https://orcid.org/0000-0001-8778-1994
Figures
Abstract
Background
In hospital medication errors are common. Our aim was to investigate risks of the analogue and digitally-supported medication process and any potential solutions.
Methods
A mixed methods study including a structured literature search and online questionnaires based on the Delphi method was conducted. First, all risks were structured into main and sub-risks and second, risks were grouped into risk clusters. Third, healthcare experts assessed risk clusters regarding their likelihood of occurrence their possible impact on patient safety. Experts were also asked to estimate the potential for digital solutions and solutions that strengthen the competence of healthcare professionals.
Results
Overall, 160 main risks and 542 sub-risks were identified. Main risks were grouped into 43 risk clusters. 33 healthcare experts (56% female, 50% with >20 years professional-experience) ranked the likelihood of occurrence and the impact on patient safety in the top 15 risk clusters regarding the process steps: admission (n = 4), prescribing (n = 3), verifying (n = 1), preparing/dispensing (n = 3), administering (n = 1), discharge (n = 1), healthcare professional competence (n = 1), and patient adherence (n = 1). 28 healthcare experts (64% female, 43% with >20 years professional-experience) mostly suggested awareness building and training, strengthened networking, and involvement of pharmacists at point-of-care as likely solutions to strengthen healthcare professional competence. For digital solutions they primarily suggested a digital medication list, digital warning systems, barcode-technology, and digital support in integrated care.
Conclusions
The medication process holds a multitude of potential risks, in both the analogue and the digital medication process. Different solutions to strengthen healthcare professional competence and in the area of digitalization were identified that could help increase patient safety and minimize possible errors.
Citation: Kopanz J, Lichtenegger K, Schwarz C, Wimmer M, Kamolz LP, Pieber T, et al. (2024) Risks in the analogue and digitally-supported medication process and potential solutions to increase patient safety in the hospital: A mixed methods study. PLoS ONE 19(2): e0297491. https://doi.org/10.1371/journal.pone.0297491
Editor: Ramune Jacobsen, University of Copenhagen: Kobenhavns Universitet, DENMARK
Received: July 7, 2023; Accepted: January 5, 2024; Published: February 27, 2024
Copyright: © 2024 Kopanz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the manuscript and its Supporting information files.
Funding: Funding number: ABT08-165397/2019 Funder: Zukunftsfonds Styria Authors: JK, CS, MM, GS, KL, and MH The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. https://www.zukunftsfonds.steiermark.at/.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Medication errors cause about 1–2% of complications in inpatients [1]. Annually, around 7,000 patients worldwide die due to illegible writing [2], and it can be assumed that this is only the tip of the iceberg, as medication errors and their effects often remain undetected [3].
Factors that contribute to medication errors are diverse [4, 5] and occur in all phases of the medication process, including handwritten prescription (from 7% to 49% error rate), transcription of medication to another document (11% error rate), dosing/dispensing (14% error rate) and administration (26% error rate) [4, 6]. Similarly, an Australian literature review described that at hospital admission two errors per three patients occurred, and in the prescription process up to one error per patient was found [7]. Errors occurred in 9% of administrations and in the discharge documentation up to two errors per patient were found. Factors that contribute to errors include a lack of training or experience, fatigue, stress, high workload, insufficient knowledge or a lack of interest on the part of the prescriber or the nursing staff [8].
The majority of digitally-supported medication processes are still partially organized in an analogue way [9–12]. An analogue medication process is defined as a process that still includes work steps and processes that do not use digital tools. For example, a process is initiated with a digital prescription tool, but the medication is then dispensed and distributed manually without further digital tools. The goal is a completely digital process which is not only initialized with a digital prescription tool but also followed by machine-supported medication dispensing and secure, barcode-supported medication distribution to patients. The completely digital process aims to minimize or even prevent medication errors by ensuring that the right medication is prescribed, dispensed, and distributed to the right patient [9–12].
This study focused on investigating risks in the analogue and digitally-supported medication process and potential solutions in a hospital setting. Thus, the long-term goal is to investigate possibilities, challenges, and competence needs in order to introduce a digitally-supported medication process to increase patient safety in hospitals and intersectoral interfaces, respectively as well as healthcare professional safety.
Patients, materials and methods
Study design and setting
This was a mixed methods study including a structured literature search and online questionnaires based on the Delphi method (Fig 1). The study was approved by the ethics committee of the Medical University of Graz (No. 32–498 ex 19/20) and was designed, conducted, performed, and analyzed in accordance with Good Clinical Practice, with the principles of the “Declaration of Helsinki”, with the laws and regulations of the participating European country.
Phase 1—Identification of main risk clusters
Literature search.
A structured literature search using a hermeneutic approach was performed to identify risks in the analogue and digitally-supported medication process in a hospital setting.
The database PubMed was searched for relevant literature between February and March 2020 to answer the research question: “What are the major risks in the hospital medication use process?”. We used the berrypicking approach [13] and also included previously identified literature when it provided important knowledge. In doing so, search terms were created to identify further significant literature [13]. The following main categories of search terms were used: risk, quality indicator, medication process, medication error, hospital, and digital. We defined keywords and MeSH terms for these main categories and combined them using the Boolean operators “AND” and “OR”. We limited the search to systematic reviews in English. Reviews concerning only the setting critically ill patients, pediatrics, emergency department, or outpatient clinic were excluded. Systematic reviews that included studies in different settings (e.g., general inpatient ward and pediatric wards and/or intensive care units) and that investigated the whole medication process and thus provided relevant information to answer the research question were included. To ensure current data we only searched for reviews published between 2010 and 2020. Results were screened regarding title and abstract. We identified a total of 40 relevant systematic reviews and chose 15 after full text screening. In these 15 systematic reviews we identified risks and main outcomes.
Grouping to risk clusters.
Identified risks from the literature were supplemented with risks from the Critical Incident Reporting System (CIRS) reports from the University Hospital of Graz and with risks identified by seven health care professionals. All CIRS cases between 2013 and 2020 were screened and risks related to the medication process were extracted. In addition, categorized "near misses" and "no CIRS cases" with risks relevant to the medication process were also extracted. All risks, including risks from the literature, risks from CIRS reports, and risks from healthcare professionals were combined into one list and structured into main risks and sub-risks of the medication process. Subsequently, two investigators independently grouped the main risks into risk cluster to identify the most relevant risks. The risk clusters were matched and in case of discrepancies a third researcher was consulted.
Phase 2—Likelihood of risk occurrence, impact on patient safety, and potential for solutions
Questionnaires.
Two online questionnaires (A, B) based on the Delphi method [14] were conducted to assess the likelihood of occurrence, the impact on patient safety, the potential for solutions for the identified risk clusters. Questionnaire A aimed to answer the research questions: “How likely will this risk cluster occur and what is the estimated impact of this risk cluster on patient safety in a hospital?”. Questionnaire B aimed to answer the research questions: “What is the potential for solutions to strengthen the competence of healthcare professionals and what is the potential of finding digital solutions in the hospital?”. In total, 75 healthcare experts from the DACH region (Germany, Austria, Switzerland) from different clinical and patient-related fields were asked to fill-in both questionnaires.
Questionnaire A. (S1 File) was sent out in July 2020 and August 2020. We asked experts to evaluate the risk clusters concerning the likelihood of occurrence and the impact on patient safety on a Likert scale ranging from 1–10. For both parameters, 10 represented the highest likelihood of occurrence and a fatal impact on patient safety, whereas 1 represented a very low likelihood of occurrence and a low impact on patient safety. Experts were also asked to identify the greatest risk in each risk cluster, regardless of how they rated other individual risks in this cluster. Results were ranked and for the top 15 risk clusters a further risk assessment was conducted and investigation on potential for solutions was assessed by adding the likelihood of occurrence (mean) and the impact on patient safety of each risk cluster (mean). Finally, these results were divided into two and were further ranked starting with the highest rating.
Questionnaire B. Questionnaire B (S2 File) (October 2020 –November 2020) was based on the top 15 risk clusters. The potential for solutions to strengthen the competence of healthcare professionals and the potential for digital solutions were analysed. We asked the same experts to evaluate the top 15 risk clusters on a Likert scale ranging from 1–10, with 10 representing a very high potential for solutions and 1 representing a very low potential for solutions. For each risk cluster, experts also had the option to give a specific suggestion for a solution by adding a comment.
Data management and statistical analysis
Data gathered from the online questionnaires were collected and pseudo-anonymized so that no conclusions could be drawn about participants. All collected data were automatically imported into the data management software EvaSys (Electric Paper. EvaSys 8.1, Electric Paper Evaluationssysteme GmbH, Lüneburg. Deutschland, 2013), and data were checked for completeness, and plausibility. The statistical analysis was carried out using descriptive statistics by using the software EvaSys. For numerical data, mean values, and standard deviations were calculated. Categorical data are presented as absolute and relative frequencies.
Results
Phase 1—Risk clusters of the hospital medication process
In total, 15 systematic reviews were included [15–29] (see Table 1). Details on the structured literature search process are presented in Fig 2.
All risks were structured in relation to the following steps in the medication process: admission, prescribing, verifying, preparing/dispensing, administering, monitoring, and discharge. Additionally, we defined additional steps that are also important in a comprehensive medication process: patient adherence, organization, healthcare professional competence, digital process, IT-security (Fig 3).
In total we identified 160 main risks and 542 sub-risks from literature, CIRS reports, and healthcare experts. Main risks were grouped into 43 risk clusters (see S1 Appendix). Risk clusters were built for all defined steps of the medication process, except for “organization” which was excluded because it is related to organizational issues only.
Burden and potential solutions for 15 top risk clusters
Questionnaire A (S1 File).
In total, 33 out of 75 experts (56% female, 50% with > 20 years of professional experience, profession: 32% nurses, 29% physicians, 23% quality management/risk management, 7% management, and 10% others) evaluated 43 risk clusters (response rate: 44%). Table 2 provides an overview of results ranked by priorities. The top 15 risk clusters comprise the following steps of the medication process: admission (n = 4), prescribing (n = 3), verifying (n = 1), preparing/dispensing (n = 3), administering (n = 1), discharge (n = 1), healthcare professional competence (n = 1), patient adherence (n = 1). The results for all 43 risk clusters are shown in the S1 Appendix.
Questionnaire B (S2 File).
28 (response rate: 37%) out of 75 experts (64% female, 43% with > 20 years of professional experience, profession: 32% nurses, 29% physicians, 25% quality management/risk management, 7% management and 7% other) evaluated the top 15 risk clusters regarding their potential for solutions to strengthen the competence of healthcare professionals and the potential for digital solutions (Table 3). Experts suggested different solutions: awareness and training for healthcare professionals, more networking, and involvement of pharmacists at point of care were the most frequently mentioned solutions to strengthen competences. As a digital solution experts mostly suggested a digital medication list, digital warning systems, use of barcode technology, and digital support in integrated care.
Discussion
This study aimed to investigate the risks of the analogue and digitally-supported medication process and the likelihood of solutions in a hospital setting. The study identified 160 main risks and 542 sub-risks regarding the medication process using literature search, review of CIRS cases, and experts’ opinions. Results underline the complexity of the medication process and its high potential for risks and consequently resulting possible medication errors in all steps [4, 6, 7, 30].
All identified risks were grouped into 43 risk clusters. According to the participating experts the greatest burden relates to the main steps in the medication process such as admission, prescribing, verifying, preparing/dispensing, administering, discharge, healthcare professional competence, and patient. Most critical risks occur at admission, in prescribing, and during preparing/dispensing of medications. Similar to our results, Roughead et al. [7] found error occurrences at admission and in medication prescribing, but they also indicated error rates in other steps of the medication process such as medication administration and discharge. A review of medication incidents revealed that administration (50%) and prescription (18%) are most critical [31]. Similar results have been found in another study, where 68% of medication errors were related to administration and 24% to prescribing based on the incident reports in Norwegian hospitals [32]. Comparability of different studies is limited as different definitions for medication errors were used and standard definitions and thus standard data collection methods for medication errors are missing [15, 16, 19, 33, 34].
To minimize the burden of risks and potential errors, experts mostly suggested the following solutions to strengthen the competence of healthcare professionals: awareness building and additional training for healthcare professionals, strengthened networking, and involvement of pharmacists at the point of care. The highest likelihood of strengthening the competence of healthcare professionals was assessed by experts in the risk cluster”missing communication/information with patients and relatives at discharge”. With regard to communication and discharge planning, a “Guide to Patient and Family Engagement in Hospital Quality and Safety” by the US Agency for Healthcare Research and Quality (AHRQ) advises healthcare professionals to engage patients and families to promote improvement in care [35]. An alternative possibility, as suggested by the American Society of Health System Pharmacists (ASHP) guideline, is the involvement of pharmacists in the discharge process who are competent in key skills, such as patient education, active listening, and interpretation of non-verbal communication [36].
With regard to digital solutions, experts primarily suggested the following: digital medication list [37], digital warning systems, barcode technology [38], and digital support in integrated care [39, 40]. Experts indicated a very high potential for digital solutions in the risk cluster “difficulties with handwritten prescription” and suggested a digital medication list as a specific solution. In a study that compared handwritten prescriptions with digital electronic prescriptions a significant decrease in the incidence of medication errors was detected when digital electronic prescription was used [41]. However, errors can also occur in the digital medication process and must be taken into account. A crucial factor during digitalization is the competence of healthcare professionals. Continuously updated knowledge and skills are essential when using digital technologies but personal attitude can have a major influence and must thus be taken into account [24, 42–47]. It is of major importance for hospitals to follow international recommendations and to enable healthcare professionals to successfully develop, select, implement, or work with digital solutions [48].
This study is limited by focusing on the hospital setting and not reflecting the medication process in other settings. However, the finding from our study can be transferred to other settings (e.g., nursing homes, home healthcare) which are also affected by risks in the medication process, their likelihood of occurrence, the impact on patient safety, and the likelihood of solutions. Another limitation is the targeted expert group that was approached to participate in the two questionnaires. Because all experts are working in the DACH region, a transfer of results to other healthcare system has to be done with caution. Nevertheless, clinical practice can profit from the results by a raised awareness of the risk clusters and the list of possible solutions.
The results of this study form the basis for a larger project that aims to investigate chances, challenges, and needed competences regarding digitally-supported medication processes. In a next step, healthcare professional competence and digital solutions will be investigated in more detail to derive concrete recommendations for intra-hospital clinical practice use.
Conclusions
The medication process holds a multitude of potential risks, in both the analogue and the digital medication process. Different solutions to strengthen healthcare professional competence and in the area of digitalization were identified that could help increase patient safety and minimize possible errors.
Supporting information
S1 Appendix. 43 risk clusters and their results from questionnaire A (likelihood of occurrence and impact on patient safety).
https://doi.org/10.1371/journal.pone.0297491.s001
(DOCX)
Acknowledgments
The authors thank all experts for their participation at the questionnaires and for their effort. Further, the authors especially acknowledge the support of David Lippitsch for preparing and analysing the questionnaires as well as the critical review of the manuscript and the editorial assistance of Selma Mautner. The contribution of all involved healthcare professionals at the Medical University of Graz is acknowledged.
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