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Immunization FaQs Amy Bachyrycz.

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1 Immunization FaQs Amy Bachyrycz

2 objectives Identify principles of vaccine in accordance with the CDC
Utilize appropriate vaccine screening questions, terms and abbreviations in accordance with the ACIP Identify proper use and vaccine selection in accordance with the CDC (case based) Implement vaccine updates, guideline changes, scientific improvements and FAQs (please ask throughout) Review of common vaccine errors in accordance with ISMP

3 Poll everywhere

4 Poll #1 Please poll, how many are up to date with your recommended vaccines? The following vaccines are recommended for healthcare personnel (HCP) influenza hepatitis B MMR varicella pertussis Lab workers only meningococcal conjugate meningococcal serogroup B polio typhoid

5 Poll #2 Should HCP be vaccinated routinely against hepatitis A?
Answer:

6 ACIP and Principles of vaccine review
The Advisory Committee on Immunization Practices (ACIP) is comprised of 15 national experts who advise CDC on the appropriate use of vaccines The ACIP meets three times a year in Atlanta; meetings are open to the public and viewable online via live webcast Vaccine principles should be covered in the screening questions asked of the patient Is the person to be vaccinated sick today? Severe illness is contraindicated in all vaccines Does the person to be vaccinated have an allergy to the vaccine? Allergy to the vaccine or it’s components is contraindicated in all vaccines Has the person to be vaccinated ever had a serious reaction to the vaccine? Safety of vaccination varies based on reported reaction Has the person to be vaccinated received other vaccines in the past 4 weeks? Minimum interval principle, one can be late not early Two or more live vaccines must be given at the same time or 4 weeks apart Is the person to be vaccinated on steroids, immunocompromised, or pregnant High dose steroids, immune deficiencies & pregnancy are contraindicated in live vaccines

7 Poll #3 Certain vaccines may contain which two additives? Answer:
The FDA performed two studies which both demonstrated the amounts in vaccines are well below what are considered toxic levels publications/search_result_record.cfm?id=45918. vac-gen/additives.htm

8 Influenza Vaccine Update
There has been public forums calling out pharmacists, stating “they are much too concerned with egg allergies when vaccinating their patients against influenza.” The ACIP has determined that a history of egg allergy is no longer considered to be a contraindication or precaution to the influenza vaccination For the 2016–17 influenza season, ACIP recommends that people with a history of egg allergy who have experienced hives after exposure to eggs should receive any inactivated influenza vaccine without specific precautions (except for the recommended 15-minute observation period for syncope for all vaccines) People who report having had an anaphylactic reaction to eggs may also receive any influenza vaccine, but it should be administered in a medical setting such as a hospital, clinic, health department, or physician office catg.d/p3094.pdf Pharmacy Times 2016 youtube video Q

9 Influenza FAQs Question: During flu season each year, several patients ask if it is too early to receive their vaccine. Does protection from the seasonal influenza vaccine decline or wane within 3 or 4 months of vaccination? Should I wait until later in the year to vaccinate my elderly or medically frail patients? Answer: The ACIP recommends to begin vaccinating with seasonal influenza in Sept. or earlier. To avoid missed opportunities, vaccinations should be offered as soon as available Antibody to the inactivated influenza vaccine declines in months following vaccination A study conducted in 2011–12 did find a decline in vaccine effectiveness late in influenza season, primarily affecting persons age 65 years and older Revaccination later in the season of people who have already been fully vaccinated is not recommended Euro Surveill 2013;18: 20388 Q

10 INFLUENZA faqS Question: Some of my patients refuse the flu shot because they insist they “got the flu” after receiving it in the past. What can I tell them? Answer: There are several reasons why this misconception persists - Less than 1% of people who are vaccinated develop flu-like symptoms, (mild fever & muscle aches & people confuse the symptoms with the flu) - Protective immunity doesn’t develop until 1–2 weeks after vaccination and patients may get exposed to the flu virus before they develop immunity - Influenza vaccine only protects against certain influenza viruses, not all viruses - The influenza vaccine is not 100% effective, especially in older persons Q vaccination/effectivenessqa.htm

11 Influenza FAQs Question: Can you talk about Fluad? I received it at my store and was not aware of the clinical difference. Answer: Fluad is for people age 65 and older and the first adjuvanted inactivated vaccine in the US - In November 2015, the FDA licensed Fluad (by the makers of Fluvirin) - An adjuvant = is a substance that’s added to a vaccine to increase immunogenicity - The MF59 adjuvant is based on squalene, an oil occurring naturally in plants & animals - Fluad has been used in Europe since 1997 and is approved in 38 other countries - In clinical studies, Fluad was more effective than regular dose vaccine in preventing influenza in elderly people - Fluad recipients reported more local reactions, such as injection site pain (25% versus 12%) and tenderness (21% versus 11%), than were reported with the inactivated influenza vaccine (IIV)

12 Poll #4 Question: I have a 2 year old patient that was flu naïve last season and received the FluMist nasal spray, which has been proven ineffective. Would this vaccine count or would the child need 2 doses one month apart again this season? Answer: Although the FluMist was deemed ineffective again one of the four strains it was proven to cover, previous doses in previous seasons are still considered effective and the second dose for this patient does not need to be repeated Q

13 Influenza FAQs Question: Do statins affect the efficacy of influenza vaccines? Answer: - Two recent studies raise the possibility that statins may blunt the effectiveness of influenza vaccines in the elderly population - Experts caution that more research is needed & because of the benefit of statins, it is not advised to stop taking the statin at this time - Influenza vaccine provides at least some protection in people who take statins, so patients should still receive an influenza vaccine - There is no change to the ACIP recommendation at this time Q

14 Influenza FAQs Question: There were several times this past season where patients (65 years or older) received the regular trivalent flu shot & then heard about the Fluzone High-Dose and wanted to receive that, too. Was it correct to refuse to re-vaccinate? Answer: You were correct in refusing to re-vaccinate - The ACIP does not recommend that anyone receive more than 1 dose of influenza vaccine in a season (whether it is trivalent vs. quadrivalent or regular vs. high dose), except for a flu vaccine naïve child up to 8 years of age

15 Influenza FAQs Question: I received an request to provide details about FluLaval (GlaxoSmithKline) in children younger than 3 years, as a 2 year old was given a 0.25 mL dose of FluLaval rather than the new recommended 0.5 mL dose. Answer: On November 18, 2016, the FDA approved an extension of the age range for FluLaval to include children 6-35 months of age (previously approved for 3 years and above) - The approval of the extended age range was based on a study showing a non- inferior response compared to children who received Fluzone - The new FluLaval dosage approved for children 6-35 months of age is 0.5 mL, which is the same as for people 3 years of age and above - If the error above was discovered while the child was still at the pharmacy, administer the other 0.25mL of the FluLaval, but since the error was discovered later, then the child should come back and be given a full repeat dose (either a 0.5 mL of FluLaval or 0.25 mL of Fluzone)

16 Poll #5 Question: A healthy 66 y/o patient received his dose of PPSV23 in January & then got a dose of PCV13 five months later at a different pharmacy. Should the PCV13 dose be repeated since it was given earlier than the 1-year interval? Answer: Q www. cdc.gov/mmwr/pdf/wk/mm6434.pdf, pages 944–7

17 Pneumococcal FAQs Question: Diabetes is an indication for giving Pneumovax 23 (PPSV23) to patients younger than age 65 years, along with smoking, asthma, and COPD. Does this include both insulin- and non-insulin-dependent diabetes? Answer: Any diagnosis of diabetes, whether type 1 or type 2, is an indication for PPSV23, so yes this would be indicated for both types. Gestational diabetes does NOT qualify as an indication for PPSV23

18 Poll #6 Question: Does a patient younger than age 65 years who smokes marijuana on a daily basis, but doesn’t smoke cigarettes, need to receive Pneumovax 23 (PPSV23) vaccine? Answer: Q

19 Pneumococcal FAQs Question: The other day I had a patient in their 70s and remember getting a pneumococcal vaccine a few years ago. Should we assume that this was Pneumovax 23 (PPSV23)? Should I assume that it was given before the 65th birthday? Answer: Yes, the ACIP allows a patient’s personal or verbal report (undocumented) of pneumonia and influenza ONLY. It is reasonable to assume that Pneumovax 23 was the pneumococcal vaccine given. - If there is any question about the age at which the dose was given, it is reasonable to give another dose of Prevnar 13 (PCV13) now, then a dose of Pneumovax 23 (PPSV23) in 1 year

20 Pneumococcal FAQs Question: A local doctor called the pharmacy and stated that the Prevnar 13 (PCV13) package insert says that in adults, antibody responses to PCV13 were diminished when given with inactivated influenza vaccine. Does this mean we should not give PCV13 and influenza vaccine at the same visit? Answer: The available data has interpreted that any changes in antibody response to either of the vaccines’ components were clinically insignificant., so if Prevnar 13 (PCV13) and the influenza vaccine are both indicated and recommended, they should be administered at the same visit page 824

21 Hepatitis b faqs Question: The other day, I had patients who were off schedule for their hepatitis B series. They came back for dose #2 in 4 to 6 months rather than getting it 1 month later. In this situation, what is the correct timing for dose #3? Answer: (series schedule is 0, 1, 6-12 mon.) - The minimal intervals for hepatitis B vaccine at least 4 weeks between doses #1 and #2, at least 8 weeks between doses #2 and #3, and at least 16 weeks between doses #1 and #3 - In these cases, 16 weeks or more had elapsed since dose #1, and I would schedule dose #3 to be given 8 weeks after dose #2 Q

22 Tetanus FAQs Question: I would like to avoid stocking both Tdap and Td vaccines to avoid errors. Is CDC likely to recommend that Tdap completely replace Td in the immunization schedule in the near future? Answer: Currently, ACIP recommends giving only 1 dose of Tdap to those who have not previously received the vaccine, with the exception of pregnant women, who should be vaccinated during EACH pregnancy - ACIP is unlikely to recommend routine Tdap revaccinations and you will need to continue to stock Td in order to administer it to patients who do not need the Tdap, as they already received their booster - Note that if a person who previously received Tdap needs a booster dose of Td, it is acceptable to administer Tdap if Td is not available at your pharmacy

23 Tetanus FAQs Question: A patient came into my pharmacy the other day with a self- reported gardening tool injury. The patient did not have any history of prior tetanus vaccinations, how much tetanus protection would the one dose provide? Also, what is the time frame between injury and vaccine to be effective? Answer: One dose of tetanus toxoid-containing vaccine (Tdap or Td) provides little or no protection - In this and most injury involved cases, the vaccine and the tetanus immune globulin (TIG) is recommended and should be given as soon as possible pinkbook/tetanus.html

24 Shingles FAQs Question: Before administering zoster vaccine is it necessary to ask if the person has ever had chickenpox or shingles? Answer: No, All people age 60 years or older, whether they have a history of chickenpox or shingles or not, should be given zoster vaccine unless they have a medical contraindication to vaccination

25 Shingles FAQs Question: If a patient received dose #1 of varicella vaccine at age 60 years, should we administer zoster vaccine as dose #2? Answer: The action taken depends on why varicella vaccine was given in the first place - If the varicella vaccine was given incorrectly (as this person should have received the zoster vaccine at this age) then dose #2 should be zoster - If the varicella vaccine was given because the person tested negative for the varicella antibody upon titer, then dose #2 should be varicella

26 Shingles fAQs Question: A dose of zoster vaccine was inadvertently given to a patient receiving chemotherapy for colon cancer. We realize this was an error (live vaccines are contraindication in cancer and other immunocompromising conditions) so please advise on what to do now? Answer: The cancer chemotherapy will not change the person’s immunity to varicella virus - The patient should be monitored for the next two weeks for symptoms that might indicate an adverse reaction, such as fever and rash - If symptoms suggestive of varicella develop, the patient can be started on antiviral therapy, such as acyclovir - An error report and VAERS should be completed

27 MMR FAQs Question: Would you consider a healthcare worker with two documented doses of MMR vaccine to be immune, even if the serology for one or more of the antigens comes back negative? Answer: Yes. Healthcare personnel (HCP) with two documented doses of MMR vaccine are considered to be immune, regardless of the results of a subsequent serologic test for measles, mumps, or rubella - Documented age appropriate vaccination supersedes the results of subsequent serologic testing page 22

28 HPV Information/FAQs Question: Which types of HPV are most likely to cause disease? Of the annual average of 26,900 HPV-related cancers in the US, approximately 64% are attributable to HPV 16 or 18 (65% for females; 63% for males), which are included in all three HPV vaccines Approximately 10% or 3400 cases/yr are attributable to HPV types 31, 33, 45, 52, and 58 (14% for females; 4% for males), which are included in the 9-valent vaccine HPV type 16, 18, 31, 33, 45, 52, or 58 account for about 81% of cervical cancers in the US

29 HPV FAQs Question: If a vaccination series was started with HPV2 or HPV4, can it be completed with HPV9 and if yes, what are the spacing intervals that should be used for the remaining doses in the 3-dose series? Answer: The ACIP states that the HPV9 may be used to continue or complete a series started with a different HPV vaccine product - The intervals between doses remain the same regardless of what vaccine is used to complete the series (0, 1-2, & 6 months with 4 months between #2 to #3)

30 Meningococcal faqs Question: Can the meningococcal conjugate (MenACWY) and MenB vaccines be given at the same visit? Answer: Yes. Meningococcal conjugate and MenB vaccines can be given at the same visit or at any time before or after the other

31 Meningococcal faqs Question: I have a 24-month-old patient with HIV, and I want to use Menactra (Sanofi Pasteur) because this is the only vaccine we have available in our pharmacy. The child received DTaP vaccine yesterday at another clinic. Can I administer Menactra today? Answer: The ACIP recommends that you wait 4 weeks from the dose of DTaP to give Menactra - This is because data suggest a reduced response to the Menactra if given within a month after DTaP - This is an exception to the vaccine principle that you only need to space out 2 live vaccines and do not need to space out non-live (since both are non-live vaccines) - In this case, the Menactra can be given either before the DTAP or at the same time as DTaP - Menveo brand MenACWY vaccine can be given at any time before or after DTaP

32 Meningococcal information/faqs
Question: What meningococcal vaccines are currently available in the United States? - Since 2005, 2 types of meningococcal vaccines have been available in the United States that protect against meningococcal serogroups A, C, W, and Y 1) meningococcal polysaccharide vaccine (MPSV4; Menomune), which is made up of polysaccharide (sugar molecules) from the surface of the meningococcal bacteria 2) meningococcal conjugate vaccines (MCV4; Menactra, Menveo) in which the polysaccharide is chemically bonded (“conjugated”) to a protein to produce better protection 3) meningococcal B (MenB-4C; Bexsero; MenB-FHbp; Trumenba)

33 Meningococcal faqs Question: Should college students be vaccinated against meningococcal disease? MCV4 vaccine is recommended for previously unvaccinated first- year college students who are age 21 years and younger, who are or will be living in a dorm Answer: Some colleges require incoming freshmen and others to be vaccinated with the conjugate vaccine (UNM does not require) - Although several small MenB outbreaks have occurred on college campuses since 2013, college students in general are not at higher risk of MenB - ACIP does not routinely recommend MenB vaccination for college students

34 Cholera Vaccine update hpv vaccine update
- June 10, the FDA approved Vaxchora (PaxVax) for the prevention of cholera in adults age 18 through 64 years traveling to cholera-affected areas The ACIP voted to change the HPV vaccination schedule from a 3-dose to a 2-dose series for those who begin the series at 9 through 14 years of age, regardless of age at series completion Those who start the series later, at 15 through 26 years of age, or who are immunocompromised, will continue to need 3 doses Merck is distributing only HPV9, and supplies of 2vHPV (Cervarix, Gardasil) in the U.S. are now depleted htm

35 HPV vaccine Update Application
Question: If dose #1 of the HPV vaccine was given before the 15th birthday and it has been more than a year since that dose was given, would the series be complete with just one additional dose? Answer: Yes, adolescents and adults who started the HPV vaccine series prior to the 15th birthday and are not immunocompromised are considered to be adequately vaccinated with just one additional HPV dose Question: If you have adolescents who have received the first 2 doses of the HPV series 1 or 2 months apart according to the 3-dose schedule, can we consider their HPV vaccine series to be complete or do we need to give these patients a third dose? Answer: People who have received 2 doses of HPV vaccine separated by less than 5 months should receive a third dose 6–12 months after dose #1 and at least 12 weeks after dose #2 Question: Will the 2-dose recommendation be retro-active for children and teens vaccinated prior to 2016? Answer: Yes, any person who ever received 2 doses of any combination of HPV vaccines can be considered fully vaccinated if dose #1 was given before the 15th birthday and the 2 doses were separated by at least 5 months

36 Meningococcal vaccine update
Bexsero (MenB-4C) has previously been recommended by ACIP for use as a 2- dose series for high-risk individuals and in outbreak settings, and may also be administered to those 16 through 23 years of age In April, 2016, the FDA approved a label change giving MenB-FHbp (Trumenba) now approval as either a 2-dose (0, 6 months) or 3-dose (0, 1–2, 6 months) series The new 2-dose series of Trumenba can be used for routine vaccination for those 16 through 23 years of age

37 Meningococcal vaccine Update application
Question: Which individuals are recommended to be vaccinated against meningococcal serogroup B disease who are not in risk groups? Answer: The ACIP recommends that a MenB (Bexsero or Trumenba) vaccine series may be administered to people 16 through 23 years of age in a 2 shot series - Trumenba series has dose #2 given at least 6 months after dose #1 - Bexsero series has dose #2 given at least 1 month after dose #1 - The Category B recommendation gives vaccine providers the opportunity to discuss the value of MenB vaccination with their patients and make a decision together

38 Meningococcal vaccine update application
Question: Should college students be vaccinated against meningococcal B disease? Answer: Although several small meningococcal serogroup B disease outbreaks have occurred on college campuses since 2013, college students in general are not at higher risk of meningococcal B disease - The ACIP does not routinely recommend MenB vaccination for college students - College students and vaccine providers may choose to receive MenB vaccine to reduce their risk of serogroup B meningococcal disease

39 Tetanus vaccine update
Previous ACIP recommendations state to vaccinate all pregnant women with Tdap vaccine during each pregnancy in the third trimester (between 27 through 36 weeks gestation) In October, the ACIP voted to give Tdap vaccination early in the 27 through 36 week gestation window to maximize passive antibody transfer to the infant The new recommendations also clarify that children 7 through 10 years of age who receive Tdap as part of a catch-up series may be given an additional Tdap for the routinely recommended adolescent dose at 11– 12 years of age

40 Hepatitis B vaccine update
On October 19, the ACIP voted to approve a single guidance document that consolidated previously published recommendations into one comprehensive statement (pending publication) The ACIP re-emphasized the importance of the hepatitis B birth dose as a safety net against chronic HBV infection by recommending that all infants should receive hepatitis B vaccine within 24 hours of birth This clears confusion that suggested a delay in administering the birth dose was acceptable

41 Medication errors Between September 2012 and October 2014, a total of 884 reports were submitted to the Institute of Safe Medication Practices (ISMP) Most reports (89%) involved vaccine errors that reached patients Hazardous conditions (11%) were associated with labeling and packaging concerns An example of a reported hazard is the labeling of RABAVERT (rabies vaccine), which fails to draw attention to the required diluent and vaccine vials. The hazard may have led to administration of RabAvert diluent alone without the vaccine component. Most common errors: 1) Influenza virus vaccine (16% of all reports) - incorrect age for vaccine given, expired vaccine, wrong route 2) Hepatitis A and HPV were the most common reports in public health offices - look alike sound alike 3) Anthrax in military offices Medical assistants (27%), registered nurses (23%), and licensed practical nurses (11%) physicians (8%), nurse practitioners (5%), and pharmacists (2%) involvement in reported errors

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