Prescribing trends in pediatric outpatients

Study type
Protocol
Date of Approval
Study reference ID
19_141
Lay Summary

Exploring and following medication prescribing trends among children and adolescents provides crucial insight into important public health issues, such as shifting disease burden and changes in access to health services. Children and adolescents comprise an understudied population; they are usually excluded from clinical trials, and although they comprise 27% of the population, only 17% of registered clinical trials involve children. The study of medication use in children is particularly important as these are critical times of development and growth and medication use in these populations is often outside the specification of the medication license. In addition, medications may have substantially different safety profiles in these patients compared to adults. Despite these facts, anecdotally, medications are increasingly prescribed in children and adolescents.

To ensure children’s health and to promote the safe use of medications in this population, there is a pressing need to describe the prescribing patterns of drugs. A utilization study of prescribing patterns over the last 20 years may assist in identifying safety signals and direct research resources towards crucial pediatric health issues. To do this, we will use the Clinical Practice Research Datalink (CPRD). We will calculate annual prescription rates of drugs of different pharmacological categories in children and adolescents. We will also specifically examine prescribing trends for the following four medications: 1) proton pump inhibitors (PPIs) for gastroesophageal reflux disease (GERD), 2) central nervous system (CNS) stimulants and drugs used for attention deficit hyperactivity disorder (ADHD), 3) antipsychotics for psychiatric disorders, and 4) metformin for metabolic abnormalities.

Technical Summary

Pediatric patients are a heterogeneous population, ranging from preterm new-borns to post-pubertal adolescents. They are considered to be more vulnerable due to physiological differences in pharmacokinetics and pharmacodynamics. Over the last decades, there has been an increase in the prescribing of drugs due to the discovery of new drugs, progress in and survival following pediatric surgery, and changes in clinical guidelines. In addition, there has been an increase in the prevalence of childhood diseases, such as gastrointestinal diseases, neurodevelopmental disorders, and obesity. Given these population-level changes and changes in clinical practice, there is an urgent need to examine prescription drug use in this understudied yet vulnerable population. We will therefore conduct a population-based longitudinal study examining pediatric prescribing patterns in the CPRD between 1998-2019.

The primary endpoint will be annual prescription rates for drugs classified according to British National Formulary (BNF) sections. We will estimate each annual prescription rate and corresponding 95% confidence interval (CIs) using Poisson regression overall and in subgroup analyses defined by age, sex, and index of multiple deprivation categories. Secondary endpoints will include annual prescription rates for proton pump inhibitors (PPIs), central nervous system (CNS) stimulants and drugs used for ADHD, antipsychotics, and metformin. We will specifically examine prescribing trends for the first three categories due to concerns regarding potential adverse effects reported in the literature and to facilitate planning subsequent safety studies regarding these medications. We will examine prescribing trends for metformin due to the increase in the worldwide prevalence obesity among children. A study examining prescribing patterns will provide crucial information on changing prescribing trends among pediatrics. This information may assist us in exploring future safety concerns of medications commonly used in pediatrics and identify medications that require post-marketing surveillance in this vulnerable population.

Health Outcomes to be Measured

Primary:
1. Annual prescription rate of 20 commonly prescribed medication groups, classified by BNF section between 1998 and 2019
2. Total number of yearly prescriptions between 1998 and 2019
Secondary:
1. Prescription rate of PPIs
2. Prescription rate of CNS stimulants and drugs used for ADHD
3. Prescription rate of antipsychotic drugs
Prescription rate of metformin

Collaborators

Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
Claire Lefebvre - Collaborator - McGill University
Ke Meng - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Reem Masarwa - Collaborator - McGill University
Robert Platt - Collaborator - McGill University

Linkages

Practice Level Index of Multiple Deprivation