Danish Patient Safety Database Research Articles

Identifying high-risk medications and error types in Danish patient safety database using disproportionality analysis.

Medication error (ME) surveillance in Danish healthcare relies on the mandatory national incident reporting system, the Danish Patient Safety Database (DPSD). Individual case reviews and descriptive statistics with frequency counts are the most often used approaches when analyzing MEs in incident reporting systems, including the DPSD. However, incident reporting systems often generate a large number of reports and may suffer from underreporting; consequently, additional approaches are needed to overcome these challenges. Disproportionality analysis (DPA) is a statistical tool used for signal detection of adverse drug reactions in pharmacovigilance reports, but the evidence for using DPA on ME analysis in safety reporting systems is limited. We aimed to test the feasibility of DPA by analysing harmful MEs reported to DPSD 2014-2018. We utilized proportional reporting ratios (PRR) to identify signals of diproportionality. We identified well-known high-risk medicines, including anticoagulants, opioids, insulins, antiepileptic, and antipsychotic drugs, and their association with several ME types and stages in a medication process. DPA might be suggested as an additional tool for screening MEs and identifying priority areas for further investigation in safety reporting systems.

Medication incidents and medication errors in Danish healthcare: A descriptive study based on medication incident reports from the Danish Patient Safety Database, 2014-2018.

In Denmark, reporting of safety incidents to the nationwide Danish Patient Safety Database (DPSD) is mandatory. Medication incident reports constitute the largest category of safety reports. We aimed to provide numbers and characteristics of medication incidents and MEs reported to DPSD focusing on medication, their severity and the trends therein. This is a cross-sectional study of medication incident reports for individuals ≥18, submitted to DPSD in 2014-2018. We performed analyses on the (1) medication incident and (2) ME levels. Out of 479 814 incident reports, 61.18% (n= 293 536) were related to individuals ≥70 and 44.6% (n= 213 974) to nursing homes. Most of the events were harmless (70.87%, n= 340 047) and 0.8% (n= 3859) had caused severe harm or death. ME-analysis (n= 444 555) revealed that paracetamol and furosemide were the most frequently reported drugs. The most common drugs for severe and fatal MEs were warfarin, methotrexate, potassium chloride, paracetamol and morphine. When the reporting ratio for all MEs and harmful MEs was considered, other drugs than the most frequently reported ones were found to be associated with harm. We found a large proportion of harmless medication incident reports and reports from community healthcare services and identified high-risk medicines associated with harm.

Patient safety incidents involving transdermal opioids: data from the Danish Patient Safety Database.

Background Transdermal opioids are widely used among elderly adults with chronic pain. However, transdermal patches may be involved in a significant proportion of opioid-related patient safety incidents, as the application process includes several subprocesses, each associated with an individual risk of error. Objective The aim was to obtain specific knowledge on patient safety incidents related to transdermal opioid treatment within both the primary care sector and the hospital sector in Denmark. Setting The study is descriptive with data provided by the Danish Patient Safety Database. Methods We manually retrieved all patient safety incidents concerning transdermal opioids reported for 2018 from (1) the hospital sector and (2) the primary care sector. Study data were collected and managed using REDCap electronic data capture tools. Main outcome measure The available information for each incident was sorted into the following categories: location, medication process, type of problem, outcome at time of reporting, and outcome classification. Results A total of 866 patient safety incidents involving transdermal opioids were reported to the Danish Patient Safety Database in 2018. No fatal incidents were present in the database. In 386 cases, the incidents were reported as harmful, and these 386 cases were analysed. Most reports came from the primary care sector (nursing home, home care or social housing). The majority of incidents were related to the administration of the patch in the medication process, and the most prevalent problem was the omission of doses. Conclusion This study has demonstrated that the administration of transdermal opioids is challenging and may cause harm, particularly in the primary care sector. To improve patient safety, optimized systems, including guidelines on drug management and the continuing education of healthcare personnel in transdermal opioid management, are necessary. These guidelines should preferably incorporate reminders and checklists, since the omission of doses was the most reported problem.

Patients Own Safety Incidents Reports to the Danish Patient Safety Database Possess a Unique but Underused Learning Potential in Patient Safety.

The aim of the study was to analyze how patients' own reports of safety incidents to the Danish Patient Safety Database can contribute to patient safety. Patient involvement enhances patient safety; however, there is a shortage of tools capable of systematically capturing and usage of patients' own reports. Since 2012, the Danish Patient Safety Database (DPSD) has comprised such a tool. A total of 209,263 incident reports were compared across the following four reporting groups: patients, relatives, doctors, and nurses. Using thematic comparison, 300 narratives from each group were compared with respect to differences and similarities in the wording of the safety incident. Only a tiny proportion of safety incidents were reported by patients' themselves (1.4%). Most of these (86%) were accepted for processing in the DPSD. Almost 90% of the accepted incidents were classified successfully. Patients' own reports were longer, more often "less severe incidents," and more often reported by female patients. Thematic content analyses revealed incident descriptions from health professionals as terse, unemotional, and extensively using medical terminology and abbreviations. In contrast patients' reports were lengthy, emotional, and focused on relations to health personal, health consequences, and communication errors. Despite the very low ratio of patients reporting an observed incident to DPSD, the finding that most patients own reports are accepted and classified makes the DPSD a promising, comprehensive tool to capture patients' own reports. However, the rich, contextualized descriptions seem insufficiently captured by established nomenclature.

Drug change: 'a hassle like no other'. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel.

Background:Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting.Method:Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held.Results:The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety.Conclusion:DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.

High-risk medications identified from the Danish Patient Safety Database and the challenge of dissemination

Since 2004, patient safety incidents in Denmark have been reported to a national patient safety reporting system – the Danish Patient Safety Database. The goal of the system is to improve patient safety. In 2011, a decision was made to develop a national list of high-risk medications based on the medication incidents reported to the Danish Patient Safety Database. The high-risk medications are defined as medications that have been involved in medication errors and have caused harm to patients. The purpose is to identify medications that posed a particular and preventable risk for patients. It became clear through updates that there was a group of medications that caused severe harm to the patients more frequently than others. Based on the list, the Danish Patient Safety Authority in 2015 identified seven groups of medications that require special attention from healthcare staff: antidiabetic medications, anticoagulants, low-dose methotrexate, concentrated potassium, opioids, gentamicin and digoxin. Better handling of these seven types of medication could improve patient safety significantly. For many years, Danish Patient Safety Authority has distributed tables and booklets about these high-risk medications. In addition, ‘patient safety warnings’ are issued when it is considered necessary. In spite of this, many patient safety incidents involving these medications still occur. This points to the fact that disseminating knowledge from a government level all the way to frontline healthcare staff poses a challenge. On that background, Danish Patient Safety Authority is exploring new ways to disseminate knowledge to frontline healthcare staff about patient safety incidents.

Medication errors in pediatric inpatients: a study based on a national mandatory reporting system.

MEs in hospitalized children occur in all medication processes and mainly involve dosing errors. Strategies should be developed to prevent MEs as these still threaten medication safety in pediatric inpatients. What is known: • Hospitalized children are more likely to experience medication errors than adults. • Voluntary national and local reporting and learning systems have previously been used to describe the nature and types of medication errors. What is new: • Medication errors in hospitalized children occur in all steps of the medication process, most frequently involving dosing errors and most commonly involving morphine, paracetamol, and gentamicin. • Of the medication errors, 1.3% cause severe harm, but no fatal errors were reported.

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.

Development and validation of a taxonomy of adverse handover events in hospital settings

To develop and validate a taxonomy to classify and support the analysis of adverse events related to patient handovers in hospital settings. A taxonomy was established using descriptions of handover events extracted from incident reports, interviews and root cause analysis reports. The inter-rater reliability and distribution of types of handover failures and causal factors. The taxonomy contains five types of failures and seven types of main causal factors. The taxonomy was validated against 432 adverse handover event descriptions contained in incident reports (stratified random sample from the Danish Patient Safety Database, 200 events) and 47 interviews with staff conducted at a large hospital in the Capital Region (232 events). The most prevalent causes of adverse events are inadequate competence (30 %), inadequate infrastructure (22 %) and busy ward (18 %). Inter-rater reliability (kappa) was 0.76 and 0.87 for reports and interviews, respectively. Communication in clinical contexts has been widely recognized as giving rise to potentially hazardous events, and handover situations are particularly prone to failures of communication or unclear allocation of responsibility. The taxonomy provides a tool for analyzing adverse handover events to identify frequent causes among reported handover failures. In turn, this provides a basis for selecting safety measures including handover protocols and training programmes.

Patient safety in drug label design: analysis of reported adverse events before and after introducing a new label design

ObjectivesTo investigate medication errors related to misinterpretation of a new drug label designed with a focus on reducing the risk of medication errors which introduced nine logical features aimed at...

GRP-131 Patient Safety – Analysing Medication-Related Adverse Events

BackgroundMedication-related adverse events (AEs) lead to increased morbidity, mortality and costs. In Denmark, frontline personnel in hospitals and in the primary care sector are obligated to report adverse events to...

GRP-070 Evaluation of the Effect on Patient Safety of a New Label Design For Medicinal Products

BackgroundIn Denmark some of the medicinal products for hospitals are produced by the hospital pharmacies and registered by Amgros (SAD products). In 2007 the Danish Society for Patient Safety, Amgros,...

Patient safety in Danish cancer care: Results from complementary studies.

216 Background: Cancer care has been a top political priority in Danish health care for the past 12 years, but there has been no specific attention towards patient safety. During the past three years, the Danish Cancer Society has carried out several studies, and in 2011 a National working group with all central stakeholders was established together with the Multidisciplinary Cancer Groups. The aim is to provide an overview of safety hazards during the cancer journey based on four different studies addressing the perspective of the health care professionals as well as the patients, and to outline the challenges in the monitoring safety in cancer based on these. Methods: Data from four studies will be presented: (1) 2,429 cancer related adverse event reports from the national Danish Patient Safety Database; (2) retrospective chart review identifying harm in 572 patient records in five inpatients cancer settings using the Global Trigger Tool; (3) errors experienced by 4,262 patients participating in a nationwide survey addressing needs and experiences with healthcare from first contact until completion of primary treatment; (4) errors experienced by the same group of patients during follow-up and rehabilitation two years after diagnosis. Results: The hazards measured varies from according to the methods used; The cancer specific AE reports were primarily related to medication, clinical, process documentation, and clinical administration. Physical harm using GTT was identified in 28% of admissions related to clinical processes, infections, and medication. 10% of the patient reported errors during contact with GP, 15% during diagnostic at hospital and 25 % during treatment. Delay, insufficient information, medication errors, and logistic errors were the most dominant errors. The results adressing patient experienced errors during follow-up and rehablitation are being analyzed. Conclusions: There are specific and serious safety challenges in cancer care and systematic monitoring is needed. Asking the patients add new knowledge. There is a need for critical evaluation of which methods to use for measuring.

Safety hazards in cancer care: findings using three different methods

BackgroundPatients with cancer are at risk of injury during treatment. Some injuries are preventable, but prevention requires knowledge about the hazards.AimsTo identify hazards and injuries relating to Danish patients with...

A multicentre survey of falls among Danish hospice patients

The risk of falling is high among palliative and end-of-life care patients, and neither a systematic fall assessment nor an evaluation of general fall prevention has been carried out at Danish hospices. This descriptive study investigated the frequency and circumstances of falls in 10 hospices comprising 110 beds during 6 months of monitoring. An average of more than two falls per hospice per month was found, with 44% of the incidents occurring during the first 5 days after admittance. Thirty-two percent of patients died within 5 days of falling. More falls occurred on Wednesdays than on any other day, and most occurred late in the evenings and at night. Only 9% were properly reported as adverse events to the Danish Patient Safety Database. The findings indicate that efforts to significantly reduce the number of falls must be based on a more focused strategy of fall prevention.

Critical incidents related to cardiac arrests reported to the Danish Patient Safety Database

Background Critical incident reports can identify areas for improvement in resuscitation practice. The Danish Patient Safety Database is a mandatory reporting system and receives critical incident reports submitted by hospital personnel. The aim of this study is to identify, analyse and categorize critical incidents related to cardiac arrests reported to the Danish Patient Safety Database. Methods The search terms “cardiac arrest” and “resuscitation” were used to identify reports in the Danish Patient Safety Database. Identified critical incidents were then classified into categories. Results One hundred and seven reports describing 122 separate incidents were identified and classified into incidents related to: alerting the resuscitation team ( n = 32; 26%), human performance ( n = 22; 18%), equipment failure ( n = 19; 16%), resuscitation equipment not available ( n = 13; 11%), physical environment ( n = 14; 11%), insufficient monitoring ( n = 14; 11%), and medication error ( n = 8; 7%). Conclusion Critical incidents related to cardiac arrest occur due to logistical, technical, teamworking and knowledge problems. These findings should be considered when planning education and implementing resuscitation practice.