Influence of social deprivation on benzodiazepines and antidepressants drugs dispensing among children and adolescents: a large cross-sectional population-based study in France

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05) PSYCHOLEPTICS

  PSYCHOLEPTICS

  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS

Population studied

• Short description of the study population:
  Inclusion criteria:; Every beneficiary, ages below 18, from the National Healthcare Insurance with the right to access, in one of the three main health insurance schemes (General Regime (RG),; Mutualité Sociale Agricole (MSA) and the Social Regime of Independents (RSI)) from the MidiPyrénées region of France were included, regardless of the age or gender. These 3 main schemes include 87% of the total region’s population.; ; Exclusion criteria:; - Some populations have been excluded due to the differences in the management of the beneficiaries: the local mutual sections for the RG, the grouping of the health insurers of the operators for the MSA and self-employed professions for the RSI; - People who died during the period of interest; - Beneficiaries to whom no IRIS could be allocated (specific codes and data related to more than 50,000 districts, built by the National Institute of Statistics and Economic Studies)
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  540295

Study design details

• Main study objective:
  To assess correlation between the number of benzodiazepines dispensing (anxiolytic and hypnotic drugs) and the European Deprivation Index (EDI).
• Outcomes:
  Correlation between EDI and number of distinct benzodiazepine drugs (ATC: N05) dispensing. Correlation between EDI and number of distinct antidepressant drugs (ATC: N06A) dispensing (in both subgroups of children below 12 and adloescent above 12). Adequacy with guidelines regarding antidepressants drug dispensing patterns.
• Data analysis plan:
  Descriptive analysis. Comparative analyses between groups (depending on EDI assessment, psychotropic drug or mental healthcare use levels) with Chi2 (or exact Fisher tests if not applicable) for categorical variables, and Student’s T test (or non-parametrical test if not applicable) or variances analyses (ANOVA for continuous variables, when relevant). p-value <0.05 will be considered as statistically significant. Univariate analyses (linear regression) of the association between the number of drugs dispensed, for each class of drugs (antidepressants, anxiolytics and hypnotics) and the EDI and other covariates, will be performed. Then, a multivariate analysis (linear regression), will be performed. A multivariate analysis will also be performed on secondary outcomes (antidepressants) and the subgroups of children below and above 12. Sensitivity analyses, regarding association between EDI or HP and levels or number of psychotropic drugs dispensing by classes of drugs.