIP consists of 15 members - experts in immunization practices and public health • ACIP develops immunization schedules and recommendations for the use of licensed vaccines • ACIP immunization schedules and recommendations are approved by CDC, AAP, ACOG, AAFP, ACP

  7. 2014 Immunization Schedules • All staff must use the same immunization schedule • Four Schedules: • Children & Adolescents • 0 through 18 years • Catch-up schedule for • ages 4 months -18 years • Adult 19 years and older • Adult based on medical • and other indications READ THE FOOTNOTES http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html http://www.cdc.gov/vaccines/schedules/hcp/adult.html

  8. Vaccine Preventable Diseases

  9. The Impact of Vaccines *MMWR 48(12);243-248 April 2, 1999 ** MMWR 62(52);ND719-732 January 3, 2014 N/A = Data not available

  10. Why is it important for an OB/Gyn practice to provide vaccines? ACOG recommends assessments of immunization status as part of the routine screening recommendations* Your practice may be the only source of medical care for many of your patients • You have an opportunity to decrease the likelihood of influenza during pregnancy (Influenza vaccine) • You can provide immunity against pertussis in young women and pregnant women and decrease the likelihood of transmission of whooping cough to vulnerable newborns and infants (Tdap vaccine) • You can offer a vaccine to prevent infection with up to 4 types of HPV for women and men through 26 years of age (HPV vaccine) • You can protect women at risk for hepatitis B infection (Hepatitis B vaccine) *ACOG Committee Opinion 558 April 2013

  11. Influenza

  12. Influenza • Influenza characteristically begins with the abrupt onset of fever, headache, myalgia, and malaise accompanied by manifestations of respiratory tract illness, such as non-productive cough, sore throat, and nasal discharge. • The major complication of influenza is pneumonia. Other complications include central nervous system disease, myositis, rhabdomyolysis, myocarditis, pericarditis, and toxic shock syndrome. Ref: Dolin, R. Clinical manifestations of seasonal influenza in adults. Post TW (Ed), UpToDate, Waltham, MA. (Accessed on March 6, 2014.)

  13. Influenza • Influenza affects about 10-20% of the population every year (spreads easily). • Responsible for over 200,000 hospitalizations a year (makes a lot of people really sick). • Peak activity December to March • It is not a “cold” or the “stomach flu.” • No good treatment – prevention is the best strategy. Ref: ACOG Committee Opinion number 558: Integrating Immunizations into Practice. April 2013.

  14. Influenza and Pregnancy • Pregnant women are at increased risk of complications and hospitalizations from influenza • Studies have shown vaccine protects against preterm birth and SGA • New mom can give the infection to baby • Influenza vaccine protects mom and baby (transfer of antibodies to fetus and baby) • CDC, ACOG and AAP have recommended influenza vaccine for women who will be pregnant during influenza season Ref: Steinhoff MC and SB Omer. “A review of fetal and infant protection associated with antenatal influenza immunization.” 2012. AJOG. 2012 Sep; 207 (3 Suppl): S21-7. Epub 2012 July 9.

  15. Effects of Influenza vaccination during pregnancy • Reduces influenza related complications in pregnant women and their infants • Infants especially <6 mos of age are at increased risk hospitalization and death from influenza related complications • Vaccinating the mother protects newborns against influenza. This is the only way of providing antibody to the newborn. Ref: ACOG Committee Opinion number 558: Integrating Immunizations into Practice. April 2013.

  16. Lack of Influenza vaccination during pregnancy <50% of pregnant women are vaccinated • Concerned it isn’t effective • Up to 89% effective • Concern over adverse fetal effects • No evidence of teratogenicity to date • Safety of vaccine in pregnancy • No evidence of harm to pregnant women or their infants even with vaccines containing thimerosal Ref: AJOG. Volume 207, No 3. September 2012. Progress in Overcoming Barriers to Influenza of Pregnant Women.

  17. Composition of Influenza Vaccinesfor 2014-2015 Season in the U.S. • Trivalent Vaccines will contain: • A/California/7/2009-like (2009 H1N1) virus • A/Texas/50/2012-like (H3N2) virus • B/Massachusetts/2/2012-like(B/Yamagata lineage) virus QuadrivalentVaccines will also contain: B/Brisbane/60/2008-like virus (B/Victoria lineage) virus Annual influenza vaccination is recommended for all persons 6 months of age and older who do not have contraindications. Ref: CDC – FluView, Updated April 4, 2014

  18. Inactivated Influenza Vaccines (IIV) Administer by Injection (Trivalent) IIV3 • Fluzone®sanofi-pasteur - 6 months of age and older • Fluarix® GSK - 3 years of age and older • FluLaval® GSK -3 years of age and older IIV3 & IIV4# • Fluarix® Quadrivalent GSK - 3 years of age and older IIV4 • Fluvirin®Novartis -4 years of age and older • Afluria® CSL - 9 years of age and older • Flucelvax® Novartis - 18 years of age and older (ccIIV3)* • FluBlok® Protein Sciences -18 through 49 years (RIV3)** • Fluzone®Intradermalsanofi-pasteur - 18 through 64 years • Fluzone® High-Dose sanofi-pasteur -65 years and older (4 X more antigen) *ccIIV3 = cell culture based trivalent inactivated influenza vaccine **RIV3 = recombinant hemagglutinin influenza vaccine Ref. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2013–2014, September 20, 2013 / 62(RR07);1-43 # Flulaval licensed by FDA for children 3 years and older August 16, 2013

  19. Live, Attenuated Influenza Vaccine (LAIV4) • Administer by Nasal spray: • FluMist® Medimmune- for healthy persons 2 through 49 years of age • -not for pregnant women Ref: Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2013–2014, September 20, 2013 / 62(RR07);1-43

  20. Immunize Pregnant Women • Immunizations are our first line of defense for the woman, fetus and baby • ACIP recommends that all pregnant women receive the inactivated influenza vaccine (IIV), regardless of pregnancy trimester • Pregnant women should NOT receive LAIV

  21. Maternal Vaccination and Influenza in Infants: A NEJM Study Control n=168 Vaccine n=175 Inactivated influenza vaccine reduced influenza by 63% in infants up to 6 months of age Zaman K et al. N Engl J Med 2008;359:1555-1564

  22. Diphtheria Tetanus Pertussis

  23. Pertussis(Whooping Cough) • Called “The cough of 100 days” in China. Should be suspected in any cough illness lasting longer than a week. • Catarrhal stage – mild cough with runny nose and nasal congestion lasting 1-2 weeks (feels like the common cold) • Paroxysmal stage – Paroxysmal coughing attacks (this is where the classic whooping sound can be heard, especially in infants and young children) which can lead to vomiting. Untreated, it lasts 2-3 months. • Convalescent stage – cough subsides over weeks to months. Ref: Yeh, S and Mink, CM. Bordetellapertussis infection in infants and children: Clinical features and diagnosis. Post TW (Ed), UpToDate, Waltham, MA. (Accessed on March 6, 2014.)

  24. Pertussis • Natural infection and vaccines do not confer life long immunity • Complications – apnea, pneumonia, weight loss, seizures, death. • Most deaths occur in infants younger than 6 mos (1% die from pertussis) • Immunization is the best way to prevent pertussis. Ref: Yeh, S and Mink, CM. Bordetellapertussis infection in infants and children: Clinical features and diagnosis. Post TW (Ed), UpToDate, Waltham, MA. (Accessed on March 6, 2014.)

  25. Tdap Vaccines Boostrix 10 years and older ADACEL10 through 64 years Both licensed for one dose Both safe for pregnant women

  26. Cocooning Strategy Parents Siblings Child Care Provider Healthcare Worker Grandparents

  27. Immunize Adults with Tdap NEW Pregnant Women A dose of Tdapshould be administered during each pregnancy, irrespective of the prior history of receiving Tdap. To maximize the maternal antibody response and passive antibody transfer to the infant, optimal timing for Tdap administration is between 27 and 36 weeks gestation. If Tdap is not given during pregnancy, and has not been given previously,administer Tdap immediately postpartum3. References: 1. MMWR January 14, 2011; 60 (1); 13-15 2. MMWR June 29, 2012; 61(25); 468-470 3. MMWR February 22, 2013 / 62(07);131-135 All adults aged 19 years and older, who have not previously received Tdap, should receive a single dose of Tdapregardless of the interval since the last dose of tetanus or diphtheria (Td).1 For adults 65 years and older Boostrix should be used, when feasible; however, either vaccine product provides protection and is considered valid.2

  28. Human Papillomavirus (HPV)

  29. Human Papillomavirus (HPV)http://www.cdc.gov/std/hpv/ • More than 100 different types of HPV. • Certain types cause cervical squamous cell cancer, cervical adenocarcinoma, vulvar and vaginal cancer, and genital warts. *Recurrent Respiratory Papillomatosis

  30. Types of Human Papilloma Virus (HPV) Mucosal/Genital ~40 types Cutaneous ~60 types High risk types 16, 18, 31, 45 (and others) Low risk types 6, 11 and others Cervical cancer Anogenital cancer Oropharyngeal Cancer Cancer precursors Low grade cervical disease Genital Warts Laryngeal Papillomas Low grade cervical disease Skin warts Hands and Feet Ref: 1.Epidemiology and Prevention of Vaccine Preventable Diseases 12th Edition, May 2012 2. Red Book – AAP 2012 Report of the Committee on Infectious Diseases

  31. HPV Vaccines Gardasil® (HPV4) Licensed for prevention of infection with HPV types 6, 11, 16, 18. Recommended for females 9 through 26 years & males 9 through 21 years. May be given to males 22 through 26 years. 3 dose schedule Ref: MMWR; December 23, 2011 / 60(50);1705-8 Cervarix® (HPV2) Licensed for prevention of infection with HPV types 16 & 18. Recommended for females 9 through 26 years. 3 dose schedule

  32. * Not mutually exclusive. ** Did not know much about HPV or HPV vaccine. Top 5 reasons for not vaccinating daughter, among parents with no intention to vaccinate in the next 12 months, NIS-Teen 2012 www.cdc.gov/vaccines/who/teens/for-hcp/downloads/HPV-provider-tip-sheet.pdf

  33. Vaccination coverage of GA adolescents aged 13-17 years Source: National Immunization Survey- Teen, US 2009 - 2012

  34. Encourage Parents To Immunize an Adolescent Try saying: Your daughter needs a vaccine today that will protect her from many cancers caused by HPV. HPV vaccine produces a better immune response in young teens than it does in older teens and young adults. I strongly believe in the importance of this cancer-preventing vaccine.

  35. ACOG Recommendations Sexually active women and women with previous abnormal cervical cytology or genital warts can receive the quadrivalent HPV vaccine • These women should be counseled that the vaccine may be less effective in women who have been exposed to HPV before vaccination than in women who were HPV naive at the time of vaccination • Women with previous HPV infection will benefit from protection against disease caused by the HPV vaccine types with which they have not been infected American College of Obstetricians and Gynecologists (ACOG). Obstet Gynecol. 2006;108:699–705.

  36. Hepatitis B Virus • Acute hepatitis – can lead to chronic hepatitis B or rarely to liver failure • Chronic hepatitis can lead to cirrhosis, hepatic decompensation, hepatocellular carcinoma, extrahepatic manifestations and death • Transmission: • Percutaneous or mucosal exposure to blood or body fluids including contaminated surfaces • Perinatal infection from HBsAg + mother. • From 1990 to 2004 there was a 75 percent decrease in acute Hepatitis B in the U.S. after onset of comprehensive vaccination strategy. Lok AS. Clinical manifestations and natural history of hepatitis B virus infection. Post TW (Ed), UpToDate, Waltham, MA. (Accessed on March 6, 2014.)

  37. Hepatitis B Vaccine Recommendations • Single antigen hepatitis B vaccine for all newborns before discharge from the nursery. Complete the series per schedule. • Hepatitis B vaccine series for all children and adolescents less than 19 years of age • All adults at risk for hepatitis B infection, including those aged 19 through 59 years with diabetes mellitus and persons of any age at risk for infection by sexual exposure, injection drug user, household contact of HBsAg positive person, healthcare workers, and those with chronic liver disease. • Anyone seeking protection from HBV infection. Acknowledgment of a specific risk factor is not a requirement for the vaccine. Teo E, Lok AS. Hepatitis B virus vaccination. Post TW (Ed), UpToDate, Waltham, MA. (Accessed on March 6, 2014.)

  38. Critical Elements for Immunization Services

  39. Every Office and Clinic Needs A Vaccine Champion! Lead your immunization team. Educate all staff about new vaccines and recommendations. Teach new staff about vaccine storage, handling, & administration. Initiate processes to improve immunization rates in your practice/facility. Assure immunizations of all staff are up-to-date.

  40. Healthcare Personnel (HCP) Need These Immunizations Annual influenza vaccine Tdap or Td Hepatitis B (exposure risk) Check immunity Validate immune status of: Varicella Measles, Mumps & Rubella (MMR) AreYOUup to date?

  41. HEPATITIS B PRE-EXPOSURE EVALUATION OF HEALTH-CARE PERSONNEL WHO RECEIVED ≥3-DOSES OF HEP B VACCINE NO POSTVACCINATION SEROLOGIC TESTING Measure antibody to hepatitis B surface antigen (anti-HBs) anti-HBs <10 mIU/mL anti-HBs ≥10mIU/mL Administer 1 dose of HepB vaccine, postvaccination serologic testing No Action for Hepatitis B prophylaxis (regardless of source patient hepatitis B surface antigen status) anti-HBs <10 mIU/mL anti-HBs ≥ 10 mIU/mL Administer 2 more doses of HepB vaccine, postvaccination serologic testing anti-HBs <10 mIU/mL anti-HBs ≥ 10mIU/mL Ref: CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Post Exposure Management MMWR Recommendations and Reports /Vol. 62/No. 10 December 20, 2013 HCP need to receive hepatitis B evaluation for all exposures

  42. Updated Vaccine Storage and Handling Recommendations Use stand-alone refrigerator and stand-alone freezer units. Use a biosafe glycol-encased probe or a similar temperature buffered probe. Use digital data loggers. Discontinue the use of dorm-style or bar-style refrigerator/freezers for ANY vaccine storage, even temporary storage. Review vaccine expiration dates and rotate vaccine stock weekly. Vaccine Storage and Handling Toolkits are now available!! Ref: Vaccine Storage and Handling Toolkit November 2012

  43. Maintaining Appropriate Vaccine Storage & Handling Assign a primary and alternate vaccine coordinator Store all vaccines as recommended by manufacturer Monitor and record temperatures of refrigerator and freezer twice daily • Take immediate action for all out-of-range temps • Implement a vaccine emergency system • Maintain temperature log records for 3 years • DO NOT STORE ANYTHING ELSE in the refrigerator!

  44. Check Expiration Date of Vaccines and Diluents Vaccine Expiration Date is 12/15/14 Use through December 15, 2014 Do NOT use on or after December 16, 2014 Vaccine Expiration Date is 12/31/14 Use through December 31, 2014 Do NOT use on or after January 1, 2015 12/15/14 12/14

  45. The 7 Rights of Vaccine Administration Right Patient Right Vaccine or Diluent Right Time* Right Dosage Right Route, Needle Length, Technique Right Site for route indicated RightDocumentation * Correct age, appropriate interval, and administer before vaccine or diluent expires Ref: Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th Edition, May 2011.

  46. Vaccine Administration Sites for Adults Intramuscular (IM) Tdap, Td, Hep A, Hep B, PCV13, IIV, MCV4, HPV Subcutaneous (SQ, SC, or sub-Q) MMR, Varicella, MPSV4, Herpes Zoster Either intramuscular or subcutaneous IPV, PPSV23 Intranasal LAIV Intradermal IIV (Fluzone)

  47. Always Document… Accept only written documentation of prior immunizations • After administering a vaccine, document: • Publication date of VIS & Date VIS given • Date, site, route, antigen(s), manufacturer, lot # • Person administering vaccine, practice name and address Document vaccine refusal in your medical record and use a vaccine refusal form with patient’s signature

  48. A ‘Birth to Death’ Immunization Registry • Providers administering vaccines in Georgia must provide appropriate information to GRITS. • GRITS personnel can work with your EHR/EMR vendor to create an interface between your system and GRITS that will drastically decrease data entry time for your practice. • Contact the GRITS Training Coordinator at 1-888-223-8644 or e-mail immreg@dhr.state.ga.us.

  49. Vaccine Adverse Events Local - pain, swelling, redness at injection site - common with inactivated vaccines - usually mild and self-limited Systemic - fever, malaise, headache - nonspecific symptoms - may be unrelated to vaccine Allergic - anaphylaxis - serious but rare Reference: Epidemiology and Prevention of Vaccine-Preventable Diseases 12th Edition (2012)

  50. Monitoring Vaccine Safety VAERS:Vaccine Adverse Event Reporting System (800) 822-7967 or http://vaers.hhs.gov/ FDA & Vaccine Safety Datalink (VSD) Project • VERP:VACCINE ERROR REPORTING SYSTEM • On line reporting at http://verp.ismp.org/ • Report even if no adverse events associated with incident • Will help identify sources of errors to help develop • prevention strategies Institute for Safe Medication Practices

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