| Autor: |
Fisher, Seymour, Bryant, Stephen G., Solovitz, Brenda L., Kluge, Ronica M. |
| Zdroj: |
Journal of Clinical Pharmacology; Nov1987, Vol. 27 Issue 11, p843-854, 12p |
| Abstrakt: |
A new patient-initiated, pharmacy-based postmarketing surveillance system is described. At the time a new prescription for a targeted drug was filled, 2705 outpatients (experimentals) randomly assigned to the new system had a printed notice attached to their medication bags: the information requested them to report any 'new or unusual symptoms' during the next 2 weeks by a toll-free telephone number to a trained nonprofessional who conducted a standardized adverse drug reaction (ADR) interview. To help validate the new system, another sample of 1109 patients (controls) did not receive a request for self-monitoring but were interviewed by telephone 2 weeks later. Target drugs were chosen from two classes for which side effect profiles are well identified: oral antibiotics and tricyclic antidepressants. Results show that within both drug classes, all patient-initiated reports closely matched those obtained from controls; the experimental and control groups also reported predictably high relative frequencies for the most commonly expected ADRs. Additional analyses suggest that a patient-initiated monitoring system could prove to be a promising complement to existing physician-based surveillance systems. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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