Off-label and unlicensed drugs in pediatric palliative care : a prospective observational study

Article indépendant

GARCIA-LOPEZ, Isabel | CUERVAS-MONS VENDRELL, Margarita | ROMERO, Irene Martin | DE NORIEGA, Iñigo | GONZALEZ, Juana Benedí | MARTINO-ALBA, Ricardo

Context: Off-label and unlicensed use of drugs is a widespread practice in pediatric care due to the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a life-limiting illness frequently receive drugs under these conditions, though no studies have established the prevalence of this practice. Aim: to describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit. Methods: A prospective, cross-sectional observational study carried out between January and October 2019. Setting/participants: The study included all patients admitted to the pediatric palliative care unit for home hospitalization and with at least one prescribed drug treatment. Results: eighty-five patients involving 1198 prescriptions were analyzed. A total of 39.6% were off-label and 12.9% were unlicensed. All received at least one off-label drug, with a median of 5 per patient (IQR = 3–7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off-label due to indication, 33.8% due to dosage, and 26.6% due to age. The main drugs used off-label were oral morphine, oral levetiracetam, inhaled albuterol, sublingual ondansetron, oral tizanidine, sublingual fentanyl, and oral diazepam. The main symptoms treated with off-label drugs were dyspnea, pain, and nausea/vomiting. Conclusions: Over half of the prescriptions in this PPCU were off-label or unlicensed. Treatment indication was one of the main reasons for off-label use. Administration of compounded preparations was common in patients with a life-limiting illness.

http://dx.doi.org/10.1016/j.jpainsymman.2020.06.014

Voir la revue «JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 60»

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