New approaches to postmarketing surveillance

✍ Scribed by Seymour Fisher; Stephen G. Bryant; Ronica M. Kluge

• Publisher: Springer
• Year: 1986
• Tongue: English
• Weight: 405 KB
• Volume: 90
• Category: Article
• ISSN: 0033-3158
• DOI: 10.1007/bf00179189

✦ Synopsis

As part of a large-scale ongoing project exploring new pharmacy-based methods of postmarketing surveillance, we are comparing a patient-initiated monitoring system to a staff-initiated approach. Here we report data only from staff-initiated, computer-directed telephone interviews with 231 outpatients approximately 2 weeks after they had been prescribed a target drug chosen from two markedly different pharmacological classes for which adverse drug reactions (ADRs) are well-documented. Our results indicate that spontaneous patient reports of "new or unusual symptoms" obtained from a standardized staff-initiated telephone interview can be quite reliable, leading to accurate detection of known tricyclic antidepressant and antibiotic ADRs.