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