Evaluation of a patient event report monitoring system

• Published in: Pharmacoepidemiology and drug safety 2000-11, Vol.9 (6), p.491-499
• Main Authors: Colebatch BPharm MClin Pharm, Karen A, Marley MD MBChB, John, Doecke, Christopher, Miles BSc, HelenB, Gilbert BPharm PhD, Andrew
• Format: Article
• Language: English
• Subjects: adverse drug reaction; pharmacoepidemiology; postmarketing surveillance
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/1099-1557(200011)9:6<491::AID-PDS532>3.0.CO;2-O

Background — Detection of adverse drug reactions needs improving. Consumer recruitment and reporting is controversial. Aim — Pilot a method of adverse drug event reporting by patients. Methods — Patients commencing on long‐term medications were asked to record adverse events in a diary for 8 months. Three methods of recruiting patients were compared, through community pharmacies by a pharmacist or a research nurse and by a clinical pharmacist in a teaching hospital. Results — 119 subjects: 77 recruited by community pharmacists, 20 by a research nurse located in community pharmacies and 22 by a clinical pharmacist. Refusal rates were 57.2, 78.0 and 53.2% respectively. Nineteen (16.0%) people withdrew and nine (7.6%) people were lost to follow‐up. Thirty (33.0%) people experienced an adverse event attributed to the medication they were taking. Conclusion — Evaluation of this patient event reporting monitoring system showed that patients can be recruited by pharmacists in community and hospital settings. Refusal rates were smaller when the community pharmacist was recruiting compared to the research nurse. Patients are capable of recording adverse medical events, particularly those that result in doctor visits or hospitalization. Copyright © 2000 John Wiley & Sons, Ltd.