EXPERIENCE IN THE DEVELOPMENT OF A POSTMARKETING SURVEILLANCE NETWORK- THE PHARMACY MEDICATION MONITORING PROGRAM

OBJECTIVE: To describe the pilot and early implementation phase of a s ystem for assembling acid recruiting cohorts of patients taking select ed prescription medications and prospectively monitoring them for new health events, DESIGN: Prospective observational study, based on telep hone interviews, of 1475 patients filling prescriptions for a nonstero idal antiinflammatory drug (NSAID). Patients were interviewed by telep hone using trained interviewers at a central site. Hospitalizations an d deaths were followed up and reviewed by an independent physician. SE TTING: Community setting in a region of Hamilton, Ontario, Canada. PAR TICIPANTS: AU consenting patients filling new or repeat prescriptions for NSAIDs at participating pharmacies, MAIN OUTCOME MEASURES: The aut hors report on the development and assessment of systems for: (1) ongo ing recruitment of patients through community pharmacies; (2) data tra nsfer from pharmacies to the coordinating center; (3) surveying patien ts; (4) classifying, coding, and evaluating new health events; and (5) following up on new serious adverse events. RESULTS: Fifty-one percen t of patients approached were recruited, and 83% of these provided com pleted interviews. For patients picking up their own medications, phar macy workload varied from 4 to 10 minutes per patient approached, Nine teen percent of patients reported having a new health problem or unusu al symptom at the initial telephone interview. Reported health-related events were similar to those described in other studies of NSAIDs. CO NCLUSIONS: Most aspects of the monitoring system performed well. One l imitation was the low recruitment rate for patients who did nor direct ly drop off or pick up their own prescriptions. Even so, this method o f patient accrual may complement alternative monitoring programs.