Themes associated with uncollected paediatric prescriptions at a large tertiary children's hospital: a retrospective, observational study.

OBJECTIVE: This study aimed to assess the number of prescriptions that were uncollected by caregivers to identify any predisposing systemic themes that may act as barriers to children receiving medications. STUDY DESIGN AND SETTING: Data were retrospectively collected on uncollected prescriptions at a single, tertiary paediatric centre over a 2-month period. This included type and classification of the drug, prescriber specialty, the timing of prescription and the child's registered postcode. Key themes were identified. RESULTS: A total of 124 uncollected prescriptions involving 94 patients were included. 103 (83%) of these were clinic prescriptions, and azathioprine was the most frequently uncollected prescription (n=6, 5%). The uncollected prescriptions most commonly fell under the 'gastrointestinal system' (n=26, 21%) and 'skin' (n=24, 19%) categories, and similarly, 24 (19%) were prescribed by the gastroenterology department and 18 (15%) by dermatology. The mean distance from the child's registered postcode was 8.5±11.8 miles (range 0.5-73.4) with a considerable number of children having a registered postcode greater than 10 miles from the hospital (n=24, 27%). Many children lived in areas corresponding to the lowest decile of the Index of Multiple Deprivation (IMD) (n=38, 42%). CONCLUSION: Urgent interventions and further prospective studies are needed to minimise the barriers that caregivers face in collecting their child's prescription.

Medication Safety Gaps in English Pediatric Inpatient Units: An Exploration Using Work Domain Analysis.

OBJECTIVES: Medication is a common cause of preventable medical harm in pediatric inpatients. This study aimed to examine the sociotechnical system surrounding pediatric medicines management, to identify potential gaps in this system and how these might contribute to adverse drug events (ADEs). METHODS: An exploratory prospective qualitative study in pediatric wards in three hospitals in the north of England was conducted between October 2020 and May 2022. Analysis included a documentary analysis of 72 policies and procedures and analysis of field notes from 60 hours of participant observation. The cognitive work analysis prompt framework was used to generate a work domain analysis (WDA) and identify potential contributory factors to ADEs. RESULTS: The WDA identified 2 functional purposes, 7 value/priority measures, 6 purpose-related functions, 11 object-related processes and 14 objects. Structured means-ends connections supported identification of 3 potential contributory factors-resource limitations, cognitive demands, and adaptation of processes. The lack of resources (equipment, materials, knowledge, and experience) created an environment where distractions and interruptions were unavoidable. Families helped provide practical support in medicines administration but were largely unacknowledged at an organizational level. There was a lack of teamwork with regards to medication with different professionals responsible for different parts of the system. Mandated safety checks on medicines were frequently omitted because of limited resources and perceived redundancy. Interventions to support adherence to safety policies were also often bypassed because they created more work. CONCLUSIONS: The WDA has provided insights into the complex system of medication safety for children in hospital and has facilitated the identification of potential contributory factors to ADEs. We therefore advocate (in priority order) for processes to involve parents in the care of their children in hospital, development of skill-mix interventions to ensure appropriate expertise is available where it is needed, and modified checking procedures to permit staff to use their skills and judgment effectively and efficiently.

Evaluation of age-banded dosing of oral paracetamol in hospitalised children: a retrospective analysis using clinical data in a tertiary paediatric hospital.

OBJECTIVE: To evaluate age-banded dosing in paediatric inpatients by determining the proportion of patients whose dose would fall outside the therapeutic range (by weight). DESIGN: A retrospective observational study. Weight and height measurements and details of hospital admissions were matched from the electronic patient record of a single, tertiary paediatric hospital. Dosage which would be given according to age-banded dosing was then compared with their weight. PARTICIPANTS: All children admitted to a single tertiary children's hospital aged 3 months to 16 years over a 5-year period. Data were cleaned to remove values likely to be erroneous and filtered to reduce bias due to patients who were admitted on multiple occasions. OUTCOMES: The main outcome was the proportion of patients who would receive a subtherapeutic or supratherapeutic paracetamol dose if given a dose based on their age. Secondary outcomes were to examine this in children of different ages and to examine the impact of alternative size-based dosing strategies. RESULTS: 100 047 admissions (in 68 310 patients) had a weight documented. If age-banded dosing had been used, a subtherapeutic dose (less than 10 mg/kg) would be given during 19 829 (20%) of the admissions and a supratherapeutic dose (over 18.75 mg/kg, 75 mg/kg/day in four doses) in 4289 (4.3%). The highest risk of a subtherapeutic dose occurred in infants just prior to reaching 6 months of age (83%) and in children just prior to reaching 8 years (66%). The highest risk of a supratherapeutic dose was at 12 years of age (35%). CONCLUSION: Age-banded dosing is not suitable for an inpatient paediatric population as approximately a quarter of patients receive a dose outside the recommended range of 10.0-18.75 mg/kg.

A review of paediatric injectable drug delivery to inform the study of product acceptability - An introduction.

AIM: The EMA defines acceptability as "the overall ability and willingness of the patient to use, and their caregiver to administer, the medicine as intended" [1]. This paper seeks to outline issues of acceptability in relation to injectable therapy, namely intravenous (IV), intramuscular (IM) and subcutaneous (SC) administration routes, and to lay a foundation to identify a minimum set of data that would satisfy Regulatory Authorities when discussing the acceptability of an injectable product. In addition, it will alert drug product developers to other factors that might contribute to good practice, alternative administration strategies and overall adherence to achieve successful treatment. Whilst the term 'parenteral' means "outside the intestine" [2,3] and so potentially covers a range of administration routes including intranasal and percutaneous administration, this review focuses on IV, IM and SC administration by injection. The use of indwelling canulae or catheters to reduce venepuncture and facilitate prolonged treatment is common and may impact acceptability [4]. This may be influenced by information provided by the manufacturer but is not always in their direct control. Other injectable products suitable for routes such as intradermal, intra-articular, intraosseous and intrathecal, share the requirement to be acceptable but are not specifically covered in this paper [2,5].

The use of Special-Order products in England between 2012 and 2020: An insight into the need for Point-of-Care manufacturing.

Point-of-care manufacturing such as 3D printing has recently received significant attention from regulatory bodies and the pharmaceutical industry. However, little information is available on the quantity of the most prescribed patient-specific items, their dosage form, and why they were required to be dispensed. In England, 'Specials' are unlicensed medicines formulated to meet the requirements of a specific prescription, prescribed if no suitable licensed alternative exists. This work aims to quantify and examine trends in the prescribing of 'Specials' in England during 2012-2020, using the NHS Business Services Authority (NHSBSA) database. Quarterly prescription data from NHSBSA for the top 500 'Specials' by quantity from 2012 to 2020 were compiled yearly. The changes in net ingredient cost, the number of items, British National Formulary (BNF) drug category, dosage form, and a potential reason for requiring a 'Special' were identified. In addition, the cost-per-unit was calculated for each category. The total spending on 'Specials' decreased by 62 % from £109.2 M in 2012 to £41.4 M in 2020, primarily due to a 55.1 % reduction in the number of 'Specials' items issued. The most frequently prescribed dosage form type of 'Special' was oral dosage forms (59.6 % of all items in 2020) particularly oral liquids. The most common reason for prescribing a 'Special' was an inappropriate dosage form (74 % of all 'Specials' in 2020). The total number of items dropped over the 8 years as commonly prescribed 'Specials' such as melatonin and cholecalciferol became licensed. In conclusion, the total spending on 'Specials' dropped from 2012 to 2020 primarily due to a reduction in the number of 'Specials' items issued and pricing changes in the Drug tariff. Based on the current demand for 'special order' products, these findings are instrumental for formulation scientists to identify 'Special' formulations to design the next generation of extemporaneous medicine to be produced at the point of care.

Ibuprofen efficacy, tolerability and safety in obese children: a systematic review.

OBJECTIVE: Childhood obesity can affect drug disposition and efficacy of ibuprofen. The primary objective was to assess efficacy of ibuprofen in obese children. DESIGN: A systematic review was undertaken following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology. Studies were identified from 12 databases. Two independent reviewers evaluated studies against the inclusion criteria and assessed for methodological quality. SETTING: Any clinical setting. PATIENTS: Patients under 18 years who were overweight/obese. INTERVENTIONS: Patients taking ibuprofen for any indication, dose or regimen. MAIN OUTCOME MEASURES: The efficacy and tolerability of ibuprofen treatment in obese children and presence of any adverse drug reactions. RESULTS: Searches identified 1305 studies. Four studies met inclusion criteria: three retrospective cohort studies (n=583, median age: 6 years, range: 1-18 years; n=200, median age: 11 years, range: 3-18 years; n=358 median age: 3.1 years, range: 1.2-8.5 years, respectively) and one case study. Each study differed in their method of dosing ibuprofen (weight-based, age-based and adjusted body weight dosing). Various doses were used: 5 mg/kg every 6 hours, 400 mg three times a day, 120 mg/dose and a dose calculated using adjusted body weight. One study reported efficacy (obese n=189, non-obese, n=394), where adequate pain control was achieved using 5 mg/kg. The other three studies did not determine if efficacy differed between obese and non-obese children.One study described adverse effects. An increased risk of bleeding with ibuprofen was noted but did not differentiate between obese and non-obese children. CONCLUSION: There are little published data to guide clinicians prescribing ibuprofen in obese children. PROSPERO REGISTRATION NUMBER: CRD42021213500.

The impact of paediatric dose range checking software.

OBJECTIVE: Dosing errors can cause significant harm in paediatric healthcare settings. Our objective was to investigate the effects of paediatric dose range checking (DRC) clinical decision support (CDS) software on overdosing-related outcomes. METHODS: A before-after study and a semistructured survey of prescribers was conducted across inpatient wards (excluding intensive care) in a regional children's hospital. DRC CDS software linked to a paediatric drug formulary was integrated into an existing electronic prescribing system. The main outcome measures were; the proportion of prescriptions with overdosing errors; overdosing-related clinical incidents; severity of clinical incidents; and acceptability of the intervention. RESULTS: The prescription overdosing error rate did not change significantly following the introduction of DRC CDS software: in the preintervention period 12/847 (1.4%) prescriptions resulted in prescription errors and in the postintervention period there were 9/684 (1.3%) prescription overdosing errors (n=21, Pearson χ2 value=0.028, p=0.868). However, there was a significant trend towards a reduction in the severity of harm associated with reported overdosing incidents (n=60, Mann-Whitney U value=301.0, p=0.012). Prescribers reported that the intervention was beneficial and they were also able to identify factors that may have contributed to the persistence of overdosing errors. CONCLUSION: DRC CDS software did not reduce the incidence of prescription overdosing errors in a paediatric hospital setting but the level of harm associated with the overdosing errors may have been reduced. Use of the software seemed to be safe and it was perceived to be beneficial by prescribers.

Cross-sectional study of prescribing errors in patients admitted to nine hospitals across North West England.

OBJECTIVE: To evaluate the prevalence, type and severity of prescribing errors observed between grades of prescriber, ward area, admission or discharge and type of medication prescribed. DESIGN: Ward-based clinical pharmacists prospectively documented prescribing errors at the point of clinically checking admission or discharge prescriptions. Error categories and severities were assigned at the point of data collection, and verified independently by the study team. SETTING: Prospective study of nine diverse National Health Service hospitals in North West England, including teaching hospitals, district hospitals and specialist services for paediatrics, women and mental health. RESULTS: Of 4238 prescriptions evaluated, one or more error was observed in 1857 (43.8%) prescriptions, with a total of 3011 errors observed. Of these, 1264 (41.9%) were minor, 1629 (54.1%) were significant, 109 (3.6%) were serious and 9 (0.30%) were potentially life threatening. The majority of errors considered to be potentially lethal (n=9) were dosing errors (n=8), mostly relating to overdose (n=7). The rate of error was not significantly different between newly qualified doctors compared with junior, middle grade or senior doctors. Multivariable analyses revealed the strongest predictor of error was the number of items on a prescription (risk of error increased 14% for each additional item). We observed a high rate of error from medication omission, particularly among patients admitted acutely into hospital. Electronic prescribing systems could potentially have prevented up to a quarter of (but not all) errors. CONCLUSIONS: In contrast to other studies, prescriber experience did not impact on overall error rate (although there were qualitative differences in error category). Given that multiple drug therapies are now the norm for many medical conditions, health systems should introduce and retain safeguards which detect and prevent error, in addition to continuing training and education, and migration to electronic prescribing systems.

Adverse events associated with intravenous phenytoin in children: a prospective study.

A prospective study was undertaken to assess the type and frequency of adverse side-effects following the use of intravenous phenytoin in children. Twenty-two children received a total of 100 doses over a 10-month period. Six patients (27%) experienced one or more side-effects, including extravasation of the drug, hypotension and cardiac arrhythmia. No patient developed skin necrosis, including the 'purple glove syndrome'. Recovery from all adverse side-effects was spontaneous and complete. It is possible that some or all of these side-effects may have been caused by an excessive rate of infusion of phenytoin or the saline 'flush' following administration of the drug. The overall frequency of side-effects was perhaps less than expected.