Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance.

Introduction: There is a need to strengthen the evidence base regarding medication use during pregnancy and to facilitate the early detection of safety signals. EudraVigilance (EV) serves as the primary system for managing and analysing information concerning suspected adverse drug reactions (ADRs) within the European Economic Area. Despite its various functionalities, the current format for electronic submissions of safety reports lacks a specific data element indicating medicine exposure during pregnancy.

Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinators.

Background: The European Medicines Agency (EMA) interacts with many different stakeholders involved in the development of drugs, including academic researchers. In recent years, EMA has collaborated more closely with academia, by taking part in external research projects such as those set up under the Horizon 2020 program in general and the Innovative Medicines Initiative in particular. The aim of this study was to evaluate the perceived added value of EMA's involvement in these projects, both from the perspective of the Agency's participating Scientific Officers and of the coordinators of the consortia that undertook them.

Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.

Scientists and regulators in Europe and the United States continue to seek methods and strategies to improve knowledge on rational use of medicines for pregnant and breastfeeding populations, an important subset of women's health. Regulatory agencies have made strides toward improvement, but much more is needed. Recognizing the importance of international collaboration, we have begun to consider how to address these important public health issues more globally.

The Clinical Practice Research Datalink for drug safety in pregnancy research: an overview.

Medicine use during pregnancy is common; however the safety of medicine use during pregnancy is largely unknown when a medicine comes to market. Electronic healthcare databases, including the Clinical Practice Research Datalink (CPRD), are increasingly being used for post-marketing surveillance in this field. The CPRD contains anonymised, longitudinal medical records routinely collected in primary care.

Healthcare databases in Europe for studying medicine use and safety during pregnancy.

Purpose: The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy.

Methods: A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed.

Guillain-Barré syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccines: a multinational self-controlled case series in Europe.

Background: The risk of Guillain-Barré syndrome (GBS) following the United States' 1976 swine flu vaccination campaign in the USA led to enhanced active surveillance during the pandemic influenza (A(H1N1)pdm09) immunization campaign. This study aimed to estimate the risk of GBS following influenza A(H1N1)pdm09 vaccination.

Methods: A self-controlled case series (SCCS) analysis was performed in Denmark, Finland, France, Netherlands, Norway, Sweden, and the United Kingdom.

Colorectal cancer risk reduction following macrogol exposure: a cohort and nested case control study in the UK.

Background And Aims: Animal studies have demonstrated macrogol laxatives may reduce colorectal cancer (CRC) risk. This study aimed to investigate the association between macrogol prescribing and CRC risk.

Methods: A case-control study nested within a cohort of laxative users was conducted using data from the UK General Practice Research Database.

International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines.

Background: The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance.

Asthma management in pregnancy.

Background: Asthma is common during pregnancy, however research is limited regarding the extent and timing of changes in asthma management associated with pregnancy.

Objective: To determine the prevalence of asthma during pregnancy and identify changes in treatment and asthma exacerbation rates associated with pregnancy, while controlling for seasonal influences.

Methods: Pregnant women with asthma were identified from the UK General Practice Research Database between 2000 and 2008.

Pandemic influenza vaccination during pregnancy: an investigation of vaccine uptake during the 2009/10 pandemic vaccination campaign in Great Britain.

Background: Pregnant women in Great Britain were recommended to receive influenza A(H1N1)pdm09 vaccines during the 2009/10 influenza pandemic, however uptake of the vaccines by pregnant women was reported to have been very low.

Aim: We sought to estimate uptake of influenza A(H1N1)pdm09 vaccines and to investigate predictors of vaccine uptake in pregnant women in Great Britain during the 2009/10 pandemic.

Results: Uptake of influenza A(H1N1)pdm09 vaccines by pregnant women was 21.

Evaluating the hazard of foetal death following H1N1 influenza vaccination; a population based cohort study in the UK GPRD.

Background: To evaluate the risk of foetal loss associated with pandemic influenza vaccination in pregnancy. Retrospective cohort study. UK General Practice Research Database Pregnancies ending in delivery or spontaneous foetal death after 21 October 2009 and starting before 01 January 2010.

Transplantation for acute liver failure in patients exposed to NSAIDs or paracetamol (acetaminophen): the multinational case-population SALT study.

Background: Most NSAIDs are thought to be able to cause hepatic injury and acute liver failure (ALF), but the event rates of those leading to transplantation (ALFT) remain uncertain.

Objectives: The aim of the study was to estimate population event rates for NSAID-associated ALFT METHODS: This was a case-population study of ALFT in 57 eligible liver transplant centres in seven countries (France, Greece, Ireland, Italy, The Netherlands, Portugal and the UK). Cases were all adults registered from 2005 to 2007 for a liver transplant following ALFT without identified clinical aetiology, exposed to an NSAID or paracetamol (acetaminophen) within 30 days before the onset of clinical symptoms.

Smoking and delay to diagnosis are associated with poorer functional outcome in psoriatic arthritis.

Objective: To identify predictors of poorer physical function in established psoriatic arthritis (PsA).

Methods: PsA patients with disease duration of ≥10 years were identified from the Bath longitudinal cohort. Physical function was assessed using the Stanford Health Assessment Questionnaire (HAQ).

The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns.

Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification.

Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom.

Methodology for a multinational case-population study on liver toxicity risks with NSAIDs: the Study of Acute Liver Transplant (SALT).

Purpose: The European Committee for Human Medicinal Products (CHMP) requested a multinational study with the aim to investigate the risk of acute liver failure (ALF) leading to registration for transplantation in patients exposed to non-steroidal anti-inflammatory drugs (NSAIDs). The method of this multinational, multicentre, retrospective case-population study, named SALT (Study of Acute Liver Transplant), is documented here.

Methods: This was a multicentre, multinational retrospective case-population study performed in France, Italy, Portugal, Greece, Ireland, the Netherlands and the UK.

Colorectal cancer incidence on the General Practice Research Database.

PURPOSE: The General Practice Research Database (GPRD) contains longitudinal patient medical records collected within UK primary care. This study aimed to identify incident cases of colorectal cancer on the GPRD and to compare incidence rates for 2007 with those reported by the UK cancer registries. METHODS: Algorithms were created to identify incident cases of colorectal cancer on the GPRD and cases were required to have additional medical codes to support the diagnosis.

Factors associated with uptake of seasonal and pandemic influenza vaccine among clinical risk groups in the UK: an analysis using the General Practice Research Database.

Background: Influenza vaccine uptake rates are low compared with uptake rates of many other vaccines. It is unclear how this differs between risk groups in the population and between pandemic and non-pandemic influenza vaccines.

Aim: This study sought to estimate uptake rates of pandemic and seasonal influenza vaccines among clinical risk groups in the UK during the 2009/2010 influenza season and to identify predictors of vaccine uptake in this cohort.

Work disability in psoriatic arthritis: a systematic review.

Objective: Work disability (WD) is an important functional outcome measure in arthritis. There is a large body of information on WD in rheumatic diseases such as RA and AS; however, until now factors that influence WD in PsA have not been systematically reviewed. Our objective was to perform a systematic and critical review of the current literature on WD and its measurement in PsA.

Comparing the General Practice Research Database and the UK Epilepsy and Pregnancy Register as tools for postmarketing teratogen surveillance: anticonvulsants and the risk of major congenital malformations.

Background: Use of pregnancy registries is a common method of postmarketing surveillance of pregnancy outcomes to identify potential teratogens. However, with the increase in electronic capture of healthcare data for administrative, audit and research purposes, data generated during routine clinical practice might be used to address questions similar to those explored using pregnancy registries.

Objectives: To establish how data from the UK General Practice Research Database (GPRD) compares with data from the UK Epilepsy and Pregnancy Register and to assess how it can contribute to postmarketing surveillance of pregnancy outcomes.

The incidence of primary glomerulonephritis worldwide: a systematic review of the literature.

Background: Little is known about the worldwide variation in incidence of primary glomerulonephritis (GN). The objective of this review was to critically appraise studies of incidence published in 1980-2010 so that an overall view of trends of these diseases can be found. This would provide important information for determining changes in rates and understanding variations between countries.