Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience.

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.

A tailor-made approach for causality assessment for ADR reports on drugs and vaccines.

Purpose: To estimate causation of adverse drug reaction (ADR) reports, causality methods were developed from a theoretical perspective. In daily practice, not all information is relevant or available, decreasing the applicability. We developed a new causality documentation tool (CausDoc) where an algorithm is combined with expert judgement.

Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study.

Introduction: Spontaneous 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.

Objective: The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.

First experiences with a tool to measure the level of clinical information present in adverse drug reaction reports.

Background: To make a proper causality assessment of an adverse drug reaction (ADR) report, a certain level of clinical information is necessary. A tool was developed to measure the level of clinical information present in ADR reports. The aim of this study was to test the validity and reliability of the clinical documentation tool (ClinDoc) in an international setting.

Experiences with the use of varenicline in daily practice in the Netherlands: a prospective, observational cohort study.

Background: Although a concise overview of adverse drug reactions (ADRs) to varenicline is available, little is known about the use of varenicline in daily practice and time-related information about ADRs.

Objective: The aim of this study was to gain insight in the safety and use of varenicline in daily practice.

Methods: A prospective, observational, non-interventional cohort study was performed.

Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands.

Background: In 2010, the Netherlands Pharmacovigilance Centre Lareb received more than 4000 reports from healthcare professionals (HCPs). All HCPs received individual personal feedback containing information about the reported drug-adverse drug reaction (ADR) association. It is unclear what type of information HCPs expect in this feedback letter.

Switch patterns before and after patent expiry of omeprazole: a case study in The Netherlands.

Background: An 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.

Aim: To describe proton pump inhibitor use and investigate substitution patterns from omeprazole before and after patent expiry.