Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee.

This study measured the exposure to different categories of medicinal products discussed by the European Union (EU) Pharmacovigilance Risk Assessment Committee from September to November 2018 in four electronic primary care health databases: IQVIA Medical Research Data-UK, IQVIA Medical Research Data-France, IQVIA Medical Research Data-Germany, and Clinical Practice Research Datalink Aurum, in the entire lifespan of each database until August 31, 2018. The assessment of 83 centrally authorized products and 45 nationally authorized products showed that coverage was better for products marketed for longer duration and worse for orphan drugs. The ability to detect associations against hypothetical comparators was better for more common events and for larger effect sizes. Coverage of advanced therapies was worse for those typically administered in a specialized rather than primary care setting. This study shows that to enable better informed regulatory decisions there is a need to access complementary data sources, particularly capturing secondary care prescribing.

Quantitative Analysis of Technological Innovation in Urology.

OBJECTIVE: To assess major areas of technological innovation in urology in the last 20 years using patent and publication data. METHODS: Patent and MEDLINE databases were searched between 1980 and 2012 electronically using the terms urology OR urological OR urologist AND "surgeon" OR "surgical" OR "surgery". The patent codes obtained were grouped in technology clusters, further analyzed with individual searches, and growth curves were plotted. Growth rates and patterns were analyzed, and patents were correlated with publications as a measure of scientific support and of clinical adoption. RESULTS: The initial search revealed 417 patents and 20,314 publications. The top 5 technology clusters in descending order were surgical instruments including urinary catheters, minimally invasive surgery (MIS), lasers, robotic surgery, and image guidance. MIS and robotic surgery were the most emergent clusters in the last 5 years. Publication and patent growth rates were closely correlated (Pearson coefficient 0.78, P <.01), but publication growth rate remained constantly higher than patent growth, suggesting validated scientific support for urologic innovation and adoption into clinical practice. CONCLUSION: Patent metrics identify emergent technological innovations and such trends are valuable to understand progress in the field of urology. New surgical technologies like robotic surgery and MIS showed exponential growth in the last decade with good scientific vigilance.

A novel drug management system in the Febuxostat versus Allopurinol Streamlined Trial: A description of a pharmacy system designed to supply medications directly to patients within a prospective multicenter randomised clinical trial.

BACKGROUND: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial. METHOD: A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee. RESULTS: To date, 65,467 packs of medication have been dispensed using the system to 3978 patients. Up to 238 packs per day have been dispensed. CONCLUSION: The Medicines Monitoring Unit Febuxostat versus Allopurinol Streamlined Trial drug management system is an effective method of administering the complex drug supply requirements of a large-scale clinical trial with advantages over existing arrangements. A low rate of loss to follow-up in the Febuxostat versus Allopurinol Streamlined Trial may be attributable to the drug management system.

Anticholinergic treatment in airways diseases.

The prevalence of chronic airways diseases such as chronic obstructive pulmonary disease and asthma is increasing. They lead to symptoms such as a cough and shortness of breath, partially through bronchoconstriction. Inhaled anticholinergics are one of a number of treatments designed to treat bronchoconstriction in airways disease. Both short-acting and long-acting agents are now available and this review highlights their efficacy and adverse event profile in chronic airways diseases.

Update on smoking cessation therapies.

As a reflection of an exponential increase in smoking rates throughout the world during the last century, the economic and human burden of mortality and morbidity related to smoking is now clearly defined. Smoking cessation is associated with health benefits for people of all ages. In this paper we provide a comprehensive review of current licensed pharmacological smoking cessation agents including efficacy and safety profiles, with comparisons of individual therapies available. Furthermore, we offer a prospective on the need for further testing of other agents including novel avenues of therapy.