The Experts below are selected from a list of 726 Experts worldwide ranked by ideXlab platform
Vassilios Fanos - One of the best experts on this subject based on the ideXlab platform.
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off label and Unlicensed prescribing for newborns and children in different settings a review of the literature and a consideration about Drug safety
Expert Opinion on Drug Safety, 2006Co-Authors: Laura Cuzzolin, A Atzei, Vassilios FanosAbstract:This review aims to give an updated overview of the worldwide situation of off-label and Unlicensed Drug Use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in the systematic review. From the authors’ analysis of the literature, the extent of paediatric Unlicensed/off label Use is higher in neonatal and paediatric intensive care units and oncology wards, compared with primary care. Moreover, among the nine studies reporting the contribution of an off-label/Unlicensed Drug Use to the occurrence of adverse events, the percentage of Unlicensed and/or off-label prescriptions involved in an adverse Drug reaction ranged between 23 and 60%. To ensure that children are not exposed to unnecessary risks, controlled clinical trials are required. In addition, future research should be directed towards the identification of individual Drugs that caUse serious ad...
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off label and Unlicensed prescribing for newborns and children in different settings a review of the literature and a consideration about Drug safety
Expert Opinion on Drug Safety, 2006Co-Authors: Laura Cuzzolin, A Atzei, Vassilios FanosAbstract:This review aims to give an updated overview of the worldwide situation of off-label and Unlicensed Drug Use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in the systematic review. From the authors' analysis of the literature, the extent of paediatric Unlicensed/off label Use is higher in neonatal and paediatric intensive care units and oncology wards, compared with primary care. Moreover, among the nine studies reporting the contribution of an off-label/Unlicensed Drug Use to the occurrence of adverse events, the percentage of Unlicensed and/or off-label prescriptions involved in an adverse Drug reaction ranged between 23 and 60%. To ensure that children are not exposed to unnecessary risks, controlled clinical trials are required. In addition, future research should be directed towards the identification of individual Drugs that caUse serious adverse Drug reactions and lack product information.
Thierry Vial - One of the best experts on this subject based on the ideXlab platform.
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o 100 relationship between adverse Drug reactions and off label Unlicensed Drug Use in hospitalised children eremi study
Archives of Disease in Childhood, 2014Co-Authors: Ka Nguyen, Y Mimouni, A Lajoinie, N Paret, S Malik, L Milliatguittard, L Elamrani, C Castellan, A M Schott, Thierry VialAbstract:Background and aim To date few studies have shown a significant association between the off-label Drug Use and adverse Drug reactions. (ADRs). The main aims of this study are to evaluate the relationship between adverse Drug reactions and Unlicensed or off-label Drugs prospectively in hospitalised children and to provide more information on prescribing practice, the amplitude, nature and consequences of Unlicensed or off-label Drug Use in paediatric inpatients. Methods In this ongoing multi-centre prospective study, the French summaries of product characteristics in Theriaque (a prescription products guide ) are being Used as a primary reference source for determining paediatric Drug labelling. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and medication is evaluated using the Naranjo and the French methods of imputability. Preliminary results for a 6 month period: 40% of the 73 detected ADRs were estimated as severe. 1498 patients have been included. Conclusions This is the first large multi-centre prospective study in France that evaluates the relationship between adverse Drug reactions and Unlicensed or off-label Drugs in hospitalised children. This study will help to identify the risk factors that could be Used to adjust preventive actions in children care, guide future research in the field and increase the awareness of physicians in detecting and declaring ADRs. This study is funded by l’ANSM (French national agency of Drug security).
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o 115 relationship between adverse Drug reactions and off label Unlicensed Drug Use in hospitalised neonates remineo study
Archives of Disease in Childhood, 2014Co-Authors: Ka Nguyen, N Paret, Thierry Vial, Frank Plaisant, C Giraud, A Beissel, A Millaret, F Alsohim, S Gaillard, O ClarisAbstract:Background and aim Data regarding the association between the off-label Drug Use and adverse Drug reactions (ADRs) in neonates is scarce. The main aims of this study are to evaluate prospectively the relationship between adverse Drug reactions and off-label or Unlicensed (OLUL) Drugs in 2 neonatal centres in Lyon (France), and to provide more information on prescribing practice, the amplitude, nature and consequences of OLUL Drug Use. Methods The French summaries of product characteristics in Theriaque 2012 (a prescription products guide ) are being Used as a primary reference source for determining Drug labelling. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and Drug is evaluated using the WHO and the French methods of imputability. Preliminary results for a 12 month period 910 neonates were included. 671 (73,7%) were preterm. 94,8% (CI 95: 93,3–96,3) of children received at least one OLUL Drug, 66% of 8891 prescriptions were Used in OLUL manner. 80% of the 96 validated ADRs were classified as severe. 84% of Drugs related to ADRs were Used in OLUL manner. Conclusion Our study confirmed that OLUL Drug utilisation is common in neonates. This study will bring more evidence on the correlation between OLUL Drug Use and ADRs. Institutions and pharmaceutical industry should develop clinical trials for neonates, and ensure they do not remain a “therapeutic orphan”. A specific reference source for Drug Used in neonates would be helpful.
Laura Cuzzolin - One of the best experts on this subject based on the ideXlab platform.
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off label and Unlicensed prescribing for newborns and children in different settings a review of the literature and a consideration about Drug safety
Expert Opinion on Drug Safety, 2006Co-Authors: Laura Cuzzolin, A Atzei, Vassilios FanosAbstract:This review aims to give an updated overview of the worldwide situation of off-label and Unlicensed Drug Use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in the systematic review. From the authors’ analysis of the literature, the extent of paediatric Unlicensed/off label Use is higher in neonatal and paediatric intensive care units and oncology wards, compared with primary care. Moreover, among the nine studies reporting the contribution of an off-label/Unlicensed Drug Use to the occurrence of adverse events, the percentage of Unlicensed and/or off-label prescriptions involved in an adverse Drug reaction ranged between 23 and 60%. To ensure that children are not exposed to unnecessary risks, controlled clinical trials are required. In addition, future research should be directed towards the identification of individual Drugs that caUse serious ad...
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off label and Unlicensed prescribing for newborns and children in different settings a review of the literature and a consideration about Drug safety
Expert Opinion on Drug Safety, 2006Co-Authors: Laura Cuzzolin, A Atzei, Vassilios FanosAbstract:This review aims to give an updated overview of the worldwide situation of off-label and Unlicensed Drug Use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in the systematic review. From the authors' analysis of the literature, the extent of paediatric Unlicensed/off label Use is higher in neonatal and paediatric intensive care units and oncology wards, compared with primary care. Moreover, among the nine studies reporting the contribution of an off-label/Unlicensed Drug Use to the occurrence of adverse events, the percentage of Unlicensed and/or off-label prescriptions involved in an adverse Drug reaction ranged between 23 and 60%. To ensure that children are not exposed to unnecessary risks, controlled clinical trials are required. In addition, future research should be directed towards the identification of individual Drugs that caUse serious adverse Drug reactions and lack product information.
Ka Nguyen - One of the best experts on this subject based on the ideXlab platform.
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o 100 relationship between adverse Drug reactions and off label Unlicensed Drug Use in hospitalised children eremi study
Archives of Disease in Childhood, 2014Co-Authors: Ka Nguyen, Y Mimouni, A Lajoinie, N Paret, S Malik, L Milliatguittard, L Elamrani, C Castellan, A M Schott, Thierry VialAbstract:Background and aim To date few studies have shown a significant association between the off-label Drug Use and adverse Drug reactions. (ADRs). The main aims of this study are to evaluate the relationship between adverse Drug reactions and Unlicensed or off-label Drugs prospectively in hospitalised children and to provide more information on prescribing practice, the amplitude, nature and consequences of Unlicensed or off-label Drug Use in paediatric inpatients. Methods In this ongoing multi-centre prospective study, the French summaries of product characteristics in Theriaque (a prescription products guide ) are being Used as a primary reference source for determining paediatric Drug labelling. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and medication is evaluated using the Naranjo and the French methods of imputability. Preliminary results for a 6 month period: 40% of the 73 detected ADRs were estimated as severe. 1498 patients have been included. Conclusions This is the first large multi-centre prospective study in France that evaluates the relationship between adverse Drug reactions and Unlicensed or off-label Drugs in hospitalised children. This study will help to identify the risk factors that could be Used to adjust preventive actions in children care, guide future research in the field and increase the awareness of physicians in detecting and declaring ADRs. This study is funded by l’ANSM (French national agency of Drug security).
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o 115 relationship between adverse Drug reactions and off label Unlicensed Drug Use in hospitalised neonates remineo study
Archives of Disease in Childhood, 2014Co-Authors: Ka Nguyen, N Paret, Thierry Vial, Frank Plaisant, C Giraud, A Beissel, A Millaret, F Alsohim, S Gaillard, O ClarisAbstract:Background and aim Data regarding the association between the off-label Drug Use and adverse Drug reactions (ADRs) in neonates is scarce. The main aims of this study are to evaluate prospectively the relationship between adverse Drug reactions and off-label or Unlicensed (OLUL) Drugs in 2 neonatal centres in Lyon (France), and to provide more information on prescribing practice, the amplitude, nature and consequences of OLUL Drug Use. Methods The French summaries of product characteristics in Theriaque 2012 (a prescription products guide ) are being Used as a primary reference source for determining Drug labelling. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and Drug is evaluated using the WHO and the French methods of imputability. Preliminary results for a 12 month period 910 neonates were included. 671 (73,7%) were preterm. 94,8% (CI 95: 93,3–96,3) of children received at least one OLUL Drug, 66% of 8891 prescriptions were Used in OLUL manner. 80% of the 96 validated ADRs were classified as severe. 84% of Drugs related to ADRs were Used in OLUL manner. Conclusion Our study confirmed that OLUL Drug utilisation is common in neonates. This study will bring more evidence on the correlation between OLUL Drug Use and ADRs. Institutions and pharmaceutical industry should develop clinical trials for neonates, and ensure they do not remain a “therapeutic orphan”. A specific reference source for Drug Used in neonates would be helpful.
Varsha J Patel - One of the best experts on this subject based on the ideXlab platform.
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off label and Unlicensed Drug Use in paediatric outpatient department a prospective study at a tertiary care teaching hospital
Journal of Young Pharmacists, 2015Co-Authors: Sunil Nagjibhai Bhadiyadara, Devang A Rana, Supriya D Malhotra, Varsha J PatelAbstract:Objective: To assess prevalence and pattern of off-label and Unlicensed Use of Drugs in paediatric outpatient department. Methods: In this prospective study, children attending paediatric outpatient department of a tertiary care teaching hospital were enrolled. Demographic data, clinical history and completeprescription given to the patient were noted. Prescriptions were analysed for off-label and Unlicensed Drug Use with the help ofrecent British National Formulary for Children (BNFC) and National Formulary of India (NFI). Results: Total of 170 patient’s data was collected over 2 months with mean age 4.19 ± 3.66 years. Out of total of 405 Drugs prescribed, 41 (10.1%)-BNFC and 32 (7.9%)-NFI were Used in off-label manner. Number of children who received at least one off-label Drug as per BNFC and NFI was 22.4% and 17.1%, respectively. Most common off-label Drug was amoxicillin being 48.8%-BNFC and 34.4%-NFI of all Drugs prescribed in this manner. Most common category for off-label prescription was inappropriate dose. Only one case was noted for Unlicensed Drug Use. Offlabel Drug prescribing significantly correlated with age of the patient and number of Drugs per prescription. Conclusion: Off-label Drug Use is prevalent in paediatric outpatient department, amoxicillin being the commonest Drug. Key words: Drug utilization, Off-label, Outdoor patients, Paediatric, Unlicensed.
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Drug utilization in pediatric neurology outpatient department a prospective study at a tertiary care teaching hospital
Journal of basic and clinical pharmacy, 2014Co-Authors: Krutika M Bhatt, Supriya D Malhotra, Kamlesh P Patel, Varsha J PatelAbstract:Background: Neurological disorders are a significant caUse of morbidity, mortality and adversely affect quality of life among pediatric patients. In India, more than 30% population is under 20 years of age, many of whom present late during the course of illness. Several Drugs prescribed to pediatric population suffering from neurological disorders may be off label or Unlicensed. Aims and Objectives: To study Drug Use pattern, identify offâÂÂÂÂlabel/Unlicensed Drug Use and to check potential for DrugâÂÂÂÂDrug interactions in patients attending outpatient department of pediatric neurology at a tertiary care teaching hospital. Methodology: Prescriptions of patients attending pediatric neurology outpatient department were collected prospectively for 8 weeks. They were analyzed for prescribing pattern, WHO core prescribing indicators, offâÂÂÂÂlabel/Unlicensed Drug Use and potential for DrugâÂÂÂÂDrug interactions. Result: A total of 140 prescriptions were collected, male female ratio being 2:1. Epilepsy was the most common diagnosis (73.57%) followed by breath holding spells, migraine and developmental disorders. Partial seizure was the most common type of epilepsy (52.42%). Average number of Drugs prescribed per patient was 1.56. Most commonly prescribed Drug was sodium valproate (25.11%) followed by phenytoin (11.41%). About 16% of the prescriptions contained newer antiepileptic Drugs. More than 60% of the Drugs were prescribed from WHO essential Drug list. In 8.57% of cases Drugs were prescribed in offâÂÂÂÂlabel/Unlicensed manner. TwentyâÂÂÂÂsix percent prescriptions showed potential for Drug interactions. Conclusion: Epilepsy is the most common neurological disease among children and adolescents. Sodium valproate is the most commonly prescribed Drug. A few prescriptions contained offâÂÂÂÂlabel/Unlicensed Drugs.
