Immunizations & Injections (Final)

Question 1

this is the maximum ability of a vaccine to produce a desired effect

Answer 1

efficacy

Question 2

this is the ability of a vaccine to produce the desired beneficial effects under real world circumstances

Answer 2

effectiveness

Question 3

the inherent ability of an antigen to induce a humeral and/or cell-medication immune response

Answer 3

immunogenicity

Question 4

this is the group/body that regulates biologic drugs (including vaccines) for use in Canada; they also determine whether the vaccine is complaint with Canada’s Food and Drugs Act Regulations

Answer 4

Health Canadas Biologics and Genetics Therapies Directorate (BGTD)

Question 5

true or false: before a vaccine is eligible to be marketed in Canada, manufacturers must submit information and data about a vaccines safety, efficacy and quality

Answer 5

true

Question 6

If a vaccine is approved by Health Canada, what two things will be issued?

Answer 6

A Notice of Compliance and a Drug Identification Number (DIN)

Question 7

this is a method used to monitor safety an effectiveness of vaccines; information about the vaccine may arise when nobody is actively looking for a problem

Answer 7

passive surveillance / spontaneous surveillance

Question 8

this is a method used to monitor safety an effectiveness of vaccines; proactively looking for information about a vaccine (e.g. adverse effect). programs in Canada include IMPACT and CANVA

Answer 8

active surveillance

Question 9

this is a method used to monitor safety an effectiveness of vaccines;
investigates effectiveness, especially in patient demographics who weren’t included in the study (e.g. patients with chronic disease)

Answer 9

vaccine effectiveness studies

Question 10

this is a method used to monitor safety an effectiveness of vaccines;
continuously monitors adverse effects

Answer 10

post-marketing surveillance

Question 11

this is a method used to monitor safety an effectiveness of vaccines; examples of this include quality monitoring (take a sample from each lot and make sure its up to standard) and safety release activities (Canadian invigilence program)

Answer 11

pharmacovigilance activities

Question 12

what are some things that can be learned from post-marketing studies and surveillance?

Answer 12

• detect rare or unexpected a/e that may not have been seen in clinical trials/pre-market
• provide information of effectiveness
• evaluate impact on target disease
• monitor vaccine coverage and uptake
• inform vaccine-related policies

Question 13

the role of this stakeholder in post-marketing surveillance includes
- reviews/approves post-marketing product changes submitted by vaccine manufactureres
- vaccine lot release program
- collects suspected adverse reaction reports from market authorization holders
- reviews safety data submitted by market authorization holders
- conduct risk/benefit assessments
- issue risk communications if necessary

Answer 13

health Canada (plays a big role)

Question 14

the role of this stakeholder in post-marketing surveillance includes
- collates, reviews, analyzes and communicates national level AEFI report data

Answer 14

public health agency of canada

Question 15

the role of this stakeholder in post-marketing surveillance includes
- conduct post-market studies to monitor the safety of vaccines (and make changes if necessary)
- preparation of annual summary reports

Answer 15

vaccine manufacturers

Question 16

the role of this stakeholder in post-marketing surveillance incudes
- AEFI (adverse events following immunization) surveillance
- collates, reviews, analyzes and communicates jurisdictional level AEFI report data to PHAC (public health agency of Canada)
- vaccine safety signal detection/investiagtion
- monitor vaccine coverage and uptake within their jurisdiction

Answer 16

Canadian health jurisdictions immunization programs (e.g. provincial/territorial health departments)

Question 17

the role of this stakeholder in post-marketing surveillance includes:
- administer vaccines safety and effectively
- report any adverse effects following vaccination
- educate patients and caregivers on vaccination

Answer 17

vaccine providers (us!)

Question 18

the role of this stakeholder in post-marketing surveillance includes:
- report any adverse effects following vaccination
- educate themselves and make informed decisions about vaccination

Answer 18

vaccine recipients/caregivers

Question 19

this is any untoward medical occurrence which follows administration of an active immunizing agent and which does not necessarily have a casual relationship with the use of vaccine

Answer 19

adverse events following immunization (AEFI)

Question 20

what type of AEFI should be reported?

Answer 20

• serious events: life threatening, results in death, results in hospitalization, prolongs an existing hospitalization, causes persistent or significant disability or is associated with congenital malformation
• unexpected or unusual events
• events requiring urgent medical attention

Question 21

how are AEFI reported?

Answer 21

• complete the form
• send the form to the local health unit (in NL: population health branch, disease control division)

Question 22

what are the 5 steps for introducing publicly funded vaccines

Answer 22

1. vaccine recommendation
2. review recommendation by provincial/territorial advisory committee
3. negotiation and funding
4. implementation and delivery
5. monitoring and evaluation

Question 23

what is the main immunization registry in NL that stores immunization information from 2003 onward

Answer 23

HEALTHeNL
- those who have received immunizations before 2003 can request a certified copy of their immunization record can contact their regional health authority

Question 24

the purpose of this is to aim to optimize the immune response while also taking into consideration different factors that can affect vaccine safety and efficacy (e.g. age, underlying health conditions, previous vaccine history, potential interactions with other vaccines or medications). these may vary with regards to number of doses required, timing of doses and recommended age groups for vaccinations

Answer 24

immunization schedules

Question 25

true or false: multiple vaccines cannot be given to an individual at the same time because it will overload the immune system

Answer 25

false

Question 26

true or false: it is better to get natural immunity then to get an immunization

Answer 26

false - better to get immunization because don't have the risks that come with actually getting sick

Question 27

true or false: there is at least 10 times more formaldehyde naturally circulating in an infants body than in a vaccine

Answer 27

true

Question 28

pharmacists in NL can administer COVID/influenza vaccines to children and adults of this age by injection or inhalation

Answer 28

2 years old or older

Question 29

pharmacists in NL can administer any injectable medication to children and adults of this age

Answer 29

5 years old or older

Question 30

what are the three routes pharmacists in NL can administer vaccines

Answer 30

IM, SC or intranasally

Question 31

a pharmacists in NL should not administer a vaccine to who?

Answer 31

- family member or close friend - a person with a history of an adverse reaction to related inhalations or injections

Question 32

what credentials to an individual in NL need in order to be injection certified?

Answer 32

- completion of education or training (CCCEP stage 2 accredited program within 1 year of application date or CCAPP accredited pharmacy program) - first aid/CPR - apply to NLPB

Question 33

true or false: pharmacists in NL can administer a drug or other substance used for cosmetic purposes

Answer 33

false

Question 34

true or false: pharmacists in NL can administer a schedule I inhalation or injection where it has been prescribed by an authorized prescriber, including an authorized pharmacist

Answer 34

true - e.g. twinrix

Question 35

true or false: pharmacists in NL can prescribe schedule I, II, III or unscheduled drugs for a preventable disease

Answer 35

true

Question 36

what are some examples of preventable diseases that pharmacists can prescribe for in NL

Answer 36

- cholera (oral, inactivated vaccine for travellers diarrhea prophylaxis -> Dukoral) - diphtheria - H. Influenzar Type B - hep A - hep B - herpes zoster (shingles) - human papillomavirus - influenza - meases - meningococcus - mumps - pertussis - pneumococcus - poliomyelitis - rotavirus - rubella - tetanus - varicella zoster (chicken pox)

Question 37

what are some vaccines that are available through public health

Answer 37

- diphtheria and tetanus q 10 years - shingles: 1 or 2 doses starting at age 50 - influenza: annually - pertussis (whooping cough): 1 dose as an adult and during each pregnancy - pneumococcal: 1 dose at 65 years of age or older

Question 38

why is it important to store vaccines correctly?

Answer 38

- loss in potency - cause wastage - decrease cost to pharmacy and healthcare system - reduce adverse effects

Question 39

true or false: bar fridges or domestic fridges can be used to store vaccines

Answer 39

false - if a domestic fridge is being used it needs to be modified to meet the NLPB standards of practice regarding the cold chain

Question 40

true or false: NLPB standards of practice require refrigerators to maintain the internal temperature regardless of the external temperature

Answer 40

true

Question 41

true or false: other items that are not considered pharmaceutical products can be kept in these refrigerators

Answer 41

false

Question 42

true or false: NLPB standards of practice requires refrigerators to be stored in the dispensary or a secure area (away from public access)

Answer 42

true

Question 43

true or false: NLPB standards of practice requires refrigerators to have either a continuous temperature monitor or a "min/max" thermometer that can be read from outside the unit

Answer 43

true

Question 44

this is the process used to maintain optimal storage conditions during transportation of tempertaure-sensitive products.

Answer 44

the cold chain

Question 45

what is the temperature that refrigerated products should be kept at

Answer 45

2-8ºC

Question 46

frozen products should be kept at ___ or lower

Answer 46

-15ºC

Question 47

true or false: when maintaining the cold chain, you can use breathable plastic mesh baskets and label the baskets clearly in the refrigerator

Answer 47

true

Question 48

true or false: when maintaining the cold chain, vaccines should be kept in their original boxes in the refrigerator

Answer 48

true

Question 49

true or false: when maintaining the cold chain, food and drink can be stored in the refrigerator

Answer 49

false

Question 50

true or false: when maintaining the cold chain, the temperature of the refrigerator should be checked and logged twice a day

Answer 50

true

Question 51

true or false: when maintaining the cold chain, vaccines can be placed in drawers or on the floor of the refrigerator

Answer 51

false! no air flow

Question 52

true or false: when maintaining the cold chain, vaccines can be placed in solid plastic trays or containers in the refrigerator

Answer 52

false

Question 53

true or false: when maintaining the cold chain, baskets should be spaced 5-8cm from the walls of the refrigerator and other baskets

Answer 53

true

Question 54

true or false: when maintaining the cold chain, the temperature should be kept at 0ºC

Answer 54

false - between 2-8

Question 55

this occurs when temperature sensitive products are exposed to temperatures outside the recommended range. this can occur during transport or storage. possible causes include: - power outage - equipment failure - issues with handling - vaccine left out at room temp - refrigerator door left open

Answer 55

break in the cold chain

Question 56

how should a break in the cold chain be managed?

Answer 56

- all affected products should be put together and quarantine them within a functional storage unit or cooler, labelling them with a "qauarantine" sign and the date not which the break in the cold chain occurred - investigate the break in the cold chain - document the event - look at public heath and/or vaccine manufacturer/supplier to see how to proceed

Question 57

true or false: all breaks in the cold chain result in product spoilage

Answer 57

false

Question 58

what are some pharmacological options for reducing pain for injections

Answer 58

topical anesthetic (lidocaine, prilocaine) apply 30-60 mins prior to injection *avoid analgesics or ice before injection

Question 59

what should be considered for patient assessment before giving an injection

Answer 59

- age/weight (for epinephrine) - allergies/intolerances - pregnancy/BF - current list of meds (including OTCs) - comorbidities - receipt of blood transfusions/blood products - immunization status - past reactions to injections/vaccines - does the patient have an indication for the medication to be injected? - does the patient have any precautions or contraindications to the drug product? - are there any other individual circumstances that need to be taken into consideration (e.g. practical needs, values, beliefs, anxiety, stress)

Question 60

what are some contraindications and precautions that should be assessed for before giving injections

Answer 60

- allergies: do not immunize if the patient has an immediate or anaphylactic allergy to any comonpenent of the vaccine; if a patient has a non-anaphylactic reaction, referral to physician may be warranted - acute illness: mild illnesses do not increase the risk of AE following vaccinations or interfere with the immune response. if a pt has a moderate/severe acute illness, the benefits and risk of immunization must be assessed. - pregnancy: most live vaccines are contraindicated or not recommended. - breastfeeding: some live vaccines can be contraindicated - anticoagulation and coagulation disorders: control of bleeding disorders should be optimized prior to vaccinations; consider using a smaller needle diameters and apply direct pressure over the site for at least 2 minutes - immunocompromised: a patients susceptibility to an infection may vary according to the degree of immune suppression (the goal is to maximize benefit while minimizing harm); immune at a time when the maximum immune response is expected - elderly patients: many have muscle atrophy + their skin is more fragile and less elastic

Question 61

true or false: an egg allergy is not a contraindication or precaution to influenza, measles-mumps-rubella (MMR), measles-mumps-rubella-varicella (MMRV), or imvamune small pox vaccine

Answer 61

false

Question 62

true or false: inactivated vaccines are considered safe in pregnancy

Answer 62

true

Question 63

true or false: most live vaccines are contraindicated or not recommended in pregnancy

Answer 63

true

Question 64

true or false: most live vaccines are contraindicated or not recommneded in breastfeeding

Answer 64

false - some live vaccines may be contraindicated

Question 65

true or false: there are no contraindications to administration in patients undergoing long-term anticoagulation

Answer 65

true

Question 66

true or false: patients should hold their anti-coagulant pre-administration

Answer 66

false - not necessary

Question 67

true or false: immunize prior to any planned immunosuppression (if possible)

Answer 67

true

Question 68

true or false: live vaccines should be avoided in severely immunocompromised patients

Answer 68

true

Question 69

this is the voluntary agreement of an individual, parent/guardian, or a substitute decision maker to immunization after meeting the elements of the informed consent process

Answer 69

informed consent

Question 70

according to NLPB's standards of practice, what needs to be provided to the patient before obtaining informed consent

Answer 70

informed consent should be obtained directly from the patient, unless its considered appropriate for someone else to speak on their behalf information such as the following should be provided to the patient: - the drug therapy being administered - the purpose, expected benefits and the risks of drug thereapy - the expected reaction/response and related timeline - common and rare s/e - rationale for the requires observation period following injection - any other monitoring/follow uo - details of planned communications

Question 71

what are some local reactions that may occur following immunization

Answer 71

- pain, redness, swelling at the injection site - nodules, cellulitis, abscess

Question 72

what are the five rights of product administration

Answer 72

1. right patient - verify pt identity + pt assessment 2. right product - 3 checks 3. right time - vaccine schedule/interval 4. right dose - look at resources 5. right route - injection site, needle length + gauge

Question 73

what are some systemic reactions that may occur following immunization

Answer 73

- fever - rash - vomiting/diarrhea - oculo-respiratory syndrome - fainting - anaphylaxis

Question 74

this is sudden, temporary unconcoisuness caused by a decreased blood supply to the brain due to pain stimuli or emotional reaction. usually occurs at the time or sooner after injection. accompanied by pallor, sweating, cold clammy skin, light-headedness, nausea before occurring

Answer 74

fainting (vasovagal syncope)

Question 75

true or false: if a patient faints and is unconscious for > 2-3 minutes, anaphylaxis tx should be started

Answer 75

true

Question 76

this is an acute, systemic & potentially fatal allergic reaction. usually occurs between 5-30 mins post-injecting. can have a recurrence after 2-9hr asymptomatic period

Answer 76

anaphylaxis

Question 77

this stage of anaphylaxis is accompanied by itchy, watery eyes, sneezing and rhinorrhea, tachycardia, nausea and apprehension

Answer 77

early

Question 78

this stage of anaphylaxis is accompanied by urticaria, upper airway edema, wheezing, coughing, sob, hypotension, vomitting and anxiety

Answer 78

mild

Question 79

this stage of anaphylaxis is accompanied by urticaria, angioedema, pallor, cyanosis, hoarseness, stridor, bronchospasm, shock, diarrhea, coma

Answer 79

late

Question 80

true or false: epinephrine can be given in the same site and the vaccine was administered

Answer 80

false - this should not be done

Question 81

how often can epinephrine be repeated if a patient continues to have an anaphylactic reaction

Answer 81

repeat q 5-15 mins as needed to a max of THREE doses

Question 82

what other medication besides epinephrine is required to be in anaphylaxis kit according to NLPB

Answer 82

diphenhydramine (Benadryl) Oral and IM

Question 83

what are the five moments for hand hydgiene

Answer 83

1. before touching a patient 2. before clean/aseptic procedure 3. after body fluid exposure risk 4. after touching a patient 5. after touching patient surroundings

Question 84

what should be checked in regards to the product before administration

Answer 84

- correct product has been selected (check 3 times: when removing from fridge, when drawing up or reconstituting and immediately prior to administration) - correct formulation has been selected (e.g. adults vs peds) - any irregularities or abnormalities in the products appearance - product is not expired - the date the vial was opened if using multi dose vial

Question 85

what parts of syringe need to be kept sterile at all times

Answer 85

tip/needle adapter and the plunger rod that goes inside the barrell

Question 86

what is the recommended syringe size for IM and SC injections

Answer 86

1ml or 3ml depending on the volume of the dose given

Question 87

what is the MAXIMUM volume that can be administered IM

Answer 87

5-18 years: 1 mL and over 19 is 2 mL note: highest you usually see in any age is 1mL

Question 88

what is the MAXIMUM volume that can be administered SC

Answer 88

maximum recommended volume is 1.5mL. if necessary, can administer up to 4 mL

Question 89

what needle gauge is used for SC injections for all ages

Answer 89

25

Question 90

what needle length is used for SC injections for all ages

Answer 90

1/2 inch

Question 91

what needle gauge is used for IM injections for all ages

Answer 91

22-25

Question 92

what needle length is used for IM injection in adults > 12

Answer 92

patients weighing < 130 lbs: 5/8 inch to 1 inch males 130-260 lbs & females 130 - 200 lbs: 1 inch males >260 lbs & females > 200 lbs: 1 & 1/2 inch

Question 92

what needle length is used for IM injection in children aged 3-12 years

Answer 92

1/2 inch to 1 inch

Question 93

true or false: 5/8" needle is an appropriate length for all ages when administering a subcutaneous injection

Answer 93

true

Question 94

true or false: a needle should NEVER be recapped after it has been used to administer a medication

Answer 94

true

Question 95

what method should be used if a needle is being recapped after drawing up the medication

Answer 95

one hand scoop method

Question 96

true or false: a sharps container should be placed to the side of your non-dominant arm

Answer 96

false - should be placed next to dominant arm that you are injecting the patient with

Question 97

true or false: if a needle stick injury occurs, the site should be watched gently with soap and water

Answer 97

true

Question 98

true or false: if a needle stick injury occurs, the site should be rinsed with bleach

Answer 98

false

Question 99

true or false: if a needle stick injury occurs, the site should be squeezed to get any dirt out

Answer 99

false

Question 100

true or false: if a needle stick injury occurs, you should let the wound bleed freely then apply a bandaid

Answer 100

true

Question 101

true or false: gloves are required for giving injections

Answer 101

not universally required - based on personal preference or warokplace policy *recommended if provider has open lesions on their hand