WHAT
IS AN ADR?
At KUH 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 nonprescription drug, or an alternative medicine.
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 KUH?
The reporting of ADR’s by health professionals is crucial to postmarketing surveillance. Easily recognized and frequent drug reactions generally are discovered during premarketing trials, but unexpected reactions may only occur after the drug is used on a large and varied population.
According to JCAHO
(Joint Commission on Accreditation of Healthcare Organizations) guidelines,
hospitals are required to develop a comprehensive ADR monitoring program and
report significant or unexpected ADRs promptly to the FDA’s MedWatch Program.
WHAT TYPE OF ADRS SHOULD BE REPORTED?
For practical reasons, it is not necessary to report “nuisance” or well known, nonserious problems associated with drug therapy (e.g., erythromycin related minor gastrointestinal upset). In addition, if a reaction is only suspected, it should be reported. Definitive causality is not necessary to report an ADR. All serious and significant ADRs should be reported to the pharmacy. Serious reactions already listed in the 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
· Results in disability
· Results in patient
death
·
Reaction associated with newly marketed drugs (within last 3
yrs)
·
Rare, unusual or unlabeled reactions with little
documentation in the literature.
·
Causes congenital anomaly
·
Reaction or lack of reaction associated with a suspected
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 contact the clinical
pharmacist or by calling the Drug Information Center’s ADR hotline number (ext.
82328) or email (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 82328) |
Patient
Name
|
Medical Record # |
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Unit
|
Service
|
Age
|
Sex |
|
Admitting
Diagnosis
|
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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 – Required treatment with Rx drug 3 – Resulted in Hospitalization 4 – Prolonged hospitalization a. > 24
hrs b. < 24 hrs 5 – Resulted in Permanent Disability 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?
Y N NA 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.
Patient Noncompliance |
|||
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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