Abstract
The lack of appropriate medicines for children has a significant impact on health care practices in various countries around the world, including Thailand. The unavailability of pediatric medicines in hospital formularies causes issues regarding off-label use and extemporaneous preparation, resulting in safety and quality risks relating to the use of medicines among children. This research aimed to identify missing pediatric formulations based on the experience of healthcare professionals in a teaching hospital in northern Thailand. A cross-sectional survey was conducted to collect data on missing pediatric formulations, the reasons for their inaccessibility, their off-label uses, their reactions to the situation, and suggestions to improve access to these identified medications. The survey was distributed to all physicians, nurses, and pharmacists involved in prescribing, preparing, dispensing, and administering pediatric medicines. A total of 218 subjects responded to the survey. Omeprazole, sildenafil, and spironolactone suspension were most often identified as missing formulations for children by physicians and pharmacists. They are unavailable on the Thai market or in any hospital formulary. For nurses, sodium bicarbonate, potassium chloride, and chloral hydrate were the most problematic formulations in terms of preparation, acceptability, and administration. These medicines were difficult to swallow because of their taste or texture.
Highlights
The lack of medicine formulations suitable for children is a global problem, in developing countries with fewer healthcare resources [1]
Pediatricians and pharmacists were asked about needed but unavailable medicines in the hospital formulary, the off-label use of medicines, and medicines considered problematic in terms of the difficulty for prescribers to determine the right dosage, their acceptability to children, and the complexity of their preparation or administration by caregivers
Many important medicines are prepared as extemporaneous products with a short shelf-life and questionable levels of acceptability
Summary
The lack of medicine formulations suitable for children is a global problem, in developing countries with fewer healthcare resources [1]. A study in Korea, for example, found that prescribing off-label/unlicensed medicines was independently associated with adverse drug events in pediatric patients [5]. The US Food and Drug Administration and the European Medicine Agency have developed guidelines emphasizing the need for specific medications for pediatric patients, the need to reduce off-label use, and the importance of the acceptability and appropriate use of pediatric drugs [6]. These efforts have resulted in a sharp increase in the number of pediatric drug studies in Europe and the US. Pharmacodynamics may differ due to differences in drug receptors, which explains the variation between children and adults in terms of the efficacy and/or safety of medicines [1,5]
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