Incidence of unlicensed and off-label prescription in children

Abstract

BackgroundMany common drugs have not been licensed for use in children.MethodsThis study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.ResultsOff-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.ConclusionsThis study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.

Off-label paediatric drug use in an Indonesian community setting

“…Pharmacotherapy is usually based on drugs that are approved for specific indications, dosages, routes of administration or populations. 6 The potential health risks are unknown, which may lead to an important public health issue. Although there is generally a lack of sufficient evidence on risk/benefit assessment, OLDU is a common practice.…”

“…Although there is generally a lack of sufficient evidence on risk/benefit assessment, OLDU is a common practice. 6 Thus, OLDU in children is a potential risk factor for ADRs. 5 In paediatric practice, OLDU prescribing is common because clinical trials are usually not conducted in children during the development process of the medication.…”

“…Off-label drug use for younger children can be prescribed at a different dose, for a different indication or by a different route of administration than what the drug is licensed for. 6 The potential health risks are unknown, which may lead to an important public health issue. Dost, a paediatrician, has stated that children differ pharmacokinetically from adults and medication for adults cannot simply be administered in smaller doses.…”

Off-Label Drug Use in Pediatric Practice: Unsolved Problems

“…Высокую распространенность использования у детей лекарственных препаратов в несоответствии с утверж-денной инструкцией по медицинскому применению наглядно демонстрируют результаты и других зарубежных исследований [19][20][21].…”

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“…The first generation of antihistamines has never been clinically tested in children; nevertheless, it is widely used. 17 These drugs are recommended for children by extrapolation from pharmacological and clinical data in adults. This might be due to physician's behavior of prescribing sub-optimal dose due to fear of toxicity in over dose.…”