Pharmacovigilance Flashcards
What groups are new drugs often not tested in
Elderly
Children
Pregnant women
Lactating women
Multiple morbidities
Polypharmacy
What lack of information get in more vulnerable groups
UNlikely detext ADRs as shorter duration - rare or prolonged reactions not picked up
What is the chance of DVT/MI w oral contraceptives
DVT/MI
What drugs can extremely rarely cause a ventricular tachycardia
Terodiline, terfenadine
What drug can rarely cause aplastic anaemia
Chloramphenicol
Objectives of pharmacovigilance
Identify prev unrecognised hazards
Evaluate changes in risks and benefits
Take action to promote safer use
Provide optimal information to users
How are ADRS reported and where to
Yellow card to MHRA online or on paper - med healthcare regulatory authority
What is the purpose of the yellow card scheme
Early identification of prev unrecognised safety hazards
What ADRs are especially important to report by yellow card
Serious ADRs
Reactions in children
New drugs/black triangle
How identify new drugs under intense surveillance
Black traingle drugs in the BNF
Regulatory actions that can be taken against a drug
Withdraw if all risk exceeds beneift (rare)
Remove an indication, add a contraindications
Add warning or precaution eg monitor
Add drug interaction
Add ADR
Inform users - drug safety update, dear dr/pharmacist letter
Where are safety of drugs reguarly updated
Drug safety update on MHRA website
