Quantitative Measurement of the Direct Public Health Impact of Medicines Withdrawals in Europe: Development of a Modelling Method and Proof-of-Concept Study to Estimate the Morbidity and Mortality Prevented by Regulatory Action.

Purpose: Removing medicines from market may benefit public health by preventing adverse drug reactions (ADRs), which should be quantified. This study's aim was to identify a model to quantify the impact of medicines' marketing authorisation (MA) withdrawal and revocation in terms of preventing morbidity and mortality.

Methods: MA withdrawals and revocations for safety reasons in France, Germany and/or the United Kingdom between July 2012 and December 2016 were identified for prescription medicines.

Challenges for Drug Repurposing in the COVID-19 Pandemic Era.

The coronavirus disease (COVID-19) pandemic has affected an estimated 16 million persons and caused 0.6 million deaths worldwide by September 2020. The pandemic has led to a rush to repurpose existing drugs, although the underlying evidence base is of variable quality.

Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?

In the current era of the COVID-19 pandemic, the world has never been more interested in the process of vaccine development. While researchers across the globe race to find an effective yet safe vaccine to protect populations from the newly emergent SARS-CoV-2 virus, more than one-third of the world has been subjected to either full or partial lockdown measures. With communities having felt the burden of prolonged isolation, finding a safe and efficacious vaccine will yield direct beneficial effects on protecting against COVID-19 morbidity and mortality and help relieve the psychological and economic load on communities living with COVID-19.

Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012.

Objectives: To assess the sources of publicly available evidence supporting withdrawal, revocation or suspension of marketing authorisations ('regulatory actions') due to safety reasons in the EU since 2012 and to investigate the time taken since initial marketing authorisation to reach these regulatory decisions.

Setting: This investigation examined the sources of evidence supporting 18 identified prescription medicinal products which underwent regulatory action due to safety reasons within the EU in the period 1 July 2012 to 31 December 2016.

Results: Eighteen single or combined active substances ('medicinal products') withdrawn, revoked or suspended within the EU for safety reasons between 2012 and 2016 met the inclusion criteria.

Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England.

Introduction: Fluenz Tetra is an intranasal quadrivalent live attenuated influenza vaccine (QLAIV) and is recommended as the vaccine of choice for children in the 2014/2015 influenza season vaccination programme in the UK.

Objective: The primary objective of the study was to estimate the crude incidence rate of adverse events of interest (AEIs) following vaccination with the nasal QLAIV early in the 2014/2015 influenza season in children and adolescents in England.

Methods: A pilot non-interventional cohort post-authorisation safety study (PASS) was conducted during the 2014/2015 influenza season in England.

Orexin Receptor Activation Generates Gamma Band Input to Cholinergic and Serotonergic Arousal System Neurons and Drives an Intrinsic Ca(2+)-Dependent Resonance in LDT and PPT Cholinergic Neurons.

A hallmark of the waking state is a shift in EEG power to higher frequencies with epochs of synchronized intracortical gamma activity (30-60 Hz) - a process associated with high-level cognitive functions. The ascending arousal system, including cholinergic laterodorsal (LDT) and pedunculopontine (PPT) tegmental neurons and serotonergic dorsal raphe (DR) neurons, promotes this state. Recently, this system has been proposed as a gamma wave generator, in part, because some neurons produce high-threshold, Ca(2+)-dependent oscillations at gamma frequencies.

Surgical repair of ileovesical fistulas: long-term complications, quality of life, and patient satisfaction.

Ileovesical fistulas (IVFs) are an uncommon complication of Crohn's disease. The aim of this study is to compare long-term surgical outcomes, assess quality of life, and quantify patient satisfaction after IVF repair. A retrospective chart review followed by a prospective survey was carried out.

Suture versus tack fixation of mesh in laparoscopic umbilical hernia repair.

Background And Objectives: Mesh fixation in laparoscopic umbilical hernia repair is poorly studied. We compared postoperative outcomes of laparoscopic umbilical hernia repair in suture versus tack mesh fixation.

Methods: Patients who underwent laparoscopic umbilical hernia repair were separated by method of mesh fixation: sutures versus primarily tacks.

Radiographic findings of anastomotic leaks.

Although computed tomography (CT) scans play an important role in the diagnosis and management of anastomotic leaks (AL), there is no consensus on what radiographic findings are associated with AL. The purpose of this study is to identify the most common CT scan findings associated with AL and whether the amount of extraluminal air or the density of extraluminal fluid can be correlated with the presence of an AL. A retrospective chart review of 210 patients with anastomotic leaks from 2003 to 2010 at Mount Sinai Medical Center was performed.

Management and outcomes of colovesical fistula repair.

This large retrospective study presents the largest colovesical fistula (CVF) series to date. We report on recurrence risk factors and patient satisfaction based on quality of life after CVF repair. Approval was obtained from The Mount Sinai School of Medicine Institutional Review Board, and a retrospective review was performed from 2003 to 2010 involving 72 consecutive patients who underwent a colovesical fistula repair.

Identification of gene expression elements in Histomonas meleagridis using splinkerette PCR, a variation of ligated adaptor PCR.

Histomonas meleagridis is the causative agent of blackhead disease in gallinaceous birds. Limited genetic information exists for this organism, with the majority of sequence information coming from the coding regions of genes. No information is available for intergenic regions that contain DNA elements required for the regulation of gene expression.

Appendectomy during pregnancy: follow-up of progeny.

Background: The incidence of appendicitis in pregnant patients is 0.04% to 0.20%, making it the most common nonobstetric surgical procedure in pregnancy.

New postgraduate qualifications in pharmacovigilance from the Drug Safety Research Unit in the UK.

The Drug Safety Research Unit in the UK has recently launched new postgraduate certificate, diploma and masters courses in pharmacovigilance, in association with the University of Portsmouth. These courses have been developed to address the continuing demand for quality accredited education in pharmacovigilance and are aimed particularly at drug safety staff working in the pharmaceutical industry, regulatory bodies or academia. Flexibility is ensured by the availability of a wide choice of units, the use of online facilities for learning and assessment, and the possibility that previous relevant training or experience may be counted towards the awards.