Adverse drug reactions Flashcards
what is an adverse drug reactions?
a response to a medicinal product which is noxious or unintedned and includes advers reactions which arise from
the use within marketing authroisiation
outside mearketing authroisiation- overdose, misuse, abuse
occupational expsoyre
what is an adverse event and how is it different to an ADR
adverse event is any undesibrale patient outcome while a patient is taking a medicine but may not necessarily be caused by medcine
so all ADR are adverse events- byt not all Adverse events are ADRs
what is the impact of ADRs
cost
increase in morbdiidty and mortality
impact on workload
ADRs have affect on compliance (in life/death ilnnes patients more accepting of tolerating ADRs wkth medicnes- chemo)
what are some key risk factos for ADRs
hepatic or relay inmpairment
age (4x more likely- increase in polypahrmy, lower clearance), eldery and neonates (immature renala dn liver function)
genetic populations
allergy
compliacne issue s
medicines
Prescribers
what does ABCDE classifcation stand for?
type A- augmented
type B- bizzare
type C- crhonic
type D- delayed
Tepe E- end of use
Describe type A ADR
augmented
predicatble from pahramcology of the causaitve agent - often dose related
incidenc is common
detection ealry in clinical developem
low mortaltiy
DOSE related,
Describe type B- ADR
bizzare
mnot preditable from pharamcology of the causative agent and are not dose-related or concentration ralted
incidenc is uncommon
mortlaity is high
managment - disconitnue therpay
usually due to immune (haptens) or genetic factors
describe type C ADR
chronic- prolonged period of exposure, develop
describe type D ADR
delayed- effects dont arise until prolonged period afrter exposure
what is type E ADR
end of use- seen after withdrawl fo mediicne
what is the DoTS classificatio. systme of ADR
recognised drawbacks and overismplications of ABCDE
Do- Dose related
T- time relatred
S- suscpetibility
describe dose related casues of ADR
hypersuscpetibility (hypersesivity reactions- allergy to subtherapuetic does)
side effects (standard therapeutic does)
toxic effects (supratherapeutic doese)
what are time related ADRS
time independend ADRS- occcur any time in therapy
time dependent ADRs
- rapid
- first dose
- early
- intermeidate
- Late
- delayed
what are some suceptibuilioty factors to ADR
age -nepnates and elderly
gender- women more suscpetible
preganncy- increased heaptic activity reduce rates of ADRs, but also increase risk of treatment failure
disease- renal or heaptic impariment
drug interactions
exogneosu factors (diet and alcochol affect drug metbaolkism- chroic alcoho,mconusmption vs acute warfien- chronoc icnduce, acute reduce)
genetics- G6PD deficiency increas risk of ARDs
