Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study
drug approval; drug compounding; drug prescriptions; off-label use; palliative care; palliative medicine; pediatrics; prevalence
Context: Off-label and unlicensed use of drugs is a widespread practice in pediatric care because of 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, although no studies have established the prevalence of this practice. Objective(s): To describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit (PPCU). Method(s): A prospective cross-sectional observational study carried out between January and October 2019. Result(s): About 85 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 five per patient (interquartile range 3-7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off label because of indication, 33.8% because of dosage, and 26.6% because of 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. Conclusion(s): More than 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. Copyright © 2020 American Academy of Hospice and Palliative Medicine
Garcia-Lopez I; Cuervas-Mons Vendrell M; Martin Romero I; de Noriega I; Benedi Gonzalez J; Martino-Alba R
Journal of Pain & Symptom Management
2020
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1016/j.jpainsymman.2020.06.014" target="_blank" rel="noreferrer noopener">10.1016/j.jpainsymman.2020.06.014</a>
Impact of compounded drugs on the caregivers' burden of home therapy management in pediatric palliative care: A descriptive study
Hospice and Palliative Care Nursing; Palliative Care; Caregivers; Child; Drug Compounding; Humans; Palliative Care; Parents; Quality of Life
BACKGROUND: Children with medical complexity need complex assistance, that considerably affects caregivers' quality of life. They often need multiple medications, with a consequent relevant risk of errors or poor compliance. Galenic (or compounded) drugs are blended in the pharmacy's laboratory worldwide according to different rules and tailoring the patient's needs. While their use may sometimes simplify these therapies, little is known about parents' attitude about this issue., AIM: This study aimed at investigating the complexity of the daily therapy management and exploring the parents' opinions about galenic compounds., DESIGN: Parents were interviewed by using a structured questionnaire., SETTING: Children followed by the Pediatric Palliative Care Network in Friuli Venezia Giulia, Italy, were included from November 2021 to April 2022. Those diagnosed with malignancies were excluded, since therapies are mainly administered through a central venous catheter., RESULTS: Thirty-four parents were interviewed. Fourteen patients took drugs orally, one via nasogastric tube (NGT), 18 via gastrostomy, and one orally + NGT. The mean number of drugs taken every day was six (2-14), in mean 10 (3-18) administrations, that overall required a mean of 44 (8-180) minutes to be delivered. Twenty-eight parents used galenic compounds, and 24 reported relevant advantages, because of a ready-to-use and safe formulation., CONCLUSIONS: The therapy management of children with medical complexity relies on parents. Galenic compounds may improve both patients' and caregivers' quality of life, either in terms of shorter time of administration or smaller risk of errors. Therefore, their use should be encouraged worldwide, according to the different reference rules.
Burlo F; Zanon D; Passone E; Toniutti M; Ponis G; Barbi E; Taucar V; De Zen L
Palliative Medicine
2023
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1177/02692163231151733" target="_blank" rel="noreferrer noopener">10.1177/02692163231151733</a>