Drug safety and Side effects

Question 1

What is an Adverse Reaction (ADR)?

What are Type A ADRs? Are they predictable? How can you treat it? Give an example

What are Type B ADRs? Are they predictable? How can you treat it? Give an example

Answer 1

• Undesirable effect of drug beyond its anticipated therapeutic effects
• • Most common type; excess of desired pharmacological effect
  • Largely predictable and potentially avoidable
  • Resolved by lowering dose or withdrawing treatment
  • Example: NSAIDS; cause GI bleeds, peptic ulcers, renal impairment, bronchospasm - due to COX inhibition, reduction of Prostaglandins
• • Rare; unrelated to known pharmacology
  • Unexpected; can be fatal
  • Need to withdraw drug and not use it again
  • Example: Hypersensitivity reaction can lead to anaphylaxis shock

Question 2

What is Pharmacovigilance? What can it lead to?

What are the 3 ways in which ADRs can be reported in the UK?

Answer 2

• • Monitoring of drug safety; allows you to compare risk and benefits
  • Can lead to drug withdrawal from market, contraindication, warnings given, dose changes
• • Yellow Card; anyone can make a report voluntarily for drug surveillance
  • Black triangle; present on drug packaging to highlight possible ADRs to new drugs
  • Green form; voluntary reports of any significant medical events for a small, selected number of drugs to find rare and unusual side effects ignored by doctors