Methods for controlling by indication for prescriptions: application to medications for neuropathic pain

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX12) gabapentin

  gabapentin

  (N03AX16) pregabalin

  pregabalin
• Medical condition to be studied:
  Neuralgia

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  6800000

Study design details

• Main study objective:
  1. to develop a general conceptual framework to disentangle the different indications of medications in large healthcare data sources. 2.to characterize the prescription pattern of medications used to treat neuropathic pain among women of childbearing age and pregnant women 3.to assess the association between prenatal exposure to neuropathic pain medications and adverse pregnancy outcomes.
• Outcomes:
  major congenital anomalies, stillbirth, preterm birth, low birth weight, small for gestational age, long-term neurodevelopmental outcomes
• Data analysis plan:
  Drug utilisation study: prevalence of medications of interest prescribed among women of childbearing age and among pregnant women, stratified by age, calendar year, data sources, and indication for prescribing Drug safety study: - cohort study : comparing “exposed” and “comparison” women. The analyses will be carried out using multivariate logistic regression, and survival analysis, depending on the outcome of interest to calculate unadjusted and adjusted odds ratios (ORs) and hazard ratios (HRs), along with 95% confidence intervals (CI). Advanced confounder adjustment methods (such as propensity score methods) might be used when appropriate to further mitigate measured confounding. - case-malformed control study using data from EUROmediCAT. We will conduct an exploratory analysis in which, for each analysis, we will consider a single EUROCAT subgroup of congenital anomaly to be the “case” group, excluding those with chromosomal conditions. Logistic regression will be used.