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      Manipulation of drugs to achieve the required dose is intrinsic to paediatric practice but is not supported by guidelines or evidence

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          Abstract

          Background

          A lack of age-appropriate formulations can make it difficult to administer medicines to children. A manipulation of the dosage form may be required to achieve the required dose. This study aimed to describe medicines that are manipulated to achieve the required dose in paediatric practice.

          Method

          A structured, undisguised observational study and postal survey. The observational study investigated drug manipulations occurring in clinical practice across three sites. The questionnaire, administered to a sample of paediatric nurses throughout the UK, surveyed manipulations conducted and nurses’ experiences and views.

          Results

          The observational study identified 310 manipulations, of which 62% involved tablets, 21% were intravenous drugs and 10% were sachets. Of the 54 observed manipulations 40 involved tablets with 65% of the tablets being cut and 30% dispersed to obtain a smaller dose. 188 manipulations were reported by questionnaire respondents, of these 46% involved tablets, 12% were intravenous drugs, and 12% were nebuliser solutions. Manipulations were predominantly, but not exclusively, identified in specialist clinical areas with more highly dependent patients. Questionnaire respondents were concerned about the accuracy of the dose achieved following manipulations and the lack of practice guidance.

          Conclusion

          Manipulations to achieve the required dose occur throughout paediatric in-patient settings. The impact of manipulations on the efficacy of the drugs, the accuracy of the dose and any adverse effects on patients is not known. There is a need to develop evidence-based guidance for manipulations of medicines in children.

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          Most cited references16

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          Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

          To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries. Prospective study of drugs administered to children in general paediatric medical wards over four weeks. Children's wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands). Children aged 4 days to 16 years admitted to general paediatric medical wards. Proportion of drugs that were used in an unlicensed or off label manner. 2262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all drug prescriptions (1036; 46%) were either unlicensed or off label. Of these 1036, 872 were off label and 164 were unlicensed. Over half of the patients (421; 67%) received an unlicensed or off label drug prescription. Use of off label or unlicensed drugs to treat children is widespread. This problem is likely to affect children throughout Europe and requires European action.
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            Survey of unlicensed and off label drug use in paediatric wards in European countries

            S Conroy (2000)
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              Tablet-splitting: a common yet not so innocent practice.

               This paper is a report of a study conducted to quantify (i) the mean deviation from theoretical weight and (ii) the mean weight loss, after tablet-splitting with three different, commonly used splitting methods.  Tablet-splitting is a widespread practice among all sectors of health care for different reasons: it increases dose flexibility, makes tablet parts easier to swallow and allows cost savings for both patients and healthcare providers. However, the tablet parts obtained are often not equal in size, and a substantial amount of tablet can be lost during splitting. Five volunteers were asked to mimic the situation in nursing homes and to split eight tablets of different sizes and shapes using three different routine methods: (i) with a splitting device (Pilomat® ), (ii) with scissors for unscored tablets or manual splitting for scored tablets and (iii) with a kitchen knife. Before and after splitting, tablets and tablet parts were weighed using an analytical balance. The data were collected in 2007. For all tablets, method 1 gave a statistically significantly lower mean deviation from theoretical weight. The difference between method 2 and method 3 was not statistically significant. When pooling the different products, method 1 also induced significantly less weight loss than the two other methods.  Large dose deviations or weight losses can occur while splitting tablets. This could have serious clinical consequences for medications with a narrow therapeutic-toxic range. On the basis of the results in this report, we recommend use of a splitting device when splitting cannot be avoided. © 2010 Blackwell Publishing Ltd.
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                Author and article information

                Journal
                BMC Pediatr
                BMC Pediatr
                BMC Pediatrics
                BioMed Central
                1471-2431
                2013
                21 May 2013
                : 13
                : 81
                Affiliations
                [1 ]Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool L12 2AP, UK
                [2 ]Cheshire, Merseyside & North Wales Medicines for Children Local Research Network, Eaton Road, Liverpool, L12 2AP, UK
                [3 ]School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK
                [4 ]Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK
                [5 ]NIHR Medicines for Children Research Network Co-ordinating Centre, Institute of Child Health, University of Liverpool, Liverpool L12 2AP, UK
                [6 ]Liverpool Women’s Hospital NHS Foundation Trust, Crown Street, Liverpool L8 7SS, UK
                Article
                1471-2431-13-81
                10.1186/1471-2431-13-81
                3691579
                23688279
                9cd52c78-3250-4384-8f44-6143e570566c
                Copyright ©2013 Richey et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 21 November 2012
                : 2 May 2013
                Categories
                Research Article

                Pediatrics
                drug manipulation,survey,dosage forms,children's medicines
                Pediatrics
                drug manipulation, survey, dosage forms, children's medicines

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