CPTP3.9 Adverse Drug Reactions Flashcards
3 possible causes of unwanted side effects of drugs
Too high drug level at therapeutic target
Drug action on therapeutic target but different tissue
Drug/metabolite acting on different target (cross reactivity)
Difference between adverse drug reaction and side effect
Side effect is any unintended effects of a drug related to its pharmacological properties
Adverse drug reactions is any adverse action that is causally attributed to the drug
What is the main aim of phase 1 drug development?
Human pharmacology, ensure no serious adverse events occur from a drug
What is the main aim of phase 2 drug development?
Therapeutic exploration
To find out if a drug is any good at the intended therapeutic purpose
What is the main aim of phase 3 drug development?
Therapeutic confirmation
To confirm the usefulness of the drug on a larger group of patients
What is the main aim of phase 4 drug development?
Pharmacovigilance
After marketing the drug, to find out what kind of side effects can occur in the population
Describe ABCDEF type adverse drug reactions
A - augmented, normal pharmacological, but quantitavely exaggerated reactions
B - bizzare, unrelated to the drugs normal pharmacology
C - chronic, dose and time related
D - delayed, time related
E - end of use, withdrawal symptoms
F - failure, unexpected failure of therapy
Example of type A ADR
Anticholinergic effects with TCAs
Example type B ADR
Anaphylaxis with penicilin
Explain a type F ADR and example.
Failure of drug to work, could be due to drug interaction
E.g. St john’s wort reducing efficacy of some antidepressants
What does DOTS stand for in terms of ADR
Dose
Timing
Susceptibility
Most common drug to cause ADRs
NSAIDS
Antiplatelets
Anticoagulants
Diuretics
Explain the meaning of Dose dependent effects in the DOTS classification
Too high dose, cause bad reaction
Normal dose cause bad reaction
Low dose cause hyper reaction in susceptible people
