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Onder G.,Catholic University of the Sacred Heart | Palmer K.,Agenzia Italiana Del Farmaco AIFA | Navickas R.,Vilnius University | Jureviciene E.,Vilnius University | And 5 more authors.
European Journal of Internal Medicine | Year: 2015

Research on multimorbidity has rapidly increased in the last decade, but evidence on the effectiveness of interventions to improve outcomes in patients with multimorbidity is limited. The European Commission is co-funding a large collaborative project named Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) in the context of the 2nd EU Health Programme 2008-2013. The present manuscript summarizes first results of the JA-CHRODIS, focuses on the identification of a population with multimorbidity who has a high or very high care demand. Identification of characteristics of multimorbid patients associated with a high rate of resource consumption and negative health outcomes is necessary to define a target population who can benefit from interventions. Indeed, multimorbidity alone cannot explain the complexity of care needs and further, stratification of the general population based on care needs is necessary for allocating resources and developing personalized, cost-efficient, and patient-centered care plans. Based on analyses of large databases from European countries a profile of the most care-demanding patients with multimorbidity is defined. Several factors associated with adverse health outcomes and resource consumption among patients with multimorbidity were identified in these analyses, including disease patterns, physical function, mental health, and socioeconomic status. These results underline that a global assessment is needed to identify patients with multimorbidity who are at risk of negative health outcomes and that a comprehensive approach, targeting not only diseases, but also social, cognitive, and functional problems should be adopted for these patients. © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.


Onder G.,Catholic University of the Sacred Heart | Bonassi S.,IRCCS San Raffaele Pisana | Abbatecola A.M.,Italian National Research Center on Aging | Folino-Gallo P.,Agenzia Italiana Del Farmaco AIFA | And 11 more authors.
Journals of Gerontology - Series A Biological Sciences and Medical Sciences | Year: 2014

Background.Poor quality of drug prescribing in older persons is often associated with increased drug-related adverse events, hospitalization, and mortality. The present study describes a set of prescribing quality indicators developed by the Geriatrics Working Group of the Italian Medicines Agency (AIFA) and estimates their prevalence in the entire elderly (≥65 years) population in Italy.Methods.We performed a cross-sectional study using 2011 data from the OsMed (Osservatorio dei Medicinali) database, which comprises all prescribed drugs that are reimbursed by the Italian National Healthcare System. Yearly prevalence of drug prescribing quality indicators in the Italian older population (n = 12,301,537) was determined.Results.Overall, 13 quality indicators addressing polypharmacy, adherence to treatment of chronic diseases, prescribing cascade, undertreatment, drug-drug interactions, and drugs to be avoided were identified. Polypharmacy was common, with more than 1.3 million individuals taking greater than or equal to 10 drugs (11.3% of the study population). The prevalence of low adherence and undertreatment was also elevated and increased with advancing age, with highest prevalence occurring in individuals aged 85 years and older. Prevalence was less than 3% for quality indicators assessing the prescribing cascade, drug-drug interactions, and drugs to be avoided.Conclusions.These results confirm the high frequency of suboptimal drug prescribing in older adults, using a database that covers the whole Italian population. In general, this descriptive study may help in prioritizing strategies aimed at improving the quality of prescribing in elderly population. © The Author 2013.


PubMed | Agenzia Italiana del Farmaco AIFA, IRCCS Ca Granda Maggiore Policlinico Hospital Foundation, Catholic University of the Sacred Heart, Vilnius University and University of Brescia
Type: Journal Article | Journal: European journal of internal medicine | Year: 2015

Research on multimorbidity has rapidly increased in the last decade, but evidence on the effectiveness of interventions to improve outcomes in patients with multimorbidity is limited. The European Commission is co-funding a large collaborative project named Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) in the context of the 2nd EU Health Programme 2008-2013. The present manuscript summarizes first results of the JA-CHRODIS, focuses on the identification of a population with multimorbidity who has a high or very high care demand. Identification of characteristics of multimorbid patients associated with a high rate of resource consumption and negative health outcomes is necessary to define a target population who can benefit from interventions. Indeed, multimorbidity alone cannot explain the complexity of care needs and further, stratification of the general population based on care needs is necessary for allocating resources and developing personalized, cost-efficient, and patient-centered care plans. Based on analyses of large databases from European countries a profile of the most care-demanding patients with multimorbidity is defined. Several factors associated with adverse health outcomes and resource consumption among patients with multimorbidity were identified in these analyses, including disease patterns, physical function, mental health, and socioeconomic status. These results underline that a global assessment is needed to identify patients with multimorbidity who are at risk of negative health outcomes and that a comprehensive approach, targeting not only diseases, but also social, cognitive, and functional problems should be adopted for these patients.


PubMed | Agenzia Italiana del Farmaco AIFA, CliCon Srl Health, Catholic University of the Sacred Heart, University of Florence and 3 more.
Type: Journal Article | Journal: Journal of the American Medical Directors Association | Year: 2016

In older adults co-occurrence of multiple diseases often leads to use of multiple medications (polypharmacy). The aim of the present study is to describe how prescription of medications varies across age groups, with specific focus on the oldest old.We performed a cross-sectional study using 2013 data from the OsMed Health-DB database (mean number of medicines and defined daily doses prescribed in 15,931,642 individuals). There were 3,378,725 individuals age 65years or older (21.2% of the study sample).The mean number of prescribed medications progressively rose from 1.9 in the age group <65years to 7.4 in the age group 80-84years and then declined, with a more marked reduction in the age group 95years or older with a mean number of 2.8 medications. A similar pattern was observed for the mean number of defined daily doses. Among participants age 65years, proton pump inhibitors were the most commonly prescribed medication (40.9% of individuals 65years), followed by platelet aggregation inhibitors (32.8%) and hydroxy-methylglutaryl-coenzyme A reductase inhibitors (26.1%). A decline in prescription was observed among individuals age 90years or older, but this reduction was less consistent for medications used to treat acute conditions (ie, antibiotics and glucocorticoids) rather than preventive medicines commonly used to treat chronic diseases (ie, antihypertensive medications and hydroxy-methylglutaryl-coenzyme A reductase inhibitors).The burden of medication treatment progressively increases till age 85 and substantially declines after age of 90years. Patterns of medication prescription widely vary across age groups.


Segec A.,European Medicines Agency | Keller-Stanislawski B.,Paul Ehrlich Institute | Vermeer N.S.,University Utrecht | Macchiarulo C.,Agenzia Italiana del Farmaco AIFA | And 3 more authors.
Clinical Pharmacology and Therapeutics | Year: 2015

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization. © 2015 American Society for Clinical Pharmacology and Therapeutics.


PubMed | European Medicines Agency, University Utrecht, Agenzia Italiana del Farmaco AIFA, Paul Ehrlich Institute and Medicines Evaluation Board
Type: Journal Article | Journal: Clinical pharmacology and therapeutics | Year: 2015

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.


Onder G.,Catholic University of the Sacred Heart | Vetrano D.L.,Catholic University of the Sacred Heart | Cherubini A.,Italian National Research Center on Aging | Fini M.,Scientific Direction | And 8 more authors.
Journal of the American Medical Directors Association | Year: 2014

In Italy, prescription drug costs represent approximately 17% of total public health expenditures. Older adults commonly use multiple drugs and, for this reason, this population is responsible for a large portion of drug-related costs. In 2012, public expenditure for pharmaceuticals in primary care exceeded 11 billion Euros (approximately 15.2 billion US $), and older adults aged 65 or older accounted for more than 60% of these costs. Recently, increased attention has been focused on studies aimed at monitoring drug use and evaluating the appropriateness of drug prescribing in older adults. In this article, we examined studies that assessed these issues in different settings at a national level. Specifically, results of surveys of prescription drug use in primary care (OsMED), hospital (GIFA, CRIME, and REPOSI) and long-term care (ULISSE and SHELTER) settings are reviewed. Overall, these studies showed that the quality of drug prescribing in older patients is far from optimal. This leads to an increased risk of negative health outcomes and increased health care costs. Data from these studies are valuable, not only to monitor drug use, but also to target interventions aimed at improving the quality of prescribing. Translating the findings of clinical research and monitoring programs will be challenging, but it will lead to quantifiable improvements in the quality of drug prescribing at a national level. © 2014 AMDA - The Society for Post-Acute and Long-Term Care Medicine.


Carbognin L.,University of Verona | Pilotto S.,University of Verona | Milella M.,Regina Elena Cancer Institute | Vaccaro V.,Regina Elena Cancer Institute | And 11 more authors.
PLoS ONE | Year: 2015

Background: The potential predictive role of programmed death-ligand-1 (PD-L1) expression on tumor cells in the context of solid tumor treated with checkpoint inhibitors targeting the PD-1 pathway represents an issue for clinical research. Methods: Overall response rate (ORR) was extracted from phase I-III trials investigating nivolumab, pembrolizumab and MPDL3280A for advanced melanoma, non-small cell lung cancer (NSCLC) and genitourinary cancer, and cumulated by adopting a fixed and random-effect model with 95% confidence interval (CI). Interaction test according to tumor PD-L1 was accomplished. A sensitivity analysis according to adopted drug, tumor type, PD-L1 cut-off and treatment line was performed. Results: Twenty trials (1,475 patients) were identified. A significant interaction (p<0.0001) according to tumor PD-L1 expression was found in the overall sample with an ORR of 34.1% (95% CI 27.6-41.3%) in the PD-L1 positive and 19.9% (95% CI 15.4-25.3%) in the PD-L1 negative population. ORR was significantly higher in PD-L1 positive in comparison to PD-L1 negative patients for nivolumab and pembrolizumab, with an absolute difference of 16.4% and 19.5%, respectively. A significant difference in activity of 22.8% and 8.7% according to PD-L1 was found for melanoma and NSCLC, respectively, with no significant difference for genitourinary cancer. Conclusion: Overall, the three antibodies provide a significant differential effect in terms of activity according to PD-L1 expression on tumor cells. The predictive value of PD-L1 on tumor cells seems to be more robust for anti-PD-1 antibody (nivolumab and pembrolizumab), and in the context of advanced melanoma and NSCLC. © 2015 Carbognin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Cangini A.,Agenzia Italiana del Farmaco AIFA | Folino Gallo P.,Agenzia Italiana del Farmaco AIFA | Rasi G.,Agenzia Italiana del Farmaco AIFA
PharmacoEconomics - Italian Research Articles | Year: 2010

Background: The high consumption of antibiotics is a concern for individual and public health, to such an extent that WHO, EU and the USA government launched joint actions to curbe their consumption. Over consumption represents also a waste of resources. Objectives: The aim of this study was to estimate the possible savings generated by a lower and more prudent use of antibiotics. Methods: The average consumption in DDD/1000 inh/day (17.25 DID) of the six regions in the lowest quartile was used as a benchmark to calculate the optimal value of consumption in every region. This benchmark value (17.25 DID) is quite near to the median European value. Possible savings were estimated for every region using both their actual costs per DDD and the lowest cost per DDD (€1.66). Results: The Italian outpatient consumption of antibiotics is one of the highest in Europe (24.22 DID) with geographic variations from 13.05 to 37.63 DID. The estimated overconsumption amounts to 154,226,068 DDD. The over expenditure linked to the overuse ranges from €316.6 millions to €413.1 millions (using for each region its actual cost or the lowest cost per DDD, respectively). Conclusions: In conclusion, important savings, up to €413 millions, could have been obtained by a more prudent use of antibiotics in the year 2009 in Italy. © 2010 Adis Data Information BV.


PubMed | University of Verona, Regina Elena Cancer Institute and Agenzia Italiana del Farmaco AIFA
Type: Journal Article | Journal: PloS one | Year: 2015

The potential predictive role of programmed death-ligand-1 (PD-L1) expression on tumor cells in the context of solid tumor treated with checkpoint inhibitors targeting the PD-1 pathway represents an issue for clinical research.Overall response rate (ORR) was extracted from phase I-III trials investigating nivolumab, pembrolizumab and MPDL3280A for advanced melanoma, non-small cell lung cancer (NSCLC) and genitourinary cancer, and cumulated by adopting a fixed and random-effect model with 95% confidence interval (CI). Interaction test according to tumor PD-L1 was accomplished. A sensitivity analysis according to adopted drug, tumor type, PD-L1 cut-off and treatment line was performed.Twenty trials (1,475 patients) were identified. A significant interaction (p<0.0001) according to tumor PD-L1 expression was found in the overall sample with an ORR of 34.1% (95% CI 27.6-41.3%) in the PD-L1 positive and 19.9% (95% CI 15.4-25.3%) in the PD-L1 negative population. ORR was significantly higher in PD-L1 positive in comparison to PD-L1 negative patients for nivolumab and pembrolizumab, with an absolute difference of 16.4% and 19.5%, respectively. A significant difference in activity of 22.8% and 8.7% according to PD-L1 was found for melanoma and NSCLC, respectively, with no significant difference for genitourinary cancer.Overall, the three antibodies provide a significant differential effect in terms of activity according to PD-L1 expression on tumor cells. The predictive value of PD-L1 on tumor cells seems to be more robust for anti-PD-1 antibody (nivolumab and pembrolizumab), and in the context of advanced melanoma and NSCLC.

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