The importance of direct patient reporting of adverse drug reactions in the safety monitoring process

K Sienkiewicz, M Burzyńska… - International Journal of …, 2021 - mdpi.com
All medicinal products authorized in the European Union are subjects of constant drug-
safety monitoring processes. It is organized in a pharmacovigilance system that is designed …

Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework

L Shafei, L Mekki, E Maklad, T Alhathal… - International Journal of …, 2023 - Springer
Abstract Background Only 5–10% of all adverse drug reactions (ADRs) are reported.
Mechanisms to support patient and public reporting offer numerous advantages to health …

Safety concerns reported by patients identified in a collaborative signal detection workshop using VigiBase: results and reflections from Lareb and Uppsala Monitoring …

S Watson, RE Chandler, H Taavola, L Härmark… - Drug safety, 2018 - Springer
Introduction Patient reporting in pharmacovigilance is important and contributes to signal
detection. However, descriptions of methodologies for using patient reports in signal …

Adverse drug reaction reporting by patients in 12 European countries

A Valinciute-Jankauskiene, L Kubiliene - International Journal of …, 2021 - mdpi.com
Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety
risks and bolster the pharmacovigilance system. The aim of this study was to examine the …

“ADR PvPI” Android mobile app: Report adverse drug reaction at any time anywhere in India

J Prakash, K Joshi, D Malik, O Mishra… - Indian journal of …, 2019 - journals.lww.com
BACKGROUND: To improve the public health and promote instant adverse drug reaction
(ADR) reporting, a need to develop an ADR Pharmacovigilance Programme of India (PvPI) …

[HTML][HTML] Co-design and development of EndoSMS, a supportive text message intervention for individuals living with endometriosis: mixed methods study

KA Sherman, MJ Pehlivan, A Singleton… - JMIR Formative …, 2022 - formative.jmir.org
Background: Endometriosis, which affects 1 in 10 people assigned female at birth, is a
chronic systemic inflammatory disease with a high symptom burden and adverse …

[HTML][HTML] Knowledge, awareness, perception and reporting of experienced adverse drug reactions among outpatients in Nigeria

R Adisa, OR Adeniyi, TO Fakeye - International journal of clinical pharmacy, 2019 - Springer
Background Higher incidence of adverse drug reactions (ADRs) remain a major cause of
morbidity and mortality. Most targeted ADR reporting activities are mainly professional …

Post-marketing safety profile of vortioxetine using a cluster analysis and a disproportionality analysis of global adverse event reports

C Ekhart, F van Hunsel, E van Puijenbroek, R Chandler… - Drug Safety, 2022 - Springer
Introduction Vortioxetine, a multimodal serotonergic drug, is widely used as treatment for
major depressive disorder. Although on the market since late 2013, the data of the relative …

Fifteen years of patient reporting–what have we learned and where are we heading to?

F van Hunsel, L Härmark, L Rolfes - Expert Opinion on Drug Safety, 2019 - Taylor & Francis
ABSTRACT Introduction: In April 2003, the Netherlands Pharmacovigilance Centre Lareb
successfully implemented patient reporting to their spontaneous reporting system. The …

Development of a multivariate prediction model to identify individual case safety reports which require clinical review

HR Gosselt, EA Bazelmans, T Lieber… - … and Drug Safety, 2022 - Wiley Online Library
Abstract Background The number of Individual Case Safety Reports (ICSRs) in
pharmacovigilance databases are rapidly increasing world‐wide. The majority of ICSRs at …