This report describes the methods and findings of a systematic review on paediatric medication error (PME). Paediatric medication errors are failures in the treatment process that cause, or have the potential to cause unnecessary pain or harm to child patients and, in extreme cases, can result in death (Aronson 2009¹; Department of Health 2006²). Medications may be given incorrectly (or omitted) either unintentionally or in ignorance, i.e. a mistake or slip in the medication treatment process. Medication errors are a common occurrence in the healthcare setting (Levine et al. 2001³) and are the most common type of errors in paediatric medicine (Ghaleb et al. 2010º). This review examines evidence on three key issues: the extent and nature of the problem in the UK; whether interventions, such as electronic prescribing or decision support tools, can reduce PME incidents; and what the key features of successful interventions are, to establish how effective interventions can be developed and implemented successfully. It was commissioned by the Department of Health (DH) in England to support the work of the Children and Young People’s Health Outcomes (CYPHO) Forum in tackling the problem of PME.
The systematic review method was used to assemble a comprehensive and unbiased summary of available research evidence on PME. The work involved employing rigorous methods for identifying and analysing available research evidence to answer the following research questions:
- What is the nature and extent of paediatric medication error (PME) in the UK?
- Which international interventions are effective for reducing the incidence of PME?
- What are the key features of effective interventions and how can they be successfully developed and implemented?
a) What is the nature and extent of paediatric medication error (PME) in the UK?
The evidence base
- 11 studies reporting national-level evidence from England, Wales and Scotland were identified.
- Five studies examined evidence from error reporting systems largely in relation to acute care; six studies identified errors from prescribing data largely in relation to primary care.
- In primary care settings, off-label prescribing is a common practice, resulting in dose errors in relation to a wide range of drugs, including antibiotics and paracetamol.
- The type of drug and the age of the patient affects whether underdoses or overdoses are more likely to be prescribed.
- In paediatric and neonatal acute care settings, dose errors are the most common type of medication error, accounting for approximately one-fifth of all errors.
- After dose errors, the next most common types of error in acute care are omitted medicine/ingredient, wrong frequency, wrong quantity and wrong drug.
- Most medication errors relating to anaesthesia are administration errors, of which ‘double doses’ account for almost half; wrong drug and wrong route administration errors are also common. 10% of incidents are prescription errors but it is unclear what types of prescription errors are involved.
- Almost half of errors relating to vaccine administration are due to administration of the wrong vaccine, over one-quarter are documentation errors and one-eighth relate to delayed vaccination.
- In relation to the preparation of paediatric chemotherapy, the three most common types of potential error are mislabelled products, wrong expiry date and transcription errors.
- In relation to parenteral nutrition preparation, transcription error, wrong drug error and labelling error were the most common types.
- Reporting of errors in the UK is currently (a) voluntary and (b) inconsistently recorded, so an accurate and comprehensive picture of rate or types of PME in UK is not currently available.
- There is a lack of evidence directly comparing which pathway points are most commonly associated with PMEs (e.g. prescribing, administration), meaning that it remains unclear as to which types of interventions would be most appropriate to target the problem.
- Although the use of ‘specials’ (i.e. the preparation of medicines in a form which is not licensed) is known to be an issue for paediatrics, due to a lack of available child-friendly dosage forms, we found no evidence on their use.
b) Which interventions are effective for reducing the incidence of PME?
The evidence base
- 37 trials were identified which evaluated the impact of interventions on PME outcomes.
- The largest body of evidence relates to electronic prescribing (n=20 trials).
- Reasonable bodies of evidence were identified in relation to education interventions (n=6 trials) and clinical decision support tools (CDST) (n=5 trials).
- Single trials were identified for each of a further six intervention types: pharmacist support, standardised paediatric formulation, structured prescription order forms, integrated care pathways, mass concentration labelling, patient history-taking software.
- Most studies examined impact on PME; other outcomes included adverse drug events (ADE), mortality, turn-around times and medication knowledge.
- Of fifteen studies examining the impact of electronic prescribing on PME, nine found statistically significant reductions and a further four found non-significant trends towards reduced PME; two studies found small non-significant increases in PME.
- Overall evidence suggests that electronic prescribing reduces mortality rates and adverse drug events (ADE), though some studies illustrated that it can be responsible for increases in these outcomes.
- Electronic prescribing may reduce turn-around times.
- Clinical decision support tools (CDST) may reduce PME and turn-around times.
- Education interventions may reduce PME and increase medication knowledge.
- Statistically significant reductions in PME were found in each of the single studies on paediatric formulations, integrated care pathways, structured prescription order forms and mass concentration labelling.
- A non-significant reduction in PME was found in the study on a computer programme for parents to support patient history taking.
- The single trial of a pharmacist support intervention was found to have significant risk of bias – therefore no conclusions can be drawn regarding this type of intervention.
- No controlled trials were identified regarding other potentially key interventions such as smart pumps.
c) What are the key features of effective interventions and how can they be successfully developed and implemented?
The evidence base
- We examined the content, development and implementation of intervention types for which strong and/or promising evidence of effectiveness was identified.
- A total of 31 interventions were examined in-depth: electronic prescribing (n=20), CDSTs (n=5) and education interventions (n=6).
- Electronic prescribing interventions achieving positive outcomes were typically customised for use with children and incorporated extensive decision support; in the three EP studies with negative findings (e.g. increased mortality) these features were largely absent.
- Evidence suggests that development and implementation of successful electronic prescribing involves: customisation for use with child patients, engaging with a range of stakeholders during development, fostering a high level of familiarity with the system prior to use, ensuring adequate IT systems and compatibility with existing hospital systems and infrastructure, careful planning and ongoing iterative development post-implementation.
- CDST interventions were less comparable than electronic prescribing interventions; they varied according to whether they were aimed at healthcare professionals or parents/carers – and whether they were designed to support administration or prescription decisions.
- Key features of CDSTs were colour coding systems, hand-held information tools or on-line information tools.
- CDSTs were viewed by users as ‘a good idea’ and were felt to increase confidence in decision making; authors suggested that the efficacy of CDSTs rests on achieving a balance between simplicity of the tool and comprehensiveness of the information
- Two key types of education interventions were identified - paediatric prescribing education for clinicians and pictographic liquid medication administration education for parents/carers
- Web-based clinician education and pictographic instructions for parents were found to be successful approaches to education; authors indicated that accessibility, low cost and ease of delivery were important features for success.
- Few studies incorporated formal process evaluations, so the findings about development and implementation are largely based on informal evidence reported by the authors of the studies.
- The smaller evidence base and the lack of comparability among the CDST and education interventions makes it difficult to determine how to develop and implement these interventions successfully.
- Dose errors appear to be a common problem in both primary care (strong evidence) and acute care (promising evidence). However, an accurate and comprehensive picture of the rates and types of PME in the UK is not currently available, largely because error reporting is often voluntary and there is significant inconsistency in the recording and categorising of errors.
- International evidence on interventions to tackle PME shows strong evidence of effectiveness for electronic prescribing; evidence regarding the efficacy of CDSTs and education interventions is promising.
- Evidence suggests that the way electronic prescribing systems are developed and implemented is crucial to their success; successful electronic prescribing systems require careful and considered development and implementation, should feature comprehensive decision support and should be customised for use with children.
Aronson JK (2009) Medication errors: what they are, how they happen, and how to avoid them. QJM: An International Journal of Medicine 102: 513-521.
Department of Health (2006) Standards for better health. London: The Stationery Office
Levine S, Cohen M, Blanchard N, Frederico F, Magelli M, Lomax C, Greiner G, Poole R, Lee C, Lesko A (2001) Guidelines for preventing medication errors in pediatrics. The Journal of Pediatric Pharmacology and Therapeutics 6: 426-442
Ghaleb M, Barber N, Franklin B, Wong I (2010) The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Archives of Disease in Childhood 95: 113-118