Lessons from a patient partnership intervention to prevent adverse drug events.

BACKGROUND: Patient safety 'best practices' that call for patient participation to prevent adverse drug events have not been rigorously evaluated. OBJECTIVE: To consider lessons learned from a patient partnership intervention to prevent adverse drug events among medical in-patients. DESIGN: Prospective randomized, controlled pilot trial. SETTING: Boston teaching hospital. Patients. Two hundred and nine adult in-patients on a general medicine unit. INTERVENTION: Intervention patients (n = 107) received drug safety information and their medication list; controls (n = 102) received drug safety information only. Measurements. Adverse drug events and close-call drug errors were identified using chart review and incident reports from nurses, pharmacists, and physicians. Patients and clinicians were surveyed about the intervention. RESULTS: In 1053 patient-days at risk, 11 patients experienced 12 adverse drug events and 16 patients experienced 18 close calls. There was a non-significant difference between intervention patients and controls in survey responses and in the adverse drug event rate (8.4% versus 2.9%, P = 0.12) and close-call rate (7.5% versus 9.8%, P = 0.57). Eleven percent of patients were aware of drug-related mistakes during the hospitalization. Among nurse respondents, 29% indicated that at least one medication error was prevented when a patient or family member identified a problem. CONCLUSION: Partnering with in-patients to prevent adverse drug events is a promising strategy but requires further study to document its efficacy.     

The prevalence of problem drug misuse in a rural county of England

Previous capture-recapture studies have estimated the prevalence of problem drug misuse in urban areas. This study estimates the prevalence in a rural county, Norfolk, using data from four sources: drug treatment agencies, probation, the arrest referral service, and police (drug-related crime with/without acquisitive crime). Careful consideration was given to methods of matching datasets and sensitivity analyses involved altering matching rules and postcode criteria. Whilst it is recognised that acquisitive crime is often related to drug use, this is the first capture-recapture study to incorporate acquisitive crime data. In further sensitivity analyses the proportion of acquisitive crime assumed to be drug-related was varied from 25-60%. The main analysis provided an estimated prevalence of problem drug use in Norfolk of 2.05% (95% confidence interval: 1.66%-2.56%) for ages 15-54 years, considerably higher than the 1.1% currently suggested for the UK. Sensitivity analyses based on varied matching and postcode criteria produced estimates ranging from 2.41%-3.37%, suggesting our estimate may be conservative. Sensitivity analyses assuming that 25-60% of acquisitive crimes were drug-related, produced estimates ranging from 2.02% to 5.73%, further supporting our main analysis. In conclusion, this study provides evidence that problem drug misuse is more prevalent in this rural population than previously thought.     

Assessment of drug-related problems in clinical nutrition patients.

BACKGROUND: Medication use in clinical nutrition patients is affected by concomitant disease states and alterations in medication administration and delivery. The purpose of this evaluation was to document the number and type of drug-related problems that occurred and to evaluate the effect pharmacists had on the care of nutrition patients. METHODS: Patients were evaluated by a pharmacist who was part of the clinical nutrition team. Drug-related problems were identified and recommendations were made to resolve them. Acceptance of the recommendations and patient outcomes were documented. RESULTS: After the evaluation of 440 patients, 220 pharmacist interventions were made. Interventions included 35 drug information requests and 185 recommendations made to solve identified drug-related problems in 126 patients. The most frequent drug-related problems were drug interactions (33/185) and untreated indications (24/185). Of 185 recommendations, 166 were accepted, and 19 were accepted with a modification. A total of 132 of 155 recommendations that were accepted or accepted with modification had a positive outcome: 45 patients responded, and 87 patients developed no complications. Six patients did not respond to the recommendation, and in 17 patients the outcome was unknown. Fifty-eight recommendations avoided potential adverse drug events. CONCLUSIONS: Pharmacist intervention identified drug-related problems in almost 30% of clinical nutrition patients. The identification and resolution of the problems had a positive effect on patient care, as indicated by patient outcome and the avoidance of adverse drug events. The drug-related problem approach identified areas in which pharmacists can educate the health care team and ensure proper medication use in this patient population.     

Estimating the costs of drug-related hospital separations in Australia

OBJECTIVE: To estimate the total hospital costs of drug-related separations in Australia from 1999/2000 to 2004/05, and separate costs for the following illicit drug classes: opioids, amphetamine, cannabis and cocaine. METHODS: Australian hospital separations between 1999/2000 to 2004/05 from the National Hospital Morbidity Dataset (NHMD) with a principal diagnosis of opioids, amphetamine, cannabis or cocaine were included, as were indirect estimates of additional 'drug-caused' separations using aetiological fractions. The costs were estimated using the year-specific case weights and costs for each respective Diagnostic Related Group (DRG). RESULTS: Total constant costs decreased from $50.8 million in 1999/2000 to $43.8 million in 2002/03 then increased to $46.7 million in 2004/05. The initial decrease was driven by a decline in numbers of opioid-related separations (with costs decreasing by $11.5 million) between 1999/2000 and 2001/02. Decreases were evident in separations within the opioid use, dependence and poisoning DRGs. Increases in costs were observed between 1999/00 and 2004/05 for amphetamine (an increase of $2.4 million), cannabis ($1.8 million) and cocaine ($330,000) related separations. Several uncommon but very expensive drug-related separations constituted 12.7% of the total drug-related separations. CONCLUSIONS AND IMPLICATIONS: Overall, the costs of drug-related hospital separations have decreased by $4.1 million between 1999 and 2005, which is primarily attributable to fewer opioid-related separations. Small reductions in the number of costly separations through harm reduction strategies have the potential to significantly reduce drug-related hospital costs.     

Proportion of Hospital Deaths Associated with Adverse Events

Objectives: To determine the fraction of hospital deaths potentially associated with the occurrence of adverse events (AE). Design: A paired (1:1) case-control study. Setting: An 800-bed, teaching tertiary care hospital. Patients: All patients older than 14 years admitted to the hospital between January 1, 1990, and January 1, 1991, were eligible. All 524 consecutive deaths (death rate of 3.74%) that occurred in the hospital comprised the case group. For each case, a control patient was matched for both primary diagnosis on admission and admission date. Measurements: The proportion of hospital deaths associated with adverse events (defined as problems of any nature and seriousness faced by the patient during hospitalization, and potentially traceable to clinical or administrative management) was estimated from attributable risks adjusted for age, sex, service, severity of illness, length of stay, and quality of the medical record. Results: For stays longer than 48 hours, the adjusted attributable risk for all adverse events was estimated to be 0.51 (0.40–0.61). When the data were stratified according to the category of adverse event, the attributable risks remained significant except for administrative problems. The greatest proportion of deaths associated with adverse events was observed for surgical adverse events [0.56 (0.38–0.71)] and nosocomial infection [0.22 (0.14–0.28)]. Conclusions: A significant proportion of intrahospital deaths were associated with AE. These results suggest the need to consider programs focused on the prevention of mortality from AE.     

Evaluation of underreporting tuberculosis in Central Italy by means of record linkage

ABSTRACT: BACKGROUND: Tuberculosis (TB) surveillance systems have some pitfalls outside of a National Tuberculosis Program and lack of efficient surveillance hampers accurate epidemiological quantification of TB burden.In the present study we assessed the quality of surveillance at the University Hospital in Pisa (UHP), Italy, and TB incidence rates over a ten year period (1999?2008). METHODS: Assessment of underreporting was done by record-linkage from two sources: databases of TB diagnoses performed in the UHP and the Italian Infectious Disease Surveillance (IIDS) system. Two different databases were examined: a) TB diagnoses reported in the Hospital Discharge Records (HDR) from three Units of UHP (Respiratory Pathophysiology, Pulmonology and Infectious Diseases Units) (TB database A); b) TB diagnoses reported in HDR of all Units of UHP plus TB positive cases obtained by the Laboratory Register (LR) of UHP (TB database B). For the TB database A, the accuracy of TB diagnosis in HDR was assessed by direct examination of the Clinical Record Forms of the patients. For the TB database B, clinical and population data were described, as well as the trend of incidence and underreporting over 10 yrs. RESULTS: In the first study 293 patients were found: 80 patients (27%) with a confirmed TB diagnosis were underreported, 39 of themwere microbiologically confirmed. Underreporting was related to age (Reported vs Non Reported, mean age: 49.27?±?20 vs 55?±?19, p?相似文献   

Measurement of adverse events using "incidence flagged" diagnosis codes

OBJECTIVE: To compare two methods for identifying adverse events using routinely recorded hospital abstract data in all public and private hospitals in Victoria, Australia. METHODS: Secondary analysis of data on all admissions in the period 1 July 2000-30 June 2001 (n = 1,645,992) to estimate the rates of adverse events using International Classification of Diseases 10th Revision Australian Modification codes alone and in combination with an "incidence" data flag indicating complicating diagnoses which arise after hospitalization; rates of incidence and pre-existing adverse events, and rates for same-day and multi-day admissions. RESULTS: In total, 8% of all admissions were recorded with an adverse event. Use of ICD codes alone identified only 59% of the events identified using the combined method, giving a prevalence rate of only 5%. Incident cases, that is, those occurring in the index admission, represented 68% of identified adverse events.The adverse events incidence rate for multi-day admissions was significantly higher at 12%, compared with the same day rate of 0.4%. CONCLUSION: An "incidence flag" is essential to identify those adverse events for which a hospital has unambiguous responsibility. Using such a flag, secondary analysis of administrative data can provide hospital quality assurance programmes with a comprehensive view of all adverse events (not just "sentinel" events) at a reasonable cost and with more timely results than more intensive methods can achieve. Although the method is likely to underestimate the true rate of adverse events (in particular, by not capturing adverse events which only manifest after discharge), in this study of Australian hospitals, rates of adverse events were found to be similar to those derived from studies using manual review of patient records.     

Prevalence of human immunodeficiency virus infection in patients with pulmonary tuberculosis at the National Chest Hospital in Jamaica.

OBJECTIVE: This study was undertaken to determine the prevalence of human immunodeficiency virus-type 1 (HIV-1) infection in patients with pulmonary tuberculosis at the National Chest Hospital in Jamaica. METHODS: This retrospective study reviewed the hospital records of 537 patients admitted over a seven-year period from 1995 to 2001. We used a standardized data collection form to obtain data for sociodemographic characteristics, clinical features, signs and symptoms, laboratory diagnosis, treatment and outcome. RESULTS: We found that 11.6% (47/406) of the patients who met the inclusion criteria and were diagnosed as having pulmonary tuberculosis were HIV-1 seropositive. Most HIV-positive patients with tuberculosis were males, and prevalence of HIV coinfection among patients with tuberculosis was highest in patients aged 30-39 years. The mortality rate in patients with tuberculosis and HIV infection was 23.4% (11/47) compared to 3.9% (14/359; P = 0.001) in HIV-negative patients. Patients were treated with standard quadruple drug therapy. No multiple drug resistance was noted in the Mycobacterium tuberculosis isolates. CONCLUSIONS: The prevalence of HIV in patients with tuberculosis in Jamaica is similar to that in other developing countries, but the mortality rate is higher and this warrants prompt diagnosis of HIV infection and early institution of highly active antiretroviral therapy.     

Cardiac tolerance of moxifloxacin: Clinical experience from a large observational French study in usual medical practice (IMMEDIAT study)

BACKGROUND: Moxifloxacin (Izilox) is prescribed for bacterial respiratory tract infections. ECG analysis done in clinical trials showed a mean QT prolongation at 6 ms that could lead to Torsades de Pointe. However, Izilox was well tolerated during clinical trials. To confirm the correct safety profile of Izilox in a large sample of patients, a French PMS study - MMEDIAT - was carried out in usual medical practice. METHODS: This prospective observational uncontrolled and monitored study was conducted in 13,578 patients with respiratory tract infection and treated with moxifloxacin 400 mg daily (duration: 5 to 10 days in accordance to the Market Authorization). Any clinical event being potentially a surrogate of a ventricular rhythm disorder ("critical event") were collected and analyzed by a Scientific Committee in charge to determine the potential cardiac origin of the reported event and to establish a causal relationship with the treatment. RESULTS: Among 13,578 patients, 1046 adverse events (678 patients [5%]) were reported, including 854 drug related events (564 patients [4.15%]). Of these 1046 adverse events, 95 (62 patients [0.46%]) were serious. A total of 189 critical adverse events (159 patients [1.2%]) were reviewed by the Scientific Committee. After analysis, 34 adverse events (28 patients [0.21%]) were assessed from potential cardiac origin. Of these 34 adverse events, 25 (19 patients [0.14%]) were assessed as drug-related: palpitations [13 patients], tachycardia [4 patients], malaise [4 patients], vertigo [3 patients] and pallor [1 patient]. All adverse events were transient and had favourable outcome. CONCLUSION: This PMS study confirmed that Izilox is well-tolerated in usual medical practice, in adequation with the safety data obtained in clinical trials.     

The incidence and cost of cardiac surgery adverse events in Australian (Victorian) hospitals 2003–2004

The aim of this study was to estimate the incidence of adverse events in acute surgical admissions for cardiac disease in admitted episodes in the year 2003–2004 and to estimate the cost of these complications to the Victorian health system. Cardiac surgery adverse events are among the most frequent and significant contributors to the morbidity, mortality and cost associated with hospitalisation. Patient-level costing data set for major Victorian public hospitals in 2003–2004 was analysed for adverse events using C-prefixed markers, denoting complications that arose during the course of hospital treatment for cardiac surgery diagnosis related groups (DRGs). The cost of adverse events was estimated by linear regression modelling, adjusted for age and co-morbidity. A total of 16,766 multi-day cardiac disease cases were identified, of whom 6,181 (36.85%) had at least one adverse event. Patients with adverse events stayed approximately 7 days longer and had four times the case fatality rate than those without. After adjustment for age and co-morbidity, the presence of an adverse event adds AUS$5,751. The sum of the total cost of adverse events for each DRG was AUS$42.855 million, representing 21.6% of total expenditure on cardiac surgery and adding 27.5% in broad terms to the cardiac surgery budget.      

Drug-related mortality and its impact on adult mortality in eight European countries

OBJECTIVE: To estimate the mortality rates from drug-related deaths and other causes among problem drug users and population attributable risk of death due to opiate use in eight study sites in Europe. METHODS: Opiate users were recruited from drug treatment centres during the period 1990-1998 and deaths followed up through national or local mortality registries. Gender-specific overall mortality rate, proportion of deaths by cause (drug-related, HIV, other), standardized mortality ratios (SMRs), and the attributable risk fraction (ARF) were estimated. RESULTS: Crude mortality rates varied from 1 per 100 person-years in the Dublin and London cohorts to 3.8 per 100 person-years in Barcelona. The highest drug-related mortality rate was 10 per 1,000 person-years in Barcelona; the rates were approximately 7 per 1,000 person-years in Denmark, London, Rome, and Vienna, and <3.5 per 1,000 person-years for the others cohorts. The mortality rate for AIDS was <2 per 1,000 person-years in all the cohorts except Lisbon, Rome, and Barcelona, for which it was approximately 6 per 1,000 person-years. The highest SMR among males was 21.1 in Barcelona, and among females the highest SMRs were 53.7 and 37.7 in Barcelona and Rome, respectively. In Denmark the ARF was 5%, whereas it was >10% in all other study sites and 24% in Barcelona. CONCLUSION: Cohort mortality studies, especially in combination with estimates of prevalence, provide useful insights into the impact of opiate use on mortality across European countries and emphasize how preventing overall and drug-related deaths among opiate users can significantly improve the health of the population.     

COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021

ObjectivesThis study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine.MethodsAdverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition.ResultsBy October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition.ConclusionThe commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.     

Prescription and safety of dimethindene maleate micropellet capsules in Hungary

INTRODUCTION: Dimethindene maleate, the active substance of the extended-release Fenistil 24 capsule, is a first-generation histamine receptor antagonist, which is marketed in 10 European countries. In Hungary approximately 200,000 boxes are sold yearly from this product, which is mainly used for treatment of symptoms associated with allergic diseases (urticaria, itch, hay fever) The aim of the present study was to gather information with the help of medical doctors about the indications, efficacy and primarily the safety of use, observed side effects and frequency of adverse events associated with this product. METHOD: During the study 4574 questionnaires were evaluated out of the 5578 filled by 249 doctors. Responses were included into the evaluation only if the address and type of polyclinic of the doctor filling the questionnaire, indication of the use of the product could be precisely identified and the patient returned for control visit at least once. RESULTS: Based on the study results in Hungary in most cases the product is prescribed according to the indications and dosing schedule given in the SPC. In this study participating doctors found the drug to be effective in 95% of cases. Unexpected, new adverse events were not observed during the study. Approximately 22% of patients reported adverse events, tiredness and sleepiness being the most frequent ones. Occurrence of sedative adverse events was more frequent among those who were prone to tiredness (51 vs. 17%). The adverse events most frequently were reported 10-12 hours after intake. The average length of treatment was 4 weeks or less. The medicine is taken usually at night, before going to sleep. CONCLUSIONS: In Hungary in most cases the product is prescribed according to the indications and dosing schedule given in the current approved Summary of Product Characteristics.     

Reporting of adverse events in systematic reviews can be improved: survey results

OBJECTIVE: To assess how information about adverse events is included in systematic reviews. STUDY DESIGN AND SETTING: We included all new Cochrane reviews published in the Cochrane Database of Systematic Reviews (CDSRs) and all new reviews (2003--2004) in the Database of Abstracts of Reviews of Effects (DAREs) in Issue 1 2005 of The Cochrane Library. RESULTS: More than half of Cochrane (44/78) and DARE (46/79) reviews assessed drug interventions. The rest assessed surgery (Cochrane [12]; DARE [10]), psychosocial, educational, or physiotherapy interventions (22; 23). Seventy-six percent (59/78) of Cochrane reviews mentioned adverse events as an outcome compared with 48% (38/79) of DARE reviews. Most reviews mentioning adverse events were of drug interventions (Cochrane [41/59]; DARE reviews [29/38]). Considering reviews that mentioned adverse events, 95% (56/59) of Cochrane reviews included only randomized trials and 73% (43/59) included an analysis of adverse events. For 10 Cochrane reviews, adverse events had not been reported by the included trials. In contrast, 58% (22/38) of DARE reviews mentioning adverse events included only randomized trials, the rest included both randomized and nonrandomized studies. CONCLUSIONS: Most Cochrane reviews of drug interventions considered adverse events. This was not the case for DARE reviews and for Cochrane reviews of nondrug interventions. This could be improved.     

Adverse drug reactions leading children to the emergency department

The aim of the study was to determine the incidence of adverse drug reactions (ADR) that led children to hospital emergency care in a university hospital in S?o Paulo, SP. Medical charts (MC) of patients seen at the pediatric emergency department were selected according to International Classification of Diseases (ICD) codes consistent with ADR. Of 23,286 cases studied, 2,409 records were selected. An ADR was observed in 83 (0.36%) MC. Most ADR occurred in children aged 1-5 years with a slight predominance in males (51.8%). The drugs most commonly involved were antibiotics for systemic use (53.0%), vaccines (9.6%) and analgesics (7.2%). Most ADR were dermatological (54.2%) or gastrointestinal (22.9%) manifestations. Two ADR were considered severe (2.4%) while 61.4% were mild and 36.1% were moderate. The incidence was lower than in the literature, probably because it is a retrospective study that used the ICD for selecting the data assessed. The characteristics of ADR are similar to those found in other countries. Interventions are needed to improve the diagnosis and the use of antibiotics, as they were the drugs most involved in the ADR observed. Research in hospital emergency is important to acknowledge ADR that occur outside the hospital setting and may help to identify the most severe ones. Despite limitations, the method requires few resources and materials, and is a good alternative to initial diagnosis. The present study should be followed by studies with higher sensitivity to detect these reactions in order to propose prevention measures.     

Impact of prenatal diagnosis on revised livebirth prevalence estimates of Down syndrome in the Lothian region of Scotland, 1978–1992

Ramsay et al. [(1991) Biomed Pharmacother 45:267–272] reported on the livebirth prevalence of Down syndrome in the Lothian region of Scotland during 1978–1989. Their results suggested a temporal association between the events of Chernobyl in April 1986 and a significant excess of cases in 1987. In the current study the data were extended for 3 years and reanalyzed, a major objective being to correct for the differential loss of fetuses with Down syndrome which occurs between prenatal diagnosis and birth. Other objectives were to estimate the prevalence reduction due to prenatal diagnosis, quinquennial maternal age-specific risk rates, and the level of ascertainment of cases. The reanalysis found a 12-year prevalence rate of 1.29 vs. the previous rate of 1.34, and a shift of the annual prevalence peak to 1988, with a reduced prevalence in 1987 compared to that found in the earlier study. The new results are less consistent in showing an association of Down syndrome clustering with the Chernobyl accident. For the 15-year study period, a 23% overall reduction in prevalence occurred due to prenatal diagnosis and elective abortion of affected fetuses, with a 50% reduction to women ≥35 years of age. For 1988–1992, these reductions were 33% and 60%, which are among the highest reported in the literature for these time periods. The estimated quinquennial maternal risk rates were very similar to others already reported, and the data are consistent with a high level of case ascertainment. Since these women are approaching the upper limits of fetal detection through advanced maternal age alone, continued reduction in prevalence rates for Down syndrome through prenatal diagnosis and elective abortion will come mostly from increased use of other (chemical) screening techniques now available. © 1996 Wiley-Liss, Inc.