Summary: | Background: There is a lack of commercially-available, age-appropriate formulations designed for administration to babies and children. This means that medicines may need to be manipulated to achieve the dose that is required in paediatric practice. This raises concerns about the dose accuracy and safety of the manipulated product. Though this is known and accepted as necessary, to date there has been no assessment of the evidence relating to these manipulations, the extent and nature of manipulations or of any associated practice issues. Objective: This thesis aimed to determine whether there is an evidence base for drug manipulations, to investigate the nature of manipulations, at the point of administration, in current clinical practice in neonatal and paediatric settings in the UK and to explore drug manipulations in the context of long-term medication administration by parents. Methods: Several methods were used to explore drug manipulations: a wide-ranging systematic review, an observation based study of drug manipulations in in-patient neonatal and paediatric areas, a UK wide survey of paediatric nurses and an interview based study with parents of children taking long-term medications. Outcomes: Manipulations to administer the required dose occur throughout practice and are not supported by evidence. Drug manipulation is intrinsic in neonatal and paediatric practice. Manipulations were identified more often in high dependency areas but were found throughout all clinical areas. Manipulations occurred more commonly with certain dosage forms, notably with tablets, but were found involving many dosage forms. Manipulations were identified involving drugs that are commonly prescribed and for prescriptions that had been written for babies and children of all ages and with a wide variety of diagnoses. Concerns relating to drug manipulations have been raised by those working in these areas. Parents described undertaking manipulations prior to administering medications to children, though undertaking these manipulations did not appear to cause undue concern. Conclusions: This thesis has reviewed the limited evidence, scoped out the nature of manipulations used in practice and by parents and suggested areas where future work would be appropriate. In exploring drug manipulation this thesis has added to ongoing discussion about the need for appropriate medication for paediatric use.
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