What is an ADR?
At KUMC an Adverse Drug Reaction 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.
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?
The reporting of ADR's by healthcare 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 in used
in a large and varied population.
According to Joint Commission on Accreditation of Healthcare Organization guidelines, hospitals are required to develop a comprehensive ADR monitoring program and report significant or unexpected ADR's promptly to the FDA.
How do I report an ADR?
To report an ADR at KUMC, complete an ADR form (available on each nursing unit) and send
it to the pharmacy. An ADR can also be filed by calling the Drug Information Center at
ext. 2328, if you have information about the patient, the reaction, the outcome, the
suspected drug, and other relevant history.
What types of ADR's should be reported?
For practical reasons, it is not necessary to report "nuisance" or well known
non-serious problems associated with drug therapy (ie. ampicillin rash or erythromycin
gastrointestinal upset). However, all serious and significant drug reactions should be
reported to the pharmacy. Serious reactions already listed in the drug's package insert
should still be reported. A significant drug reaction is defined by any of the following
criteria:
Ninety-three adverse drug reactions were voluntarily reported at KUMC from July 1994 to June 1995. The following graphs display the type and route of the medications involved.
Figure 1.
Figure 2.
The dramatic rise of ADR's in children less than 10 years of age is due to a newly developed program to monitor reactions in the neonatal population. The increased reporting of adverse drug reactions in this age group have not been accounted for before this year. Figure 3 shows the distribution of the reported ADR's by age groups.
Figure 3.
While a product problem differs from an adverse event, it is equally important for health professionals to monitor and report. A product problem includes any concern regarding the quality, performance or safety of any medical device or drug product such as, defective components, poor packaging or labeling, and device malfunction. These problems can be reported directly to the FDA, 24 hours a day by calling 1-800-FDA-1088.
The product problem would need to be described in sufficient detail so that the circumstances surrounding the defect or malfunction of the medical product can be understood. If available, the results of any evaluation of a malfunctioning device and any relevant maintenance / service information should be included.
Here is an example of the form used to report an adverse drug event. The addressograph of the patient is imprinted on the right side. The type of reaction (ex. rash, thrombocytopenia, etc.), the probable drug, any concurrent medications, and treatment of the reaction need to be documented. On the back of the form are several questions that need to be answered to determine causality of the adverse drug reaction. If you have questions about completing the form, contact your floor pharmacist, the inpatient pharmacy, or the Drug Information Center.
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