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Firenze, Italy

Del Pozo-Ruiz J.J.,Pharmaceutical Service | Martin-Perez E.,Hospital San Juan de Dios | Malafarina V.,Clinica Los Manzanos
European Geriatric Medicine

Introduction Sequential antibiotic therapy (SAT) is an important phase of treatment and an attempt to bring the change to oral treatment forward. We assessed the impact of SAT on the costs of antibiotic treatment on hospitalized elderly patients. Methods This was a prospective study in which 204 patients were assessed. Duration and costs of IV and oral treatment were recorded, as well as the day for switching from IV to oral treatment, mean stay and readmissions, and the results were confronted between the two phases of the study: observational and interventional. Mean antibiotic intake was defined as defined daily dose per every 100 stays (DDD/100S). Results Fifty-two were included in the observational phase and 59 in the interventional phase, mean age 80.0 ± 7.4, 52.3% women. Changeover of treatment was brought forward an average of 1.7 and 1.3 days with ciprofloxacin and levofloxacin, respectively, during the intervention phase compared to the observational phase (P < 0.001). The mean cost per unit in the intervention phase was reduced by 28.64 € with levofloxacin and by 24.28 € with ciprofloxacin. Intravenous DDDs/100S were reduced from 0.069 ± 0.023 to 0.042 ± 0.006 (P < 0.001) for levofloxacin and from 0.068 ± 0.029 to 0.038 ± 0.012 (P < 0.001) for ciprofloxacin. Conclusions Pharmaceutical intervention based on a SAT achieved reduction of the length of treatment of antibiotic IV treatment and thus also achieved a reduction in treatment costs. The intervention was not associated to an increase in relapse and was therefore efficient and cost effective. © 2015 Elsevier Masson SAS and European Union Geriatric Medicine Society. All rights reserved. Source

Carnovale C.,University of Milan | Brusadelli T.,University of Milan | Zuccotti G.,University of Milan | Beretta S.,University of Milan | And 10 more authors.
Expert Opinion on Drug Safety

Objective: To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP).Research design and methods: Adverse drug reactions (ADRs) were collected for individuals aged 0-17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use.Results: We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization.Conclusions: The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients. © Informa UK, Ltd. Source

Pallaver F.,Santa Chiara Hospital | Riviera A.P.,University of Verona | Piffer S.,Epidemiological Service | Ricciardi R.,University of Pisa | And 3 more authors.

Background: The recent literature suggests that the incidence and prevalence of myasthenia gravis (MG) are changing. We performed a population-based study of MG in the province of Trentino (524,826 inhabitants) and compared the results with those collected 20 years ago. Methods: Multiple sources of information (discharge diagnosis, antibody tests and anticholinesterase drugs) were analyzed. Incidence was calculated from 2005 to 2009. Prevalence was calculated on December 31, 2009. Comparison was made with descriptive statistics for 1981-1990 for the identical region. Results: Incidence and prevalence greatly increased in comparison with 1981-1990 data. The prevalence rate increased from 82.9 (95% confidence interval, CI, 58.4-114.3) in 1990 to 129.6 (95% CI 100.6-164.3) per million population, whereas the average annual incidence increased from 7.4 (95% CI 5-10.4) per million person-years in 1981-1990 to 14.8 (95% CI 10.5-20.3) in 2005-2009. This increase was mainly due to male patients with late-onset MG. Conclusions: The study confirms the increase in incidence and prevalence of late-onset MG in the same region 20 years apart. So we should consider MG also as a disease of the elderly. © 2011 S. Karger AG, Basel. Source

Carnovale C.,University of Milan | Pellegrino P.,University of Milan | Perrone V.,University of Milan | Antoniazzi S.,University of Milan | And 5 more authors.
Journal of Clinical Pharmacy and Therapeutics

What is known and objective: Chronic constipation is very frequent in the general population. Although usually considered banal, this disorder has considerable personal, social and healthcare impact. Several studies have shown that the psychological impact exceeds that caused by rheumatoid arthritis or haemodialysis. Recently, prucalopride, a highly selective 5-HT4 receptor agonist has been shown to improve the symptoms of chronic constipation and to have a beneficial effect on social and healthcare impact. The drug was approved by the European Medicine Agency, in 2009 at a dose of 2 mg/day, 'for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief'. Neurological side effects or psychiatric disorders have not been reported previously with prucalopride. We present the case of a 61-year-old woman, who developed such adverse effects when given prucalopride for the treatment for chronic constipation. Case summary: A few hours after oral administration of this drug at therapeutic dose (2 mg/day), the patient experienced life-threatening neurological effects that included visual hallucination, loss of balance and memory, disorientation, exhaustion and suicidal ideation. Analysis with the Naranjo algorithm indicated a 'possible' relationship between prucalopride and these disorders. What is new and conclusion: This is the first report of prucalopride-induced neurological side effects and psychiatric disorders with prucalopride. The absence of other similar reports suggests that prucalopride rarely causes these adverse effects. © 2013 John Wiley & Sons Ltd. Source

Marciano I.,Unit of Clinical Pharmacology | Ingrasciotta Y.,Unit of Clinical Pharmacology | Giorgianni F.,Unit of Clinical Pharmacology | Bolcato J.,Pharmaceutical Service | And 18 more authors.

Background: Granulocyte colony-stimulating factors (G-CSFs) are biological products for which the main indication of use is chemotherapy-induced neutropenia. Biosimilars of G-CSFs have been available in Europe since 2007. Objective: The objective of this study was to investigate the prescribing pattern of G-CSFs in five Italian centres using different healthcare policy interventions to promote the use of biosimilars in routine care. Methods: This retrospective, population-based drug utilization study was conducted during the years 2009–2014 using the administrative databases of the Caserta, Treviso and Palermo Local Health Units (LHUs) and the Tuscany and Umbria regions. G-CSF users were characterized and the prevalence of use, proportion of biosimilar users and switching pattern of different G-CSFs were evaluated over time and across centres. Results: Overall, 30,247 patients were treated with G-CSFs in the years 2009–2014, of which 29,083 (96.2 %) were naïve users. The overall prevalence of G-CSF use increased from 0.8 per 1000 inhabitants in 2009 to 1.1 per 1000 in 2014. An increase in the proportion of the use of the biosimilar filgrastim by the total G-CSF users was observed in all centres: from 0.2 % (2009) to 66.2 % (2014). However, heterogeneity across different centres was reported, with the largest increase in Treviso LHU (from 0 to 89.1 % from 2009 to 2014). During the first year of treatment, switching between different G-CSFs was frequent (20.3 %). Conclusions: Heterogeneity in the use of G-CSF and, in particular, biosimilar filgrastim across different Italian centres was observed, probably due to different regional healthcare policy interventions. During the first year of treatment, switching between different G-CSFs was frequent. Considering the impact of biological drugs on pharmaceutical expenses, it is necessary to harmonize healthcare policies promoting the use of biological drugs with the lowest cost. © 2016 Springer International Publishing Switzerland Source

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