Table 1.

Factors influencing adverse drug reaction (ADR) underreporting

Predisposing factors
Knowledge
Unsure how to report an ADR
Unsure who is responsible for reporting ADRs
Unsure which drug was responsible for the ADR
Unsure if the reaction was a side effect rather than an ADR
Attitudes and beliefs
Believed only safe drugs are allowed on the market
Concerned about confidentiality of information
Reporting could show ignorance
Concerned about legal liability by reporting
Difficult to admit harm to patient
Willing to publish or report only unusual cases in the literature
Disabling factors
Too busy to send ADR reports
Form unavailable when needed
Insufficient data to complete a report

Source: Adapted from Kelly et al (2004).