Absolute risk, in the context of drug safety and pharmacovigilance, refers to the actual numerical probability or likelihood of experiencing a specific adverse event or side effect associated with the use of a particular drug or medication. It represents the precise measure of the risk in terms of the number of cases or events per a specific population or unit of exposure.
To calculate absolute risk in pharmacovigilance, researchers typically gather data on the number of individuals exposed to a drug and the number of individuals who experience a specific adverse event while using that drug. By dividing the number of adverse events by the total number of exposed individuals, they can determine the absolute risk of that event occurring.
For example, if a clinical trial involving 1,000 patients taking a certain medication found that 20 of them experienced a particular side effect, the absolute risk of that side effect would be 20 divided by 1,000, which is 0.02 or 2%. This means that there is a 2% absolute risk of experiencing that specific side effect when using the medication.
Absolute risk is an essential concept in pharmacovigilance as it provides a quantitative measure of the safety profile of a drug, allowing healthcare professionals, regulatory agencies, and patients to make informed decisions about its use. It helps in assessing the benefit-risk ratio of a medication and can influence prescribing practices, labeling requirements, and regulatory decisions.