Regional Center for Pharmacovigilance

Lombardy Region, Italy

Regional Center for Pharmacovigilance

Lombardy Region, Italy

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Conti V.,Regional Center for Pharmacovigilance | Venegoni M.,Regional Center for Pharmacovigilance | Cocci A.,Regional Center for Pharmacovigilance | Fortino I.,Regional Health Ministry | Barbui C.,University of Verona
BMC Psychiatry | Year: 2015

Background: Only three observational studies investigated whether exposure to antipsychotics is associated with an increased risk of pulmonary embolism, with conflicting results. This study was therefore carried out to establish the risk of pulmonary embolism associated with antipsychotic drugs, and to ascertain the risk associated with first- and second-generation antipsychotic drugs, and with exposure to individual drugs. Methods: We identified 84,253 adult individuals who began antipsychotic treatment in a large Italian health care system. Cases were all cohort members who were hospitalized for non-fatal or fatal pulmonary embolism during follow-up. Up to 20 controls for each case were extracted from the study cohort using incidence density sampling and matched by age at cohort entry and gender. Each individual was classified as current, recent or past antipsychotic user. The occurrence non-fatal or fatal pulmonary embolism was the outcome of interest. Results: Compared to past use, current antipsychotic use more than double the risk of pulmonary embolism (odds ratio 2.31, 95% confidence interval 1.16 to 4.59), while recent use did not increase the risk. Both conventional and atypical antipsychotic exposure was associated with an increase in risk, and the concomitant use of both classes increased the risk of four times (odds ratio 4.21, 95% confidence interval 1.53 to 11.59). Conclusions: Adding the results of this case-control study to a recent meta-analysis of three observational studies substantially changed the overall estimate, which now indicates that antipsychotic exposure significantly increases the risk of pulmonary embolism. © 2015 Conti et al.; licensee BioMed Central.


Barbui C.,University of Verona | Conti V.,Regional Center for Pharmacovigilance | Purgato M.,University of Verona | Cipriani A.,University of Verona | And 3 more authors.
Epidemiology and Psychiatric Sciences | Year: 2013

Aims. To determine the prevalence of women of childbearing age with schizophrenia and bipolar disorder exposed to antipsychotic (AP) drugs and mood stabilizers (MS) in Lombardy, a European region of 10 million inhabitants and 1Â 752Â 285 women of childbearing age. Methods. The data concerning psychiatric care, drug treatments and pregnancy outcomes were retrieved from local administrative databases during a 12-month census period. Results. During a 12-month census period, 2893 women of childbearing age with schizophrenia (74.8% of all women of childbearing age with schizophrenia) and 918 with bipolar disorder (80.1% of all women of childbearing age with bipolar disorder) were exposed to AP drugs or MS, yielding a prevalence of exposure for women with schizophrenia of 1.65 (95% confidence interval (CI) 1.59-1.71) per 1000 female inhabitants, and for women with bipolar disorder of 0.52 (95% CI 0.49-0.55) per 1000 female inhabitants. Persistent exposure to potentially teratogenic medications accounted for one in every 1000 women of childbearing age. Of the 57 pregnancies in women with schizophrenia, normal delivery was recorded in 23 (40%) cases; of the 26 pregnancies in women with bipolar disorder, normal delivery was recorded in 10 (38%) cases. Conclusions. In women of childbearing age with severe mental disorders, exposure to psychotropic drugs is substantial, which suggests that the issue of reproductive health is epidemiologically relevant and a major public health concern. © 2013 Cambridge University Press.


Lora A.,Azienda Ospedaliera Della Provincia di Lecco | Conti V.,Regional Center for Pharmacovigilance | Leoni O.,Regional Center for Pharmacovigilance | Rivolta A.L.,Regional Center for Pharmacovigilance
Psychiatric Services | Year: 2011

Objective: This study assessed whether patients being treated for schizophrenia spectrum and affective disorders in Lombardy receive adequate treatment and sought predictors of adequate treatment. Methods: Patients were aged ≥18, were residents of Italy's Lombardy region, and were treated in 2007 for schizophrenia spectrum and affective disorders (N=44,462). The patients were assessed as part of a retrospective analysis of pharmaceutical and mental health services databases. Adequacy of 12-month treatment from the first psychiatric contact in 2007 was assessed at the patient level. A hierarchical log-binomial regression model was fitted to estimate relative risk and 95% confidence intervals for association between patients, characteristics of the departments of mental health (DMH), and receipt of minimally adequate treatment. Results: About half the patients with serious mental disorders did not receive adequate care; 45.5% of patients with depressive disorders, 55.7% of those with bipolar disorders, and 49.3% of those with schizophrenia spectrum disorders received minimally adequate treatment. Diagnosis of a schizophrenia spectrum disorder or bipolar disorder and male gender predicted adequate treatment, whereas employment and high comorbidity predicted inadequate treatment. Patients who received mental health services in the past year were significantly more likely to receive adequate treatment compared with those who had received services in the past five years or new patients. Conclusions: Minimally adequate treatment is a useful indicator to monitor quality of care in Italy's regional mental health system. These data should be used at regional and local levels to implement clinical audits, to create benchmark measures, and to define new quality-improvement projects to meet specific DMH needs.


Conti V.,Regional Center for Pharmacovigilance | Lora A.,Azienda Ospedaliera della Provincia di Lecco | Cipriani A.,University of Verona | Fortino I.,Operative Unit of Territorial Health Services | And 2 more authors.
European Journal of Clinical Pharmacology | Year: 2012

Purpose The aim of this study was to measure persistence with pharmacological treatment in the specialist mental healthcare of patients with schizophrenia, bipolar disorder, and unipolar depression in Lombardy, a region of 10 million inhabitants located in the northernmost part of Italy. Methods The data concerning psychiatric care used in this study were retrieved from the regional Psychiatric Information System, while information on drug treatment was retrieved from the regional administrative database. Time to lack of persistence with initial pharmacological treatment was the outcome measure. Results A total of 11,797 patients, followed in the specialist mental healthcare system, started a new pharmacological treatment for depression, schizophrenia, or bipolar disorder during 2007. Overall, 8,500 patients (72.1%) discontinued treatment during the 12 month follow-up, with a median duration of 101 days. Very similar discontinuation rates were observed in patients with unipolar depression, schizophrenia, and bipolar disorder. In the multivariate analysis, operational definitions of continuity and intensity of care were the most robust determinants of persistence with drug treatment in each of the three cohorts of psychiatric diagnoses. Conclusions High rates of treatment discontinuation were found in a population of patients with severe mental disorders followed in the specialist mental healthcare system of an Italian region, with no differences among patients with unipolar major depression, schizophrenia, and bipolar disorder. These findings corroborate the notion that the problem of treatment discontinuation in psychiatric disorders is a factor related to the capacity of the mental health system to assure and maintain continuity and intensity of care. © Springer-Verlag 2012.


Trotta F.,National Institute of Health | Trotta F.,Italian Medicines Agency AIFA | Da Cas R.,National Institute of Health | Spila S.,National Institute of Health | And 4 more authors.
BMJ (Online) | Year: 2014

Objective To assess the risk of maternal, fetal, and neonatal outcomes associated with the administration of an MF59 adjuvanted A/H1N1 vaccine during pregnancy. Design Historical cohort study. Setting Singleton pregnancies of the resident population of the Lombardy region of Italy. Participants All deliveries between 1 October 2009 and 30 September 2010. Data on exposure to A/H1N1 pandemic vaccine, pregnancy, and birth outcomes were retrieved from regional databases. Vaccinated and non-vaccinated women were compared in a propensity score matched analysis to estimate risks of adverse outcomes. Main outcome measures Main maternal outcomes included type of delivery, admission to intensive care unit, eclampsia, and gestational diabetes; fetal and neonatal outcomes included perinatal deaths, small for gestational age births, and congenital malformations. Results Among the 86 171 eligible pregnancies, 6246 women were vaccinated (3615 (57.9%) in the third trimester and 2557 (40.9%) in the second trimester). No difference was observed in terms of spontaneous deliveries (adjusted odds ratio 1.02, 95% confidence interval 0.96 to 1.08) or admissions to intensive care units (0.95, 0.47 to 1.88), whereas a limited increase in the prevalence of gestational diabetes (1.26, 1.04 to 1.53) and eclampsia (1.19, 1.04 to 1.39) was seen in vaccinated women. Rates of fetal and neonatal outcomes were similar in vaccinated and non-vaccinated women. A slight increase in congenital malformations, although not statistically significant, was present in the exposed cohort (1.14, 0.99 to 1.31). Conclusions Our findings add relevant information about the safety of the MF59 adjuvanted A/H1N1 vaccine in pregnancy. Residual confounding may partly explain the increased risk of some maternal outcomes. Meta-analysis of published studies should be conducted to further clarify the risk of infrequent outcomes, such as specific congenital malformations.


Spinogatti F.,Cremona Hospital | Civenti G.,Directorate General for Health | Conti V.,Regional Center for Pharmacovigilance | Lora A.,Lecco Hospital
Social Psychiatry and Psychiatric Epidemiology | Year: 2015

Purpose: To analyze the differences in mental health service utilization by immigrant and native populations of Lombardy, an Italian region that hosts one-fourth of the immigrants living in Italy. Method: The data are drawn from the regional mental health information system (based on the case register model), which supplies information on the users and mental health activities of the Departments of Mental Health, Lombardy, a region of about 10 million people; 139,775 adult users were treated in mental health services in 2010. Results: Mental health services are used by 11.3 immigrant users out of 1,000 immigrants (with marked differences depending on country of origin) compared with 17.0 native users. Acute mental health services are used more frequently by immigrant patients; the types of intervention provided to immigrants differ from those provided to the native population (mainly as far as psychotherapeutic interventions is concerned), while gender differences are substantial. Conclusions: The number of immigrant users using mental health services has increased notably in recent years, and in Lombardy it has been observed that the use of such services differs from service unit to service unit. This raises the problem of how to increase the cultural awareness of mental health professionals dealing with the mental health needs of the immigrant population. On the whole, immigrants use community mental health services less than the native population; however, immigrants tend to be more frequently admitted to general hospital psychiatric units during acute phases and both the utilization rates and gender differ greatly, depending on the country of origin. © 2014, Springer-Verlag Berlin Heidelberg.


Corrao G.,University of Milan Bicocca | Conti V.,University of Milan Bicocca | Conti V.,Regional Center for Pharmacovigilance | Merlino L.,Operative Unit | And 2 more authors.
Clinical Therapeutics | Year: 2010

Background: Previous studies have reported that statin use was associated with reductions in cardiovascular morbidity and mortality among patients with dyslipidemia, even without established cardiovascular disease. However, inadequate adherence may reduce statins' protective effects. Objective: The aim of this work was to investigate whether an association exists between statin adherence when used as primary prevention and risk of subsequent ischemic heart disease (IHD). Methods: People aged ≥18 years who were residents of Italy's Lombardy region and were newly treated with statins in 2002 to 2003 were assessed as part of a retrospective analysis of data from a healthservices database. Patients who were hospitalized for IHD during this period were identified with hospitaldischarge information from a health-services database; IHD-related hospitalizations were identified by International Classification of Diseases, Ninth Revision, Clinical Modification, codes for acute myocardial infarction (410), acute and subacute forms of IHD (411), and/or codes concerning coronary revascularization (36.0-36.9). Four groups of patients were excluded: those with ≥1 lipid-lowering drug within 2 years before the index prescription (to limit the sample to treatment initiators); those who had been hospitalized for cardiovascular disease or had used medications for IHD or heart failure within 2 years before the index date (to limit the study to primary prevention); those who did not have ≥1 year of follow-up; and those who received only 1 dispensation of a statin during the first year after the index prescription. Follow-up continued until hospitalization for IHD or any other cardiovascular cause, death from any cause, emigration, or the end of the study period (June 30, 2007). The proportion of days covered (PDC) by therapy with statins was the exposure variable; it served as a proxy for adherence. PDC (and therefore adherence) was categorized as very low (≤25%), low (26%-50%), intermediate (51%-75%), or high (≥75%) coverage. A proportional hazards model was fitted to estimate hazard ratio (HR) and 95% CIs for the association between time-dependent categories of PDC and time of IHD hospitalization, after correcting for covariates. Results: A group of 90,832 patients was included; during follow-up, 1480 patients experienced a hospitalization for IHD. After the Cox proportional hazards model was adjusted for age, sex, type of statin dispensed at index prescription, current use of other selected drugs (ie, antidiabetics, antihypertensives, digitalis or organic nitrates, or other cardiac medications), Charlson comorbidity index, and whether or not a given patient switched statins, those with low, intermediate, or high statin coverage had HR (95% CI) values of 0.85 (0.72-0.98), 0.82 (0.71-0.95), and 0.81 (0.71-0.94), respectively, compared with patients with very low coverage. Conclusions: In these Italian subjects without a history of cardiovascular disease, low, intermediate, and high levels of adherence to statin pharmaco-therapy were associated with lower risk of nonfatal IHD compared with those who had very low (≤25%) adherence. However, these findings have several limitations, such as the use of database information (rather than medical records), the assumption that PDC accurately represented actual adherence, and confounding (ie, unmeasured factors related to PDC or to adherence may have influenced clinical outcomes). © 2010.


Barbui C.,University of Verona | Conti V.,Regional Center for Pharmacovigilance | Cipriani A.,University of Verona
Drug Safety | Year: 2014

Background Venous thromboembolism (VTE) is a serious disorder that may be complicated by pulmonary embolism (PE). Case reports and observational studies published in thee arly 1950s suggested that antipsychotic (AP) drugs may represent a risk factor, while observational studies conducted in the last 3 decades have provided conflicting results. Objective The aim was to investigate whether AP drugs increase the risk of VTE and PE, and to ascertain the risk associated with first- and second-generation AP drugs and with exposure to individual drugs. Data Source Relevant studies were located by searching MEDLINE, PubMed, EMBASE, PsychINFO, CINAHL and Scopus up to March 2013. Reference lists of relevant papers and previous review articles were hand searched for other relevant studies. Study Selection Based on the titles and abstracts of 1,386 citations, we identified 30 potentially relevant studies. Of these, 17 studies were eligible for inclusion and were included in the meta-analysis. Main Outcomes and Measures The primary outcome measure of this meta-analysis was the occurrence of VTE or PE in individuals exposed to AP drugs in comparison with individuals unexposed or with past exposure to AP drugs. Results Antipsychotic exposure was associated with a significant increase in risk of developing VTE [odds ratio (OR) 1.54, 95 % confidence interval (CI) 1.28-1.86, 11 studies]. Exposure to APs did not significantly increase the risk of PE (OR 4.90, 95 %CI 0.77-30.98, three studies), but the overall estimate was highly heterogeneous and the CI included the possibility of substantial harm. Random-effects meta-analysis on the risk ofVTEassociated with exposure to first- (OR 1.74, 95 % CI 1.28-2.37, six studies) and second-generation (OR 2.07, 95 % CI 1.74-2.52, five studies) APs revealed an increased risk. Only a few studies provided data on individual drugs, and estimates of effect were very uncertain. Conclusions Antipsychotic exposure in unselected patient populationsmay be associated with a 50 %increase in the risk of developing VTE. However, between-study heterogeneity limits the confidence in this estimate. This increased risk similarly applies to first- and second-generation AP drugs. © 2013 Springer International Publishing Switzerland.


Barbui C.,University of Verona | Conti V.,Regional Center for Pharmacovigilance
Epidemiology and Psychiatric Sciences | Year: 2015

One of the major challenges with antidepressant (AD) use is poor adherence and early treatment discontinuation. In addition to socio-demographic and clinical variables, treatment discontinuation may also be related to the capacity of the health system to assure and maintain continuity and intensity of care. Among health system factors that may interfere with adherence to pharmacological treatment, use of generic drugs may play a key role. It has been argued that, although the lower cost of generics may favour persistence on treatment, a widespread a priori scepticism about their effectiveness and safety by doctors and patients may have an opposite effect. This compelling research question has recently been addressed by an observational cohort study that involved 16Â 778 Medicare fee-for-service beneficiaries who received a new depression diagnosis and initiated generic v. brand AD therapy. The study found that generic initiation was associated with improved adherence. The benefits resulted from the lower out-of-pocket cost associated with generic ADs. In this commentary, we discuss the main findings of this study in view of its methodological strengths and limitations, and we suggest implications for policy. © 2014 Cambridge University Press.


Roberto G.,University of Bologna | Raschi E.,University of Bologna | Piccinni C.,University of Bologna | Conti V.,Regional Center for Pharmacovigilance | And 5 more authors.
Cephalalgia | Year: 2015

Background: Apart from the underlying cardiovascular (CV) risk associated with migraine, both triptans and ergotamines can induce vasoconstriction and potentially increase the risk of serious ischemic events. Because of the low frequency of such events in eligible patients, randomized controlled trials are not exhaustive to assess the drug-related CV risk. Observational studies are, therefore, an essential source of information to clarify this matter of concern. Aim: The aim of this study was to systematically review the available published observational studies investigating the risk of serious CV events in triptan or ergotamine users, as compared to unexposed migraineur controls. Methods: We systematically searched MEDLINE and EMBASE electronic databases for cohort or case-control studies up to December 1, 2013. Studies retrieved from CDSR, DARE and HTA databases of the Cochrane Library were used for snowballing. Studies investigating the risk of any CV outcome in patients with a migraine diagnosis and exposed to triptans or ergotamines were considered for inclusion. Selection of studies, data extraction, and risk of bias assessment were conducted independently by two reviewers. Pooled odds ratios (ORs) with 95% confidence interval (95% CI) were computed using a random-effects model for studies and outcomes judged eligible for quantitative data synthesis. Results: From a total of 3370 citations retrieved, after duplicate removal and screening, only four studies met the inclusion criteria (three nested case-control analyses and one retrospective cohort study). These studies investigated the risk of different CV outcomes associated with either the recency or the intensity of exposure to the studied drugs. As for the intensity of use, the pooled OR of serious ischemic events was 2.28 (95% CI 1.18-4.41; I2=0%) for ergotamine use (two studies), whereas for triptans (three studies) it was 0.86 (95% CI 0.52-1.43; I2=24.5%). Recent use of ergotamines was not significantly associated with any CV outcome (only one available study). Two studies investigated the risk of stroke related to recent triptan use: the first study reported an OR of 0.90 (0.64-1.26), and the second one suggested an increased risk of 2.51 (1.10-5.71). In this case, because of the high degree of heterogeneity, results were not pooled. Conclusions: To date, few comparative observational studies have investigated the CV safety of migraine-specific drugs in clinical practice. Evidence gathered here suggests that intense consumption of ergotamines may be associated with an increased risk of serious ischemic complications. As for triptans, available studies do not suggest strong CV safety issues, although no firm conclusions can be drawn. In particular, evidence on stroke risk is conflicting. However, if an increase of the absolute stroke risk in recently exposed patients does actually exist, it must be small. Overall, residual uncontrolled confounding factors reduce the confidence in the risk estimates collected from the included studies. Further investigations are needed to better define the risk for rare but serious CV events related to triptan and ergotamine use for treatment of migraine. © International Headache Society 2014.

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