Left ventricular assist device-related infections: does the time of onset matter?

Journal of Artificial Organs - A frequent complication of left ventricular assist devices (LVAD) is the LVAD-associated infections (LVADIs). Contamination may occur during initial surgery/admission...     

Cost evolution of biological agents for the treatment of spondyloarthritis in a tertiary hospital: influential factors in price

Background Spending on biological agents has risen dramatically due to the high cost of the drugs and the increased prevalence of spondyloarthritis. Objective To evaluate the annual cost per patient and cost for each biological drug for treating patients with spondyloarthritis from 2009 to 2016, and to calculate factors that affect treatment cost, such as optimizing therapies by monitoring drug serum levels, the use of biosimilar-TNF inhibitors, and official discounts or negotiated rebates in biologicals acquired by the pharmacy department. Method Retrospective, observational study in a Spanish tertiary hospital. Main outcome Annual cost per patient and per drug. Factors that influenced the costs and socio-demographic parameters and disease activity. Results A total of 129, 215, and 224 patients were treated in 2009, 2013, and 2016, respectively. The annual cost per patient decreased: EUR11,604 in 2009, EUR8513 in 2013, and EUR7464 in 2016. The introduction of new drugs drives economic competition, leading to total savings per drug, with discounts reaching 5.8, 12.4, 16.7, 17.7, 13.7, and 24.8% for original infliximab, etanercept, adalimumab, ertolizumab, golimumab, and secukinumab, respectively, while rebates for biosimilar infliximab reached 31.90% in 2016. The number of patients with optimized therapies reached 47.5% in 2016, which led to cost savings of EUR798,614, in addition to savings from official discounts and rebates of EUR252,706 and savings from optimized therapies of EUR545,908 in 2016. Conclusion The cost of biological treatments declined after official discounts, negotiated rebates, and optimized therapies, leading to a significant decrease in the annual cost per patient. The greatest contribution to economic savings in biological therapy according to our study was biological therapy optimization.     

Evaluation of the effect of acetazolamide versus mannitol on cisplatin-induced nephrotoxicity,a pilot study

Background Cisplatin-induced nephrotoxicity still occurs despite the intensive hydration approach adapted to prevent its occurrence. Objective Evaluation of the effect of acetazolamide (ACTZ) on minimizing cisplatin-induced nephrotoxicity compared to mannitol when added to hydration regimen. Setting Nasser Institute Cancer Center (NICC), Cairo, Egypt. Method A total of 35 patients planned to receive cisplatin were divided into two groups: 20 patients received mannitol and 15 patients received ACTZ. Both groups received standard hydration measures as well for prevention of cisplatin-induced nephrotoxicity. Main outcome measure Patients’ kidney function was assessed using serum creatinine, creatinine clearance and blood urea nitrogen. Kidney injury was assessed using RIFLE criteria. Patients’ liver function tests and hematological parameters were also monitored. Results Patients in the mannitol group showed higher risk of developing kidney injury (30%) whereas those in the ACTZ group showed lower risk (8.9%), relative risk (RR) 0.269, 95% CI 0.108–0.815. No statistically significant difference occurred between the two groups concerning liver function tests or hematological parameters. Conclusion Use of ACTZ in addition to intensive hydration may have more beneficial effect on minimizing cisplatin-induced nephrotoxicity compared to mannitol plus intensive hydration approach. A large multicenter randomized clinical trials is recommended to confirm study results and to assess effect of ACTZ on tumor response.     

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

The terminology used in pharmacovigilance can cause confusion, because there are similar terms that describe different phenomena (e.g. adverse reactions, adverse drug reactions, and side effects). Incorrect use of terminology can have negative effects on the reporting of adverse drug reactions and on the interpretation of these reports. To explain the most common terms used in pharmacovigilance, this article first describes the pharmacovigilance workflow process in the European Union and, as an example, in Italy. Then, the article reviews common pharmacovigilance terms.