Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling.

OBJECTIVE: This study aimed to compare the approval of medicines for attention deficit/hyperactivity disorder (ADHD) for pediatric patients across five countries. METHOD: A document analysis was completed, using the drug labeling for ADHD medicines from five countries; United Kingdom, Australia, New Zealand, Canada and United States (US). Comparisons of available formulations and approval information for ADHD medicine use in pediatric patients were made. RESULTS: The US had the highest number of approved medicines and medicine forms across the studied countries (29 medicine forms for 10 approved medicines). Approved age and dosage variations across countries and missing dosage information were identified in several drug labeling. CONCLUSIONS: The discrepancies in approval information in ADHD medicine drug labeling and differing availability of medicine formulations across countries suggest variations in the management of ADHD across countries. The update of drug labeling and further research into reasons for variability and impact on practice are needed.

Rates of psychotropic medicine prescribing in paediatric populations in Australian general practice from 2000-2016.

General practitioner (GP) prescribing of psychotropic medicines to paediatric patients is increasing across countries, sparking the need for additional research into this field. We examined prescribing rates, GP and patient characteristics and indications associated with prescribing psychotropic medicines to paediatric patients in Australian general practice, using data from the Bettering the Evaluation and Care of Health (BEACH) program. We extracted all encounters with children aged 3 to 17 from 2000 to 2016. Psychotropic medicines were defined as those in the ATC codes N05 (Psycholeptics) and N06 (Psychoanaleptics). Of the 144,397 encounters, GPs prescribed 1829 psychotropic medicines to paediatric patients at an average rate of 1.16 prescriptions per 100 encounters (95% confidence interval 1.09-1.23). We found that the rate of psychotropic medicines prescribed to paediatric patients in Australian general practice increased. Patients who were adolescent, female, socio-economically disadvantaged or from an English-speaking background were significantly more likely to be prescribed a psychotropic medicine. GP practices in remote or regional areas and Australian graduate GPs were more likely to prescribe psychotropic medicines to paediatric patients. Depression, attention deficit hyperactivity disorder, anxiety and autism were the most common psychiatric indications managed with psychotropic medicines. Antidepressants, psychostimulants, benzodiazepines, antipsychotics and other psychotropic medicines were prescribed, signifying a high rate of off-label use. Sertraline was the most common psychotropic medicine prescribed, followed by fluoxetine and methylphenidate. Future studies involving data from other prescribers, e.g. paediatricians and psychiatrists, and studies linking prescribed medicines to their indications may widen our understanding of psychotropic medicine prescribing in Australian paediatric patients.

An International Comparison of the Information in the Regulatory-Approved Drug Labeling and Prescribing Guidelines for Pediatric Depression.

Objectives: To determine the differences in information between prescribing guidelines and drug labeling, as well as to compare the approval of psychotropic medicines for major depression in pediatric patients ("pediatric depression") across countries. Methods: The recommendations of The Maudsley Prescribing Guidelines in Psychiatry (MPGP) for the treatment of pediatric depression (<18 years) were compared against the regulatory-approved drug-labeling documents from the United Kingdom, Australia, New Zealand, Canada, and the United States. The use of medicines outside of their regulatory approval is defined as off-label use, so differences between the drug labeling and MPGP were characterized according to unapproved age, indication, dosage, or route of administration. Information in the drug labeling was also compared across countries. Results: MPGP provides recommendations for 6 medicines for the treatment of pediatric depression, for which, 30 drug labeling were retrieved. Three of 30 drug labeling were consistent with MPGP recommendations (fluoxetine in the United Kingdom, fluoxetine and escitalopram in the United States). Differences in information between MPGP and the drug labeling were identified in 26 of 30 drug labeling analyzed, most often due to age (24/26) followed by indication (2/26). No differences pertaining to dosage or route of administration information were identified. The number of approved psychotropic medicines varied across the studied countries and we found cross-country discrepancies in information in the drug labeling. Conclusion: Significant differences in information exists between MPGP and the drug labeling for psychotropic medicines for pediatric depression, due to unapproved ages or indications. Additionally, approval information in the drug labeling are not consistent across countries. Further research into reasons for variability and impact on practice may be warranted.