How much are biosimilars used in southern Italy?: a retrospective analysis of epoetin utilization in the local health unit of Messina in the years 2010-2011.

BACKGROUND: Epoetins are one of the three biologics for which biosimilars are available in Italy. So far, there is a lack of Italian national/regional longitudinal data about epoetin use. OBJECTIVE: The aim of this study was to evaluate the prescribing pattern of epoetins (reference products and biosimilars) in a Local Health Unit (LHU) of Southern Italy in recent years. METHODS: A retrospective drug utilization study was conducted during the period 1 January 2010 - 31 May 2011. The data source was the dispensing database of the Messina LHU, which contains anonymized data about dispensed drugs (including epoetins) that are prescribed by specialists to the residents in the catchment area. Indication of use and prescribed dosage of epoetins were derived by the therapeutic plans filled in by specialists and linked to drug dispensing records. Prevalence of epoetin use in the province of Messina (653 810 inhabitants) in 2010 was calculated. Furthermore, frequency analyses by sex, age, indication of use of epoetin users, as well as measurement of volume of use (defined daily dose [DDD]/1000/day) and expenditure of epoetins in 2010 were also performed. Analysis of the switching pattern between different reference products and biosimilar epoetins was performed. RESULTS: Overall, 4288 patients were treated with epoetins during the study period (mean age ± SD: 74.2 ± 13.7; females: 52%). Darbepoetin alpha and reference product epoetin alpha accounted overall for 79.8% of epoetin users, while biosimilars of epoetin alpha accounted for 0.9%. Among 1247 epoetin users for whom the therapeutic plan was revised, 1065 (85.4%) were treated because of anemia due to chronic kidney disease and 158 (12.6%) because of chemotherapy-induced anemia. In 2010, prevalence of epoetin use was 5.5 (95% CI 5.3, 5.7) per 1000 inhabitants in the province of Messina. The volume of use and related expenditure for epoetins was 3.58 DDD/1000 inhabitants/day and Euro 5 572 457 (about Euro 8.50 per capita/day) in 2010. Switching between different epoetins was very frequent (21.8% of users) but switching from reference products to biosimilars was very rare. CONCLUSIONS: Epoetins are frequently dispensed to residents in the province of Messina, mainly for the treatment of chronic kidney disease-related anemia, with a relevant impact on the pharmaceutical expenditure covered by the National Health System. Use of biosimilar products is very low in both naïve patients and in those who switch from other reference product epoetins.

Economic results of a palivizumab seasonal prophylaxis using a cohorting software and vial sharing.

BACKGROUND: Respiratory syncytial virus is the most important pathogen in lower respiratory tract infection in infants and young children. In high-risk populations it may develop severe, sometimes fatal, lower respiratory tract infections. A proportion of these infants require admission to intensive care units due to the severity of the condition and the level of care needed. Furthermore, we must consider the possible increased risk of asthma following RSV infection in infancy. METHODS: The aim of this work is to show how we strictly coordinated, during the 2008-2009 RSV season, the delivery of prophylaxis while minimising drug cost through vial sharing and cohorting infants with a software performed through Visual Basic programming system. RESULTS: By using this method we have been able to obtain a saving of the 29.2% compared to the theoretical amount. No infant requested hospitalisation for a RSV infection. CONCLUSIONS: Such a model ensures all patients to receive appropriate immunization and thus positively influencing the cost-benefit of palivizumab prophylaxis. We hope that our model of care delivery will be of use to other hospitals.

Fast drug stability determination by LC variable-parameter kinetic experiments.

Variable-parameter kinetic experiments were carried out using HPLC as analytical instrument. The hydrolysis of aspirin was followed both at variable-temperature and at variable-pH conditions. The peak areas relative to salicylic acid were processed by direct fit to a mathematical model and/or by differential method obtaining, by single experiments, the values of the apparent rate constant in the whole range of temperature and pH studied. The results, although the discontinuity of this kind of analysis, are in agreement with those obtained by constant-parameter kinetics but saving experimental time.

Variable-ionic strength kinetic experiments in drug stability studies.

The dependence of the pseudo-first-order rate constant on the ionic strength for the alkaline hydrolysis of indomethacin has been obtained, for the first time, in a single kinetic experiment carried out by varying with time the salt concentration inside the reaction vessel. The kinetic profile obtained was processed using as a mathematical model the variable-parameter kinetic equation containing the Bronsted-Bjerrum equation as the dependence function. The results are in good agreement with those obtained by the traditional method but the experimental time is reduced to about one-tenth.

Correlation between quality of life assessment and a personality neurobiologic model in dialyzed patients.

The Short Form 36 Health Survey (SF-36) is a self-administered scoring system that has been widely used and validated as a quality of life (QOL) assessment tool. In our study, a cluster analysis of SF-36 scores was performed in 50 healthy volunteers (controls) and 50 neurobiologically asymptomatic patients on maintenance hemodialysis (MHD). Firstly, we assayed the tendency to form clusters from each of the investigated dimensions. Statistic analysis was performed using the Student's t-test for independent measurements and multiple regression analysis. Secondly, we attempted to evaluate if the MHD to apply to both groups a general psychobiological personality model developed by Cloninger in 1987. Cloninger describes three independent personality dimensions: novelty seeking (NS), harm avoidance (HA)and reward dependence (RD). Each personality dimension would be the expression of hereditary variations integrating the three main brain systems, respectively: dopaminergic, serotoninergic and noradrenergic. Finally, we then aimed to investigate possible interferences among the seric concentrations of the neuromodulators and SF-36 scores, in the attempt to identify, using a simple approach, the complex personality structure of MHD patients. QOL self-assessment and seric neuromodulators were measured in both groups, choosing an interdialytic day for MHD patients. We found that MHD patients perceived a significant worsening in their QOL in all investigated dimensions with respect to the controls. In addition, they showed significantly lower dopamine and serotonine concentrations and significantly higher noradrenaline concentrations. Therefore, our study, confirmed data reported previously in the literature, that cluster analysis of SF-36 scores provides different results in the MHD population in comparison to normal subjects. In fact, comparing the hierarchical trees of both groups, it appeared evident that in MHD patients, cluster dimensions were greater than in the controls. In cluster compositions showed differences between the two groups. In fact, in MHD patients there were only a few of the clusters that were observed in the controls (mental health and social functioning, vitality and general health), while role-physical and role-emotional dimensions aligned outside the hierarchical tree, with a considerable linkage distance. In our opinion, it is fascinating that the three Cloninger neuromodulators could suggest that HD patient personalities are potentially cyclothymiac, altering the disposition of the two role functions inside the hierarchical tree.

Temperature-rate profiles by polarimetric variable-temperature kinetic experiments to study racemization reactions.

The racemization of (-)-adrenaline was followed by polarimetric variable-temperature kinetic experiments obtaining activation parameters and k(obs)(T) profile in one tenth of the time usually spent for traditional kinetic runs. A polarimeter connected to a computer for the acquisition and processing of the analytical data was used. The kinetic profiles were processed by both an integral method and a differential method. The results are in good agreement with each other and with those obtained by constant-temperature kinetics.