Purpose: The lack of drugs specifically assessed for paediatric use results in a widespread off-label drug use. The aim of this work is to identify experiences and attitudes towards paediatrics off-label prescribing in a university teaching paediatric hospital.
Methods: A questionnaire of 24 items was sent by email to 409 paediatricians in February 2013.
Data Collected: frequency of off-label prescribing, sources of information, concern about safety and adverse events with off-label drug use, proportion of parents informed and order with "off-label" mention.
Results: Eighty questionnaires were returned. Over 81% of responders were familiar with the concept of off-label drugs prescribing. The most common reason given for off-label prescribing was for a younger age (74%) and for another indication (28%). They (79%) used a colleague's opinion and the most important sources of information used were the literature (72%), international guidelines (62%), the French National Formulary Vidal (56%) and national guidelines (46%). Although 54% of responders expressed concerns about safety about off-label prescription, only 29% had observed adverse event with off-label drug use. Two third of respondents informed the parents but off-label prescribing cannot be always explained to family. Many respondents (81%) did not write "off-label" mention on prescription. However, 52% stated that they would be willing to undertake off-label prescription monitoring with a local observatory.
Conclusion: Our study describes the perceptions and attitudes of paediatrician's regarding off-label prescribing for children. Patient information and documentation in the patient file remain incomplete. The prospective collection of off-label prescription will locally be performed.
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http://dx.doi.org/10.1016/j.pharma.2015.08.002 | DOI Listing |
Transl Pediatr
December 2024
Eastman Institute for Oral Health, Center of Orofacial Pain and Temporomandibular Joint Disorders, Rochester, NY, USA.
Background: Migraine is a neurological disorder that is chronic and presents with episodes of paroxysmal features consisting of multiphase attacks of head pain, along with other symptoms related to neurological dysfunction such as sensitivity to movement, photophobia, phonophobia, nausea, and vomiting. Antiseizure medications are frequently used for the treatment of migraine. Of the antiseizure medications, sodium valproate and topiramate have received approval from the Food and Drug Administration (FDA) to prevent adult migraine.
View Article and Find Full Text PDFJACC Case Rep
January 2025
Department of Cardiovascular Medicine, Richmond Heart & Vascular Associates, Richmond, Virginia, USA.
Transcatheter edge-to-edge repair (TEER) is approved for patients with symptomatic severe mitral regurgitation (MR) who are deemed inoperable or at high surgical risk with life expectancy of more than 1 year, but has also been used off-label in patients with hypertrophic obstructive cardiomyopathy (HOCM) for symptomatic relief who are not candidates for septal reduction therapy. An 83-year-old woman with decompensated heart failure was found to have HOCM with systolic anterior motion of the mitral valve and a large P2 flail segment with ruptured cords. TEER was performed resulting in mild MR and resolution of the prior left ventricular outflow tract gradient.
View Article and Find Full Text PDFInfection
November 2024
Division of Neonatology, Department of Women's and Children's Health, University of Leipzig Medical Center, Liebigstraße 20a, 04103, Leipzig, Germany.
Purpose: Ureaplasma species (spp.) are relevant contributors to preterm birth but may also cause invasive infections particularly in very immature preterm infants. This study aimed to assess the incidence of neonatal Ureaplasma infections of the central nervous system (CNS).
View Article and Find Full Text PDFClin Psychol Psychother
January 2025
Anhui University of Technology, Maanshan, Anhui, China.
Intermittent explosive disorder (IED) is characterized by sudden, disproportionate outbursts of anger that can severely impact individuals' quality of life, causing difficulties in maintaining relationships, issues at work or school and potential legal troubles. This study aimed to systematically review and meta-analyse the effectiveness of psychological and pharmacological treatments for IED, drawing insights from both case studies and randomized controlled trials (RCTs). A total of 12 RCTs and 14 case studies were included in this comprehensive analysis.
View Article and Find Full Text PDFObstet Gynecol
January 2025
Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, Weill Cornell Medicine, New York, New York; and Womack Army Medical Center, Fort Liberty, North Carolina.
Medical devices are an essential component of the practice of obstetrics and gynecology. These devices may, at times, suffer from a defect or failure, which could result in a product liability lawsuit when associated with patient harm. Medical device product liability lawsuits are directed toward the device manufacturer when a patient suffers harm because of a device.
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