6 - Pharmacovigilence and Pharmacogenetics Flashcards
What is pharmacovigilance?
- Pharmacovigilance is the process of identifying and then responding to safety issues about marketed drugs
- It involves surveying the safety of drugs and developing strategies to minimise the risk and optimise benefits
- Most common clinical adverse event is a drug reaction
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What are the aims of pharmacovigilance?
- Identify previously unrecognised drug safety hazards
- Elucidate factors predisposing to toxicity
- Obtain evidence of safety so that a new drug’s uses may be widened
- ‘False positive’ adverse drug reaction
What is an adverse drug reaction and what are some serious ADR’s?
A response that occurs in a patient to a drug, even though it has been given in the therapeutic range. Can have type A and B
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What are type A and type B ADRs?
Type A: usually a consequence of the drug’s primary pharmacological effect (e.g. bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug
- Exaggerated pharmacological respons, predictable, dose dependent, common, high morbidity, low mortality
Type B: bizarre or novel responses that cannot be predicted from the known pharmacology of a drug
- Not expected from known pharmacology, unpredictable, independent of dose, rare, high mortality
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What are some examples of type A and type B ADRs?
Type A:
- Bleeding with warfarin
- Hypoglycaemia with metformin
Type B:
- Anaphylaxis with penicillin
- Agranulocytosis with clozapine
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What are the limitations of pre-marketing clinical studies in identifying drug safety issues?
- Small number of patients treated
- Frequent exclusion of patients who might be at greater risk of ADRs
- Selected following precise diagnoses
- Limited duration of treatment
- Restricted doses
STUDY POPULATION NOT REPRESENTATIVE OF WHOLE
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How can we identify ADRs?
- Spontaneous reporting
- Cohort studies
- Case control studies
Describe the three steps involved in the spontaneous reporting of ADRs
⇒ Recognition of a possible ADR
⇒ Establishing possible causal relationship
⇒ Reporting observations
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What are the advantages of spontaneous reporting?
- Operates as soon as drug is marketed
- Involves all doctors worldwide
- Overlooks all drugs so simple
- Inexpensive
- Continues indefinitely
- Accessible by all health care professionals and patients and carers
What are the limitations of spontaneous reporting?
- Delays in reporting
- Poor quality data
- Misleading reports
- No control group
- Gross under-reporting of possible ADRs
- Effect of publicity
- Duplication
What are the four mechanisms of action for an ADR?
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What is the process in the UK of spontaneous reporting of ADRs?
Yellow Card Scheme
Report all suspected ADRs even minor ones
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What are the factors affecting the under-reporting of ADRs?
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What is pharmacogenetics?
- Pharmacogenetics is the science of understanding how different individual genotypes relate to different drugs
- It enables physicians to know which drugs will therefore be safe and effective for an individual patient
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What is pharmacogenomics?
Pharmacogenomics is pharmacogenetics applied to an entire genome
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