Are pediatrics taking the prescribed tablet dosage form? Practices of off-label tablet modification in pediatric wards: A prospective observational study

Tablet manipulation (modification) is a practice where the licensed tablet product is customized into reduced fractions of doses or changed into dispersions using solvents because of suitable dose for paediatrics and neonates are frequently unavailable. As a result, unlicensed dosage form frequently used after manipulation, outside what is approved by drug regulatory authorities. Objective: To assess the practice of off-label tablet manipulation in pediatric and neonatal wards at selected public hospitals in Ethiopia.Methods: A prospective, direct observational approach was used to investigate the frequency, nature and appropriateness of tablet manipulations in neonatal and pediatrics patients of two public hospitals of Ethiopia from April 12, to June 30, 2021.Results: During the study period a total of 303 tablet manipulations were observed. Two hundred nine (69%) of tablets were dispensed to pediatric patients to be taken after split into lower strengths. The remaining nighty four (31%) tablets were manipulated into dispersion using 0.9% normal saline as a main solvent. Interestingly, 48 (15.8%) of tablet manipulations into dispersions involved practically insoluble drugs whose manipulation may probably affect their bioavail-ability. In 12.5% (12/94) dispersion manipulations, large undissolved fractions were observed during administration through naso-gastric tubes. The most commonly manipulated tablets were drugs for central nervous system (n = 135, 44.6%) followed by cardiovascular drugs (n = 85, 28%).Conclusions: and recommendations: The study revealed the off-label use of tablets for pediatrics age groups is very common in Ethiopia. Evidence-based guidelines for tablet manipulations should be practiced to improve the safety of paediatric drug use. As for policy implication, this study concurs with previous scientific recommendations that manufacturers introduce a wide range of dosage forms to reduce the need for manipulations.

Automated summary

Off-label tablet manipulation is a common practice in pediatric and neonatal wards in Ethiopia. This study emphasizes the need for evidence-based guidelines and a wider range of dosage forms to ensure the safety of pediatric drug use.