[PDF] Top 20 Off-Label Use of Medical Devices in Children

... of medical and surgical devices through advocacy with stakeholders and the federal ...with medical societies, advocacy groups, industry, researchers, and government officials to identify and ... See full document

... Background: Children are routinely prescribed medicine and most of them are lacking safety and efficacy ...of off- label use of medicines and its ...and off-label use was ... See full document

... to children is ...in children and safety and efficacy of children‘s medicines are frequently supported by low quality of ...to children are on an off- label or unlicensed basis. The ... See full document

... to off- label ...to use drugs off label and to publish results related to off-label use, but it is not acceptable to receive re- muneration from the sponsor for ... See full document

... of use of PEG laxatives for constipation in children, as represented by a single trade-named prescription ...laxative use for constipation in France. Patient medical records in the database ... See full document

... Drug dosing remains one of the most urgent con- siderations in off-label prescribing. To provide effec- tive dosing, one must accept that there are basically two strategies for providing drug therapy. The ... See full document

... before the procedure; 2 patients received repeated doses after their procedure. In addition to rFVIIa, 8 of 16 patients received FFP and/or platelet transfusions before the procedure. Only 1 of 16 patients had ... See full document

... The Children ’ s Hospital at Westmead, Concord Hospital, John Hunter Hospital, Liverpool Hospital, Prince of Wales Hospital, St Vincent ’ s Hospital, Sydney Children ’ s Hospital; Northern Territory: Alice ... See full document

... the off label drug prescriptions have very different proportions occurring variations in studies from ...in children, which is often grounded in clinical ...the use of medicines off ... See full document

... of off- label use and unlicensed medicines are shown in Tables ...were off-label or ...or off-label medicine and 116 (11%) of 1046 admissions experienced an ...1574 ... See full document

... the off-label use of drugs in Pediatrics is further amplified in certain areas, where even more problems related to the difficulty of developing clinical trials for specific type of patients, ... See full document

... for children are unlicensed for their age category or used outside the specifications in the medicine licences (off-label use), and few medicines have been properly tested for use in ... See full document

... and off-label drug use were determined per age group (0 –1, 2–5, 6 –11, or 12–16 years) and per ATC subgroup (third ...or off-label prescription as a function of several possi- ble risk ... See full document

... for use in ...an off- label medicine for age and weight, intranasal administration of adrenaline rather than intravenous route, and the use as an analgesic of morphine without pediatric ... See full document

... of off-label use de fi ned by age ( , 2 years) and initial treatment (no previous treatment with a topical corticosteroid) during the periods be- fore the FDA ’ s regulatory actions (2001 – 2004) and ... See full document

... in children, off-label use of antimicrobial prophylaxis is often the usual treatment of children with vesicoureteral reflux, and such use is increasingly being called into ... See full document

... and medical boards for enforcement, but it would avoid the need for the agency to be responsible for enforcement at the provider level, something it does not currently ...and medical boards would have to be ... See full document

... The extension of prescribing information of already licensed products with pediatric data are a matter of public interest and therefore should be solved be- tween the industry and the medical community with public ... See full document

... The Amplatzer Vascular Plug (St. Jude Medical, St Paul, Minne- sota) is approved for vessel occlusion in the cardiopulmonary and peripheral vasculature that would have required many coils. How- ever, experience in ... See full document

... were off- label 23 ...of off-label used by them was conservative (only un-approved indication was considered), since it did not include dosage, frequency, route of administration, duration of ... See full document