The initial project period of two and one-half years has been dedicated to the development and validation of a totally new approach to postmarketing surveillance in ambulatory patients. As a complement to the existing physician-initiated reporting systems, we proposed a method based upon a patient-initiated reporting system via a toll-free telephone number to a central monitoring station where a cadre of interviewers have been trained to conduct a computer-assisted interview with each patient who calls to report new adverse clinical events (ACEs). Preliminary results from the first methodologically oriented study indicate that the system appears to be effective in detecting well-known, short-term adverse drug reactions (ADRs) from antibotics and tricyclic antidepressants, and is now ready to be field-tested for its ability to detect unknown ADRs from newly approved psychopharmacologic agents. Therefore, the principal aims of this five-year renewal application are as follows: 1) To utilize our patient-initiated reporting method in a more definitive test of the system's ability to detect possible ADRs from recently approved antidepressant and anxiolytic drugs. 2) Within the limiations of possible biases introduced by using only consenting patients within a restricted geographical region, to derive more accurate estimates of ADR incidences for those ACEs identified by the patient-initiated monitoring system. 3) To estimate how accurately patients can attribute causality to ACEs reported after initiating treatment with newly approved psychiatric drugs, and then to determine the contribution of these patient attributions to the overall validity of the new postmarketing system. 4) To extend our original postmarketing surveillance objective (limited to identifying only adverse events) and now attempt to also detect unsuspected benefits: i.e., new therapeutic indications or reduced incidences of ADRs.
| Fisher, S; Bryant, S G; Solovitz, B L et al. (1987) A patient-initiated postmarketing surveillance system. Psychopharmacol Bull 23:400-4 |
| Solovitz, B L; Fisher, S; Bryant, S G et al. (1987) How well can patients discriminate drug-related side effects from extraneous new symptoms? Psychopharmacol Bull 23:189-92 |
| Bryant, S G; Fisher, S; Kluge, R M (1987) Increased frequency of doxycycline side effects. Pharmacotherapy 7:125-9 |
| Fisher, S; Bryant, S G; Solovitz, B L et al. (1987) Patient-initiated postmarketing surveillance: a validation study. J Clin Pharmacol 27:843-54 |
| Bryant, S G; Fisher, S; Kluge, R M (1987) Long-term versus short-term amitriptyline side effects as measured by a postmarketing surveillance system. J Clin Psychopharmacol 7:78-82 |
| Fisher, S; Bryant, S G; Kluge, R M (1986) Measuring adverse drug reactions in a postmarketing surveillance system. Psychopharmacol Bull 22:272-7 |
| Fisher, S; Bryant, S G; Kluge, R M (1986) New approaches to postmarketing surveillance. Psychopharmacology (Berl) 90:347-50 |
