A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms
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DruX I n / u m f C i n Joiirniil. Vol. 33. pp. Y07-Y?0, IYYY Printed in the USA. All rights reserved.
A MODEL FOR UNDERSTANDING PATIENT ATTRIBUTION OF ADVERSE DRUG REACTION SYMPTOMS JANE E. DEWITT,MS, RPH PhD Student. Division of Clinical and Administrative Pharmacy. College of Pharmacy, and Clinical Pharmacist, llniversity of Iowa Hospitals and Clinics
BERNARDA. SOROPMAN, PHD, RPH Associate Professor. Division of Clinical and Administrative Pharmacy, College of Pharmacy The University of Iowa Iowa City. Iowa
The study uddressed issues surrounding the pntient j . recognition of whether a symptom is d r u g or niseiise-related. Studies have demonstrated that the infornmtion the Iaypopulation has about illness can be organized into Jive categories: identity (symptoms and label), cause. time course. consequences. and cure. These elements, termed illness representations or prototyes. facilitate patient interpretation and response to symptoms as they occur the ore tic ally^ patients may have such a framework f o r interpretation of symptoms thrit thev considered adverse drug reactions. The purpose of this study was to explore whether ( i n adverse drug reaction ( A I M ) prototype esists. A self-administered questionnaire wus used t o elicit the subject i perceptions and awareness of adverse drug reactions. Subjects n'ere also asked to make judgments about severity of ADRs and frequency of piirticulur symptoms as drug-related effects. The study population was a sample of 338 adults visiting afnmi1.v practice clinic over a four-week period. A majority of the respondents reported personal e.rperienc-e of an ADR and described the event with information nhich was consistent with the Jive categories. Subjects who reported ADR e-rperience believed drug reactions occur more frequently and are less severe than those without such crperience. Results also indicated that people have knowledge about ADR symptoms that is substantially accurate. and may use a protofipe tofacilitate identification of svmptonis as iin adverse ej'ect. Key Words: Adverse drug reaction; Illness representations; Symptoms
INTRODUCTION NEW 'harmace'ticals do not expose the full extent of potential adverse effects associated with the drug. In early trials there is an attempt to isolate drug effects from confounding elements by
Reprint address: Jane E. DeWitt, MS, RPh. S557 College of Phamiacy, The University of Iowa. Iowa City. IA 52242. E-mail: [email protected].
excluding- patients with concomitant disease . or other drug therapy from the study population. In addition, clinical trials often do not reveal the adverse effects that emerge with long-term use, nor do they target large enough populations to identify effects that are rare. In an effort to capture the missing information, the Food and Drug Administration (FDA) conducts a postmarketing surveilhnce reporting system for adverse drug reactions. The spontaneous reporting system,
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Jone E. De Witt rind Bernard A. Sor
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