Publications by authors named "Joanna Lem"

Purpose: A national additional risk minimization measures (aRMMs) program was implemented to train pharmacists for safe supply of non-prescription Viagra Connect (VC) to erectile dysfunction (ED) patients in United Kingdom (UK). A survey aimed to evaluate the effectiveness of aRMMs.

Methods: A cross-sectional, web-based survey enrolled ED patients who purchased at least 1 supply of VC in UK, using a structured self-administered questionnaire.

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Background To support reclassification in the UK of sildenafil citrate (50 mg) from prescription-only medicine to a pharmacy medicine (P status) under the brand name "Viagra Connect", additional risk minimisation measures were implemented that included training materials and an optional checklist to assist community pharmacists in the safe supply of Viagra Connect to suitable patients. Objective To evaluate the effectiveness of Viagra Connect additional risk minimisation measures by assessing community pharmacists' participation in training, their knowledge of key risk messages, and utilisation of the checklist. Setting A post-authorisation safety study implemented as a web-based survey, conducted in a representative population of UK community pharmacists.

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Background: Voriconazole is an extended-spectrum antifungal agent approved for the treatment and prophylaxis of invasive aspergillosis and other serious fungal infections. In 2014, additional risk minimization measures (aRMM) consisting of a Healthcare Professional (HCP) Question and Answer (Q&A) Brochure, HCP Checklist, and Patient Alert Card were implemented on a rolling basis across the European Union (EU) to mitigate three key risks with voriconazole: phototoxicity, squamous cell carcinoma (SCC) of the skin, and hepatotoxicity. The risks of phototoxicity and hepatotoxicity have been documented in the Summary of Product Characteristics (SmPC) since voriconazole was first approved in the EU in 2002.

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Objective: The Follow-Up Study of patients previously enrolled in Exubera controlled clinical trials (FUSE) was designed to evaluate whether patients previously treated with Exubera (EXU; insulin human [rDNA origin], inhaled powder) in controlled clinical trials died because of incident primary lung cancer at a substantially higher rate than patients treated with a comparator.

Research Design And Methods: FUSE is a hybrid, randomized, controlled trial/cohort study including participants of 17 prior EXU clinical trials. Pooled patient data from these trials were used, and the subset of patients enrolled in the follow-up cohort study was followed prospectively for 2 years in order to evaluate the incidence of fatal and nonfatal primary lung cancers and all-cause mortality.

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Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.

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We report the analysis of CPI-613, the first member of a large set of analogs of lipoic acid (lipoate) we have investigated as potential anticancer agents. CPI-613 strongly disrupts mitochondrial metabolism, with selectivity for tumor cells in culture. This mitochondrial disruption includes activation of the well-characterized, lipoate-responsive regulatory phosphorylation of the E1α pyruvate dehydrogenase (PDH) subunit.

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