Overcoming Barriers to the Effective Management of Severe Asthma in Italy.

INTRODUCTION: People with severe asthma (SA) often have poor disease control and quality of life, and are at high risk of exacerbations, lung function decline and asthma-related death. The present expert opinion article aimed to identify unmet needs in the management of SA in Italy, and propose possible solutions to address these needs. METHODS: At five multidisciplinary events in Italy, attendees identified factors that interfered with the effective management of SA and suggested how these barriers could be overcome. A core group of 12 Italian experts (pulmonologists, general practitioners, allergists, payers and patients) identified the main issues and proposed possible solutions based on the results from the meetings and relevant articles from the literature. RESULTS AND CONCLUSIONS: We reviewed the gap between real-world practice and guidelines, oral corticosteroid overuse, SA-related mortality, and barriers to effective SA treatment. Common themes were lack of awareness about SA among both patients and clinicians, and lack of networking/information exchange between those involved in the treatment of SA. Participants agreed on the need to implement patient education and create multidisciplinary groups of specialists to improve SA management through multidisciplinary educational initiatives, meetings with local experts, development of a flow chart for referral/connection with local experts and specialized centers. Clinical instruments that might help specialists improve SA management included referral networks, integrated care pathways, phenotyping and treatment algorithms, exacerbation tracking, and examination of electronic medical records for patients with uncontrolled asthma. The following actions need to be implemented in Italy: i) maximize the use of advanced therapies, eg, biologics; ii) increase/improve education for physicians and patients; iii) improve multidisciplinary communication and care coordination; iv) introduce regional and local protocols for SA diagnosis and treatment; and v) change the structure of healthcare services to reduce specialist waiting times and facilitate access to biologic therapies.

Enlightening chronic obstructive pulmonary disease through patients' and caregivers' narratives.

PURPOSE: The primary aim of this research was to raise awareness for COPD through real narratives of patients, caregivers, and pulmonologists. The second objective includes providing clinicians new means of caring for and treating patients with COPD. METHODS: Using narrative medicine, testimonies from patients, their caregivers, and clinicians were collected through an online questionnaire enriched by a narrative plot. Narrations were analyzed throughout descriptive statistics and an elaboration of recurring words and expressions. RESULTS: Throughout the project, 350 narratives were collected from 235 patients, 55 caregivers, and 60 physicians. Though a generally neutral reaction had been observed upon diagnosis, COPD had been found to have a high impact on the patients' and caregivers' lives. Metaphors utilized by patients and caregivers were suggestive of fear and panic unlike those utilized by clinicians who usually had a more technical approach. Smoking was a significant concern for not only patients and caregivers but also clinicians. CONCLUSION: Physicians are therefore challenged to find new ways of communicating COPD to raise awareness on this pathology and encourage corrective habits. An important social objective should be the implementation of a health system that is able to optimize patients' and caregivers' lives.

Concurrent Use of Low-Dose Aspirin and Omega-3 Fatty Acids and Risk of Upper Gastrointestinal Complications: A Cohort Study with Nested Case-Control Analysis.

The risk of upper gastrointestinal complications (UGIC) due to low-dose aspirin (LDA) can be further increased by the concurrent exposure to other antithrombotic agents. Little is known on the combined therapy with LDA and medications containing omega-3 (OM3) fatty acids, which also exert antiplatelet activity. The aim of this study was to investigate the risk of UGIC in patients exposed to LDA-OM3 combination. The Italian Health Search IMS Health Longitudinal Patients Database was used to perform a population-based cohort study. Patients aged ≥18 years with cardio- or cerebrovascular ischaemic disease recorded between 2002 and 2012 (cohort entry) were selected. All UGIC cases (index date) observed up to December 2013 were identified. According to a nested case-control analysis, up to 10 controls were matched to each case on age, sex and calendar period. The risk of UGIC was investigated among current (up to 30 days preceding index date), recent (31-60 days) and past users (61-365 days) of the LDA-OM3 combination. Exposure assessment was lagged by 30 days to minimize reverse causation. Additionally, a duration-response analysis was performed. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using conditional logistic regression. Non-users of the LDA-OM3 combination were the reference category. Current (OR = 0.66; 95% CI: 0.44-1.00), recent (OR = 0.83; 95% CI: 0.52-1.33) and past users (OR = 0.81; 95% CI: 0.57-1.15) did not statistically significantly increase the risk of UGIC. No duration-response relationship was found. Our results suggest that LDA-OM3 combination therapy does not affect the UGIC risk in patients with cardio- or cerebrovascular ischaemic diseases. Given the novelty of these findings, further studies are needed.

Association between satisfaction and stress with aspects of job and practice management among primary care physicians.

BACKGROUND: Reforms introduced in the last decade in Italian general practice, have contributed to the changing role of primary care physicians (PCPs) within the Italian National Health Service, with potential difficulties adapting that may lead to job stress and dissatisfaction. The present study aims to compare job satisfaction and stress levels of PCPs working in primary healthcare teams (PHCTs) with those for practitioners operating in single ambulatory offices, and to assess potential associations with aspects of job and practice management. METHOD: A postal survey was conducted between January and March 2005 among PCPs working in Tuscany. Data were collected by using a structured questionnaire containing questions concerning personal, professional, job and practice characteristics. The Warr-Cook-Wall scale and the Cooper test were used to assess job satisfaction and stress, respectively. RESULTS: From 3043 PCPs, a response rate of 45.2% was achieved. Significant differences were found between PHCT physicians and solo practitioners in several aspects of their job. Physicians working in PHCTs appeared more satisfied in some aspects of their practice such as organisation, whereas they were less satisfied about workload and interaction with other healthcare providers. Multivariate modelling showed relevant aspects of dissatisfaction and stress, particularly the difficulties of collaboration with other healthcare providers, and access to specialised services. CONCLUSION: Reform strategies aimed at improving the quality of care among PCPs needs to take into account the contextual determinants of physician satisfaction and stress, and should highlight programmes that might be pursued to improve the integration of PCPs within the Italian National Health System.

Pharmacological treatment after acute myocardial infarction from 2001 to 2006: a survey in Italian primary care.

BACKGROUND: Pharmacological preventive therapy after acute myocardial infarction (AMI) is strictly recommended because of its great efficacy. Little is known about long-term utilization of drugs related to cardiovascular secondary prevention in everyday practice. DESIGN: A population-based cohort study on the basis of an Italian general practice database. METHODS: Searching a large primary-care Italian database (Health Search), we selected five cohorts of patients with first occurrence of AMI from 2001 to 2005, respectively, and analyzed prescriptions of antithrombotic agents, beta-blockers, statins and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) from 2001 to 2006 (follow-up ranging from 1 to 5 years). RESULTS: We identified 4764 patients (mean age 67; 35% female) discharged from hospital after first-ever AMI. The prescription rate in the first year after AMI was suboptimal (beta-blockers 35.1%, aspirin or warfarin 75.0%, ACE-inhibitors or ARBs 61.6%, statins 52.8%) but showed a continuous improvement from 2001 to 2005. The prescription rate decreased slightly during the follow-up, but showed a complex pattern with a variable but significant number of patients discontinuing or resuming the therapy. CONCLUSIONS: The prescription of recommended drugs after AMI has increased from 2001 to 2006 in Italy, but the prescription rate remains largely unsatisfactory. Therapeutic continuity is also suboptimal.

Gynecomastia possibly induced by rosuvastatin.

Gynecomastia is characterized by benign progressive enlargement of the male breast. A pharmacologic origin is identified in 10-20% of cases. Several case reports have associated this condition to the use of statins. However, to our knowledge, no case of rosuvastatin-induced gynecomastia has been reported in the literature. We describe a 57-year-old man who developed bilateral gynecomastia after 2 months of rosuvastatin therapy. After switching to a different statin, atorvastatin, his symptoms resolved within 1 month. Use of the Naranjo adverse drug reaction probability scale indicated a possible relationship between the patient's development of gynecomastia and rosuvastatin therapy. The relatively strong effect of rosuvastatin on inhibiting steroidogenesis might have explained why our patient's gynecomastia occurred only with this agent. Clinicians should be aware of the possibility of adverse endocrine reactions when statins are prescribed, including newer agents such as rosuvastatin.

Neuropsychiatric reactions to drugs: an analysis of spontaneous reports from general practitioners in Italy.

Limited information is available on drug-induced neuropsychiatric disorders in general practice. The spontaneous reports of both neurological and psychiatric adverse drug reactions (ADRs) collected during a 2-year period in PharmaSearch database, an Italian database recording reports of ADRs from general practitioners (GPs), were examined. Between January 2002 and December 2003, 171 general practitioners sent to PharmaSearch a total of 1131 reports corresponding to 1892 ADRs. Of overall reports, 310 (27.4%) involved the central nervous system resulting in 440 neuropsychiatric reactions (specifically, 241 neurological and 199 psychiatric). In our survey, 40 reports were excluded because they were incomplete or contradictory and thus classified as 'unlikely' or 'unclassifiable'. Therefore, the present analysis was carried out on 270 reports with 391 neuropsychiatric reactions (213 neurological and 178 psychiatric, respectively). Vertigo (16.4%), confusion (10.7%) and headache (10.0%) were the reactions more commonly reported. Drugs indicated for the treatment of nervous system disorders (ATC 1 code=N) accounted only for 38.4% of neuropsychiatric reactions, while most of these reactions were related to drugs indicated for other than nervous system diseases. Non-steroidal anti-inflammatory drugs (NSAIDs), fluoroquinolones, antidepressant drugs, opioids, and drugs for peptic ulcer were the categories most frequently suspected for neuropsychiatric reactions. Of 391 neuropsychiatric reactions, 78 (19.9%) were unlabeled and 41 (10.5%) were serious. In conclusion, the present study carried out in general practice underlines the importance of neuropsychiatric ADRs and reminds GPs to pay attention to this kind of toxicity when they prescribe pharmacological agents to their patients.