Adverse effects

Question 1

Describe the nature of predictable/ pharmacological adverse effects.

Answer 1

• Excessive pharmacological action
• Often seen with a class of drugs
• Alternative pharmacological action:
  1. Aspirin = bleeding vs. anti-inflammatory action.
  2. Anti-histamines: multiplereceptors

Question 2

Describe the nature of unpredictable/non-pharmacological adverse effects

Answer 2

• Often seen with only a specific member of a class
• Due to other action of drugs:
  1. ACE inhibitors (cough)

Question 3

Describe the nature of idiosyncratic/dose-independent adverse effects.

Answer 3

• Adverse effects that cannot be explained by the known mechanisms of action of the offending agent.
• Develop mostly unpredictably in susceptible individuals only.

Question 4

Describe the role of medication errors in adverse drug events.

Answer 4

• An error in process that can or does lead to an ADE.
• Usually results in no harm.
• Is usually preventable.
• Caused by E.g. lack of therapeutic training, inadequate drug knowledge and experience or inadequate knowledge of the patient.

Question 5

Describe the role of contaminants and generic bioequivalence in ADEs.

Answer 5

• Generic bio equivalents: absence of a significant difference in rate and extent of absorption.
• Cheaper than the branded product but not the same:
  1. Contaminants are different
  2. Synthetic method is likely different
  3. Not made to the same standard as branded product.
• Needs to be within 0.8 and 1.25 of reference. Tests on small number of health volunteers.
• May result in lack of bio equivalence between the brand and generic drug. Patient can get ^ dose = ^ ADE, or low dose- no effect.

Question 6

Describe the risk management strategies for drugs with serious ADEs

Answer 6

• Used to allow use of a drug but reduce the risk of an adverse effect.
• 2 types of risk strategies:
  1. RMP
  2. REMS.

Question 7

Compare RMP and REMS.

Answer 7

• Similar but different strategies.
• EMA Risk management plan (RMP): uses summary of product characteristics (SmPC) to communicate precautions with drugs.
• FDA risk evaluation and mitigation strategy (REMS) uses specific company communication plans e.g. black box warning.