Estimating the prevalence of depression associated with healthcare use in France using administrative databases.

BACKGROUND: Quantitative indicators are needed in order to define priorities, plan policies and evaluate public health interventions in mental health. The aim of this study was to assess the contribution of a large and exhaustive French national administrative database to study and monitor treated depression by comparing the prevalence and characteristics of the population using significant healthcare resources for depression as identified by different estimation methods and sources and to discuss the advantages and drawbacks of these methods. METHODS: This study included the French population covered by the main health insurance scheme in 2012 (Régime général, 86% of the insured French population). Data were extracted from the French health insurance claim database (SNIIRAM), which contains information on all reimbursements, including treatments and hospital stays in France. The following distinct sources of the SNIIRAM were used to select persons with depression: diagnoses of long-term or costly conditions, data from national hospital claims and data concerning all national health insurance reimbursements for drugs. RESULTS: In 2012, we included 58,753,200 individuals covered by the main health insurance scheme; 271,275 individuals had full coverage for depression; 179,470 individuals had been admitted to a psychiatric hospital and 66,595 individuals admitted to a general hospital with a diagnosis of depression during a 2-year timeframe and 144,670 individuals had more than three reimbursements for antidepressants during the study year (with a history of hospitalisation for depression during the past 5 years). Only 16% of individuals were selected by more than one source. CONCLUSIONS: We propose an algorithm that includes persons recently hospitalised for depression, or with a history of hospitalisation for depression and still taking antidepressants, or with full coverage for depression as a specific long-term or costly condition, yielding a prevalence estimate of 0.93% or 544,105 individuals. Changes in the case selection methodology have major consequences on the frequency count and characteristics of the selected population, and consequently on the conclusions that can be drawn from the data, emphasizing the importance of defining the characteristics of the target population before the study in order to produce relevant results.

Cohort of one million patients initiating antidepressant treatment in France: 12-month follow-up.

AIMS: Previous studies have shown that the recommended minimum 6-month period for antidepressant treatment is actually observed for only a minority of patients. The objectives of this study were to characterise patients with newly prescribed antidepressant treatment in France and identify factors possibly associated with insufficient duration of treatment or the occurrence of certain events such as sick leave, hospitalisations and suicide attempts. METHODS: Data were extracted from the French health insurance database (SNIIRAM) and the national hospitalisation database (PMSI) for patients covered by the main French health insurance scheme representing 75% of the French population. Patients were included if they had a newly prescribed antidepressant in 2011, but no prior psychiatric diagnosis identified in the databases and no significant psychiatric medication (such as antipsychotic or mood stabiliser) in 2009-2010. RESULTS: A total of 998 710 patients (2% of the overall population), with a mean age of 50 years and 66% of females, initiated an antidepressant in 2011, which was prescribed by a general practitioner in 89% of cases. Five generic names, including three selective serotonin reuptake inhibitors, accounted for 75% of first prescriptions. Only one reimbursement was observed for 40% of patients. Treatment duration was less than 6 months for more than 80% of patients, more frequently for low income earners, and varied according to age, gender and region. The median time lag between first visit and antidepressant initiation was 27 days. Hospitalisation related to a psychiatric disease over the following 12 months was observed for 3% of patients. CONCLUSION: Duration of treatment and follow-up were both insufficient for the majority of French patients initiating antidepressant treatment in 2011, which may reflect poor quality of care for people with mood or anxiety disorders, possibly because of overdiagnosis and inappropriate drug treatment, or poor adherence and side effects, or poor follow-up.

Homeopathy in France in 2011-2012 according to reimbursements in the French national health insurance database (SNIIRAM).

BACKGROUND: The use of homeopathic medicine is poorly described and the frequency of combined allopathic and homeopathic prescriptions is unknown. OBJECTIVE: To analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance. METHODS: The French national health insurance databases (SNIIRAM) were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012. RESULTS: A total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period, i.e. 10.2% of the overall population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements. A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Allopathic medicines were coprescribed with 55% of homeopathic prescriptions. CONCLUSION: Many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines.

Prevalence and incidence of systemic lupus erythematosus in France: a 2010 nation-wide population-based study.

To date, only a small number of studies have examined the epidemiology of systemic lupus erythematosus (SLE) on a nation-wide basis. We used French national administrative databases to analyze the nation-wide prevalence and incidence rates of SLE within the largest French health insurance scheme, which covers 86% of the population (almost 58,200,000 individuals). Patients with SLE were identified if they had full coverage for a chronic disease with a code (ICD-10th M32) in the health insurance information system, or if they had a SLE code in the hospital discharge database as a primary or secondary diagnosis in 2010. We defined incident cases as patients who had a new long-term disease diagnosis of SLE in 2010. Overall, 27,369 individuals were identified as having SLE, of whom 88% were female. The crude 2010 prevalence of identified SLE was 47.0/100,000, and the WHO age-standardized rate was 40.8/100,000. The crude 2010 annual incidence of SLE was 3.32 cases per 100,000 with peaks in females aged 30-39 years old (9.11/100,000) and in males aged 50-59 years old (1.78/100,000). Major differences in regional age-standardized prevalence rates were observed, with the highest rates in the Caribbean oversea areas (up to 126.7/100,000), and the lowest rates in north-western metropolitan territories (down to 29.6/100,000). This is the largest nation-wide population-based study of SLE patients to date, based on more than 58 million beneficiaries of the French health insurance system. These data and subsequent analyses provide guidance to both clinicians and policymakers for improving care of SLE.

Does insulin glargine increase the risk of cancer compared with other basal insulins?: A French nationwide cohort study based on national administrative databases.

OBJECTIVE: To explore in France the relationship between insulin glargine use and overall and specific cancer risks in type 2 diabetic patients compared with other basal insulins. RESEARCH DESIGN AND METHODS: Data were extracted from French health insurance information system (Système National d'Information Inter-Régimes de l'Assurance Maladie) linked with data from the French Hospital Discharge database (Programme de Médicalisation des Systèmes d'Information). Included were 70,027 patients aged 40-79 years who started a basal insulin in 2007-2009. Cox proportional hazards models with age as time-scale were used to calculate multivariate-adjusted hazard ratios for associations between type of basal insulin and risk of overall cancer, breast cancer, and seven other cancer sites. RESULTS: The median follow-up was 2.67 years in patients exposed to insulin glargine. Absolute event rates for all cancer in patients exposed to glargine versus other basal insulin users were 1,622 and 1,643 per 100,000 person-years, respectively. No significant association was observed between glargine exposure and overall cancer incidence after adjustment for sex, with a hazard ratio of 0.97 (95% CI 0.87-1.07), or after additional adjustment for any other hypoglycemic agent use and duration of diabetes. No increased risk of breast cancer was observed for glargine users compared with other basal insulins users, with a fully adjusted hazard ratio of 1.08 (0.72-1.62). CONCLUSIONS: In a large cohort of patients newly treated by basal insulin, no increased risk of any cancer was observed in insulin glargine users compared with other basal insulin users. Because follow-up did not exceed 4 years, longer-term studies are needed.

Improving the managed entry of new medicines: sharing experiences across Europe.

The 3-day course on the managed entry of new medicines was run by the Piperska group, which is a pan-European group striving to enhance the health of the public as a whole and the individual patient through exchanging ideas and research around the rational use of drugs. Participants included health authority and health insurance personnel, academics and those from commercial organizations. The principal aim of the conference was to bring together people to discuss ways to improve the managed entry of new drugs.

HPV vaccination in France: uptake, costs and issues for the National Health Insurance.

INTRODUCTION: Two vaccines for primary prevention of cervical cancer are available in France, Gardasil® and Cervarix®, since 2007 and 2008 respectively. Currently, the French guidelines indicate vaccination of girls aged 14 with a catch-up program for females from 15 to 23 years old. In France, the reimbursement rate for these vaccines is 65% of the vaccine price, resulting in Gardasil® being the fifth highest drug expenditure of the main scheme of the French National Health Insurance in 2008. The purpose of this study is to provide data on vaccination coverage and costs in France until 31 December 2009. In addition, the current vaccination coverage rate is compared with the coverage rates assumed in cost-effectiveness studies. METHODS: Data were extracted from the National Health Insurance Information System (SNIIRAM). The SNIIRAM records all reimbursements of medical costs to patients--including drugs--by the French public Health Insurance Schemes since 2004. The analysis was performed for the period of July 2007 until December 2009 using the data of the general scheme of National Health Insurance covering about 88% of the French population, i.e., 56.5 million people. Vaccination rates for one or three doses were determined for the target and catch-up population using the 2009 reference population from the general health insurance scheme as the denominator. RESULTS: The cumulative number of doses reached 2,900,000 at the end of 2009. About 1,200,000 girls and young women have been reimbursed for at least one vaccine dose, of these 96.5% females aged 14-23 years. Among the target group, reimbursement for at least one dose remained low, from 50.8% for girls aged 14 years in 2007 to 41.7% and 20.5% for girls aged 14 years in 2008 and 2009 respectively. In terms of complete vaccination, only 33.3% of girls of the age of 14 years in 2007 and 23.7% in 2008 were reimbursed for 3 doses of HPV vaccine. The maximum uptake in the catch-up group for both 1 and 3 doses was observed for women born in 1992 (15 years in 2007) with 52.5% and 35.6% respectively. CONCLUSION: Low rates of coverage have been observed both in the target and catch-up groups in France. Considering this, the cost-effectiveness of vaccination in combination with opportunistic screening or organized screening needs to be re-evaluated.

Benfluorex and valvular heart disease: a cohort study of a million people with diabetes mellitus.

PURPOSE: To evaluate and quantify in diabetic patients treated with benfluorex in France, a fenfluramine-derivated product, a possible increase in risk of valvular heart disease, previously suggested by several published case reports. METHODS: This was a French comparative cohort study using data from two large national linked databases, health insurance system (SNIIRAM) and hospitalization (PMSI). Patients aged 40-69 years with reimbursement for oral antidiabetic and/or insulin in 2006 were eligible. Exposed patients were defined as patients with at least one benfluorex reimbursement in 2006. Selected admission diagnoses of interest in 2007 and 2008 PMSI databases were valvular insufficiency for any cause, mitral insufficiency, aortic insufficiency, and valvular replacement surgery with cardiopulmonary bypass. Relative risks (RR) were adjusted on gender, age, and history of chronic cardiovascular disease. RESULTS: A total of 1,048173 diabetic patients were included, with 43,044 (4.1%) exposed to benfluorex. The risk of hospitalization in 2007 and 2008 for any cardiac valvular insufficiency was higher in the benfluorex group: crude RR=2.9 [95% confidence interval 2.2-3.7] and adjusted RR=3.1 [2.4-4.0], with a lower risk for patients with lower cumulative dose of benfluorex. Adjusted RR for mitral insufficiency and aortic insufficiency admissions were 2.5 [1.9-3.7] and 4.4 [3.0-6.6], respectively. Adjusted RR for valvular replacement surgery was 3.9 [2.6-6.1]. CONCLUSIONS: Benfluorex in diabetic patients was significantly associated with hospitalization for valvular heart disease in the 2 years following benfluorex exposure. Linkage between SNIIRAM and PMSI databases is in France a valuable tool to quantify the risk of serious adverse drug reactions.

Stevens-Johnson syndrome and toxic epidermal necrolysis induced by amifostine during head and neck radiotherapy.

Amifostine is an organic thiophosphate prodrug used for cytoprotection against toxic effects of radiotherapy and chemotherapy. In a European prospective study of SJS/TEN, six patients were suspected to have SJS/TEN associated with amifostine. Our findings suggest that the risk of life-threatening cutaneous adverse reactions to amifostine could be significantly increased.

Allopurinol is the most common cause of Stevens-Johnson syndrome and toxic epidermal necrolysis in Europe and Israel.

BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous adverse reactions. OBJECTIVES: We sought to update knowledge on the causes of SJS or TEN with a focus on the rate of allopurinol-associated cases and to identify risk factors for allopurinol-associated SJS or TEN. METHODS: We conducted a multinational case-control study. RESULTS: In all, 379 patients with severe cutaneous adverse reactions validated as SJS or TEN and 1505 matched hospitalized control subjects were enrolled. Allopurinol was the drug most frequently associated with SJS or TEN, with 66 exposed patients (17.4%) and 28 exposed control subjects (1.9%) (adjusted odds ratio = 18, 95% confidence interval: 11-32). Allopurinol use was greater than in a previous case-control European study. Daily doses equal to or greater than 200 mg were associated with a higher risk (adjusted odds ratio = 36, 95% confidence interval: 17-76) than lower doses (adjusted odds ratio = 3.0, 95% confidence interval: 1.1-8.4). The risk was restricted to short-term use (

Effects of treatments on the mortality of Stevens-Johnson syndrome and toxic epidermal necrolysis: A retrospective study on patients included in the prospective EuroSCAR Study.

BACKGROUND: No treatment modality has been established as standard for patients with Stevens-Johnson syndrome and toxic epidermal necrolysis. OBJECTIVE: We sought to evaluate the effect of treatment on mortality in a large cohort of patients with Stevens-Johnson syndrome or toxic epidermal necrolysis. METHODS: Data on therapy were retrospectively collected from patients in France and Germany enrolled in EuroSCAR, a case-control study of risk factors. RESULTS: Neither intravenous immunoglobulins nor corticosteroids showed any significant effect on mortality in comparison with supportive care only. Compared with supportive care, odds ratios for death were 1.4 (95% confidence interval: 0.6-4.3) for intravenous immunoglobulins in France and 1.5 (0.5-4.4) in Germany, and 0.4 (0.1-1.7) for corticosteroids in France and 0.3 (0.1-1.1) in Germany. LIMITATIONS: Such an observational study with retrospective data collection has obvious limitations, including heterogeneity between the countries, supportive care, treatment doses, and durations. CONCLUSIONS: We found no sufficient evidence of a benefit for any specific treatment. The trend for a beneficial effect of corticosteroids deserves further exploration.

Medication sales and syndromic surveillance, France.

Although syndromic surveillance systems using nonclinical data have been implemented in the United States, the approach has yet to be tested in France. We present the results of the first model based on drug sales that detects the onset of influenza season and forecasts its trend. Using weekly lagged sales of a selected set of medications, we forecast influenzalike illness (ILI) incidence at the national and regional level for 3 epidemic seasons (2000-01, 2001-02, and 2002-03) and validate the model with real-time updating on the fourth (2003-04). For national forecasts 1-3 weeks ahead, the correlation between observed ILI incidence and forecast was 0.85-0.96, an improvement over the current surveillance method in France. Our findings indicate that drug sales are a useful additional tool to syndromic surveillance, a complementary and independent source of information, and a potential improvement for early warning systems for both epidemic and pandemic planning.