workshop 19 - post marketing surveillance

Question 1

what are post marketing surveillance science and activities related to?

Answer 1

detection
assessment
understanding
prevention
of adverse effects or any other medicine-
related problem.

formal systems in place are EMA and FDA

Question 2

what does the yellow card scheme report?

Answer 2

a medicine causes side effects

a medicine doesn’t work properly

a medicine is of poor quality

think a medicine or medical device is fake or counterfeit

someone is injured by a medical device, either because it labelling or instruction aren’t clear, it is broken or it has been misused

a patient’s treatment is interrupted because of a faulty device
someone receives the wrong diagnosis because of a medical device (includes online calculators/nomograms)

Question 3

what are black triangle drugs?

Answer 3

“Adverse reactions to drugs” section
“Black triangle” drugs
MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, denoted by Black Triangle symbol (▼)
MHRA usually assesses the ▼ status 2 years after marketing
The symbol is not removed until the safety of the drug is well established.

Question 4

what re drugs that have been taken off the market?

Answer 4

Rosiglitazone
Cisapride
Sibutramine
Sertindole
Rofecoxib
Ximelagatran

Question 5

What approaches or strategies could be taken to avoid (minimise) the withdrawal of medicines in the future? ​​

Answer 5

carry out thorootuvh clinical trials to ensure the audit, efficacy and safety of the drug are properly assessed before they are releases on to the market.

have a longer clinical trial period to understand the effect and visually see the effecst in patients.