Guide for Vaccine Screening Tool and Consent Form 2020 - medSask

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Guide for Vaccine Screening Tool and Consent Form 2020
                                                   Oct 2020
                                             Updated 13 Nov 2020

How to use this Guide
The Guide for Vaccine Screening Tool and Consent Form Questions (the Guide) has been developed by
medSask and the Pharmacy Association of Saskatchewan as a support document to the Vaccine
Screening Tool and Consent Form (the Form), see Appendix 1.

This guide is intended to provide rationale for the questions included on the Form and direction in the
specific situations. This is not a comprehensive vaccine guide. Pharmacists need to consult the
Saskatchewan Immunization Manual (SIM) and/or the Canadian Immunization Guide (CIG) for vaccine
eligibility/recommendations and specific vaccine information. Also see references in Appendix 2.

Each section in the Guide has the relevant questions from the Form, with answers providing context and
intent of the question and how to proceed based on the patient response:
     Inactivated Influenza Vaccine, to which questions 1-5 are relevant;
     Other Inactivated Vaccines, to which questions 1-7 are relevant; and
     All Live Vaccines (including Live Attenuated Influenza Vaccine), to which questions 1-10 are
        relevant

Colour coding has been used to more easily identify the specific vaccine for which you need information:
     Green indicates inactivated influenza vaccine (IIV)
     Purple indicates inactivated vaccines other than influenza vaccine
     Orange indicates live attenuated influenza vaccine (LAIV)
     Red indicates live vaccines other than LAIV

The information has been organized in this manner because influenza is the vaccine most commonly
administered by pharmacists; however, there are some differences and/or other considerations when
administering other inactivated and live vaccines.

The accompanying Form meets the record keeping requirements as set out by the Regulatory Bylaws of
the Saskatchewan College of Pharmacy Professionals regulating the Administration of Drugs by Injection
and Other Routes by a pharmacist. A list of the documentation requirements, can be found in Appendix
3 of this document.

Special thanks to the Saskatchewan College of Pharmacy Professionals for providing feedback into the
development of this document.
Acronyms Used in the Guide

BCG = Bacille Calmette-Guerin                             MMR = measles, mumps, rubella
CIG = the Canadian Immunization Guide                     MMRV = measles, mumps, rubella, varicella
IIV = inactivated influenza vaccine                       SIM = the Saskatchewan Immunization Manual
LAIV = live attenuated influenza vaccine (FluMist®)

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Contents
Q1. Feel sick today? ................................................................................................ 3
Q2. Have allergies to medications, food, a vaccine component, or latex?................................................... 4
Q3. Ever have a serious reaction after receiving a vaccination? .................................................................. 5
Q4. Have any of the following medical conditions: ...................................................................................... 6
   A. Bleeding problems (e.g. haemophilia, thrombocytopenia) .................................................................. 6
   B. Asthma, Severe ..................................................................................................................................... 6
   C. Lymphatic circulation impairment ....................................................................................................... 6
   D. Cancer, HIV Infection, other immune system disorders or transplant candidate/recipient................ 7
       i. General & Other Immunocompromised States not Specified Below ................................................ 7
       ii. Cancer................................................................................................................................................ 8
       iii. Human Immunodeficiency Virus (HIV) Infection.............................................................................. 9
Q5. Take any of the following medications (currently, recently): .............................................................. 11
   A. Anticoagulants/Antiplatelets .............................................................................................................. 11
   B. Drugs that affect immune system ...................................................................................................... 12
   C. Antiviral or Antibacterial drugs ........................................................................................................... 15
Q6. For women: Are you pregnant or breastfeeding or is there a chance you could become pregnant
during the next month? .............................................................................................................................. 16
Q7. Have received any vaccinations in the past 4 weeks? Plans for travel in the upcoming 4 weeks? ..... 17
Q8. Require a TB skin test within next 4 weeks? Ever have a positive TB skin test?.................................. 18
Q9. Have close contact with anyone with a weakened immune system ................................................... 18
Q10. During the past year, received a transfusion of blood or blood products, or immune globulin (Ig)?19
Appendix 1 – Vaccine Screening Tool and Consent Form........................................................................... 20
Appendix 2 – References and Recommended Resources........................................................................... 22
Appendix 3 – Documentation Requirements ............................................................................................. 23

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Questions - Do you (or your child/dependent):

Q1. Feel sick today?
Inactivated influenza vaccine, Other Inactivated Vaccines and Other Live Vaccines
     There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse
        events. Mild illnesses (such as otitis media, upper respiratory infections, upset stomach, and
        diarrhea) are NOT contraindications to vaccination, acknowledging that during the COVID-19
        pandemic, individuals who do not meet screening criteria will be asked to defer immunization.
     A moderate, or severe acute illness, with or without a fever, may be reason to delay
        immunization. Benefits need to be weighed against risks. Expert opinion is strongly
        recommended in this situation.
             o Benefits may include:
                     protection in a high risk exposure situation
                     short window of opportunity
             o Risks may include:
                     vaccine-related adverse event (particularly fever) could complicate the
                         management of the individual
                     events associated with the acute illness may be misperceived as vaccine-related
                         adverse events

Live Attenuated Influenza Vaccine
     As for inactivated influenza vaccine PLUS:
            o If significant nasal congestion is present that might interfere with delivery of LAIV to the
               nasopharyngeal mucosa, IIV can be administered instead; LAIV can be deferred until
               resolution of the illness but taking the opportunity to vaccinate at time of presentation
               is preferred.

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Q2. Have allergies to medications, food, a vaccine component, or latex?
Vaccines should not be administered to individuals who have had an anaphylactic reaction to any of the
vaccine components, with the exception of egg (see below). Refer patients who report a severe
reaction to other ingredients to their primary care provider or Public Health for further assessment.

All Vaccines

   Vaccine antigens
    A vaccine is contraindicated in an individual with a history of anaphylaxis after previous
      administration of the same vaccine or same antigen. Refer to primary care provider for further
      investigation.

   Nonmedicinal Ingredients - may be present in vaccine products, usually only in trace amounts.
   Consult individual vaccine monographs for the list of nonmedicinal ingredients contained in each
   product. The SK Drug Plan and Extended Benefits Branch provides the components of the publicly
   funded influenza vaccines.
    Egg proteins (ovalbumin) - Studies show that egg-allergic individuals, even those who report a
       severe reaction, may be vaccinated with the full dose of most vaccines without prior vaccine
       skin testing, even if the vaccines contain trace amounts of eggs.
           o Inactivated influenza vaccine and MMR/MMRV, may have trace amounts of eggs but
               have been found to be safe in egg-allergic individuals.
           o **An exception is the rabies vaccine RabAvert®, which generally should not be
               received by patients reporting anaphylactic reactions to eggs. Eggs are not used in the
               manufacturing of the rabies vaccine Imovax®. See SIM–Chapter 6 for more details.
    Thimerosal - minute amount is present in some multi-dose vials as a preservative but not in
       single dose vials or prefilled syringes or the inhaled vaccine product.
           o Inactivated Influenza vaccine - refer patients with documented allergy to thimerosal (or
               those requesting) to Public Health to receive a thimerosal-free product.
           o Other vaccines - If thimerosal-free products are not available for other vaccines, refer to
               the primary care provider or Public Health. Note that thimerosal is considered safe in
               pregnancy.
    Latex - some tips of syringe plungers, tips of prefilled syringes and vial stoppers contain latex.
       These products need to be avoided in those reporting anaphylactic allergic reaction to latex. For
       reactions other than anaphylactic (often contact allergy), latex-containing products may be
       used.
    Antibiotics (such as gentamicin, neomycin or kanamycin) – if the reaction reported is not
       anaphylactic (e.g. is a contact allergy or delayed type immune reaction) the product can be
       administered.
    Adjuvants - e.g. aluminum hydroxide, aluminum phosphate, AS01B, AS04, MF59
    Other common ingredients: buffers (such as sodium chloride, potassium chloride, disodium
       hydrogen phosphate heptahydrate, potassium dihydrogen phosphate), gelatin, surfactants (such
       as α-tocopheryl hydrogen succinate, cetrimonium bromide, polysorbate 80, sodium
       deoxycholate, Triton X-100) ethanol, formaldehyde and sucrose.

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Q3. Ever have a serious reaction after receiving a vaccination?
  Anaphylactic shock

  All Vaccines
   Vaccines are contraindicated for individuals who have had an anaphylactic reaction to a
       previous dose. Refer patients who have previously experienced severe lower respiratory
       symptoms (wheeze, chest tightness, difficulty breathing) within 24 hours of a vaccination, an
       apparent significant allergic reaction to the vaccine or any other symptoms (e.g. hives, throat
       constriction, difficulty swallowing) that raise concern regarding the safety of re-immunization.
       Because of the morbidity and mortality associated with vaccine-preventable diseases, a
       diagnosis of vaccine allergy should not be made without confirmation from medical experts.

  Guillain-Barre syndrome (GBS) (a neurological condition that can cause paralysis)
  Inactivated Influenza Vaccine and Live Attenuated Influenza Vaccine
   Although the evidence associating influenza and GBS is inadequate to accept or reject a causal
      relationship, avoiding subsequent influenza vaccination of all individuals known to have had GBS
      within six weeks of previous influenza vaccination is recommended at this time. However, the
      potential risk of GBS recurrence associated with influenza vaccination must be balanced against
      the risk of GBS associated with influenza infection itself. Vaccination may still be warranted -
      refer patients to their primary care provider for assessment of risk.

  Tetanus toxoid-containing vaccine:
   Cases of GBS following toxoid-containing vaccination have been reported, though population
      studies have not found a causal association. Individuals who develop GBS within 6 weeks of
      receipt of tetanus toxoid-containing vaccine should not receive a further dose.

  Reactions from past vaccines that may be reported and of concern but do not warrant withholding
  future vaccinations:
   extensive limb swelling
   syncope
   febrile seizure
   cutaneous reactions

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Q4. Have any of the following medical conditions:
A. Bleeding problems (e.g. haemophilia, thrombocytopenia)
   General:
    Bleeding disorders are NOT contraindications to injectable vaccine administration. To reduce
      bleeding risk:
          o A fine gauge needle (23, 25, or 27 G) should be used.
          o Apply direct pressure (without rubbing) to the injection site for 5 to 10 minutes after
              injection to stop the bleeding.
    For patients with haemophilia, if there is concern that the injection may stimulate bleeding,
      schedule the injection shortly after the administration of anti-haemophilia therapy. It is
      advisable to administer the vaccine approximately 3-4 hours after the anti-haemophilia therapy
      that decreases the risk of bleeding and haematoma. See SIM – Chapter 7 for more details.

   MMR and MMRV Vaccines
    Always consult with the patient’s physician/specialist prior to MMR immunization if they have
     had an episode of thrombocytopenia in the past, which may or may not have occurred within 6
     weeks of a previous MMR/MMRV vaccine.

B. Asthma, Severe
   Live Attenuated Influenza Vaccine
    LAIV is not recommended for patients with severe asthma (defined as currently on oral or high
       dose inhaled glucocorticosteroids or active wheezing) or those who have had to seek medical
       attention for wheezing in the 7 days prior to vaccination.
    LAIV can be given to patients with stable, non-severe asthma.

C. Lymphatic circulation impairment (e.g. lymphedema, axillary lymph node removal
[mastectomy, lumpectomy], amputation)
   All Vaccines

      Injection of a vaccine into an area where lymphatic circulation may be impaired (e.g. deltoid
       injection in an individual with local lymphedema, lymphangioma, axillary lymph node dissection,
       A-V fistula, upper limb amputation) could theoretically result in an impaired immune response
       due to impaired vaccine absorption, although there are no data to support this. Consider an
       alternative injection site if possible.
           o Note that axillary lymph node dissection is most commonly associated with mastectomy
                and lumpectomy, though not all patients who have undergone these procedures have
                lymph node dissection so this should be clarified if possible.
           o If lymphatic circulation impairment is unilateral, inject in the opposite arm; if bilateral,
                the vastus lateralis is a suitable alternate site.
           o As this is a theoretical concern, some patients, in consultation with their healthcare
                providers, may decide to use the deltoid even if bilateral involvement.

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D. Cancer, HIV Infection, other immune system disorders or transplant
candidate/recipient

i. General & Other Immunocompromised States not Specified Below
     See SIM – Chapter 7 and CIG- Immunization of immunocompromised persons for more details.
      In general, immunocompromised individuals are more susceptible to vaccine-preventable
       infections and may have severe infections, making vaccination even more important. The
       safety and effectiveness of vaccines in immunocompromised individuals are determined by the
       type of immunodeficiency and degree of immunosuppression.
      Tip: For the vast majority of patients receiving cancer treatment, influenza immunization is
       recommended and even more so this year with COVID-19 circulating. However, there are a few
       exceptions that can be found in the Saskatchewan Cancer Agency’s (SCA) Influenza
       Immunization Guideline 2020.
           o Inquiring if an individual has/is receiving cancer treatment at the time of first contact
                regarding the flu shot is helpful in catching these particular individuals who should not
                receive the flu shot this year.
      People who are severely immunocompromised or in whom immune status is uncertain should
       not receive live vaccines because of the risk of disease caused by the vaccine strains, or may not
       mount an appropriate immune response to inactivated vaccines. Refer these individuals to
       Travel Health Center/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert).
       Contact Public Health or Travel Health Centers to be directed in other areas of the province.
      See information in Question 5B regarding drugs that affect the immune system if applicable.

   Inactivated Influenza Vaccine and Inactivated Vaccines
    There are few contraindications to the use of inactivated vaccines in these individuals. See
       section ii (cancer) below for some exceptions. However, the immune response to inactivated
       vaccines is suboptimal (depending on level of immunodeficiency).
            o Try to immunize before immunosuppression ensues (if possible); otherwise, try to
                 immunize at time of anticipated maximum immune response (though this is often not
                 established). .
    As these patients are at greater risk of infection, up-to-date immunization, including annual
       IIV, is important.

   Live Attenuated Influenza Vaccine and Other Live Vaccines
    Administration of live vaccines may cause uncontrollable replication of the virus or bacterium
       and result in serious adverse events in immunocompromised patients.
    If available, use an inactivated form of the antigen (e.g. herpes zoster, influenza, typhoid).
    If live vaccine is required and no inactivated form is available/suitable, refer individual to Travel
       Health Center/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact
       Public Health or Travel Health Centers to be directed in other areas of the province.
           o Some live vaccines (e.g. MMR, varicella) are given to some of these patients depending
               on degree of immunosuppression, susceptibility, age and vaccine history. See SIM-
               Chapter 7 for details but refer these patients.

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ii. Cancer
    General
     Tip: For the vast majority of patients receiving cancer treatment, influenza immunization is
       recommended and even more so this year with COVID-19 circulating. However, there are a few
       exceptions that can be found in SCA’s Influenza Immunization Guideline 2020.
           o Inquiring if an individual has/is receiving cancer treatment at the time of first contact
               regarding the flu shot is helpful in catching these particular individuals who should not
               receive the flu shot this year.
     In general, if a patient is 3 months post-chemotherapy or if immunosuppression has been
       discontinued for at least 3 months (6 months or more for anti-B cell antibodies), the cancer is in
       remission and T cell function is normal, the individual is no longer considered
       immunocompromised.
     See information in Question 4D regarding lymphatic circulation for those who have undergone
       mastectomy or lumpectomy and/or are experiencing lymphedema.

    Inactivated Influenza vaccine
     Inactivated influenza vaccine is strongly recommended for individuals with cancer unless
        medically contraindicated. Refer to the Saskatchewan Cancer Agency’s (SCA) Influenza
        Immunization Guideline 2020 for all individuals with cancer. This document addresses:
            o medical contraindications to IIV
            o timing of IIV in relation to anticancer treatments
            o recommendations for candidates, donors and recipients of stem cell transplants (SCT)
            o how to determine specific anticancer treatments of individuals
            o encouragement to immunize close contacts with IIV

    Other Inactivated Vaccines
     Inactivated vaccines can be safely administered at any time before, during or after
       immunosuppression; however, response may be suboptimal depending on degree of
       immunosuppression during anticancer treatment.
     Refer to SCA’s Influenza Immunization Guideline 2020, which provides durations to wait before
       administering IIV.
            o The durations in this document would be minimum durations for other inactivated
                vaccines.
            o Depending on the vaccine and risk of infection, the decision may be made to defer
                vaccination until immune function has been restored (or improved).
            o Consult with SCA regarding suitability and timing of other inactivated vaccines.
            o Timing and vaccine requirements vary among those who have received SCT. Refer to or
                consult with SCA to ensure appropriate vaccination and timing.
            o SCT donors should receive inactivated vaccines at least 2 weeks prior to stem cell
                collection.

    Hepatitis B Vaccine
     Should be given at double the dose and using a 3- or 4-dose schedule.

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Human Papillomavirus Vaccine
    Should be given following routine age indications but using a 3-dose schedule, regardless of age.

   Live Attenuated Influenza Vaccine and Other Live Attenuated Vaccines
    These vaccines should not be administered during anticancer treatment and for at least:
           o 3 months after completion of chemotherapy and/or radiotherapy, if cancer is in
               remission and T cell function is normal.
           o 6 months or more after completion of anti-B cell antibodies (e.g. rituximab,
               obinutuzumab, alemtuzumab), if cancer is in remission and T cell function is normal.
           o 24 months post SCT. Consultation with SCA or Travel Health Center/ Specialty
               Immunization Clinic is required prior to immunization with live vaccines.
    Live vaccines should not be given within 4 weeks of the start of immunosuppressive therapy.
    If available, use an inactivated form of the antigen (e.g. herpes zoster, influenza, typhoid).
    Consult SCA if immune status unknown and live vaccine is only option.

iii. Human Immunodeficiency Virus (HIV) Infection
   Inactivated Influenza Vaccine
    Recommended annually for those 6 months and older.

   Other Inactivated Vaccines
    HIV infection is not a contraindication to inactivated vaccines.
    Inactivated vaccines can be administered at any point in course of infection.
           o If immune suppression is severe in an untreated or newly treated individual and
               likelihood of exposure to the vaccine-preventable disease is low, may consider deferring
               vaccination pending immune recovery after effective antiretroviral therapy. These
               individuals should be referred to Travel Health Center/ Specialty Immunization Clinic
               (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centers
               to be directed in other areas of the province.

   Hepatitis B Vaccine
    Hepatitis B vaccine should be given at double the routine dose and using a 3 or 4 dose schedule.
    Post-immunization titres should be done one month after completing a primary hepatitis B
      vaccine series.

   Human Papillomavirus Vaccine
    Should be given following routine age indications but using a 3-dose schedule, regardless of age.

   Rabies Vaccine
    Post-immunization titres should be done one month after completing a rabies vaccine series.

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Live Attenuated Influenza Vaccine
 Children: As of 2020-21, NACI recommends IIV to be used in children but if IM injection is
    unacceptable by parent or substitute decision maker, LAIV can be administered to children with
    HIV who meet the following criteria:
        o age 2–17 years; and
        o have been receiving HAART for ≥4 months; and
        o have a CD4 count ≥500/µL if 2–5 years of age, or ≥200/µL if 6–17 years of age
             (measured within 100 days before administration of LAIV); and
        o have HIV plasma ribonucleic acid (RNA)
Q5. Take any of the following medications (currently, recently):
A. Anticoagulants/Antiplatelets
   General
    Use of anticoagulants/antiplatelets are NOT contraindications to injectable vaccine
      administration. To reduce bleeding risk:
          o A fine gauge needle (23, 25, or 27 G) should be used.
          o Apply direct pressure (without rubbing) to the injection site for 5 to 10 minutes after
             injection to stop the bleeding.

   Live Attenuated Influenza Vaccine
    LAIV is contraindicated for children and adolescents, 2 to 17 years of age, currently receiving
       salicylate therapy because of the association of Reye's syndrome with ASA and wild-type
       influenza infection. They should receive IIV instead. It is recommended that initiation of
       salicylate-containing products be delayed for four weeks after receipt of LAIV in children less
       than 18 years of age.

   MMRV and Varicella Vaccines
    An association exists among use of salicylates in children and adolescents, wild-type varicella
     virus and Reye’s syndrome.
    Ideally, children and adolescents requiring chronic salicylate therapy should receive varicella
     vaccination prior to initiating the chronic salicylate therapy.
    Refer children and adolescents taking chronic salicylate therapy to Public Health so that
     theoretical risks associated with varicella vaccine can be weighed against the known risks
     associated with wild-type varicella infection and for close monitoring if varicella vaccine is
     administered.

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B. Drugs that affect immune system - such as prednisone, other steroids, anticancer drugs,
monoclonal antibodies, other biologics, and others – often for treatment of inflammatory conditions
(e.g. rheumatoid arthritis, Crohn’s disease, psoriasis), other conditions or for transplant recipients.

    General
     In general, immunocompromised individuals are more susceptible to vaccine-preventable
       infections and may have severe infections, making appropriate vaccination even more
       important. The safety and effectiveness of vaccines in immunocompromised individuals are
       determined by the type of immunodeficiency and degree of immunosuppression.
     Also see Question 4D for conditions causing immunosuppression, if applicable.
     Certain drugs (e.g. calcineurin inhibitors, monoclonal antibodies, other biologics, cytotoxic
       drugs) used post-transplant or to treat conditions such as cancer, and inflammatory conditions
       such as rheumatoid arthritis, Crohn’s disease, psoriasis, etc. may have a significant effect on the
       immune system.
     People who are severely immunocompromised or in whom immune status is uncertain should
       not receive live vaccines because of the risk of disease caused by the vaccine strains, or may not
       mount an appropriate immune response to inactivated vaccines. Refer these individuals to
       Travel Health Center/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert).
       Contact Public Health or Travel Health Centers to be directed in other areas of the province.
     Corticosteroid therapy is not a contraindication to inactivated or live vaccine administration
       when:
                    steroid therapy is short-term (i.e., less than 14 days)
                             e.g. 1250 mg prednisone once daily x 5 days
                    a low to moderate dose (i.e. < 2 mg/kg/day for a child or < 20 mg/day for an
                        adult of prednisone or its equivalent)
                             e.g. 15 mg prednisone (adult) once daily x 4 months
                    long-term, alternate-day treatment with short-acting preparations
                             e.g. 7.5 mg prednisone (adult) every other day
                    maintenance physiologic replacement therapy
                    administered topically, inhaled, or locally injected (e.g. joint injection).

            o   There should be an interval of at least 4 weeks after discontinuation of high-dose
                systemic steroids before vaccines are administered.
                     high dose: ≥2 mg/kg/day (child), ≥20 mg/kg/day (adult) prednisone or
                        equivalent for ≥ 14 days

    Inactivated Influenza Vaccine
     As these patients are at greater risk of infection, up-to-date immunization, including annual
        IIV, is important, even if a lower immune response is expected.
     See Other Inactivated Vaccines below for more general information.
     For those with cancer, refer to the Saskatchewan Cancer Agency’s (SCA) Influenza Immunization
        Guideline 2020 for durations to wait before administering IIV according to anticancer treatment.

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Other Inactivated Vaccines
 The immunocompromised state is not a contraindication to the use of inactivated vaccines.
   However, the immune response to inactivated vaccines is suboptimal (depending on level of
   immunodeficiency) and a delay may be required between completion of immunosuppressive
   therapy and vaccination.
        o Ideally, inactivated vaccines should be given prior to initiation of agents causing
            immunosuppression (≥ 14 days) or at least 3 months (6 months if anti-B cell antibodies,
            e.g., rituximab) after therapy is discontinued to ensure immunogenicity.
        o A period of at least three months should elapse post-transplant before administering
            inactivated vaccines.
        o If immunosuppressive agent has already been started and is chronic therapy, try to
            immunize at time of anticipated maximum immune response (which often has not been
            determined).
 If risk of exposure is low, consideration may be given to deferring inactivated vaccines until the
   individual is the least immunosuppressed.
 Doses may need to be repeated when the individual is no longer immunosuppressed unless
   antibody response can be demonstrated.
 For those receiving anticancer treatment, refer to SCA’s Influenza Immunization Guideline
   2020, which provides durations to wait before administering IIV.
        o The durations in this document would be minimum durations for other inactivated
            vaccines.
        o Depending on the vaccine and risk of infection, the decision may be made to defer
            vaccination until immune function has been restored (or improved).
        o Consult with SCA regarding suitability and timing of other inactivated vaccines.

Hepatitis B Vaccine
 Should be given at double the dose and using a 3- or 4-dose schedule.

Human Papillomavirus Vaccine
 Should be given following routine age indications but using a 3-dose schedule, regardless of age.

Live Attenuated Influenza Vaccine and Other Live Attenuated Vaccines
 Administration of live vaccines may cause uncontrollable replication of the virus or bacterium
    and result in serious adverse events in immunocompromised patients and is contraindicated in
    most cases.
 Live vaccines should be given prior to initiation of agents causing immunosuppression (≥ 4
    weeks) or at least 3 months (6 months if anti-B cell antibodies, e.g. rituximab) after therapy is
    discontinued to reduce the risk of disease caused by the vaccine strain.
 If available, use an inactivated form of the antigen (e.g. herpes zoster, influenza, typhoid).
 If live vaccine is required and no inactivated form is available/suitable, refer to Travel Health
    Center/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public
    Health or Travel Health Centers to be directed in other areas of the province.
        o Some live vaccines (e.g. MMR, varicella) are given to some of these patients depending
            on degree of immunosuppression, susceptibility, age and vaccine history. See SIM –
            Chapter 7 for details but refer these patients.

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   The safety and efficacy of live vaccines during low dose intermittent or maintenance therapy
    with non-corticosteroid immunosuppressive drugs are generally unknown (see herpes zoster
    below for exceptions).
   A careful risk-benefit assessment should be done if live attenuated vaccines are to be
    considered in patients on low dose immunosuppression – see varicella and live herpes zoster
    vaccines below for definition.

Varicella and Live Herpes Zoster Vaccines
 For herpes zoster, use recombinant herpes zoster vaccine (Shingrix®) unless unavailable or
    contraindicated.
 These live vaccines can be considered in those taking low-dose immunosuppression defined as:
         o low dose methotrexate (≤ 0.4 mg/kg/week)
         o azathioprine (≤ 3 mg/kg/day)
         o 6-mercaptopurine (≤ 1.5 mg/kg/day)
         o < 2 mg/kg/day for a child or < 20 mg/day for an adult of prednisone or its equivalent
 If combination low dose immunosuppression is being used, consult or refer to Travel Health
    Center/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public
    Health or Travel Health Centers to be directed in other areas of the province.

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C. Antiviral or Antibacterial drugs
   Inactivated Influenza Vaccine and Other Inactivated Vaccines
    There is no reason to withhold inactivated vaccines for patients taking antivirals (including those
       active against influenza and varicella) or antibacterials.

   Live Attenuated Influenza Vaccine
    LAIV should not be administered for at least 48 hours after antiviral agents active against
       influenza (oseltamivir, zanamivir) are stopped, and these antiviral agents, unless medically
       indicated, should not be administered until two weeks after receipt of LAIV so that the antiviral
       agents do not kill the replicating virus.
    If these antiviral agents are administered within this time frame (i.e., between 48 hours before
       and two weeks after LAIV is given), revaccination should take place at least 48 hours after the
       antivirals are stopped.

   MMRV, Varicella and Live Attenuated Herpes Zoster Vaccines
    Systemic antiviral therapy active against varicella zoster virus (e.g. acyclovir, valacyclovir,
     famciclovir) should be avoided for at least 24 hours before vaccine administration as it may
     affect the reproduction of and reduce the efficacy of a varicella-containing vaccine or a live
     zoster vaccine.
         o If taking these antivirals and herpes zoster vaccination is required, use the recombinant
              herpes zoster vaccine.
    Systemic antiviral therapy active against varicella zoster virus (e.g. acyclovir, valacyclovir,
     famciclovir) should not be started until at least 14 days following administration of a varicella-
     containing vaccine or a live zoster vaccine as the antivirals to prevent the antiviral from killing
     the replicating virus.
    On the basis of expert opinion, it is recommended that individuals taking long-term antiviral
     therapy should discontinue these drugs, if possible, from at least 24 hours before administration
     of a varicella-containing vaccine or a live zoster vaccine, and should not restart antiviral therapy
     until 14 days after vaccine administration.

   Live Oral Typhoid Vaccine
    Live oral typhoid vaccine should be delayed 48 to 72 hours after completing treatment with
       antibiotics active against Salmonella typhi.
    Antibiotics active against Salmonella typhi should not be initiated until at least 72 hours
       following the last dose of the oral typhoid vaccine series.
    Examples of antibiotics active against S. typhi (not an exhaustive list) include: azithromycin, 3rd-
       generation cephalosporins, carbapenems, sulfonamides and fluoroquinolones.

                                                                                                        15
Q6. For women: Are you pregnant or breastfeeding or is there a chance
you could become pregnant during the next month?
  Inactivated Influenza Vaccine
   Encourage vaccination as pregnant women are at high risk of influenza-related complications or
      hospitalization.
   Women who are breastfeeding should receive this vaccine if not received while pregnant.

  Other Inactivated Vaccines
   No precautions or concerns with most inactivated vaccines in pregnancy (see exceptions below)
     and breastfeeding.
   Vaccination during pregnancy protects the mother from vaccine-preventable diseases that may
     otherwise be acquired and be transmitted to the fetus or infant.
   Several vaccines are recommended during pregnancy. See CIG- Immunization in pregnancy and
     breastfeeding for details.

      Inactivated Vaccines to Avoid in Pregnancy:
      Human Papillomavirus Vaccine
       Not recommended during pregnancy due to limited safety and effectiveness data.
       If a vaccine dose has inadvertently been administered during pregnancy, no intervention is
          indicated, but completion of the series should be delayed until after pregnancy.

      Recombinant Herpes Zoster Vaccine
       Should be used with caution in pregnant woman due to no data in this population (though is
         unlikely to be indicated).

  Live Attenuated Influenza Vaccine
   Due to a lack of safety data at this time, LAIV should not be administered to pregnant women
      due to the theoretical risk to the fetus from administering a live virus vaccine.
   LAIV can be administered to breastfeeding women.

  Other Live Vaccines
  Pregnancy
     In general, live vaccines are contraindicated in pregnancy, as there is a theoretical risk
      to the fetus.
          o There may be some individual cases in which the benefits outweigh the theoretical risk
              (e.g. rubella outbreak).

  Breastfeeding
   MMR and varicella vaccine should be administered to breastfeeding women if indicated.
   If herpes zoster (unlikely to be indicated in a breastfeeding woman) or typhoid vaccinations are
      required, inactivated should be used.
   Safety data are not well established for yellow fever, smallpox and BCG, which are unlikely to be
      administered in a pharmacy. See CIG - Immunization in pregnancy and breastfeeding for details.

                                                                                                   16
Q7. Have received any vaccinations in the past 4 weeks? Have plans for
travel in the upcoming 4 weeks?
   These questions are asked so that timing of vaccines can be coordinated for those:

          o who have received vaccines in the last 4 weeks; and/or
          o who may be receiving vaccines in the upcoming 4 weeks for travel (which may or not be
              known depending if travel assessment has been undertaken)

  Inactivated Influenza Vaccine and Other Inactivated Vaccines
   No precautions or concerns with inactivated vaccines in relation to timing of other vaccines.
          o Inactivated vaccines can be administered concomitantly or at any time before or after
               the administration of any other live attenuated or inactivated vaccine using different
               injection sites and separate needles and syringes.
      Exception
          o Different formulations of vaccine that protect against the same disease (e.g.
               pneumococcal vaccine, meningococcal vaccine) should not be administered
               concomitantly.

  Live Attenuated Influenza Vaccine
   Given the lack of data for immune interference, and that LAIV is not a parenteral vaccine, LAIV
      can be administered concomitantly or at any time before or after the administration of any
      other live attenuated or inactivated vaccine.

  Other Live Parenteral Vaccines
   Live vaccines given by the parenteral route may be administered concomitantly with all other
     vaccines during the same visit, using different injection sites and separate needles and syringes.
   In general, if two live parenteral vaccines are not administered concomitantly, there should be
     a period of at least 4 weeks before the second live parenteral vaccine is given. See exceptions
     below.
   If live parenteral vaccines are given too close together, the immune response to the second
     dose may be affected by the first dose and is considered invalid; the second dose should be
     repeated at the recommended interval.
   Minimum intervals for vaccine series (e.g. varicella-containing vaccines) still apply such that
     often > 4 weeks is required between doses.
      Exception
          o   Live varicella-containing vaccine should be not administered at the same time as
              smallpox vaccine; separate immunizations by at least 4 weeks.

  Other Live Oral Vaccines
   Live vaccines given by the oral route may be administered concomitantly with all other vaccines
     during the same visit or at any time before or after of the administration of any other live
     attenuated (parenteral, oral, or intranasal) or inactivated vaccine.
      Exception
         Administration of live oral typhoid vaccine and live oral cholera vaccine needs to
              be separated by at least 8 hours.

                                                                                                        17
Q8. Require a TB skin test within next 4 weeks? Ever have a positive TB
skin test?
  Inactivated Influenza Vaccine and Other Inactivated Vaccines
   No contraindications or precautions exist in those who require a TB skin test in the next 4
      weeks.
   No contraindications or precautions exist in those who have a history of a positive TB skin test.

  Live Attenuated Influenza Vaccine and Other Live Vaccines
   A false negative skin test can occur if a live vaccine such as LAIV is given BEFORE the TB skin test.
      If a live vaccine is given, wait at least 4 weeks before doing the TB skin test. All vaccines, live or
      inactivated, can be given on the same day or at any time AFTER a TB skin test.
   A positive TB test (at any time) is NOT a contraindication to LAIV.

  MMR, MMRV, Varicella, Live Herpes Zoster, and BCG Vaccines
   A positive test indicative of active, untreated TB is a contraindication for MMR (measles,
    mumps, and rubella), MMRV (measles, mumps, rubella and varicella), univalent varicella, live
    herpes zoster, and BCG (Bacille Calmette-Guerin) vaccines as a precautionary measure.

Q9. Have close contact with anyone with a weakened immune system
  Inactivated Influenza Vaccine and Other Inactivated Vaccines
   No precautions or concerns.
   Inactivated Influenza vaccination and maintaining up-to-date routine immunizations should be
      encouraged for all close contacts of anyone with a weakened immune system.

  Live Attenuated Influenza Vaccine
   Inactivated Influenza Vaccine is preferred.
   LAIV recipients should avoid close association with individuals with severe immune
      compromising conditions (e.g. bone marrow transplant recipients requiring isolation) for at least
      two weeks following vaccination, because of the theoretical risk for transmission.

  MMRV, Varicella, and Live Attenuated Herpes Zoster Vaccines
   For herpes zoster vaccination, preferably use the recombinant vaccine.
   If a vaccine recipient develops a varicella-like rash within 42 days of vaccine administration, the
    rash should be covered and the vaccinee should avoid direct contact with the
    immunocompromised individual for the duration of the rash.

                                                                                                         18
10. During the past year, have received a transfusion of blood or blood
products, or immune globulin (Ig)?
There is minimal or no interaction between blood products or Ig preparations and:
      Inactivated vaccines
      Live intranasal vaccine
      Live oral vaccines
      Bacille Calmette-Guerin (BCG) vaccine
      Yellow fever vaccine

    MMR, MMRV, Varicella, and Live Attenuated Herpes Zoster Vaccines
     Blood products and Ig may reduce effectiveness of these live vaccines if given too closely
      together.
     Refer to CIG - Blood products, human immunoglobulin and timing of immunization for details.

                                                    © 2020 medSask
No part of this work may be reproduced, distributed, or transmitted in any form or by any means unless authorized by medSask.
For copyright permission requests, please contact druginfo@usask.ca.

                                                                                                                          19
Appendix 1 – Vaccine Screening Tool and Consent Form
Patient Information
Name: (Last, First)                               Date of Birth: (YYYY-MM-DD)
Address:
Health Services Number:                           Gender:  M  F  O       Weight:
Daytime Phone Number:                             Alternate Phone Number:
Emergency Contact Information
Name:                                             Phone Number:
Screening
The following questions will help determine if a vaccine is right for you today. A “yes” to any question
does not necessarily mean you should not be vaccinated, but your pharmacist should be aware of it and
may have some additional questions for you.
Do you (or your child / dependent):
1. Feel sick today?                                                                             Yes  No
2. Have allergies to medications, food, a vaccine component, or latex?                          Yes  No
3. Ever have a serious reaction after receiving a vaccination?                                  Yes  No
4. Have any of the following medical conditions:                                                Yes  No
    bleeding problems
    asthma
    lymphatic circulation impairment (e.g. lymphedema, axillary lymph node removal
     [mastectomy, lumpectomy], amputation)
    cancer, HIV infection, other immune system disorders
5. Take any of the following medications (currently, recently):                                 Yes  No
     blood thinners (aspirin, warfarin, Eliquis®, Lixiana®, Pradaxa®, Xarelto®, etc.)

    drugs that affect immune system such as prednisone, other steroids, anticancer
   drugs, monoclonal antibodies, other biologics, and others – often for treatment of
   inflammatory conditions (e.g. rheumatoid arthritis, Crohn’s disease, psoriasis), other
   conditions, or transplant recipients

     antiviral or antibacterial drugs
6. For women: Are you pregnant or breastfeeding or is there a chance you could become
                                                                                           Yes      No
   pregnant during the next month?
7. Have received any vaccinations in the past 4 weeks? Have plans for travel in the
                                                                                           Yes      No
   upcoming 4 weeks?
8. Require a TB skin test within next 4 weeks? Ever have a positive TB skin test?          Yes      No
9. Have close contact with anyone with a weakened immune system?                           Yes      No
10. During the past year, have received a transfusion of blood or blood products, or
                                                                                           Yes      No
   immune globulin (Ig)?
             For Inactivated Influenza Vaccine see Q1-5 For Other Inactivated Vaccines see Q1-7
                                 For All Live Vaccines (incl. LAIV) see Q1-10
                  Pharmacists: see the accompanying Guide for interpretation of answers

                                                                                                     20
Declaration of Consent:
        I confirm that I have read or had explained to me the attached vaccine information sheet regarding
        the risks, benefits and potential side effects associated with the vaccine(s). I have had the
        opportunity to have my questions answered by the pharmacist and am satisfied with and
        understand the information I have been given. I consent to the pharmacist prescribing and/or
        administering vaccine(s) for myself or my child /dependent and understand the requirement for
        post-injection observation by the pharmacist for 15 minutes. I understand health information may
        be shared with another healthcare provider as necessary for care.

        ___________________________________________________                                                      __________________
        Signature of:  Vaccine Recipient  Parent /Guardian                               Proxy                Date

For Pharmacist Use Only

                                                                                                                                        Date & Time of
     Vaccine: Name, Manufacturer,                                                        Dose
                                                    Dose          Site       Route                  Pharmacist Name                        Injection
              DIN, Lot#, Expiry Date                                                      #
                                                                                                                                         (if applicable)
1.

2.

3.

4.

Adverse reaction:  No  Yes – describe reaction below                            Completed Adverse Event following Injection (AEFI) form

 Discussed publicly funded options, if applicable.
 Reported immunization to electronic provincial registry (if applicable)
 Notified primary care practitioner: Name                                                                   Fax #
 If vaccination series, appointment date for next injection:
              No part of this work may be reproduced, distributed, or transmitted in any form or by any means unless authorized by medSask.
                                           For copyright permission requests, please contact druginfo@usask.ca.

                                                                                                                                              21
Appendix 2 – References and Recommended Resources

Saskatchewan Immunization Manual, especially:
     Chapter 6 – Contraindications and Precautions
     Chapter 7 – Immunization of Special Populations
     Chapter 8 – Administration of Biological Products
     Chapter 10 – Biological Products
     Chapter 11 – Adverse Events Following Immunization
     Chapter 12 – Anaphylaxis Management

Canadian Immunization Guide, especially:
      Vaccine Administration Practices
      Timing of Vaccine Administration
      Blood Products, Human Immunoglobulin and Timing of Immunization
      Contents of Immunizing Agents for Use in Canada
      Contraindications, Precautions and Concerns
      Early Vaccine Reactions Including Anaphylaxis
      Immunization in Pregnancy and Breastfeeding
      Immunization of Persons with Chronic Diseases
      Immunization of Immunocompromised Persons
      Immunization of Travellers
      Active Vaccines – monographs of the vaccines

Saskatchewan College of Pharmacy Professionals
      Sep 2020 MicroSCOPe – Special Edition: Preparing for Flu Season

Drug Plan and Extended Benefits Branch
      Seasonal Influenza Immunization Program

Pharmacy Association of Saskatchewan
      Influenza Immunization Program

                                                                         22
Appendix 3 – Documentation Requirements
As set out in PART L – Pharmacist Authority: Administration of Drugs by Injection and Other Routes of
The Regulatory Bylaws of the Saskatchewan College of Pharmacy Professionals

Reporting

6. A licensed pharmacist who administers a drug to a patient must report the details of the
administration (which may include personal health information as that term is defined in The
Health Information Protection Act) as follows:
             a) report all Schedule II drug administration to the patient’s primary care provider in
                accordance with Council policy; and
             b) report all vaccinations to the immunization reporting or record keeping system,
                electronic or otherwise, designated by the minister of Health for vaccines. The report
                must be in the form and be provided in the timeframe that the minister requires.

Record Keeping

7. A licensed pharmacist who administers a drug to a patient must make and retain a record in the
pharmacy of the following:
             a) the patient’s name and address;
             b) the name of the drug and total dose administered;
             c) for an advanced method or vaccination by any method, identification of the
                manufacturer, lot number and expiry date of the drug;
             d) for an advanced method, the route of administration, dosage and the location on the
                body where the drug was administered;
             e) the name of the licensed pharmacist administering the drug;
             f) the date and the time of administration;
             g) any adverse events; and
             h) the price, if there is a charge for administration.

See Appendix 1 for a form that meets these requirements.

Notification for Children Five to Eight Years of Age

       A Notification of Administration of Influenza Vaccine form for each child five to eight years of
        age must be completed and sent to the Drug Plan and Extended Benefits Branch within three
        business days of vaccine administration. The form can be found at the Seasonal Influenza
        Immunization Program.

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