BackgroundA 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.MethodA 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.ResultsThe 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.ConclusionManipulations 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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systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice.International Journal of Pharmaceutics http://dx.doi.org/10. 1016/j.ijpharm.2016.12.032 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. This study sought to determine whether there is an evidence base for drug manipulation to obtain 37 the required dose, a common feature of paediatric clinical practice. A systematic review of the 38 data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic 39 reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any 40 dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, 41 contamination and comparison of methods of manipulation were included. Case studies and 42 letters were excluded. Fifty studies were eligible for inclusion, 49 of which involved tablets 43 being cut, split, crushed or dispersed. The remaining one study involved the manipulation of 44 suppositories of one drug. No eligible studies concerning manipulation of oral capsules or 45 liquids, rectal enemas, nebuliser solutions, injections or transdermal patches were identified. 46Twenty four of the tablet studies considered dose accuracy using weight and/or drug content. In 47 studies that considered weight using adapted pharmacopoeial specifications, the percentage of 48 halved tablets meeting these specifications ranged from 30% to 100%. Eighteen studies 49 investigated bioavailability, pharmacokinetics or clinical outcomes following manipulations 50 which included nine delayed or modified release formulations. In each of these nine studies the 51 entirety of the dosage form was administered. Only one of the 18 studies was identified where 52 drugs were manipulated to obtain a proportion of the dosage form, and that proportion 53 administered. The five studies that considered patient perception found that having to manipulate 54 the tablets did not have a negative impact on adherence. Of the 49 studies only two studies 55 reported investigating children. This review yielded limited evidence to support manipulation of 56 medicines for children. The results cannot be extrapolated between dosage forms, methods of 57 manipulation or between different brands of the same drug. 58 59 4 INTRODUCTION 60Many medicines given to children are used "off-label" because the medicine has only been 61 researched and authorised for adults. Often the dosage form (e.g., tablets, capsules, 62 suppositories) is suitable for administration to adults but not to younger children (Waller, 2007). 63Age...

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