Individual variation to drugs and adverse drug reactions (L25) Flashcards
what is an adverse drug reaction?
a harmful or seriously unpleasant event occurring at a dose intended for therapeutic effect and that calls for a reduction of the dose or withdrawal of the drug
drug safety is a relative concept and needs to take what into account?
- severity of the ADR
- the disease
- therapeutic alternatives
- individual perception and acceptance of risk
what features suggest a cause and effect relationship between drug administration and ADR?
- time sequence between taking drug and ADR
- reaction corresponds to the known pharmacology of the drug
- reaction stops on cessation of drug
- reaction returns on restarting drug
when do ADR usually occur?
relatively quickly
but some don’t show until a child is born
what is the yellow card?
used by anyone who believes they may have an ADR
what is a side effect?
unavoidable consequence of drug administration - less harmful than an ADR
arising as unwanted action is just an integral as the therapeutic effect to the pharmacology of the drug
can sometimes be on clinical benefit
what is a secondary adverse effect?
indirect causation, secondary to the drug
eg. opportunistic infections due to glucocorticoid therapy
risk factors of getting an ADR
- age
- sex
- medical history
- disease
- current medication
- ethnicity
age as a risk factor
elderly more likely to have increases ADRs
• 3 fold increase over 60
• increased medications
• pharmacokinetic factors
neonates susceptible due to difference in pharmacokinetic factors
• don’t have same expression of phase 2 enzymes
• different fat-water distributions
sex as a risk factor
females more susceptible - express hormones in different ways and different amounts
different CYPs
medical history as a risk factor
if has ADR to 1 drug, more likely to experience ADR to another drug
disease as a risk factor
pharmacokinetic factors
increases chance of getting ADR
current medication as a risk factor
drug interactions
changes metabolic reactions
ethnicity as a risk factor
intrinsic factors
pharmacokinetic factors
• 90% Japanese ar nefast acetylators
• only 50% of caucasians
pharmacodynamic factors
extrinsic risk factors
alcohol
diet
smoking