Pharmacovigilance 2

Question 1

What is the minimum information required for an individual case safety report?

Answer 1

• an identifiable reporter
• an identifiable patient eg age, gender, initials
• identifiable drug
• identifiable suspected ADR

Question 2

How do we do causality assessment for ADRs?

Answer 2

1) Pharmacologic plausibility:
- chemical nature of molecule/class
- assumable intrinsic activity
- dosage and duration of therapy fitting
- pharmacokinetics (conc at relevant site) fitting

2) Chronology:
- temporal relationship
- dechallenge, possibly rechallenge (usually dont do this)

3) Synergistic-pharmacokinetic eg drug raise conc of another drug
4) Synergistic in a broad sense

Question 3

How do we diagnose Drug Induced Liver Injury (DILI)?

Answer 3

• exclusion of viral serology
• negative metabolic screen (autoimmune disorders or diseases that causes liver injury) eg Antinuclear Antibody Test (ANA)
• daily alcohol intake < 20g
• absence of biliary or focal liver pathology on ultrasound or CT scan of abdomen

Question 4

What is the local legislation on PV requirements for therapeutic products?

Answer 4

• duty to maintain records of defects and adverse effects
• duty to report adverse effects
• duty to report defects
• duty to notify authority concerning recall
• duty to carry out risk management plan
• submission of benefit-risk evaluation report

Question 5

How does the industry do risk management?

Answer 5

Risk management is a continuous process throughout the life cycle of a product to optimize the benefit-risk balance:

• proactive risk assessment pre and post market
• develop and implement tools to minimize risks
• continual reassessment of benefit-risk balance