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

Abstract

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.

Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

“…This can be 375 with the aim to improve acceptability, to facilitate administration, provide an appropriate dose, or a combination thereof. The nature, motives and consequences of these practices remains an under researched area; however, they have been widely reported amongst healthcare professionals (Skwierczynski and Conroy, 2008, Akram and Mullen, 2012, Richey et al, 2013 and as "coping strategies" among children and their caregivers (Hansen et al, 2008, Adams et al, 2013, Bryson, 380 2014.…”

Relative bioavailability of bedaquiline tablets suspended in water: Implications for dosing in children

“…Data on the safety and dosing of bedaquiline from paediatric trials across the age range (0–17 years) is expected to be available long before the paediatric formulation used in the studies is registered and widely available, as there are many barriers preventing access to TB medications in children 20, including the development, manufacturer, licensure, procurement and uptake of paediatric drug formulations. Given no other choice due to the lack of child friendly formulations, adult formulations manipulated either by splitting, crushing, dissolving or suspending are frequently used in paediatric TB care, especially for MDR‐TB 10. However, the impact of such manipulation on drug exposures or formulation acceptability is often unknown.…”

“…However, administration of these tablets to young children who cannot swallow tablets may require suspending or crushing the adult formulation. Such formulation manipulation for paediatric administration, which is commonly done for most second‐line TB drugs given in children, may affect the bioavailability 10. Characterizing the effect of suspending bedaquiline tablets on the bioavailability would inform the safe and effective use of this formulation in young children, potentially accelerating access to this much needed medication, given limited treatment options and availability of child‐friendly formulations in children.…”

Extemporaneous Compounding Practice by Pharmacists: A Systematic Review

“…Most of the studies were using pharmacists in hospital or community practice as a target of respondents [13,14,17,18]. Two studies are invited hospital pharmacists for data source [11,15]. Richey et al [11], Pappas et al [12] and Lindbald et al [16] invited physicians served as a respondent for the source of information [11,12].…”

“…Five studies used a questionnaire to identify the current practice of compounding [7,[11][12][13][14], with various way of delivering questionnaire include self-administered, face to face interviews [13], or mailed questionnaire. Richey used a combination of questionnaire and direct observation and compared the results of data [11]. Two studies conducted data records in practice including logbook of compounding [15] and prescription record [16].…”