Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation

Lindell-Osuagwu, Leena; Hakkarainen, M; Sepponen, Kati; Vainio, K; Naaranlahti, Toivo; Kokki, Hannu

doi:10.1111/jcpt.12119

Cited by 44 publications

(75 citation statements)

References 28 publications

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“…On the other hand, other studies reported that the route of administration was the most common reason for off-labeled/unlicensed prescriptions,713 for example, buccal administration of sedatives and analgesics, and administration of drugs via enteral feeding tube. We believe that the differences between our study and previous reports regarding the reasons might be the differences in the route of administration in children.…”

Section: Discussionmentioning

confidence: 99%

“…We believe that the differences between our study and previous reports regarding the reasons might be the differences in the route of administration in children. For example, according to Lindell-Osuagwu et al,13 buccal administration of sedatives and analgesics was the primary reason for off-labeled/unlicensed prescriptions. In the centers we investigated, buccal or nasal administration of drugs in children were rare.…”

Section: Discussionmentioning

confidence: 99%

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Safety and Efficacy of Off-label and Unlicensed Medicines in Children

et al. 2018

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BackgroundThe aim of this study was to explore the use of off-label/unlicensed drugs to confirm the safety and efficacy of their prescription in children in Korea.MethodsIn this retrospective study, we analyzed data of patients who received any of the 32 drugs between January–December 2014 in tertiary hospitals in Korea, including demographics, diagnoses, reasons for the medication, administration route, and details of adverse drug reactions. Additionally, the mortality in the cohort was assessed. The primary outcomes were efficacy and safety, including mortality, of these drugs in pediatric patients. The secondary outcomes were the current statuses of the use of off-label/unlicensed drugs in two centers.ResultsTotally, 5,130 prescriptions were found in 2,779 patients. Age (73.5%) and indication (11.7%) were the most frequent reasons for prescriptions being off-labeled/unlicensed. Approximately 88% of the prescriptions were effective, and 19% of the patients developed adverse drug reactions. The number of prescriptions was significantly higher in children with adverse drug reactions than it was in those without (2.8 vs. 1.5; P < 0.001). The number of prescribed off-label/unlicensed medicines and age at prescription were independently associated with adverse drug events (odds ratio, 1.55 and 1.1; P < 0.001 and 0.034, respectively).ConclusionChildren are still prescribed medicines that are not authorized in terms of age, weight, indications, or routes of administration. Therefore, many old products require re-assessment of authorization. More prospective clinical studies should be performed to confirm the efficacy and safety of drugs in the pediatric population.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Off-label and Unlicensed Medicines in Children

et al. 2018

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“…Several retrospective and prospective studies have been conducted in the United Kingdom (UK) [3–5], France [6], the Netherlands [7], Germany [8, 9], Switzerland [10], Finland [11, 12], Croatia [13], Italy [14], Portugal [15], across Europe [16], United States (US) [17], Brazil [18], Ireland [19], Israel [20], Malaysia [21] and Australia [1, 22, 23] in various hospital settings that have included Emergency Department patients, outpatients or inpatients (general and medical wards and paediatric and neonatal intensive care units). Most of the studies have been conducted over a period of weeks or months.…”

Section: Introductionmentioning

confidence: 99%

Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital

et al. 2015

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PurposeTo estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia.MethodsA 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and prescribing data were collected. Drugs were classified as off-label or unlicensed based on Australian registration data. A hierarchical system of age, indication, route of administration and dosage was used. Drugs were classified according to the Anatomical Therapeutic Chemical Code.ResultsA total of 1,037 paediatric patients were selected where 2,654 prescriptions for 330 different drugs were prescribed to 699 patients (67.4%). Most off-label drugs (n = 295; 43.3%) were from the nervous system; a majority of unlicensed drugs were systemic hormonal preparations excluding sex hormones (n = 22, 32.4%). Inpatients were prescribed more off-label drugs than outpatients or Emergency Department patients (p < 0.0001). Most off-label prescribing occurred in infants and children (31.7% and 35.9% respectively) and the highest percentage of unlicensed prescribing (7.2%) occurred in infants (p < 0.0001). There were 25.7% of off-label and 2.6% of unlicensed medications prescribed across all three settings. Common reasons for off-label prescribing were dosage (47.4%) and age (43.2%).ConclusionThis study confirmed off-label and unlicensed use of drugs remains common. Further, that prevalence of both is influenced by the clinical setting, which has implications in regards to medication misadventure, and the need to have systems in place to minimise medication errors. Further, there remains a need for changes in the regulatory system in Australia to ensure that manufacturers incorporate, as it becomes available, evidence regarding efficacy and safety of their drugs in children in the official product information.

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“…For example, Lindell-Osuagwu et al compared offlabel and unlicensed prescription rates in several paediatric wards in a Finnish university hospital. They actually found that off-label use and unlicensed drug use was more prevalent in 2011 than in 2001 (87). Also, on the basis of 117,665 admissions over 1 year in a French paediatric hospital, Lajoinie et al concluded that young children are still commonly treated with unlicensed drugs (88).…”

Section: Paediatric Regulation: Progress and Future Perspectivesmentioning

confidence: 99%

Paediatric Drug Development and Formulation Design—a European Perspective

Riet‐Nales

Kozarewicz²,

Aylward

et al. 2016

AAPS PharmSciTech

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Abstract.The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize Bbetter^medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the BGuideline on the Pharmaceutical Development of Medicines for Paediatric Use.^Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.

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Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation

Abstract: The prescribing for off-label use and unauthorized medicines was more prevalent in 2011 than in 2001. This indicates that the recent legislation has had only minor or no impact on the authorizing status of medicines commonly used in paediatric inpatients in specialized care.

Cited by 44 publications

References 28 publications

Safety and Efficacy of Off-label and Unlicensed Medicines in Children

Safety and Efficacy of Off-label and Unlicensed Medicines in Children

Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital

Paediatric Drug Development and Formulation Design—a European Perspective

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