Abstract
Background: In paediatric wards, children are often reluctant to receive medication from nurses and eventually it is given by the parents. It is a common practice for nurses to hand the medication to mothers to give to their children, However, it is an ‘informal’ practice and lacks evidence-based guidelines.
Objectives: To develop a contextualised and adapted evidence-based guideline to support nurses to partner with mothers/carers so that they can safely give oral medication to their hospitalised child under the supervision of a competent nurse.
Method: Existing relevant guidelines were identified through searches of bibliographic databases and websites. The AGREE II: Appraisal of Guidelines for Research and Evaluation II instrument was used to appraise the quality of the identified sources. The process of guideline adaptation recommended by the South African Guidelines Excellence project was followed, and a list of adapted recommendations was developed, aligned with the legislative and regulatory frameworks for nursing in South Africa. Accessible end user documentation was developed.
Results: Six sources were screened and three sources were found to be eligible and were subjected to full appraisal. Two guidelines and one policy document were identified as suitable for adaptation. Expert consultation confirmed that the resulting adapted guideline was sound, easy to understand, and well presented for the target audience.
Conclusion: This process successfully led to the development of a modified evidence-based practice guideline to enable nurses to partner with mothers/caregivers in safely giving oral medication to their hospitalised child in lower-resourced African settings.
Keywords: medication; paediatrics; hospital; nursing; safety; guideline; family; mother.
Introduction
Medication errors are one of the most frequent causes of adverse events in the hospital setting and children are believed to be at a higher risk of harm from such errors (Maaskant et al. 2015). Adverse drug events and potential adverse drug events represent a considerable hazard for the paediatric inpatient population; adverse drug events also represent a large cost imposition upon the healthcare sector worldwide (Kunac et al. 2009).
Reports of the incidence of error type in the hospital setting vary. A systematic review of studies related to medication errors in children worldwide found that the most common type of medication error was dosing error (Ghaleb et al. 2006). Other studies have found that the most common medication error by nurses included omissions without valid reason and failure to record (Haw, Stubbs & Dickens 2007). Evidence regarding the extent of the problem in African healthcare settings is scarce (Mekonnen et al. 2018:1–24). A systematic review of publications related to adverse drug events in 18 African hospitals (of which six studies were from South Africa) reported higher rates of medication errors than hospitals from developed countries, although reports were variable and inconsistent (Mekonnen et al. 2018). Reported rates of medication errors in African settings vary considerably, but appear to be higher in paediatric care settings than for adult patients (Mekonnen et al. 2018), possibly because of the added complexity of dosing. Reports of more serious errors appear to be less common, but the consequences of harm can be serious, particularly in situations involving the wrong route of administration, such as an oral suspension given intravenously.
It is the legal responsibility of registered nurses to administer medication to patients, monitor reactions, as well as facilitate the attainment of optimum health for the individual and the family. The execution of the nursing regimen should be according to the legal and regulatory context of South Africa within the scope of practice of the registered nurse (South African Nursing Council [SANC] 2013) and the nurse’s regulation on acts and omissions (South African Nursing Council (SANC) 2014).
Fulfilling these responsibilities is often challenging in the context of lower-resourced African healthcare settings. Factors that contribute to medication errors in African hospitals include environmental factors, such as workplace distraction and high workload, as well as staff fatigue and inadequate knowledge or insufficient training (Mekonnen et al. 2018). Despite the acknowledged scale of the problem, there is limited evidence regarding interventions that are effective in preventing medication errors in the paediatric population (Maaskant et al. 2015) and an almost complete lack of evidence specific to the African settings. It has however been estimated that up to 43.5% of medication errors in African settings may be preventable (Mekonnen et al. 2018). Effective strategies to reduce medication errors in African settings need to be aligned with the context and realities.
A significant issue is the lack of human resources for health in many countries in sub-Saharan Africa (Hoffman et al. 2012). In paediatric wards, medication has to be checked by two registered nurses before it is administered, however this is difficult in low resourced African settings, which often leads to delays in medication administration because a second nurse is not always available on the floor.
A distinctive feature of many African paediatric wards is the presence of a caregiver (often the mother) who is admitted with the child (North et al. 2020). It has been reported that caregivers of admitted children assist with a variety of daily activities including bathing of children, feeding and even monitoring of medication for the children (Hoffman et al. 2012). It is a common practice for nurses to hand the medication to a mother/caregiver to give to their hospitalised child, if a child is reluctant to take the medication from a nurse (Williams, Caldwell & Collins 2016). However, such practice is usually informal and invisible (North et al. 2019). Nurses in lower-resourced settings are often unsure to what degree they ‘should’ involve the mothers and may have concerns about ethics or their scope of practice (Phiri, Kafulafula & Chorwe-Sungani 2017). There is still a gap in the current evidence base for parent participation, especially in developing countries given the higher levels of involvement of mothers/caregivers (Phiri et al. 2017; Power & Frank 2008).
An evidence-based practice approach will assist the nurse in moving away from traditional nursing practices, into a more current research-based approach for better patient care outcomes. Evidence-based nursing practices allow for quality improvement plans, which include clinical practice guidelines, designed to assist with different approaches to better patient care outcomes (Stetler et al. 1998). There is however a lack of high quality evidence-based practice guidelines for nurses partnering with mothers in giving oral medication to their hospitalised children, which are contextually appropriate to a South African setting. The purpose of this study was therefore to develop a contextualised and adapted evidence-based guideline to enable nurses to partner with mothers or caregivers to be competent in giving oral medication to their hospitalised child safely under the supervision of a competent nurse in the South African settings.
Research methods and design
Overview of study design
A six step method was followed for the modification of guidelines. This incorporated a three-tiered process of guideline modification recommended by Dizon, Machingaidze and Grimmer (2016) as shown in Figure 1.
Setting
This guideline is intended for use by nurses (registered professional nurse or a child nurse practitioner) and mothers or caregivers partnering together, to safely give oral medication to their hospitalised child in lower-resourced paediatric wards in South Africa.
Population
A Population–Concept–Context (P-C-C) approach was used to define the focus for the guideline, as follows:
- Population: Children in hospital and their mothers who are involved in their care.
- Concepts: The involvement of mothers in the administration of oral medication to their children.
- Context: Paediatric wards in a lower resourced health facility in Southern Africa.
Process of guideline development and rationale for guideline modification
In the following sections, a detailed description of the methods used at each of the six stages outlined above (see Figure 1) is provided.
Developing new evidence-based practice guidelines can be time-consuming and expensive, and this can be even more difficult in a low resourced country settings. A more efficient approach could be to adopt, adapt or contextualise recommendations from existing evidence-based guidelines and tailor them to the local context (Dizon et al. 2016).
Step 1: Identification of existing guidelines
A structured, transparent and replicable search (PubMed and Cumulative Index to Nursing and Allied Health Literature [CINAHL]), as well as grey literature searches were conducted using keywords to identify the existing guidelines relating to the topic of concern, with a focus on identifying sources relevant to the P-C-C approach described above.
The language selected was English; publication types included journal articles, systematic reviews, guidelines and electronic books. We did not specify a date range as we anticipated that eligible sources would be few and our aim was to be as comprehensive as possible.
Step 2: Appraisal of existing guidelines
The AGREE II: Appraisal of Guidelines for Research and Evaluation II instrument was used to appraise the quality of the identified sources (Brouwers et al. 2010).
The AGREE II instrument is a 23-item tool, with six quality domains, which enable assessment of the quality, the appropriate methodological strategies and the rigour of development. Appraisal was carried out independently by three independent reviewers who were all children (or paediatric) nurses and postgraduate students with recent training in the appraisal method. Identified guidelines were appraised individually and the scores were handed back to the project leaders for compilation and resolution of any disparities of more than three. The individual raw scores were summarised, total scores were calculated and then presented in the form of a table.
Guideline modification
As recommended by Dizon et al. (2016), the process of guideline adaptation should involve compilation of the evidence base prior to reviewing and modifying existing recommendations. A table was created to record the process of modification.
Step 3: Compilation of the evidence base
Recommendations of the each included guideline, together with the associated evidence or rationale as stated in the original guideline, were tabulated. The purpose of this was to ensure that any modifications made later would be informed by the relevant evidence base and would preserve the rigour of development of the original source.
Step 4: Modification of recommendations
The recommendations were assessed using prompts, which were adapted from the United Kingdom National Institute for Clinical Evidence (NICE) baseline assessment tool (NICE 2015). This prompted consideration of priorities, risks, relevance to the proposed setting and any additional actions that would be needed for implementation in the proposed setting. The table described above was updated to record decisions for each recommendation, which were either to: (1) include without modification, (2) include with modification or (3) exclude with stated reasons.
Consultation with content experts
Expert input is essential in determining relevance and applicability of research evidence to local contexts (Dizon et al. 2016). Content experts were consulted for expert opinion during the development of the modified guideline as part of a structured series of activities. Consultees included an advanced paediatric nurse practitioner from South Africa familiar with the process of evidence-based guideline development and postgraduate peers at University of Cape Town who were experienced paediatric nursing specialists with training in guideline appraisal and deep experience of local settings and contexts. Consultation centred on eliciting feedback and suggestions for improving draft recommendations and end user documentation, related to prioritisation and relevance, risk and safety implication issues, and comprehensive application of the evidence base.
Step 5: Scoring recommendations according to levels of evidence and grade of recommendation
For each of the new or adapted practice recommendations, we assessed whether there was a need to provide a supporting rationale or whether the existing rationale needed to be strengthened or contextualised with evidence specific to the setting. We undertook further focused literature searches with guidance from a specialist librarian to ensure that all recommendations were supported by evidence-based rationale statements. We assigned each recommendation and rationale a score for the level of evidence from I (highest quality) to V (least robust), and the grade of recommendation from A (strong evidence of efficacy, strongly recommended) to E (strong evidence against efficacy or for adverse outcome, never recommended) using the approach described by Xynos et al. (2016).
An additional scoring system was developed to support recommendations that related to the legislative and regulatory frameworks that govern nursing practices in South Africa and which could be regarded as mandatory recommendations. These recommendations were indicated as a legal requirement (LR) or regulatory requirement (RR).
Developing end user guidance documents
We wanted to ensure that the key messages of our guideline would be accessible to nurses. A flowchart is a ‘process map’ with easy to understand diagrams of step-by-step instructions to assist in understanding an existing process or develop ideas about how to improve it (Institute for Health Improvement 2020). Flowcharts are valuable in nursing as they allow for an accurate step-by-step process of how to perform a specific task, which allows for quick and efficient patient care that is in line with the policy and the protocol. Flowcharts can help nurses make quick and safe decisions to prioritise actions (Sánchez et al. 2007). As the final step in the process of guideline modification, we created a flowchart as a visual representation of the adapted and contextualised recommendations.
Results
The six step methodology described above resulted in the following outcomes at each step.
Step 1: Guideline identification
The bibliographic database search, grey literature search, and the consultation resulted in the identification of six sources. After initial screening by title and summary, two guidelines and one policy statement were selected for full text review as they met the inclusion criteria for our search. The guidelines were as follows:
- Guideline 1: ‘Guy’s and St. Thomas’ – National Health Service (NHS) (UK) Foundation Trust. (2018). Clinical Guideline/Protocol for self/carer administration of medicines to adults and paediatric patients’.
- Guideline 2 (policy statement): ‘Aberdeenshire Council (2016). Supporting Children and Young People with Health Care Needs and Managing Medicines in Educational Establishments. NHS Grampian – Aberdeenshire Council’.
- Guideline 3: ‘NICE guideline [NG5] Published date: (2015). Medicines optimisation: The safe and effective use of medicines to enable the best possible outcomes’.
Step 2: Appraisal of the existing guidelines
The individual raw scores were summarised and total scores were calculated as shown in Table 1. The widest range of scoring was found in Domain 3 (rigour of development). This may reflect the availability of information about the process of development, which was not fully described in all cases. Guideline authors were contacted by email to request additional information, however feedback received did not include any additional information.
| TABLE 1: Domain scores obtained following guideline appraisal using the AGREE II tool. |
Guideline adaptation
Step 3: Compilation of the evidence base
Levels of evidence for the relevant recommendations in the existing guidelines were scored between II (small or large randomised control trials (RCTs) with a suspicion of bias, or meta-analysis of such trials with demonstrated heterogeneity) and V (studies without control group, case reports and expert opinion).
As a result of this exercise, informed by the available evidence about medication errors in African settings, we decided that the priority areas for our guideline to focus on should be:
- Supporting nurses to partner with mothers to give medication to their child, working within a well-defined professional and ethico-legal framework
- Actions to prevent the most common and the most serious types of reported medication errors: omissions without valid reason and failure to record and wrong route of administration.
Step 4: Modification of recommendations
A total of 40 recommendations relevant to the topic were identified from the included sources. After consideration of priorities, risks and relevance to the proposed setting, none of the recommendations were identified as suitable to include without modification. A total of 21 recommendations were excluded for stated reasons including lack of applicability to the settings. A total of 19 recommendations were identified as suitable to include with modification. This remaining set of 19 recommendations contained closely similar material and the list was edited and further reduced to a final list of 12 adapted and contextualised recommendations, which were categorised into four themes (assessment, teaching, implementation and documentation) aligned with the nursing process (with the help of expert consultation). These are presented in Table 2.
| TABLE 2: Recommendations with level of evidence and grade of recommendation. |
Step 5: Scoring new recommendations according to levels of evidence and grade of recommendation
For the final list of 12 recommendations, the levels for the grades of evidence scored between II and V and strength of recommendations were graded between B and C, which was the same as before modification. Recommendations graded C were additionally supported by feedback from the clinical experts consulted, with the low grading thought to reflect a lack of impact studies rather than a likelihood of ineffectiveness.
Expert consultation confirmed that the resulting adapted guideline was sound, easy to understand and well-presented for the target audience.
Developing end user guidance documents
Step 6: Presentation of recommendations
A flowchart (Figure 2) was developed to present the 12 final recommendations as an easy way to understand visual representation of the recommendations in the form of step-by-step instructions, grouped into four themes as a quick reference for nurses in the ward. Supporting tools were included for the enrolment and training of the mother or caregiver, adapted from the Guy’s and St. Thomas’ guideline (2018). End user documentation has been made available online (see data availability statement), which include: assessment of mothers’ understanding and willingness to participate (Tool 1); and how the medicines should be given (Tool 2).
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FIGURE 2: Flowchart summary to guide nursing actions. |
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Discussion
Key findings
It has been acknowledged that current practice in many wards is for nurses to hand medication to mothers to give to their children, but this is usually an ‘informal’ practice and lacks evidence-based guidelines. We found that this issue is amenable to improvement through evidence-based guidance (Williams et al. 2016), and that there was a need for a guideline specific to the population and setting. Our contextualised and adapted evidence-based guideline is intended to enable nurses to partner with mothers or carers (regardless of literacy levels) to be competent and safely give oral medication to their hospitalised child under the supervision of a competent nurse in South African settings.
Discussion of key findings
We found limited evidence regarding interventions that are effective in preventing medication errors in the paediatric population (Maaskant et al. 2015), and no examples of high-quality evidence-based guidelines specific to nurses partnering with mothers to give medication in paediatric settings. However, the strength of evidence regarding the positive impact of interventions that promote self-care and education about medications management is good (West-Oram, Lister & Dougherty 2015), suggesting that the recommendations are likely to be beneficial.
We identified two main categories of problem as the focus for our contextualised guideline. Firstly, we prioritised the need for the guideline to support nursing practice by aligning with a well-defined professional and ethico-legal framework. Nurses working without explicit policies concerning partnering with mothers find that practice varies between wards and sisters in charge, leaving nurses unsure of what is an acceptable practice and how to fulfil their professional responsibilities (Phiri et al. 2017). Involving mothers in giving medication seems to be an invisible and informal nursing practice (North et al. 2019). Informal nursing practices are difficult to reflect on or improve, so an important first step is to recognise and acknowledge the practice of nurses partnering with mothers to give medication to their hospitalised children. Once this is recognised, nurses will be better able to reflect on their practices and take any necessary steps to improve them. Even when informal practices are acknowledged, nurses may be unsure of the extent to which they can delegate (Human & Mogotlane 2017). In our experience, nurses are often unclear about whether they can delegate responsibility for giving medication to a child’s mother and may wrongly assume they should not be doing this. By addressing the scope of practice and clarifying how a competent nurse can responsibly delegate this activity, in accordance with the regulations and after obtaining informed consent, we have tried to ensure our guideline will be understandable and acceptable to nurses, and that they provide a basis for informed professional practice. We have also included an assessment of mothers’ competence as a practical tool to support nurses in responsibly delegating to mothers (after obtaining informed consent) whilst remaining in a supervisory role.
Secondly, the area that we prioritised was to focus on nursing actions to prevent the most common and the most serious reported types of medication errors (Maaskant et al. 2015): omissions without valid reason and failure to record and wrong route of administration. As medication errors in children are one of the most frequent causes of adverse events in the hospital setting, we hoped to address barriers to improving practice in order to support implementation. The recommendations are intended to reduce the workload for nurses, by safely enrolling mothers in active care giving. This active involvement can have other benefits.
Involvement of mothers in the care of the child forges relationships between the mother and the nurse, and encourages the family of the child to have a sense of trust in the nurses working closely with the child and the mother (Salmani, Abbaszadeh & Rassouli 2014). High-quality African nursing practices have been described, where mothers were expected by nurses to become quickly competent at managing the hospitalised child’s health needs, and participate in care such as observing the child’s condition, tube feeding, prescribed physiotherapy exercises, providing a reassuring presence for the child during procedures and dressing changes and assisting with giving medication (North et al. 2020). This suggests that it is feasible to involve mothers in this aspect of care-giving and that nurses can do so with confidence, supported by evidence, as part of strategies to reduce medication errors and improve safety for children in hospital.
Strengths and weaknesses
The focus of our guideline is on supporting nurses to partner with mothers to give medication. We have assumed that registered professional nurses will be competent to fulfil this role. Additional work to support nurses in maintaining and updating their knowledge in respect of medicines management would be valuable.
Although we ensured that all recommendations were supported by evidence-based rationale statements, we were limited by the availability of evidence. It was beyond the scope of our study to undertake a systematic review for every recommendation. Instead we have transparently presented the results from limited but focused literature searches. We recommend further research to build the evidence base on this topic, particularly looking at the outcomes of interventions.
Recommendations
Prior to implementing this guideline, the nurse with overall responsibility for medicines management on the ward should agree to a list of medications with the head pharmacist, the head clinician and the nursing unit manager on which medications can and cannot be handed to mothers for administration to their children. The overall responsibility for administration of oral medication in the ward belongs to the nurse. The nurse will have continuing responsibility for recognising and acting upon changes in a patient’s condition, regardless of the mother/carer’s participation in the process (Guy’s and St. Thomas’- NHS Foundation Trust 2018).
Conclusion
This process successfully led to the development of a modified evidence-based practice guideline to enable nurses to partner with mothers or carers in safely giving oral medication to their hospitalised child in South African settings. The guideline can be used by nurses to review and improve the care offered to children, with the aim of contributing to a safer care through reduced medication errors.
Acknowledgements
The authors would like to acknowledge:
Dilshaad Brey and Nombeko Mashiya (Bongani Mayosi Health Sciences Library, University of Cape Town) assisted with search design and information retrieval.
Heide Kunzmann (Christian Barnard Hospital) advised on the formulation of recommendations and presentation of the end user documentation.
Angela Leonard (The Harry Crossley Children’s Nursing Development Unit, Department of Paediatrics, University of Cape Town) assisted with flowchart design and editing of the manuscript.
Dr Nina Power (Postdoctoral Research Fellow, Department of Paediatrics, University of Cape Town) provided additional supervision.
Adess Mwale, Busisiwe Jama and Elijeschca Crous, students of the Master of Nursing (Child Nursing) programme at the University of Cape Town, co-appraised the guidelines.
Competing interests
The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.
Authors’ contributions
The project involved individual and group work by A.A. and N.H., supervised by N.N., A.A. and N.H. produced the first draft of this manuscript and N.N. assisted with revising it for publication.
Ethical considerations
This article followed all ethical standards for research without direct contact with human or animal subjects.
Funding information
A.A. and N.H. were supported by a Postgraduate Publications Incentive Grant from the Faculty of Health Sciences at the University of Cape Town whilst writing this manuscript. A.A. received The Harry Crossley Bursary for study towards the degree of Master of Nursing in Child Nursing and N.H. received the Marjorie McIntosh Postgraduate Bursary in Nursing and Midwifery, the Sleepnet Bursary for Master of Nursing in Child Nursing and additional support from Phatisa.
Data availability
Supplementary material including evidence summaries and details of the appraisal of included guidelines will be made available upon reasonable request from the corresponding author, N.H. All end user documentation has been made available online at https://vula.uct.ac.za/access/content/group/9c29ba04-b1ee-49b9-8c85-9a468b556ce2/MNCN/MNCN_1_.html
Disclaimer
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or positions of any affiliated agencies of the authors, and the Publisher.
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