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Manipulation of Drugs Required in Children (MODRIC) – A Guide for Health Professionals

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Context

A lack of authorised commercially available, age-appropriate formulations makes it difficult to administer medicines to babies and children. Many pharmaceutical dosage forms are designed for adults and a proportion of the available dose may therefore be required for administration to paediatric patients. This can lead to manipulation of the medicine at the point of care. An observational research study conducted on neonatal and paediatric wards in North West England combined with a national questionnaire study (MODRIC) identified that the manipulation of drugs to achieve the required dose was common practice but not supported by guidelines or evidence.

Aims

•To describe options available to avoid manipulation of medicines •Where manipulation is necessary, to provide readily accessible, easy to read guidance for delivering appropriate and reproducible medicine doses to neonatal and paediatric patients where no suitable medicinal product is available at the point of care •To reduce risk to the product functionality, patient, person undertaking the manipulation and environment •To inform healthcare professionals of best practice and potential risk associated with manipulation of medicines •To raise awareness amongst regulators, advisory bodies and the pharmaceutical industry that manipulations occur but that carers would not have to manipulate if age-appropriate dosage forms

Description

This guideline summarises the evidence from a systematic review alongside the findings from an observational study of manipulations in neonatal and paediatric practice and a questionnaire administered to a sample of children’s nurses throughout the UK. Key features are: a) An introductory statement on options to avoid manipulation of medicines (e.g. appropriate dose-rounding, consideration of a similar but alternative pharmacological product). b) A description of the manipulation of medicinal products to deliver an appropriate dose in the absence of a suitable formulation at the point of care. This includes the methods of manipulation considered appropriate for solid oral dose forms and preparations intended for injection, inhalation, rectal and topical administration. c) An assessment of risk potential for the patient, product and operator when performing a manipulation.

Implementation

Manipulation of Drugs Required in Children (MODRIC) – A Guide for Health Professionals has been made available and publicised within the organisations in which it was developed. To date there are no data on the impact of its implementation but an evaluation of its impact in the context of a package of medication safety work is planned.

Suggestions for further implementation

The recommendations within the guideline have been developed primarily for Healthcare Professionals working in the UK, but could be used as a reference document by international parties developing local guidance.With additional stakeholder consultation (currently ongoing),they could be adapted to provide information for parents/carers who need to manipulate medicines at home.

Challenges and learning

In future similar projects, we would disseminate our guidelines/tool more rapidly and extensively in order to maximise their impact in a timely manner. This would be achieved by factoring in appropriate resources for the formulation and execution of an effective dissemination strategy. A strength of the development process was the bringing together of a broad-based multidisciplinary team, with complementary skills and knowledge inclusive of a rigorous approach to the identification, assessment and interpretation of the available evidence. In addition there was considerable experience within the team around processes for guideline development, both national (NICE) and international (WHO).

Quality assurance/MHRA registration

The Guideline Development Group (for composition see below) included representatives from healthcare professionals,guideline experts,formulations experts, parents and quality control professionals.A writing group from the MODRIC (Manipulations of Drugs Required in Children) Steering Committee drafted the initial Guideline and the recommendations.These drafts were discussed and further developed by the guideline development