Systematic Collection of Patient-Reported Adverse Drug Reactions: A Path to Patient-Centred Pharmacovigilance

Abstract

1 IntroductionOver the past 15 years, evidence has mounted that patientself-reporting of symptomatic adverse drug reactions isboth feasible and informative. Multiple recent reports havedescribed programmes internationally in which patientself-reports provide data beyond reporting by health pro-fessionals [1–5]. Various models have been used and thereare several essential lessons to be learned from theseexperiences, in addition to work using patient-reported datain related contexts such as clinical trials and routine clin-ical practice.2 It is Essential to Systematically Collect Informationfrom Patients Rather than Rely on SpontaneousReportingMany adverse event reporting systems rely on volun-tary (spontaneous) reports by patients and/or clinicians.Although submitted information can be informative insome cases, the denominator of potential reporters isunknown, and many adverse reactions are missed due tolack of interest, willingness, availability, or awareness ofstakeholders to report. As a result, the absolute number ofreports collected via these systems is generally low andoften does not reflect the experience of patients comparedwith systematic collection [6]. Patients are not engaged aspartners in the data collection enterprise.Systematic elicitation of information from patientsprovides a known denominator and a more comprehensivepicture within a population. This can be achieved in limitedpopulations via registries, or through wide implementationusing existing or envisioned infrastructure to engagepatients. The paper by Leone et al. in this issue of DrugSafety [7] describes successful implementation of a regio-nal programme through the mechanism of local pharma-cies. Information is systematically elicited from patientswho are engaged by their local pharmacists. This approachdoes more than use an existing infrastructure of localpharmacies for distribution of questionnaires–it creates apartnership between practitioners and patients in anendeavour to understand the experience of both the indi-vidual patient and the broader population.This programme mirrors successful engagement approa-ches in other contexts, such as clinical trials where datamanagers form relationships with patients to encouragereporting, or routine practice settings where customizedinvitation letters are sent to patients from their doctor ornurse.3 Backup Data Collection Systems ReduceMissing DataA lesson learned from the collection of patient-reportedinformation in prospective clinical trials and registries isthat the frequency of missing patient reports is highlydependent on how this information is collected. In partic-ular, data can be recovered from those who are initiallyunable or unwilling to self-report, through the use ofbackup data collection methods. These may include elec-tronic reminders via mail, email or telephone, with ahuman call to those who continue not to report. This