Immunization and Injection. Providing Immunization and Injection Services

Immunization and Injection Providing Immunization and Injection Services

V 2.0_2017

Introducing a Resource to Support the Pharmacist in Providing Immunization and Injection Services Immunizations have saved more lives in the last century than any other health intervention. 1 The recognition by provincial governments of the value of pharmacist professional services in the area of immunization and injection has had a tremendous impact on the accessibility of these services to the public. The speed at which provincial Colleges of Pharmacy have put regulations into place to serve the needs of the public has been impressive, as has the uptake of education by pharmacists that meets standards necessary to implement immunization and injection services. This Immunization and Injection Counselling Guide has been developed as a quick reference resource to aid pharmacists in the efficient and effective provision of immunization and injection services. Please note that there is an opportunity to earn 1 continuing education unit (Canadian Council on Continuing Education in Pharmacy) by answering 10 questions. Instructions for submission of answers are outlined at the conclusion of this guide. i

How to Become an Injection Pharmacist Oversight of the qualifications required by a pharmacist to administer immunizations and injections to patients is provided by each province s College of Pharmacy. In general, a pharmacist must have completed the following and registered their training with their provincial College: 2 Successful completion of an approved Canadian Council on Continuing Education in Pharmacy (CCCEP) program which meets the criteria of competency-mapped accreditation.* Valid certification in CPR and First Aid (the equivalent of St. John Ambulance or Red Cross Standard First Aid and CPR/AED) * CCCEP competency-mapped accreditation addresses the 15 competencies for pharmacist injection accreditation as outlined by the National Association of Pharmacy Regulatory Authorities (NAPRA). The document outlining the competencies can be found at: http://napra.ca/content_files/files/supplemental_competencies_on_injection_for_ Canadian_Pharmacists2012.pdf The certificate in immunization issued by a program provider of a competency-mapped accredited program is recognized by all provinces currently authorizing pharmacists to provide injection services. 2 ii

Table 1: Immunization and Injection Programs Competency-Mapped Accredited as of June 16, 2015 2 Program Provider Pear Healthcare Solutions Inc. Online Access to Program www.healthelearning.ca Alberta Pharmacists Association British Columbia Pharmacy Association Dalhousie Continuing Pharmacy Education Leslie Dan Faculty of Pharmacy, University of Toronto College of Pharmacists of Manitoba Ontario Pharmacists Association Memorial University School of Pharmacy rxbriefcase (Advancing Practice) University of Saskatchewan www.rxa.ca www.bcpharmacy.ca/nodes/home www.dal.ca/faculty/healthprofessions/cpe.html http://cpd.pharmacy.utoronto.ca/programs/injections.html http://mpha.in1touch.org/ www.opatoday.com www.mun.ca/pharmacy/ www.advancingpractice.com www.usask.ca/pharmacy-nutrition/professional-services/cpdp/ iii

Table 2: Rules, Regulations, and Fees for Pharmacist Immunization and Injection According to Province as of November 2015* Province Injection Privileges Publicly Funded Fee for Injection Restrictions for Injectable Vaccines BC IM, SC, or ID injections $10/injection Vaccines only 6 yrs of age or older AB SK MB Drugs and immunizations by injection Influenza immunizations (Oct 2015) Influenza, Tdap, Pneumonia, HPV $20 per patient assessment and injection (maximum 2 per day per patient) 5 yrs of age or older Influenza: 9 years of age and older $13 per injection 9 years of age or older Fluviral injection only $7 per injection 7 years of age or older ON Influenza immunizations only $7.50 per injection $5 for Intranasal 5 yrs of age or older QC N/A N/A N/A NB Drugs and immunizations by injection $12/injection 5 yrs of age or older NS IM or SC injection $12/injection 6 yrs of age or older PEI Influenza, Schedule B vaccines Drugs other than vaccines Up to $12.36 for influenza injection for high risk patients 5 yrs of age or older for influenza 18 yrs of age or older for schedule B vaccines 5 yrs of age or older for drugs other than vaccines NFLD Drugs and immunizations by injection $13/injection for provincial drug plan beneficiaries 5 years of age or older *Information as per provincial college or pharmacist association iv

Table of Contents Immunization and Injection Summary 3 Immunization for Family Members 13 Immunization for Older Adults 27 Travel Health Immunization 33 Dispelling the Myths of Immunization 37 References 41 CE Questions 45 Notes 51 1

Immunization and Injection Summary

Immunization and Injection Summary Vaccine Components and Types of Vaccine A Refresher Vaccines contain several components: 3 The antigen (immunogen): This is the component that stimulates the recipient s immune response (e.g., killed virus or bacteria; or part of a bacteria or virus that does not cause the disease) Adjuvants: These are usually aluminum salts added to the vaccine to make the antigen stimulate a stronger and/or longer lasting immune response in the vaccine recipient Preservatives: These are chemicals designed to prevent contamination of vaccines with bacteria or fungi (e.g., thimerosal) Additives: These are chemicals added by manufacturers for quality assurance purposes (e.g., to preserve a neutral ph or to stabilize the proteins during the manufacturing process) Common additives include potassium or sodium salts, lactose, antibiotics (neomycin), polysorbate 20, human serum albumin, animal proteins such as gelatin and bovine serum albumin, egg or yeast proteins, glycerol, amino acids and enzymes, formaldehyde Vaccines stimulate an immune response via the following mechanisms: 3 Live-attenuated vaccine weakened strains of virus that do not cause disease. Examples include (virus) measles, mumps, rubella, yellow fever, herpes zoster and varicella, as well as some influenza vaccines and (bacteria) Bacille Calmette-Guérin (BCG), oral typhoid Inactivated vaccine either killed organisms or an inactivated form of toxin. Examples of killed organisms include hepatitis A, Japanese encephalitis, IPV (polio), rabies. Examples of inactivated toxins include diphtheria and tetanus. Purified components of the organism Examples (cell wall proteins conjugated to polysaccharide) include Hib (H. influenzae type b), meningococcal conjugate, and pneumococcal conjugate. Additional examples include (polysaccharide components from the organism) meningococcal, pneumococcal, and injectable typhoid vaccines. These polysaccharide vaccines are often not as effective in children younger than two years old, and so are typically given to older persons. 4

Vaccine Timing 4 Many vaccinations require multiple doses to confer immunity and may require booster doses later in life Immunizations can start even before a person is at risk for acquiring an infection (even on the first day of life) May be given together, and often several immunogens are combined into one injection, such as in the DTaP (diphtheria, tetanus, acellular pertussis) vaccine. There are no contraindications to giving multiple injections of vaccines at any one visit (exceptions: pneumococcal polysaccharide and pneumococcal conjugate vaccines are not to be given at same time; oral inactivated Travellers Diarrhea vaccine/cholera vaccine should not be given at same time as oral typhoid vaccine). Live vaccines should either be given during the same visit or spaced at least four weeks apart due to a less than robust response to the vaccines if given together before four weeks have passed. Immunizations of live-virus vaccines are usually delayed until at least twelve months of age. Since infants have an immature immune response, especially to polysaccharide vaccines, these vaccines are usually only given to older persons. Newer conjugate forms have been developed that are effective in infants. As a general rule, vaccines should not be given earlier than their recommended schedule, but can be given later. Refer to the product monograph for details of specific vaccine timing of administration. 5

Immunization and Injection Summary Table 3: Abbreviations and Brand Names of Vaccines Used in Immunization Schedules 5 Abbreviation Vaccine Brand Names Important Note: Refer to vaccine-specific chapters in Part 4 of the Canadian Immunization Guide for brand-specific recommendations. (See http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-eng.php) BCG Bacillus Calmette-Guérin BCG Vaccine DTaP-HB-IPV-Hib DTaP-IPV DTaP-IPV-Hib Diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio, Haemophilus influenzae type b (pediatric) Diphtheria, tetanus, acellular pertussis, inactivated polio (pediatric) Diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type b (pediatric) INFANRIX hexa TM QUADRACEL PEDIACEL HA Hepatitis A AVAXIM AVAXIM Pediatric HAVRIX 1440 HAVRIX 720 Junior VAQTA HAHB Hepatitis A, hepatitis B TWINRIX TWINRIX Junior HB Hepatitis B ENGERIX -B RECOMBIVAX HB Hib Haemophilus influenzae type b Act-HIB HPV 2 Human papillomavirus CERVARIX TM HPV 4 Human papillomavirus GARDASIL Inf Influenza AGRIFLU FLUAD FLUMIST FLUVIRAL INFLUVAC INTANZA VAXIGRIP FLUAD IPV Polio (inactivated) IMOVAX Polio 6

Table 3: Abbreviations and Brand Names of Vaccines Used in Immunization Schedules 5 Abbreviation Vaccine Brand Names Important Note: Refer to vaccine-specific chapters in Part 4 of the Canadian Immunization Guide for brand-specific recommendations. (See http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-eng.php) Men-C-ACYW-135 Meningococcal conjugate quadrivalent Menactra Menveo TM Men-C-C Meningococcal conjugate monovalent Meningitec Menjugate NeisVac-C MMR Measles, mumps, rubella M-M-R II PRIORIX MMRV Measles, mumps, rubella, varicella PRIORIX-TETRA Pneu-C-13 Pneumococcal conjugate 13-valent Prevnar 13 Pneu-P-23 Pneumococcal polysaccharide 23-valent PNEUMOVAX 23 PNEUMO 23 Rab Rabies IMOVAX Rabies RabAvert Rot-1 Rotavirus monovalent ROTARIX TM Rot-5 Rotavirus pentavalent RotaTeq Td Tetanus, diphtheria (reduced) Td ADSORBED Tdap Tdap-IPV Td-IPV Tetanus, diphtheria (reduced), acellular pertussis (reduced) Tetanus, diphtheria (reduced), acellular pertussis (reduced), inactivated polio Tetanus, diphtheria (reduced), inactivated polio ADACEL BOOSTRIX ADACEL -POLIO BOOSTRIX -POLIO Td POLIO ADSORBED Typh-I Typhoid (injection) TYPHIM Vi TYPHERIX Typh-O Typhoid (oral) Vivotif Var Varicella (chickenpox) VARILRIX VARIVAX III Zos Herpes zoster (shingles) ZOSTAVAX 7

Immunization and Injection Summary Table 4: Recommended Immunization Schedules (National) Birth to 17 Years 5 Vaccine DTaP-IPV-Hib or DTaP-HB-IPV-Hib Recommended Schedule and Comments 2, 4, 6 mos. and 18 mos. Number of doses of Hib vaccine required varies if immunization begins at 7 mos. or older DTaP-IPV or Tdap-IPV Tdap Rotavirus Pneu-C-13 Men C-C Men-C-ACYW-135 4-6 years 14-16 years (10 years after last dose) 2-6 months Rot-5 vacccine 3 doses, at least 4 weeks apart; Rot-1 vaccine 2 doses, at least 4 weeks apart First dose between 6 weeks and 14 weeks. Do not initiate series in infants aged 15 weeks or older. Administer all doses by age 8 months plus 0 days 2, 4, 12 months If dosing started at 7-11 months 2 doses, at least 8 wks apart followed by 3 rd dose after 12 months of age at least 8 weeks after 2 nd dose Varies according to province. In general, healthy children receive 1 dose at 12 months, but some provinces may use schedule starting in infancy 1 dose (or 1 dose of Men C-C) at 12 years 8 MMR Var or MMRV HB 1 st dose at 12-15 months, 2 nd dose at 18 months of age or anytime thereafter, but typically before school 1 st dose at 12-15 months, 2 nd dose at 18 months or anytime thereafter, but typically before school 1 st dose at 12-15 months, 2nd dose at 18 months of age or anytime thereafter, but typically before school. Preferred schedule months 0, 1 and 6 (1st dose = month 0) with at least 4 weeks between the 1 st and 2 nd dose, at least 2 months between the 2 nd and 3 rd dose, and at least 4 months between the 1 st and 3 rd dose; For 11-15 years of age 2-dose schedule (months 0 and 4-6, depending on product used) HPV* Girls HPV 2 vaccine months 0, 1, 6 or HPV 4 Vaccine months 0, 2 and 6 Boys HPV 4 vaccine months 0, 2 and 6 * Provincial school systems have now implemented 2-dose regimen as it is not significantly less effective than 3-dose schedule Inf Annually for children 6 months of age and older. For children 6 months to less than 9 years of age receiving Inf for the first time, 2 doses, at least 4 weeks apart is recommended

Table 5: Recommended Immunization Schedules (National) Healthy Adults 5 Influenza Vaccine Pneumococcal Polysaccharide 23-valent Herpes Zoster Human Papillomavirus vaccine Tetanus, diphtheria Tetanus, diphtheria, acellular pertussis Measles-Mumps Meningococcal conjugate Pertussis Polio Rubella Varicella 1 dose annually Recommended Schedule and Comments Adults 65 years of age or older 1 dose 1 dose indicated for adults 50 years of age and older Women up to and including 26 years of age bivalent (HPV 2) or quadrivalent (HPV 4) vaccine (see HPV section for more information regarding new HPV 9 vaccine) Men up to and including 26 years of age HPV 4 vaccine 1 booster dose every 10 years 1 dose in adulthood for pertussis protection regardless of interval from last dose of Td Susceptible adults born in or after 1970 1 dose MMR vaccine Born before 1970 - consider immune Adults up to and including 24 years of age not immunized in adolescence 1 dose One dose of acellular pertussis-containing vaccine (Tdap) in adulthood Adults who will be in close contact with young infants should be immunized as early as possible Primary series for previously unimmunized adults when a primary series of tetanus and diphtheria toxoid-containing vaccine is being given (i.e., Tdap-IPV) or with routine tetanus and diphtheria toxoid containing vaccine booster doses (i.e., Td-IPV) Susceptible adults - 1 dose MMR vaccine If vaccine is indicated, pregnant women should be immunized after delivery Susceptible adults up to and including 49 years of age 2 doses; if previously received 1 dose should receive a second dose Known seronegative adults 50 years of age and older 2 doses routine testing is not advised 9

Immunization and Injection Summary Province/Territory Immunization Schedules Each province determines which vaccines will be covered for its residents and the times the different vaccines will be administered in the provincial program. This has caused wide variation in the publicly funded immunization programs throughout Canada. Other services, such as the utilization of vaccine registries, vary tremendously among different provinces. Some provinces maintain electronic provincial databases of all the vaccines administered to their residents. This facilitates assessment and analysis of immunization rates and ongoing safety and efficacy monitoring. Other provinces rely strictly on paperbased models for documenting the administration of vaccines. The different immunization schedules in Canada are listed in the table on the next page. 10

Table 6: Province/Territory Immunization Schedules Province Alberta Website Listing Provincial Immunization Schedule http://www.health.alberta.ca/health-info/imm-routine-schedule.html British Columbia Manitoba http://www.healthlinkbc.ca/toolsvideos/immunization/ http://www.gov.mb.ca/health/publichealth/cdc/div/schedules.html New Brunswick Newfoundland and Labrador Northwest Territories Nova Scotia http://www2.gnb.ca/content/dam/gnb/departments/h-s/pdf/en/cdc/ Immunization/RoutineImmunizationSchedule.pdf http://www.health.gov.nl.ca/health/publichealth/cdc/section_2_routine_ Immunization_Schedules.pdf http://www.hss.gov.nt.ca/sites/default/files/nwt_immunization_schedule_0.pdf http://novascotia.ca/dhw/cdpc/immunization.asp Nunavut Ontario Prince Edward Island Quebec Saskatchewan http://gov.nu.ca/sites/default/files/files/approved%20immunization%20 Schedules(adult)(1).pdf http://www.health.gov.on.ca/en/pro/programs/immunization/docs/ immunization_schedule.pdf https://www.princeedwardisland.ca/en/information/health-and-wellness/ adult-and-child-immunization-pei http://sante.gouv.qc.ca/en/programmes-et-mesures-daide/ programme-quebecois-d-immunisation/ http://www.ehealthsask.ca/services/manuals/documents/sim-chapter5.pdf Yukon www.hss.gov.yk.ca/pdf/immunization_schedule_en.pdf 11

Immunization for Family Members

Immunization for Family Members Educating Patients about Vaccines Following are some key points to make with patients and/or parents/caregivers about vaccines: 1 Vaccines are the most effective way to prevent many infectious diseases In the last century, vaccines have saved more lives than any other health intervention Vaccines contain weakened, killed or harmless components of microbes to stimulate our natural immune response Vaccines prompt the development of the same antibodies and immune cells as are developed after exposure to a disease, but without the risks associated with the disease The vaccines used in Canada are rigorously tested and are safe for use.* It often takes ten years before a vaccine has been studied thoroughly enough to be approved for use by Health Canada Immunization protects healthy individuals but also protects against spread of infection to high-risk individuals Currently there are over 25 infectious diseases that are targeted by vaccines Increase awareness about the importance of immunization record-keeping Excellent tool for record keeping available on Immunize.ca website at http://immunize. ca/en/learn/records.aspx * Dispelling the Myths of Immunization can be found later in this Vaccine Counselling Guide 15

Immunization for Family Members Annual Influenza Vaccination 7 Benefits of the vaccine In healthy children, efficacy against laboratory-confirmed influenza ranges from approximately 54% to 63% In healthy adults, inactivated influenza vaccine efficacy against laboratory-confirmed influenza is approximately 80% In observational studies, influenza vaccine reduced the number of physician visits, hospitalizations and deaths in high-risk persons 18-64 years of age, hospitalizations for cardiac disease and stroke in the elderly, and hospitalization and deaths in persons with diabetes mellitus 18 years of age and older Administration protocol Trivalent/quadrivalent inactivated vaccine (TIV/QIV) 0.5 ml intramuscularly (IM) Live-attenuated influenza vaccine (LAIV) (2-59 years) 0.2 ml (0.1 ml per nostril) Potential vaccine side effects TIV/QIV administered via IM route soreness at the injection site lasting up to two days, but rarely interferes with normal activities; post-vaccination fever in 12% or less of immunized children 1 to 5 years of age; mild to moderate and temporary myalgia, headache, fatigue and malaise (more frequent with adjuvanted compared to non-adjuvanted vaccine) LAIV nasal congestion and runny nose most common Need for additional vaccine injections in the future Influenza vaccine is indicated on an annual basis 16

Frequently Asked Questions Q. I m allergic to eggs. Since all TIV and QIV influenza vaccine products available in Canada contain trace amounts of residual egg protein, should I receive the annual flu vaccine? A. According to the National Advisory Committee on Immunization (NACI), egg-allergic individuals may be vaccinated against influenza using TIV or QIV, without prior influenza vaccine skin test and with the full dose, irrespective of a past severe reaction to egg. Due to lack of data, the use of LAIV in egg-allergic persons is not recommended. Q. Should I receive a flu shot if I am pregnant or breastfeeding? A. Yes, in fact all pregnant women, at any stage of pregnancy, are high priority for receiving inactivated (i.e., TIV or QIV) influenza vaccine for many reasons. These include increased risk of influenza-associated morbidity and potential adverse birth outcomes associated with maternal respiratory hospitalization or influenza during pregnancy. Newborns may also be protected from influenza if the expectant mother is vaccinated. LAIV should not be administered to pregnant women due to lack of safety data, but it may be administered to breastfeeding women. Q. Why is there an age restriction on administration of LAIV? A. LAIV should not be administered to children less than 24 months of age due to increased risk of wheezing. LAIV is not recommended for people 60 years and older because there is lack of evidence of efficacy in this patient population compared to TIV/QIV administration via the IM route. 17

Immunization for Family Members Human Papillomavirus (HPV) Vaccine Benefits of the vaccine HPV 2 and HPV 4 vaccine is almost 100% effective against HPV types 16- and 18-related cervical disease which is responsible for approximately 70% of cervical cancers. HPV 4 vaccine is also effective against HPV types 6, 11, 16 and 18 which are responsible for approximately 90% of anal and genital warts in males and females. 8 A new HPV 9 vaccine is now available and is effective against five more HPV types which are responsible for an additional 20% of cervical cancers. 9 The nine HPV types are known to cause approximately 90% of cervical cancers, 80% of cervical precancers, 75% of HPV-related vulvar, vaginal and anal cancers and precancers, and over 90% of genital warts. Administration protocol Each dose of HPV vaccine is 0.5 ml and is administered via the IM route. Three-dose (0, 2, 6 months) schedules are used for HPV 4 and HPV 9 vaccine. In immunocompetent adolescents 9-14 years, 2 doses may be administered (0 and 6-12 months). 10 HPV 4 vaccine is approved for use in females and males aged 9-26, while HPV 2 vaccine is approved for use in females aged 10-25. 8 The HPV 9 vaccine is approved for use in females aged 9 through 45 years and in males aged 9 through 26 years. 9 Publicly funded programs exist in all provinces, and age of administration of the vaccine varies by province. As of October 2016, Alberta, Manitoba, Nova Scotia, Ontario, PEI and Quebec offer publicly funded programs for boys. HPV vaccine recipients should be observed for 15 minutes after vaccine administration to avoid serious injury in the event of syncope. 8 Potential vaccine side effects 8 The most common adverse events are vaccination site pain (82% to 92%), swelling (24% to 44%) or redness (24% to 48%). These are mild to moderate in intensity and resolve over a few days in 94% of cases. Anaphylaxis is exceedingly rare. Need for additional vaccine injections in the future 8 Re-immunization with HPV vaccine is not indicated at this time. Protection lasts at least seven years. 18

Frequently Asked Questions 8 Q. Can HPV vaccine be given at the same time as other vaccines? A. HPV vaccine may be administered at the same time as other age-appropriate vaccines at different injection sites and using separate needles and syringes. Q. Can HPV vaccine be used during pregnancy? A. HPV vaccine is not recommended for use in pregnancy because data on use during pregnancy is limited. Adverse events to the recipient or adverse events to the fetus have not been associated with HPV vaccine use to date. Q. Is cervical cancer screening required in women who have received HPV vaccine? A. Since HPV vaccine is effective only against cervical cancer caused by some HPV types, cervical cancer screening should be conducted in all women regardless of HPV immunization. Also, women who were infected with HPV prior to immunization are susceptible to cervical cancer. 19

Immunization for Family Members Tetanus Toxoid 11 Benefits of the vaccine After a complete primary series (at least 3 doses) antibody concentrations that are protective against tetanus are present in over 99% of individuals vaccinated. However, there is declining immunity over time. Administration protocol As part of routine immunization of infants and children (see Table 4) via DTaP-IPV-Hib or DTaP-HB-IPV-Hib vaccine at 2, 4, 6 and 12 to 23 months of age (usually at 18 months of age). A booster dose of either DTaP-IPV or Tdap-IPV vaccine is administered at 4 to 6 years of age and a booster dose of Tdap vaccine 10 years later at 14 to 16 years of age. A booster dose of Td vaccine should be received every 10 years throughout adult life. A tetanus toxoid-containing vaccine, with or without tetanus immune globulin, may be required in wound management, depending on both the nature of the wound and the vaccination history. Tetanus toxoid-containing vaccines are administered via the IM route at a dose of 0.5 ml. Potential vaccine side effects The most common adverse reactions to childhood tetanus toxoid-containing combination vaccines are redness, swelling and pain at the injection site. A nodule which is palpable at the injection site may persist for several weeks. More serious local issues are usually a result of administering the vaccine subcutaneously in error. Mild systemic reactions which may include fever, irritability, fussiness or any combination have been reported in 8% to 29% of individuals. Drowsiness is reported in 40% to 52% of individuals. In adults, booster doses of Tdap or Td vaccine commonly lead to pain, redness and swelling at the injection site, headache, and fatigue. Fever and chills are also common. Need for additional vaccine injections in the future One dose of Td vaccine should be received every 10 years in adulthood. 20

Frequently Asked Questions Q. Can I receive Td vaccine if I am pregnant? A. There is no evidence to suggest a risk to the pregnancy or to the fetus from immunization of the mother with Td vaccine. Q. When should tetanus immune globulin be given in addition to Td vaccine in managing a wound that is more than a minor clean wound? A. Timely and thorough wound cleaning is an important first step to removing the source of toxin production and neutralizing any toxin which may have been released. High circulating concentrations of tetanus antibody, which inactivate the toxin, can only be achieved by prior completion of the tetanus toxoid-containing vaccine series or immediate administration of tetanus immune globulin. For those who are unimmunized or incompletely immunized, treatment should consist of both tetanus immune globulin and tetanus toxoid-containing vaccine given at different injection sites and using separate needles and syringes. Q. Why do I need to get a tetanus booster every 10 years? A. Tetanus is one of the only vaccine-preventable illnesses where herd immunity does not exist due to it originating from the soil. That is why a 10-year booster is so important. 21

Immunization for Family Members Hepatitis B Vaccine 12 Benefits of the vaccine Hepatitis B vaccine is 95% to 100% effective if a complete vaccine series is received prior to exposure to hepatitis B virus. Hepatitis B vaccination and one dose of hepatitis B immune globulin administered within 24 hours after birth are 85% to 95% effective in preventing hepatitis B infection in exposed neonates. Administration protocol Hepatitis B vaccine is administered via the IM route. Although there are several authorized schedules for hepatitis B vaccine, the preferred schedule is month 0, month 1 and month 6, with at least four weeks between the first and second dose, two months between the second and third dose, and four months between the first and the third dose. Doses are according to particular hepatitis B-containing vaccine used (i.e., monovalent hepatitis B, DTaP-HB-IPV-Hib, or hepatitis A-hepatitis B combination, age, and medical circumstances (e.g., dialysis, chronic renal failure and some immunocompromised individuals aged 20 years and older may require higher dose). See http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-hepb-eng.php. Also see Considerations for Travel Health Immunization. Potential vaccine side effects Reactions to hepatitis B vaccine are usually mild and temporary and may include irritability, headache, fatigue, and pain and redness at the injection site. Need for additional vaccine injections in the future Routine booster doses are not recommended for immunocompetent individuals. Immunity is long lasting even though antibody may be undetectable in serum. Immunocompromised persons, persons with chronic renal disease or on dialysis and those undergoing chemotherapy who have responded initially to hepatitis B vaccine may require booster doses periodically if anti-hbs titres fall below 10 IU/L. 22

Frequently Asked Questions Q. When is post-exposure administration of hepatitis B vaccine indicated? A. Post-exposure prevention should be considered for infants born to hepatitis B-infected mothers, individuals potentially exposed to blood or bodily fluids containing hepatitis B virus, and household and sexual contacts of an acute hepatitis B case or chronic carrier. Q. Can hepatitis B-containing vaccines be administered at the same time as other vaccines? A. Yes, hepatitis B-containing vaccines can be administered at the same time as other vaccines, but at different injection sites and with separate needles and syringes. Q. How are most cases of hepatitis B acquired? A. In Canada, most acute cases of hepatitis B occur in unimmunized people 25 years of age and older who acquire infection through unprotected sexual activity, sharing injection drug equipment, household contact with a hepatitis B carrier or procedures with percutaneous exposure. A high percentage of hepatitis B carriers in Canada are immigrants from a hepatitis B endemic area. 23

Immunization for Family Members Varicella (Chickenpox) Vaccine Benefits of the vaccine Varicella vaccines are estimated to be 94.4% effective in children after a single dose, and 98.3% effective following a second dose. Administration protocol Varicella is now indicated for routine childhood immunization. The first dose of varicellacontaining vaccine (i.e., univalent varicella or MMRV) is given at 12-15 months of age and the second dose at 18 months of age or any time thereafter but typically before school age. Children 12 months to 12 years of age not immunized on the routine schedule should receive 2 doses of any varicella-containing vaccine at least three months apart. If rapid, complete protection is required, a minimum interval of six weeks between doses may be used. For adolescents and adults under 50 years of age who may be susceptible to varicella, and who have tested negative for antibodies against varicella, two doses of varicella vaccine, at least six weeks apart, should be received. If an adolescent or adult under 50 years of age has received only one dose of varicella vaccine, then a second dose should be offered. Please refer to Herpes Zoster Vaccine for adults 50 years of age and older at risk of varicella infection. Univalent varicella vaccine should be administered via the subcutaneous route. MMRV vaccine should be administered via the subcutaneous or intramuscular route according to manufacturer s directions. Potential vaccine side effects Adverse effects to varicella vaccines are generally mild and may include pain, swelling and redness at the injection site in 10% to 20% of recipients. Low-grade fever occurs in 10% to 15% of recipients and a varicella-like rash occurs in 3% to 5% of individuals receiving the vaccine after the first dose and 1% after the second dose. Need for additional vaccine injections in the future It is not necessary to re-immunize with varicella-containing vaccine if age- and riskappropriate vaccination has been conducted. Herpes zoster vaccine is recommended in older age (50-60 years and older) as per information found in the section entitled Herpes Zoster Vaccine. 24

Frequently Asked Questions Q. Are there any contraindications and/or precautions to the use of varicella vaccine given that it consists of live-attenuated varicella virus? A. Yes, varicella-containing vaccines are contraindicated during pregnancy. Women should delay pregnancy by at least four weeks following vaccination with a univalent varicella vaccine. Although there is a theoretical risk to the fetus, there is no evidence that demonstrates a teratogenic risk. Therefore, termination of pregnancy should not be recommended should a woman be vaccinated while pregnant. In addition, immunocompromised individuals should not receive live vaccines unless approval from the individual s attending physician is received. Live vaccines are generally not recommended for individuals with congenital immunodeficiency states. Some exceptions do exist. Please see http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-vari-eng.php. Administration of varicella-containing vaccines should be delayed in persons with moderate or severe acute illness and should be delayed by at least four weeks and ideally six weeks following measles infection. It should also be delayed by at least four weeks after a person has received another live vaccine (but can be given at the same time as another live vaccine). It is recommended to avoid the use of salicylates for six weeks after immunization with varicella-containing vaccines. Q. Are there any issues with taking antiviral therapy after receiving varicellacontaining vaccine? A. Yes, systemic antiviral therapy such as acyclovir, valacyclovir and famciclovir should be avoided for at least 24 hours before administration of vaccine until 14 days after as it may reduce the efficacy of the vaccine. 25

Immunization for Older Adults

Immunization for Older Adults Herpes Zoster Vaccine 14 Benefits of the vaccine Evidence suggests that in adults 60 years of age and older, overall vaccine efficacy is 51.3% for prevention of herpes zoster (HZ) incidence and 66.5% for prevention of postherpetic neuralgia (PHN). In individuals aged 50-59 years, the percentage reduction of HZ and PHN incidence is at least as high as in the 60 years and older age bracket, but the incidence of HZ disease is lower. The duration of protection of HZ vaccination beyond seven years is unknown. Administration protocol One dose of HZ vaccine (0.65 ml) should be administered subcutaneously (SC) to individuals 50 years of age or older without contraindications. Potential vaccine side effects Reactions to HZ vaccine are generally mild and may include injection site pain, swelling or redness in approximately 48% of recipients. Need for additional vaccine injections in the future Currently, there is no recommendation for booster doses of HZ vaccine as the efficacy of protection beyond seven years has not been assessed. Research is ongoing in this area. Frequently Asked Questions Q. How does the HZ vaccine differ from the univalent varicella vaccine? A. The HZ vaccine contains the same components as the univalent varicella vaccine, but with an approximately 14-fold or higher virus concentration. Q. Who should NOT be given the HZ vaccine? A. The vaccine is indicated only for individuals 50 years of age and older. It should not generally be given to individuals with primary or acquired immune deficiency but may be given to those on low dose immunosuppressant drugs as approved by the attending physician. 29

Immunization for Older Adults Pneumococcal Vaccine (for Adults) 15 Benefits of the vaccine Pneumococcal polysaccharide-23 (Pneu-P-23) vaccine is estimated to be 50% to 80% effective against invasive pneumococcal disease among the elderly and in high-risk groups. Administration protocol One dose of Pneu-P-23 vaccine should be administered to all adults 65 years of age and older, and to immunocompetent adults less than 65 years of age in long-term care facilities. Adults who are at high risk of invasive pneumococcal disease, including immunocompromised individuals, should receive one dose of pneumococcal conjugate 13-valent (Pneu-C-13) vaccine followed 8 weeks later by one dose of Pneu-P-23 vaccine. Adults with hematopoietic stem cell transplant should receive three doses of Pneu-C-13 at least four weeks apart, starting 3-9 months after transplant. A dose of Pneu-P-23 should be provided 12-18 months post-transplant. A single re-immunization with Pneu-P-23 is recommended. Each dose of pneumococcal vaccine is 0.5 ml. Conjugated pneumococcal vaccine (i.e., Pneu-C-13) is injected via the IM route. The Pneu-P-23 vaccine may be administered via either the SC or IM route. Potential vaccine side effects Adverse effects to pneumococcal vaccine is normally limited to redness, swelling and soreness at the injection site. Need for additional vaccine injections in the future Conjugate pneumococcal vaccine does not need to be administered again if age- and risk-appropriate vaccination has been achieved. Routine re-immunization of healthy individuals with Pneu-P-23 is not recommended. For those at any age at highest risk of invasive pneumococcal disease, re-immunization after 5 years should be considered according to circumstances. Re-vaccination following a second dose is not routinely recommended. Pneu-P-23 vaccine should be received no sooner than eight weeks after Pneu-C-13 vaccine and no sooner than five years after the initial dose of Pneu-P-23. Also, Pneu-C-13 should be given no sooner than one year after Pneu-P-23 vaccine has been administered. 30

Frequently Asked Questions Q. Why are there two different types of pneumococcal vaccine? A. Pneumococcal vaccine is available as a polysaccharide complex or a conjugated protein derivative. The polysaccharide formulation does not stimulate an effective immune response in children and so is reserved for older populations. Although the conjugate vaccine has historically been used mostly in children, research has indicated potential benefits in adults when used along with the pneumococcal polysaccharide vaccine. Pneumococcal conjugate vaccine has received an indication for prevention of community-acquired pneumonia, whereas pneumococcal polysaccharide vaccine does not have this indication. If sequential administration of conjugate and polysaccharide vaccines is being considered, the conjugate vaccine should be given first (with appropriate time interval between the two vaccines). 31

Travel Health Immunization

Travel Health Immunization Determining Vaccine Requirements Country travel advice for vaccine recommendations and advisories can be found at: http://travel.gc.ca/ http://wwwnc.cdc.gov/travel/ The Committee to Advise on Tropical Medicine and Travel (CATMAT) website at http://www.phac-aspc.gc.ca/tmp-pmv/catmat-ccmtmv/index-eng.php Note: Recommendations for individual vaccination of travellers is dependent not only on country of travel, but regions of countries, itinerary, accommodation, length of travel and vaccination history. Table 7: General Travel Vaccines Information 16 Vaccine Hepatitis A Japanese Encephalitis Meningococcal disease Comments Prevalence patterns vary among regions within a country. Some expert clinicians recommend hepatitis A vaccination for anyone travelling outside North America. Two-dose schedule (0, 180-360 days). Protection at 70% two weeks after first dose and 100% after four weeks. Hepatitis A vaccine can be administered up until the day of travel. Rare cases ~ 1/1 million travellers. Virus transmitted via mosquito bites. Mostly in rural, agricultural areas of Asia. A series of two doses (0.5 ml IM) given on days 0 and 28 should be administered. The immunization series should be completed 10 to 14 days before potential exposure to JE to develop an adequate antibody response. An accelerated schedule is not available. However, if there is insufficient time to administer the recommended twodose schedule before entering a JE risk situation, a single dose of JE vaccine may be considered and the vaccinee advised that protection against JE may not be reliable. Alternatively, simultaneous administration of two doses of JE vaccine (given with separate injections at separate injection sites) may be considered; however, the risks and benefits of this approach must be critically evaluated. Proof of vaccination required by Saudi Arabia before entry to Hajj or Umrah in Mecca. Additional areas of concern are savannah areas of sub-saharan Africa extending from Gambia and Senegal in the west to Ethiopia and Western Eritrea in the east. Travellers should be vaccinated with Men-C-ACYW, 4CMenB or both vaccines, depending on the risk of meningococcal disease in the area of travel. The prevalent strain of meningococcal disease can vary significantly depending on the region of the world. 34

Table 7: General Travel Vaccines Information 16 Vaccine Rabies Yellow Fever Typhoid Malaria Comments For travellers to rabies endemic areas, including children who may not know to stay away from animals that may be rabid. Pre-exposure immunization: three 1.0 ml intramuscular (IM) or 0.1 ml intradermal (ID) doses of rabies vaccine given on days 0, 7 and any time between days 21 to 28. Note: postexposure care for a patient who was not pre-vaccinated requires emergency immunoglobulin which may not be available in many parts of the world. Virus transmitted via mosquito bites in Sub-Saharan Africa and tropical South America. International laws require vaccination to enter certain countries must carry International Certificate of Vaccination, which provides proof of immunization at least 10 days before entering endemic country. Only certain travel health clinics licensed to administer yellow fever vaccine. Search Yellow Fever Vaccination Centres in Canada. From contaminated food and water. India, Pakistan, Bangladesh are highest risk areas although risk substantial in many areas. There are three types of typhoid vaccines: parenteral (Typh-I), parenteral combined with hepatitis A (HA-Typh-I), and oral (Typh-O). These vaccines provide approximately 50% protection against clinical disease. Protection following Typh-I vaccine lasts for three years; protection following Typh-O vaccine lasts for about seven years. Vaccination should be given at least two weeks prior to travel. Virus transmitted via mosquito bites. Prevention is through chemoprophylaxis. Many regimens and choice of medication depends on area visited and local resistance patterns. Patients travelling to an area of risk for malaria should be referred to a travel clinic. 35

Dispelling the Myths of Immunization

Dispelling the Myths of Immunization Myth: Vaccines weaken the immune system Fact: Vaccines don t weaken the immune system; in fact, they activate the immune system to produce antibodies to diseases. 17 Myth: Vaccines are more dangerous than the diseases they prevent Fact: The vaccines used in Canada are rigorously tested and are safe for use. It often takes ten years before a vaccine has been studied thoroughly enough to be approved for use by Health Canada. 17 Myth: Vaccines are unnecessary, because the organisms causing them have been virtually eradicated Fact: Vaccine-preventable diseases still exist, and most will continue to survive despite our use of vaccines. Most are part of our environment and cannot be eradicated, only prevented. 17 Although many of these conditions are rare in Canada, with international travel being so common, an infected person is only a plane flight away. Myth: Herd immunity will protect my family, so we don t need immunizations Fact: Herd immunity is an ineffective way to protect people from vaccine-preventable diseases. When immunization rates drop, even by a small percentage, infections with those vaccine-preventable diseases skyrocket, as do deaths caused by those diseases. 17 In addition, tetanus is a soil-borne illness and there is no herd immunity at all. Myth: Because vaccines have been around for so long, there s no need to continue them Fact: Immunization is the most effective strategy to protect against vaccine-preventable diseases. 17 Myth: Severe side effects from vaccines are common Fact: While vaccines do have the potential to have some side effects, serious side effects are uncommon. The most commonly reported side effects are mild, such as fever or muscle aches, and occur at rates similar to those seen with placebo injections. 17 38

Myth: Influenza vaccine causes people to get the flu Fact: Injected influenza vaccines are prepared by inactivating the virus. It is not possible to get influenza from the injected vaccine. Some individuals do experience some soreness, tenderness, redness or swelling where the shot was given. A small percentage may also experience a low grade fever, headache and muscle aches, which reflect the body s natural immune response. 17 The intranasal flu vaccine is made from live-attenuated (very weakened) viruses which cannot cause influenza. Some individuals may experience runny nose, mild congestion or cough. 17 Myth: It is better to get the disease naturally than to get the vaccine Fact: Vaccines prompt the development of the same antibodies and immune cells as are developed after exposure to a disease, only without the risks associated with the disease. Because of the development of the antibodies before disease exposure, they are ready to defend against the disease upon new exposure. Some vaccines (e.g., tetanus) actually provide stronger immunity than occurs through natural infection. 17 Myth: MMR vaccine causes autism in children Fact: Rigorous scientific evidence that includes the results of 23 studies supports the view that immunization is not associated with an increased risk of autism. One retrospective cohort study of over 500,000 children born in Denmark between 1991 and 1998 found no difference in rates of autism between groups of children who were vaccinated with MMR and those who were not vaccinated. 17 Fear of a link between autism and MMR vaccine administration began after a study published in 1998 that included 12 children with inflammatory disease found that eight had autism. 10 A retraction was published in the journal in 2004, with 10 of the 13 authors stating that there is no connection between the MMR vaccine and the bowel/autism syndrome. 17 Myth: The added components of vaccines are dangerous Fact: Thimerosal has never been shown in studies to cause neurological problems (the chemical form of mercury contained is not the same type that causes neurological damage). 17 Formaldehyde is naturally found in the human body. Infant circulation contains 10 times the amount of formaldehyde found in vaccines under normal circumstances. 17 Aluminum in vaccines is very safe. Amounts in vaccines are similar to the amount found in infant formula and breast milk. 17 Gelatin must be sourced from countries whose cattle are free from Mad Cow Disease. 17 39

References

References 1. Public Health Agency of Canada. Immunization. The most successful public health measure. Available at http://www.phac-aspc.gc.ca/im/measure-intervention-eng.php. Accessed Oct. 19, 2015. 2. Canadian Council on Continuing Education in Pharmacy. Available at http://www.cccep.ca/index_content.php?id=121. Accessed Dec. 14, 2015. 3. Canadian Immunization Guide (Evergreen): Basic Immunology and Vaccinology. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-13-eng.php. Accessed Oct. 19, 2015. 4. Canadian Immunization Guide (Evergreen). Part 1. Timing of Vaccine Administration. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-09-eng.php. Accessed Oct. 19, 2015. 5. Canadian Immunization Guide (Evergreen). Part 1. Recommended Immunization Schedules. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-12-eng.php#tab8. Accessed Oct. 19, 2015. 6. Government of Canada. Provincial and Territorial Immunization Information. Available online at http://healthycanadians.gc.ca/healthy-living-vie-saine/ immunization-immunisation/children-enfants/schedule-calendrier-eng.php. Accessed Oct. 19, 2015. 7. Canadian Immunization Guide (Evergreen). Part 4. Active Vaccines. Influenza Vaccine. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-influenza-eng.php. Accessed Oct. 19, 2015. 8. Canadian Immunization Guide (Evergreen). Part 4. Active Vaccines. Human Papillomavirus Vaccine. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-hpv-vph-eng.php. Accessed Oct. 19, 2015. 9. The Society of Obstetricians and Gynaecologists of Canada. Gardasil 9 HPV vaccine now available in Canada. Available online at http://sogc.org/news_items/gardasil-9-hpv-vaccine-now-available-in-canada-2/. Accessed Oct. 19, 2015. 10. Public Health Agency of Canada. Update on the recommended Human Papillomavirus (HPV) vaccine immunization schedule. Available online at http://www.phac-aspc.gc.ca/naci-ccni/acs-dcc/2015/hpv-vph_0215-eng.php. Accessed Oct. 19, 2015. 42

11. Canadian Immunization Guide (Evergreen). Part 4. Active Vaccines. Tetanus Toxoid. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-tet-eng.php. Accessed Oct. 19, 2015. 12. Canadian Immunization Guide. Part 4. Active Vaccines. Hepatitis B Vaccine. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-hepb-eng.php. Accessed Oct. 19, 2015. 13. Canadian Immunization Guide. Part 4. Active Vaccines. Varicella (Chickenpox) Vaccine. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-vari-eng.php. Accessed Oct. 19, 2015. 14. Canadian Immunization Guide. Part 4. Active Vaccines. Herpes Zoster (Shingles) Vaccine. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-herp-zona-eng.php. Accessed Oct. 19, 2015. 15. Canadian Immunization Guide. Part 4. Active Vaccines. Pneumococcal Vaccine. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-pneu-eng.php. Accessed Oct. 19, 2015. 16. Canadian Immunization Guide. Part 3. Immunization of Travellers. Available online at http://www.phac-aspc.gc.ca/publicat/cig-gci/p03-10-eng.php. Accessed Oct. 25, 2015. 17. ImmunizeBC. Immunization Communication Tool. Available online at http://immunizebc.ca/sites/default/files/docs/immunizationcommunicationtoolfinal.pdf. Accessed Oct. 19, 2015. 43