Immunizations & Injections (Final) Flashcards
this is the maximum ability of a vaccine to produce a desired effect
efficacy
this is the ability of a vaccine to produce the desired beneficial effects under real world circumstances
effectiveness
the inherent ability of an antigen to induce a humeral and/or cell-medication immune response
immunogenicity
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
Health Canadas Biologics and Genetics Therapies Directorate (BGTD)
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
true
If a vaccine is approved by Health Canada, what two things will be issued?
A Notice of Compliance and a Drug Identification Number (DIN)
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
passive surveillance / spontaneous surveillance
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
active surveillance
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)
vaccine effectiveness studies
this is a method used to monitor safety an effectiveness of vaccines;
continuously monitors adverse effects
post-marketing surveillance
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)
pharmacovigilance activities
what are some things that can be learned from post-marketing studies and surveillance?
- 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
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
health Canada (plays a big role)
the role of this stakeholder in post-marketing surveillance includes
- collates, reviews, analyzes and communicates national level AEFI report data
public health agency of canada
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
vaccine manufacturers
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
Canadian health jurisdictions immunization programs (e.g. provincial/territorial health departments)
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
vaccine providers (us!)
the role of this stakeholder in post-marketing surveillance includes:
- report any adverse effects following vaccination
- educate themselves and make informed decisions about vaccination
vaccine recipients/caregivers
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
adverse events following immunization (AEFI)
what type of AEFI should be reported?
- 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
how are AEFI reported?
- complete the form
- send the form to the local health unit (in NL: population health branch, disease control division)
what are the 5 steps for introducing publicly funded vaccines
- vaccine recommendation
- review recommendation by provincial/territorial advisory committee
- negotiation and funding
- implementation and delivery
- monitoring and evaluation
what is the main immunization registry in NL that stores immunization information from 2003 onward
HEALTHeNL
- those who have received immunizations before 2003 can request a certified copy of their immunization record can contact their regional health authority
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
immunization schedules
true or false: multiple vaccines cannot be given to an individual at the same time because it will overload the immune system
false
true or false: it is better to get natural immunity then to get an immunization
false - better to get immunization because don’t have the risks that come with actually getting sick
true or false: there is at least 10 times more formaldehyde naturally circulating in an infants body than in a vaccine
true
pharmacists in NL can administer COVID/influenza vaccines to children and adults of this age by injection or inhalation
2 years old or older
pharmacists in NL can administer any injectable medication to children and adults of this age
5 years old or older
what are the three routes pharmacists in NL can administer vaccines
IM, SC or intranasally
a pharmacists in NL should not administer a vaccine to who?
- family member or close friend
- a person with a history of an adverse reaction to related inhalations or injections
what credentials to an individual in NL need in order to be injection certified?
- 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
true or false: pharmacists in NL can administer a drug or other substance used for cosmetic purposes
false
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
true - e.g. twinrix
true or false: pharmacists in NL can prescribe schedule I, II, III or unscheduled drugs for a preventable disease
true
what are some examples of preventable diseases that pharmacists can prescribe for in NL
- 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)
what are some vaccines that are available through public health
- 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
why is it important to store vaccines correctly?
- loss in potency
- cause wastage
- decrease cost to pharmacy and healthcare system
- reduce adverse effects
true or false: bar fridges or domestic fridges can be used to store vaccines
false
- if a domestic fridge is being used it needs to be modified to meet the NLPB standards of practice regarding the cold chain
true or false: NLPB standards of practice require refrigerators to maintain the internal temperature regardless of the external temperature
true
true or false: other items that are not considered pharmaceutical products can be kept in these refrigerators
false
true or false: NLPB standards of practice requires refrigerators to be stored in the dispensary or a secure area (away from public access)
true
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
true
this is the process used to maintain optimal storage conditions during transportation of tempertaure-sensitive products.
the cold chain
what is the temperature that refrigerated products should be kept at
2-8ºC
frozen products should be kept at ___ or lower
-15ºC
true or false: when maintaining the cold chain, you can use breathable plastic mesh baskets and label the baskets clearly in the refrigerator
true
true or false: when maintaining the cold chain, vaccines should be kept in their original boxes in the refrigerator
true
true or false: when maintaining the cold chain, food and drink can be stored in the refrigerator
false
true or false: when maintaining the cold chain, the temperature of the refrigerator should be checked and logged twice a day
true
true or false: when maintaining the cold chain, vaccines can be placed in drawers or on the floor of the refrigerator
false! no air flow
true or false: when maintaining the cold chain, vaccines can be placed in solid plastic trays or containers in the refrigerator
false
true or false: when maintaining the cold chain, baskets should be spaced 5-8cm from the walls of the refrigerator and other baskets
true
true or false: when maintaining the cold chain, the temperature should be kept at 0ºC
false - between 2-8
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
break in the cold chain
how should a break in the cold chain be managed?
- 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
true or false: all breaks in the cold chain result in product spoilage
false
what are some pharmacological options for reducing pain for injections
topical anesthetic (lidocaine, prilocaine) apply 30-60 mins prior to injection
*avoid analgesics or ice before injection
what should be considered for patient assessment before giving an injection
- 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)
what are some contraindications and precautions that should be assessed for before giving injections
- 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
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
false
true or false: inactivated vaccines are considered safe in pregnancy
true
true or false: most live vaccines are contraindicated or not recommended in pregnancy
true
true or false: most live vaccines are contraindicated or not recommneded in breastfeeding
false - some live vaccines may be contraindicated
true or false: there are no contraindications to administration in patients undergoing long-term anticoagulation
true
true or false: patients should hold their anti-coagulant pre-administration
false - not necessary
true or false: immunize prior to any planned immunosuppression (if possible)
true
true or false: live vaccines should be avoided in severely immunocompromised patients
true
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
informed consent
according to NLPB’s standards of practice, what needs to be provided to the patient before obtaining informed consent
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
what are some local reactions that may occur following immunization
- pain, redness, swelling at the injection site
- nodules, cellulitis, abscess
what are the five rights of product administration
- right patient - verify pt identity + pt assessment
- right product - 3 checks
- right time - vaccine schedule/interval
- right dose - look at resources
- right route - injection site, needle length + gauge
what are some systemic reactions that may occur following immunization
- fever
- rash
- vomiting/diarrhea
- oculo-respiratory syndrome
- fainting
- anaphylaxis
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
fainting (vasovagal syncope)
true or false: if a patient faints and is unconscious for > 2-3 minutes, anaphylaxis tx should be started
true
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
anaphylaxis
this stage of anaphylaxis is accompanied by itchy, watery eyes, sneezing and rhinorrhea, tachycardia, nausea and apprehension
early
this stage of anaphylaxis is accompanied by urticaria, upper airway edema, wheezing, coughing, sob, hypotension, vomitting and anxiety
mild
this stage of anaphylaxis is accompanied by urticaria, angioedema, pallor, cyanosis, hoarseness, stridor, bronchospasm, shock, diarrhea, coma
late
true or false: epinephrine can be given in the same site and the vaccine was administered
false - this should not be done
how often can epinephrine be repeated if a patient continues to have an anaphylactic reaction
repeat q 5-15 mins as needed to a max of THREE doses
what other medication besides epinephrine is required to be in anaphylaxis kit according to NLPB
diphenhydramine (Benadryl) Oral and IM
what are the five moments for hand hydgiene
- before touching a patient
- before clean/aseptic procedure
- after body fluid exposure risk
- after touching a patient
- after touching patient surroundings
what should be checked in regards to the product before administration
- 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
what parts of syringe need to be kept sterile at all times
tip/needle adapter and the plunger rod that goes inside the barrell
what is the recommended syringe size for IM and SC injections
1ml or 3ml depending on the volume of the dose given
what is the MAXIMUM volume that can be administered IM
5-18 years: 1 mL and over 19 is 2 mL
note: highest you usually see in any age is 1mL
what is the MAXIMUM volume that can be administered SC
maximum recommended volume is 1.5mL. if necessary, can administer up to 4 mL
what needle gauge is used for SC injections for all ages
25
what needle length is used for SC injections for all ages
1/2 inch
what needle gauge is used for IM injections for all ages
22-25
what needle length is used for IM injection in adults > 12
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
what needle length is used for IM injection in children aged 3-12 years
1/2 inch to 1 inch
true or false: 5/8” needle is an appropriate length for all ages when administering a subcutaneous injection
true
true or false: a needle should NEVER be recapped after it has been used to administer a medication
true
what method should be used if a needle is being recapped after drawing up the medication
one hand scoop method
true or false: a sharps container should be placed to the side of your non-dominant arm
false - should be placed next to dominant arm that you are injecting the patient with
true or false: if a needle stick injury occurs, the site should be watched gently with soap and water
true
true or false: if a needle stick injury occurs, the site should be rinsed with bleach
false
true or false: if a needle stick injury occurs, the site should be squeezed to get any dirt out
false
true or false: if a needle stick injury occurs, you should let the wound bleed freely then apply a bandaid
true
true or false: gloves are required for giving injections
not universally required - based on personal preference or warokplace policy
*recommended if provider has open lesions on their hand
