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BACKGROUND: Hospitalization rates (HR), emergency care prevalence (ECP) and case fatality proportions (CFP) of hospitalized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) patients in one municipality have not been studied, including how these differ from other pandemic or seasonal viral diseases, such as influenza A/B or norovirus. These analyses and their comparison with negative-tested hospitalized patients are the purpose of the present study. METHODS: A total of 67,000 cases of hospitalized patients of a tertiary care hospital and data of the regional health institute were analyzed to calculate HR, ECP and CFP of SARS-CoV2, influenza A/B and norovirus genotype 1/2. RESULTS: In the city and district of Fürth (Germany), 824 persons (0.34%) tested SARS-CoV-2-positive through 7 May 2020, 162 of whom (19.7%) were hospitalized. Furthermore, 48 out of 91 patients died in hospital (CFP 11.0%). During the flu/norovirus season 2019/2020 992 inhabitants were flu-positive and 135 norovirus-positive, of whom 202 (20.3%) and 125 (91.9%), respectively, were hospitalized. The ECPs were 4.1%, 2.0% and 0.6%. The CFPs of the SARS-CoV-2-, influenza- and norovirus-positive hospital cohort were 29.1%, 3.0% and 1.6%, while CFPs of the negative-tested were 5.9%, 4.8% and 6.9% with an in-hospital mortality of 2.1% for 2020. CONCLUSIONS: While HRs of SARS-CoV2 and influenza were similar, CFPs differ significantly. CFPs of negative-tested patients were comparable between the three infectious diseases.
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COVID-19 , Infecções por Caliciviridae , Influenza Humana , COVID-19/epidemiologia , Infecções por Caliciviridae/diagnóstico , Infecções por Caliciviridae/epidemiologia , Humanos , Influenza Humana/epidemiologia , Pandemias , SARS-CoV-2RESUMO
BACKGROUND: Multiresistant Gram-negative bacteria (MRGN) are a growing clinical problem. The practical implementation of the recommendation of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) for screening according to 4MRGN (MRGN resistant to all four categories of antibiotics), however, varies considerably between emergency departments. OBJECTIVES: This study is intended to give an overview of the status quo and the quality assurance of 4MRGN screening and to show possibilities for process optimization. MATERIALS AND METHODS: In 2018, a web-based survey was conducted among emergency room directors and directors of clinics in the Association of Hospital Directors in Germany (VKD). RESULTS: The response rate of the 267 clinics surveyed was 31.1%. In all, 83.4% of the emergency rooms surveyed routinely screen for multiresistant pathogens. In 71.8% a standard procedure (SOP) is defined and 82.0% of the test criteria refer to the KRINKO recommendation. Only 39.7% of the clinics follow it without in-house adaptation. No clinic can give an exact number of actual risk patients per year. According to the median, 55 patients in an emergency room met the KRINKO screening criteria in 2017. Only 40 patients were screened for suspected 4MRGN. Quality assurance of the screening was performed by 41.0% of emergency departments. The responsibility lies mainly with the hygiene department. CONCLUSIONS: Even if screenings are carried out as far as possible, there is a lack of standardization in the recording of case numbers and quality assurance. Therefore, it can be assumed that there are numerous individuals with undetected 4MRGN. As a quality indicator, SOPs could clearly assign responsibilities and improve infection hygiene.
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Infecção Hospitalar , Farmacorresistência Bacteriana Múltipla , Infecção Hospitalar/diagnóstico , Serviço Hospitalar de Emergência , Alemanha , Bactérias Gram-Negativas , HumanosRESUMO
BACKGROUND: Overall, there is only little data in health care research on the subject of emergency care in older patients in Germany. The aim of the present study is to assess the older emergency patient in regard to the core data set "Emergency Department" of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI). MATERIALS AND METHODS: Monocentric, retrospective observational study. RESULTS: In the observation period, a total of 29,391 emergency patients were treated at the interdisciplinary emergency center. Of these, 8072 emergency patients were ≥65 years old (27.4%). With increasing age, paramedic ambulances (RTW) or physician-led ambulances (NEF) are increasingly used (pâ¯< 0.001). Older emergency patients arriving by a physician-led emergency service show a 38.9-fold increase in mortality compared to ambulatory patients (odds ratioâ¯= 38.98 [29.22-51.87]). The initial assessment, using the Manchester Triage System (MTS), shows a steady rise towards higher urgency levels with increasing age (pâ¯< 0.001). In the multivariate analysis within the individual age clusters, there is a correlation between the triage level and hospital mortality, unrelated to gender (pâ¯< 0.001). Likewise the use of consulting physicians can be linked to advanced age (pâ¯< 0.001). Also the length of stay in the interdisciplinary emergency center correlates highly with age (pâ¯< 0.001). CONCLUSION: The older emergency patient clearly differs from younger emergency patients in all key performance indicators considered and already poses a special challenge to emergency departments.
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Serviços Médicos de Emergência , Medicina de Emergência , Idoso , Serviço Hospitalar de Emergência , Alemanha , Humanos , TriagemRESUMO
We report a case of a 62 year old patient, who was hospitalised due to haemorrhagic shock. The cause was a rupture of the pulmonary artery due to metastasis of a renal cell carcinoma. This cause is now reported for the first time. The primary tumour (pT2,pN0,M0,R0) was resected 25 years ago. This case demonstrates that after curative nephrectomy pulmonary metastasis can occur, even after decades. This is why patients of this type need lifelong follow-up.
RESUMO
An intercostal artery laceration is a rare iatrogenic complication following thoracocentesis and concerns especially elderly patients. We report a case of a severe hemorrhagic shock in a 93-year old patient due to diagnostic thoracocentesis.
Assuntos
Músculos Intercostais/irrigação sanguínea , Lacerações/etiologia , Choque Hemorrágico/etiologia , Toracentese/efeitos adversos , Artérias Torácicas/lesões , Idoso de 80 Anos ou mais , Humanos , Doença IatrogênicaRESUMO
BACKGROUND: A large number of patients present to the emergency department (ED) for evaluation of acute chest pain. About 10-15% are caused by acute myocardial infarction (MI), and over 50% of cases are due to noncardiac reasons. Further improvement for chest pain evaluation appears necessary. OBJECTIVES: What are current options to improve chest pain evaluation in Germany? METHODS: A selective literature search was performed using the following terms: "chest pain", "emergency department", "acute coronary syndrome" and "chest pain evaluation". RESULTS AND DISCUSSION: A working group of the German Society of Cardiology published recommendations for infrastructure, equipment and organisation of chest pain units in Germany, which should be separated from the ED of hospitals and be under the leadership of a cardiologist. A symptom-based decision for acute care would be preferable if all differential diagnoses of diseases could be managed by one medical specialty: However, all four main symptoms of patients with acute MI (chest pain, acute dyspnea, abdominal pain, dizziness) are also caused by diseases of different specialties. Evaluation and treatment of acute chest pain by representatives of one specialty would lead to over- or undertreatment of affected patients. Therefore we suggest a multidisciplinary evaluation of patients with acute chest pain including representatives of emergency and critical care physicians, cardiologists, internists, geriatricians, family physicians, premedics and emergency nurses. Definition of key indicators of performance and institutionalized feedback will help to further improve quality of care.
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Algoritmos , Dor no Peito/etiologia , Dor no Peito/terapia , Unidades de Cuidados Coronarianos/organização & administração , Serviço Hospitalar de Emergência/organização & administração , Equipe de Assistência ao Paciente/organização & administração , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Comportamento Cooperativo , Alemanha , Humanos , Comunicação Interdisciplinar , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia , Melhoria de Qualidade/organização & administraçãoRESUMO
BACKGROUND: Information technology in health care has a clear potential to improve the quality and efficiency of health care, especially in the area of medication processes. On the other hand, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. OBJECTIVES: To summarize definitions and observations on IT usage in pharmacotherapy and to derive recommendations and future research priorities for decision makers and domain experts. METHODS: This memorandum was developed in a consensus-based iterative process that included workshops and e-mail discussions among 21 experts coordinated by the Drug Information Systems Working Group of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). RESULTS: The recommendations address, among other things, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions, and the need for their continuous evaluation. CONCLUSION: Information technology can help to improve medication safety. However, challenges remain regarding access to information, quality of information, and measurable benefits.
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Erros Médicos/prevenção & controle , Informática Médica , Conduta do Tratamento Medicamentoso/normas , Segurança do Paciente , Melhoria de Qualidade , HumanosRESUMO
One of the chief complaints in the emergency department is abdominal pain which is associated with a large spectrum of possible underlying diagnoses. Life-threatening diseases have to be identified urgently to treat them rapidly either conservatively or by surgical intervention. The algorithm presented in this article starts with the triage in the emergency department. After triage the first step in the algorithm is an interdisciplinary communication to start the standardized diagnostic process which includes medical history, clinical examination, laboratory analyses, ultrasound and electrocardiogram. Further diagnostic escalation should be done in unspecific and urgent cases of abdominal pain after consulting a specialist. In approximately 30 % of patients with abdominal pain on admittance to an emergency department the cause remains unclear after undergoing the diagnostic process. In these cases it can be useful for risk stratification to transfer the patient to a ward related to the emergency department for observation und further diagnostics.
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Dor Abdominal/etiologia , Algoritmos , Procedimentos Clínicos , Serviço Hospitalar de Emergência , Comportamento Cooperativo , Diagnóstico Diferencial , Alemanha , Humanos , Comunicação Interdisciplinar , Observação , Admissão do Paciente , Garantia da Qualidade dos Cuidados de Saúde , Medição de Risco , TriagemRESUMO
BACKGROUND: Endoscopic access to strictured biliodigestive anastomoses often is difficult and may require percutaneous transhepatic biliary drainage or reoperation. METHODS: Push- or push-and-pull enteroscopy was used to diagnose disease and treat 24 postsurgical patients with suspected strictured biliodigestive anastomosis. Endoscopic retrograde cholangiography and biliary interventional procedures were used. Endoscopic accessibility, diagnosis of disease, therapeutic success, and complication rates were investigated at a single tertiary university gastroenterology center. RESULTS: Push enteroscopy reached biliary enteroanastomoses in 5 of the 24 patients (20.8%), whereas push-and-pull enteroscopy found choledocho- or hepaticojejunostomies in 17 of the remaining 19 postsurgical patients (89.4%). In all, successful enteroscopic intervention was achieved for 21 of the 24 patients (87.5%), whereas only 3 patients had to undergo percutaneous cholangiodrainage (12.5%). Cicatricially changed biliodigestive anastomoses were found in 14 of 21 patients (66.6%) including a mucosal type stricture in 7 patients (50%), an intramural type stricture in 5 patients (35.7%), and a ductal type stricture in 2 patients (14.2%). The remaining seven patients (33.3%) were normal. Enteroscopic interventions at strictured biliodigestive anastomosis included ostium incision for 8 (57.1%) and endoprosthesis insertion for 13 (92.8%) of the 14 patients, with prompt resolution of cholestasis and cholangitis. The major complications for the 24 patients involving 68 double-balloon enteroscopy (DBE) examinations comprised 2 perforations (8.3% per patient), 1 mild peritonitis (4.1%), and 1 cholangitis (4.1%), whereas minor complications were experienced by up to 20.8% of the patients. CONCLUSIONS: Modern interventional enteroscopy yields a high rate of successful interventions for strictured biliodigestive anastomosis, requires ostium incision for mucosal and intramural types of strictures, and helps to reduce percutaneous approaches.
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Procedimentos Cirúrgicos do Sistema Biliar/métodos , Enteroscopia de Duplo Balão , Complicações Pós-Operatórias/cirurgia , Anastomose Cirúrgica , Constrição Patológica/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND/AIM: The female gender appears to suffer from more adverse drug reactions (ADRs) than the male gender. So far, there has been no epidemiologic study analyzing gender-based differences in drug prescribing and its ADR risks. The aim of the present study was to establish a drug risk stratification adjusted to age, number of prescriptions and drug classes with respect to gender differences based on intensive data acquisition methods. METHOD: A prospective multicenter study was conducted in several departments in Germany and Israel (pediatrics, medicine and geriatrics) enclosing 2,371 inpatients. RESULTS: A total of 25,532 drug prescriptions during hospitalization were evaluated. At least 1 ADR was found in 774 patients (32.6%). Drugs for the cardiovascular system, nervous system, alimentary tract and musculoskeletal system were prescribed most often in females. The following drug classes led significantly more often to ADRs in women as compared to men: alimentary tract (OR 0.5; p = 0.0002), cardiovascular system (OR 0.72; p = 0.0140), musculoskeletal system (OR 0.31; p = 0.0004) and nervous system (OR 0.62; p = 0.0023). After adjustment to age, total number of prescriptions and drug class, only anti-infectives (antibacterials) and musculoskeletal system (anti-inflammatory) drugs stand out as causing more ADRs in women. CONCLUSION: Antibacterials and anti-inflammatory agents cause more ADRs in females as compared to males.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Prescrições de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/induzido quimicamente , Medicamentos sob Prescrição/efeitos adversos , Prescrições de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Alemanha , Humanos , Israel , Masculino , Medicamentos sob Prescrição/administração & dosagem , Estudos Prospectivos , Fatores SexuaisRESUMO
BACKGROUND: Several publications indicate that the female gender experiences a higher incidence of adverse drug reactions (ADRs) than does the male gender. The reasons, however, remain unclear. Gender-specific differences in the pharmacokinetic and pharmacodynamic behaviour of drugs could not be identified as an explanation. The aim of this study was to analyse ADR risk with respect to gender, age and number of prescribed drugs. METHODS: A prospective multicenter study based on intensive pharmacovigilance was conducted. Information on patient characteristics and evaluated ADRs was stored in a pharmacovigilance database--KLASSE. RESULTS: In 2,371 patients (1,012 female subjects), 25,532 drugs were prescribed. In 782 patients, at least one ADR was found. A multivariate regression analysis adjusting for age, body mass index (BMI) and number of prescribed drugs showed a significant influence of female gender on the risk of encountering ADRs [odds ratio (OR) 1.596, confidence interval (CI) 1.31-1.94; p < 0.0001). Dose-related ADRs (51.8%) were the dominant type in female subjects. Comparing system organ classes of the World Health Organisation (SOC-WHO), cardiovascular (CV) ADRs were particularly frequent in female subjects (OR 1.92, CI 1.15-3.19; p = 0.012). CONCLUSION: Our data confirm the higher risk of ADRs among female subjects compared with a male cohort. Several explanations were investigated. No single risk factor could be identified.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Distribuição por Idade , Idoso , Estudos de Coortes , Bases de Dados Factuais , Relação Dose-Resposta a Droga , Interações Medicamentosas , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Preparações Farmacêuticas/classificação , Farmacoepidemiologia , Prevalência , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: Recent studies show that nearly half of the hospitalized patients are readmitted within 6 months from discharge. No data exist about the relationship between adverse drug reactions (ADRs) and readmittance to a department of internal medicine. OBJECTIVES: The primary aims of the study were to determine if ADRs could be used as predictors for recurrent hospitalizations in internal medicine and to evaluate the economic impact of ADRs on hospitalization costs. DESIGN AND SETTING: A cohort-based, prospective, 18-month pharmacoepidemiological survey was conducted in the Department I of Internal Medicine at the University Hospital of Erlangen. All patients were intensively monitored for ADRs by a pharmacoepidemiological team. ADRs were evaluated for their offending drugs, probability, severity, preventability and classified by WHO-ART. During a 6-month period ADR-positive patients were matched to non-ADR patients applying diagnosis-related group categorization in order to measure the impact of ADRs on the duration and frequency of hospitalization. RESULTS: Of 1000 admissions 424 patients had single admissions and 206 patients had recurrent readmissions (min 1, max 9). The prevalence of readmissions was 37% (n = 370). In 145 (23%) of 630 patients, 305 ADRs were observed. The ADR incidence was similar in first admissions and readmissions. ADRs were not found to predict further readmissions and lack of ADRs did not preclude readmissions. ADRs caused hospitalizations in 6.2% of first admissions and in 4.2% of readmissions. According to the Schumock algorithm 135 (44.3%) ADRs were found to be preventable. The occurrence and numbers of ADRs per admission were found to prolong hospitalization period significantly (r = 0.48 and 0.51, P < 0.001, n = 135). Of 9107 treatment days 20% were caused by in-house (1130 days) and community-acquired ADRs (669 days). In admissions and readmissions 11% (>973 days) of all treatment days were judged to be preventable. CONCLUSIONS: Intensified drug monitoring supported by information technology in internal medicine is essential for early detecting and prevention of ADRs and saving hospital resources.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Readmissão do Paciente/economia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Infecciosos/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Fármacos do Sistema Nervoso Central/efeitos adversos , Tratamento Farmacológico/economia , Eletrólitos/efeitos adversos , Fármacos Gastrointestinais/efeitos adversos , Hormônios/efeitos adversos , Humanos , Tempo de Internação , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de TempoRESUMO
AIM: To investigate the effectiveness of a computer monitoring system that detects adverse drug reactions (ADRs) by laboratory signals in gastroenterology. METHODS: A prospective, 6-month, pharmaco-epidemiological survey was carried out on a gastroenterological ward at the University Hospital Erlangen-Nuremberg. Two methods were used to identify ADRs. (i) All charts were reviewed daily by physicians and clinical pharmacists. (ii) A computer monitoring system generated a daily list of automatic laboratory signals and alerts of ADRs, including patient data and dates of events. RESULTS: One hundred and nine ADRs were detected in 474 admissions (377 patients). The computer monitoring system generated 4454 automatic laboratory signals from 39 819 laboratory parameters tested, and issued 2328 alerts, 914 (39%) of which were associated with ADRs; 574 (25%) were associated with ADR-positive admissions. Of all the alerts generated, signals of hepatotoxicity (1255), followed by coagulation disorders (407) and haematological toxicity (207), were prevalent. Correspondingly, the prevailing ADRs were concerned with the metabolic and hepato-gastrointestinal system (61). The sensitivity was 91%: 69 of 76 ADR-positive patients were indicated by an alert. The specificity of alerts was increased from 23% to 76% after implementation of an automatic laboratory signal trend monitoring algorithm. CONCLUSION: This study shows that a computer monitoring system is a useful tool for the systematic and automated detection of ADRs in gastroenterological patients.
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Diagnóstico por Computador/normas , Gastroenteropatias/induzido quimicamente , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Idoso de 80 Anos ou mais , Técnicas de Laboratório Clínico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sensibilidade e EspecificidadeRESUMO
Many patients with chronic pancreatitis (CP) complain of several types of food intolerance despite elimination of fat and alcohol. Since there are no data on serum immunoglobulin E (IgE) concentrations in CP, IgE concentrations in serum were detected in 97 persons with CP and 50 controls. IgE was analyzed by the use of a highly sensitive fluoro-enzyme-immunoassay. In CP, a significantly raised IgE level (mean +/- SEM; 286.1 +/- 49 KU/L; p < 0.0001) was detected compared with controls (65.2 +/- 13 KU/L). CP-patients without alcohol consumption and normal exocrine pancreatic function were found to have only slightly elevated serum IgE values (120.2 +/- 54 KU/L), whereas patients with exocrine insufficiency treated with enzyme supplementation showed an IgE level of 153.7 +/- 51 and exocrine insufficient patients without treatment of 261.0 +/- 173 KU/L (p = 0.01). IgE levels were far more elevated in the corresponding groups with continued alcohol consumption (> 25 g/day). Alcohol consuming patients with CP and normal pancreatic function had a mean serum IgE of 295.0 +/- 114 KU/L, while patients with alcohol consumption and sufficiently treated exocrine pancreatic insufficiency showed a serum IgE of 393.7 +/- 147 KU/L (p = 0.03). Non-enzyme supplemented patients with CP and exocrine pancreatic insufficiency were characterized by approximately 10-fold increased serum IgE (1080.0 +/- 313 KU/L; p = 0.001). Non-allergic, alcohol consuming patients with CP have significantly increased serum IgE values. Since patients without alcohol consumption and normal pancreatic function or sufficiently treated exocrine insufficiency showed clearly lower IgE values than non-compliant patients with manifest exocrine pancreatic insufficiency, these results are compatible with the assumption that a reduced rate of antigen digestion in exocrine pancreatic insufficiency may lead to an increased intestinal antigen load, stimulating an abnormal humoral immune response with IgE production. Alcohol may further contribute to this by damaging the mucosal barrier.
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Consumo de Bebidas Alcoólicas/efeitos adversos , Insuficiência Pancreática Exócrina/imunologia , Hipersensibilidade Alimentar/imunologia , Imunoglobulina E/sangue , Pancreatite/imunologia , Adulto , Idoso , Consumo de Bebidas Alcoólicas/imunologia , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Recusa do Paciente ao TratamentoRESUMO
Risperidone, a widely used atypical and potent neuroleptic drug, is assumed to induce fewer hepatic side-effects than phenothiazine anti-psychotics. Recently, we observed a case of risperidone-induced cholestatic hepatotoxicity. A 37-year-old male developed a rapid increase in liver enzymes and cholestatic parameters after starting treatment with risperidone for paranoid psychosis. Work-up for other potential aetiologies was negative. The results of a percutaneous liver biopsy were consistent with drug-induced liver injury and cholestasis. Over the course of one month after the discontinuance of all anti-psychotic agents, the liver function test results returned to near-normal values. This observation supports the need to monitor cholestatic parameters in addition to liver function enzymes during initiation and the first weeks of risperidone intake.
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Antipsicóticos/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Colestase/induzido quimicamente , Risperidona/efeitos adversos , Adulto , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Colestase/diagnóstico , Humanos , Fígado/efeitos dos fármacos , Testes de Função Hepática , MasculinoRESUMO
BACKGROUND: It has been claimed that the risk of adverse drug reactions increases with age. However, only limited data exist for disease-group specific risks and none for patients with liver and gastrointestinal diseases. AIMS: To determine the incidence and characteristics of adverse drug reactions and the physicians' awareness of adverse drug reactions. METHODS: During a 7-month period, a prospective survey of 532 male patients (158 aged 65 years or older; 30%) was conducted on a hepatogastroenterological ward of a tertiary-care university hospital, using intensive bedside and computer-assisted drug surveillance methods. RESULTS: No difference was found in the overall rate of adverse drug reactions between older and younger patients (25.9% vs. 24.2%) during 6213 treatment days. However, a significantly higher risk for developing adverse drug reactions could be shown for the elderly with biliary tract diseases (P < 0.01). Independently of age, patients suffering from gastric ulcers, acute episodes of pancreatitis, cholangitis or inflammatory bowel diseases were at high risk of adverse drug reactions. Adverse drug reaction-associated mortality was encountered in four elderly and none of the younger patients. Secondary pharmacological effects and drug toxicity were the main types of adverse drug reactions for both age groups. Although 75.3% of the adverse drug reactions were predictable, only 37.5% of all adverse drug reactions were recognized by the staff physicians. CONCLUSION: In hepatogastroenterological patients, advancing age was not associated with an overall increased risk of adverse drug reactions except for patients with biliary tract diseases. In the elderly, adverse drug reactions were more severe and carried higher mortality. Guidelines and educational programs should be developed to increase the awareness of adverse drug reactions and their prevention, especially in high risk patients and, thus, to improve patient outcomes.
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Fármacos Gastrointestinais/efeitos adversos , Gastroenteropatias/tratamento farmacológico , Fatores Etários , Idoso , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Hepatopatias/tratamento farmacológico , Masculino , Estudos ProspectivosRESUMO
OBJECTIVE: To implement a computer-based adverse drug reaction monitoring system and compare its results with those of stimulated spontaneous reporting, and to assess the excess lengths of stay and costs of patients with verified adverse drug reactions. DESIGN: A prospective cohort study was used to assess the efficacy of computer-based monitoring, and case-matching was used to assess excess length of stay and costs. SETTING: This was a study of all patients admitted to a medical ward of a university hospital in Germany between June and December 1997. PATIENTS AND PARTICIPANTS: 379 patients were included, most of whom had infectious, gastrointestinal or liver diseases, or sleep apnoea syndrome. Patients admitted because of adverse drug reactions were excluded. METHODS: All automatically generated laboratory signals and reports were evaluated by a team consisting of a clinical pharmacologist, a clinician and a pharmacist for their likelihood of being an adverse drug reaction. They were classified by severity and causality. For verified adverse drug reactions, control patients with similar primary diagnosis, age, gender and time of admission but without adverse drug reactions were matched to the cases in order to assess the excess length of hospitalisation caused by an adverse drug reaction. RESULTS: Adverse drug reactions were detected in 12% of patients by the computer-based monitoring system and stimulated spontaneous reporting together (46 adverse reactions in 45 patients) during 1718 treatment days. Computer-based monitoring identified adverse drug reactions in 34 cases, and stimulated spontaneous reporting in 17 cases. Only 5 adverse drug reactions were detected by both methods. The relative sensitivity of computer-based monitoring was 74% (relative specificity 75%), and that of stimulated spontaneous reporting was 37% (relative specificity 98%). All 3 serious adverse drug reactions were detected by computer-based monitoring, but only 2 out of the 3 were detected by stimulated spontaneous reporting. The percentage of automatically generated laboratory signals associated with an adverse drug reaction (positive predictive value) was 13%. The mean excess length of stay was 3.5 days per adverse drug reaction. 48% of adverse reactions were predictable and detected solely by computer-based monitoring. Therefore, the potential for savings on this ward from the introduction of computer-based monitoring can be calculated as EUR56 200/year ($US59 600/year) [ 1999 values]. CONCLUSION: Computer monitoring is an effective method for improving the detection of adverse drug reactions in inpatients. The excess length of stay and costs caused by adverse drug reactions are substantial and might be considerably reduced by earlier detection.