Pharmacovigilance

Question 1

Define ADRs

Answer 1

Adverse drug reaction is any unexpected, unintended, undesired, or excessive response to a medicine.

Question 2

Define adverse events

Answer 2

An unfavourable outcome that occurs during or after use of a drug but is not necessarily caused by it

Question 3

Define side effects

Answer 3

Any unintended effect of a pharmaceutical product that occurs at a dose normally used for therapeutic purposes. can be beneficial.

Question 4

Define pharmacovigilance

Answer 4

Science of activities related to detection, assessment, understanding, and prevention of adverse effects or drug related problems.

includes herbal, traditional, CAMS, blood and biological products, medical devices, and vaccines.

Question 5

Signal detection - science behind detection of an ADR

Answer 5

Provide early signals about possible problems.

Signal is an alert that a drug could be associated with a hazard. Three cases of an association between drug and ADR is a signal.
Five cases= strong signal

Question 6

Classify and provide strengths/limitation of tools to evaluate a causal link.

Answer 6

Operational algorithms - used to assess successive causality criteria through means of scores or decision tree. not easily identify ADRs.
- e.g. naranjo ADR probability scale 0= doubt, 9= definite ADR

Expert opinions - assess causality in suspected ADR. not very reproducible and unstated/unquantified. lacks standards and is subjective.

Probabilistic approach - Bayesian approach and epidemiological data to estimate probability of causality w/ statistics. Determine the likelihood of ADR. Complex calculations, know prior odds, best method.

Question 7

What to report and how to report and ADR

Answer 7

New drugs- report all suspected reactions

Established drugs- report all serious/unexpected ADRs or if an increased frequency is observed

Report ADRs in special populations

Drug withdrawals

Include: patient information, contact details of reporter, description of reaction, medicine and medication history, date of onset, how it was treated, outcome reaction and date.

Report to TGA, WHO, hospital databases.

Question 8

Challenges of reporting an ADR

Answer 8

Low level of suspicion
Fear of legal implications
Lack of training
Paperwork
No financial incentive
Unaware of procedure

Question 9

ATTEND DR

Answer 9

A- abnormality. subjective/objective.
T- taken (suspected drug).
T- timeline. check before ADR, timing, and after.
E- evidence. check ADRs and frequency noted.
N- nothing else (other cause).
D- dose. dose dependent.
D- dechallenge. improve if stopping or reducing dose?
R- rechallenge. re-administer drug.

Question 10

Signal of disproportionate reporting

Answer 10

SDR is a statistical finding that does not imply a causal relationship between a drug and ADR
Try to increase signal-to-noise ratio.