In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process. The main scientific limitations of this process are highlighted, together with some suggestions for dealing with them.

Completed suicide (CS) is a leading cause of death worldwide and its rates are available for most developed countries. On the other hand, attempted suicide (AS) is a risk factor for CS but there are limited data on its rates in various countries. In constructing a ratio for AS/CS rates, most would agree that for CS, the denominator should be the annual suicide rate (per 100 000). As for the ratio's numerator (AS) per 100 000, there are three possible calculations: (1) annual prevalence from population surveys, (2) annual prevalence from national clinical registers or (3) lifetime prevalence from population surveys. We think that the first possibility would probably be the best choice but, unfortunately, surveys providing the annual prevalence of AS are lacking for most countries. Annual prevalence from national registers is also lacking for most countries and is contaminated by under-reporting. Therefore, in this editorial, we are left with only the last option, a ratio for lifetime prevalence of AS (per 100 000) divided by annual rate of CS (per 100 000). This ratio for AS/CS rates appears to differ substantially across countries worldwide but presents no big regional differences other than two remarkable exceptions, one per continent. In Europe, Spain and France had greater ratios (174.4 and 152.5, respectively) than Italy (64.1). In Asia/Pacific, New Zealand has a higher ratio (345.9) compared with China (75.8) and Japan (76.9). The ratio for AS/CS rates could be a good index for implementing evidence-informed decision-making regarding suicidal behaviour (SB) among health service managers, and for helping them in the allocation of health resources for the prevention of SB.

Background – The patterns of antidepressant and antipsychotìc drag prescribing have rarely been studied in large and geographically defined catchment areas. In the present study we examined the prevalence and distribution of antidepressant and antipsychotic prescribing in Lombardy, a northern Italy region of nine million inhabitants. Methods – This study used the Regional Administrative Database of Lombardy. This database includes all prescriptions reimbursed by the National Health System in the population living in this region. All antidepressant and antipsychotic prescriptions dispensed from the 1st January to the 31st December 2001 were extracted and prevalence data calculated by dividing antidepressant and antipsychotic users by the total number of male and female residents in each age group. In addition, from the Regional database of hospital admissions we extracted all patients aged 65 or above with cerebrovascular-related outcomes for the year 2002. The two databases were linked anonymously with the aim of investigating the relationship between exposure to psychotropics and occurrence of cerebrovascular accidents in the elderly. Results – During the study period 404, 238 individuals were dispensed antidepressants, yielding a prevalence of use of 2.85 (95% CI 2.84, 2.87) per 100 males and 5.92 (95% CI 5.90, 5.94) per 100 females. The prevalence of use progressively rose with age in both sexes, with the highest rates in old and very old individuals. The majority of individuals received a pharmacological treatment with selective-serotonin reuptake inhibitors only, slightly more than 12% received a treatment with tricyclic antidepressants. A total of 86, 187 subjects were dispensed antipsychotic agents, yielding a prevalence of use of 0.87 (95% CI 0.86, 0.88) per 100 males and 1.01 (95% CI 1.00, 1.02) per 100 females. The prevalence of use progressively rose with age in both sexes, with the highest rates in old and very old subjects. Concerning the relationship between exposure to second-generation antipsychotics (SGAs) and occurrence of cerebrovascular (CBV) accidents, the analysis showed a significantly increased risk of CBV events in elderly subjects exposed to SGAs in comparison with those exposed to first-generation antipsychotics (FGAs) (3, 31%, 95% CI 2, 95–3, 69 vs. 2, 37%, 95% CI 2, 19–2, 57). Finally the analysis indicated no differences in the proportion of cerebrovascular events in elderly subjects exposed to TCAs and SSRIs. Conclusions – The very high rates of antidepressant and antipsychotic drug prescribing detected in late life suggest the need of characterising these individuals in terms of medical and psychiatric characteristics, needs and quality of life. It also suggests the need for pragmatic clinical trials, carried out in the general practice, with the aim of assessing whether antidepressants are effective in these conditions. The data provide preliminary epidemiological evidence that exposure to SGAs, in comparison with exposure to FGAs, significantly increased the risk of cerebrovascular accidents in the elderly.

Declaration of Interest: none.

Depression in the elderly is common and exhibits a distinctive phenomenology, due to neurobiological, physiological, psychological and social changes related to ageing. Most elderly with depression are managed in primary health care. Although the number of scientific publications related to geriatric psychiatry has increased, there are still important gaps. Implementation of evidence-based guidelines for managing depression in primary care has had limited success, but has led to improvements compared to standard care. It is logical that the determinants (barriers and enablers) of implementing depression guidelines can be identified and can guide the selection of more effective implementation strategies that are tailored to address those determinants. We are testing that logic as part of a multinational implementation research project called ‘Tailored Implementation for Chronic Diseases’ (TICD). Our focus in Norway is on the management of depression in the elderly in primary care. We will identify the determinants of implementing evidence-based recommendations using various methods and comparing those methods. We will then use different methods to match the implementation interventions to the identified determinants and compare those methods. Finally, we will evaluate the resulting tailored implementation strategy in a randomized trial.

No treatment has caused a greater revolution in the treatment of people with schizophrenia than chlorpromazine. The new generation of drugs has been embraced by psychiatry with an enthusiasm fostered by the unmet needs of both patients and industry. Recent, independently funded trials have highlighted already existing data illustrating how the new antipsychotics drugs are an additional advance but not a revolution. In this story there are lessons for psychiatry to opt for science rather than seduction.

Aim – Delinquency among adolescents and antecedent conduct disorder among children has been recognized as a growing public mental health problem in contemporary societies. The contribution of the neighbourhood environment to delinquent behaviour was examined in a cohort of Dutch adolescents (aged approximately 11 years at baseline; n=394). Methods – Multilevel regression analyses estimated associations between baseline neighbourhood socioeconomic status and social capital, and delinquent behaviour two years later controlling for individual-level variables. Results – A significant interaction effect was found between neighbourhood environment variables and gender in models of delinquency, indicating that associations between neighbourhood environment variables and delinquency were apparent, for the most part, in girls only. However, higher level of neighbourhood informal social control was associated with increased delinquency rates in boys. Conclusion – In girls there is a longitudinal association between neighbourhood characteristics and delinquency, suggesting complex gender differences in the way the wider social environment impacts on behavioural outcomes.

Objective - This study aims to improve the economic knowledge of major depression. It reports the investigation methodology and some preliminary indications on direct and indirect costs associated to this illness. Setting - Centro Psicosociale (CPS) USSL 72, Magenta (Mi) Italy. Design - We enrolled 10 patients (7F and 3M) with age between 34 and 65 (average 49.2 + 10.2 SD) at the first contact with CPS for an episode of major depression and we followed them up for 3 months. Main Measure Outcomes - At each visit we perform a clinical evaluation (HRS-D, CGI, DOTES) and we administered an interview to collect data in order to quantify social costs (direct and indirect) related to the observation period. Results - At the end of the 3 month period, all patients showed an improvement of the simptomatolgy as expressed by HRS-D (final score at least 50% below the initial one). Our accounting model estimated that the full cost of a psychiatric visit (on average lasting 47.8 minutes) is 107.537 Italian Liras. For the 10 patients under observation direct costs amounted to 9.402.000 It. Liras; psychiatric visits represented 70% of these costs. According to a conservative approach, indirect costs (value of labor time lost) amounted to 13.254.000 It. Liras if patients and relatives are considered and to 11.044.000 It. Liras if only patients time is evaluated. Conclusion - The paper presents a methodological proposal aimed to assess social costs of major depression. It also reports a first attempt to measure these costs in a prospective study performed in a public psychiatric centre. Our results have to be considered in the light of the limited sample of patients under observation and have to be regarded as strictly dependent on the specific context both in terms of the organizational settings and the characteristics of patients.

Aim – The high economic and social costs associated with the ‘common mental disorders’, and the need to scale up appropriate care services, are now widely recognized, but responses vary from country to country. In Britain, a current government initiative to promote psychological therapy is driven both by economic pressures and by research on the factors of happiness, or life-satisfaction. This article provides a short critical review of the project. Method – A health policy analysis, with regard to problem definition; objectives; sources of information; criteria for evaluation; impact on existing services, and comparison with alternative strategies. Results – The new programme, Improving Access to Psychological Therapies (IAPT), aims to expand treatment services by training 3,600 ‘psychological therapists’ in cognitive behavioural therapy (CBT), which they will then apply in the wider community. This service, with an initial budget of £173 million, will provide treatment for depression and chronic anxiety from local centres across the country. The programme is intended to pay for itself by reducing incapacity costs. Closer examination, however, raises questions concerning the project’s theoretical basis, logistics and research methodology, and casts doubt on its advantages over alternative approaches. Conclusions – The IAPT project is ill-designed to achieve its objectives and unsuitable as a model for treatment and care of the common mental disorders in other countries. An alternative strategy, based on closer integration of community mental health and primary health care, should be tested and on previous experience seems likely to prove more cost-effective.

Declaration of Interest: None.

Objective – The aim of the study was to show, trough the calculation of the direct costs of supports and treatments actually provided by a NHS Mental Health Department, the presence of associations between four diagnostic groups (schizophrenia, affective psychosis, paranoia and neurotic disorders) and their overall and items (community care, rehabilitation facilities and in-patients services) costs. Setting – Mental Health Department and CSM “Scalo” (NHS Mental Centre), AUSL “Citta di Bologna”, Emilia-Romagna Region. Design – Yearly direct costs were calculated for a sample (n = 75) of all patients (N = 745) who during 365 days had more than four contacts with CSM and also for four randomised diagnostic groups (n = 30 per group). Main outcome measures – We calculated unit costs of 15 types of services provided by CSM, selected according to the yearly number of services provided and the time spent by each health professional, and the in patient-cost per all days spent in a public or private sector hospital for psychiatric care. Results – The statistic analysis, performed with the help of the Kruskal-Wallis test, showed significantly higher overall costs for the schizophrenic patients than the sample-group and the neurotic disorders-group; besides a significant difference in the item costs for rehabilitation facilities was found between the schizophrenic group and the paranoia, neurotic disorders groups and the sample one, whereas no significant differences in costs of inpatients services and drugs administration were tested between the groups. Conclusions – The results of our study allow to demonstrate that there are cost differences between the diagnosis (direct costs are highest for schizophrenic patients and lowest for those with neurotic disorders) and that the costs evaluation can be used to ensure appropriate provisions to Mental Health Department for support and treatment of a wide range of psychiatric disorders.