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Adverse Drug Reaction Reporting

An Adverse Drug Reaction (ADR) can be reported by a nurse, physician, pharmacist, respiratory therapist, or any other clinician. 

You can also send an ADR directly to the Pharmacy Quality Improvement Coordinator by clicking here.  Or you can call 543-3641 or 33641 to report your ADR. 

ADRs include any reaction to a drug that is unexpected or undesirable and results in:

  • a change in drug therapy, including a change in dosage or discontinuation of therapy

  • initial or prolonged hospitalization

  • intervention (supportive treatment) to prevent permanent impairment or damage

  • a life threatening event

  • permanent disability

  • death

  • congenital anomaly

An ADR also includes all reactions to new drugs (drugs on the market for 3 years or less).

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

  • assessment of the safety of drug therapies. This is especially important for new drugs. Premarketing frequencies of ADRs are based on a "select study population". Postmarketing frequencies of ADRs provide a better overall reflection of adverse events in the general population. Reporting of ADRs 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 ADRs (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 ADRs 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 ADR rates over time.

To derive maximum benefit from the ADR program, it is important that all clinicians assume responsibility in reporting adverse drug reactions. For questions concerning an ADR or to report an ADR please call 33461.