Manipulation of medicines, necessary in everyday practice for individualised doses in paediatric care

Introduction: Manipulation of medicines is often necessary in the paediatric setting due to lack of medicines suitable for paediatric patients. There are previous short-term frequency studies in different paediatric settings, but no long-term studies and no comparison between two different years in the same setting. In 2007 the Paediatric Regulation was implemented in Europe to stimulate drug companies to develop more information around medicines for children and new dosage forms suitable for paediatric patients. An alternative to manipulation of medicines is to use extemporaneous preparations in correct strengths. Aim: The overall research aim of this thesis was to study how and to what extent manipulation of medicines is being done and its effect on dosing accuracy in paediatric care. A specific aim was to compare the use of extemporaneous preparations in two different years. Methods: The setting for three of the four studies was a large paediatric university hospital in Sweden, and the fourth study was performed at a hospital pharmacy. Data for paper I and IV were extracted from a large registry containing material regarding patient data, care, and medicines from the hospital electronic health record, TakeCare. In Paper I data regarding all solid oral and rectal administrations where a part of a solid dosage form needed to be administered were counted. Comparisons were then made between the included study years 2009 and 2019 and between inpatients and patients at the emergency department. Semi-structured interviews with registered nurses and pharmacists were performed in Paper II. All interviews were audio recorded, transcribed verbatim, and analysed qualitatively using content analysis. In Paper III five different brands of tablets were split into halves and quarters. The resulting parts were then weighed and compared with expected weight, according to criteria in the European Pharmacopoeia and the United States Pharmacopoeia. The frequency of patients with at least one oral extemporaneous preparation was counted from the registry data and compared for inpatients in 2009 and 2019 in Paper IV. Results: There was no difference in the frequency of inpatients with manipulated oral medicines, when comparing data from 2009 and 2019. For manipulations of rectal medicines there was a statistically significant decrease for both inpatients and patients at the emergency department, as well as for manipulations of oral medicines to patients at the emergency department. Registered nurses and pharmacists state that manipulation of medicines to paediatric patients is frequent, and forces both professions to work outside the box. Splitting of tablets into halves results in more correct parts than splitting further into quarters. The frequency of patients with extemporaneous preparations increased between the study years. Conclusion: There is still a lack of suitable dosage forms and strengths of medicines to paediatric patients in 2019 which leads to manipulation of medicines, or the use of extemporaneous preparations. For individual substances the introduction of a dosage form suitable for paediatric use, decreases, or even erases the need to manipulate or use extemporaneous preparations. Pharmacists are valued members in the ward team, contributing with specific knowledge around medicines