Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India

Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary.Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression.Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI;P<0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI;P<0.001).Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.

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Off-label use of tamoxifen in a Chinese tertiary care hospital

International Journal of Clinical Pharmacy ◽

10.1007/s11096-019-00788-5 ◽

2019 ◽

Vol 41 (2) ◽

pp. 555-562

Author(s):

Jianhui Yang ◽

Wubin Lin ◽

Yao Chen

Keyword(s):

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Off Label Use ◽

Off Label ◽

Label Use

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Adverse drug reactions to off label use of drugs in spontaneously reported cases at a tertiary care hospital

National Journal of Physiology Pharmacy and Pharmacology ◽

10.5455/njppp.2021.11.07236202115072021 ◽

2021 ◽

pp. 1

Author(s):

Kalpana Dudhal ◽

Neha Kadhe ◽

Sudhir Pawar

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Off Label Use ◽

Drug Reactions ◽

Off Label ◽

Label Use

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Pattern of Use Unlicensed Medication in Pediatrics: A Retrospective Study at Major Tertiary Care Hospital in Saudi Arabia

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i19a31329 ◽

2021 ◽

pp. 61-68

Author(s):

Abdulaziz Alolayan ◽

Basil Almansour ◽

Yasmin Barnawi ◽

Husam Munawar ◽

Saad Almodamegh ◽

...

Keyword(s):

Saudi Arabia ◽

Tertiary Care Hospital ◽

Therapeutic Option ◽

Pediatric Population ◽

Tertiary Care ◽

Medication Use ◽

Care Hospital ◽

Off Label Use ◽

Off Label ◽

Label Use

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.

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