ADR Flashcards
What’s the other name for TYPE A adverse drug reactions?
Type A = augumented
What’s the other name for Type B ADR?
Type B = bizzaire/ idiosyncratic
What’s type A reactions?
Type A (augmented)
- reactions that are predictable from the known pharmacology
- often represent an exaggeration of pharmacological effect of the drug
What are Type B reactions?
Types B (idiosyncratic/ bizarre)
- unpredictable from the knowledge of the basic pharmacology of the drug
- show no dose-response relationship
May be : chemical, biochemical, immunological -> these complex processes influence the reaction
Phases in drug development
Phase I - healthy volunteers ->to understand bioavailability of the drug
Phase II - inpatient -> to identify dose, kinetics and dynamics of the drug
Phase III - patients -> 1st efficacy and safety studies (how effective under ideal condition) with exclusion and inclusion criteria (comparison to placebo)
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When the drug company can apply for the license for the drug?
Once the drug got through phase 1, 2 and 3
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Where can this be usually detected in drug development process:
Type A reactions
Type B reactions
Types A -> usually during phases 1 - 3
Type B -> usually during phase 4 *
* only with large exposure, when drug is on the market
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What’s ‘role of 3’ in pre-marketing detection of the ADR?
Role of 3 in ADR
- if 30 exposed persons -> 1 in 10 show ADR
- if 300 exposed -> 1 in 100 will show ADR
- 3000 espossed -> 1 in 1000 show ADR
- 30 000 -> 1 in 10 000 show ADR
* Not all ADR will show up in the early phases of clinical trials (some rare reactions detected only with large exposure - when clinically available)
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Are the long term effects detected in phase III pre-marketing testing?
Not, as it is short-lasting
What phase III for?
Phase III is for efficacy
How to recognise ADR?
When a patient develops new symptoms
T -> temporal relationship -> does the effect occur after the drug has started? (most ADR occur in first 3 months after the drug started)
R - re-challenge -> if you give same drug, same dose again -> pt will develop symptom again (done in mild ADR only)
E - exclusion of other causes -> to check if the symptom is not due to other cause
N - novelty -> check if someone else had same drug reaction; but maybe you will be first to identify the ADR
D - de-challenge -> dose reduction/ withdrawal (would reduction of drug improve the effect?)
What’s the yellow card?
To report suspected ADR -> MHRA* collects the data and assess the safety of the drug
MHRA = Medicine and Healthcare products Regulatory Agency
What is ADR with Warfarin?
- MoA
- antidote
Warfarin -> May cause hematoma
*higher the dose = higher risk of bleeding
- MoA: warfarin prevents vit K -> vitamin K- dependant clotting factors (2, 7, 9 and 10) are decreased
- antidote: vitamin K
What factors will determine the dosage of Warfarin )?
Warfarin doses
- elderly -> lower doses -> this is because the liver get smaller with age
- weight increase -> higher doses
- gender
- age
- other meds
- nutritional status
- genetics
*to determine the dose -> we check INR
Direct Oral Anticoagulant
- elimination depends on what organ?
DOAC
- excreted by the kidney
Therefore in kidney impairment -> need to reduce the dose due to risk of bleeding