Flashcards in Session 14 Deck (21):
What is pharmacovigilance?
Identifying and responding to safety issues about marketing drugs.
What are the 4 main aims of pharmacovigilance?
1) Find unrecognised drug safety hazards
2) Remove factors predisposing to toxicity
3) Get evidence of safety so new drugs uses can be widened
4) 'False positive' ADRs
Give two limitations of pre-marketing studies.
Small number of patients, restricted type of patients, limited duration of treatment, high level of patient monitoring, specialist doctors.
Give two limitations of routine clinical experience.
Large number of patients, type of patients guided by indication, usually any type of doctor.
What are type A ADRs?
Exaggerated pharmacological response, predictable, dose-dependent, common, high morbidity, low mortality.
What are type B ADRs?
Not expected, unpredictable, independent of dose, rare and high mortality.
Give three ways that ADRs can be identified.
Spontaneous recording, cohort studies, case-control studies.
Give three advantages of spontaneous reporting of ADRs.
As soon as the drug is marketed, entire population, all doctors, all drugs, detects common and rare reactions, inexpensive, continues indefinitely.
Give three advantages of case-control studies to identify ADRs.
Good for rare ADRs, can give a quick answer if suitable database available, relatively low cost, indicates degree of increased risk.
When should the yellow card ADR scheme be used?
-Recently introduced products
-All reactions to vaccines
-Reactions to established products
What is pharmacogenetics?
Understanding how different individual genotypes relate to different drugs. Hence knowing which drug will be safe and effective for an individual patient.
Give three risk factors for drug inefficiency or toxicity
DDIs, age, renal and liver function, concurrent illness, smoking and alcohol, genetic variation.
How can absent or reduced CYP 2D6 activity lead to ADRs?
-Decreased 1st pass metabolism and drug elimination
-Accumulation of the drug as a result of reduced metabolism
-Re-routing of metabolism.
Name the three types of corticosteroids.
Glucocorticoids (cortisol), mineralocorticoids (aldosterone), sex steroids.
Give three metabolic actions of glucocorticoids.
Stimulates glycogenolysis and gluconeogenesis.
Give three signs of excess mineralocorticoids.
Hypernatraemia, hypertension, hypokalaemia.
Give three signs of glucocorticoid deficiency.
Hypoglycaemia, weight loss, nausea, hypotension, underweight.
Give four uses of steroid drugs.
Inflammatory diseases, immunosuppression, malignancy, adrenal insifficiency, cushing's disease, preterm birth.
Give three ADRs of glucocorticoids.
Osteoporosis, avascular necrosis, peptic ulcers, hypertension, diabetes, cataracts, corneal damage.
Describe a hypo-adrenal crisis.
Hypotension, hypoglycaemia, hyponatraemia, hypokalaemia, severe dehydration, death if untreated.