lecture 1.4 (pharmacovigilance/ drug safety)

Question 1

What is pharmacovigilance?

Answer 1

WHO defines PV as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of marketed drugs or those under trial.

Question 2

What are the aims of pharmacovigilance?

Answer 2

1. Improve patient care and safety in relation to the use of medicines
2. Improve public health safety in relation to the use of medicines.
3. By detecting problems related to the use of medicines and communicate in a timely manner

Question 3

What is pharmacovigilance comprised of?

Answer 3

1. Collecting and managing data on the safety of drugs on the market.
2. Analyzing the data to detect ‘signals’
3. Evaluating data and making decisions with regard to safety issues
4. Acting to protect public health
5. Communication with stakeholders

Question 4

Name drug that was withdrawn from market due to ‘pharmacovigilance’.

Answer 4

Vioxx withdrawn worldwide 2004 due to cardiac problems .

Zantac withdrawn worldwide 2020 due to carcinogen

Valsartan for high BP recalled in US from manufacturers due to contamination

Question 5

What are the parties directly involved in pharmacovigilance?

Answer 5

-patients
-doctors, pharmacists, nurses and healthcare professionals
-govt bodies responsible for drug safety monitoring
-importers, agencies and distributors

Question 6

What do the key pharmacovigilance guidelines cover?

Answer 6

1. Adverse Drug Reaction reports (when, what)
2. Procedure for a medicine to be withdrawn from the market (recall procedure)