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A large number of currently available antipsychotic drugs are included into two main classes: traditional (or first-generation), and atypical (or second-generation) antipsychotics. This wide availability of medicinal products allows, at least in part, to address the need to identify the most appropriate treatment for the individual patient. A precondition for the effectiveness of antipsychotic treatment is the adherence, a multi-determined phenomenon that depends on factors related to the pharmacological properties of each agent and on factors independent from the therapy: among them, therapeutic alliance between patients and medical team, patient's belief in benefits and risks of medicines, and patient's relationship with the family and social environment are the most clearly recognized. The collection of data from patient helps the management of the individual clinical case, but this information could also become a source of data for research. In both cases, data must be collected in a ordered and well-coded way, therefore numerous instruments (like questionnaires and registers) are developing. This approach permits to make a recognition of patient's perception of his health condition, as well as the positive and negative outcomes of his pharmacological treatment. These tools are known in the literature by the name of PROMs (patient-reported outcome measures). From the clinical point of view, the PROMs can reduce the gap between patient and clinician in different therapeutic areas. They also enables the physician to identify the most suitable treatment to the individual patient, to meet his needs and preferences, and to adapt the therapy over time to the changes of his medical condition. About the research, the effects reported by the patient, in terms of both benefits and adverse reactions, represent important information useful to conduct observational studies that better define the benefit-risk profile of drug therapies, especially in psychiatry.

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)

European Medicines Agency (EMA) recently recommended additional measures to better manage the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with natalizumab (Tysabri). Although benefits of treatment with natalizumab continue to outweigh risks for patients with highly active relapsing-remitting multiple sclerosis (RRMS), EMA warned that the risk of PML (EMA/37607/2010) increases after two years of treatment and clinicians should to discuss the risk of natalizumab with patient both treatment starts and again after two years. However, to date, any evidence on Tysabri therapy duration is available. The aim of the study is to analyse actual duration of therapy with natalizumab and any cause of discontinuation in patients with RRMS in the Emilia-Romagna region from Tysabri Registry (Mancardi et al.,2008). From the Tysabri Registry, an accurate program of surveillance of Italian Agency of Medicine, patients treated with Tysabri in Emilia-Romagna region were selected from January 2007 (start-date of registry) until 30 June 2010. Drug prescriptions were analysed in order to identify start and end of natalizumab treatment for each patient. Discontinuation therapy was defined when a drug prescription was not been renewed after 30 days from latest one. The probability of discontinuation of treatment was analyzed by the Kaplan-Meier survival curve, defining as "event" the permanent discontinuation of treatment. Moreover, a distribution of drug interruption causes was performed. From 198 patients with at least 1 natalizumab prescription, 73% (145 subjects) were still on treatment at the end of the follow-up period, while the remaining 27% (53) discontinued Tysabri. Among patients who discontinued therapy, the median therapy length was 12 months, with a maximum of 35 and a minimum of 1 month. In the first two years of therapy, the frequency of interruption was low and uniform throughout the period, while in the third year increased the rate of therapy withdraw and this difference is statistically significant (p

Introduction: In September 2010, FDA announced the ongoing investigation on a possible association between long-term use of pioglitazone and bladder cancer. The aim of our study was to provide the contribution of spontaneous adverse event reporting analysis on causality assessment between bladder cancer and pioglitazone. Methods: Association between antidiabetic drugs and bladder cancer was analyzed by the case/non reports recorded in FDA_AERS (Adverse Event Reporting System) between 2004 and 2009. Cases were represented by the reports of reactions included in the MedDRA high-level term ‘Bladder neoplasms’ for a given drug; non-cases were all the reports of other reactions associated to the same drug. For each drug, the association between such drug and bladder cancer was calculated by using the ADR reporting odds ratio (ROR). To weight the influence on ROR of male and older age, well known risk factors for bladder cancer, stratified analyses were performed. Furthermore, to consider the possible effect of notoriety bias a year-by-year analysis was performed. Results: Overall, 93 reports of bladder cancer were retrieved, Corresponding to 138 drug reaction pairs, with 31 concerning pioglitazone, 29 insulin, 25 metformin, 13 glimepiride, 8 exenatide; 22 others. ROR was significantly >1 for pioglitazione (4.30; 95%CI 2.82–6.52, P < 0.001), gliclazide (3.56; 1.42–8.39, P = 0.001) and acarbose (5.12; 1.61–14.33, P < 0.001), although for the last two drugs only a few cases were reported (6 and 4, respectively). Concerning pioglitazone, ROR resulted statistically significant both in female (5.19; 2.15–12.11) and male (3.86; 2.37–6.26), but only in older patients (>65 years); moreover the stratified year-by-year analysis showed a statistically significant ROR for 2004, 2006, 2007 and 2008. Conclusions: We found a definite signal for bladder cancer associated with pioglitazone use. The demographic characteristics of the selected cases were consistent with bladder cancer epidemiology (male gender, old age). A weaker signal was also associated with gliclazide and a much weaker signal with acarbose. Of note, the occurrence of >5 events, although resulting in a statistically significant ROR, may be considered clinically meaningless because too much open to reporting biases. The presence of a signal for pioglitazone also before main relevant publications (PROactive 2005) supports the importance of this safety issue despite its notoriety among clinicians. This safety signal should stimulate more specific studies to confirm or reject the causality relationship between pioglitazone and bladder cancer, and to quantify the magnitude of the hazard.

Introduction: QT prolongation is a recognized surrogate marker of proarrhythmia, namely Torsade de Pointes (TdP). Recently, interest has emerged on the possible arrhythmic risk associated with QT shortening. Materials and Methods: From the publicly accessible FDA_AERS (January 2001-December 2009), spontaneous reports of TdP, QT prolongation/shortening were selected. The reporting frequency (restricted to drugs reported as suspect) was provided for top five agents by calculating the ratio between cases of interest and other reports in the database. The list was analyzed according to Arizona_CERT current information (www.azcert.org). Results: From 1,644,133 total FDA reports, TdP was identified in 1482 cases (0.009%), QT prolongation in 3502 (0.002%), whereas QT shortening only in 35 reports (with 30 reported drugs). The reporting frequency for TdP was: cisapride (10.7%, 77 cases), sotalol (9.9%, 70), methadone (4.1%, 143), fluconazole (3.9%, 91), amiodarone (3.4%, 160). The rank for QT prolongation was: cisapride (38.7%, 223 cases), arsenic trioxide (13.5% 83), sotalol (10.7%, 75), nilotinib (10.6%, 94), methadone (4.3%, 150). All agents are grouped in the ‘Torsades List’ of the Arizona_CERT website, except fluconazole (‘Conditional Torsades List’). Rufinamide and digoxin (considered as QT shortening drugs) received only one report each. Conclusion: The reporting frequencies of TdP and QT prolongation involved similar drugs and are in line with information reported by Arizona_CERT, although fluconazole deserves further investigation regarding its pro-arrhythmic risk. The clinical impact of QT shortening remains elusive. The research leading to these results has received funding from the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement n 241679 – the ARITMO project.

Introduction: Unlike QT prolongation, drug-related QT shortening has recently emerged as a potential predictor of proarrhythmic risk, but its actual significance is unclear. Materials and Methods: Data mining approach was carried out on publicly accessible FDA spontaneous reports (January 2001-December 2009) to retrieve cases where QT shortening/prolongation was reported. The case-by-case analysis was performed on QT shortening and focused on suspected and concomitant drugs, co-reported arrhythmia-related events and severity of cases. Results: Among 1,644,133 total FDA reports, QT prolongation was reported in 3502 cases, whereas QT shortening only in 35 reports. Among cases reporting QT shortening, five drugs were reported twice as suspect (i. e. aripiprazole, atomoxetine, clozapine, moxifloxacin and ziprasidone). Digoxin and rufinamide (considered as QT shortening drugs), received one report each. In 10 cases, both QT shortening and prolongation were paradoxically reported and related to suspect drugs known for QT prolonging effect (i.e. arsenic trioxide, moxifloxacin, clarithromycin, cotrimoxazole, ziprasidone and sunitinib). Most cases (89%) were characterized by atrial and/or ventricular arrhythmias, with seven cases reporting potentially fatal events (i.e. ventricular fibrillation and/or cardiac arrest). Sixty-eight percent of cases were serious (i.e. causing death or hospitalization) and 70% occurred in females. Conclusion: These reports are consistent with the hypothesis that QT shortening may predict arrhythmias, although the clinical impact of QT shortening remains elusive and further investigation is needed. Pharmacovigilance reports should meet a common standard of ‘minimum requirements’ to become a more reliable indicator of risk. The research leading to these results has received funding from the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement n 241679 – the ARITMO project.

Background. In clinical trials, adherence with oral anti-osteoporotic therapies is generally high, in contrast with the clinical practice post-authorization. Poor adherence to oral bisphosphonates leads to reduced medication efficacy, exposure to unjustified adverse reactions and raised the health expenditure. Reasons for non-adherent behaviour could include: difficulty taking medication as prescribed, experience of adverse effect and worry of long term harm, scepticism of drug effectiveness and poor perception of the disease consequences (Silverman et al. 2011). The objectives of this study were to quantify the proportion of non-adherent subjects and to define predictors of non-adherence with bisphosphonates in order to develop possible interventions to improve compliance. Methods. A retrospective cohort study has been conducted using administrative database of 13 units joined in the Italian BEST (Bisphosphonate Effectiveness Safety Trade-off) study, accounting for 18 million inhabitants. Patients with at least 2 prescriptions of oral bisphosphonates through 2003–2007 were selected. Exclusion criteria were age

Background. The ESOPO (Epidemiologic Study on the Prevalence of Osteoporosis) study (Adami et al. 2003) estimated a prevalence of osteoporosis, among Italian women and men, of about 23% and 14%, respectively. Oral bisphosphonates, decreasing the fracture rate, represent the first-line therapy in osteoporosis (Favus 2010). An increased use (+8%) of bisphosphonates was observed during 2003-2009 period in Italy (OSMED 2009), however pharmacoepidemiology analysis on this issue are poorly performed. This study aimed to describe the use of oral bisphosphonates in several Italian areas during 2003-2007. Methods. Prescription data of oral bisphosphonates were retrieved from the administrative databases of 13 units joined in the Italian study BEST (Bisphosphonate Effectiveness Safety Trade-off), that covered 18 million inhabitants of which 10 million were >40 years. The selected cohort included patients aged >40 years, with at least 2 prescriptions of oral bisphosphonates through 2003–2007 in order to exclude pill-taster or any data mistakes. Patients affected by Paget’s disease or cancer were excluded. Key measurements were: distribution of oral bisphosphonates users by gender, age, daily or weekly formulation, active substance, 1-year prevalence rate and incidence rate. Results. We collected data concerning 191,839 users of oral bisphosphonates. Women represented the main users of bisphosphonates, and the distribution by age was comparable in both genders. Consumption of bisphosphonates was higher in subjects aged 60-80, with a female/male ratio 6:1 in this subgroup. Within our cohort, 15,901 (8%) patients started the treatment with daily formulations, while 175,938 (92%) with weekly formulations. As far as the choice of the active substance at first prescription is concerned, 65% of patients received alendronic acid, 27% risedronic acid and 8% fixed combination of colecalciferol and alendronic acid. The prevalence rate was 0.7 per 100 persons/year in 2003 and gradually increased each year during observed period, until 1.7 in 2007. Instead, the incidence rate steadied around 0.5 per 100 persons/year in the full period. Conclusion. Our analysis showed an increased prevalence and a constant incidence of bisphosphonates use in 2003-2007 in Italy. This data could be affected by population aging, at the same time they seem to reflect a good clinical practice in prescription of these drugs.

Background. The notoriety bias (i.e. increased reporting of adverse drug events following safety alerts) may significantly impact on signal detection in spontaneous reporting systems (Pariente et al., 2007). This study aimed at evaluating the contribution of this bias on reporting of pancreatitis with antidiabetics, with exenatide as the main drug of interest. Methods. A case-control study was performed on the FDA_AERS (Adverse Event Reporting System) database to analyze the association between antidiabetic drugs and pancreatitis. The analysis covered the period 2005 (exenatide was launched on the market in April 2005) through 2009. The base cohort consisted of Adverse Drug Reactions (ADRs) for antidiabetics. Cases were represented by reports of pancreatitis according to the Medical Dictionary for Regulatory Activities (MedDRA), whereas all other ADRs reported with antidiabetics were considered controls. Disproportionality analysis was conducted by calculating Reporting Odds Ratios (RORs) with corresponding 95%CI, thus estimating the strength of the association. Significant disproportionality was formally defined when the lower limit of the 95%CI was >1. The contribution of notoriety bias was evaluated by performing a quarter-by-quarter analysis. Results. Exenatide was reported in 709 cases of pancreatitis, followed by metformin (630), insulin (349), glimepiride (148), pioglitazone (146), glibenclamide (142), sitagliptin (128), rosiglitazone (126) and glipizide (114). The cumulative disproportionality analysis (2005-2009) found significant disporportionality only for exenatide (ROR=1.71; 95%CI=1.57-1.87) and sitagliptin (ROR=1.82; 95%CI=1.52-2.18). For exenatide, the quarter-by-quarter analysis revealed that disproportionality signal appeared in the fourth quarter (Q4) of 2007, rapidly increased with a first peak in Q3 of 2008, remained statistically significant and reached a second peak in Q4 of 2009. Therefore, reporting was strongly influenced by the FDA alert first issued in October 2007 and updated in August 2008 on the risk of pancreatitis. Notably, the number of total reports for exenatide (an indirect marker of drug consumption) showed a rapid increase from its marketing approval, with a first peak in Q1 of 2006 (“Weber effect”, Hartnell et al. 2004) and a strong decrease after the updated FDA alert. The parallel decrease in the total number of reports may reflect the attitude towards reduced prescriptions due to increased risk perception by physicians. Conclusion. In the FDA_AERS, the notoriety bias significantly contributed to increased reporting frequency of pancreatitis with exenatide. Awareness of this important bias should not affect clinician’s vigilance on this serious drug-event association.

Background: In the general population, lack of adherence to statins remains a widespread phenomenon and an important matter of concern both in terms of cost-effectiveness and risk-benefit profile. Objectives: To evaluate the occurrence of cardiovascular (CV) events in patients treated with statins in Italy, focusing on the role of adherence to therapy. Methods: We selected Emilia Romagna inhabitants who received statins in Jan-Feb 2005. Drug prescriptions and hospital admissions were analysed for the following 36 months, focusing on CV events, adherence to therapy and patient risk profile. Cox regression was used to assess how the hazard associated with patient risk and to adherence changed over time. Results: Among 137,217 selected patients, 29% experienced CV events over the 3-year period. These events were more frequent in older than 80 yrs (HR 2.70; 95% CI 2.51– 2.89), treated also for hypertension, angina or heart failure (2.44; 2.35-2.53) or using statins for secondary prevention (2.22; 2.17–2.26). Only 24% of statin recipients adhered to therapy over the 3-year period. No matter what risk factors, adherence significantly reduced the occurrence of CVevents (average:—30%). Non-adherent patients showed an increased risk as follows: strongly non-adherent (adjOR 1.19; 95% CI 1.15–1.23), slightly non-adherent (1.25;1.21– 1.30), highly variable over years in the amount of statins received (1.69;1.62–1.77). Conclusions: The present study shows the key role of adherence to statin therapy at any level of patients’ CV risk. The lower odd of CV events in strongly non-adherent patients suggests that this group may include subjects who did not require pharmacological treatment. Whenever statins are appropriately started, cooperation between physician and patient to ensure uninterrupted treatment is the mainstay of appropriateness.

Introduzione. Il profilo di sicurezza dei glitazoni, rosiglitazone e pioglitazone, è attualmente sotto indagine da parte delle agenzie regolatorie internazionali, FDA ed EMA. Diversi studi successivi alla loro commercializzazione hanno fatto emergere possibili associazioni tra questi farmaci e reazioni avverse gravi. Nel giugno 2007 Nissen ha pubblicato una metanalisi che evidenziava un aumento di eventi cardiovascolari per il rosiglitazone, rischio confermato da studi successivi. Altri studi clinici suggeriscono possibili associazioni anche con danni oculari e ossei. Il presente studio ha l'obiettivo di delineare il profilo di sicurezza dei glitazoni per ciò che riguarda l'infarto miocardico, l'edema maculare e il rischio di fratture, mediante l'analisi delle segnalazioni spontanee presenti nel database FDA_AERS (Adverse Event Reporting System). Metodi. Sono state raccolte tutte le segnalazioni spontanee di reazioni avverse (Adverse Drug Reaction - ADR) da farmaci antidiabetici presenti nel database FDA_AERS da gennaio 2005 a dicembre 2008. I dati sono stati sottoposti a procedure di data cleaning semiautomatiche, per eliminare i duplicati e i record multipli. L'associazione farmaco-reazione è stata analizzata mediante il metodo del caso/non-caso. I casi sono rappresentati dalle segnalazioni in cui i glitazoni sono associati alla specifica reazione, classificata secondo la terminologia MedDRA, mentre i non-casi sono costituiti dalle segnalazioni della stessa reazione associata a farmaci antidiabetici diversi dai glitazoni. L'associazione farmaco-razione è stata analizzata calcolando il Reporting Odds Ratio (ROR) che identifica una disproporzionalità tra il farmaco oggetto dell'analisi e gli altri farmaci antidiabetici. L'analisi è stata eseguita sia per classi di farmaci antidiabetici, sia per singolo principio attivo. Infine, allo scopo di valutare il possibile pubblication bias sull'incidenza di segnalazione l'analisi è stata effettuata anche per singolo trimestre. Risultati. Sono state raccolte 77.669 segnalazioni di ADR da antidiabetici, corrispondenti a 301.950 coppie farmaco-reazione. Queste riguardavano principalmente biguanidi (26%), seguite da sulfaniluree (22%), exenatide (18%) e glitazoni (16%). I glitazoni hanno mostrato una disproporzionalità significativa per l'infarto miocardico (ROR 4,71 IC95% 4,40-5,05), per l'edema maculare (3,88; 2,79-5,39) e per le fratture (1,73; 1,53-1,96). Considerando i due glitazoni separatamente, il solo rosiglitazone è risultato associato all'infarto del miocardio (7,86; 7,34-8,34) e all'edema maculare (5,55; 3,94-7,79), mentre il pioglitazone al rischio di fratture (2,00; 1,70-2,35) in particolare al livello degli arti e del bacino. L'analisi del trend temporale per l'ROR dell'infarto miocardico evidenzia che già nel periodo gennaio-marzo2005 il valore di ROR era statisticamente significativo (3,13; 2,38-4,10), per poi raggiungere un picco nel periodo ottobre-dicembre 2007 (8,71; 6,02-12,90). Conclusioni. Lo studio ha confermato, tramite l'analisi delle segnalazioni spontanee, il rischio di infarto miocardico, di edema maculare e di fratture per il glitazoni rispetto agli altri farmaci antidiabetici. Inoltre, è stata evidenziata un'ampia differenza tra rosiglitazone e pioglitazone, il primo associato a infarto miocardico ed edema maculare, mentre il secondo al rischio di fratture. L'analisi del trend temporale mostra come l'impiego dei dati di segnalazioni spontanee può generare segnali di farmacovigilanza precoci, in quanto l'infarto miocardico presentava un segnale di disproporzionalità ben prima della pubblicazione della metanalisi di Nissen del 2007. I risultati del presente studio contribuiscono a delineare il profilo di rischio dei glitazoni e a sottolineare le differenze esistenti tra i due principi attivi; informazioni fondamentali per consentire alle agenzie regolatorie di rivalutare il rapporto rischio/beneficio di questi farmaci.

Background: Thiazolidinediones (TZDs) are used for the therapy of type II diabetes. Several warning on their cardiovascular (CV) and fracture risks have been raised. Their benefit/risk profile is therefore still uncertain. Objectives: To evaluate the safety profile of TZDs, in particular on the risk of CV events and bone fractures, on the basis of FDA Adverse Event Reporting System (AERS). Methods: Association between drugs and ADRs was analysed by case/non case method. Cases were ADR reports with TZDs as suspected drug and non-cases were all same reactions induced by other drugs. Association between TZDs and ADRs were calculated by the ADR reporting odds ratio (ROR). Safety data for TZDs, and for individual drugs, were compared against other anti-diabetic drugs. Results: Evidence of disproportionality were observed for CV ADRs compared to other anti-diabetics, in particular for cardiac failure congestive (ROR 6.11, CI 95%5.68–6.56 vs 0.66, 0.60–0.73) and myocardial infarction (2.46, 2.33–2.59 vs 0.32, 0.30–0.34). Rosiglitazone showed the highest ROR for cardiac ADRs, whereas pioglitazone only for cardiac failure. Concerning fractures, TZDs showed significant RORs compared to other anti-diabetic drugs, e.g. radius (3.64, 2.15–6.06 vs 0.47, 0.24–0.91), foot (2.16, 1.55–2.99 vs 0.98, 77–1.24), and humerus (2.76, 1.82– 4.15 vs 0.28, 0.15–0.51). Among TZDs, pioglitazone achieved significant RORs for ulna, radius, fibula, humerus, tibia and ankle fractures, whereas rosiglitazone was significantly associated to foot, humerus and radius fractures. Conclusions: The frequency of CV reactions and fractures occurrences were significantly higher for TZDs in comparison to other anti-diabetic drugs. Rosiglitazone showed a significant disproportionality for CV ADRs whereas pioglitazone for multiple site fractures. These differences should be considered when rosiglitazone or pioglitazone are prescribed.

Introduction. The risk-benefit profile of thiazolidinediones (TZDs), oral hypoglycaemic agents has been recently widely discussed in literature. As second-line treatment of type 2 diabetes their reimbursement has been associated in the ER Region to a treatment plans (TP), whose data allow the assessment of appropriateness, effectiveness, safety. Methods. The TP data were analyzed on the following parameters: age and sex of patients, TZD prescribed, other antidiabetic drugs, Hb1Ac and BMI values in first prescription, Hb1Ac value in following prescriptions, any major complications. Results. The investigation has been conducted on 788 PT, for 448 patients(mean age 65.7 yrs, 59% men), from April 2008 to November 2009. Up to 78.8% of first prescriptions were for pioglitazone, and 67.2% for metformin and sulphonylurea. The Hb1Ac and BMI values, in the first prescription, were respectively > 7% in 71.4% and ≥25 kg/m2 in 79% patients. Only in ¼ of the 49.3% of patients follow-up measures, HB1/Ac decreased. Complications were reported in 10.5% of pts, with a prevalence of cardiovascular events (3.2% for rosiglitazone, 2.7% for pioglitazone). Conclusion. The results show an adherence to the international guidelines criterias and to the labelled therapeutic indications for glitazones' prescription. Glitazones therapy seems to be effective in a quarter of patients and seems to be relatively safe; TPs provide an useful tool to monitor therapy safety, and effectiveness in diabetic patients.

Introduzione. In Italia gli studi di farmacoutilizzazione in ambito ospedaliero sono scarsi, al contrario di quelli riguardanti la farmaceutica convenzionata. Tuttavia, l'analisi della variabilità prescrittiva tra aree cliniche diverse o tra classi di farmaci, può fornire uno strumento utile per valutare l'appropriatezza d'uso dei farmaci e il corretto impiego delle risorse in ospedale. Pertanto, l'obiettivo di questo studio è analizzare i dati di spesa e di consumo ospedalieri come punto di partenza per individuare indicatori di appropriatezza d'uso dei farmaci in ospedale e progettare interventi tesi a migliorare le scelte terapeutiche. Metodi. Lo studio ha analizzato i dati di consumo e di spesa degli ospedali della Regione Emilia-Romagna negli anni 2004-2009. Il dato relativo al numero delle DDD consumate da ogni singola Azienda proviene dal flusso regionale AFO (Assistenza Farmaceutica Ospedaliera), mentre il dato relativo alla giornate di degenza deriva dall'archivio regionale delle Schede di Dimissione Ospedaliera (SDO). I dati di consumo e di spesa sono stati analizzati per Azienda, per ATC e per disciplina. Per l'analisi dei consumi è stato impiegato l'indicatore di volume di utilizzo dei farmaci in ambito ospedaliero, DDD/100 Giornate di Degenza (GdD), mentre i dati di spesa sono stati espressi in euro/100 GdD. Per le discipline che hanno registrato la maggiore spesa, sono stati messi a confronto il consumo e la spesa di ogni singola Azienda al fine di distinguere il contributo del costo unitario dei farmaci da quello delle quantità utilizzate e individuare le relative criticità. Risultati. Nel periodo 2004-2009, si è osservato un trend di aumento dei consumi per quasi tutte le Aziende della Regione Emilia-Romagna. Il consumo medio nel 2004 è stato di 1.304 DDD/100 GdD, mentre nel 2009 di 1.512 DDD/100 GdD. Anche la spesa farmaceutica ha registrato un trend di crescita, da una media di 2.648 euro/100 GdD nel 2004 a una media di 3.041 euro/100 GdD nel 2009. Il più alto volume di consumo e di spesa tra le diverse Aziende è stato raggiunto nel 2009 con 2.307 DDD/100 GdD e 6.652 euro/100 GdD. L'analisi dei consumi ha rilevato che i farmaci che agiscono sugli organi emopoietici (ATC B) sono i maggiormente impiegati (358 DDD/100 GdD nel 2009), seguiti dai farmaci dermatologici (ATC D, 234 DDD/100 GdD), e dai farmaci cardiovascolari (ATC C) e gastrointestinali (ATC A, 189 e 187 DDD/100GdD rispettivamente). I farmaci che influiscono maggiormente sulla spesa sono gli antineoplastici (ATC L, 1.296 euro/100 GdD nel 2009, 43% della spesa totale), seguiti dai farmaci antiinfettivi (ATC J, 700 euro/100 GdD, 23%) e dai sostituti ematici (ATC B, 480 euro/100 GdD, 16%). Tra le discipline, quella che ha fatto registrare il maggior valore di spesa è la terapia intensiva. Per tale disciplina, i valori di consumo nel 2009 variano tra 6.000 DDD/100 GdD e 36.000 DDD/100 GdD tra le diverse Aziende, mentre quelli di spesa tra 9.000 euro/100 GdD e 50.000/ euro/100 GdD. Confrontando i volumi di consumo e di spesa per ogni Azienda, è emerso che alcune realtà presentano alti livelli di spesa seppure i loro consumi siano in linea con la media regionale. Conclusioni. Nei sei anni considerati, il consumo e la spesa dei farmaci negli ospedali della Regione Emilia-Romagna sono aumentati di circa il 14% mostrando un andamento parallelo nella crescita. I valori di spesa e consumo sono risultati molto variabili tra le diverse classi di farmaci. Per le discipline a maggior spesa è stata riscontrata un'ampia variabilità tra le Aziende e alcune di queste si discostano ampiamente, sia in termini di consumo che di spesa, dalla media regionale. Questo studio rappresenta un'analisi preliminare fondamentale per individuare le aree terapeutiche di maggiore criticità al fine di migliorare l'uso dei farmaci in ospedale.