Flashcards in Prescribing Deck (22)
Why do you prescribe differently for children?
Decreased body weight
Different body composition
Decreased surface area
What extra steps do you take to ensure safety when giving children fluids?
Do U&Es every day
What is an ADR?
Adverse drug reaction
An unwanted or harmful reaction which occurs after administration of a drug/drugs and is suspected or known to be due to the drug(s)
Name the 2 types of ADR and their differences
Type A: pharmacological mechanism, predictable, readily reversible on stopping drug/lowering dose
Type B: Idiosynchratic/immunological, not predictable, unrelated to dose, prolonged/permanent/fatal
Give 2 examples of a type A ADR
Dry cough with ACEi
Bradycardia with B-blockers
Give 2 examples of type B ADRs
Angioedema with ACEi
What % of ADRs are type A?
What % of hospital admissions are due to ADRs?
In a patient information leaflet, what does a very common ADR mean?
>10% patients (1/10)
In a patient information leaflet, what does a common ADR mean?
1%-10% patients (1/10-1/100)
In a patient information leaflet, what does a very rare ADR mean?
less than 0.01%
What ensures all medicines are regulated?
The Medicines Act of 1968
Safety, quality, efficacy
Name 3 UK organisations involved in the regulation of drugs
MHRA (Medical & Healthcare Products Regulatory Agency)
CHM (Commission Medicines Agency)
BP (British pharmacopoeia)
How are ADRs identified before drug is licensed??
Genetic screening for carcinogens
Acute single dose studies
Rodent & dog short term studies
90 days rodent and dog doses
How many phases are there in clinical trials?
What is involved in stage 1 of a clinical trial?
Route and metabolic fate is defined in normal volunteers (n less than 50)
What is involved in stage 2 of a clinical trial?
Therapeutic profile and dose regimen is defined
Dose ranging (n less than 500)
What is involved in stage 3 of a clinical trial?
Clinical efficacy determined, compared to placebo/comparator
Longer duration (n less than 500)
What is involved in stage 4 of a clinical trial?
Post marketing surveillance (pharmacovigilance)
How do you assess an ADR?
Nature and severity of reaction
History and timings
Relationship to dose
Complete drug history
Review ADR profile of drug
Complete yellow card
Specific investigatons/further complications/drug monitoring?
Do you break the doctor-patient confidentiality if you fill in a yellow card without their consent?
No, yellow cards do not violate patient confidentiality