Off-label drug use among hospitalised children: identifying areas with the highest need for research

Hsien, Linda; Breddemann, André; Frobel, Anne-Kristina; Heusch, A.; Schmidt, Klaus G.; Läer, Stephanie

doi:10.1007/s11096-008-9193-8

Cited by 63 publications

(68 citation statements)

References 20 publications

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“…The most common reasons for off-label use were that the medicine was prescribed at a different dose or frequency, in a different formulation, or in an age group for which it had not been licensed [4]. Off-label use of drugs in a pediatric ward in Germany was reported to be 31% [6], in Switzerland 25% [7], in the Netherlands 44% [8]. Such a big difference between reported studies could be explained by different categories being taken into consideration when assigning off-label status: some only considered one type of off-label use, while others considered up to six (age, dose, indication route, formulation, contraindication, and lack of pediatric license).…”

Section: Discussionmentioning

confidence: 99%

Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey

Palčevski

Skočibušić

Vlahović‐Palčevski

2012

Eur J Clin Pharmacol

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Unlicensed and off-label drug use is common. It is not illegal and may be clinically appropriate but is associated with a number of clinical, safety, and ethical issues. Regulatory authorities should use existing clinical evidence on the use of off-label and unlicensed drugs in decision making. Marketing authorization holders and national regulatory authorities should monitor for any safety concerns associated with unlicensed and off-label drug use and take appropriate measures as well as identify research priorities and mandate clinical studies to resolve important questions.

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Section: Discussionmentioning

confidence: 99%

Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey

Palčevski

Skočibušić

Vlahović‐Palčevski

2012

Eur J Clin Pharmacol

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“…Off-label drugs were categorized with a hierarchical system established by Hsien et al [12] Categories of off-label were defined as follows:…”

Section: Methodsmentioning

confidence: 99%

“…Once drugs were classified into a higher level (e.g. off-label category for age), those drugs were not analyzed for possible classification into any subsequent category [12]. Further, drugs were categorized unlicensed if they were unregistered drugs, unlicensed formulations of registered drugs or the use of nonpharmacological substances as medicines [2].…”

Section: Methodsmentioning

confidence: 99%

Off-Label and Unlicensed Prescribing in Pediatric Inpatients With Nephrotic Syndrome in a Major Teaching Hospital: An Indonesian Context

Ramadaniati

Tambunan²,

Khairani³

et al. 2016

Asian J Pharm Clin Res

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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 that 1023 (65.9%) of the drug prescriptions were used either off-label/unlicensed. Most off-label drugs (n=433, 42.4%) were from nondiuretics antihypertensive 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.

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“…Other authors have obtained consistent results and have detected similar, and even higher rates. 11,12 In terms of design, it is worth noting that PCTs have remarkably changed over the past years at our site: they went from being mostly randomized, controlled studies to almost the same number as open-label, non-randomized and uncontrolled studies. It is known that randomized and controlled clinical trials are the best tools to assess the effectiveness and safety of a treatment, but open-label uncontrolled studies are less complex and require a smaller financial investment.…”

Section: Eighty-seven Pcts and 449 Active Ingredients W E R E A S S Ementioning

confidence: 99%

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients

2014

Arch Argent Pediat

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Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26%) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2% of PCTs were non-randomized and uncontrolled studies, and only 39.1% were randomized, controlled trials. Of all studied drugs, 77% corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed.

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Off-label drug use among hospitalised children: identifying areas with the highest need for research

Cited by 63 publications

References 20 publications

Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey

Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey

Off-Label and Unlicensed Prescribing in Pediatric Inpatients With Nephrotic Syndrome in a Major Teaching Hospital: An Indonesian Context

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients

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