Drug utilization and off-label drug use among Spanish emergency room paediatric patients

Abstract

Objective To describe the use of medicines and to determine the frequency of off-label use in emergency room paediatric patients. Patients and methods A prospective, observational and descriptive study was carried out in the setting of the paediatric emergency room of a Spanish general hospital. Medicines used by children <14 years prior to their emergency room visit were analysed based on information collected from parents/guardians and relatives for each drug prescription. Off-label use was defined as the utilization of a drug at an indication, dosage, frequency or route of administration that differed from the specifications in the Summary of Product Characteristics or by children outside the authorized age group. Results The patient cohort comprised 462 children, among whom 336 children had been prescribed 667 prescriptions. Of the medicines prescribed, 90% fell into only five 5 Anatomical Therapeutic Chemical Classification System groups. The most frequent active principles were ibuprofen and paracetamol. Of a total of 152 different formulations recorded, no paediatric information was provided for 40 formulations, and one formulation was contraindicated in children. Based on the established criteria, 338 prescriptions were off-label: no paediatric information or contraindication in children were available (82 prescriptions); the drug was used for an indication different from the authorized one (111 prescriptions); drug use was inconsistent with age recommendations (16 prescriptions); drug use was inconsistent with dose/frequency (129 prescriptions). Of the 152 formulations, 107 were occasionally used in an off-label manner. Conclusions Although the mean number of drugs used in children is small, off-label use is frequent. Research efforts should target paediatric studies that allow a rational drug use in children.

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

“…Our data confirm findings which show that antiemetics display a high rate of off-label prescriptions [61]. Some studies included in this systematic review reported that antibiotics, such as amikacin [29,32,36,42], amoxicillin [21,23,25,29,38] and ceftriaxone [34,36,42], were also prescribed off-label and/or unlicenced, thus confirming previous reports that antibiotics are the most prescribed off-label and/or unlicenced drug subgroups [2,56,62,63].…”

“…However, other factors, such as the presence of a different formulation or contraindication, were regarded as off-label or unlicenced by different authors. Only 12 papers [19,20,28,30,32,33,35,38,39,46,49,51] accepted the definition of off-label and/or unlicenced drugs proposed by Turner et al [19]. Unlike the latter [19], some authors viewed contraindicated drugs for paediatric use as unlicenced [22,27,34,43,47,48] and drugs with a formulation other than that which had been approved as offlabel [21-25, 27, 34, 40, 41, 43, 47, 50].…”

“…All studies assessed the extent of off-label prescriptions and two papers reported off-label and unlicensed data as combined [37,46]; the extent of unlicensed prescribing was not assessed by seven studies [31,33,36,38,40,51,52] ( Table 2). The off-label prescription data revealed a high degree of use, rising as high as 70.6 % in one study [35], with a median of 39.0 %, and the use of unlicensed prescriptions rose to 47.9 % [22], with median of 13.0 %.…”

A nationwide evaluation of off-label drug utilization in Turkey

“…OLDU is a common practice throughout the world with rates reported to be between 18% and 36% in adults (3)(4)(5)(6) and 3%-87% in pediatric patients (7)(8)(9)(10)(11)(12)(13)(14)(15). Moreover, the incidence of OLDU may vary depending on several factors such as the healthcare facility and the disease profile (11).…”

Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions

“…Off-label prescription also varied with respect to dosage, indication, route of administration and therapeutic group [1][2][3]. Analgesics (paracetamol, ketoprofen, thiopental, fentanyl), bronchodilators (budesonide and salbutamol) and psychotropic drugs were among those medicines most frequently prescribed offlabel across countries [7][8][9][10]. Very few studies have examined the contribution of medicines used in children in an off-label or unlicensed manner to ADR occurrence [7].…”