Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US

Abstract

BackgroundPreparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. In 2012, the FDA Center for Devices and Radiologic Health (CDRH) launched a free, public mobile AE reporting app, MedWatcher, for patients and clinicians. During the same year, a patient community on Facebook adopted the app to submit reports involving a hysteroscopic sterilization device, brand name Essure®.MethodsPatient community outreach was conducted to administrators of the group “Essure Problems” (approximately 18,000 members as of June 2015) to gather individual case safety reports (ICSRs). After agreeing on key reporting principles, group administrators encouraged members to report via the app. Semi-structured forms in the app mirrored fields of the MedWatch 3500 form. ICSRs were transmitted to CDRH via an electronic gateway, and anonymized versions were posted in the app. Data collected from May 11, 2013 to December 7, 2014 were analyzed. Narrative texts were coded by trained and certified MedDRA coders (version 17). Descriptive statistics and metrics, including VigiGrade completeness scores, were analyzed. Various incentives and motivations to report in the Facebook group were observed.ResultsThe average Essure AE report took 11.4 min (±10) to complete. Submissions from 1349 women, average age 34 years, were analyzed. Serious events, including hospitalization, disability, and permanent damage after implantation, were reported by 1047 women (77.6 %). A total of 13,135 product–event pairs were reported, comprising 327 unique preferred terms, most frequently fatigue (n = 491), back pain (468), and pelvic pain (459). Important medical events (IMEs), most frequently mental impairment (142), device dislocation (108), and salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido (n = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered “well documented” 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals.ConclusionsOutreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further researc...

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

“…This pilot has the advantage of enabling direct feedback to reporters, and further interaction with the reporter is facilitated [35,37]. In the US, the FDA's Medwatcher app has been key in identifying problems with the Essure Ò device [38]. A prerequisite for submitting a report of a suspected adverse drug reaction to a spontaneous reporting system is that the patient knows that the system exists and that he or she can use it to report.…”

‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework

“…Amid the general lack of definitions, some articles regarding risk management of medicinal products [22,34] nevertheless discuss the quantity and quality of (patient) engagement, involvement or participation, or add understandings of 'activation' and 'empowerment'. The authors of one more sophisticated empirical study have gone further to consider engagement for pharmacovigilance via a model of 'motivation, incentives, activation and behaviour' (MIAB) [29]. The precise relationship between MIAB and engagement is not specified, though the original social science study on which these authors draw refers to MIAB as an 'engagement mechanism' [35].…”

“…The recognition of such tensions helps us understand the shortcomings in the effectiveness of these engagement interventions. More successful engagement, as seen within some empirical studies, can be understood in terms of a fuller and more consistent embracing of participatory models [29,47].…”

“…Campaigns by national bodies, for example to increase ADR reporting or appropriate prescribing, are also engagement interventions. Evidence on the depth, dynamics and behavioural impact of engagement is so far available from a small number of pharmacovigilance studies: for example, HCPs describe themselves as being more likely to report ADRs within a therapeutic advice service where they could receive advice in return [56]; or the meaning and motivations of engagement, not least in relation to community belonging, positive feedback (from an online platform) and related feelings of altruism, were deemed fundamental for MUs' usage of safety information and ADR reporting [29,57]. Here we see not only that the depth of engagement is pertinent but, moreover, the interactive dynamics, emotions and meaningful experience-the texture [58]-of engagement processes are also fundamental to their effectiveness [47].…”

“…In practice, pharmacovigilance is composed of structured processes, including aggregating adverse drug reaction (ADR) case reports [1,[11][12][13][14][15], reviewing pharmacoepidemiological and other study data, identifying and assessing new risks and making decisions [11,[16][17][18][19][20][21] on risk management strategies [22] and their implementation in healthcare [23][24][25][26]. While engagement is increasingly pursued in practice [27,28] and receives global attention [8], empirical research [16,29] into pharmacovigilance engagement remains in its infancy [7]. Conceptual precision (construct validity) is vital for the internal validity of research [30].…”