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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

CIG = the Canadian Immunization Guide

IIV = inactivated influenza vaccine

LAIV = live attenuated influenza vaccine (FluMist®)

MMR = measles, mumps, rubella

MMRV = measles, mumps, rubella, varicella

SIM = the Saskatchewan Immunization Manual

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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

Hint: For easier navigation, open the Bookmarks Panel

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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) <10,000 copies/mL (measured within 100 days

before administration of LAIV).

Adults: LAIV is contraindicated in adults with HIV infection due to the lack of evidence for its immunogenicity and safety in this population, and given that LAIV may be less effective than IIV in adults.

Other Live Vaccines

If available, use an inactivated form of the antigen (e.g. herpes zoster, typhoid).

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. While some live vaccines may be appropriate, the risks and benefits need to be carefully considered in consultation with an infectious disease specialist/immunologist.

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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 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.

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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.

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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.

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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.

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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.

20

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: bleeding problems asthma lymphatic circulation impairment (e.g. lymphedema, axillary lymph node removal [mastectomy, lumpectomy], amputation) cancer, HIV infection, other immune system disorders

Yes No

5. Take any of the following medications (currently, recently): 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

Yes No

6. For women: Are you pregnant or breastfeeding or is there a chance you could become pregnant during the next month?

Yes No

7. Have received any vaccinations in the past 4 weeks? Have plans for travel in the upcoming 4 weeks?

Yes No

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 immune globulin (Ig)?

Yes No

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

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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

Vaccine: Name, Manufacturer, DIN, Lot#, Expiry Date

Dose Site Route Dose

# Pharmacist Name

Date & Time of Injection

(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.

22

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

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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.