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Off label psychiatry

M Kölch, P L Plener
Pharmacotherapeutic interventions are available for most psychiatric disorders in children. Evidence for these interventions varies, depending on the targeted disorders. For attention-deficit/hyperactivity disorder, a sound database on efficacy and safety of medication exists. For other common disorders or psychopathological phenomena like disruptive behavior, anxiety disorders, depressive disorders, or autism, data on efficacy and safety are much scarcer. This selective review aims to provide an overview about current psychopharmacological interventions in child and adolescent psychiatry...
October 13, 2016: Pharmacopsychiatry
Sameer Hassamal, Susan Waller, Kimberly Reese, Claudia Testa
Valproic acid (VPA) is approved by the Food and Drug Administration (FDA) for the treatment of manic or mixed episodes associated with bipolar disorder. VPA is also used off-label to treat other conditions in psychiatry such as impulse control disorders, major depression, and posttraumatic stress disorder (PTSD). Although VPA is mostly well-tolerated, common adverse effects include gastrointestinal symptoms (nausea, vomiting, diarrhea), neurological symptoms (sedation, ataxia, tremor), weight gain, and alopecia...
2016: Türk Psikiyatri Dergisi, Turkish Journal of Psychiatry
Manfred Gerlach, Karin Egberts, Su-Yin Dang, Paul Plener, Regina Taurines, Claudia Mehler-Wex, Marcel Romanos
INTRODUCTION: Off-label or unlicensed use of psychotropic drugs is common rather than the exception in child and adolescent psychiatry. This use exposes patients to an unknown additional risk of ineffective or even harmful treatment. In addition, treatment with psychotropic drugs during a period of life when the patient undergoes marked developmental hormonal and neurobiological changes often requires different dosing regimes in later life and may result in adverse drug reactions, which are either not seen in adults at all or not in the same frequency...
August 23, 2016: Expert Opinion on Drug Safety
Julie Vestergaard Braüner, Lily Manzello Johansen, Troels Roesbjerg, Anne Katrine Pagsberg
This study aimed to describe the frequency of off-label prescriptions of psychopharmacological drugs in a child and adolescent psychiatric setting. A cross-sectional study was conducted on November 1, 2014, including all inpatients and outpatients at the Mental Health Centre for Child and Adolescent Psychiatry, Capital Region of Denmark, aged 0 to 17 years receiving medical treatment with antidepressants, antipsychotic agents, benzodiazepines, melatonin and/or attention deficit hyperactivity disorder (ADHD) medication...
October 2016: Journal of Clinical Psychopharmacology
Aditya N Sharma, Celso Arango, David Coghill, Paul Gringras, David J Nutt, Peter Pratt, Allan H Young, Chris Hollis
The off-label use of medicines for children and adolescents remains a common and important issue for prescribing practice across child and adolescent psychiatry, paediatrics and primary care. This editorial focusses on psychotropic drug treatment, which plays an essential part in the comprehensive management of a range of child and adolescent psychiatric disorders. Despite a growing evidence base for drug treatment in child and adolescent psychiatric disorders, much psychotropic medication continues to be prescribed off-label (i...
May 2016: Journal of Psychopharmacology
Christophe Bartoli, Caroline Berland-Benhaim, Caroline Sastre, Valerie Baillif-Couniou, Pascal Kintz, Georges Leonetti, Anne-Laure Pelissier-Alicot
In psychiatry, the molecules available and the dosages recommended when a drug receives marketing authorization are not always adequate to treat patients with major behavioral disturbances. Off-label prescribing is frequent in this context, with regard to the indications and the dosages given as well as to the drug combinations used. However, if complications or death occur, the practitioner's liability may be engaged. The authors report three deaths attributed to off-label prescribing in psychiatry and which led to charges against the physicians...
November 2015: Journal of Forensic Sciences
Antonio M Persico, Celso Arango, Jan K Buitelaar, Christoph U Correll, Jeffrey C Glennon, Pieter J Hoekstra, Carmen Moreno, Benedetto Vitiello, Jacob Vorstman, Alessandro Zuddas
Paediatric psychopharmacology holds great promise in two equally important areas of enormous biomedical and social impact, namely the treatment of behavioural abnormalities in children and adolescents, and the prevention of psychiatric disorders with adolescent- or adult-onset. Yet, in striking contrast, pharmacological treatment options presently available in child and adolescent psychiatry are dramatically limited. The most important currently unmet needs in paediatric psychopharmacology are: the frequent off-label prescription of medications to children and adolescents based exclusively on data from randomized controlled studies involving adult patients; the frequent lack of age-specific dose, long-term efficacy and tolerability/safety data; the lack of effective medications for many paediatric psychiatric disorders, most critically autism spectrum disorder; the scarcity and limitations of randomized placebo-controlled trials in paediatric psychopharmacology; the unexplored potential for the prevention of psychiatric disorders with adolescent- and adult-onset; the current lack of biomarkers to predict treatment response and severe adverse effects; the need for better preclinical data to foster the successful development of novel drug therapies; and the effective dissemination of evidence-based treatments to the general public, to better inform patients and families of the benefits and risks of pharmacological interventions during development...
October 2015: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
Noa Tsujii, Takuya Saito, Yuji Izumoto, Masahide Usami, Takashi Okada, Hideki Negoro, Junzo Iida
OBJECTIVE: In child and adolescent psychiatry, the off-label prescribing of psychotropic medications is common. The purpose of this study was to examine the experiences of Japanese child and adolescent psychiatrists with off-label prescribing to children and/or adolescents (hereafter referred to as "children") and to identify the factors associated with these experiences. METHODS: A prospective questionnaire was sent to 1628 psychiatrists belonging to the Japanese Society for Child and Adolescent Psychiatry...
September 2016: Journal of Child and Adolescent Psychopharmacology
Svetlana Goločorbin Kon, Ivana Iliković, Momir Mikov
INTRODUCTION: The application of drugs in accordance with the marketing authorization issued by the regulatory authority is considered on-label use, while off-label drug use frequently occurs in medical practice. It includes the application of drugs beyond approved indications; for unapproved age group, with different dosage regimens or different administration route. Medical specialists frequently prescribe an off-label drug in pediatrics, neonatology, geriatrics, psychiatry and oncology...
January 2015: Medicinski Pregled
Benedikt Stegmann, Christian A Rexroth, Katharina Wenzel-Seifert, Ekkehard Haen
OBJECTIVE: This contribution evaluates the prevalence, medication use as well as age and sex distribution in inpatients with hyperkinetic disorders at the KinderAGATE hospitals for 2009-2012. METHOD: The age, sex, leading diagnosis, prescribed medication, and dosage of each patient were recorded anonymously twice a year. They provide an outstanding epidemiological basis for the observation of the actual situation in child and adolescent psychiatry. RESULTS: Compared to our patient collective, patients diagnosed with hyperkinetic disorders (25...
March 2015: Zeitschrift Für Kinder- und Jugendpsychiatrie und Psychotherapie
M Teresa Martínez-Lazcano, Sara Esplá-González, Paola Herraiz-Robles, Pilar Hernández-Pérez, Raquel Chillerón-Cuenca, Emilio Pol-Yanguas
OBJECTIVE: Valproic acid is often used in psychiatry to treat schizophrenia and other conditions outside of indication ("off-label"). However, its effectiveness has not been sufficiently demonstrated and its use is not exempt of adverse effects. This study's main objective is to determine the frequency of use of valproic acid in approved indications and the "off-label" use in psychiatric patients. METHODS: A cross-sectional study on July 7, 2014 with a sample of 167 patients residents in a psychiatric center was designed...
March 2015: Farmacia Hospitalaria
Darshan Kharadi, Kamlesh Patel, Devang Rana, Varsha Patel
INTRODUCTION: Off-label drug prescribing is very common in Psychiatry. US-Food and Drug Administration has defined off-label drug as "use of drugs for the indication, dosage form, regimen, patient or other use constraint not mentioned in the approved labeling." OBJECTIVE: The objective was to evaluate off-label drug use in patients attending Outpatient Department of Psychiatry. MATERIALS AND METHODS: One year prospective, cross sectional study was conducted on patients attending Psychiatry Outpatient Department...
March 2015: Journal of Basic and Clinical Pharmacy
Marcia A Kearns, Kristin M Hawley
We employed a national survey of child psychiatrists to examine typical prescribing practices for children with anxiety, depression, and disruptive behavior disorders. We examined the extent to which polypharmacy and off-label prescribing occur in routine practice and the degree to which child characteristics, child psychiatrist characteristics, and medication availability may influence these prescribing practices. We found that child psychiatrists most often prescribed medications that were on-label according to U...
November 2014: Journal of Psychiatric Practice
Christine Schmäl, Katja Becker, Ruth Berg, Michael Brünger, Gerd Lehmkuhl, Klaus-Ulrich Oehler, Thorsten Ruppert, Claus Staudter, Götz-Erik Trott, Ralf W Dittmann
Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed "off-label" because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902/2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups...
November 2014: Zeitschrift Für Kinder- und Jugendpsychiatrie und Psychotherapie
Inmaculada Baeza, Elena de la Serna, Rosa Calvo-Escalona, Astrid Morer, Jessica Merchán-Naranjo, Cecilia Tapia, Ma Carmen Martínez-Cantarero, Patrícia Andrés, José A Alda, Bernardo Sánchez, Celso Arango, Josefina Castro-Fornieles
OBJECTIVE: The objective of this study was to analyze the initial treatment with antipsychotics (APs) and its changes during the first year of treatment in patients visited in specialized child and adolescent psychiatry departments. METHODS: Participants were 265 patients, aged 4 to 17 years, who attended consecutively at 4 different centers and were naive of AP or quasi-naive (less than 30 days since the beginning of AP treatment). Type of AP, dosage, and concomitant medication were registered at baseline, 1, 3, 6, and 12 months after beginning the treatment with AP...
October 2014: Journal of Clinical Psychopharmacology
Jeffery A Demland, Yonghua Jing, Christina M L Kelton, Jeff J Guo, Hong Li, Patricia R Wigle
BACKGROUND: Postmarketing surveillance that identifies patients at high risk for receiving off-label medications will help ensure that the benefits of such treatment outweigh the risks. Because many off-label uses have little scientific support, tracking the extent to which they occur as well as the particular circumstances under which they occur is important. OBJECTIVE: To describe the drug-use pattern for patients with bipolar disorder, and to identify demographic and clinical factors associated with off-label use of atypical antipsychotics before US Food and Drug Administration approval for this indication...
June 2009: American Health & Drug Benefits
Julia Gibson, Duc Nguyen, Jana Davidson, Constadina Panagiotopoulos
OBJECTIVE: The authors describe a pilot evaluation of an educational handbook designed to increase resident knowledge of second-generation antipsychotic (SGA) use in the pediatric population, with an emphasis on metabolic monitoring. METHODS: An educational handbook focusing on SGA use in children and adolescents was introduced to psychiatry residents undergoing a child psychiatry rotation. Baseline and post-intervention questionnaires were administered to determine whether SGA knowledge increased...
April 2015: Academic Psychiatry
Ian Larkin, Desmond Ang, Jerry Avorn, Aaron S Kesselheim
The treatment of pediatric depression is controversial because it includes substantial prescribing of drugs for uses that have not been approved by the Food and Drug Administration ("off label") and are not evidence based. Some academic medical centers (AMCs) restrict "detailing" by pharmaceutical sales representatives, or the promoting of drugs directly to physicians via sales calls, to reduce the effect of such marketing on physician prescribing. With data from thirty-one geographically diverse AMCs and their affiliated hospitals, we used a difference-in-differences model to estimate the effect of anti-detailing policies on off-label prescribing of antidepressants and antipsychotics by pediatricians and by child and adolescent psychiatrists in the period January 2006-June 2009...
June 2014: Health Affairs
Antonio Bruno, Vincenzo M Romeo, Gianluca Pandolfo, Giuseppe Scimeca, Rocco A Zoccali, Maria Rosaria A Muscatello
BACKGROUND: The aims of this study were to evaluate a combination of aripiprazole and topiramate in the treatment of opioid-dependent patients with schizoaffective disorder undergoing methadone maintenance therapy (MMT) and, further, to taper off patients from methadone treatment. METHODS: Twenty patients who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for opioid dependence and schizoaffective disorder receiving MMT (80 mg/day) were given aripiprazole (10 mg/day) plus topiramate (up to 200 mg/day) for 8 weeks...
2014: Substance Abuse
Angie Mae Rodday, Susan K Parsons, Christoph U Correll, Adelaide S Robb, Bonnie T Zima, Tully S Saunders, Laurel K Leslie
OBJECTIVE: The purpose of this study was to examine psychiatrists' attitudes and practices in prescribing second-generation antipsychotics (SGA) to children and adolescents (referred to here as "children") and identify factors associated with off-label SGA use. METHODS: A survey was mailed to a national, randomly selected sample of 1600 child and adolescent psychiatrists identified by the American Medical Association. Multivariable logistic regression was used to identify factors, including psychiatrists' characteristics, practice characteristics, and psychiatrists' attitudes, that are associated with off-label SGA use (i...
March 2014: Journal of Child and Adolescent Psychopharmacology
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