The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member countries and manufacturers in assessing and developing these medicines.
The document focuses on specific areas of attention and is not meant to address « general regulatory principles, » according to WHO. Additionally, it does not cover extemporaneous preparations and compounding, which are covered in a separate guidance.
Due to a lack of suitable formulations for pediatric patients, pharmacists, healthcare professionals, parents, and caregivers often need to modify adult medications in ways not specified in the Summary of Product Characteristics (SmPC) or product labeling, according to the document. These modifications can include breaking, crushing, or cutting tablets. WHO said the risks associated with manipulating dosage forms for children have been documented over “many decades.”…
