Pharmacovigilance

Question 1

Define adverse drug reactions

Answer 1

noxious, unintended or undesired reaction occurring at doses normally for the preventative, diagnosis, or treatment of disease

Question 2

Define adverse event

Answer 2

An unfavourable outcome that occurs during or after the use of a drug or other intervention but is NOT necessarily caused by it

Question 3

Define side effect

Answer 3

any unintended effect of a pharmaceutical product that occurs at doses normally used for therapeutic purposes

Question 4

Define pharmacovigilance

Answer 4

Science of activities related to detection, assessment, understanding, and prevention of adverse effects or any possible drug problem

Question 5

What is a signal? (context of pharmvig)

Answer 5

Alert from one of many different sources that a drug could be associated with potential hazard

Question 6

When is a ADR case considered a signal?

Answer 6

When THREE cases of causal association between a drug and new ADR occur

Question 7

When is an ADR case considered a strong signal?

Answer 7

Five cases of ADR occur

Question 8

What is signal of disproportionate reporting (SDR)?

Answer 8

Statistical finding that does not imply a causal relationship between a drug and the ADR

Question 9

What the signal noise ratio?

Answer 9

Measure’s the difference between the signal and the noise

How likely other factors are to have contributed to the adverse advent rather than the drug

Question 10

What are the three mechanisms/processes used to evaluate causal links between drugs and ADRs?

Answer 10

Operational algorithms

Expert opinion

Probabilistic approach

Question 11

How is operational algorithm used to evaluate causal links of ADRs?

Answer 11

Address the question of alternative etiological causes of ADR w/ yes or no and unknown answers.

Assesses successive causality criteria combined by means of scores or a decision tree

Like a survey/questionnaire

Question 12

What are the limitations of an operational algorithm?

Answer 12

Relies on patient’s ability to notice issue was present in part or happened after drug

Weighing determined by person (subjective) (e.g. definite ADR 9+, 5-8 is probable ADR, 1-4 is possible ADR)

Does not account for drug-drug interactions

Question 13

How is expert opinion used to evaluate causal links of ADRs?

Answer 13

Expert opinion is typically used for orphan drugs

Question 14

What are the limitations to expert opinion in the evaluation of causal links?

Answer 14

Unstructured opinion is not reproducible

Components of opinion are unstated and unquantified

Subjective, lacks standardisation

Question 15

How is probabilistic approach used to evaluate causal links of ADRs?

Answer 15

Uses bayesian approach and epidemiological data to calculate and estimate probability of causality

Determines/estimates likelihood of ADR with suspected drug

Question 16

What are the limitations of the probabilistic approach in the evaluation of causal links?

Answer 16

Development of probabilistic measures requires knowledge of prior odds and likelihood ratios

Requires complex calculations

Question 17

When do you report an ADR for a new drug?

Answer 17

report all suspected

Question 18

Who are the global partners in pharmacovigilance?

Answer 18

The WHO Quality Assurance and Safety: Medicine Team –> provide guidance and support on drug safety matters

Uppsala Monitoring Centre –> manage international database of ADR reports received from national centres

Question 19

Other than the global partners in PV, what are some other partners?

Answer 19

National Pharmacovigilance Centres: (TGA)

Hospitals and academia

Health professionals = success of reporting system depends on their voluntary reporting

Patients = know actual benefit and harm

Question 20

What are some challenges in reporting ADRs?

Answer 20

Failure to detect reaction due to low lvls of suspicion

Fear of legal implications, lack of training about drug therapy

Lack of clear responsibility for reporting, no financial incentive to report, unaware of reporting procedure

Fear of removal of useful drugs

Question 21

What is the ATTEND DR acronym used for?

Answer 21

Used to evaluate the causality of an ADR

It is an operational algorithm

Question 22

What does ATTEND DR stand for?

Answer 22

A- Abnormality/adverse effect = evidence for ADR subjective/objective?

T - taken (suspected drug) = did they take the drug?

T - Timeline = was ADR before or after drug was taken?

E - Evidence = do ADRs match those in literature?

N - Nothing else = other causes for ADRs? pre-existing issues?

D - Dose = does the ADR worsen with inc dose?

D- Dechallenge = does the ADR improve if the drug is removed?

R - Rechallenge = re-administration of suspected drug after dechallenge