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Biomedical subjects

L Garattini

Publications and source records attributed to L Garattini.

At least 19 recordsLinked to original sources
PubMed2006

Pharmacoeconomic studies in Italy: a critical review of the literature.

To assess the state of pharmacoeconomics in Italy we reviewed all the original studies published by Italian authors in national and international journals from January 1994 to December 2003. We selected 70 articles and broadly assessed 92 economic evaluations (EEs) since some articles contained multiple analyses. We adopted common analysis criteria to allow methodological comparison of the studies. The variables investigated can be grouped into three categories: general methods, costs, and consequences. To further assess the quality of the EEs, we decided to rank them according to criteria of both clinical and economic good practice. Then, to complete our critical evaluation, we analysed whether sponsorship might have somehow affected the results. Our analysis seems to support the widespread scepticism of the Italian NHS decision-makers towards pharmacoeconomic studies, whose results seem to be biased by flawed methods and sponsors' interference with results.

Economics, Pharmaceutical↗
PubMed2002

Is EQ-5D a valid measure of HRQoL in patients with movement disorders? A comparison with SF-36 and FIM questionnaires.

We assessed the descriptive part of the EQ-5D system in rehabilitation patients with validity severe moving disorders and compared it with the FIM and the SF-36 Health Survey in a sample of 60 patients. We analyzed the EQ-5D convergent validity and the correlations between EQ-5D scores and a clinical variables. The internal validity of the EQ-5D instrument proved good. Moreover, the EQ-5D discriminated symptom severity as scored by the FIM and the SF-36 correspondent subscales. We analyzed the sensitivity of the EQ-5D only with respect to the ability of patients to move with or without a wheelchair. Most patients considered "moving a wheelchair" as a good way of "getting about." This investigation can be considered a pilot study on the performance of the EQ-5D in a group of pathologies involving various degrees of movement disorders. The findings show possible problems of misinterpretation in the levels of the mobility dimension.

Journal Article↗
PubMed2002

Pharmacoeconomic analysis of prescriptions in Italian pediatric general practice.

Most drugs used by children are prescribed by general pediatric practitioners (GPPs) in ambulatory settings. Prescription profiles are affected by GPPs' attitudes while the cost is related to the reimbursement modality. This study evaluated the Italian National Health Service (INHS) and family expenditures associated with prescribing practices to children younger than 12 years. Forty-two GPPs from southern Italy participated in the study. All visits recorded by GPPs during a 13-week period (February-April 1998), including telephone contacts and office and home visits were analyzed. The cost analysis of prescriptions is based on a sample of randomly selected consultations. INHS and family expenditures were evaluated according to reimbursement modalities for drug prescriptions. Total expenditure induced by all prescriptions during the study period was about 148 million Italian lire (7650 euros); 54% of this was borne by the INHS and the rest remaining by families. When corrections according to prescription modalities - following appropriate reimbursement form - were applied, only 49% of total expenditure were covered by INHS and 51% by families. Analysis of expenditures showed that drugs for symptomatic therapies (e.g., cough and cold preparations, analgesics, antipyretics) and vitamins accounted for most of the families' expenditure, while antibacterial and antiasthmatic drugs did so for the INHS. Of the ten most prescribed drugs the cost of three fell entirely on the family: paracetamol (the most commonly prescribed drug),morniflumate, and ambroxol. Therapeutic indications causing greatest expenditures for families were all the common,trivial childhood symptoms such as cough, fever, rhinitis, flu, and pharyngitis. Despite the universal coverage for pharmaceutical care more than one-half of drug therapy expenditures for children was covered directly by the parents. Prescription attitudes by GPPs remain the crucial factor for an equal cost distribution between families and the INHS.

Journal Article↗
PubMed2002

The costs of epilepsy in Italy: a prospective cost-of-illness study in referral patients with disease of different severity.

PURPOSE: [corrected] Epilepsy poses a considerable economic burden on society. However, information is insufficient on the comparative costs of different disease varieties. The purpose of this study was to compare the direct costs of epilepsy in referral patients with disease of different severity and duration. METHODS: Patients with newly diagnosed epilepsy (NDE), seizure remission (SR), occasional seizures (OS), frequent non-drug-resistant (NDR) and drug-resistant (DR) seizures, and surgical candidates (SC) from 14 epilepsy centers were the target population. All patients were followed prospectively for 12 months and all medical and paramedical contacts for diagnostic and therapeutic services were noted with details, using ad-hoc diaries and semistructured questionnaires. RESULTS: The study population comprised 525 consecutive children and adults with partial (68%), generalized (25%) and undetermined epilepsy (4%) as follows: NDE 70; SR 131; OS 108; NDR 101; DR 107; SC 8. Ambulatory visits (mean 2.8 per patient per year) were the leading service in all groups, followed by EEG recordings (1.8) and biochemical assays (1.1). At entry, the commonest drugs were carbamazepine (50%), valproate (37%), phenobarbital (21%), vigabatrin (14%) and lamotrigine (11%). New antiepileptic drugs (AED) were used increasingly with the severity of the disease. The total annual costs varied significantly across groups: 3945 Euro (SC), 2198 Euro (DR), 1626 Euro (NDR), 1002 Euro (NDE), 558 Euro (OS), 412 Euro (SR). The main item of expenditure was hospital stay (including day-hospital), followed by drug treatment and outpatient visits. The costs of outpatient services, hospital services and drugs varied significantly across groups. CONCLUSIONS: The direct costs of epilepsy vary significantly depending on the severity of the disease and the response to treatment. Hospital admissions and drugs are the commonest items of expenditure.

Adolescent↗
PubMed2001

A comparative analysis of domiciliary oxygen therapy in five European countries.

This comparative study analyses the domestic market of domiciliary oxygen therapy in five European countries (Denmark, France, Germany, Italy, and the UK) according to a common checklist of subjects. Domestic legislation, prescription procedures, delivery, and the market situation concerning oxygen therapy were considered. The analysis involved (i) reviewing the literature on oxygen therapy in national and international journals, and (ii) interviewing a selected expert panel of market operators in each country (composed of at least one civil servant, one physician, one distributor, and one oxygen manufacturer). The analysis did not find any specific relationship between the health care system framework and the oxygen therapy market, except for a greater inclination towards home care in national health services. In all these countries oxygen therapy is reimbursed, but the type of supply and its diffusion differ widely. The spread of domiciliary care has undermined the traditional role of pharmacies in the oxygen distribution chain in all countries except Italy. The study did not help identify any specific country that can be considered a benchmark for oxygen therapy, each one dealing with oxygen therapy in a different way. An economic evaluation of the different supply modalities could help improve decision making by public authorities.

Cross-Cultural Comparison↗
PubMed2001

Ramipril prolongs life and is cost effective in chronic proteinuric nephropathies.

BACKGROUND: Our objectives were to predict the long-term cost and efficacy of the angiotensin-converting enzyme, ramipril, in patients with nondiabetic chronic nephropathies. METHODS: The time to end-stage renal disease (ESRD) was predicted by two different models based on the rate of glomerular filtration rate decline (DeltaGFR) and incidence of ESRD (events) measured during the Ramipril Efficacy in Nephropathy Trial in 117 and 166 patients, respectively, randomized to comparable blood pressure control with ramipril or conventional therapy. Direct medical costs of conservative and renal replacement therapy were estimated by a payer perspective, and cases more and less favorable to ramipril were computed by a sensitivity analysis. The study took place at the Clinical Research Center for Rare Diseases, "Aldo & Cele Daccò," Bergamo, Italy. Patients included those with chronic, nondiabetic nephropathies and persistent urinary protein excretion rate >/=3 g/24 h. Time to ESRD, survival, and direct costs of conservative and renal replacement therapy are discussed. RESULTS: Both in the DeltaGFR-based or events-based models, ramipril delayed progression to ESRD and prolonged patient survival by 1.5 to 2.2 and 1.2 to 1.4 years, respectively, and saved $16,605 to $23,894 lifetime and $2, 422 to $4203 yearly direct costs per patient. Even in the less favorable hypotheses, ramipril allowed lifetime and yearly cost savings that exceeded 10 to 11 and 20 to 40 times, respectively, the additional costs related to prolonged survival. CONCLUSIONS: In our study population, ramipril prolongs life while saving money because of its beneficial effect on the course of nondiabetic chronic nephropathies.

Adult↗
PubMed2001

The costs of childhood epilepsy in Italy: comparative findings from three health care settings.

PURPOSE: To determine the direct costs of epilepsy in a child neurology referral population, stratified by disease, duration, and severity, comparing three different health care settings [i.e., teaching or clinical research (CR) hospitals, general hospitals, and outpatient services]. METHODS: Patients were accepted if they had confirmed epilepsy and were resident in the center catchment area. Eligible subjects were grouped in the following categories: (a) newly diagnosed patients; (b) patients with epilepsy in remission; (c) patients with active non-drug-resistant epilepsy; and (d) those with drug-resistant epilepsy. Over a 12-month period, data regarding the consuming of all resources (i.e., consultations, tests, hospital admissions, drugs), were collected for each patient. Using the Italian National Health Service tariffs, the unit cost of each resource was calculated and indicated in Euros, the European currency. RESULTS: A total of 189 patients was enrolled by two teaching-CR hospitals, two general hospitals, and two outpatient services. The patients were evenly distributed across the four categories of epilepsy. The mean annual cost per person with epilepsy was 1,767 Euros. Drug-resistant epilepsy was the most expensive category (3,268 Euros) followed by newly diagnosed epilepsy (1,907 Euros), active non-drug-resistant epilepsy (1,112 Euros), and epilepsy in remission (844 Euros). Costs were generally highest in teaching-CR hospitals and lowest in outpatient services. Hospital services were the major cost in all epilepsy groups, followed by drugs. CONCLUSIONS: The cost of epilepsy in children and adolescents in Italy tends to vary significantly depending on the severity and duration of the disease Hospitals services and drugs are the major sources of costs. The setting of health care plays a significant role in the variation of the costs, even for patients in the same category of epilepsy.

Adolescent↗
PubMed2001

Resource utilization and hospital cost of HIV/AIDS care in Italy in the era of highly active antiretroviral therapy.

This study set out: (1) to describe resource utilization patterns among four groups of HIV-infected patients at different stages of the disease, and (2) to estimate the direct hospital costs of HIV/AIDS care among these patients in Italy. It is a multi-centre, prospective observational study conducted between August 1997 and July 1998. The 483 patients, enrolled in five infectious diseases departments located in different areas of Italy, were stratified into four groups according to their CD4+ lymphocyte cell count and status of AIDS Defining Illness (ADI) at enrolment. Average direct hospital costs (L = Italian Lire, 1997 exchange rate US$ 1 = 1,704 Italian Lire) were L.23,725,584 (US$ 13,923.5), L.15,208,287 (US$ 8,925.1), L.11,942,761 (US$ 7,008.7) and L.7,660,942 (US$ 4,495.9) for the four groups of patients. More than 80% of patients in the first group and about 65% of patients in the second group received highly active antiretroviral therapy (HAART). The proportion of patients receiving HAART in the third and fourth group increased from 37.1% to 56.5% and from 15.3% to 31.5%. The number of hospital days observed in this study was much lower than previously published numbers in Italy. These results may indicate a shift of costs from hospitalisation to outpatient care and ARV.

Acquired Immunodeficiency Syndrome↗
PubMed2001

Cost analysis of dialysis modalities in Italy.

This study analyses management and costs of dialysis in the Italian National Health Service (NHS). Information on efficacy and health-related quality of life (HRQOL) based on the existing literature also is presented. The clinical differences between the dialysis modalities seem to be related to their appropriateness to specific patient groups. Efficacy rates are similar and the only differences are in complications and HRQOL. Traditional haemodialysis (THD) can be done by Italian patients in dialysis centres or in hospital. Highflux haemodialysis (HFHD) is generally only done in hospital. Peritoneal dialysis (PD) is usually done at home. The cost analysis was performed on a sample of Italian dialysis centres and hospitals, according to the full cost method. As expected, HFHD was more expensive than THD and PD, but no marked differences emerged among the different HFHD modalities. THD modalities in dialysis centres were less costly than in hospitals. Automated PD (APD) was much more expensive (almost twice) than continuous ambulatory PD (CAPD), the cheapest method in absolute terms. This study confirms that dialysis is costly and that it is very difficult to assess the cost-effectiveness of the different approaches. Although this study has limits, it should provide sufficient analytical information to local healthcare managers for more rational allocation of financial resources to dialysis services.

Ambulatory Care Facilities↗
PubMed2001

Direct costs of schizophrenia in Italian community psychiatric services.

OBJECTIVE: To estimate resource utilisation and direct costs of treatment for patients with schizophrenia in Italian Community Mental Health Centers (CMHCs). DESIGN: Multicentre, retrospective observational study. CMHCs recruited all patients who attended a follow-up consultation during the period September to December 1998. At enrollment, psychiatrists completed a questionnaire on consumption of resources in the 2 months before recruitment. SETTING: 14 CMHCs. PERSPECTIVE: Italian National Health Service (INHS). PATIENTS: 702 patients with a diagnosis of schizophrenia or other psychotic disorders, defined according to the Diagnostic and Statistical Manual of Mental Disorders-fourth edition. These patients had been followed by the CMHCs for at least 2 years and attended a follow-up consultation either during the period September to December 1998 or on randomly selected days during this period. Patients were classified into seven groups according to their diagnosis. RESULTS: The mean direct cost of patients with schizophrenia in the 2-month observation period was 2,234,475 Italian lire [L] (1154.01 Euro; EUR); direct costs ranged from L.1,545,818 to L.2,775,658 (EUR798.35 to EUR1433.51) by prognostic group. There was wide variability for prognostic groups in the impact of most cost components on total cost. Admissions accounted for between 11.4 and 56.3% of the total cost, daycare centre days for between 11.3 and 35.5%, home visits for 7.8 to 16.4%, and day-hospital days for 5.4 to 32.8%. Antipsychotics and anxiolytics were the most prescribed drugs and also the most costly. CONCLUSION: Despite the limitations of the study related to the short period considered, we believe this study offers some interesting information on the burden of schizophrenia, a disease for which its cost has received limited attention so far in Italy.

Adult↗
PubMed2000

A comparative analysis of generics markets in five European countries.

A generic medicine is a faithful copy of a mature drug--no longer under patent marketed with the chemical name of the active ingredient. This article analyses generics markets in five European countries: France, Germany Italy, The Netherlands and the U.K. The study investigate all the main issues--patent, approval to market, pricing and reimbursement, prescription and distribution--which affect the life cycle of a pharmaceutical product. The situation in the five countries varied widely. Because of European harmonization, patent legislation and approval procedures no longer affect much the development of generics. Only national legislation on patent protection approved before the EU directive came into force still plays a role. Approval differences seem to be due mainly to common practice, rather than to the regulations themselves. None of the countries have an efficient public information system on patent expiry. Generics have had more success in countries with more flexible pricing policies. Reimbursement has not yet been used widely to discriminate between generics and proprietary drugs. Financial incentives are based more on physicians' prescribing behaviour than on pharmacists. The freedom of pharmacy ownership and the consequent possibility of dispensing pharmaceuticals through different channels affects dramatically the structure of generics markets. A free market of wholesalers and retailers can enhance a comparative market, through horizontal and vertical integration all along the distribution chain. Such an environment has stimulate the success of unbranded generics by delegating strong purchasing power to distributors.

Commerce↗
PubMed2000

The cost of urinary incontinence in Italian women. A cross-sectional study. Gruppo di Studio Incontinenza.

OBJECTIVE: To offer cost estimates of urinary incontinence (UI) in the general population based on prospectively collected data. DESIGN: We analyzed individual costs in a sample of women with UI who were identified in the framework of a cross-sectional study on the prevalence of UI in women aged > 40 years. SETTING: Six areas in Italy. INTERVENTION: Home interview. PATIENTS AND PARTICIPANTS: Women were identified among the patients registered with a network of general practitioners operating in each area using computer-generated random number lists. RESULTS: A total of 2767 women were identified. Of these, 408 (14.7%) reported UI during the year before the interview and 229 underwent a detailed interview on UI-related costs. On the basis of this information, we estimated the direct costs associated with UI from the perspective of the Italian National Health Service (INHS). The lifetime cost per patient of diagnosis was 80,131 Italian lire (L) (exchange rate: $US1 = L1618). Consultations accounted for only 20% of the diagnostic cost, diagnostic tests for 36% and hospital admissions for diagnostic procedures accounted for 44%. The diagnosis cost estimate seems low, partly because several women did not request either consultations or diagnostic tests (the overall rate per patient was 0.76 for consultations and 0.39 for diagnostic tests). The only appreciable treatment cost, according to the INHS perspective, was for diapers. The annual cost per patient for diapers was L255,519. The prevalence of UI in women aged > 40 years in Italy is estimated in the study at 9.3%. Thus, combining this information with the cost estimates, the annual treatment cost of UI in Italian women aged > 40 years is L351,800 billion, considering diapers and drugs only. CONCLUSION: This study has estimated the individual cost of UI in the general population. These figures may be useful when designing economic evaluations of UI.

Adult↗
PubMed1999

A model for calculating costs of hospital wards: an Italian experience.

Until recently Italian hospitals had no cost accounting or activity data collection systems, being formally required only to do financial book-keeping. The cost analysis method presented here might be used to set up detailed and complete hospital cost accounting, which would permit a better understanding of patterns of resource distribution among departments, better opportunities for cost saving and cost control for hospital managers and health authorities. The study first identified a framework within which to assess the annual cost related to a hospital ward, then calculated the mean bed day cost for each speciality. Cost data were collected over one year in 1996 from manually compiled records, at one local hospital in Northern Italy. Costs were estimated following a step-down allocation method. Wards requiring a major amount of resources per day of stay are intensive cardio-coronary unit (US$650.689), and ophthalmology (US$483.322). The less expensive ward is general medicine (US$148.645). The cost analysis method presented in this study might be used to set a detailed and complete hospital cost database, which is a necessary tool for hospital managers to realise cost control and cost recovery.

Accounting↗
PubMed1999

Costs of diabetes. A methodological analysis of the literature.

OBJECTIVE: To review studies on the costs of diabetes and its complications through a scheme designed specifically for assessing the quality of cost-of-illness (COI) studies. DESIGN AND SETTING: The methodology of COI studies in diabetes was analysed in order to assess the significance of quantitative results. The scheme adopted 7 items identified as the main points for discussing the methodological choices governing the results. We also used a checklist based on questions related to the 7 items. MAIN OUTCOME MEASURES AND RESULTS: The answers showed that many studies appear not to give technical details, so it is hard to understand the method. Methodological choices varied widely between the studies. This is probably due to the lack of consensus on the methodology of COI studies. Based on the findings of this review, we suggest also some specific points that could help produce more reliable results on the costs of diabetes. CONCLUSIONS: Clearly, a general consensus on COI studies is still remote, making the value of any comparison of results questionable.

Cost of Illness↗
PubMed1998

The economic cost of epilepsy: a review.

Epilepsy is the most prevalent chronic neurologic condition. In developed countries, its incidence is 30-50 per 100,000 population per year and the prevalence is approximately 5-8 cases per 1,000 population. The rapid growth of health care expenditures has led to increased interest in economic evaluation of health care programs. We reviewed studies on the costs of epilepsy to assess the significance of their quantitative results, through a specific scheme of analysis. The main findings of our study are that a general consensus on cost of illness evaluation is still remote and many studies lack technical details, making difficult any useful comparison of results. New efforts should be realized to achieve a major degree of standardization in methodological processes.

Cost of Illness↗
PubMed1998

The German experience in reference pricing.

Price regulation schemes function both as a means for public authorities to contain costs, and as an economic tool to support the national pharmaceutical industry. This twofold contradictory aim of public intervention in pharmaceutical demand and supply makes such pricing schemes difficult to apply. This article concerns the reference price scheme which concerns setting a price cap for each active ingredient, or group of active ingredients considered equivalent according to some feature (e.g. therapeutic effects and chemical structure). In 1989, the reference price scheme for reimbursable drugs was introduced in Germany to reduce pharmaceutical expenditure, which had been steadily increasing in the past. The study investigates the economic effects of introducing reference prices in Germany in order to assess whether this system has been effective in containing public pharmaceutical expenditure. We conclude that the reference price scheme is an effective tool for price control, but cost containment requires further measures.

Analgesics, Non-Narcotic↗