Updating the WHO Model Lists of Essential Medicines to promote global access to the most cost-effective and safe medicines for mental disorders.

Since 1977, the WHO Model Lists of Essential Medicines (EML) have been a benchmark to guide the procurement of medicines at the national level, especially in low-income and middle-income countries. Aiming to include the most effective, safe, and cost-effective medicines for priority conditions, WHO updates the EML for adults and the EML for children every 2 years. Over the past 45 years, updates to the EML mental health section have been infrequent, in most cases with additions of individual medicines. A comprehensive revision of the entire section has never been attempted. With the aim of increasing the use of the WHO EML to expand the selection of the most effective and safe medicines for mental disorders, a series of evidence-based applications were submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines in 2022, recommending a substantial revision of the entire mental health section. In this Health Policy, we summarise the recommended update and the evidence justifying it. We also discuss challenges in the update process, suggesting possible solutions. The requested comprehensive revision of the WHO EML mental health section aligns the list with the latest evidence. The revision offers an opportunity for countries to promote access to the most effective, safe, and cost-effective medicines for mental disorders, contributing to universal health coverage and global mental health equity.

Views and experiences of migrants and stakeholders involved in social and health care for migrants in Italy during the COVID-19 pandemic: a qualitative study.

BACKGROUND: The COVID-19 pandemic has had major and potentially long-lasting effects on mental health and wellbeing across populations worldwide. However, these impacts were not felt equally, leading to an exacerbation of health inequalities, especially affecting vulnerable populations such as migrants, refugees and asylum seekers. Aiming to inform the adaptation and implementation of psychological intervention programmes, the present study investigated priority mental health needs in this population group. METHODS: Participants were adult asylum seekers, refugees and migrants (ARMs) and stakeholders with experience in the field of migration living in Verona, Italy, and fluent in Italian and English. A two-stage process was carried out to examine their needs using qualitative methods including free listing interviews and focus group discussions, according to Module One of the DIME (Design, Implementation, Monitoring, and Evaluation) manual. Data were analyzed using an inductive thematic analyses approach. RESULTS: A total of 19 participants (12 stakeholders, 7 ARMs) completed the free listing interviews and 20 participants (12 stakeholders and 8 ARMs) attended focus group discussions. Salient problems and functions that emerged during free listing interviews were discussed during the focus group discussions. During the COVID-19 pandemic, ARMs struggled with many everyday living difficulties in their resettlement country due to social and economic issues, revealing a strong influence of contextual factors in determining mental health. Both ARMs and stakeholders highlighted a mismatch between needs, expectations and interventions as factors that may hamper proper implementation of health and social programmes. CONCLUSIONS: The present findings could help in the adaptation and implementation of psychological interventions targeting the needs of asylum seekers, refugees and migrants aiming to find a match between needs, expectations, and the corresponding interventions. TRIAL REGISTRATION: Registration number 2021-UNVRCLE-0106707, February 11 2021.

Cost-effectiveness of the Self-Help Plus Intervention for Adult Syrian Refugees Hosted in Turkey.

Importance: The cost-effectiveness of the Self-Help Plus (SH+) program, a group-based, guided, self-help psychological intervention developed by the World Health Organization for people affected by adversity, is unclear. Objective: To investigate the cost-utility of providing the SH+ intervention combined with enhanced usual care vs enhanced usual care alone for Syrian refugees or asylum seekers hosted in Turkey. Design, Setting, and Participants: This economic evaluation was performed as a prespecified part of an assessor-blinded randomized clinical trial conducted between October 1, 2018, and November 30, 2019, with 6-month follow-up. A total of 627 adults with psychological distress but no diagnosed psychiatric disorder were randomly assigned to the intervention group or the enhanced usual care group. Interventions: The SH+ program was a 5-session (2 hours each), group-based, stress management course in which participants learned self-help skills for managing stress by listening to audio sessions. The SH+ sessions were facilitated by briefly trained, nonspecialist individuals, and an illustrated book was provided to group members. Th intervention group received the SH+ intervention plus enhanced usual care; the control group received only enhanced usual care from the local health care system. Enhanced usual care included access to free health care services provided by primary and secondary institutions plus details on nongovernmental organizations and freely available mental health services, social services, and community networks for people under temporary protection of Turkey and refugees. Main Outcomes and Measures: The primary outcome measure was incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the Turkish health care system. An intention-to-treat analysis was used including all participants who were randomized and for whom baseline data on costs and QALYs were available. Data were analyzed September 30, 2020, to July 30, 2021. Results: Of 627 participants (mean [SD] age, 31.3 [9.0] years; 393 [62.9%] women), 313 were included in the analysis for the SH+ group and 314 in the analysis for the enhanced usual care group. An incremental cost-utility ratio estimate of T£6068 ($1147) per QALY gained was found when the SH+ intervention was provided to groups of 10 Syrian refugees. At a willingness to pay per QALY gained of T£14 831 ($2802), the SH+ intervention had a 97.5% chance of being cost-effective compared with enhanced usual care alone. Conclusions and Relevance: This economic evaluation suggests that implementation of the SH+ intervention compared with enhanced usual care alone for adult Syrian refugees or asylum seekers hosted in Turkey is cost-effective from the perspective of the Turkish health care system when both international and country-specific willingness-to-pay thresholds were applied.

[Second-generation antipsychotics and cardio-metabolic events: real-world analysis and healthcare costs]. / Antipsicotici di seconda generazione ed eventi cardio-metabolici: analisi real-world e costi assistenziali.

OBJECTIVE: This analysis has identified and characterized new users of second-generation antipsychotics (SGA) in Italy and has assessed the occurrence of cardio-metabolic (CM) events over 3 years after the SGA starting therapy and the annual healthcare costs, in the perspective of the Italian National Health System (INHS). METHODS: Starting from the Fondazione ReS (Ricerca e Salute)'s database, adults treated with SGA in 2015 (index supply) were selected. By analyzing 2 previous years, treatment incidence and presence/absence of CM diseases or predisposing conditions (PC) to these events were defined and 3 cohorts were identified: A) with CM or predisposing conditions, B) only with PC, C) without neither CM nor predisposing conditions. Cohorts B and C were paired with patients with the same clinical profiles but without any SGA supply. Into cohorts and related paired groups, CM diseases/predisposing conditions occurred (cases) during the 3-year follow-up after the index supply were searched. Cases were compared with related control groups in terms of probability of CM disease/predisposing conditions occurrence (survival analysis to the event - Kaplan-Meier curves). RESULTS: Among more than 4 million adults, 12,218 were incident to SGA (2.8 x1,000): 2,732 composed cohort A (22.5%) with median age 80 (69;87), 1,492 cohort B (12.3%) with median age 77 (63;85), 7,904 cohort C (65.2%) with median age 60 (37;84). They were mostly females. The treatment incidence increased with age. The probabilities of CM events were: 15.8% and 13.3% among cases and controls of cohort B, and 7.5% and 5.1% among cases and controls of cohort C. Probabilities of predisposing conditions occurrence were 10% and 7.0% among cases and controls of cohort C. All differences were significant (p<0.01). The mean integrated healthcare cost was similar between case and control. Hospitalizations accounted for the most expenditure. DISCUSSION AND CONCLUSION: CM events or predisposing conditions occurrence in the elderly is both a clinical and an economic issue for the INHS. The proper therapeutic choice and monitoring of patient treated with antipsychotics must be encouraged.

A Systematic Review of the Use of Telepsychiatry in Depression.

Telepsychiatry, the use of televideo in psychiatric assessment and treatment, is utilized throughout Canada. Major depressive disorder (MDD) is common, with significant burdens of suffering and cost. This systematic review explores the literature on the use of televideo to diagnose and treat MDD, particularly acceptability and patient satisfaction, efficacy, and cost-effectiveness. A literature search was conducted for years 1946 to 2019. Study eligibility criteria included: MDD as the condition of interest, use of televideo technology, randomized controlled trials (RCTs), Adult (18 years or older) population, any clinical setting, and any healthcare professional providing care. The study must have included at least one of the following measures, satisfaction, efficacy, and cost-effectiveness. Fourteen studies were included. Satisfaction is equivalent to or significantly higher than face-to-face intervention. Both televideo and control groups found relief from depressive symptoms, with differences either statistically insignificant or in favour of televideo. Despite increased cost upfront for televideo due to the technology required, televideo would eventually be more cost-effective due to reducing travel expenses. Limitations include that there is little RCT data, and what exists often uses a collaborative treatment model. Many studies consisted solely of U.S. Veterans, and have limited generalizability. Further research needed to directly compare psychiatrist assessment over televideo versus in-person, and determine if particular patient subgroups benefit more from televideo or in-person intervention.Systematic review registration number: CRD42016048224.

Interventions for adults with a history of complex traumatic events: the INCiTE mixed-methods systematic review.

BACKGROUND: People with a history of complex traumatic events typically experience trauma and stressor disorders and additional mental comorbidities. It is not known if existing evidence-based treatments are effective and acceptable for this group of people. OBJECTIVE: To identify candidate psychological and non-pharmacological treatments for future research. DESIGN: Mixed-methods systematic review. PARTICIPANTS: Adults aged ≥ 18 years with a history of complex traumatic events. INTERVENTIONS: Psychological interventions versus control or active control; pharmacological interventions versus placebo. MAIN OUTCOME MEASURES: Post-traumatic stress disorder symptoms, common mental health problems and attrition. DATA SOURCES: Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 onwards); Cochrane Central Register of Controlled Trials (CENTRAL) (from inception); EMBASE (1974 to 2017 week 16); International Pharmaceutical Abstracts (1970 onwards); MEDLINE and MEDLINE Epub Ahead of Print and In-Process & Other Non-Indexed Citations (1946 to present); Published International Literature on Traumatic Stress (PILOTS) (1987 onwards); PsycINFO (1806 to April week 2 2017); and Science Citation Index (1900 onwards). Searches were conducted between April and August 2017. REVIEW METHODS: Eligible studies were singly screened and disagreements were resolved at consensus meetings. The risk of bias was assessed using the Cochrane risk-of-bias tool and a bespoke version of a quality appraisal checklist used by the National Institute for Health and Care Excellence. A meta-analysis was conducted across all populations for each intervention category and for population subgroups. Moderators of effectiveness were assessed using metaregression and a component network meta-analysis. A qualitative synthesis was undertaken to summarise the acceptability of interventions with the relevance of findings assessed by the GRADE-CERQual checklist. RESULTS: One hundred and four randomised controlled trials and nine non-randomised controlled trials were included. For the qualitative acceptability review, 4324 records were identified and nine studies were included. The population subgroups were veterans, childhood sexual abuse victims, war affected, refugees and domestic violence victims. Psychological interventions were superior to the control post treatment for reducing post-traumatic stress disorder symptoms (standardised mean difference -0.90, 95% confidence interval -1.14 to -0.66; number of trials = 39) and also for associated symptoms of depression, but not anxiety. Trauma-focused therapies were the most effective interventions across all populations for post-traumatic stress disorder and depression. Multicomponent and trauma-focused interventions were effective for negative self-concept. Phase-based approaches were also superior to the control for post-traumatic stress disorder and depression and showed the most benefit for managing emotional dysregulation and interpersonal problems. Only antipsychotic medication was effective for reducing post-traumatic stress disorder symptoms; medications were not effective for mental comorbidities. Eight qualitative studies were included. Interventions were more acceptable if service users could identify benefits and if they were delivered in ways that accommodated their personal and social needs. LIMITATIONS: Assessments about long-term effectiveness of interventions were not possible. Studies that included outcomes related to comorbid psychiatric states, such as borderline personality disorder, and populations from prisons and humanitarian crises were under-represented. CONCLUSIONS: Evidence-based psychological interventions are effective and acceptable post treatment for reducing post-traumatic stress disorder symptoms and depression and anxiety in people with complex trauma. These interventions were less effective in veterans and had less of an impact on symptoms associated with complex post-traumatic stress disorder. FUTURE WORK: Definitive trials of phase-based versus non-phase-based interventions with long-term follow-up for post-traumatic stress disorder and associated mental comorbidities. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017055523. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 43. See the NIHR Journals Library website for further project information.

Traumatic events that happen often and that are difficult to escape from, such as childhood abuse, are sometimes known as complex traumatic events. People who have a history of complex traumatic events can develop post-traumatic stress disorder and can also suffer from other mental health problems. It is not known if people who experience complex traumatic events can benefit from existing psychological treatments or medications, or if these treatments are acceptable. This review aimed to find out which treatments are most effective and acceptable for mental health problems in people with complex trauma histories, and to identify the frontrunners for future research. We searched electronic databases for evidence about treatment effectiveness and acceptability in adults with a history of complex traumatic events. We found 104 randomised controlled trials and nine non-randomised controlled trials that tested the effectiveness of psychological and/or medications, as well as nine studies that used interviews and focus groups to describe the acceptability of psychological treatments. The studies were split across different populations that included veterans, refugees, people who had experienced childhood sexual abuse and domestic violence, and civilians affected by war. We found that psychological treatments that focused on improving symptoms associated with trauma were effective for reducing post-traumatic stress disorder symptoms and depression across all populations and fewer people dropped out of these treatments, suggesting that they are acceptable. However, trauma-focused treatments were less effective among veterans than among other groups and less effective for reducing other psychological symptoms commonly experienced by people with complex trauma histories. Phased treatments that first start with helping people to feel safe before focusing on trauma symptoms might be beneficial for both post-traumatic stress disorder and additional psychological symptoms. There was little evidence that medications, other than antipsychotics, were effective for post-traumatic stress disorder symptoms. Future work should test if phased treatments are more effective than non-phased treatments over the long term.

An overview of systematic reviews on mental health promotion, prevention, and treatment of common mental disorders for refugees, asylum seekers, and internally displaced persons.

BACKGROUND: Migrants who have been forced to leave their home, such as refugees, asylum seekers, and internally displaced persons (IDP), are likely to experience stressors which may lead to mental health problems. The efficacy of interventions for mental health promotion, prevention, and treatment may differ in this population. OBJECTIVES: With this overview of systematic reviews, we will map the characteristics and methodological quality of existing systematic reviews and registered systematic review protocols on the promotion of mental health and prevention and treatment of common mental disorders among refugees, asylum seekers, and IDPs. The findings from this overview will be used to prioritise and inform future Cochrane reviews on the mental health of involuntary migrants. METHODS: We searched Ovid MEDLINE (1945 onwards), Ovid Embase (1974 onwards), Ovid PsycINFO, ProQuest PTSDpubs, Web of Science Core Collection, Cochrane Database of Systematic Reviews, NIHR Journals Library, CRD databases (archived), DoPHER, Epistemonikos, Health Evidence, 3ie International Initiative for Impact Evaluation, and PROSPERO, to identify systematic reviews of mental health interventions for involuntary migrants. We did not apply any restrictions on date, language, or publication status to the searches. We included systematic reviews or protocols for systematic reviews of interventions aimed at refugees, asylum seekers, and internally displaced persons. Interventions must have been aimed at mental health promotion (for example, classroom-based well-being interventions for children), prevention of mental health problems (for example, trauma-focussed Cognitive Behavioural Therapy to prevent post-traumatic stress disorder), or treatment of common mental disorders and symptoms (for example, narrative exposure therapy to treat symptoms of trauma). After screening abstracts and full-text manuscripts in duplicate, we extracted data on the characteristics of the reviews, the interventions examined in reviews, and the number of primary studies included in each review. Methodological quality of the included systematic reviews was assessed using AMSTAR 2. MAIN RESULTS: The overview includes 23 systematic reviews and 15 registered systematic review protocols. Of the 23 published systematic reviews, meta-analyses were conducted in eight reviews. It was more common for the search strategy or inclusion criteria of the reviews to state that studies involving refugees were eligible for inclusion (23/23), than for asylum seekers (14/23) or IDPs (7/23) to be explicitly mentioned. In most reviews, study eligiblity was either not restricted by participant age (9/23), or restricted to adults (10/23). Reviews commonly reported on studies of diagnosis or symptoms of post-traumatic stress disorder or trauma (11/23) and were less likely to report on depression or anxiety (6/23). In 15 reviews the intervention of interest was focused on/ specific to psychological therapy. Across all 23 reviews, the interventions most commonly identified from primary studies were general Cognitive Behavioural Therapy, Narrative Exposure Therapy, and a range of different integrative and interpersonal therapies. Even though many reviews included studies of participants without a diagnosis of a mental health problem, they often assessed mental health treatments and did not usually distinguish between promotion, prevention, and treatment in the review aims. Together the 23 systematic reviews included 336 references, of which 175 were unique primary studies. Limitations to the methodological quality of reviews most commonly related to reporting of selection criteria (21/23), absence of a protocol (19/23), reporting of study design (20/23), search strategy (22/23), and funding sources of primary studies (19/23). AUTHORS' CONCLUSIONS: Gaps exist in the evidence on mental health interventions for refugees, asylum seekers, and internally displaced persons. Most reviews do not specify that internally displaced persons are included in the selection criteria, even though they make up the majority of involuntary migrants worldwide. Reviews specific to mental health promotion and prevention of common mental disorders are missing, and there is more evidence available for adults or mixed populations than for children. The literature is focused on post-traumatic stress disorder and trauma-related symptoms, with less attention for depression and anxiety disorders. Better quality systematic reviews and better report of review design and methods would help those who may use these reviews to inform implementation of mental health interventions.

Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries.

The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.

Real-world data on new users of atypical antipsychotics: characterisation, prescription patterns, healthcare costs and early cardio-metabolic occurrences from a large Italian database.

PURPOSE: To describe new users of atypical antipsychotics (APs) in terms of sociodemographic characteristics, cardio-metabolic risk profile, prescription patterns, healthcare costs and cardio-metabolic events over the 24 months after treatment initiation. METHODS: Atypical AP new users were selected from the ReS database and grouped into three: patients already affected by cardio-metabolic diseases (group A), patients without these clinical conditions but with predisposing conditions (group B) and patients without cardio-metabolic diseases and predisposing conditions (group C). Annual prescription patterns and healthcare costs were analysed. Subjects of groups B and C were matched with controls to compare the occurrences of cardio-metabolic events over 24 months. RESULTS: Thirty-two thousand thirty-four new users of atypical APs were selected (median age 69). The 22.3% had cardio-metabolic diseases, 14.8% had predisposing conditions and 62.9% had none of these. The 99.3% received monotherapy. The mean annual cost per patient was €2785, and the median cost was €1108. After 24 months, a cardio-metabolic event occurred in 11.5% of group B vs. 8.7% of the controls (p < .01), and in 5.0% of group C vs. 2.1% of the controls (p < .01). CONCLUSION: Patients treated with atypical AP were on average old and, in a non-negligible amount, with cardio-metabolic disease or predisposing conditions. New users of atypical APs showed a significantly higher likelihood to develop a cardio-metabolic event early after treatment initiation.

Psychological and Psychosomatic Symptoms of Second Victims of Adverse Events: a Systematic Review and Meta-Analysis.

OBJECTIVES: Despite growing interest in the second-victim phenomenon and greater awareness of its consequences, there has not been a meta-analysis quantifying the negative impact of adverse events on providers involved in adverse events. This study systematically reviewed the types and prevalence of psychological and psychosomatic symptoms among second victims. METHODS: We conducted a systematic review of nine electronic databases up to February 2017, without restrictions to publication date or language, examining also additional sources (e.g., gray literature, volumes of journals). Two reviewers performed the search, selection process, quality assessment, data extraction, and synthesis. We resolved disagreements by consensus and/or involving a third reviewer. Quantitative studies on the prevalence of psychological and psychosomatic symptoms of second victims were eligible for inclusion. We used random effects modeling to calculate the overall prevalence rates and the I statistic. RESULTS: Of 7210 records retrieved, 98 potentially relevant studies were identified. Full-text evaluation led to a final selection of 18 studies, based on the reports of 11,649 healthcare providers involved in adverse events. The most prevalent symptoms were troubling memories (81%, 95% confidence interval [CI] = 46-95), anxiety/concern (76%, 95% CI = 33-95), anger toward themselves (75%, 95% CI = 59-86), regret/remorse (72%, 95% CI = 62-81), distress (70%, 95% CI = 60-79), fear of future errors (56%, 95% CI = 34-75), embarrassment (52%, 95% CI = 31-72), guilt (51%, 95% CI = 41-62), and sleeping difficulties (35%, 95% CI = 22-51). CONCLUSIONS: Second victims report a high prevalence and wide range of psychological symptoms. More than two-thirds of providers reported troubling memories, anxiety, anger, remorse, and distress. Preventive and therapeutic programs should aim to decrease second victims' emotional distress.

Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials.

INTRODUCTION: This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey. METHODS AND ANALYSIS: Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness. ETHICS AND DISSEMINATION: The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings. TRIALS REGISTRATION NUMBERS: NCT03571347, NCT03587896.

Ongoing initiatives within the Scottish National Health Service to affect the prescribing of selective serotonin reuptake inhibitors and their influence.

Aim: Increasing use of selective serotonin-reuptake inhibitors (SSRIs) in Scotland, coupled with safety concerns with some SSRIs, and the increasing availability of generic SSRIs, have resulted in multiple initiatives to improve the quality and efficiency of their prescribing in Scotland. Our aim is to assess their influence to provide future direction. Materials & methods: The prescription costs analysis database was used to document utilization and expenditure on SSRIs between 2001 and 2017 alongside documenting the initiatives. Results: Multiple interventions over the years increased international nonproprietary name prescribing up to 99.9% lowering overall costs. This, coupled with initiatives to limit escitalopram prescribing due to concerns with its value, resulted in a 73.7% reduction in SSRI expenditure between 2001 and 2017 despite a 2.34-fold increase in utilization. Safety warnings resulted in a significant reduction in the prescribing of paroxetine, citalopram and escitalopram alongside a significant increase in sertraline Conclusion: Multiple initiatives have increased the quality and efficiency of SSRI prescribing in Scotland providing direction to others.

Costs in the Treatment of Schizophrenia in Adults Receiving Atypical Antipsychotics: An 11-Year Cohort in Brazil.

BACKGROUND: Schizophrenia is associated with significant economic burden. In Brazil, antipsychotic drugs and outpatient and hospital services are provided by the Brazilian National Health System (SUS) for patients with schizophrenia. However, few studies capture the cost of managing these patients within the Brazilian NHS. This is important to appraise different management approaches within universal healthcare systems. OBJECTIVE: Our objective was to use real-world data to describe the costs associated with the treatment of schizophrenia in adults receiving atypical antipsychotics in Brazil from 2000 to 2010. METHODS: We integrated three national databases for adult patients with schizophrenia receiving one or more atypical antipsychotics. We assessed only direct medical costs and the study was conducted from a public-payer perspective. A multivariate log-linear regression model was performed to evaluate associations between costs and clinical and demographic variables. RESULTS: We identified 174,310 patients with schizophrenia, with mean ± standard deviation (SD) annual costs of $US1811.92 ± 284.39 per patient. Atypical antipsychotics accounted for 79.7% of total costs, with a mean annual cost per patient of $US1578.74 ± 240.40. Mean annual costs per patient were $US2482.90 ± 302.92 for psychiatric hospitalization and $US862.96 ± 160.18 for outpatient psychiatric care. Olanzapine was used by 47.7% of patients and represented 62.8% of the total costs of atypical antipsychotics. Patients who used clozapine had the highest mean annual cost per patient for outpatient psychiatric care and psychiatric hospitalization. CONCLUSIONS: Atypical antipsychotics were responsible for the majority of the schizophrenia treatment costs, and psychiatric hospitalization costs were the highest mean annual cost per patient. Authorities should ensure efficient use of atypical antipsychotics and encourage outpatient psychiatric care over psychiatric hospitalization where possible.

Access to and Use of Psychiatric Services by Migrants Resettled in Northern Italy.

The present study was conducted to describe access to and use of psychiatric services by migrants resettled in a large and well-defined catchment area. The study was conducted in a catchment area of 459,536 inhabitants in Verona, a city located in the Northeast of Italy. Using a psychiatric case register, all native and migrant individuals with a first ever psychiatric contact from 2000 to 2015 were identified. Service use data during the 12 months following first contact were collected. During the study period a total of 2610 migrants and 28,860 natives had at least one psychiatric contact. A progressive rise in the proportion of migrants seeking psychiatric care was observed, from 2.5% in 2000 to more than 14% in 2015. During the 12 months following first contact, the proportion of patients with a single consultation did not differ between resettled migrants and natives. However, migrants were more often marked users or heavy users of psychiatric services. Multivariate linear regression analyses showed that younger male individuals with psychotic disorders experienced higher psychiatric services use regardless their native or migrant condition. In a large catchment area with a well-developed community-based system of mental health care a progressive rise in the number of migrants seeking psychiatric care was observed. The pattern of service use during the 12 months after first contact was not related to nationality, suggesting the capacity of community psychiatric services to retain people in care. These findings call for the development of culturally and linguistically appropriate community psychiatric services.

WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries.

QUESTION: Despite mental, neurological and substance use (MNS) disorders being highly prevalent, there is a worldwide gap between service need and provision. WHO launched its Mental Health Gap Action Programme (mhGAP) in 2008, and the Intervention Guide (mhGAP-IG) in 2010. mhGAP-IG provides evidence-based guidance and tools for assessment and integrated management of priority MNS disorders in low and middle-income countries (LMICs), using clinical decision-making protocols. It targets a non-specialised primary healthcare audience, but has also been used by ministries, non-governmental organisations and academics, for mental health service scale-up in 90 countries. This review aimed to identify evidence to date for mhGAP-IG implementation in LMICs. STUDY SELECTION AND ANALYSIS: We searched MEDLINE, Embase, PsycINFO, Web of Knowledge/Web of Science, Scopus, CINAHL, LILACS, SciELO/Web of Science, Cochrane, Pubmed databases and Google Scholar for studies reporting evidence, experience or evaluation of mhGAP-IG in LMICs, in any language. Data were extracted from included papers, but heterogeneity prevented meta-analysis. FINDINGS: We conducted a systematic review of evidence to date, of mhGAP-IG implementation and evaluation in LMICs. Thirty-three included studies reported 15 training courses, 9 clinical implementations, 3 country contextualisations, 3 economic models, 2 uses as control interventions and 1 use to develop a rating scale. Our review identified the importance of detailed reports of contextual challenges in the field, alongside detailed protocols, qualitative studies and randomised controlled trials. CONCLUSIONS: The mhGAP-IG literature is substantial, relative to other published evaluations of clinical practice guidelines: an important contribution to a neglected field.

Closing forensic psychiatric hospitals in Italy: a new revolution begins?

On 30 May 2014 the Italian Parliament approved a new law regarding forensic psychiatric hospitals. Forensic psychiatric hospitals are facilities that admit individuals who have committed a criminal offence but lack criminal responsibility because of a mental disorder and are deemed as dangerous to public safety. Here we report the key aspects of the new legislation together with some critical considerations.

Parent skills training for parents of children or adults with developmental disorders: systematic review and meta-analysis protocol.

INTRODUCTION: Developmental disorders, including intellectual disability and autism spectrum disorders, may limit an individual's capacity to conduct daily activities. The emotional and economic burden on families caring for an individual with a developmental disorder is substantial, and quality of life may be limited by a lack of services. Therefore, finding effective treatments to help this population should be a priority. Recent work has shown parent skills training interventions improve developmental, behavioural and family outcomes. The purpose of this review protocol is to extend previous findings by systematically analysing randomised controlled trials of parent skills training programmes for parents of children with developmental disorders including intellectual disabilities and autism spectrum disorders and use meta-analytic techniques to identify programme components reliably associated with successful outcomes of parent skills training programmes. METHODS AND ANALYSIS: We will include all studies conducted using randomised control trials designs that compare a group of parents receiving a parent skills training programme to a group of parents in a no-treatment control, waitlist control or treatment as usual comparison group. To locate studies, we will conduct an extensive electronic database search and then use snowball methods, with no limits to publication year or language. We will present a narrative synthesis including visual displays of study effects on child and parental outcomes and conduct a quantitative synthesis of the effects of parent skills training programmes using meta-analytic techniques. ETHICS AND DISSEMINATION: No ethical issues are foreseen and ethical approval is not required given this is a protocol for a systematic review. The findings of this study will be disseminated through peer-reviewed publications and international conference presentations. Updates of the review will be conducted, as necessary, to inform and guide practice. TRIAL REGISTRATION NUMBER: PROSPERO (CRD42014006993).

Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

BACKGROUND: Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. METHODS: Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). RESULTS: There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. CONCLUSION: Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no 'spillover' effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation.

Paroxetine versus other anti-depressive agents for depression.

BACKGROUND: Paroxetine is the most potent inhibitor of the reuptake of serotonin of all selective serotonin reuptake inhibitors (SSRIs) and has been studied in many randomised controlled trials (RCTs). However, these comparative studies provided contrasting findings and systematic reviews of RCTs have always considered the SSRIs as a group, and evidence applicable to this group of drugs might not be applicable to paroxetine alone. The present systematic review assessed the efficacy and tolerability profile of paroxetine in comparison with tricyclics (TCAs), SSRIs and newer or non-conventional agents. OBJECTIVES: 1. To determine the efficacy of paroxetine in comparison with other anti-depressive agents in alleviating the acute symptoms of Major Depressive Disorder.2. To review acceptability of treatment with paroxetine in comparison with other anti-depressive agents.3. To investigate the adverse effects of paroxetine in comparison with other anti-depressive agents. SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialized Register (CCDANCTR, to 30 September 2012), which includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). Reference lists of relevant papers and previous systematic reviews were handsearched. Pharmaceutical companies marketing paroxetine and experts in this field were contacted for supplemental data. SELECTION CRITERIA: All randomised controlled trials allocating participants with major depression to paroxetine versus any other antidepressants (ADs), both conventional (such as TCAs, SSRIs) and newer or non-conventional (such as hypericum). For trials which had a cross-over design, only results from the first randomisation period were considered. DATA COLLECTION AND ANALYSIS: Two review authors independently checked eligibility and extracted data using a standard form. Data were then entered in RevMan 5.2 with a double-entry procedure. Information extracted included study and participant characteristics, intervention details, settings and efficacy, acceptability and tolerability measures. MAIN RESULTS: A total of 115 randomised controlled trials (26,134 participants) were included. In 54 studies paroxetine was compared with older ADs, in 21 studies with another SSRI, and in 40 studies with a newer or non-conventional antidepressant other than SSRIs. For the primary outcome (patients who responded to treatment), paroxetine was more effective than reboxetine at increasing patients who responded early to treatment (Odds Ratio (OR): 0.66, 95% Confidence Interval (CI) 0.50 to 0.87, number needed to treat to provide benefit (NNTb) = 16, 95% CI 10 to 50, at one to four weeks, 3 RCTs, 1375 participants, moderate quality of evidence), and less effective than mirtazapine (OR: 2.39, 95% CI 1.42 to 4.02, NNTb = 8, 95% CI 5 to 14, at one to four weeks, 3 RCTs, 726 participants, moderate quality of evidence). Paroxetine was less effective than citalopram in improving response to treatment (OR: 1.54, 95% CI 1.04 to 2.28, NNTb = 9, 95% CI 5 to 102, at six to 12 weeks, 1 RCT, 406 participants, moderate quality of evidence). We found no clear evidence that paroxetine was more or less effective compared with other antidepressants at increasing response to treatment at acute (six to 12 weeks), early (one to four weeks), or longer term follow-up (four to six months). Paroxetine was associated with a lower rate of adverse events than amitriptyline, imipramine and older ADs as a class, but was less well tolerated than agomelatine and hypericum. Included studies were generally at unclear or high risk of bias due to poor reporting of allocation concealment and blinding of outcome assessment, and incomplete reporting of outcomes. AUTHORS' CONCLUSIONS: Some possibly clinically meaningful differences between paroxetine and other ADs exist, but no definitive conclusions can be drawn from these findings. In terms of response, there was a moderate quality of evidence that citalopram was better than paroxetine in the acute phase (six to 12 weeks), although only one study contributed data. In terms of early response to treatment (one to four weeks) there was moderate quality of evidence that mirtazapine was better than paroxetine and that paroxetine was better than reboxetine. However there was no clear evidence that paroxetine was better or worse compared with other antidepressants at increasing response to treatment at any time point. Even if some differences were identified, the findings from this review are better thought as hypothesis forming rather than hypothesis testing and it would be reassuring to see the conclusions replicated in future trials. Finally, most of included studies were at unclear or high risk of bias, and were sponsored by the drug industry. The potential for overestimation of treatment effect due to sponsorship bias should be borne in mind.