This paper presents Part 2 of a literature review examining medication safety in the Australian acute care setting. This review was undertaken for the Australian Commission on Safety and Quality in Health Care, updating the 2002 national report on medication safety. Part 2 of the review examined the Australian evidence base for approaches to build safer medication systems in acute care.
A literature search was conducted to identify Australian studies and programs published from 2002 to 2008 which examined strategies and activities for improving medication safety in acute care.
Results and conclusion
Since 2002 there has been significant progress in strategies to improve prescription writing in hospitals with the introduction of a National Inpatient Medication Chart. There are also systems in place to ensure a nationally coordinated approach to the ongoing optimisation of the chart. Progress has been made with Australian research examining the implementation of computerised prescribing systems with clinical decision support. These studies have highlighted barriers and facilitators to the introduction of such systems that can inform wider implementation. However, Australian studies assessing outcomes of this strategy on medication incidents or patient outcomes are still lacking. In studies assessing education for reducing medication errors, academic detailing has been demonstrated to reduce errors in prescriptions for Schedule 8 medicines and a program was shown to be effective in reducing error prone prescribing abbreviations. Published studies continue to support the role of clinical pharmacist services in improving medication safety. Studies on strategies to improve communication between different care settings, such as liaison pharmacist services, have focussed on implementation issues now that funding is available for community-based services. Double checking versus single-checking by nurses and patient self-administration in hospital has been assessed in small studies. No new studies were located assessing the impact of individual patient medication supply, adverse drug event alerts or bar coding. There is still limited research assessing the impact of an integrated systems approach on medication safety in Australian acute care.
To determine the extent to which the use of a clinical informatics tool that implements prospective monitoring plans reduces the incidence of potential delirium, falls, hospitalizations potentially due to adverse drug events, and mortality.
Randomized cluster trial.
Twenty-five nursing homes serviced by two long-term care pharmacies.
Residents living in nursing homes during 2003 (1,711 in 12 intervention; 1,491 in 13 usual care) and 2004 (1,769 in 12 intervention; 1,552 in 13 usual care).
The pharmacy automatically generated Geriatric Risk Assessment MedGuide (GRAM) reports and automated monitoring plans for falls and delirium within 24 hours of admission or as part of the normal time frame of federally mandated drug regimen review.
Incidence of potential delirium, falls, hospitalizations potentially due to adverse drug events, and mortality.
GRAM triggered monitoring plans for 491 residents. Newly admitted residents in the intervention homes experienced a lower rate of potential delirium onset than those in usual care homes (adjusted hazard ratio (HR) = 0.42, 95% confidence interval (CI) = 0.35–0.52), overall hospitalization (adjusted HR = 0.89, 95% CI = 0.72–1.09), and mortality (adjusted HR = 0.88, 95% CI = 0.66–1.16). In longer stay residents, the effects of the intervention were attenuated, and all estimates included unity.
Using health information technology in long-term care pharmacies to identify residents who might benefit from the implementation of prospective medication monitoring care plans when complex medication regimens carry potential risks for falls and delirium may reduce adverse effects associated with appropriate medication use.
nursing homes; health information technology; delirium; pharmacy practice
Background: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care.
Methods: We reviewed 30 121 randomly selected records from 51 randomly selected acute care, non-psychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians.
Results: Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test χ2 = 21.04, p<0.0001). Using weighted totals we estimated that among the 2 671 863 patients discharged from New York hospitals in 1984 there were 98 609 adverse events and 27 179 adverse events involving negligence. Rates of adverse events rose with age (p<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p<0.0001), but no differences in the percentage due to negligence.
Conclusions: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.
Opioid analgesics are high-alert medications known to cause adverse drug events.
The purpose of this study was to determine the cause of opioid incidents requiring administration of naloxone, an opioid reversal agent. The specific objectives were to determine the number of opioid incidents and the proportion of incidents documented through occurrence reporting and to characterize the incidents by phase in the medication-use process, by type of incident, and by drug responsible for toxic effects.
A retrospective chart analysis was conducted using records from 2 acute care centres in the Regina Qu’Appelle Health Region. The study included inpatients who received naloxone for reversal of opioid toxicity resulting from licit, in-hospital opioid use. Cases were classified as preventable or nonpreventable. Preventable cases were analyzed to determine the phase of the medication-use process during which the incident occurred. These cases were also grouped thematically by the type of incident. The drug most likely responsible for opioid toxicity was determined for each case. The proportion of cases documented by occurrence reporting was also noted.
Thirty-six cases involving administration of naloxone were identified, of which 29 (81%) were deemed preventable. Of these 29 preventable cases, the primary medication incident occurred most frequently in the prescribing phase (23 [79%]), but multiple phases were often involved. The cases were grouped into 6 themes according to the type of incident. Morphine was the drug that most frequently resulted in toxic effects (18 cases [50%]). Only two of the cases (5.6%) were documented by occurrence reports.
Preventable opioid incidents occurred in the acute care centres under study. A combination of medication safety initiatives involving multiple disciplines may be required to decrease the incidence of these events and to better document their occurrence.
medication incident; medication safety; opioid; naloxone; incident lié au médicament; sécurité des médicaments; opioïde; naloxone
A world-renowned physician-researcher, David Bates, MD, MSc, is Chief of the Division of General Medicine at the Brigham and Women's Hospital in Boston, MA, and a Professor at Harvard Medical School and the Harvard School of Public Health, where he is codirector of the Program in Clinical Effectiveness. He is the Medical Director of Clinical and Quality Analysis, Information Systems at Partners HealthCare System, Inc. He is also the former Chair of the National Alliance for Primary Care Informatics (NAPCI) and the Chairman of the American Medical Informatics Association (AMIA). Dr Bates' primary interests are in information technology and how it can be used to improve safety and quality. He has conducted extensive research on medication safety in particular, evaluating the incidence and preventability of adverse drug events. He is the author of over 350 publications in peer-reviewed journals.
David Bates, MD, MSc
Adverse drug events are an important cause of preventable hospitalizations.
To identify whether patient report of receipt of medication instructions and markers of complex care (multiple physicians, recent hospitalization) predict the risk of serious bleeding for older adults on warfarin.
Prospective cohort study of older adults.
Subjects filled new or refill prescriptions for warfarin at the time of enrollment.
Hospitalizations were identified through a state-wide registry. Discharge summaries of hospitalizations for possible warfarin related bleeding events were reviewed by trained abstractors and clinical experts. Incidence rate ratios (IRR) were estimated based on person-months of exposure using Poisson regression models.
From March 2002 through May 2003, we enrolled a total of 2346 adults on warfarin. Over a two-year follow-up period, there were 126 hospitalizations due to warfarin-related bleeding (4.6 hospitalizations per 100 person-years of exposure). Patients who reported receiving medication instructions from either a physician or nurse plus a pharmacist had a 60% reduced rate of subsequently experiencing a serious bleeding event over the next 2 years (adjusted IRR 0.40, 95% CI 0.24–0.68). Having ≥4 physicians providing medication prescriptions over the last 3 months and filling prescriptions at >1 pharmacy over the last 3 months were independently associated with increased bleeding rates (adjusted IRRs 2.37, 95% CI 1.22–4.57 and 1.61, 95% CI 0.97–2.67, respectively).
The rate of warfarin-related hospitalization for bleeding is substantially lower for patients who report receiving medication instructions from a physician or nurse and a pharmacist.
anticoagulation; patient communication; medication safety
Medication can be effective but can also be harmful and even cause hospital admissions. Medication review or pharmacotherapy review has often been proposed as a solution to prevent these admissions and to improve the effectiveness and safety of pharmacotherapy. However, most published randomised controlled trials on pharmacotherapy reviews showed no or little effect on morbidity and mortality. Therefore we designed the PHARM (Preventing Hospital Admissions by Reviewing Medication)-study with the objective to study the effect of the total pharmaceutical care process on medication related hospital admissions and on adverse drug events, survival and quality of life.
The PHARM-study is designed as a cluster randomised, controlled, multi-centre study in an integrated primary care setting. Patients with a high risk of a medication related hospital admission are included in the study with randomisation at GP (general practitioner) level. We aim to include 14200 patients, 7100 in each arm, from at least 142 pharmacy practices.
The intervention consists of a patient-centred, structured, pharmaceutical care process. This process consists of several steps, is continuous and occurrs over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patient's pharmacotherapy, the formulation and execution of a pharmaceutical care plan combined with the monitoring and follow up evaluation of the care plan and pharmacotherapy. The patient's own pharmacist and GP carry out the intervention. The control group receives usual care.
The primary outcome of the study is the frequency of hospital admissions related to medication within the study period of 12 months of each patient. The secondary outcomes are survival, quality of life, adverse drug events and severe adverse drug events. The outcomes will be analysed by using mixed-effects Cox models.
The PHARM-study is one of the largest controlled trials to study the effectiveness of the total pharmaceutical care process. The study should therefore provide evidence as to whether such a pharmaceutical care process should be implemented in the primary care setting.
Trial number: NTR 2647
Acute drug overdosing is an important cause of organ dysfunction and metabolic derangements and the patients often require intensive care. This study aims to determine the clinical pattern of severe drug overdose as well as the factors influencing the duration of intensive care
The clinical characteristics and course of consecutive adult patients admitted with a diagnosis of acute drug poisoning in the ICU of a tertiary hospital in Oman from January 2007 to December 2008 were reviewed retrospectively from the electronic case records.
Acute drug poisoning (n=29) constituted 3.9% of admissions to the ICU. Mean age was 29.38±7.9 years. They were brought in by their relatives (72%) or the state services (24%). Accidental poisoning was noted in 21 patients (72%) and suicidal overdosing in 6 (21%). The commonest drug was an opioid (65.5%). Glasgow Coma Scale score of ≤8 was recorded in 18 (62.1%). Sixty two percent of patients required mechanical ventilation. The prominent complications were hypotension in 9 (31%), pulmonary in 19 (65.5%), hepatic in 18 (62.1%) and renal in 12 (41.4%) patients. The major electrolytes abnormalities were low bicarbonate in 11 (37.9%), hyponatremia in 5 (17.2%) and hypokalemia in 4 (13.8%). Patients stayed in the ICU for 1 to 20 days (median-2 days). Factors associated with a longer ICU stay included hypotension upon arrival (p=0.048) and the need for mechanical ventilation on the first (p=0.001) and second (p=0.001) days of hospitalization. There was no mortality.
Early and prompt intensive medical therapy in acute drug poisoning can favorably influence the outcome. In addition, the presence of hypotension and requirement of mechanical ventilation on the first two days of hospitalization were responsible for prolonged ICU stay.
Drug overdose; intensive care; opiates; Oman
Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published.
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature.
This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting.
Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.
Post-marketing surveillance; Medical device; Incident; Adverse event; Malfunction
Adverse events (AEs) are adverse outcomes caused by medical care. Several studies have indicated that a substantial number of patients experience AEs before or during hospitalization. However, few data describe AEs after hospital discharge. We determined the incidence, severity, preventability and ameliorability of AEs in patients discharged from the general internal medicine service of a Canadian hospital.
At a multisite Canadian teaching hospital, we prospectively studied patients who were consecutively discharged home or to a seniors' residence from the general internal medicine service during a 14-week interval in 2002. We used telephone interview and chart review to identify outcomes after discharge. Two physicians independently reviewed each outcome to determine if the patient experienced an AE. The severity, preventability and ameliorability of all AEs were classified.
During the study period, outcomes were determined for 328 of the 361 eligible patients, who averaged 71 years of age (interquartile range 54–81 years). After discharge, 76 of the 328 patients experienced at least 1 AE (overall incidence 23%, 95% confidence interval [CI] 19%–28%). The AE severity ranged from symptoms only (68% of the AEs) or symptoms associated with a nonpermanent disability (25%) to permanent disability (3%) or death (3%). The most common AEs were adverse drug events (72%), therapeutic errors (16%) and nosocomial infections (11%). Of the 76 patients, 38 had an AE that was either preventable or ameliorable (overall incidence 12%, 95% CI 9%–16%).
Approximately one-quarter of patients in our study had an AE after hospital discharge, and half of the AEs were preventable or ameliorable.
To determine the frequency of medical adverse events in elderly patients admitted to an acute care geriatric unit, the predictive factors of occurrence, and the correlation between adverse events and hospital mortality rates.
This prospective study included 171 admissions of patients aged 60 years and older in the acute care geriatric unit in a teaching hospital in Brazil between 2007 and 2008. The following variables were assessed at admission: the patient age, gender, number of prescription drugs, geriatric syndromes (e.g., immobility, postural instability, dementia, depression, delirium, and incontinence), comorbidities, functional status (evaluated with the Katz Index of Independence in Activities of Daily Living), and severity of illness (evaluated with the Simplified Acute Physiology Score II). The incidence of delirium, infection, mortality, and the prescription of potentially inappropriate medications (based on the Beers criteria) were assessed during hospitalization. An observer who was uninvolved in patient care reported the adverse events.
The mean age of the sample was 78.12 years. A total of 187 medical adverse events occurred in 94 admissions (55%). The predictors of medical adverse events were undetermined. Compared with the patients with no adverse events, the patients with medical adverse events had a significantly longer hospital stay (21.41±15.08 days versus 10.91±7.21 days) and a higher mortality rate (39 deaths [41.5%] versus 17 deaths [22.1%]). Mortality was significantly predicted by the Simplified Acute Physiology Score II score (odds ratio [OR] = 1.13, confidence interval [CI] 95%, 1.07 to 1.20), the Katz score (OR = 1.47, CI 95%, 1.18 to 1.83), and medical adverse events (OR = 3.59, CI 95%, 1.55 to 8.30).
Medical adverse events should be monitored in every elderly hospitalized patient because there is no risk profile for susceptible patients, and the consequences of adverse events are serious, sometimes leading to longer hospital stays or even death.
Adverse Events; Elderly; Hospitalization; Risk Factor
Information about Medical Emergency Teams (METs) in Australia and New Zealand (ANZ) is limited to local studies and a cluster randomised controlled trial (the Medical Emergency Response and Intervention Trial [MERIT]). Thus, we sought to describe the timing of the introduction of METs into ANZ hospitals relative to relevant publications and to assess changes in the incidence and rate of intensive care unit (ICU) admissions due to a ward cardiac arrest (CA) and ICU readmissions.
We used the Australian and New Zealand Intensive Care Society database to obtain the study data. We related MET introduction to publications about adverse events and MET services. We compared the incidence and rate of readmissions and admitted CAs from wards before and after the introduction of an MET. Finally, we identified hospitals without an MET system which had contributed to the database for at least two years from 2002 to 2005 and measured the incidence of adverse events from the first year of contribution to the second.
The MET status was known for 131 of the 172 (76.2%) hospitals that did not participate in the MERIT study. Among these hospitals, 110 (64.1%) had introduced an MET service by 2005. In the 79 hospitals in which the MET commencement date was known, 75% had introduced an MET by May 2002. Of the 110 hospitals in which an MET service was introduced, 24 (21.8%) contributed continuous data in the year before and after the known commencement date. In these hospitals, the mean incidence of CAs admitted to the ICU from the wards changed from 6.33 per year before to 5.04 per year in the year after the MET service began (difference of 1.29 per year, 95% confidence interval [CI] -0.09 to 2.67; P = 0.0244). The incidence of ICU readmissions and the mortality for both ICU-admitted CAs from wards and ICU readmissions did not change. Data were available to calculate the change in ICU admissions due to ward CAs for 16 of 62 (25.8%) hospitals without an MET system. In these hospitals, admissions to the ICU after a ward CA decreased from 5.0 per year in the first year of data contribution to 4.2 per year in the following year (difference of 0.8 per year, 95% CI -0.81 to 3.49; P = 0.3).
Approximately 60% of hospitals in ANZ with an ICU report having an MET service. Most introduced the MET service early and in association with literature related to adverse events. Although available in only a quarter of hospitals, temporal trends suggest an overall decrease in the incidence of ward CAs admitted to the ICU in MET as well as non-MET hospitals.
We assessed whether medication safety improved when a medication profiling program was added to a computerized provider order entry system.
Between June 2001 and January 2002 we profiled outpatients with potential prescribing errors using computerized retrospective drug utilization software. We focused primarily on drug interactions. Patients were randomly assigned either to Provider Feedback or to Usual Care. Subsequent adverse drug event (ADE) incidence and other outcomes, including ADE preventability and severity, occurring up to 1 year following the last profiling date were evaluated retrospectively by a pharmacist blinded to patient assignment.
Data were abstracted using a study-designed instrument. An ADE was defined by an Adverse Drug Reaction Probability scale score of 1 or more. Statistical analyses included negative binomial regression for comparing ADE incidence.
Of 913 patients in the analytic sample, 371 patients (41%) had one or more ADEs. Incidence, by individual, was not significantly different between Usual Care and Provider Feedback groups (37% vs. 45%; p = 0.06; Coefficient, 0.19; 95% CI: −0.008, 0.390). ADE severity was also similar. For example, 51% of ADEs in the Usual Care and 58% in the Provider Feedback groups involved symptoms that were not serious (95% CI for the difference, −15%, 2%). Finally, ADE preventability did not differ. For example, 16% in the Usual Care group and 17% in the Provider Feedback group had an associated warning (95% CI for the difference, −7 to 5%; p = 0.79).
Medications safety did not improve with the addition of a medication profiling program to an electronic prescribing system.
Estimates suggest that approximately 1 in 10 patients admitted to hospital experience an adverse event resulting in harm. Methods to improve patient safety have concentrated on developing safer systems of care and promoting changes in professional behaviour. There is a growing international interest in the development of interventions that promote the role of patients preventing error, but limited evidence of effectiveness of such interventions. The present study aims to undertake a randomised controlled trial of patient-led teaching of junior doctors about patient safety.
A randomised cluster controlled trial will be conducted. The intervention will be incorporated into the mandatory training of junior doctors training programme on patient safety. The study will be conducted in the Yorkshire and Humber region in the North of England. Patients who have experienced a safety incident in the NHS will be recruited. Patients will be identified through National Patient Safety Champions and local Trust contacts. Patients will receive training and be supported to talk to small groups of trainees about their experiences. The primary aim of the patient-led teaching module is to increase the awareness of patient safety issues amongst doctors, allow reflection on their own attitudes towards safety and promote an optimal culture among the doctors to improve safety in practice. A mixture of qualitative and quantitative methods will be used to evaluate the impact of the intervention, using the Attitudes to Patient Safety Questionnaire (APSQ) as our primary quantitative outcome, as well as focus groups and semi-structured interviews.
The research team face a number of challenges in developing the intervention, including integrating a new method of teaching into an existing curriculum, facilitating effective patient involvement and identifying suitable outcome measures.
Current controlled Trials: ISRCTN94241579
Inappropriate medication prescription is a common cause of preventable adverse drug events among elderly persons in the primary care setting.
The aim of this systematic review is to quantify the extent of inappropriate prescription to elderly persons in the primary care setting.
We systematically searched Ovid-Medline and Ovid-EMBASE from 1950 and 1980 respectively to March 2012. Two independent reviewers screened and selected primary studies published in English that measured (in)appropriate medication prescription among elderly persons (>65 years) in the primary care setting. We extracted data sources, instruments for assessing medication prescription appropriateness, and the rate of inappropriate medication prescriptions. We grouped the reported individual medications according to the Anatomical Therapeutic and Chemical (ATC) classification and compared the median rate of inappropriate medication prescription and its range within each therapeutic class.
We included 19 studies, 14 of which used the Beers criteria as the instrument for assessing appropriateness of prescriptions. The median rate of inappropriate medication prescriptions (IMP) was 20.5% [IQR 18.1 to 25.6%.]. Medications with largest median rate of inappropriate medication prescriptions were propoxyphene 4.52(0.10–23.30)%, doxazosin 3.96 (0.32 15.70)%, diphenhydramine 3.30(0.02–4.40)% and amitriptiline 3.20 (0.05–20.5)% in a decreasing order of IMP rate. Available studies described unequal sets of medications and different measurement tools to estimate the overall prevalence of inappropriate prescription.
Approximately one in five prescriptions to elderly persons in primary care is inappropropriate despite the attention that has been directed to quality of prescription. Diphenhydramine and amitriptiline are the most common inappropriately prescribed medications with high risk adverse events while propoxyphene and doxazoxin are the most commonly prescribed medications with low risk adverse events. These medications are good candidates for being targeted for improvement e.g. by computerized clinical decision support.
The epidemiology of adverse drug events (ADEs) and medication errors has received little evaluation outside the U.S. and Europe, and extrapolating from these data might not be valid, especially regarding selecting and prioritizing solutions.
To assess the incidence and preventability of ADEs and medication errors in Japan.
The Japan Adverse Drug Events (JADE) study was a prospective cohort study.
A cohort of 3,459 adults admitted to a stratified random sample of seven medical and eight surgical wards and three intensive care units in three tertiary care hospitals over 6 months.
We measured ADE and medication error rates from daily reviews of charts, laboratories, incident reports, and prescription queries by on-site reviewers; presence of a signal was considered an incident. Two independent physicians reviewed incidents to determine whether they were ADEs or medication errors and to assess severity and preventability.
We identified 1,010 ADEs and 514 medication errors (incidence: 17.0 and 8.7 per 1,000 patient-days, respectively) during the study period. Among ADEs, 1.6%, 4.9% and 33% were fatal, life-threatening and serious, respectively. Among ADEs, 14% were preventable. The rate per admission was 29 per 100 admissions, higher than in U.S. studies because associated with of the long length of hospital stay in Japan (mean, 17 days).
The epidemiology and nature of ADEs and medication errors in Japan were similar to other countries, although more frequent per admission. Solutions that worked in these countries might thus improve medication safety in Japan, as could shortening hospital length of stay.
adverse drug events; epidemiology; medication errors; patient safety
Adverse events are unintended patient injuries that arise from healthcare management resulting in disability, prolonged hospital stay or death. Adverse events that require intensive care admission imply a considerable financial burden to the healthcare system. The epidemiology of adverse events in Belgian hospitals has never been assessed systematically.
A multistage retrospective review study of patients requiring a transfer to a higher level of care will be conducted in six hospitals in the province of Limburg. Patient records are reviewed starting from January 2012 by a clinical team consisting of a research nurse, a physician and a clinical pharmacist. Besides the incidence and the level of causation and preventability, also the type of adverse events and their consequences (patient harm, mortality and length of stay) will be assessed. Moreover, the adequacy of the patient records and quality/usefulness of the method of medical record review will be evaluated.
This paper describes the rationale for a retrospective review study of adverse events that necessitate a higher level of care. More specifically, we are particularly interested in increasing our understanding in the preventability and root causes of these events in order to implement improvement strategies. Attention is paid to the strengths and limitations of the study design.
Medical errors; Adverse events; Medical records; Medical audit; Intensive care units; Hospitals
Drug overdose is a leading cause of cardiac arrest and is currently the second leading cause of overall injury-related fatality in the United States. Despite these statistics, the incidence of adverse cardiovascular events (ACVEs) in emergency department (ED) patients following acute drug overdose is unknown. With this study, we address the 2010 American Heart Association Emergency Cardiovascular Care update calling for research to characterize the incidence of in-hospital ACVE following drug overdose.
This was a prospective cohort study at two tertiary care hospitals over 12 months. Consecutive adult ED patients with acute drug overdose were prospectively followed to hospital discharge. The main outcome was occurrence of in-hospital ACVE, defined as the occurrence of one or more of the following: myocardial injury, shock, ventricular dysrhythmia, and cardiac arrest.
There were 459 ED patients with suspected drug overdose, of whom 274 acute drug overdose qualified and were included for analysis (mean [±SE] age = 40.3 [±1.0] years; 63% male). Hospital course was complicated by ACVE in 16 patients (some had more than one): 12 myocardial injury, three shock, two dysrhythmia, and three cardiac arrest. The incidence of ACVE was 5.8% overall (95% confidence interval [CI] = 3.6% to 9.3%) and 10.7% (95% CI = 6.6% to 16.9%) among inpatient admissions, with all-cause mortality at 0.7% (95% CI = 0.2% to 2.6%).
Based on this study of adult patients with acute drug overdose, ACVE may occur in up to 9.3% overall and up to 16.9% of hospital admissions. Implications for the evaluation and triage of ED patients with acute drug overdose require further study with regard to optimizing interventions to prevent adverse events.
Patient safety is a fundamental component of good quality health care. Checklists have been proposed as a method of improving patient safety. This systematic review, asked "In acute hospital settings, would the use of safety checklists applied by medical care teams, compared to not using checklists, improve patient safety?"
We searched the Cochrane Library, MEDLINE, CINAHL, and EMBASE for randomised controlled trials published in English before September 2009. Studies were selected and appraised by two reviewers independently in consultation with colleagues, using inclusion, exclusion and appraisal criteria established a priori.
Nine cohort studies with historical controls studies from four hospital care settings were included-intensive care unit, emergency department, surgery, and acute care. The studies used a variety of designs of safety checklists, and implemented them in different ways, however most incorporated an educational component to teach the staff how to use the checklist. The studies assessed outcomes occurring a few weeks to a maximum of 12 months post-implementation, and these outcomes were diverse.
The studies were generally of low to moderate quality and of low levels of evidence, with all but one of the studies containing a high risk of bias.
The results of these studies suggest some improvements in patient safety arising from use of safety checklists, but these were not consistent across all studies or for all outcomes. Some studies showed no difference in outcomes between checklist use and standard care without a checklist. Due to the variations in setting, checklist design, educational training given, and outcomes measured, it was unfeasible to accurately summarise any trends across all studies.
The included studies suggest some benefits of using safety checklists to improve protocol adherence and patient safety, but due to the risk of bias in these studies, their results should be interpreted with caution. More high quality and studies, are needed to enable confident conclusions about the effectiveness of safety checklists in acute hospital settings.
To perform a systematic review of adverse events associated with herb use in the pediatric population. Since many health care providers get their information about the safety of herbal medicine from case reports published in the medical literature, it is important to assess the quality of these case reports.
Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. Based on the International Society of Epidemiology's “Guidelines for Submitting Adverse Events Reports for Publication”, we assigned a guideline adherence score (0-17) to each case report.
Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 – 8 years old, and 23 % between the ages 9-18 years old. In a few cases, the child used a product that was contaminated (5%) or adulterated (2%). Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Mean guideline adherence score was 12.5 (range 6 – 17).
There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably, and do not contribute in a meaningful way to guiding clinical recommendations.
herbs; adverse events; pediatric; systematic review
To create a voluntary reporting method for identifying adverse events (AEs) and potential adverse events (PAEs) among medical inpatients.
Medical house officers asked their peers about obstacles to care, injuries or extended hospitalizations, and problems with medications that affected their patients. Two independent reviewers coded event narratives for adverse outcomes, responsible parties, preventability, and process problems. We corroborated house officers' reports with hospital incident reports and conducted a retrospective chart review.
The cardiac step-down, oncology, and medical intensive care units of an urban teaching hospital.
Structured confidential interviews by postgraduate year-2 and -3 medical residents of interns during work rounds.
MEASUREMENTS AND MAIN RESULTS
Respondents reported 88 events over 3 months. AEs occurred among 5 patients (0.5% of admissions) and PAEs among 48 patients (4.9% of admissions). Delayed diagnoses and treatments figured prominently among PAEs (54%). Clinicians were responsible for the greatest number of incidents (55%), followed by workers in the laboratory (11%), radiology (15%), and pharmacy (3%). Respondents identified a variety of problematic processes of care, including problems with diagnosis (16%), therapy (26%), and failure to provide clinical and support services (29%). We corroborated 84% of reported events in the medical record. Participants found voluntary peer reporting of medical errors unobtrusive and agreed that it could be implemented on a regular basis.
A physician-based voluntary reporting system for medical errors is feasible and acceptable to front-line clinicians.
adverse events; medical error; voluntary reporting
Objective To assess the effectiveness of acute geriatric units compared with conventional care units in adults aged 65 or more admitted to hospital for acute medical disorders.
Design Systematic review and meta-analysis.
Data sources Medline, Embase, and the Cochrane Library up to 31 August 2008, and references from published literature.
Review methods Randomised trials, non-randomised trials, and case-control studies were included. Exclusions were studies based on administrative databases, those that assessed care for a single disorder, those that evaluated acute and subacute care units, and those in which patients were admitted to the acute geriatric unit after three or more days of being admitted to hospital. Two investigators independently selected the studies and extracted the data.
Results 11 studies were included of which five were randomised trials, four non-randomised trials, and two case-control studies. The randomised trials showed that compared with older people admitted to conventional care units those admitted to acute geriatric units had a lower risk of functional decline at discharge (combined odds ratio 0.82, 95% confidence interval 0.68 to 0.99) and were more likely to live at home after discharge (1.30, 1.11 to 1.52), with no differences in case fatality (0.83, 0.60 to 1.14). The global analysis of all studies, including non-randomised trials, showed similar results.
Conclusions Care of people aged 65 or more with acute medical disorders in acute geriatric units produces a functional benefit compared with conventional hospital care, and increases the likelihood of living at home after discharge.
The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication.
All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN’s Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments.
Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their antidepressant treatment on their own.
The present study indicates that free text comments as often contained in case reports directly submitted by patients can be of value in pharmacovigilance and provide important information on how a drug may affect the person using it and influence his or her personal life.
Published studies have shown that pharmacists on medical rounds reduce the incidence of preventable adverse drug events (ADEs). However, the impact of a dedicated pharmacist who provides consistent patient care in a critical care unit remains to be evaluated.
To determine the impact of a pharmacist who is permanently assigned to the medical intensive care unit (MICU) on the incidence of preventable ADEs, drug charges, and length of stay (LOS) in the MICU.
A randomized, experimental versus historical control group design was used. Preventable ADEs were identified and validated by 2 pharmacists and a critical care physician. Information about MICU drug charges and LOS were obtained from the hospital administrative database.
The intervention group had fewer occurrences of ADEs (10 ADEs/1,000 patient days) when compared to the control group (28 ADEs/1,000 patient days) at a significance level of .03. No significant differences were found between the 2 groups in MICU drug charges and LOS. The vast majority of the 596 documented recommended interventions (99%) were accepted by the medical team. Nutrition monitoring, medication indicated but not prescribed, and dosage modification were the top 3 problems identified by the pharmacist.
The addition of a dedicated critical care pharmacist to the MICU medical team improves the safe use of medication. The services of a dedicated critical care pharmacist should be expanded to include weekend hours to ensure the benefits of improved medication safety.
adverse drug events; medication safety; pharmacist; staffing model
Incident reporting systems (IRS) are used to identify medical errors in order to learn from mistakes and improve patient safety in hospitals. However, IRS contain only a small fraction of occurring incidents. A more comprehensive overview of medical error in hospitals may be obtained by combining information from multiple sources. The WHO has developed the International Classification for Patient Safety (ICPS) in order to enable comparison of incident reports from different sources and institutions.
The aim of this paper was to provide a more comprehensive overview of medical error in hospitals using a combination of different information sources. Incident reports collected from IRS, patient complaints and retrospective chart review in an academic acute care hospital were classified using the ICPS. The main outcome measures were distribution of incidents over the thirteen categories of the ICPS classifier “Incident type”, described as odds ratios (OR) and proportional similarity indices (PSI).
A total of 1012 incidents resulted in 1282 classified items. Large differences between data from IRS and patient complaints (PSI = 0.32) and from IRS and retrospective chart review (PSI = 0.31) were mainly attributable to behaviour (OR = 6.08), clinical administration (OR = 5.14), clinical process (OR = 6.73) and resources (OR = 2.06).
IRS do not capture all incidents in hospitals and should be combined with complementary information about diagnostic error and delayed treatment from patient complaints and retrospective chart review. Since incidents that are not recorded in IRS do not lead to remedial and preventive action in response to IRS reports, healthcare centres that have access to different incident detection methods should harness information from all sources to improve patient safety.