Classification status of drugs generally used for self-medication in children: a targeted review of regulatory documents

Background: Self-medication given by parents or caregivers is a common practice among children. Several frequently used drugs are often administered without professional supervision. This study compares regulatory classifications of common paediatric self-medication drugs across ten countries, aiming to uncover trends based on product type and national policies. Methods: Data were primarily collected from official drug regulatory agency websites and supplemented from other relevant sources. Twelve widely used drugs were reviewed, by focusing on classification status, approved indications, and paediatric age restrictions. Content and comparative analyses were conducted. Results: The findings revealed that drugs indicated for fever, pain, mucolytic effects, and non-sedating antihistamines were mostly classified as non-prescription. For drugs with the same active ingredient, but different strengths or dosage forms, compared within the same country, the classification status generally remained unchanged, even across different paediatric age groups. Drugs for asthma and topical corticosteroids were likely to be classified as prescription drugs. In some countries, such as the United Kingdom, Australia, and Singapore, the same drug preparation had different classification statuses which were based on factors such as approved indication and pack size. Additionally, Singapore and Indonesia implement prescription-exemption systems. These allow supply of certain prescription drugs without a prescription under specific conditions. Conclusion: Commonly used drugs for paediatric self-medication are classified as both non-prescription and prescription. This reflects diverse regulatory approaches across countries. Regulators play a key role in ensuring safe use of self-medication in children. Lack of harmonisation address a critical need for globally consistent paediatric drug classification scheme. They empower consumers through mechanisms such as clear, accessible patient information leaflets and other educational tools.