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Patient Awareness of the Severity of Their Information and Medication Management-Related Adverse Events

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Rinnakkaistallenteet Yhteiskuntatieteiden ja kauppatieteiden tiedekunta

2020

Patient Awareness of the Severity of Their Information and Medication

Management-Related Adverse Events

Saranto, K

Artikkelit tieteellisissä kokoomateoksissa

© 2020 The authors and IOS Press

CC BY http://creativecommons.org/licenses/by/4.0/

http://dx.doi.org/10.3233/SHTI200494

https://erepo.uef.fi/handle/123456789/8296

Downloaded from University of Eastern Finland's eRepository

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Patient Awareness of the Severity of heir Information and Medication Management-

elated Adverse Events

Kaija SARANTO a,1, Samuli KOPONEN a, Hanna KUUSISTO a,b and Eija KIVEKÄS a

a University of Eastern Finland, Kuopio Campus, Finland

b Tampere University Hospital, Finland

Abstract. Adverse events (AEs) in healthcare are commonly reported internationally. However, the structure of event reporting varies based on the healthcare service system, legislation, and the safety culture among service providers. Based on several studies, medication management-related errors have a long history of being reported. However, there is evidence that information management-related errors increase workload, costs, and patient suffering. This study focuses on AEs reported in the categories of medication and information management in a national reporting system. Our aim was to determine whether patients were informed about these errors and whether there were any relationships between the severity of these errors and the disclosure to patients. Based on the results, almost all errors in both categories without any harm to patients were disclosed to patients. Patients were not informed about 40% of information management-related AEs that caused severe harm.

Keywords. safety, incident reporting, medication error, information management, disclosure

1. Introduction

Adverse event (AE) reporting systems are important tools to monitor both safety hazards and quality concerns in care delivery. Various means are used both at a hospital and national level to report the status of patient safety. Based on the results of a survey, AE reporting systems and technologies vary among countries, and reporting practices within a hospital are distinct [1]. Depending on tools and instructions, AE reporting is often voluntary, which causes a lack of trust in the statistics due to the presumption of underreporting. In hospitals, 10% of AEs are detected by reporting systems, which is a major barrier to understanding errors and preventing harm [2]. Another often-discussed barrier to reporting is the fear of blame, which is associated with a blame culture instead of a safety culture. Blame has commonly been associated with events where a complaint was anticipated. Blame is also allocated easier when equipment or patient factors are considered to have caused AEs [3].

1 Corresponding Author, Kaija SARANTO, University of Eastern Finland, Kuopio Campus, Finland; E- mail: kaija.saranto@uef.fi

T R

© 2020 The authors and IOS Press.

This article is published online with Open Access by IOS Press and distributed under the terms of the Creative Commons Attribution Non-Commercial License 4.0 (CC BY-NC 4.0).

doi:10.3233/SHTI200494

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Previous studies indicate that it is difficult for healthcare professionals to discuss safety events with patients, especially when using words like “error” or “mistake” [2,3].

Reason describes in his Swiss cheese model how AEs are frequently the result of multiple smaller errors within a failed system; it is not important whose fault the error was but why and how defenses failed [4]. AEs mostly occur as a consequence of latent errors in the system that lead to unsafe clinical practices [5]. The prevalence of disclosure seems to be higher in the United States and Europe than in other regions. The reported frequency of disclosure of patient safety incidents (DPSIs) among the general public is relatively lower than the frequency of DPSIs reported by medical professionals.

Furthermore, patients emphasized the key elements of DPSIs, such as an apology, explanation, and promising to avoid its recurrence, but these essential elements were often missing [5-6]. Of patients who reported harm, 11.4% received an apology from the clinician or medical organization. In addition, most of the general public has little experience with full disclosure [6].

Medication errors (MEs) are the most often reported AEs [1,6]. Factors contributing to MEs can be classified as failures in prescribing, failures in medication review process, or failures in drug administration. The classification used in this study in AE reporting often overlaps with events classified in the category of information management, which includes failures in the coordination of care, documentation, and communication as subcategories that cause distraction and interruptions in information flow. Whether classified as a medication management-related or an information management-related AE, MEs are surprisingly more often regarded as severe AEs due to the possibility of fatal consequences [6].

The purpose of this study was to describe the severity of AEs and analyze whether patients were informed about the events. The study aimed to answer the following questions: What kind of relationship exists between the severity of events and the type of event, and what kind of relationship exist between the severity of events and disclosure to patients?

2. Materials and methods

The data consists of AE reports from 44 public and 3 private healthcare organizations in Finland that are considered to have harmed the reputation of the organization. The AE reports were collected from the years 2007-2016 [7]. From all the data we collected, reports were classified either as information management-related or medication management-related events. Data on the severity of harm and the potential disclosure to patients were collected for both error categories. The data were analyzed using cross- tabulation and chi-squared tests.

3. Results

The total number of AE reports was 99512. The number of medication management- related errors was 49935 (50.2%), and the number of information management-related errors was 18891 (19.0%). The prevalence of information management-related and medication management-related events from 2007-2016 show that the number of these two AEs have been the same during these years.

K. Saranto et al. / Patient Awareness of the Severity 64

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The severity of events and the type of events demonstrated that information management-related and medication management-related AEs caused mainly no harm or minimal harm. The most severe errors occurred in emergency care and in intensive care units, and the most frequent severity of all events was minimal harm. The most serious events involved only a single AE type.

The distribution of medication management-related and information management- related errors that caused harm slightly differed (Table 1).

Table 1. Medication management-related and information management-related errors and their severity No harm Minimal

harm Moderate harm Severe harm Total Medication-

related 24966 13842 2248 180 41236

60.5% 33.6% 5.5% 0.4% 100.0%

Information-

related 8904 5328 1513 145 15890

56.0% 33.5% 9.5% 0.9% 100.0%

Total 33870 19170 3761 325 57126

59.3% 33.6% 6.6% 0.6% 100.0%

Figure 1 shows the rates of AE disclosure by the degree of harm caused to patients.

When the event did not harm patients, patients were often informed (96% and 90% for medication management-related and information management-related errors, respectively). Minimal, moderate, and severe harm caused by information management- related AEs were disclosed in more than half of the cases (58%, 62%, and 58%, respectively). Medication management-related AEs were disclosed more often than information management-related errors.

Figure 1. The rate of error disclosure by the degree of harm caused to patients.

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We examined this relationship further with a chi-squared test, which indicated a significant difference in disclosure between categories of harm (χ2(3) = 2145.14, p <

0.001).

4. Discussion and Conclusions

The number of medication- and information management-related events reported remained almost constant. Studies have also confirmed the problem of categories with overlapping subcategories [1-2]. In our study, AEs classified as information management AEs included failures in the coordination of care, documentation, and communication as the subcategories that caused distraction and interruptions in information flow.

The severity of AEs illustrated that the most serious events were infrequent. The mean of the severity of events demonstrated that AEs caused mostly minimal or no harm.

This study confirms the findings of previous studies that minor events are often disclosed to patients [3] and medication management-related AEs are disclosed to patients more often than information management-related AEs [6]. In terms of event disclosure, minor harm caused to a patient seemed to reduce the frequency of disclosure to the patient [3].

This tendency can be observed throughout our data and all types of AEs. The frequency of disclosures of medication management-related events increased as the severity of the event increased from minimal to severe. The frequency of information management- related event disclosure seemed to be lower than that of medication management-related event disclosure. A proportion of 80% of medication management-related and 60% of information management-related AEs that caused severe harm were disclosed to patients.

These proportions are higher than those in previous studies [3,5], in which 65% of AEs were disclosed. Almost all AEs in both categories without harm to patients were disclosed to patients.

Further research will clarify the reason the disclosure of severe AEs was lower than that of events with no harm. Furthermore, more information on why disclosures did not increase when the severity of information management-related AEs increased is needed.

References

[1] Morello RT, Lowthian JA, Barker AL, McGinnes R, Dunt D, Brand C et al., Strategies for improving patient safety culture in hospitals: a systematic review, BMJ Qual Saf 22 (2013), 11–18.

[2] Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W, Patients’ and physicians’ attitudes regarding the disclosure of medical errors, JAMA 289 (2003), 1001–1007.

[3] Schwappach DLB, Koeck CM, What makes an error unacceptable? A factorial survey on the disclosure of medical errors, International Journal for Quality in Health Care 16 (2004), 317–326.

[4] Reason J, Human error: models and management, BMJ 320 (2000), 768-770.

[5] Gallagher TH, Studdert D, Levinson W, Disclosing harmful medical errors to patients, New Engl J Med 356 (2007), 2713–9.

[6] Pintor-Mármol A, Baena MI, Fajardo PC, Sabater-Hernández D, Sáez-Benito L, García-Cárdenas MV, et al., Terms used in patient safety related to medication: a literature review, Pharmacoepidemiology and Drug Safety 21 (2012), 799–809

[7] Awanic Ltd. HaiPro. Available at: http://awanic.com/eng/. Accessed November 10, 2019.

K. Saranto et al. / Patient Awareness of the Severity 66

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