Pharmacovigilance

Question 1

Pharmacovigilance is the process of

Answer 1

• Monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects
  
  • Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
  • Providing information to healthcare professionals and patients to optimise safe and effective use of medicines
  • Monitoring the impact of any action taken
    Pharmacovigilance is therefore primarily concerned with the safety profile of the product in use

Question 2

Tell me about Directive 2001/83/EC Article 104

Answer 2

• MA holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance
  
  • QPPV is responsible for:
    ○ The establishment and maintenance of the MA holder’s pharmacovigilance system
    ○ Preparing pharmacovigilance reports
    ○ Answering requests from Health Authorities
    Providing Health Authorities with any other information relevant to product safety

Question 3

An adverse drug reaction (ADR) can be due to either

Answer 3

a) An intrinsic property of the active ingredient(s)
* The QPPV is responsible for tracking and trending
b) An extrinsic factor in the product manufacture
* The manufacturing QP is responsible for investigating
○ Thus the QPPV and manufacturing QPs need to work together to determine root cause of the ADR