Pediatric patient safety: identification and characterization of adverse events, adverse drug events, and medical error.
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Child, Hospitalized↗
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Results for “adverse event”
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The Shift Coupon: an innovative method to monitor adverse events.
Adverse events are one method of measuring hospital quality; however, collecting these data is problematic. This article reports findings from a study conducted to collect data about the occurrence of adverse events in the hospital setting using an instrument called the Shift Coupon. The results demonstrated the viability of the Shift Coupon to collect adverse events data and identified the most commonly reported adverse events and nurse-reported causes of adverse events.
Accidental Falls↗
Mood stabilizers and treatment adherence in bipolar disorder: addressing adverse events.
Adverse events associated with lithium and anticonvulsant use in patients with bipolar disorder have been determined to decrease rates of treatment adherence; however, research that explores how adverse events influence treatment adherence, and which events have the greatest impact, is sparse and limited. This paper reviews the existing literature regarding common side effects encountered with lithium and anticonvulsant use in patients with bipolar disorder and presents data regarding their impact on treatment adherence. Guidelines for reducing and limiting adverse events are highlighted, as are recommendations for improving compliance associated with the experience of adverse events in the bipolar disorder population.
Anticonvulsants↗
Adverse events and preventable adverse events in children.
CONTEXT: Patient safety has been recognized as an important problem in health care. However, knowledge about adverse events and preventable adverse events in children is relatively limited. OBJECTIVE: To describe the incidence and types of adverse events and preventable adverse events in children. DESIGN: Analysis of pediatric hospitalizations in the Colorado and Utah Medical Practice Study, which involved a retrospective, 2-level (nurse and physician) medical record review of a population-based, representative sample of all pediatric hospital discharges. MAIN MEASURES: Adverse events were defined as an injury caused by medical management rather than disease processes that resulted in either prolonged hospitalization or disability at discharge. A preventable adverse event was defined as an avoidable adverse event based on currently available knowledge and accepted practices. PATIENTS: 3719 discharged hospital patients, 0-20 years old, and 7528 nonelderly (21-65 years old) discharged adult patients in Colorado and Utah. SETTING: All hospitals in Colorado and Utah. RESULTS: Adverse events occurred in 1% of pediatric hospitalizations in Colorado and Utah; 0.6% were preventable. Preventable adverse events rates were 0.53% in neonates and infants (0-0.99 years), 0.22% in children 1-12 years of age, and 0.95% in adolescents 13-20 years of age, compared with a rate of 1.50% in nonelderly adults. Of preventable adverse event types, birth related (32.2%) and diagnostic related (30.4%) events were the most common and were significantly more common than surgically related preventable adverse events (3.5%). CONCLUSIONS: These data suggest that approximately 70,000 children hospitalized in the United States experience an adverse event each year; 60% of these events may be preventable. The epidemiology of adverse events and preventable adverse events in children is different than in adults. To reduce the adverse events that occur in hospitalized children, research should focus on adolescent hospitalized patients, birth-related medical care, and diagnostics in pediatric medicine.
Adolescent↗
Screening for adverse events.
Adverse events (AEs) in medical patients are common, costly, and often preventable. Development of quality improvement programs to decrease the number and impact of AEs demands effective methods for screening for AEs on a routine basis. Here we describe the impact, types, and potential causes of AEs and review various techniques for identifying AEs. We evaluate the use of generic screening criteria in detail and describe a recent study of the sensitivity and specificity of individual generic screening criteria and combinations of these criteria. In general, the most sensitive screens were the least specific and no small sub-set of screens identified a large percentage of adverse events. Combinations of screens that were limited to administrative data were the least expensive, but none were particularly sensitive, although in practice they might be effective since routine screening is currently rarely done. As computer systems increase in sophistication sensitivity will improve. We also discuss recent studies that suggest that programs that screen for and identify AEs can be useful in reducing AE rates. While tools for identifying AEs have strengths and weaknesses, they can play an important role in organizations' quality improvement portfolios.
Adverse Drug Reaction Reporting Systems↗
Counting the costs of drug-related adverse events.
Adverse drug events occur frequently and lead to a significant number of fatalities each year. It has been estimated that fatalities directly attributable to adverse drug reactions are the fourth to sixth leading cause of death in US hospitals, exceeding deaths caused by pneumonia and diabetes. The economic burden resulting from drug-related morbidity and mortality is equally significant and has been conservatively estimated at $US30 billion dollars annually, and could exceed $US130 billion in a worst-case scenario. Since many adverse drug events are considered preventable, increased efforts should be made to avoid classes of drugs that are problem-prone and to initiate diligent monitoring of drugs with predictable toxicities. Programmes should also be implemented that improve medication use practices within institutions. Although nearly all drugs are capable of producing an injury, certain drugs are more likely to do so. Prevention of drug-related morbidity and mortality has become an increasingly important requirement for reducing healthcare expenditures. This article will review studies that examine the economic implications of drug-related adverse events.
Animals↗
Comparison of three methods for estimating rates of adverse events and rates of preventable adverse events in acute care hospitals.
OBJECTIVES: To compare the effectiveness, reliability, and acceptability of estimating rates of adverse events and rates of preventable adverse events using three methods: cross sectional (data gathered in one day), prospective (data gathered during hospital stay), and retrospective (review of medical records). DESIGN: Independent assessment of three methods applied to one sample. SETTING: 37 wards in seven hospitals (three public, four private) in southwestern France. PARTICIPANTS: 778 patients: medical (n = 278), surgical (n = 263), and obstetric (n = 237). MAIN OUTCOME MEASURES: The main outcome measures were the proportion of cases (patients with at least one adverse event) identified by each method compared with a reference list of cases confirmed by ward staff and the proportion of preventable cases (patients with at least one preventable adverse event). Secondary outcome measures were inter-rater reliability of screening and identification, perceived workload, and face validity of results. RESULTS: The prospective and retrospective methods identified similar numbers of medical and surgical cases (70% and 66% of the total, respectively) but the prospective method identified more preventable cases (64% and 40%, respectively), had good reliability for identification (kappa = 0.83), represented an acceptable workload, and had higher face validity. The cross sectional method showed a large number of false positives and identified none of the most serious adverse events. None of the methods was appropriate for obstetrics. CONCLUSION: The prospective method of data collection may be more appropriate for epidemiological studies that aim to convince clinical teams that their errors contribute significantly to adverse events, to study organisational and human factors, and to assess the impact of risk reduction programmes.
Chi-Square Distribution↗
[Adverse events and adverse reactions associated with drugs--important actual spontaneous reporting of the drug event].
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Adverse Drug Reaction Reporting Systems↗
Safety of anthrax vaccine: a review by the Anthrax Vaccine Expert Committee (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).
PURPOSE: To assess the safety of a licensed anthrax vaccine given to nearly 400,000 US military personnel, reports of adverse events (AEs) submitted to the Vaccine Adverse Event Reporting System (VAERS) were reviewed and evaluated medically. METHODS: The Anthrax Vaccine Expert Committee (AVEC), a civilian panel of private-sector physicians and other scientists, reviewed 602 VAERS reports using a Delphic approach (structured expert consensus) to assess the causal relationship between vaccination and the reported AEs and sought to identify unexpected patterns in the occurrence of medically important events. Reports were entered into a database and used to profile AEs with respect to person, type/location, relative frequency, severity/impact, concomitant illness or receipt of other drugs or vaccines, and vaccine lot. RESULTS: Nearly half the reports noted a local injection-site AE, with more than one-third of these involving a moderate to large degree of inflammation. Six events qualified as serious AEs (SAEs), and all were judged to be certain consequences of vaccination. Three-quarters of the reports cited a systemic AE (most common: flu-like symptoms, malaise, rash, arthralgia, headache), but only six individual medically important events were judged possibly or probably due to vaccine (aggravation of spondyloarthropathy (2), anaphylactoid reaction, arthritis (2), bronchiolitis obliterans organizing pneumonia). CONCLUSIONS: Since some cases of local inflammation involved distal paresthesia, AVEC recommends giving subcutaneous injections of AVA over the inferior deltoid instead of the triceps to avoid compression injury to the ulnar nerve. At this time, ongoing evaluation of VAERS reports does not suggest a high frequency or unusual pattern of serious or other medically important AEs.
Adolescent↗
Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994.
OBJECTIVE: To provide an overview of the data, function, and performance of the Vaccine Adverse Event Reporting System. DESIGN: Descriptive and correlational analyses. SETTING: United States, 1991 through 1994. SUBJECTS: Reports to the Vaccine Adverse Event Reporting System, a passive national surveillance system, that represents temporal (but not necessarily causal) relationships between vaccinations and adverse events. MAIN OUTCOME MEASURES: Demographic variables, birth weight, vaccine type, severity of adverse event after immunization. RESULTS: A total of 38,787 adverse events was reported during the study period without a clearly increasing or decreasing trend in the annual number of total reports or deaths. Of the deaths with known age, 72.4% were reported in the first year of life, and 63.7% of these were male. The peak age for death reports was 1 to 3 months, with a gradual decline through age 9 months, after which death was relatively rare. Adverse events with onset of symptoms the day of vaccination accounted for 45.5% of total reports; 20.4% had onset of symptoms the following day. Onset within 2 weeks after vaccination was noted for 92.5% of all reports. Simultaneous administration of multiple vaccines was noted in 75.7% of reports for immunizations at ages younger than 20 years. In contrast, among those 20 years or older, only 6.0% of reports named multiple vaccines. Wide geographic variations were noted in adverse event reporting rates for children younger than 2 years, and the states with the lowest reporting rates of less serious events included the most populous states. CONCLUSIONS: The peak age of deaths at ages 1 to 3 months could be expected on the basis of prior studies showing that sudden infant death syndrome deaths peak at that age, that most deaths in the Vaccine Adverse Event Reporting System are attributed to sudden infant death syndrome, and that sudden infant death syndrome has not been associated with vaccination. The large number of reports and national coverage of the Vaccine Adverse Events Reporting System make it useful for monitoring the safety of vaccine lots and for accumulating case series to detect or better understand adverse events that may occur too rarely to be assessed in clinical trials or in the larger studies that are sometimes carried out by manufacturers after vaccine licensure (phase IV studies).
Adolescent↗
Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).
PURPOSE: To assess the safety of a licensed anthrax vaccine (AVA) given to more than 500,000 US military personnel, through review and medical evaluation of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS). METHODS: AEs were summarized by person, vaccine lot, type, frequency and impact. A Delphic approach was used to tentatively assess causality in an effort to detect serious AEs (SAEs) or other medically important AEs (OMIAEs) possibly attributable to AVA. RESULTS: The Anthrax Vaccine Expert Committee (AVEC) reviewed 1841 reports describing 3991 AEs (9.4 reports/10,000 doses of AVA) that were submitted to VAERS from 1Q1998 through 4Q2001. One hundred forty-seven reports described an SAE or OMIAE, of which 26 were tentatively rated as possible, probable or certain consequences of vaccination (injection-site reaction [12], 'anaphylactic-like reaction' [5] and eight other systemic AEs [1-2 each]). CONCLUSIONS: This review produced no evidence for an unusual rate of any SAE or OMIAE attributable to AVA. It supported an earlier impression that AVA may cause significant local inflammation and should be administered over the deltoid rather than the triceps to avoid direct or compression injury to the ulnar nerve. The subjects of VAERS reports tended to be older than all recipients of AVA. Females generally had and/or reported AEs more often than males, but transient articular reactions were surprisingly more common in males. Variations in the frequency or severity (as judged by hospitalization and/or loss of duty) of reported AEs did not suggest a significant problem with (1) a particular lot of AVA, (2) recurrent AEs after multiple doses or (3) vaccination of persons with a concomitant illness or those given other vaccines or medications.
Adult↗
Placebo adverse events in headache trials: headache as an adverse event of placebo.
We analysed the adverse events of placebo in acute and preventive randomized, double-blind, placebo-controlled studies for migraine treatment. Fifty-seven trials (oral triptans, non-steroidal anti-inflammatory drugs, nasal ergot alkaloids and preventive agents) were included. From 10 to 30% of subjects reported adverse events after placebo. Most common were features associated with a migraine attack, such as nausea, phono- and photophobia. Other frequent complaints resembled those of the active drug (e.g. chest pressure in triptan trials). A third group of adverse events appeared to be coincidental (e.g. sleep disturbance). Adverse events following placebo are probably related to the drug under study and the symptomatology of migraine; some have no obvious explanation.
Administration, Intranasal↗
The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada.
BACKGROUND: Research into adverse events (AEs) has highlighted the need to improve patient safety. AEs are unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management. We estimated the incidence of AEs among patients in Canadian acute care hospitals. METHODS: We randomly selected 1 teaching, 1 large community and 2 small community hospitals in each of 5 provinces (British Columbia, Alberta, Ontario, Quebec and Nova Scotia) and reviewed a random sample of charts for nonpsychiatric, nonobstetric adult patients in each hospital for the fiscal year 2000. Trained reviewers screened all eligible charts, and physicians reviewed the positively screened charts to identify AEs and determine their preventability. RESULTS: At least 1 screening criterion was identified in 1527 (40.8%) of 3745 charts. The physician reviewers identified AEs in 255 of the charts. After adjustment for the sampling strategy, the AE rate was 7.5 per 100 hospital admissions (95% confidence interval [CI] 5.7- 9.3). Among the patients with AEs, events judged to be preventable occurred in 36.9% (95% CI 32.0%-41.8%) and death in 20.8% (95% CI 7.8%-33.8%). Physician reviewers estimated that 1521 additional hospital days were associated with AEs. Although men and women experienced equal rates of AEs, patients who had AEs were significantly older than those who did not (mean age [and standard deviation] 64.9 [16.7] v. 62.0 [18.4] years; p = 0.016). INTERPRETATION: The overall incidence rate of AEs of 7.5% in our study suggests that, of the almost 2.5 million annual hospital admissions in Canada similar to the type studied, about 185 000 are associated with an AE and close to 70 000 of these are potentially preventable.
Canada↗
Validation of a discharge summary term search method to detect adverse events.
OBJECTIVE: Adverse events are poor health outcomes caused by medical care. Measuring them is necessary for quality improvements, but current detection methods are inadequate. We performed this study to validate a previously derived method of adverse event detection using term searching in physician-dictated discharge summaries. DESIGN: This was a retrospective, chart review study of a random sample of 245 adult medicine and surgery patients admitted to a multicampus academic medical center in 2002. MEASUREMENTS: The authors used a commercially available search engine to scan discharge summaries for the presence of 104 terms that potentially indicate an adverse event. Summaries with any of these terms were reviewed by a physician to determine the term's context. Screen-positive summaries had a term that was contextually indicative of an adverse event. We used a two-stage chart review as the gold standard to determine the true presence or absence of an adverse event. RESULTS: The average patient age was 62 years (standard deviation 18.6) and 55% were admitted to a medical service. By gold standard criteria, 48 of 245 patients had an adverse event. Term searching classified 27 cases with an adverse event, with 11 true positives; 218 cases were classified as not having an adverse event, with 181 true negatives. The sensitivity, specificity, and positive and negative predictive values were 0.23 (95% confidence interval [CI]=0.11-0.35), 0.92 (95% CI=0.88-0.96), 0.41 (95% CI=0.25-0.59), and 0.83 (95% CI=95% 0.77-0.97), respectively. CONCLUSION: Although the sensitivity of the method is low, its high specificity means that the method could be used to replace expensive manual chart reviews by nurses.
Academic Medical Centers↗
Adverse events and adverse outcomes.
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Humans↗
Adverse events in British hospitals. Adverse events may occur whatever course of action is pursued.
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Aged↗
Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group.
PURPOSE: To examine the feasibility of pharmacist-led intensive hospital monitoring of adverse events (AEs) associated with newly marketed drugs. SUBJECTS/SETTING: 303 patients admitted to Southampton Hospitals who were prescribed selected newly marketed drugs during their inpatient stay in 1998. METHODS: Prospective observational study. Patients were identified from computerized pharmacy records, clinical pharmacist ward rounds, dispensary records or via nursing staff. The pharmacist reviewed medical notes and recorded AEs, suspected adverse drug reactions (ADRs) and reasons for stopping drugs. OUTCOMES: Incidence of AEs, ADRs; proportionate agreement between the physician's and pharmacist's event recording. RESULTS: 303 patients were monitored. Of the patients taking newly marketed drugs 92% were identifiable using pharmacy computer systems and pharmacist ward visits. There were 21 (7%) suspected ADRs detected during this pilot study. The types of adverse events detected were broadly similar to those identified by general practice-based prescription event monitoring. However, biochemical changes featured more frequently than in general practice. Differences between adverse events recorded by pharmacist and physician were systematic and attributed to differences in event coding. CONCLUSION: Pharmacist-led monitoring in a typical NHS hospital setting was effective at detecting ADRs in newly marketed drugs. However, this effort might have been substantially less time-consuming and more effective were electronic patient records (EPRs) available. Pharmacy computer systems are not designed to be patient focused and are therefore unable to identify patients taking newly marketed drugs. It is argued that future EPR and computerised patient-specific prescribing systems should be designed to capture this data in the same way as some US systems are currently able to do.
Computers↗
[Efforts to prevent adverse events in the United States--health care risk management and a fresh perspective on adverse events prevention].
Not causing adverse events is never-ceasing issue in the health care field. However, the advances and greater specialization of medical technologies and the increasing number of elderly people, are all factors in the occurrence of adverse events. At the same time, greater efficiency is now demanded in the health care field, and the problem of preventing adverse events has become tougher than ever before. Given the situation, a fresh perspective on attempts to prevent adverse events may be important. One hint for such a new perspective is the health care risk management that is widely practiced in the health care field in the United States. This was introduced in the mid-1970s to counter the disputes and lawsuits at the time, but over the years the focus has shifted to the importance of prevention, and is now recognized as a means to work toward the assurance of quality of health care. Hints are also found in the suggestions related to adverse events prevention. In "To Err Is Human," published in November 1999 in the United States, includes proposals to "respect human limits in process design" and "promote effective team functioning," which are just the approaches we should adopt for a new perspective. I would also like to draw attention to the idea that there should be investigations into "developing effective mechanisms for identifying and dealing with unsafe practitioners" and the importance of "protecting voluntary reporting systems" that is mentioned. Adopting American methods unchanged to the health care system in Japan may not be appropriate, but the way of thinking and know-how from health care risk management, as well as the suggestions for adverse events prevention will provide us new perspectives on adverse events prevention, from which we should work toward a system of more efficient, and high-quality adverse events prevention.
Japan↗