BackgroundA paucity of data exists to examine nurses’ satisfaction with the use of insulin pens with safety needles in hospitalized patients with diabetes. We investigated major determinants of nurses’ preference of the method of insulin administration in the context of a General Hospital in Northern Italy.MethodsConsecutive patients admitted to three hospital units of different care intensity requiring insulin received insulin therapy through either the vial/syringe method (October to December 2012) or pen/safety needles with dual-ended protection method (January to March 2013). Before the implementation of insulin pens, floor nurses received a specific training program for proper insulin pen injection technique including individual testing of the devices (pen/safety needles). At the end of the study, nurses completed the Nursing Satisfaction Survey Questionnaire. Cronbach’s alpha was used to determine the internal consistency and reliability of the questionnaire. Major determinants of satisfaction were investigated through an exploratory factor analysis. The association between each retained factor and time spent to teach patients how to self-inject insulin with pen devices was also investigated.ResultsFifty-three out of 60 nurses (mean age ± SD 36.2 ± 8.5 years, 85 % women, 57 % with 10+ years of working experience) returned the questionnaire. Internal consistency of the questionnaire was satisfactory (Cronbach’s alpha > 0.9). Three months after their introduction, about 92 % of nurses considered pen devices an “improvement” over the vial/syringe method. Two factors explained 85 % of nurses’ satisfaction, one related to convenience and ease of use, and the other to satisfaction/time spent for dose preparation and administration. The latter factor was inversely correlated with time spent on patients’ training tasks.ConclusionsNurses’ satisfaction with pen devices was higher than previously reported, possibly reinforced by safety needles with dual-ended protection. Perceived workload was a major determinant of nurse satisfaction using pen devices with safety needles. To facilitate the introduction of insulin pens in the hospital setting, it should be specifically addressed during training programs in the switch-over period.

BackgroundTo assess costs and safety of insulin pen devices and safety needles as compared to vial/syringes in hospitalized patients requiring insulin therapy in a General Hospital in Northern Italy.Materials and MethodsIn a prospective 9-month study, consecutive patients admitted to three Hospital Units received insulin therapy through either a traditional disposable syringe method, or pen/safety needles with dual-ended protection, or disposable safety syringes. We compared the median direct (insulin and devices) and indirect (insulin supply at discharge, insulin wastage) costs of a 10-day in-hospital insulin treatment in the 3 study groups, additionally accounting for the costs related to the observed needlestick injury rate. Patients’ safety during in-hospital stay (hypo- and hyperglycemia episodes) and satisfaction were also assessed.ResultsN=360 patients (55% men, mean age 75.6 years, 57% with DM since ≥10 years) were recruited in the study. Insulin pens had higher median direct cost than both traditional syringes (43 vs. 18 €/patient, p<.0001) and safety syringes (21.5 €/patient, p<.0001). However, when also indirect and injuries costs were taken into account, the estimated savings for using pens over traditional syringes were as high as 32 €/patient (45.8 vs. 77.6 €/patient, p-value <.0001). No differences in patients’ safety were observed. 74% and 12% of patients using pens and syringes would like to continue the method at home, respectively (p<0.0001).DiscussionA selective use of individual pre-filled pens/safety needles for patients who are likely to continue insulin therapy at home may strongly reduce hospital diabetes treatment related costs.

ObjectivesThe UK Prospective Diabetes Study (UKPDS) Risk Engine (RE) provides the best risk estimates available for people with type 2 diabetes (T2D), so it was applied to patients on persistent sitagliptin treatment.DesignA ‘real-world’ retrospective, observational, single-center study.SettingThe study was performed in a general hospital in Northern Italy in order: (1) to validate UKPDS RE in a cohort of Italian participants with T2D without prespecified diabetes duration, with/without cardiovascular (CV) disease, treated with sitagliptin; (2) to confirm CV risk gender difference; (3) to evaluate the effect on metabolic control and on CV risk evolution obtained by ‘add-on’ persistent sitagliptin treatment.ParticipantsSitagliptin 100 mg once a day was taken by 462 participants with T2D: 170 of them (males: 106; age: 63.6±8.8; T2D duration: 11.58±7.33; females: 64; age: 65.6±7.95; T2D duration 13.5±7.9) were treated for 48 months with the same dosage.InterventionsAn analysis of normality was performed both for continuous, and for groups variables on UKPDS RE percentage values, defining the requirement of a base log10 transformation to normalize risk factor values for analysis validation.ResultsThe evaluation of CV risk evolution by gender (t-test) confirmed the expected statistical difference (p<0.0001). Sitagliptin obtained significant results after 12 months, and at the end of the observation, both on metabolic control (expressed by glycated hemoglobin) and on UKPDS RE. Analysis of variance test revealed a significant effect on CV risk after 12 months (p=0.003), and after 48 months (p=0.04). A bivariate correlation analysis revealed a correlation index (r)=0.2 between the two variables (p<0.05).ConclusionsThese ‘real-world’ data obtained applying UKPDS RE may reflect patients’ and clinicians’ interest in realizing individual CV risk, and its evolution. Sitagliptin-persistent treatment for a medium–long period obtained an improvement on metabolic control, as well as a reduction on CV risk.

Background As the result of a possible shortage of methoxy polyethylene glycol epoetin beta (CERA) within Italy, with the agreement of the EMA, AIFA (the Italian Medicines Agency) prepared a document inviting prescribers to switch patients who were undergoing treatment with different doses of CERA to any Erythropoiesis Stimulating Agent (ESA), for the treatment of anaemia associated with chronic kidney disease (CKD). This recommendation emphasised the need to monitor haemoglobin levels (Hb) and safety and efficacy parameters. Purpose To evaluate variations of efficacy (Hb levels) and safety (immunological reaction) of a new treatment, in patients with CKD after switching from CERA to epoetin zeta (EPO zeta), as per international and national guidelines. To keep the same Hb level obtained before the shift. To compare the cost differences of the two ESAs. Materials and MethodsA preliminary observational study (April–September 2012) was carried on CKD patients in haemodialysis care at the Department of Nephrology. The patients enrolled were treated with some of the doses of CERA indicated in the Recommendation for at least ten months. We evaluated ESA dosage, Hb level and dosage/kg. ResultsThe study included 12 patients (7 men and 5 women) with mean age 56.64 years (range 40–75). All patients were treated with EPO zeta (average initial dose 6500 IU/Kg/week); after monthly monitoring of Hb levels, the initial dose of EPO zeta was increased by 7.69% (average dose 7000 IU/Kg/week) and three months later, the median Hb level observed was 11.28 g/dl. Statistical analysis showed no significant difference between CERA and EPO zeta in terms of Hb level (P = 0.408). No adverse events due to treatment were recorded; no variation in iron supplementation The use of EPO zeta resulted in savings of 250 euro per month/patient versus CERA treatment. Conclusions After switching from CERA therapy, the use of EPO zeta appears effective and safe for CKD patient treatment. Data showed the need to increase the dose of EPO zeta to maintain a steady Hb level. Despite the increased consumption, the use of this biosimilar could contribute to containing pharmaceutical costs. No conflict of interest.

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