Table 2.

Data fields from the existing adverse drug event reporting forms that clinicians felt should be omitted.

Data field		Justification for excluding
Patient Information
	Height or weight	Future providers can obtain this information from patients or their records. Height and weight may be relevant to dosing, but are not essential for assessing most ADEsa and patients’ medication regimen.
	Medical history or concomitant disease states	Burdensome to enter, especially for complex patients. Future providers can often obtain this information from patients or their records.
Reporter Information
	Phone or mailing address or email	Burdensome to enter. If future providers have the reporter’s name, role, and institution, they will likely be able to find the contact information online.
ADE Information
	Reaction start or end date, duration	Can be difficult to pinpoint (eg, delirium). Free text description of timelines is more accurate and in line with clinician charting practices.
	Severity or seriousness	Even with standardized definitions, severity or seriousness assessments are often subjective, differ across contexts, and are prone to error. This information may be better communicated via other fields such as the patient’s outcome (eg, was the patient hospitalized?), their treatment (did the ADE require treatment? Was the drug discontinued?), symptom or diagnosis (eg, anaphylactic reaction or upset stomach), lab data (eg, low sodium of 115 or 125), and dechallenge results (resolved or worsening).
	Rechallenge information	Often unavailable at the point-of-care, or impractical, unethical, or harmful to re-expose the patient intentionally.
Health Product(s)
	Prescribed dose or frequency	The dose prescribed is less relevant than the dose that the patient actually took or received in relation to the ADE. Prescription information can be accessed elsewhere if needed.
	Product strength	The dosage taken by the patient is more important. Given the product name or DINb or NPNc, product strength can usually be obtained.
	Source (eg, pharmacy, grocery store, internet, other)	Generally not essential for assessing the ADE and the patient’s medication regimen.
	Product start or end date, duration	Can be difficult to accurately collect (must rely on patient memory or prescription records that may be unavailable or inaccurate). Free text description of timelines is more accurate and in line with clinician charting practices.
	Manufacturer	Not essential for assessing the ADE and the patient’s medication regimen.
	Batch or lot #	Burdensome to gather; will often require tracing to pharmacy. Very rarely essential for assessing the ADE and the patient’s medication regimen.
	Concomitant health products	Providers should be able to enter multiple suspect drugs, but a complete account of the patient’s medication regimen is burdensome to enter, especially for complex patients. Future providers can usually obtain other medication information from the patient, their records, or by linkage to electronic medication dispensing information depending on the jurisdiction where care is provided.

^aADE: adverse drug event.

^bDIN: Drug Identification Number.

^cNPN: Natural Product Number.