Off-label drug use in pediatric wards: a prospective study in a tertiary care hospital in Pune

Vohra, Faizal; Pawar, Sanjay

doi:10.4103/1687-4315.190400

Cited by 2 publications

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References 2 publications

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“…A stark similarity between our study and the other studies on is that salbutamol and ondansetron are often prescribed in an off label way . Manufacturers of these drugs must take note of these studies so as to bring about a change in their labelling specifications.…”

Section: Discussionsupporting

confidence: 57%

“…[2] A stark similarity between our study and the other studies on is that salbutamol and ondansetron are often prescribed in an off label way. [2,9,13,15] Manufacturers of these drugs must take note of these studies so as to bring about a change in their labelling specifications. Three studies report paracetamol to be off label for age and dose whereas no prescription of paracetamol was considered as off label in our study as it was found to be prescribed according to labelled dose and age specifications.…”

Section: Discussionmentioning

confidence: 99%

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The practice of off label prescribing and associated adverse drug reactions in pediatric inpatients in a tertiary care hospital in India

Rajan

Kurian

Ansari

et al. 2019

Journal of Pharmaceutical Health Services Research

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Objectives To assess the extent of use, patterns, variables and Adverse Drug Reactions associated with off label prescribing in Pediatrics. Methods A prospective observational study was conducted for a period of 6 months for children of the age group 0‐17 years in a tertiary care Hospital in Maharashtra, India. Off label drug use was assessed using Micromedex and British National Formulary for Children (BNFC 2016–2017). Adverse Drug Reactions (ADRs) were assessed according to the physicians' notes, recorded during the patient's hospital stay. Pearson correlation coefficient was computed to assess the relationship between age and the number of off‐ label drugs. Odds ratio was calculated for the occurrence of ADRs in on‐label prescriptions Vs off label‐prescriptions. A P value of <0.05 was considered as significant. Key findings A total of 1514 prescriptions were evaluated in 300 patients. Out of which 542 (35.79%) and 423 (27.9%) were off label according to Micromedex and BNFC respectively. The number of patients who received at least one off label was found to be 225 (75%) – Micromedex and 223 (74.3%) – BNFC Unspecified indication and use of drugs outside the specified age limit were identified as the main variables associated with off label prescribing. Highest proportion of off‐label drugs was found in Alimentary system. A total of 35 ADRs (OR 6.92 CI 95%(OR 6.92, 95% CI, 3.13‐15.27)) were identified in 31 patients. Conclusions Off‐label drug use is prevalent in the pediatric population and warrants an evidence‐based approach to improve prescribing practices in pediatrics.

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Section: Discussionsupporting

confidence: 57%

Section: Discussionmentioning

confidence: 99%

The practice of off label prescribing and associated adverse drug reactions in pediatric inpatients in a tertiary care hospital in India

Rajan

Kurian

Ansari

et al. 2019

Journal of Pharmaceutical Health Services Research

Self Cite

View full text Add to dashboard Cite

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Extent and Pattern of Off-Label and Unlicensed Drug Utilization in Neonatal Intensive Care Unit in the Tertiary Care Teaching Hospital

Vadher¹,

Parkar²,

Goud³

2022

IJAR

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Background & Objectives: Many drugs that are used to treat children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efcacy. As a result, drugs that are used to treat children are either not licensed for use in pediatric patients (unlicensed) or prescribed outside the terms of the product license (off-label).The extent of off-label and unlicensed drug use in neonates is unknown. Hence the purpose of the study is to determine the extent and pattern of off-label and unlicensed use of drugs amongst neonates in neonatal intensive care unit of a tertiary care hospital. A prospective study was carried Materials and Methods: out on 69 patients admitted in a tertiary care hospital for the period of ve months. Demographic data and complete prescriptions were noted in predesigned case record form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classied in regards to their indications by using Anatomical Therapeutic Chemical Classication. The frequency was measured in terms of percentage and multiple binary logistic regressions were used for selecting confounding factors. A Results: total of 329 drugs were prescribed out of which 183(55.6%) were off-label and 65(19.8%) were unlicensed remaining 81(24.6%) labelled drugs. Most off-label drugs were prescribed for indication of alimentary tract (93.6%) and anti-infective (38.6%). Signicant confounding factors for prescription of unlicensed drugs were single diagnosis (OR 0.20, P<0.05) and hospital stay (OR 1.30, P<0.05) Common reasons for off-label prescribing were dosage 52.4% and age 23.2%. There was a high extent of utilization of off-label and unlicensed drugs. Hence Conclusion: , national drug regulatory authorities need to review and revise existing guidelines for safe administration of such drugs.

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Off-label drug use in pediatric wards: a prospective study in a tertiary care hospital in Pune

Cited by 2 publications

References 2 publications

The practice of off label prescribing and associated adverse drug reactions in pediatric inpatients in a tertiary care hospital in India

The practice of off label prescribing and associated adverse drug reactions in pediatric inpatients in a tertiary care hospital in India

Extent and Pattern of Off-Label and Unlicensed Drug Utilization in Neonatal Intensive Care Unit in the Tertiary Care Teaching Hospital

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