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Abstract
Objectives Medication errors (MEs) are a leading cause of morbidity and mortality in the healthcare system. Patients admitted to intensive care units (ICUs) are potentially more susceptible to MEs due to severity of illness, the complexity of treatments they receive and the challenging nature of the ICU setting. The European Association of Hospital Pharmacists established a Special Interest Group (SIG) to undertake a programme of work to develop and prioritise recommendations to support medication safety improvement in ICUs across Europe.
Methods Initial policy recommendations for medication safety within the ICU environment were developed following reviews of the literature and engagement with relevant stakeholders. A Delphi panel of 21 members of the SIG, that comprised healthcare professionals (HCPs) with expertise in ICU and/or medication safety, was convened in 2022. We conducted two rounds using a modified Delphi technique whereby participants anonymously ranked on a 9-point Likert Scale the policy recommendations according to their priority for implementation.
Results In total, 32 policy recommendations were developed. In Delphi Round 1, 19 HCPs participated; consensus was achieved on most recommendations and partial consensus on six. In Delphi Round 2, 18 HCPs participated. After two Delphi rounds, consensus was achieved on all 32 recommendations. All recommendations were considered ‘high priority’ except one that was considered ‘medium priority’.
Conclusions Through this study it was possible to develop and prioritise evidence-based policy recommendations to enhance medication safety, which may contribute to reducing MEs in ICUs across Europe. All recommendations were considered ‘high priority’ for implementation except one, indicating the perceived value of these recommendations in improving medication safety through preventing MEs in ICUs.
- CRITICAL CARE
- MEDICATION SYSTEMS, HOSPITAL
- PHARMACY SERVICE, HOSPITAL
- Practice Guidelines as Topic
- Safety
- MEDICAL ERRORS
Data availability statement
Data are available upon reasonable request
Statistics from Altmetric.com
- CRITICAL CARE
- MEDICATION SYSTEMS, HOSPITAL
- PHARMACY SERVICE, HOSPITAL
- Practice Guidelines as Topic
- Safety
- MEDICAL ERRORS
Introduction
Medication errors (MEs) are a leading cause of morbidity and mortality in the healthcare system.1 Patients admitted to intensive care units (ICUs) are potentially more susceptible to MEs due to the complexity and intensity of treatments they receive.2 Previous studies have identified risk factors contributing towards MEs and reported on strategies that could prevent them.3 4 To support individual hospitals and health organisations in ME risk mitigation, the European Association of Hospital Pharmacists (EAHP) established a Special Interest Group (SIG) that set out to develop a set of recommendations for reducing MEs in European ICUs. The body of work comprised four work packages; the first of these was two literature reviews to: (1) Determine the prevalence of MEs, identify potential sources, causes and contributing factors to MEs; and (2) Identify prevention strategies for improving medication safety in the ICU setting.5 Formal systematic reviews or comparison of the evidence base supporting these strategies was beyond the scope of the available resources.
The second work package, an e-survey, was conducted with healthcare professionals (HCPs) working in ICUs to identify the medication safety practices most commonly used, or planned for implementation, in ICUs (submitted for publication). The third work package involved focus group discussions with ICU and medication safety HCPs to explore patient safety culture and advancement of medication safety, and the factors influencing implementation of ME prevention strategies in ICUs across Europe (submitted for publication).
This study describes the fourth work package, the aim of which was to use the findings from the three other work packages to develop and prioritise a list of policy recommendations to support medication safety improvement in ICUs across Europe.
Methods
Study design
A modified Delphi technique, a methodology that uses a panel of experts to achieve consensus in a clearly defined and systematic manner, was employed by the EAHP SIG to develop and prioritise the list of policy recommendations. This technique has commonly been used to produce recommendations, including best practice and international patient safety recommendations, where available evidence is lacking or unavailable.6
The classical Delphi technique uses a series of questionnaires issued to an expert panel in an iterative manner. A summary of results from individual rounds is provided as anonymous feedback in subsequent rounds, with the aim of converging opinion and reaching consensus.6 The term ‘modified’ Delphi has been applied where face-to-face or online meetings, in tandem with the iterative rounds of consensus, are used. Other modifications include a research team, rather than an expert panel, defining the issues requiring consensus during the initial phase of the process.6 For this study, the research team—a subgroup of the SIG—undertook development of the initial list of policy recommendations based on the earlier phases of this study as described above. This group was comprised of seven pharmacists from different European countries, of whom three were actively working in university hospital ICUs, one was a medication safety pharmacist, and three were academic pharmacists with expertise in medication safety. A further modification from the classical Delphi technique was that we conducted the first consensus round during an online meeting in place of distributing the questionnaire to the panel members separately.
For the subsequent stages of the study, all members of the EAHP SIG (n=21) were invited to participate as members of the expert Delphi panel. As part of their selection for the SIG, each member was working within ICUs and/or working as medication safety experts and therefore could be considered experts and eligible to participate in the panel. The SIG membership comprised a diverse group of HCPs from 13 European countries within northern, southern and western European regions. 16 members had a pharmacy background, 4 had a medical background and 1 a nursing background; 17 were women. This study is reported according to Jünger et al’s recommended ‘Guidance on Conducting and REporting DElphi Studies (CREDES)’.7
Ethical considerations
Participation by the panel of experts was voluntary and confidential and no incentives were offered. Each SIG member received an email with a cover letter and a participant information sheet. Participants were also informed that submission of their responses via the online survey tool would be considered as proof of informed consent to participate. Although anonymity is commonly preserved in Delphi studies, this was not possible in this study as participants were known to each other through their SIG membership. However, the identities of individual participants who opted to participate was not known and responses were submitted anonymously into a General Data Protection Regulation compliant online survey tool (easy-feedback.com).
Development of recommendations and Delphi consensus processes
Stage 1: Identification of recommendations
The following sources of information, as provided by earlier phases of the SIG work packages, were used to develop the initial list of the policy recommendations to be presented to the Delphi panel:
ME prevention strategies used to improve medication safety in the ICU environment as identified through the literature review;5 8–28
ME prevention strategies both currently in use and being planned in ICUs across Europe as identified through the conducted survey; and
Perceptions of patient safety, medication safety, and experiences of ME prevention strategies as identified from the focus group discussions.
The initial list of policy recommendations was categorised and agreed on by the SIG subgroup prior to commencement of Stage 2.
Stage 2: Iterative consensus rounds
A series of iterative consensus rounds were commenced in October 2022, with prior agreement that a maximum of three rounds would be held. The online survey tool (easy-feedback.com) was used for recording the responses. The level of priority of each recommendation was scored using a 9-point Likert scale where a score of 1 indicated ‘definitely not a priority’ and a score of 9 indicated ‘a key priority’. Additional guidance or specific criteria for prioritisation were not provided.
In addition to the Likert scale score for each recommendation, participants were also invited to record any comments on individual recommendations within a dedicated section on the online survey. These comments provided a better understanding of the rationale behind the responses provided at each round and they could be used to modify the recommendations for future rounds as appropriate.
Anonymous responses were downloaded for further analysis using Microsoft Excel (V.2016 or newer). The median and IQR for each recommendation was calculated and the results analysed for the degree of consensus. The following predetermined consensus definitions were applied:29
‘Consensus’ was considered to exist if the IQR of the participants’ responses fell within any 3-point range.
‘Disagreement’ was considered to exist if the IQR spanned both the 1–3 range and the 7–9 range.
If neither consensus nor disagreement existed, ‘Partial Agreement’ was considered to have occurred.
Where consensus existed, it was considered that the recommendation was a ‘high priority’ if the median score was within the 7–9 range, a ‘low priority’ if it was within the 1–3 range and a ‘medium priority’ if it was within the 4–6 range.
After each round, feedback was provided to all panel members which included the distribution of the panel’s response and the list of comments.
Delphi Panel Round 1
All 21 members of the SIG received an invitation to participate in Delphi Round 1. A virtual presentation describing the process for achieving consensus in an iterative manner was delivered to the participants. They were then presented with a brief description of each recommendation as determined in Stage 1. To allow panel members to familiarise themselves with the recommendations, the complete list was sent to all members of the SIG in advance of the meeting.
A link to the online survey was provided in an email during the meeting and the participants were instructed that they could submit their responses either during or after the meeting. It was also reiterated that participants did not need to conform to the group view. In addition, each individual panel member was asked to download and save their own responses. In subsequent rounds, this allowed panel members to see both their own response and that of the rest of the panel without knowing the identity of the other individuals providing scores or comments.
On completion of this, and subsequent rounds, a single reminder email with a link to the Delphi survey was sent to the panel prior to the stated deadline.
Subsequent Delphi Panel Rounds
Those recommendations for which consensus was not reached during previous rounds were progressed to subsequent rounds in an iterative manner. Recommendations were modified, where appropriate, based on the comments received during the previous round. An updated version of the online survey was devised specifically for each round. The original wording of any amended recommendations was included in the survey along with: the reworded recommendation, the median and IQR of the panel’s scores, and any comments provided by individual panel members in the previous round.
In contrast to Delphi Round 1, subsequent rounds were conducted by email in consideration of geographical diversity and time constraints of individual Delphi panel members. Each participant received an email with a link to the survey and were asked to submit their scores using the online survey tool within 7 days of receipt of the email. The participants had the option to amend or retain their own Delphi Round 1 score having considered the group results of Delphi Round 1.
Results
Thirty-two initial policy recommendations (grouped into eight categories) to improve medication safety in ICUs across Europe were developed. Due to the anonymous participation, the backgrounds of the respondents cannot be described but details on the full EAHP SIG membership (n=21) are described above.
Delphi panel Round 1
The presentation for Round 1 of the Delphi panel took place on 13 October 2022. A total of 19 HCPs participated and all but one of the participants scored each of the 32 policy recommendations; one participant did not to respond to Recommendation #28. Consensus was achieved on 26 of the recommendations (table 1), with partial consensus on six recommendations (Recommendations 5, 6, 8, 13, 27 and 30). Disagreement was not found on any recommendation. Recommendations 4, 8 and 30 were considered as medium priority, with the remaining 29 considered to be of high priority.
The consensus received for, and the priority given to, the policy recommendations in Delphi Round 1 by the Delphi panel of experts (n=19)*
The feedback received during Delphi Round 1 was used to modify, as appropriate, the wording of the six recommendations (Recommendations 5, 6, 8, 13, 27, 30) that had received partial consensus for Delphi Round 2. All but two (Recommendations 6 and 30) were reworded.
Delphi Panel Round 2
Eighteen HCPs provided their responses for Recommendations 8, 13 and 27, and 17 HCPs to Recommendation 30 (table 2) in the Delphi Round 2 survey sent by email to the panel on 15 November 2022. After this round was completed, a discrepancy in the calculation of the IQR of two recommendations in Delphi Round 1 data was identified. This was corrected and a supplementary Delphi Round 2b was arranged for prioritising Recommendations 5 and 6 (table 2); the original Round 2 was subsequently referred to as Delphi Round 2a. Seventeen HCPs responded to the Round 2b survey which was circulated by email on 6 December 2022. The participants classified all recommendations as ‘high priority’ with ‘consensus’ in the combined results for each portion of Delphi Round 2 (table 2).
The consensus received for, and the priority given to, the policy recommendations in Delphi Rounds 2a and 2b by the Delphi panel of experts (n=18)*
Final policy recommendations on medication safety improvement in intensive care
After two Delphi Panel rounds, consensus was achieved on all 32 policy recommendations. All but one (Recommendation 4; medium priority) were considered as ‘high priority’. Further Delphi Panel rounds were not required. The final recommendations are presented in table 3 along with a selection of supporting evidence from research studies, published policies or standards, and a summary of the relevant facilitators as identified from the focus group discussions conducted in one of the other SIG work packages.
Policy recommendations on medication safety improvements in the ICU setting
Discussion
A panel of HCPs from up to 13 different European countries have produced a consensus-based list of 32 policy recommendations for medication safety improvement in the intensive care setting. The high consensus levels and prioritisation of almost all of these recommendations are indicative of the need for safety initiatives to mitigate the risks, both perceived and evident from previously published research, associated with medication management in ICUs. The medication management process in the ICU is complex; a study in the paediatric ICU setting identified 30 subtasks as part of the prescribing process alone and how each of these needed to be completed correctly in order for the correct prescription to be written.30 This complexity in the medication use process in tandem with the acuity of illness of the ICU patient cohort requires multifaceted risk mitigation strategies and interventions.3 We adopted a systems approach when developing these recommendations as we recognised that reducing the occurrence of MEs and promoting patient safety requires changes to the underlying system of care. This is apparent in the breadth of policy recommendations over eight discrete categories ranging from the entire health system, to individual organisations, down to local ICU-level interventions and resources.
We have supplied examples of supporting literature for many of the policy recommendations as outlined in table 3, however, it has not been possible to provide an exhaustive list. An evidence base exists for many ME reduction strategies, for example, benefits of an ICU clinical pharmacy service21 and electronic prescribing,24 but there is a gap in peer-reviewed evidence for others. In these cases, despite recommendations from individual professional bodies and patient safety organisations, robust evidence is still lacking. Reasons for this include the complexity of some of the proposed interventions, particularly those which are technology-based. Not only is successful implementation of these a significant undertaking requiring significant resources, but achieving and demonstrating intended benefits is also complex and difficult.31 The potential for unintended consequences and implications of changes in workflow also require consideration.32 Where research is conducted on these systems, comparing results from studies using different methodologies, disparate systems and levels of integration impedes generalisability of reported results. Despite this, use of technology in medication processes in European ICUs is increasing, as evidenced from the use of electronic prescribing, automated dispensing cabinets and ‘smart-pumps’, as reported in the survey conducted by the SIG in an earlier phase of this research.5 The consensus reached by the expert panel in this study provides further weight to support the need for investment in these solutions.
Many of the policy recommendations deemed to be high priority require few resources and should be more achievable in most ICUs. Although lower down on the Institute of Safe Medication Practices Rank Order of Error Reduction Strategies, the use of good policy, procedures and provision of education and information to support staff in key areas such as management of high-risk and intravenous medications were considered high priority by the panel.33 Standardisation, widely recognised by safety agencies as key to medication safety, was also identified as a priority. Although some of these strategies are more onerous to implement, for example, standard concentration infusions, with others reliant on conditions being met outside of individual organisations, for example, access to unit-dose medications, many are achievable within individual ICUs without substantial investment in terms of time or financial resources.
Strengths and limitations
A key strength of this study was the representation from 13 European countries covering the northern, southern and western regions of Europe. Utilisation of online meetings in addition to email—a modified version of the Delphi technique—facilitated this broad participation, while also allowing verbal clarification of understanding where necessary for non-native English speakers. Furthermore, use of purposive sampling in assembly of the EAHP SIG and the subsequent willingness to participate, ensured the panel composition included HCPs from various backgrounds in ICU settings and/or medication safety with relevant expertise. The range of resources used to develop the initial list of recommendations, including both previous literature and new information as gathered from the survey and focus groups, provides confidence that both previously identified ME prevention strategies and perceptions of HCPs working in ICUs and within medication safety across Europe were incorporated. Limitations include identification of the recommendations from literature review and expert opinion, without measures of effectiveness based on quality of evidence, and the inability to stratify the recommendations on ease of implementation or requisite resources. Further limitations include lack of participation of HCPs from eastern Europe and over-representation by pharmacists. As with any Delphi panel study, there may be some response bias such as individuals with greater interest or expertise in medication safety being more likely to participate.
Conclusion
The Delphi technique was successfully used to develop and prioritise policy recommendations to enhance medication safety in ICUs in Europe. All recommendations, except one, were considered ‘high priority’ for implementation, indicative of the perceived value of these recommendations in improving medication safety by preventing MEs from occurring in ICUs. The results of this study can help inform individual ICUs in reviewing their local context and identifying priorities to improve medication safety.
What this paper adds
What is already known on this topic
The intensive care unit is a challenging setting for safe medication use.
Critically ill patients, high-risk interventions and the complex intensive care unit environment combine to increase the risk of medication errors.
Medication errors can occur across multiple points in the medication use process.
What this study adds
This study, which used evidence from literature and stakeholders, adopted a systems approach to develop 32 policy recommendations across eight categories.
Through the use of Delphi methodology, consensus and prioritisation of these recommendations was undertaken.
How this study might affect research, practice or policy
These recommendations can be used by intensive care units to develop strategies relevant to their context to improve medication safety practices.
Data availability statement
Data are available upon reasonable request
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and was approved by the University of Helsinki Ethical Review Board in Humanities and Social and Behavioural Sciences (Statement: 18/2022). Participants gave informed consent to participate in the study before taking part.
Acknowledgments
The authors thank Stephanie Kohl, Gonzalo Marzal-Lopez, Lena Sheehan and Sufian Muhammad for their support during the work of the SIG, and Anne Hiselius, Andreas Valentin, Emily Whittome and Samuel Garcia for their initial contribution to the work of the SIG.
References
Footnotes
EAHP Statement 4: Clinical Pharmacy Services. EAHP Statement 5: Patient Safety and Quality Assurance.
MH and SM are joint first authors.
Collaborators The EAHP Special Interest Group for the Investigation of Medication Errors in Intensive Care Units comprised of the following individuals: Angela Amigoni (Italy), Irene Aquerreta (Spain), Božena Bürmen (Slovenia), Andrea Burch (Switzerland), Claire Chapuis (France), Suzanne Cooper (United Kingdom), John Dade (United Kingdom), Bryony Dean Franklin (United Kingdom), Dylan W. De Lange (the Netherlands), Moninne Howlett (Republic of Ireland), Minna Kurttila (Finland), Raisa Laaksonen (Co-Chair of the SIG, Finland), Chiara Lamesta (Italy), Jana Lass (Estonia), Maria Cruz Martin (Spain), Suzanne McCarthy (Republic of Ireland), Virginia Silvari (Co-Chair of the SIG, Republic of Ireland), Inese Sviestina (Latvia).
Contributors MH is guarantor of this study and is responsible for overall content. MH and SM contributed equally to this paper and are first authors; they designed the study methodology and data collection tool, analysed the data, finalised the recommendations, and drafted and revised the paper. RL and VS conceptualised the study, contributed to the design of the study, monitored data collection and analysis, and revised the paper. BDF contributed to the design of the study and revised the paper. All members of the EAHP Special Interest Group for the Investigation of Medication Errors in Intensive Care Units contributed to the design of the study.
Funding The EAHP has received funding from BD (Becton, Dickinson and Company) for the running of the SIG. However, the SIG is independent of the pharmaceutical company providing research funding to the EAHP. BDF is supported by the National Institute for Health and Care Research (NIHR) North West London Patient Safety Research Collaboration and the NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at Imperial College in partnership with Public Health England (PHE). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, PHE or the Department of Health and Social Care.
Competing interests RL and VS are associate editors of the European Journal of Hospital Pharmacy. All other authors declare no competing interests.
Provenance and peer review Not commissioned; externally peer reviewed.