R3 w1 - Adverse drug reactions and sources of evidence

What is an ADR?

• a response to a medicinal product which is noxious and unintended, where a causal relationship between the medicinal product and the adverse event is either known or strongly suspected

• side effect

What are some brief disadvantages to ADRS?

• mortality, morbidity

• cost nhs billions

• patient impact - clinical,social, financial,psychological

What are the types of adrs?

What are the dose related to ADRs?

● Hypersusceptibility: ADRs at subtherapeutic doses (eg anaphylaxis with penicillins)

● Collateral effects (side effects): ADRs at therapeutic doses (eg hypokalaemia with loop diuretics)

● Toxic effects: ADRs at supratherapeutic doses (eg liver damage with paracetamol)

What is Type A- augmented?

• Most common

• Effect of drug pharmacology at a therapeutic dose, not life-threatening

• dose dependent reversible when stopping the drug

Examples

• Bleeding with anticoagulants
• Bradycardia with beta-blockers ( low heart rate )
• Loose stools with laxatives
• Hypoglycaemia with gliclazide, insulin

What is Type B - Bizarre?

• Uncommon

• not related to pharmacology; unpredictable ( allergies)

• immune-mediated reactions

• not dose-related

• serious mortality and morbidity

• not necessarily reversible when stopping drugs

Examples:

• Anaphylaxis with penicillin
• Tendon rupture with quinolone antibiotics, statins
• Stevens-Johnson syndrome with IV vancomycin

What are features of drug allergies?

What are ADR types C-E?

What is Type F?

What are the risk factors for ADR?

How are ADRs identified?

• This can happen at several stages. Many of these are linked to the processes that occur during initial drug development.

What are the key aspects of identifying the cause of ADRs?

What are some questions to ask when there are adverse reactions?

How do you manage ADRs?

● Treat ADR if required
● Manage causative drug (if known) – stop / review dose/swap to an alternative
● Advise on avoidance of ADR where appropriate, e.g. use a spacer device and appropriate inhaler technique and rinse mouth after steroid inhaler to avoid oral thrush
● Inform patient/carer and document clearly

How do you report ADRs

• Document clearly in the patient records

• report by yellow card

What are some sources of evidence that can be used to look at unknown adrs?