Medication errors involving anticoagulants: Data from the Danish patient safety database.

Reporting of adverse incidents is mandatory in Denmark. All reported adverse incidents are made anonymously, and stored in an encrypted database. It is the purpose of this descriptive study to describe the severity of adverse medication incidents caused by oral anticoagulants in hospitals. All moderate, severe and fatal reports concerning non-vitamin K antagonist oral anticoagulants were analyzed from date of marketing until July 8 2014. The data collection for warfarin was from January 1 2014 until July 8 2014. Three independent specialists in clinical pharmacology evaluated the severity of incident outcomes. A total of 147 adverse medication incidents were analyzed, and showed that de facto or potentially fatal and serious incidents were most frequently associated with sector change (admission to or discharge from hospital, or undergoing surgery) and resulted from insufficient or excess dosing. Physicians should be aware when prescribing and changing anticoagulant therapy to avoid severe or fatal incidents.

Identifying Facilitators and Barriers for Patient Safety in a Medicine Label Design System Using Patient Simulation and Interviews.

OBJECTIVES: Medicine label design plays an important role in improving patient safety. This study aimed at identifying facilitators and barriers in a medicine label system to prevent medication errors in clinical use by health care professionals. METHODS: The study design is qualitative and exploratory, with a convenience sample of 10 nurses and 10 physicians from different acute care specialties working in hospitals in the Capital Region of Denmark. In 2 patient simulation scenarios and a sorting task, the participants selected the medicines from a range of ampules, vials, and infusion bags. After each scenario and in the end of the study, the participants were interviewed. Notes were validated with the participants, and content was analyzed. RESULTS: The label design benefited from the standardized construction of the labels, the clear layout and font, and some warning signs. The complexity of the system and some inconsistencies (different meaning of colors) posed challenges, when considered with the actual application context, in which there is little time to get familiar with the design features. CONCLUSIONS: For optimizing medicine labels and obtaining the full benefit of label design features on patient safety, it is necessary to consider the context in which they are used.

Medication errors detected in non-traditional databases: types of errors in methotrexate dosing as listed in four different Danish registers.

AIMS: We have looked for medication errors involving the use of low-dose methotrexate, by extracting information from Danish sources other than traditional pharmacovigilance databases. We used the data to establish the relative frequencies of different types of errors. METHODS: We searched four databases for cases involving low-dose methotrexate between 1999 and 2011: the Danish Patient Safety Databases (DPSD), controlled by the Danish National Agency for Patients' Rights and Complaints, the Patient Compensation Association (PCA), the Danish Poison and Information Centre (DPIC), and the online database of the Department for Patient Complaints (DPC). We categorized the place where the error occurred, the processes and types of error involved, the person responsible, and the clinical outcome. RESULTS: We identified 173 errors. In 109 (63%), either harm resulted or could not be excluded; of these, 26 (15%) resulted in serious harm, including nine deaths (5%); 53 (31%) involved incorrect daily administration; and 107 (62%) involved a dosing error. Sixteen events (9.2%) concerned insufficient or faulty monitoring, with four serious outcomes and two deaths. Prescription errors involving daily rather than weekly administration, by hospital physicians, were most likely to result in serious outcomes, including deaths. The error mechanism was evaluated in 129 events. Action-based errors comprised 50 % and knowledge-based errors 34 %. Action-based errors were more likely to result in completed errors, whereas knowledge-based errors more often resulted in near misses. CONCLUSIONS: The medication errors in this survey were most often action-based (50%) and knowledge-based (34%), suggesting that greater attention should be paid to education and surveillance of medical personnel who prescribe and monitor methotrexate, particularly physicians, who accounted for 40% of the errors.

Drug dosing in patients with renal insufficiency in a hospital setting using electronic prescribing and automated reporting of estimated glomerular filtration rate.

In patients with impaired renal function, drug dose adjustment is often required. Non-adherence to clinical prescribing recommendations may result in severe adverse events. In previous studies, the prevalence rate of non-adherence to recommended dosing has been reported to be 19-67%. Using the clinical support system Renbase(®) as reference, we investigated the use and dosing of drugs in patients with impaired renal function in a university hospital setting using electronic prescription and automatic reporting of estimated glomerular filtration rate (eGFR). In all, 232 patients with an eGFR in the range of 10-49 ml/min./1.73 m(2) were included. We identified 436 episodes with administration of renal risk drugs (prescribed to 183 patients): 410 drugs required dose adjustment according to the eGFR and 26 should be avoided. In total, the use or dosing of 66 (15%) of the 436 renal risk drugs was not in agreement with recommendations in Renbase(®) . This reflects less disagreement with expert guidelines than reported previously, indicating a possible beneficial effect of electronic prescribing and reporting of eGFR. However, we also found that disagreement to some extent reflected inappropriate drug use. We conclude that despite implementation of electronic prescribing and automated reporting of eGFR, patients with renal insufficiency may still be exposed to inappropriate drug use, with potential increased risk of adverse effects. Initiatives to reduce medication errors such as the use of electronic decision support systems should be explored.

3,520 medication errors evaluated to assess the potential for IT-based decision support.

We have previously studied system failures involved in medication errors using a limited number of root cause analyses as source. The aim of this study was to describe a larger number of medication errors with respect to harm, involved medicines and involved system problems - thus providing information for the development of IT-based decision support. We evaluated 3,520 medication error reports derived from 12 months of consecutive reporting from 13 hospitals in the Capital Region of Denmark. We found 0.65% errors with serious harm and 16% with moderate harm. A small number of medicines were involved in the majority of the errors. The problems in the medication error process were heterogeneous. Some were related to specific medicines and others were related to the computerized order entry system. Accordingly decision support targeted at specific medicines and improved IT systems are part of the continuing work to reduce the frequency of medication errors.

Aggregated review of route cause analyses related to medication.

Since 2001 when the systematic analysis of serious patient safety incidents was implemented, a number of root cause analyses have been completed. Common to these is that the medication of the patient has been problematic and has had serious consequences for the patient. In the analyses the events causing the patient safety incidents are described in detail, the causes are identified and a plan of actions is created.

Decision support to avoid medication errors - how far have we come in Denmark and what are the present challenges.

The number of medication errors reported to The Danish National Board of Health in Denmark exceeds 5000 per year. It is well known that computerized physician order entry (CPOE) with addition of decision support tools may reduce the frequency of medication errors. The primary scope of the work in Denmark has been to help health care professionals avoiding harmful errors. Using data primarily from The Danish National Board of Health, based on the reports of errors from Danish hospitals, and with our previous foundation in the international literature, we analyzed the errors which led to harmful conditions or death. In the process we developed a methodical consensus for identifying which medicines should have a warning attached, and we systematized the different kind of warnings. The following validation of the data resulted in a final list of 14 classes of drugs or drug substances, which all have been involved in serious medication errors. At present time there is a total of 136 different medicines with warnings found in the drug database for health professionals from Infomatum A/S (www.medicin.dk). In a parallel matter other decision support tools from Infomatum A/S(2) are available or in progress e.g. ensuring use of correct dosage based on normal range, information about drugs used during pregnancy, etc. A major challenge when implementing decision support for medication processes has been to ensure useful coding of the medicines, A/S there does not exist one unique identification number for each drug substance.

Computerised Physician Order Entry (CPOE).

The purpose of this study is to examine how everyday use of the Computerised Physician Order Entry (CPOE) system in the Capital Region of Denmark has led to medication errors. The study is based on clinicians' reporting of patient safety incidents. It was found that the immediate causes of the patient safety incidents primarily relates to a) a mismatch between clinical work routines and the structure of the CPOE system, b) the complexity of the user interface, and c) lack of barriers against commonly occurring, severe errors in some areas of the CPOE system. The following was concluded: A well designed CPOE system should be intuitive, provide barriers against serious mistakes, and make the correct choice an easy one. Furthermore it was concluded that it is important that the CPOE system closely supports accepted clinical work routines and that risk assessment is performed prior to implementing new design or functionality.

[Drug mix-ups]. / Forvekslinger af laegemidler.

We investigated drug mix-ups at a Danish hospital. We found 115 drug mix-ups among 1,554 medication errors (7%). The majority were packing mix-ups with insulin, infusion fluids and prepared syringes. The most frequent cause of name confusions was illegible handwriting. Packing mix-up occurring during routine dispensing may be prevented with bar-coding, and package mix-ups occurring in acute situations may be prevented through better package design focusing on reducing the risk of mix-ups.

[Serious medication order errors at hospitals]. / Alvorlige medicinordinationsfejl på sygehuse.

INTRODUCTION: Medication order errors are frequent in Denmark. It is necessary to know the reasons why these errors happen to be able to implement initiatives limiting medication order errors. MATERIAL AND METHODS: In this study we analyzed 811 medications order errors, which were reported as unintended events. RESULTS: The medication order errors were associated with at total of 98 medicinal product; hence nine medicinal products caused 18 errors with severe or catastrophic harm to patients. 46.0% of the errors were incorrect medicinal product, 47.7% were incorrect dosage and 6.3% of the orders were double ordering. Penicillin and warfarin were the most frequently involved medicinal products. The products that most frequently caused severe or catastrophic patient harm were insulin and warfarin. The most frequent errors were "no medicinal product prescribed" and "incorrect medicinal product". The errors with the most severe consequences for the patients were due to "medication was not discontinued" (sevoflurane and warfarin) and "poor patient compliance" (warfarin and insulin). A common feature concerning the errors' origin was incorrect handling of information. CONCLUSION: Specific initiatives should be taken to counter the above-mentioned problems and reduce the occurrence of medication order errors. Such measures may comprise control, medication reconciliation and imposition of clinical decision support.

[Clinical decision support: Is the number of medication errors reduced?]. / Beslutningsstøtte til elektronisk patientmedicinering: reduceres forekomsten af medicineringsfejl?

22 papers on clinical decision support (CDS) for computer physician order entry (CPOE) and the ability to reduce medication errors were reviewed. Among the 22 original clinical trials, 21 demonstrated a reduced number of medication errors after the implementation of CDS. The effect was strongest for 2nd and 3rd generation of the CDS-systems. CPOE with CDS is time consuming and may generate new medication errors in itself. All the trials had poor designs. A Danish data source for CDS has not yet been established.

[Adverse events management. Methods and results of a development project]. / Håndtering af utilsigtede haendelser. Metode og resultater af et udviklingsprojekt.

INTRODUCTION: This article describes the methods and results of a project in the Copenhagen Hospital Corporation (H:S) on preventing adverse events. The aim of the project was to raise awareness about patients' safety, test a reporting system for adverse events, develop and test methods of analysis of events and propagate ideas about how to prevent adverse events. MATERIALS AND METHODS: H:S developed an action plan and a reporting system for adverse events, founded an organization and developed an educational program on theories and methods of learning from adverse events for both leaders and employees. RESULTS: During the three-year period from 1 January 2002 to 31 December 2004, the H:S staff reported 6011 adverse events. In the same period, the organization completed 92 root cause analyses. More than half of these dealt with events that had been optional to report, the other half events that had been mandatory to report. CONCLUSION: The number of reports and the front-line staff's attitude towards reporting shows that the H:S succeeded in founding a safety culture. Future work should be centred on developing and testing methods that will prevent adverse events from happening. The objective is to suggest and complete preventive initiatives which will help increase patient safety.

[The Good Medical Department. Results from a national survey of quality in 1998]. / Den gode medicinske afdeling. Resultater fra en national undersøgelse af kvalitet i 1998.

INTRODUCTION: This cross-sectional study describes quality related data from 39 medical wards in Denmark. MATERIAL AND METHODS: The study is based on a review of 1517 medical records and a short patient interview. The medical departments took part voluntarily in the study, which was initiated by the Danish Society for Internal Medicine. RESULTS: A total of 23 quality-related indicators related to the planning of the treatment, documentation in patient records, and care were registered. The day before the data collection was an inactive inpatient day for 22.8 +/- 1.1% of patients. Allergy was insufficiently documented in the medical record for 18.8 +/- 1.0% of patients. Weight was not documented in 48.8 +/- 1.3% of patients. Considerations about anticoagulation treatment of atrial fibrillation were not documented in 50.1 +/- 3.6% of patients with atrial fibrillation. DISCUSSION: This study indicates that it is possible on a voluntary basis to collect and distribute quality-related data. The survey has recently been repeated with a modified data registration sheet.