OFF-LABEL AND UNLICENSED PRESCRIBING IN PEDIATRIC INPATIENTS WITH NEPHROTIC SYNDROME IN A MAJOR TEACHING HOSPITAL: AN INDONESIAN CONTEXT

Hesty u Ramadaniati; Taralan Tambunan; Sondang Khairani; Happy S Adisty

doi:10.22159/ajpcr.2017.v10i1.15477

Authors

Hesty u Ramadaniati Faculty of Pharmacy Pancasila University
Taralan Tambunan
Sondang Khairani
Happy S Adisty

DOI:

https://doi.org/10.22159/ajpcr.2017.v10i1.15477

Abstract

Objective: To estimate the prevalence of off-label and unlicensed prescribing in pediatric inpatients with nephrotic syndrome in a major teaching hospital in Indonesia.

Methods: A retrospective study was conducted in study hospital using medical records from pediatric inpatients with nephrotic syndrome during the period of January-December 2015. Patient and prescribing data were collected, and drugs were classified as on-label or off-label/unlicensed based on the Indonesia National Drug Information (IONI). Thereafter, off-label drugs were categorized with a hierarchical system of age, indication, route of administration, and dosage.

Results: There were 1553 drugs with 94 different types of drug administered to 67 patients during the study period. The data uncovered that1023 Â (65.9%) Â of Â the Â drug Â prescriptions Â were Â used Â either Â off-label/unlicensed. Â Most Â off-label Â drugs Â (n=433, Â 42.4%) Â were Â from Â nondiureticsantihypertensive drugs. The most common drugs used in an off-label/unlicensed manner were prednisolone and lisinopril. The high rate of off-label drug use in children was mainly related to age (n=772, 75.5%). Pediatrics with nephrotic syndrome was vulnerable to off-label uses where every patient received at least two off-label drugs. It seems that off-label prescribing in pediatric with nephrotic syndrome was not influenced by age or gender as every patient received off-label drugs.

Conclusion: Despite the high prevalence of off-label use in pediatric patients with nephrotic syndrome, this use is supported by evidence-based prescribing. Further, there remains a need for supporting clinical trials for pediatric drugs and updating IONI as the standard drug information in Indonesia to provide complete product information for pediatric use.

Keywords: Off-label drug, Syndrome nephrotic, Inpatient, Pediatrics.

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Author Biography

Hesty u Ramadaniati, Faculty of Pharmacy Pancasila University

Department of Clinical and Community Pharmacy

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