Gaps in Accessibility of Pediatric Formulations: A Cross-Sectional Observational Study of a Teaching Hospital in Northern Thailand

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.

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

“…From primary health services in Indonesia, pediatric patients aged 0–5 years (74.33%) mostly receive extemporaneous preparations, the majority of which are divided powders (88.36%) and oral suspensions (8.06%) [ 24 ]. In Thailand, 73.5% of pediatric patients receive off-label drugs [ 25 ]. In Brazil, newborns admitted to the neonatal care unit (NCU) also receive compound preparations [ 26 ].…”

“…The risks of drug compounding include formula failure, microbial contamination, calculation errors, patient acceptance issues, health and safety risks, therapeutic risks, clinical consequences, and factors related to clinical risk [ 18 ]. During the drug compounding process, grinding, diluting, adding additional ingredients, etc., errors that affect the efficacy and safety as well as patient acceptance, can occur [ 25 ]. The previous study observed variations in the extemporaneous glucocorticoid for asthma therapy in children.…”

Development and evaluation of an assessment of the age-appropriateness/inappropriateness of formulations used in children

“…The tool uses reports of direct observation of attempted/successful administration to confirm and thus expand upon the ages of children and reasons why a medicine may either be classified as AaF or AiF [ 23 , 27 – 29 ]. The classification ‘Maybe age-appropriate’ indicates that the DF was either authorised but used OL or was an UL medicine.…”

Evaluation of the type and frequency of extemporaneous formulations dispensed in hospital and community pharmacies

“…3 Although commercially available medicines meet the therapeutic needs of most patients, lack of appropriate dosage forms, doses or strengths for certain patient groups is not uncommon. 4 , 5 , 6 , 7 , 8 Notably, extemporaneously compounded medications are more frequently required in the pharmaceutical care of paediatric and geriatric patients. In the case of paediatric patients, licensed formulations may be unavailable.…”