Drug Safety Monitor

 October                                                                        1998

ADVERSE DRUG REACTION REPORTING

WHAT IS AN ADR?

At KUMC an adverse drug reaction (ADR) is defined as a "serious or significant reaction, injury, toxicity, sensitivity reaction or bioequivalence problem associated with the therapeutic use of a prescription or non prescription drug.

This definition includes a single effect or a cluster of abnormal signs, symptoms and laboratory tests. Excluded are reactions due to drug abuse or intentional overdoses.

WHY SHOULD I REPORT AN ADR AT KUMC?

The reporting of ADR’s by health professionals is crucial to postmarketing drug surveillance. Easily recognized and frequent drug reactions generally are discovered during premarketing trials, but unexpected reactions may only occur after the drug is used in a large and varied population.

According to JCAHO (Joint Commission on Accreditation of Healthcare Organiz-ations) guidelines, hospitals are required to develop a comprehensive ADR monitoring program and report significant or unexpected ADR’s promptly to the FDA’s MedWatch program.

WHAT TYPES OF ADRS SHOULD BE REPORTED?

For practical reasons, it is not necessary to report "nuisance" or well known, non-serious problems associated with drug therapy (e.g., ampicillin rash or erythromycin gastrointestinal upset). In addition, if a reaction is only suspected, it still should be reported. Definite causality is not needed to report an ADR. However, all serious and significant drug reactions should be reported to the pharmacy. Serious reactions already listed in the product’s package insert should also be reported. A significant reaction is defined as any of the following criteria:

  • Results in patient hospitalization
  • Prolongs hospitalization > 24 hrs
  • Requires intervention or treatment with prescription medication to prevent permanent impairment
  • Results in disability
  • Results in patient death
  • Reaction associated with new chemical entity (those drugs marketed within the last three years)
  • Rare, unusual or unlabeled reactions with little documentation in the literature
  • Causes congenital anomaly
  • Reaction or lack of therapeutic effect associated with a bioequivalence problem

HOW DO I REPORT AN ADR?

To report an ADR at KUMC, complete an ADR form (available on nursing units) and send to the pharmacy. An ADR can also be filed by contacting the clinical pharmacist for that nursing unit, or, by contacting the Drug Information Center (ext. 2328 or druginfo@kumc.edu)

 

The University of Kansas Medical Center

Suspected Drug Reaction Report

Reporting adverse drug reactions (ADR) is mandated by JCAHO for hospital accreditation. These reports are essential in identifying rare reactions or reactions occurring under special circumstances which are not found in premarketing trials.

Complete both sides of this form for any suspected drug reaction and return to the PHARMACY. All information on this report is confidential and protected from public disclosure.

If you have any questions regarding this form or how to report an ADR please call the Drug Information Center (ext 2328)

 Patient Name Medical Record #
Unit Service Age Sex
Admitting Diagnosis
Suspected Drug(s), Route of Administration, Dosage Regimen Date of Reaction

 
Date(s) of Drug Administration Describe the Reaction(s)

 

(Please Continue on Opposite Side of Card)
Relevant Information (Labs, Allergies)

 

Concomitant Drugs and Dates of Administration (Exclude Those Use to Treat Reaction

 Action Take with Suspected Drug

1 – Drug discontinued
2 – Dosage reduced
3 – Patient Counseled

 Therapy Used to Treat Rxn
Patient Outcomes (Circle All That Apply)

1 – Symptoms resolved or improved
2 – Resulted in permanent disability
3 – Resulted in hospitalization
4 – Required treatment with Rx drug
5 – Prolonged hospitalization
           a. > 24 hrs b. < 24 hrs
6 – Patient Death
7 – None of the above, required no therapy

 3.   Did the adverse drug reaction (ADR) occur after suspected                   Y N
    drug administration?
4. Did the ADR improve after the drug was stopped or dose decreased?    Y N
5. Did the ADR reappear when the drug was readministered?                NA Y N
6. Are there any alternative factors which could have caused the ADR?    Y N

Specify: __________________________________

7. Did the patient have a previous history of similar reaction to same drug or          class of drugs?                                                                                  Y N
8. Was this a preventable reaction?                                                  Y N
        Please circle           a. Known drug-drug interaction
                                      b. Patient allergic history to medication
                                      c. Medication error
Reporter’s Initials Date Reported Completed by the KUMC Drug Information Center
1. Is this reaction stated in the package insert?   Y N
2. Are there published reports regarding this    
   reaction?                                                             Y   N		 Date Received by DIC
Reporter’s Profession (Circle One)
MD    RN     RPh     RT        Other _______		 Entry Date: ADR Database

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