Slide 1
Medicine safety monitoring continues after approval
Pharmacovigilance monitors and investigates possible harms associated with medicines and vaccines. Approval does not end the process of learning about safety.
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Use after approval may involve more people, longer exposure and circumstances not fully represented in trials. That broader experience can reveal questions that smaller, earlier studies could not settle.
Slide 2
Suspected adverse-event reports raise questions
Patients, clinicians and manufacturers can report suspected adverse events. A pattern of reports may provide a signal for further evaluation.
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An event occurring after a medicine is taken does not by itself prove the medicine caused it. The underlying illness, another product or an unrelated event may offer alternative explanations.
Slide 3
Reports can be incomplete, duplicated or uneven
Spontaneous reporting systems can contain incomplete or duplicate reports. Not every event is reported, and reporting behavior changes over time.
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Public attention can increase reporting of a particular concern. Comparing raw report totals across products therefore risks comparing differences in awareness and use rather than differences in actual harm.
Slide 4
Report counts lack a reliable count of exposed people
Report counts usually do not show how many exposed people were at risk. They cannot automatically be converted into an incidence rate.
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A rate needs an appropriate population and observation period as well as an event count. Investigators may need other data sources to estimate frequency and test a suspected association.
Slide 5
A safety signal needs assessment with further evidence
Investigators examine possible safety signals using multiple kinds of evidence. The aim is to improve understanding of a product’s benefits and risks.
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Assessment may support updated information, additional research or regulatory action. A signal is therefore the beginning of a safety question, not a final conclusion that every reported event was caused by the product.