Farmeconomia. Health economics and therapeutic pathways
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    Unita di consumo dei farmaci e valutazioni farmacoeconomiche: uso e misuso di DDD e PDD

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    In pharmacoeconomical evaluations the quantification of drug utilization has to be done on the basis of measurement units that allow comparisons among series of longitudinal and transversal data. The most common techniques used for the analysis and the comparison of drug utilization patterns are based either on the Defined Daily Dose (DDD), a unit system proposed by WHO’s Drug Utilization Research Group, or on the Prescribed Daily Dose (PDD), a statistical parameter obtained from the analysis of drug prescriptions. This article illustrates the meaning of the main indicators of drug consumption that can be build with these techniques, underlining their utility and limitations. The DDD is the conventionally established theoretical mean daily dose of a drug, referred to a way of administration and to its main indication. It is, therefore, a mere technical measurement unit that cannot be interpreted as mean prescribed or consumed dose, and even less as recommended dose. The PDD, on the contrary, is not a measurement unit but a statistical mean value, that expresses the central tendency of the prescription variability in a defined setting. Starting from Italian data on the consumption of wide-spread antibiotics, the use and interpretation of various indicators based on the DDDs and PDDs are discussed. The parameters derived with the DDD technique are suitable for monitoring drug utilization and pharmaceutical expenditure. The PDD method is more direct, indicates the mean quantities actually prescribed and permits the estimation of the total dose consumed per therapeutic cycle and of other clinically relevant parameters, but requires the acquisition of more data than the other technique does. It is also important to remark the fact that both methods can’t be directly used for economical evaluations trying to assess the efficiency of resource allocation, as they are not correlated to the clinical outcomes of the therapy

    Il trattamento di pazienti con sepsi grave mediante drotrecogin alfa: una valutazione economica con riferimento all’Italia

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    Sepsis can be defined as a spectrum of clinical conditions caused by the immune response of a host to infection or trauma and characterized by systemic inflammation and coagulation. Particularly in elderly, immunocompromised and critically ill patients, sepsis is a major cause of morbidity and mortality in intensive care units (ICUs) worldwide. In the US, sepsis is the leading cause of death in noncoronary ICU patients. Drotrecogin alfa, or recombinant human activated protein C, has antithrombotic, antiinflammatory, and profibrinolytic properties. Recently in a phase III trial (PROWESS), Drotrecogin alfa demonstrated significantly reduced mortality in severe sepsis patients at 28 days. In this trial important value factors for the assessment of costs and outcomes of severe sepsis were also considered. The purpose of the present study is to determine the economic burden of the treatment with Drotrecogin alfa, according to a cost-effectiveness analysis based on the data of the PROWESS trial. The study has been adapted to the italian health environment. As regards to the costs per surviving patient and costs per QALY (Quality Adjusted Life Year), the predicted cost-effectiveness ratio of drotrecogin alfa in severe sepsis patients is much lower than the standard values considered as acceptable in the international litterature

    Osteoporosi: la malattia e il suo costo sanitario

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    Osteoporosis is a disorder of bone re-modeling, characterized by loss of its micro-architecture and decreased bone density, which lead to fragility and high risk of fracture following moderate traumata. Osteoporosisrelated pathological fractures occur more frequently in post-menopausal women, and the WHO estimates that the risk of osteoporotic fractures in women is approximately 40% during lifetime. The prevention of these osteoporotic fractures is considered one of the primary objectives for the control of the economical health burden of modern societies. The first part of this paper briefly outlines the physio-pathological basis, the epidemiology, the diagnosis and the available treatment options for osteoporosis, with particular regard to those therapies that are able to reduce the incidence of pathological fractures, that represent the main cost factor of the disease. In the second part, we reviewed the economical evaluations published on the cost of illness and of the costefficacy of the treatments. The studies that have analyzed the cost of osteoporosis, although incompletely, highlight that the greatest expenditures are related to hospitalization and rehabilitation after hip fracture, while the cost for the pharmacological treatment is relatively low. The cost-efficacy and cost-utility analyses conducted on pharmacological treatment are quite heterogeneous, and therefore hardly comparable, beside being conducted in countries with different health systems; the obtained data are nor directly transferable to the Italian setting. However, it emerges that diphosphonates, estrogens and SERMs (selective estrogen receptor modulators) are among the drugs with more favorable cost/effectiveness ratio, but there is still an uncertainty in the detection of the appropriate patient groups, which is crucial for the clinical, economical and ethical optimization of prevention interventions

    Utilità e costo/efficacia del dinoprostone in ostetricia

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    Pregnancy-related hypertension, intrauterine growth retardation, post-maturity and unfavorable local conditions are among the most frequent indications for labor induction. There are two competing strategies for the induction of labor in term pregnancies: formal induction with artificial rupture of the membranes and/or intravenous oxytocin on one side, and cervical ripening and induction with exogenous prostaglandins on the other. The use of prostaglandins in obstetrics relies on two pharmacological properties: the capacity of inducing the biochemical changes in the connective tissue of the cervix that lead to its maturation and the stimulation of the uterine smooth musculature. While the latter property is shared with oxytocin, the former offers great clinical advantages, in particular in those women that present an indication for labor induction but whose cervix, normally assessed with the use of the Bishop score, does not show “ripeness”, i.e. does not permit vaginal delivery. Since the acquisition cost of the prostaglandins is quite high, but the clinical benefit appears evident, several studies have analyzed the overall economical impact of their use, both as pre-induction cervical ripening agents and as induction drugs. When compared to a strategy of expectant management in term pregnancies without cervical ripeness, exogenous prostaglandin administration has proven to be more cost-effective and better accepted by the patients. Prostaglandins have also proven to be more cost-effective than oxytocin and/or amniotomy in women with an indication to labor induction and unripe cervix, due to the reduced number of induction failures and cesarean sections required with this strategy. The economical analyses that have compared oxytocin and prostaglandins in women with ripe cervices deliver more ambiguous data, but it appears that their cost-effectiveness is comparable. Furthermore, none of the reviewed studies has considered intangible costs, but it is a wide-spread opinion that induction with prostaglandins results in a more “natural” and less painful labor

    Il ruolo della SPECT in associazione a iofupane nella diagnosi della Malattia di Parkinson: i risultati di un’esperienza

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    According to the latest data, in Italy 200.000 patients are affected by the Parkinson’s Disease, and the trend is bound to go up. Generally the diagnosis, crucial in this pathology, is based on the clinic observation. But the absence of typical signs or symptoms increases the possibility of diagnostic mistakes. Ioflupane (DATSCAN ®) is a new diagnostic agent indicated for detecting loss of functional dopaminergic neuron terminals in the striatum of patients with clinically uncertain Parkinsonian Syndromes. The use of Ioflupane (DATSCAN ®) in association with the single-photon emission computed tomography (SPECT) allows to improve the diagnosis. Applying systematically this diagnostic model could cause a significant reduction in hospedalization cost, with less trouble for patients and a better quality of life. Aim of this study is to show the clinical and economic consequences of the use of Ioflupane (DATSCAN â) in association with SPECT as a new standard for the diagnosis of Parkinson’s Disease, considering the perspective of the National Heath System (NHS) and a single hospital structure

    Efficienza tecnologica e produttiva delle strutture trasfusionali in Italia

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    In all the developed countries the methods of blood collection and production are relevant subjects for the pharmacoeconomics studies, because of their health and economic implications related to the health policies in this area. The “blood market” rappresents an area where the sanitary items, the economic items and also the ethic items must be broached at the same time; therefore it can be considered emblematic. By this situation arises Progetto CO.R.SA. (COsti Raccolta SAngue), a project for estimating productivity and cost for a representive sample of italian trasfusional structure (ST). The study is supported by Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI). In Italy there are about 380 ST, but only 30 ST resulted suitable for the study. The analysis investigates six rates concerning: a) wastes; b) technological efficiency; c) personnel productivity. The present work describes only the informations on ST organization and production, delaying the results about costs to a specific further report

    Lo studio FAST: FAringotonsillite STreptococcica in età pediatrica Impatto farmacoeconomico delle Linee Guida dell’American Academy of Pediatrics sulla pratica clinica di 600 pediatri italiani

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    The American Academy of Pediatrics (AAP) has recently published its new guidelines for the treatment of pediatric tonsillopharyngitis; a diagnostic test for the detection of streptococci is recommended, followed by a treatment with penicillins (10 days) or cephalosporins (5 days) in case of positivity, and by no treatment otherwise. The success of a guideline, in general, depends on its diffusion in practice and on its adaptability to different local settings. The aim of the present study (FAST) was the evaluation of the clinical and economical impact of the application of the AAP guidelines in the Italian reality. The study was conducted with the cooperation of 600 pediatricians, uniformly distributed on the Italian territory, and involved 3072 patients. The pediatricians were left free to decide whether to follow the guidelines or not. The results of the analysis indicate that only some 20% of the pediatricians adhered to the suggested protocol; the total cost (calculated in the perspective of the National Health System, with a time horizon of about 3 months) per patient, nonetheless, resulted inferior in the group treated according to the proposed protocol (50,45 • vs. 53,30 •). Furthermore, a lower incidence of complications occurred in these patients. Among the “off-protocol” behaviors, two showed particularly evident misuse of health resources: inappropriate treatment after test positivity (59,15 •/patient), and treatment after test negativity (14% of the total population). Another interesting, although not surprising, result of this study was the evidence that penicillins are as effective as cephalosporins in the short-term, but significantly inferior in terms of complications, positivity for streptococci at the control test, and complications detected at follow-up

    Costi del trattamento con oloprazina nelle fasi iniziali della schizofrenia

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    Objective: In Italy, use of olanzapine in the public sector was limited by law to patients that had failed treatment with conventional antipsychotics, due to the higher purchase price of the drug. This restriction prevented first-episode patients and patients early in the course of their illness from being treated with olanzapine. The present study investigates economic consequences of this policy. Design: The present study retrospectively outlines treatment costs of patients switched to olanzapine during the early stages of schizophrenia as compared to the costs of patients switched during a later stage of the illness. Setting: The study was conducted within Italian Community Mental Health Services. Patients: The cost of pharmacological and non-pharmacological treatment was retrospectively calculated in 25 out-patients with schizophrenia and related disorders over a one-year span. Thirteen patients were switched to olanzapine in the early stage of their illness, prior to drug approval under a compassionate use regimen. Twelve patients started olanzapine under the restriction in a later stage of illness following failed treatment with a conventional antipsychotic. Results: While total treatment costs between the two groups was similar, cost distribution was different. Early Switch patients had higher drug costs and higher rehabilitation costs, while Late Switch patients had higher hospitalisation costs. Conclusions: Small patient numbers and design limitations prevent conclusions being drawn regarding the ultimate impact on outcome and total treatment cost of restriction of olanzapine to second-line use. Despite this, our findings demonstrate that within the context of the Italian CMHS, patients treated with olanzapine while still in the early stages of schizophrenia do not necessarily cost more overall compared to patients who receive olanzapine after failing treatment with a conventional antipsychotic

    Storia naturale dell’infiammazione allergica

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    Allergic pathologies are the most common immunologic diseases and their prevalence and severity show a constantly increasing trend in industrialized countries. The present article presents some recent epidemiological data, the natural development of the allergic inflammation and its pathophysiology, focusing on the recent concept of a “minimal persistent inflammation”, with particular regard to its long term treatment with antiallergic drugs. In fact, according to the most recent interpretations, allergy has to be considered as a complex phenomenon, characterized by a inflammatory response to allergenic stimuli. The complicated interrelation between cells, cytokines and affected structures is described. Very often allergic diseases of the upper airways are associated with and complicate asthma, and data that support the benefits of treating these diseases as a whole are presented. Long-term treatment of allergies with antiflogistic/antiallergic molecules is capable of reducing tissutal damage, besides improving the quality of life of the patient and lowering the frequency of acute episodes. The chronic treatment with antiallergic drugs appears to be favorable also from a pharmacoeconomical point of view, as it is associated with a reduction of overall pharmaceutical expenses and of lost working/school days, as well as determining an improved quality of life for the patient and its relatives, particularly in pediatric age. The management of the allergic patient has always to be approached with an integrated multidisciplinary attitude, in which the efforts tend to the identification of all concurrent diseases, because the optimal treatment may be achieved only with the recognition and the resolution of all underlying diseases

    Malnutrizione associata a patologie, una problematica da risolvere

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    Disease-related malnutrition, the most frequent cause of undernourishment in industrialized countries, appears to be highly prevalent among western patient populations, interesting up to 60% of the hospitalized and almost one fifth of the persons attending to the general medicine service. There are several reasons for this high prevalence, among which pathology-related causes, inadequate presentation of the meals in hospitals and institutions, and low recognition of nutritional problems by health professionals. Several studies have shown that undernourished patients have higher morbidity and mortality rates than the general population and suffer of more and more severe complications, leading to prolonged hospital stays and worse clinical outcomes. This determines a much higher Health costs, estimated in an English study as a yearly additional burden of over 7 billion £ for the National Heath Service. Nutritional interventions, such as the administration of oral supplements or enteral tube feeding, are capable to increase body mass index (BMI), that is considered the most reliable indicator of the nutritional status, muscle strength and overall psycho-physical performance, determining an improved quality of life and a reduced need for medical assistance. These functional improvements go alongside with better clinical outcomes, as shown by a reduced mortality rate, shorter hospital stays and lower incidence of complications observed after supplementation. Studies that have analyzed the economical impact of nutritional supplementation in terms of cost-benefit have shown that the cost of enteral nutritional interventions is almost negligible when compared to the associated savings in the production of the health service, mainly determined by lower hospitalization rates, shorter hospital stays, reduced costs for the treatment of complications and for the consultation of specialists. Greater awareness of the health professionals and more encouraging health policies toward nutritional interventions are required to reduce the clinical and economical impact of this unnecessarily wide-spread condition

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    Farmeconomia. Health economics and therapeutic pathways
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