Guidelines for submitting adverse event reports for publication are necessary to ensure published reports have value

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A published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product. However, shortcomings in vital information in published cases can often limit the value of such reports by failing to provide sufficient details. Recent guidelines endorsed by the International Society for Pharmacoepidemiology and the International Society of Pharmacovigilance have identified information that should always be considered for inclusion in a report submitted for publication

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