Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information.

A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication between pharmacovigilance experts (PVEs) and healthcare professionals (HCPs) for exchanging unique and informative adverse event (AE) information. The solution was implemented in a commercially available electronic health record (EHR) system/platform, no direct contact between PVEs and the HCPs was possible. The Clinical Affairs team of the EHR vendor was used as an intermediary to ensure appropriate information was exchanged while protecting HCP and patient privacy.

Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility.

Introduction: Spontaneous reporting of adverse events has increased steadily over the past decades, and although this trend has contributed to improving post-marketing surveillance pharmacovigilance activities, the consequent amount of data generated is challenging to manually review during assessment, with each individual report requiring review by pharmacovigilance experts. This highlights a clear need for alternative or complementary methodologies to help prioritise review.

Objective: Here, we aimed to develop and test an automated methodology, the Clinical Utility Score for Prioritisation (CUSP), to assist pharmacovigilance experts in prioritising clinical assessment of safety data to improve the rapidity of case series review when case volumes are large.

Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks.

Introduction: The basis of pharmacovigilance is provided by the exchange of Individual Case Safety Reports (ICSRs) between the recipient of the original report and other interested parties, which include Marketing Authorization Holders (MAHs) and Health Authorities (HAs). Different regulators have different reporting requirements for report transmission. This results in replication of each ICSR that will exist in multiple locations.

Engaging Patients Online Healthcare Fora: Three Pharmacovigilance Use Cases.

Increasingly, patient-generated safety insights are shared online, via general social media platforms or dedicated healthcare fora which give patients the opportunity to discuss their disease and treatment options. We evaluated three areas of potential interest for the use of social media in pharmacovigilance. To evaluate how social media may complement existing safety signal detection capabilities, we identified two use cases (drug/adverse event [AE] pairs) and then evaluated the frequency of AE discussions across a range of social media channels.