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Adverse Drug Event Reporting

An Adverse Drug Event (ADE) can be reported by a nurse, physician, pharmacist, respiratory therapist, or any other person who become aware of the event.

Benefits of an ADE monitoring and reporting system include the following:

  • Assessment of the safety of drug therapies. This is especially important for new drugs. Premarketing frequencies of ADEs are based on a "select study population". Postmarketing frequencies of ADEs provide a better overall reflection of adverse events in the general population. Reporting of ADEs for new drugs has led to the withdrawal of drugs from the market and modification of the package insert information.
  • Provides a method of identifying preventable ADEs (e.g., vancomycin infusion-related "red man syndrome").
  • Provides important modification in the use of the involved drugs (e.g., changes in dosage and administration recommendations).
  • Provides education of health professionals on adverse drug effects (reports of ADEs are sent to departmental quality assurance for feedback to their staff).
  • Provides quality assurance screening findings for use in drug use evaluation (MUE) programs.
  • Provides a measurement of ADE rates over time.

To derive maximum benefit from the ADE program, it is important that all clinicians assume responsibility in reporting adverse drug reactions.

For questions, please contact the Medication Safety Specialist at srafie@ucsd.edu.