10 januari: Pharmacovigilance

Question 1

Eric made a ‘mental note’ for a possible exam question for this question: Why are CTs conducted?

Answer 1

CTs must demonstrate ‘safety’, ‘efficacy’ and ‘quality’ of a compound.

Question 2

Define AE and give an example.
Recorded? yes/no
Reported? yes/no

Answer 2

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. e.g. new disease, broken limb.
Recorded, but not reported.

Question 3

Define ADR and give an example.
Recorded? yes/no
Reported? yes/no

Answer 3

All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR (not necessarily unexpected). e.g. hair loss in chemotherapy.
Recorded, not necessarily reported.

Question 4

Define SUSAR.
Recorded? yes/no
Reported? yes/no

Answer 4

Serious Unexpected Suspected Adverse Reaction; a serious ADR, the nature or severity of which is not consistent with the applicable product information. Recorded and immediately reported.

Question 5

When is an ADR a SUSAR?

Answer 5

• death
• life threatening
• hospitalisation
• persistent/significant disability/incapacity
• birth defect

Question 6

Who determines the seriousness of an AE?

Answer 6

The investigator (& sponsor).

Question 7

To whom do you report SUSARs and what is the related timeframe?

Answer 7

Regulatory authorities, ethic committees and all investigators working with the product. All SUSARs within 15 days, fatal/life threatening within 7.