Injections I

efficacy

the maximum ability of a vaccine to produce a desired effect

effectiveness

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

immunogenecity

the inherent ability of an antigen to induce a humoral and/or cell mediated immune response

who approves biologic drugs (including vaccines) in Canada

Health Canada’s biologics and Genetics Therapies Directorate (BGTD)

before a vaccine is elgible to be marketed in Canada, manufacturers must submit info and data about a vaccine’s ____________

safety, efficacy, quality

if a vaccine is approved, health canada will issue a __________

notice of compliance and drug identification number (DIN)

methods used to monitor vaccine safety and effectiveness

passive surveillance

active surveillance

vaccine effectiveness studies

post marketing surveillance

pharmacovigilance activities

what can be learned from post marketing studies and surveillance

detect rare or unexpected AE

provide info on effectiveness

evaluate impact on target disease

monitor vaccine coverage and uptake

inform vaccine related policies

list the stakeholders involved in post marketing surveillance

Health Canada

Public Health Agency of Canada

Vaccine Manufacturers

Canadian health jurisdictions immunization programs (ex: provincial/territorial health departments)

Vaccine providers

Vaccine recipients/caregivers

Health Canada’s role in post marketing surveillance

reviews/approves post marketing product changes submitted by vaccine manufacturers

vaccine lot release program

collects suspected AE reports from market authorization holders

conduct risk-benefit assessment

issue risk communications if necessary

Public Health Agency of Canada’s role in post marketing surveillance

collates, reviews, analyzes and communicates national AEFI report data

vaccine manufacturers role in post marketing surveillance

conduct post market studies to monitor the safety of vaccines (and make changes if necessary)

preparation of annual summary reports

Canadian health jurisdictions immunization programs role in post marketing surveillance

AEFI surveillance

collates, reviews, analyzes and communicates jurisdictional AEFI report data to PHAC

vaccine safety signal detection/investigation

monitor vaccine coverage and uptake within their jurisdiction

vaccine providers role in post marketing surveillance

administer vaccines safely and effectively

report any AE following vaccination

educate pts and caregivers about vaccination

vaccine recipients/caregivers role in post marketing surveillance

report any AE following vaccination

educate themselves and make informed decisions about vaccination

definition of adverse events following immunization (AEFI)

any untoward medical occurence which follows administration of an active immunizing agent which does not necessarily have a causal relationship with the use of a vaccine

which types of AEFI should be reported

serious events; life threatining or results in death, hospitilization, prolongs a hospitalization, causes persistent or significant disability/incapacity, or is associated with congenital malformation

unexpected or unusual events

events requiring urgent medical attention

how to report AEFI

complete AEFI form

• include as many details as possible (info ab the immunizing agent, details of ae, impact and level of care obtained as a result, outcome of ae at the time the report is made)

send form to local health unit in your province/terittory

• in NL: Population Health Branch, Disease Control Division

process for introducing publicly funded vaccines

1. vaccine recommendation

2. review by provinical advisory committee

3. negotiation and funding

4. implementation and delivery

5. monitoring and evaluation

status of immunization registries in NL

electronic health record (HEALTHeNL)- only stores immunization info from 2003 onward, other injections like vit b12 etc not recorded

those in NL who received immunizations before 2003 can request a copy thru their regional health authority

whats the point of immunization schedules

aim to optimize the immune repsonse, while also taking into consideration different factors that can affect vaccine safety and efficacy

ex: age, underlying health conditions, previous vaccine history, potential interactions with other vaccines or meds

beneficence

act in the best interest of your patients and promote their well being

non maleficence

first do no harm

justice

emphasizes a fair, equitable and appropriate treatment of patients

autonomy

an individuals right to make their own decisions and choices, based on their personal values and beliefd

communication methods to provide info regarding immunizations

embrace a recipient centered approach

respect differences of opinion

present benefits and risks fairly and equally

clearly communicate knowledge using an evidence based approach

5C’s model of vaccine hesitancy

confidence

complacency

convenience

calculation

collective responsibility

3 factors influencing perspective on immunizations

contextual influences: arise from historic, sociocultural, environmental, health system/institutional, economic, or political factors

ex: media, messaging from leaders, religion/culture, socio economic influences, political or policy influences

individual/group influences: arise from personal perception of vaccines or from the social/peer environment

ex: personal or family/community member experiences with vaccination, beliefs or attitudes, knowledge and awareness, perceived risk vs benefit

vaccination influences: specific issues that are related directly to vaccination

ex: introduction of a new vaccine or new info for an existing vaccine, mode of administration, method of delivery, reliabiltiy/source of vaccine, vaccine schedule, costs.

strategies for addressing vaccine hesitancy

recognize the role HCPs play in the decision making process

build trust

start early

use a presumptive statement

use motivational interviewing techniques

keep messages short and simple

address pain head on

focus on protection of the individual and community

remind parents that community immunity does not guarentee personal protection

use visual aids

tell stories

pharmacist scope in canada for administering vaccines

children and adults >/= 6mo

influenza vaccine ± other vaccines ± other injectable meds (vit b12)

intramuscular and subcutaneous ± intranasal, subdermal, intravenous

pharmacist scope in NL for administering vaccines

children and adults >/= 2 years of age

>/=2 for covid and influenzae

>/=5 for all other injectable meds

IM, Subq, intranasal

should not administer to a family member or close friend, or a person with a history of adverse reaction to related inhalations/injections

studnet requirements for injecting

registered with NLBP (+ professional liability insurance

completed injection and education training

have first aid and cpr certification as outlines by NLPB

inject under direct supervision of a pharmacist who is authorized to provide injections

provincial and territorial publicly funded vaccines for health adults

diphteria and tetanus every 10yr

shingles 1-2 doses starting age 50

influenza annualy

pertussis 1 dose as an adult and during each pregnancy

pneumococcal 1 dose at age 65+