Characterisation of Drug Interaction Related Signals Leading to EU Regulatory Action and a Methodological Review of Novel Drug Interaction Signal Detection Methods in the Post-Marketing Setting
CPRD StudyPrimary Care PASS Study
Characterisation of Drug Interaction Related Signals Leading to EU Regulatory Action and a Methodological Review of Novel Drug Interaction Signal Detection Methods in the Post-Marketing Setting.
Impact Analyses of European Pharmacovigilance Interventions on Public Health Burden
CPRD StudyPrimary Care PASS Study
This interim analysis tested a method for predicting public health impact of PV interventions on a subset of products based on drug utilisation data and expected changes in morbidity.
Monitoring the Safety of Exenatide Once-Weekly (Bydureon®) in Primary Care in England: Results from a PASS
CPRD StudyPrimary Care PASS Study
Incidence of AP was low in Bydureon® users and consistent with prior clinical trial/observational data.
Utilisation of Exenatide Once-Weekly (Bydureon®) in Primary Care in England: Results From a PASS
CPRD StudyPrimary Care PASS Study
Bydureon® was largely used in accordance with prescribing recommendations in 1o care in England, with most frequent use in pts with poor diabetic control where treatment with alternative ADMs may have been unsuccessful.
Utilisation Of Dulaglutide In Primary Care In England: Interim Results From A Post Authorisation Safety Study
CPRD StudyPrimary Care PASS Study
Dulaglutide is a once-weekly injectable long acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) authorised in England for the treatment of type 2 diabetes mellitus (T2DM).
The Association between Direct Oral Anticoagulants and Gynaecological Bleeding in Women v. Standard Therapy: A Systematic Review
CPRD StudyPrimary Care PASS Study
Women receiving anticoagulation are susceptible to the added risk of gynaecological bleeding (GB).
Risk Factors of Major Bleeding in Patients Prescribed Rivaroxaban in Primary Care in England
CPRD StudyPrimary Care PASS Study
The association between oral anticoagulant use and bleeding risk has been widely reported.
References
34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), Prague, August 2018
Sources of evidence supporting post-marketing pharmacovigilance regulatory actions since 2012.
Abstract 1823CPRD StudyPrimary Care PASS Study
Major updates to the European Union (EU) pharmacovigilance (PV) legislation were implemented in July 2012.
Passive enhanced safety surveillance in children receiving Fluenz ® Tetra vaccination in England during the early 2017 influenza season.
Abstract 2085CPRD StudyPrimary Care PASS Study
Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza vaccine recommended for use in children aged 2 to 17 years vaccination as part of the seasonal influenza immunisation campaign in the UK.