Incidence of potential drug interactions in a transplant centre setting and relevance of electronic alerts for clinical practice support

Background Adverse drug events may occur as a result of drug–drug interactions (DDIs). Information technology (IT) systems can be an important decision-making tool for healthcare workers to identify DDIs.Objective The aim of the study is to analyse drug prescriptions in our main hospital units, in order to measure the incidence and severity of potential DDIs. The utility of clinical decision-support systems (CDSSs) and computerised physician order entry (CPOE) in term of alerts adherence was also assessed. DDIs were assessed using a Micromedex healthcare series database.Methods The system, adopted by the hospital, generates alerts for prescriptions with negative interactions and thanks to an 'acknowledgement function' it is possible to verify physician adherence to alerts. This function, although used previously, became mandatory from September 2010. Physician adherence to alerts and mean monthly incidence of potential DDIs in analysed units, before and after the mandatory 'acknowledgement function', were calculated.Results The intensive care unit (ICU) registered the greatest incidence of potential DDIs (49.0%), followed by the abdominal surgery unit and dialysis (43.4 and 42.0%, respectively). The cardiothoracic surgery unit (41.6%), step-down unit (38.3%) and post-anaesthesia care unit (30.0%) were comparable. The operating theatre and endoscopy registered the fewest potential DDIs (28.2 and 22.7%, respectively). Adherence to alerts after the 'acknowledgement function' increased by 25.0% in the ICU, 54.0% in the cardiothoracic surgery unit, 52.5% in the abdominal surgery unit, 58.0% in the stepdown unit, 67.0% in dialysis, 51.0% in endoscopy and 48.0% in the post-anaesthesia care unit. In the operating theatre, adherence to alerts decreased from 34.0 to 30.0%. The incidence of potential DDIs after mandatory use of the 'acknowledgement function' decreased slightly in endoscopy (–2.9%), the abdominal surgery unit (–2.7%), dialysis (–1.9%) and the step-down unit (–1.4%).Conclusions Improving DDI alerts will improved patient safety by more appropriately alerting clinicians

Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: A two-center, matched case-control study

Background: Recent reports have suggested the efficacy of a double carbapenem (DC) combination, including ertapenem, for the treatment of carbapenem-resistant Klebsiella pneumoniae (CR-Kp) infections. We aimed to evaluate the clinical impact of such a regimen in critically ill patients. Methods: This case-control (1:2), observational, two-center study involved critically ill adults with a microbiologically documented CR-Kp invasive infection treated with the DC regimen matched with those receiving a standard treatment (ST) (i.e., colistin, tigecycline, or gentamicin). Results: The primary end point was 28-day mortality. Secondary outcomes were clinical cure, microbiological eradication, duration of mechanical ventilation and of vasopressors, and 90-day mortality. Forty-eight patients treated with DC were matched with 96 controls. Occurrence of septic shock at infection and high procalcitonin levels were significantly more frequent in patients receiving DC treatment (p < 0.01). The 28-day mortality was significantly higher in patients receiving ST compared with the DC group (47.9% vs 29.2%, p = 0.04). Similarly, clinical cure and microbiological eradication were significantly higher when DC was used in patients infected with CR-Kp strains resistant to colistin (13/20 (65%) vs 10/32 (31.3%), p = 0.03 and 11/19 (57.9%) vs 7/27 (25.9%), p = 0.04, respectively). In the logistic regression and multivariate Cox-regression models, the DC regimen was associated with a reduction in 28-day mortality (OR 0.33, 95% CI 0.13-0.87 and OR 0.43, 95% CI 0.23-0.79, respectively). Conclusions: Improved 28-day mortality was associated with the DC regimen compared with ST for severe CR-Kp infections. A randomized trial is needed to confirm these observational results. Trial registration: ClinicalTrials.gov NCT03094494. Registered 28 March 2017

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications

Introduction: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. Methodology: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. Results: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. Conclusion: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe. © Copyright © 2020 Miljković, Godman, Kovačević, Polidori, Tzimis, Hoppe-Tichy, Saar, Antofie, Horvath, De Rijdt, Vida, Kkolou, Preece, Tubić, Peppard, Martinez, Yubero, Haddad, Rajinac, Zelić, Jenzer, Tartar, Gitler, Jeske, Davidescu, Beraud, Kuruc-Poje, Haag, Fischer, Sviestina, Ljubojević, Markestad, Vujić-Aleksić, Nežić, Crkvenčić, Linnolahti, Ašanin, Duborija-Kovačević, Bochenek, Huys and Miljković

Evidence-based application of explicit criteria to assess the appropriateness of geriatric prescriptions at admission and hospital stay.

BackgroundInappropriate prescribing in the elderly is a critical issue in primary care, causing a higher risk of Adverse Drug Reactions (ADRs) and resulting in major patient safety concerns. At international level, many tools have been developed to identify Potentially Inappropriate Medications (PIMs).ObjectiveThe aim of this study was the application of Beers, Screening Tool of Older People's Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) and Improving Prescribing in the Elderly Tool (IPET) criteria as key tool to improve the quality of prescribing.MethodsA retrospective study was conducted using the aforementioned criteria. Two different cohorts of elderly patients were enrolled between January 2015 and December 2016, 1800 at admission and 1466 at hospital stay. The index of each criterion divided by politherapy were correlated with comorbidities (Pearson correlation). A comparison was made between admission and hospital stay through a Student's t test of the average of the index.ResultsThe Proton Pump Inhibitors (PPIs) were the most prescribed PIMs according Beers criteria in both patient cohorts (56%). The most detected drug-drug and drug-disease interactions at admission and at hospital stay were 3 or more drugs active on the Central Nervous System (CNS) as they can predispose to fall-risk. The most detected PIMs with STOPP criteria at admission were PPIs administered for more than 8 weeks. Inhaled β2-agonists or antimuscarinics were the most prescribed Potential Prescription Omissions (PPOs) according to START criteria. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) in patients with high blood pressure were the most detected PIMs according to IPET criteria during hospital stay. A significant correlation between the comorbidities and the all index at hospital stay, while at admission there was no significant correlation for Beers and IPET index.ConclusionThe prescriptive criteria were a useful tool for assessing the quality of prescriptions in the geriatric population and identifying their critical issues

Vulnerabilità e irregolarità dei lavoratori nel settore agricolo: percezione, determinanti, interventi

L’analisi dei molteplici fattori che determinano la vulnerabilità dei lavoratori migranti impiegati in agricoltura, realizzata nei Presìdi del Progetto di Caritas Italiana, evidenzia la necessità di adottare, sul piano normativo e politico, un approccio ad ampio raggio, per superare la potenziale inefficacia sia di interventi specifici, sia di misure generali che non prevedano, nella loro implementazione, adeguate forme di flessibilità e di adattamento ai diversi contesti locali

Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology

Purpose: The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD). Methods: We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis. Patients were treated with epoetin alfa, beta, and darbepoetin as originator and epoetin zeta as biosimilar. Hemoglobin levels have been analyzed at baseline and after 3, 6, and 12 months. Descriptive statistics were used to analyze the results. Results: At baseline, 47 patients were in the biosimilar group and 57 in the originator; the basal level of hemoglobin was similar between the groups (mean Hb 9.4 and 9.3 g/dL, respectively). Median age, weight, and comorbidities were almost comparable. After 3 months, 44 patients remained in the biosimilar group and 48 in the originator; hemoglobin increase was significantly greater in patients treated with biosimilar [absolute increase 1.6 vs 1.0 g/dL, p < 0.001]. After 6 and 12 months, number of patients fall furthermore. Hemoglobin levels increased more in the biosimilar group after 6 months (2.1 vs 1.1 g/dL, p < 0.001) and 12 months (2.0 vs 1.0 g/dL, p < 0.001). Conclusions: Biosimilar ESAs have similar risk/benefit profile compared to originators. Our data are in agreement with relevant scientific literature and, on the other hand, they are in contrast with common thought that considers biosimilar less efficacious and less safe than originators