Ethics committees and research in Italy: seeking new regulatory frameworks (with a look at the past)

The legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this article provides a brief review of the history of ethic committees in Italy. We then discuss certain considerations about the current situation and formulate some proposals in terms of the regulatory choices that must be made. There is a vital need for rules that promote efficiency, to guarantee that Italy’s position remains competitive and attractive within the European Union

Association between benzodiazepine prescriptions and potential risk factors of adverse drug reactions among elderly and very elderly: findings from Friuli Venezia Giulia region, Italy

Background: benzodiazepines (BDZs) highly increase the risk of adverse drug reactions (ADRs), especially in the elderly with certain medical conditions.  Methods: point-prevalence study in December 2017; 2,456 patients ≥65 years were included from 14 regional public and private hospitals, 24 long-term chronic care facilities (LTCCFs) and 20 nursing homes (NHs). Data regarded BDZ prescriptions and comorbidities, co-prescriptions, or concurrent diseases, which could increase the risk of ADRs in BDZ users. Univariate and multivariate logistic regression analyses were used to assess associations between ADRs in BDZ users vs. non-users, as well as within users.  Results: 671 patients were prescribed BDZ, whose half were in NHs. Being prescribed 10 or more drugs was twice more common among BDZ users compared to non-users. BDZs were prescribed for long-term to 80% of patients in NHs, while proportions were halved in hospitals and LTCCFs. In the analyses within BDZ users, patients in NHs and LTCCFs were at higher risk of dementia and concurrent use of opioid analgesic and antipsychotics compared to hospitalized patients.  Conclusions: the use of BDZs in older patients is common in FVG. A great extent of comorbidities and concurrent medications at higher risk of ADRs was found. Analyses in different healthcare settings can allow to drive evidence-based interventions in order to discourage the use of BDZs and monitor the raise of ADRs

Errors and omissions in hospital prescriptions: a survey of prescription writing in a hospital

Background: The frequency of drug prescription errors is high. Excluding errors in decision making, the remaining are mainly due to order ambiguity, non standard nomenclature and writing illegibility. The aim of this study is to analyse, as a part of a continuous quality improvement program, the quality of prescriptions writing for antibiotics, in an Italian University Hospital as a risk factor for prescription errors. Methods: The point prevalence survey, carried out in May 26-30 2008, involved 41 inpatient Units. Every parenteral or oral antibiotic prescription was analysed for legibility (generic or brand drug name, dose, frequency of administration) and completeness (generic or brand name, dose, frequency of administration, route of administration, date of prescription and signature of the prescriber). Eight doctors (residents in Hygiene and Preventive Medicine) and two pharmacists performed the survey by reviewing the clinical records of medical, surgical or intensive care section inpatients. The antibiotics drug category was chosen because its use is widespread in the setting considered. Results: Out of 756 inpatients included in the study, 408 antibiotic prescriptions were found in 298 patients (mean prescriptions per patient 1.4; SD \ub1 0.6). Overall 92.7% (38/41) of the Units had at least one patient with antibiotic prescription. Legibility was in compliance with 78.9% of generic or brand names, 69.4% of doses, 80.1% of frequency of administration, whereas completeness was fulfilled for 95.6% of generic or brand names, 76.7% of doses, 83.6% of frequency of administration, 87% of routes of administration, 43.9% of dates of prescription and 33.3% of physician's signature. Overall 23.9% of prescriptions were illegible and 29.9% of prescriptions were incomplete. Legibility and completeness are higher in unusual drugs prescriptions. Conclusion: The Intensive Care Section performed best as far as quality of prescription writing was concerned when compared with the Medical and Surgical Sections. Nevertheless the overall illegibility and incompleteness (above 20%) are unacceptably high. Values need to be improved by enhancing the safety culture and in particular the awareness of the professionals on the consequences that a bad prescription writing can produc

Errors and omissions in hospital prescriptions: a survey of prescription writing in a hospital

Background: The frequency of drug prescription errors is high. Excluding errors in decision making, the remaining are mainly due to order ambiguity, non standard nomenclature and writing illegibility. The aim of this study is to analyse, as a part of a continuous quality improvement program, the quality of prescriptions writing for antibiotics, in an Italian University Hospital as a risk factor for prescription errors. Methods: The point prevalence survey, carried out in May 26-30 2008, involved 41 inpatient Units. Every parenteral or oral antibiotic prescription was analysed for legibility (generic or brand drug name, dose, frequency of administration) and completeness (generic or brand name, dose, frequency of administration, route of administration, date of prescription and signature of the prescriber). Eight doctors (residents in Hygiene and Preventive Medicine) and two pharmacists performed the survey by reviewing the clinical records of medical, surgical or intensive care section inpatients. The antibiotics drug category was chosen because its use is widespread in the setting considered. Results: Out of 756 inpatients included in the study, 408 antibiotic prescriptions were found in 298 patients (mean prescriptions per patient 1.4; SD \ub1 0.6). Overall 92.7% (38/41) of the Units had at least one patient with antibiotic prescription. Legibility was in compliance with 78.9% of generic or brand names, 69.4% of doses, 80.1% of frequency of administration, whereas completeness was fulfilled for 95.6% of generic or brand names, 76.7% of doses, 83.6% of frequency of administration, 87% of routes of administration, 43.9% of dates of prescription and 33.3% of physician's signature. Overall 23.9% of prescriptions were illegible and 29.9% of prescriptions were incomplete. Legibility and completeness are higher in unusual drugs prescriptions. Conclusion: The Intensive Care Section performed best as far as quality of prescription writing was concerned when compared with the Medical and Surgical Sections. Nevertheless the overall illegibility and incompleteness (above 20%) are unacceptably high. Values need to be improved by enhancing the safety culture and in particular the awareness of the professionals on the consequences that a bad prescription writing can produc

Identification of targets for quality improvement in antimicrobial prescribing : the web-based ESAC Point Prevalence Survey 2009

Objectives: Since electronic prescribing is limited to few hospitals, point prevalence surveys, such as the standardized European Surveillance of Antimicrobial Consumption point prevalence survey (ESAC PPS), are an alternative tool for monitoring prescribing and helping to identify performance indicators and prescribing trends. The main objective of this study was to identify and assess targets for quality improvement. Methods: Each hospital had to carry out the survey within 2 weeks. Each department had to be surveyed in 1 day. Data collected, for all inpatients, included age and gender. For patients on systemic antimicrobial treatment, the antimicrobial/s, infection/prophylaxis site, reason in medical notes and guideline compliance were also collected. A central database using a web-based tool (WebPPS) developed in-house was used for data entry. Results: Combination of two or more antimicrobials accounted for 30% of use. Surgical prophylaxis was prolonged (>1 day) in 53% of cases. 'Intensive care' had higher proportions of treated patients (53% versus 29%), combination therapy (49% versus 31%), hospital-acquired infections (49% versus 31%) and parenteral administration (91% versus 61%). 'Reason in notes' was documented in 76%, and 'guideline compliance' occurred in 62% of patients. Conclusions: The ESAC PPS provided useful information on the quality of prescribing, which identified a number of targets for quality improvement. These could apply to specific departments or whole hospitals. Intensive care, which has different characteristics, should not be compared with general wards with respect to combination therapy, hospital-acquired infections or parenteral proportion. The study confirmed that the ESAC PPS methodology can be used on a large number of hospitals at regional, national, continental or global level.The ESAC project was supported by a grant from the European Centre for Disease Prevention and Control (ECDC; Grant Agreement 2007/001).peer-reviewe

Are Hospitalizations for Percutaneous Coronary Procedures Missed Opportunities for Teaching Rules of Secondary Prevention?

Background and aims: Percutaneous coronary intervention (PCI) is the most frequently used revascularization approach, often repeatedly applied. The quest for the ultimate revascularization procedure however may capture cardiologist’s attention and lead them to minimize the issue of secondary prevention in their patients. Aims of this study were to assess: 1. The individual risk factor profile, 2. The relation between the risk factors correction and the number of hospital admissions for elective procedures, 3. The appropriateness of medical treatment in patients admitted for elective coronary invasive procedures (diagnostic and interventional). 4. The patients knowledge of threshold values for cardiovascular risk factors. Patients and Methods: 100 patients (71% males, mean age 68 years) consecutively admitted for elective coronary angiography or PCI. They underwent a classical risk factors assessment and were divided in three groups according to the number of admissions for coronary angiography and in two groups according to the number of PCIs. Results: Fifty-seven % of patients had been previously admitted for invasive examination at least three times and 58% had already been treated with at least one PCI. Seventyone % were treated with beta-blockers but only 25% of them received a dosage found effective in RCTs (randomized clinical trials). Sixty % were treated with ACE-inhibitors and 83% received the dosage found effective in RCTs. Fifty-two % were treated with statins and 95% received a dosage found effective in RCTs. Nine % were still active smokers. Fourtynine % had a LDL cholesterol level above 100 mg/dL. The percentage of patients not on target was unrelated to the number of hospital admissions for invasive procedures. Conclusions: Modern cardiology is quickly embracing high tech procedures and trials results but often fails to spend enough time teaching how to control risk factors according to the recommendations of the evidence-based guidelines, even independently of the number of hospitalizations for invasive cardiovascular procedures

A case-crossover study of sleep, fatigue, and other transient exposures at workplace and the risk of non-fatal occupational injuries among the employees of an Italian academic hospital

Objectives: Transient exposure with acute effect has been shown to affect the risk of occupational injuries in various industrial settings and at the healthcare workplace. The objective of this study has been to identify transient exposures related to occupational injury risk in an Italian teaching hospital. Material and Methods: A case-crossover study was conducted among the employees of the University Hospital of Udine who reported an occupational injury, commuting accident, or incident involving biological risk in a 15-month period in the years 2013 and 2014. The matched-pair interval approach was used to assess the role of acute sleep deprivation whereas the usual frequency approach was used for other 13 transient exposures. Results: Sleep hours were not associated with the risk of injuries whereas a significant risk increase was associated with fatigue, rush, distraction, emergency situations, teaching to or being taught by someone, non-compliant patients, bloody operative/work field, excess noise, complex procedures, and anger. Conclusions: We identified transient exposures that increased the risk of occupational injuries in an Italian teaching hospital, providing indications for interventions to increase workers' safety at the healthcare workplace. Int J Occup Med Environ Health 2016;29(6):1001–100

Healthcare Workers' Compliance with Hand Hygiene After the Introduction of an Alcohol-Based Handrub

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Extended-spectrum β-lactamase-producing Escherichia coli from extraintestinal infections in humans and from food-producing animals in Italy: a 'One Health' study

In recent years, Escherichia coli producing extended spectrum beta-lactamases (ESBL) have become a serious public health problem and food-producing animals (FPA) have been suggested as a potential reservoir/source. In this study, we aimed to compare ESBL-producing E. coli isolates from different sources. ESBL-producing E. coli isolates were collected from humans (n=480) and FPA (n=445) in Italy (2016-2017). Isolates were screened for the presence of ESBL and carbapenemase genes and classified according to phylogenetic group and MLST genotyping. mcr-1 to -5 genes were searched for in colistin resistant isolates. CTX-M was the most frequent ESBL-type in both human and animal isolates. CTX-M-15 prevailed in humans (75%) and cattle (51.1%) but not in poultry (36.6%). CTX-M-1 was common (58%) in pigs. SHV-type and CMY-2-like were found in FPA, especially in poultry (17.0% and 29.9%, respectively). 29 isolates were mcr-1 carriers (3 from humans and 26 from FPA). No carbapenemase genes were detected. Human isolates mostly belonged to phylogroup B2 (76.5%). Animal isolates were distributed among groups A (35.7%), B1 (26.1%) and C (12.4%). Few animal isolates (almost all from poultry) were classified into group B2 (4.3%). Most human isolates (83.4%) belonged to the pandemic ST131 clone and frequently carried CTX-M-15 (75.9%). ST131 was rarely detected in FPA (n=3 isolates from poultry). Nineteen STs were shared in both sources with ST10, ST410 and ST69 being more frequently detected. According to our results the potential exchange of ESBL genes from animals to humans is feasible, underlying the need for a strict monitoring based on an "One Health" approach