This is the first tool to give insight in the level of relevant clinical information present in ADR reports. It can be used internationally to compare reports coming from different reporting methods and different types of reporters in pharmacovigilance.

IntroductionSpontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form.ObjectiveThe objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.MethodsThe app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis.ResultsHigher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78–85%, reference: 78–98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled.ConclusionThe WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0679-6) contains supplementary material, which is available to authorized users.

This prospective cohort study has given insight into latency time and action taken with varenicline when ADRs occur during treatment with varenicline in daily practice. It confirms the ADR pattern detected prior to marketing of the drug.

Introduction Due to the COVID-19 vaccination campaign, national pharmacovigilance (PV) centres had to deal with high volumes of Individual Case Safety Reports (ICSRs) that needed to be processed and assessed in a short time span. This necessitated the development of a dedicated system to enable near real-time vaccine safety monitoring at the Dutch PV Centre Lareb. Objectives To describe infrastructure, processes and Adverse Events Following Immunisation (AEFIs) reported for vaccine safety monitoring of COVID-19 vaccines during a large-scale vaccination campaign in the Netherlands. Methods A COVID-19 tailored vaccine web-based reporting form collected information on the vaccine administered, AEFIs and other (medical) information. A fully automated process for ICSRs enabled the handling of the majority of common and known reported AEFIs. All other ICSRs were triaged daily and processed separately. There were daily signal detection meetings and weekly reports for batch analysis. ResultsIn 2021, Lareb received 184,411 ICSRs, a reporting rate of 0.67% for vaccines given in the Netherlands. 887,954 AEFIs were reported, mostly well-known, nonserious AEFIs; 2.4% were serious and 0.3% were fatal. 33.1% of all ICSRs were processed fully automatically. Based on the daily triage, 4.2% were flagged as 'high priority'; 62.7% as 'low-priority'. Twenty-seven signals and news stories about the COVID-19 vaccines were disseminated. Conclusions Due to automatic processing of well-known AEFIs, daily triage and signal detection meetings, 99.9% of the ICSRs were processed within the compliance timeframe to Eudravigilance, and signal detection was performed during a large-scale vaccination campaign. These experiences may serve as a blueprint for future mass vaccination programs.

SUMMARY BackgroundAn increase of therapeutic substitution after patent expiry might have a negative effect on cost-savings generated with newly introduced generic drugs. To evaluate influences of patent expiry on therapeutic substitution, switch behaviour before and after patent expiry was investigated.