Abstract
Background: Unlicensed medication use (off label use) is common in pediatrics practice. There are more than 75% of drugs which approved for using in adults, data of efficacy and safety in pediatric population is not completely available, and missed data might be due to some reasons mainly ethical consideration. Our study aimed to assess practicing of using of unlicensed medication in pediatrics at major tertiary care hospital in Saudi Arabia.
Methods: A retrospective review of pediatrics prescriptions that were prescribed as unlicensed medication use by collection of all unlicensed use forms that known as form B which approved by pharmacy and therapeutics (P&T) committee at Prince Sultan Military Medical city (PSMMC). Data collection stared from January 2018 until the end of 2020. Children up to 14 years of age and administered at least one medication were eligible to participate in the study.
Results: The total collected off label prescriptions (both in and out patients) was 128 from January 2018 till end of 2020. Prescription for females were 39.84% while their male counterparts were 60.16%. Ophthalmology, Oncology and both Otorhinolaryngology and general pediatrics were the most frequent specialties prescribed unlicensed medications by 34.38%, 19.53% and 8.59% respectively. Overall, unlicensed medicine use was highest (33.6%) for products belong to monoclonal antibodies class. Surgical intervention was the commonest indication for using unlicensed medication (35.94%) followed by infectious diseases treatment (14.06%). Represented as the cumulative off-label frequency percentage, the most common reason of off-label use was by indication (35.94%), frequency (33.18%), Dose (19.82%), while for the route was almost (11.06%). The highest frequency of off label prescriptions according to pharmacological class split by gender and age category showed significance level of 0.045 in males and 0.001 in infants respectively.
Conclusion: Class variability of unlicensed medications in this study, sought us to confirm that physician using this therapeutic option yet ethically, but in a disorganized manner. Thus, prescribing unlicensed drugs specifically in pediatric needs to be better validated by current and new evidence. The findings of this study call for further research across the kingdom to start off label legislation process under SFDA authority. Current off-label dosage amounts pose concerns about drug safety exceptionally in children.