Pharmacovigilance Flashcards
Define adverse drug reactions
noxious, unintended or undesired reaction occurring at doses normally for the preventative, diagnosis, or treatment of disease
Define adverse event
An unfavourable outcome that occurs during or after the use of a drug or other intervention but is NOT necessarily caused by it
Define side effect
any unintended effect of a pharmaceutical product that occurs at doses normally used for therapeutic purposes
Define pharmacovigilance
Science of activities related to detection, assessment, understanding, and prevention of adverse effects or any possible drug problem
What is a signal? (context of pharmvig)
Alert from one of many different sources that a drug could be associated with potential hazard
When is a ADR case considered a signal?
When THREE cases of causal association between a drug and new ADR occur
When is an ADR case considered a strong signal?
Five cases of ADR occur
What is signal of disproportionate reporting (SDR)?
Statistical finding that does not imply a causal relationship between a drug and the ADR
What the signal noise ratio?
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
What are the three mechanisms/processes used to evaluate causal links between drugs and ADRs?
Operational algorithms
Expert opinion
Probabilistic approach
How is operational algorithm used to evaluate causal links of ADRs?
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
What are the limitations of an operational algorithm?
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
How is expert opinion used to evaluate causal links of ADRs?
Expert opinion is typically used for orphan drugs
What are the limitations to expert opinion in the evaluation of causal links?
Unstructured opinion is not reproducible
Components of opinion are unstated and unquantified
Subjective, lacks standardisation
How is probabilistic approach used to evaluate causal links of ADRs?
Uses bayesian approach and epidemiological data to calculate and estimate probability of causality
Determines/estimates likelihood of ADR with suspected drug
What are the limitations of the probabilistic approach in the evaluation of causal links?
Development of probabilistic measures requires knowledge of prior odds and likelihood ratios
Requires complex calculations
When do you report an ADR for a new drug?
report all suspected
Who are the global partners in pharmacovigilance?
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
Other than the global partners in PV, what are some other partners?
National Pharmacovigilance Centres: (TGA)
Hospitals and academia
Health professionals = success of reporting system depends on their voluntary reporting
Patients = know actual benefit and harm
What are some challenges in reporting ADRs?
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
What is the ATTEND DR acronym used for?
Used to evaluate the causality of an ADR
It is an operational algorithm
What does ATTEND DR stand for?
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
