Recognition of adverse drug events in older hospitalized medical patients.

OBJECTIVE: To assess medical teams' ability to recognize adverse drug events (ADEs) in older inpatients. METHODS: The study cohort comprised 250 patients aged 65 years or older consecutively admitted to Internal Medicine wards of three hospitals in the Netherlands between April and November 2007. An independent expert team identified ADEs present upon admission or occurring during hospitalization by a structured retrospective patient chart review. For all ADEs identified, the expert team assessed causality, severity, preventability, and recognition by medical teams. RESULTS: The medical teams did not recognize 19.9 % of all ADEs present upon admission {60.4 ADEs [95 % confidence interval (CI) 51.5-70.8] per 100 hospitalizations} and 20.3 % of all ADEs occurring during the hospital stay [47.2 ADEs (95 % CI 39.4-56.5) per 100 hospitalizations]. Unrecognized ADEs were significantly more often ADEs with possible causality (p=0.014, df=1), ADEs caused by medication errors (p<0.001, df=1), and ADEs not manifesting as new symptoms (p<0.001, df=1). The medical teams did not recognize 23.2 % of mild to moderately severe ADEs and 16.5 % of severe, life-threatening, or fatal ADEs. The recognition of ADEs varied with event type. CONCLUSIONS: The recognition of ADEs by medical teams was substantial for those ADEs with evident causality and with clinically apparent and severe consequences. ADEs mimicking underlying pathologies with a lower severity went unrecognized much more often, as did those resulting only in abnormal laboratory values. Tools to improve the recognition of ADEs by medical teams should, therefore, focus on those ADEs that are more challenging to detect.

Nature and timing of incidents intercepted by the SURPASS checklist in surgical patients.

INTRODUCTION: More than half of in-hospital adverse events can be attributed to a surgical discipline. Checklists can effectively decrease errors and adverse events. However, the mechanisms by which checklists lead to increased safety are unclear. This study aimed to assess the number, nature and timing of incidents intercepted by use of the Surgical Patient Safety System (SURPASS) checklist, a patient-specific multidisciplinary checklist that covers the entire surgical patient pathway. METHODS: The checklist was implemented in two academic hospitals and four teaching hospitals in the Netherlands. Users of the checklist had three options for each item that was checked: 'not applicable', 'yes' and 'intercepted by checklist'. In each hospital, the first 1000 completed checklists were entered into an online central database. RESULTS: In six participating hospitals, 6313 checklists were collected. One or more incidents were intercepted in 2562 checklists (40.6%). In total, 6312 incidents were intercepted. After correction for the number of items and the extent of adherence in each part of the checklist, the number of intercepted incidents was highest in the preoperative and postoperative stages. CONCLUSIONS: The checklist intercepts many potentially harmful incidents across all stages of the surgical patient pathway. The majority of incidents were intercepted in the preoperative and postoperative stages of the pathway. The degree to which these incidents would have been intercepted by a single checklist in the operating room only, compared with a checklist for the entire surgical pathway, remains a subject for future study.

Identification of deteriorating patients on general wards; measurement of vital parameters and potential effectiveness of the Modified Early Warning Score.

BACKGROUND AND PURPOSE: Clear and detectable signs of deterioration have been shown to be present in many patients multiple hours before undergoing a serious life-threatening event. To date, few studies are available describing normal practice and the possible effectiveness of structured tools regarding recognition of deteriorating patients. The aim of this study was to describe the current practice in measurement and documentation of vital signs and the possible usefulness of the Modified Early Warning Score (MEWS) to identify deteriorating patients on hospital wards. METHODS: A retrospective observational study of medical and surgical patients from 2007 with a severe adverse event including cardiopulmonary arrest, unplanned intensive care unit admission, emergency surgery, or unexpected death was performed. We studied all vital parameters that were collected and documented in the 48 hours before these events, and the MEWS was retrospectively calculated. RESULTS: Two hundred four patients were included. In the 48 hours before the event, a total of 2688 measurements of one or more vital signs were taken. Overall, 81% of the patients had an MEWS value of 3 or more at least once during the 48 hours before their event. Recordings of vital signs were mostly incomplete. Even when the MEWS was 3 or more, respiratory rate, diuresis, and oxygen saturation were documented in only 30% to 66% of assessments.

The effect of an active on-ward participation of hospital pharmacists in Internal Medicine teams on preventable Adverse Drug Events in elderly inpatients: protocol of the WINGS study (Ward-oriented pharmacy in newly admitted geriatric seniors).

BACKGROUND: The potential of clinical interventions, aiming at reduction of preventable Adverse Drug Events (preventable ADEs) during hospital stay, have been studied extensively. Clinical Pharmacy is a well-established and effective service, usually consisting of full-time on-ward participation of clinical pharmacists in medical teams. Within the current Hospital Pharmacy organisation in the Netherlands, such on-ward service is less feasible and therefore not yet established. However, given the substantial incidence of preventable ADEs in Dutch hospitals found in recent studies, appears warranted. Therefore, "Ward-Oriented Pharmacy", an on-ward service tailored to the Dutch hospital setting, will be developed. This service will consist of multifaceted interventions implemented in the Internal Medicine wards by hospital pharmacists. The effect of this service on preventable ADEs in elderly inpatients will be measured. Elderly patients are at high risk for ADEs due to multi-morbidity, concomitant disabilities and polypharmacy. Most studies on the incidence and preventability of ADEs in elderly patients have been conducted in the outpatient setting or on admission to a hospital, and fewer in the inpatient setting. Moreover, recognition of ADEs by the treating physicians is challenging in elderly patients because their disease presentation is often atypical and complex. Detailed information about the performance of the treating physicians in ADE recognition is scarce. METHODS/DESIGN: The design is a multi-centre, interrupted time series study. Patients of 65 years or older, consecutively admitted to Internal Medicine wards will be included. After a pre-measurement, a Ward-Oriented Pharmacy service will be introduced and the effect of this service will be assessed during a post-measurement. The primary outcome measures are the ADE prevalence on admission and ADE incidence during hospital stay. These outcomes will be assessed using structured retrospective chart review by an independent expert panel. This assessment will include determination of causality, severity and preventability of ADEs. In addition, the extent to which ADEs are recognised and managed by the treating physicians will be considered. DISCUSSION: The primary goal of the WINGS study is to assess whether a significant reduction in preventable ADEs in elderly inpatients can be achieved by a Ward-Oriented Pharmacy service offered. A comprehensive ADE detection method will be used based on expert opinion and retrospective, trigger-tool enhanced, chart review.

Prevention of surgical malpractice claims by use of a surgical safety checklist.

OBJECTIVE: To assess what proportion of surgical malpractice claims might be prevented by the use of a surgical safety checklist. BACKGROUND: Surgical disciplines are overrepresented in the distribution of adverse events. The recently described multidisciplinary SURgical PAtient Safety System (SURPASS) checklist covers the entire surgical pathway from admission to discharge and is being validated in various ways. Malpractice claims constitute an important source of information on adverse events. In this study, surgical malpractice claims were evaluated in detail to assess the proportion and nature of claims that might have been prevented if the SURPASS checklist had been used. METHODS: A retrospective claim record review was performed using the database of the largest Dutch insurance company for medical liability. All accepted or settled closed surgical malpractice claims filed as a consequence of an incident that occurred between January 1, 2004 and December 31, 2005 were included. Data on the type and outcome of the incident and contributing factors were extracted. All contributing factors were compared to the SURPASS checklist to assess which incidents the checklist might have prevented. RESULTS: We included 294 claims. Failure in diagnosis and peroperative damage were the most common types of incident; cognitive contributing factors were present in two-thirds of claims. Of a total of 412 contributing factors, 29% might have been intercepted by the SURPASS checklist. The checklist might have prevented 40% of deaths and 29% of incidents leading to permanent damage. CONCLUSION: Nearly one-third of all contributing factors in accepted surgical malpractice claims of patients that had undergone surgery might have been intercepted by using a comprehensive surgical safety checklist. A considerable amount of damage, both physical and financial, is likely to be prevented by using the SURPASS checklist.

Effect of a comprehensive surgical safety system on patient outcomes.

BACKGROUND: Adverse events in patients who have undergone surgery constitute a large proportion of iatrogenic illnesses. Most surgical safety interventions have focused on the operating room. Since more than half of all surgical errors occur outside the operating room, it is likely that a more substantial improvement in outcomes can be achieved by targeting the entire surgical pathway. METHODS: We examined the effects on patient outcomes of a comprehensive, multidisciplinary surgical safety checklist, including items such as medication, marking of the operative side, and use of postoperative instructions. The checklist was implemented in six hospitals with high standards of care. All complications occurring during admission were documented prospectively. We compared the rate of complications during a baseline period of 3 months with the rate during a 3-month period after implementation of the checklist, while accounting for potential confounders. Similar data were collected from a control group of five hospitals. RESULTS: In a comparison of 3760 patients observed before implementation of the checklist with 3820 patients observed after implementation, the total number of complications per 100 patients decreased from 27.3 (95% confidence interval [CI], 25.9 to 28.7) to 16.7 (95% CI, 15.6 to 17.9), for an absolute risk reduction of 10.6 (95% CI, 8.7 to 12.4). The proportion of patients with one or more complications decreased from 15.4% to 10.6% (P<0.001). In-hospital mortality decreased from 1.5% (95% CI, 1.2 to 2.0) to 0.8% (95% CI, 0.6 to 1.1), for an absolute risk reduction of 0.7 percentage points (95% CI, 0.2 to 1.2). Outcomes did not change in the control hospitals. CONCLUSIONS: Implementation of this comprehensive checklist was associated with a reduction in surgical complications and mortality in hospitals with a high standard of care. (Netherlands Trial Register number, NTR1943.).

The SURgical PAtient Safety System (SURPASS) checklist optimizes timing of antibiotic prophylaxis.

BACKGROUND: Surgical site infection (SSI) is an adverse event in which a close relation between process of care and outcome has been demonstrated: administration of antibiotic prophylaxis decreases the risk of SSI. In our tertiary referral centre, a SURgical PAtient Safety System (SURPASS) checklist was developed and implemented. This multidisciplinary checklist covers the entire surgical pathway and includes, among other items, administration of antibiotic prophylaxis before induction of anaesthesia. The aim of this study was to determine the effect of SURPASS implementation on timing of antibiotic prophylaxis. METHODS: A retrospective analysis was performed on two cohorts of patients: one cohort of surgical patients that underwent surgery before implementation of the checklist and a comparable cohort after implementation. The interval between administration of antibiotic prophylaxis and incision was compared between the two cohorts. RESULTS: A total of 772 surgical procedures were included. More than half of procedures were gastro-intestinal; others were vascular, trauma and hernia repair procedures. After implementation, the checklist was used in 81.4% of procedures. The interval between administration of antibiotic prophylaxis and incision increased from 23.9 minutes before implementation of SURPASS to 29.9 minutes after implementation (p = 0.047). In procedures where the checklist was used, the interval increased to 32.9 minutes (p = 0.004). The proportion of patients that did not receive antibiotics until after the incision decreased significantly. CONCLUSION: The use of the SURPASS checklist leads to better compliance with regard to the timing of antibiotic prophylaxis administration.

Application of the Bow-Tie model in medication safety risk analysis: consecutive experience in two hospitals in the Netherlands.

BACKGROUND: To improve medication safety effectively, one should systematically analyse and assess the risks for medication errors and determine the possible causes. So far, no risk-analysis instrument exists in healthcare that can be used to analyse and visualize risks, causes and consequences of potential adverse events in a prospective manner. In high-risk industries such as petrochemistry and aviation, the Bow-Tie model is frequently used. This model combines causes, errors, preventive and recovery measures, and consequences in one model and gives insight into the magnitude and causes of existing safety risks. The aim of our project was to study the usefulness of the Bow-Tie model in the hospital setting for prospective analysis of risks in the medication process in order to develop a practicable method. METHODS: The model was first adapted to the clinical setting. Thereafter, the risk-analysis model was applied in a large tertiary teaching hospital in multidisciplinary sessions. The sessions and risk-analysis method were evaluated on the following aspects: applicability, comprehensibility, creation of awareness in and motivation of participants, and the capability of the 'system approach' (the approach taken by the Bow-Tie model, which focuses on the conditions under which individuals work and tries to build defences to avert errors or mitigate their effects, in contrast to a 'person approach', which focuses on errors of individuals, blaming them for forgetfulness, inattention etc.). Based on this evaluation, the risk analysis method was adjusted and consecutively applied in a general teaching hospital. After evaluation of the sessions in the second hospital a recommended method for risk analysis with the Bow-Tie model was defined. RESULTS: The risk-analysis method with the Bow-Tie model in the first hospital gave insight into many medication safety-related risks. However, the method was insufficient on comprehensibility and on the creation of awareness and motivation owing to a great number of determined risks which made thorough analysis, drawing of Bow-Ties and prioritizing difficult. The adjusted method in the second hospital focused more on the in-depth analysis of a small number of important safety issues of a department with specific attention for underlying causes. This approach was considered better in applicability, comprehensibility and the creation of awareness. Furthermore, by analyzing underlying causes, more attention could be paid to latent conditions (which can translate into error-provoking conditions) within the system. CONCLUSION: We found the Bow-Tie to be an appropriate model for prospective risk analysis of medication safety in a hospital. By applying the model in two hospitals consecutively we developed a feasible method for risk-analysis sessions. Key factors of this recommended method are a focus on the prioritized selection of safety issues and specific attention to latent conditions within the system by analysing these safety issues in depth to the root causes with the help of the Bow-Tie model.

The effect of low molecular weight heparin on survival in patients with advanced malignancy.

PURPOSE: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. METHODS: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. RESULTS: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1%) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). CONCLUSION: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation.

Thrombosis prophylaxis in patient populations with a central venous catheter: a systematic review.

BACKGROUND: Central venous catheters (CVCs) are used in a wide variety of patients. Associated complications are thrombosis and infection. It is a matter of debate whether thromboprophylaxis is beneficial. METHODS: We performed a systematic review of 3 different patient populations to render the available information in the literature more accessible to clinical practice: patients receiving parenteral nutrition (PN), patients with cancer, and patients admitted to intensive care units. RESULTS: Prophylaxis with heparin added to PN was found to give a nonsignificant reduction in the incidence of catheter-related thrombosis (pooled relative risk of randomized studies, 0.77; 95% confidence interval [CI], 0.11-5.48). In cancer patients, both low-dose warfarin and low-molecular-weight heparin significantly reduced the incidence of catheter-related thrombosis (relative risk of randomized studies, 0.25 [95% CI, 0.09-0.70] and 0.10 [95% CI, 0.01-0.71], respectively). So far, intensive care patients have hardly been studied with respect to thromboprophylaxis and the incidence of CVC thrombosis. Any effect of the type of catheter could not be established because of small numbers. There was no apparent increase in bleeding events with prophylactic anticoagulation in patients with CVCs. CONCLUSIONS: In the small number of patients studied, the addition of heparin to PN did not significantly decrease the risk of catheter-related thrombosis, whereas warfarin and dalteparin did decrease the thrombosis risk in cancer patients with CVCs. There is no apparent increase in bleeding events with prophylactic anticoagulants in patients with CVCs.