PCV2 - Direct-To-Patient Contact and Proactive Pharmacovigilance System: A Case Study

Abstract

Post-authorization non-interventional safety studies typically enroll patients at sites and safety events are reported and collected as appropriate by site personnel during standard-of-care visits. Although this is the traditional approach, it has several practical shortcomings: infrequent or irregular standard-of-care visits; patients switching health care providers; transient nature of some safety events; treatment at non-study sites, and the lack of care-seeking for the safety events. An alternative study design that overcomes several of these shortcomings includes direct-to-patient contact (DPC) and follow-up. The purpose of this study is to describe patients’ short and long term management patterns including the detection and verification of events of interest by contacting patients’ event treating physician (ETP). This is multinational multicenter observational prospective longitudinal cohort study involving 10,600 patients in Europe and South America. Patients were enrolled at hospital and followed up by telephone by a specialized DPC unit at 6 weeks then quarterly up to 2 years after hospital discharge. Data collected include clinical outcomes, safety events of interest, economic burden and quality of life. A total of 88,276 phone calls to patients were performed, achieving a reachable rate of 88.5% and an interview successful rate of 84.6%. 87.2% of the initial sample completed the 2-year follow-up period: 5.7% of the sample died, 6.0% voluntarily withdrew and 0.9% was withdrawn to participate to a clinical trial. Only 19 patients were never reached (0.2%). In total, 2144 events of interest were detected and a medical verification from ETPs was obtained in 72.3% of the case. This study demonstrates that DPC along with a proactive pharmacovigilance system achieved very high response rates from both patients and ETPs. It represents an effective alternative methodology to collect patients data, including safety data, in real life settings.