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1.
Curr Drug Saf ; 18(2): 253-263, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-35702788

RESUMO

BACKGROUND: Adverse drug events (ADE) and medication errors (ME) provide large numbers of victims. Older people are more susceptible to these events, due to the continuing search for several chronic degenerative disease treatments. The Third Global Patient Safety Challenge announced the objective of reducing unnecessary polypharmacy, encouraging deprescription, and aiming to ensure the prescription of medications in an appropriate manner, based on the best evidence and taking into account the individual factors of people. OBJECTIVE: To evaluate whether Pharmaceutical Care (PC), when inserted in a geriatric ward and the context of person-centered health care, cooperates with the safety of pharmacotherapy in older individuals in Brazil. METHODS: This is an investigative, single-arm, preliminary study. INCLUSION CRITERIA: individuals aged ≥60 years and admitted to the geriatric ward between August 2019 to January 2020. The PC (with the practice of pharmacotherapeutic follow-up, medication reconciliation, and pharmacotherapy review) was made available to identify ADE and ME, as well as the associated factors and clinical outcomes, were analyzed. RESULTS: 60 participants were included. It was found that, on hospital admission, 93.3% of them were polymedicated and 86.7% had a history of using potentially inappropriate medications (PIM). ADE and ME were detected in 43 individuals (71.7%) and, in total, 115 incidents were identified, with drugs that act on the nervous system associated with them (31.9%). Acceptance of the PC's recommendations reached the rate of 85.2%. Polypharmacy (p=0.03) and the presence of multiple diseases (p=0.03) had an effect on the presentation of ADE and ME. The number of medications in use decreased in the comparison between admission and hospital discharge (p<0.0001). CONCLUSION: This investigative study indicated that ADE and ME are linked to the polypharmacy in use at the beginning of hospitalization. On the other hand, we showed that the PC (inserted in the multidisciplinary team) contributed to the deprescribing of medications at hospital discharge. Therefore, the PC can provide improvements in this scenario.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Assistência Farmacêutica , Idoso , Humanos , Brasil , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Hospitalização , Prescrição Inadequada , Polimedicação
2.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1536027

RESUMO

Introducción la trimetoprima y el sulfametoxazol es una combinación de agentes antimicrobianos, con su uso se han descrito algunas reacciones adversas, entre las que están las alteraciones electrolíticas como la hipercalemia. Objetivo la revisión de este caso se propone como una estrategia que permite proveer herramientas al personal de salud para la detección de un evento adverso como la hipercalcemia asociada a la administración de trimeoprim sulfametoxazol, antimicrobianos ampliamente usados en servicios de urgencias, hospitalización, unidades de cuidados especiales/intensivos e incluso de manera ambulatoria. Presentación de caso se presenta el reporte de un paciente sin los factores de riesgo descritos en la literatura para el desarrollo de hipercalemia, permitiendo a través de su discusión sensibilizar al personal de salud sobre este efecto, siendo además el primer caso reportado en nuestro medio en un paciente menor de 50 años. Discusión y conclusión Desde 1983 se registran los primeros casos de hipercalcemia asociados a la administración de estos antimicrobianos, describiéndose diferentes factores de riesgo como la edad, la coexistencia de insuficiencia renal, el uso de diuréticos ahorradores de potasio, antihipertensivos inhibidores de la enzima convertidora de angiotensina y receptores de angiotensina 2, si bien es importante vigilar estrechamente a estos grupos de riesgo, este evento puede presentarse también en ausencia de los mismos, como en el caso de este paciente.


Introduction Trimethoprim and sulfamethoxazole is a combination of antimicrobial agents, with its use some adverse reactions have been described, including electrolyte disturbances such as hyperkalemia. Purpose The review of this case is proposed as a strategy that allows providing iper to health personnel for the detection iper adverse iperc such as ipercalcemia associated with the administration of trimeoprim sulfamethoxazole, antimicrobials widely used in emergency services, hospitalization, special/intensive care units and even on an outpatient basis. Case presentation A patient case report is presented without the additional risk factors described in the literature for the development of hyperkalemia, allowing through its discussion to sensitize health personnel about this effect, also being the first case reported in our environment in a patient under 50 years old. Discussion and conclusion Since 1983, the first cases of hypercalcaemia associated with the administration of these antimicrobials have been recorded, describing different risk factors such as age, the coexistence of renal failure, the use of potassium-sparing diuretics, antihypertensive inhibitors of the angiotensin-converting enzyme and receptors. Of angiotensin 2, although it is important to closely monitor these risk groups, this event can also occur in their absence, as in the case of this patient.

3.
Curr Drug Saf ; 17(3): 183-192, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34649491

RESUMO

BACKGROUND: Extemporaneous compounding (EC) involves the preparation of a therapeutic product for specific patient need. However, there is a potential relationship between this procedure and the occurrence of health incidents (HI). The use of trigger tools increases HI identification. OBJECTIVE: This study assessed the performance of EC as a trigger to detect potential health incidents arising from this procedure. METHODS: A one-month observational and cross-sectional study was performed in internal medicine ward and intensive care unit of medium-sized hospital. Data collection was carried out in 5 stages: all triggered patients with dysphagia or enteral feeding tube with prescription of EC were included; EC executed in prescribed standardized drugs was observed; the procedure was compared with the hospital guide and scientific literature; HI monitoring and their evaluation using WHO and NCC MERP algorithms; a search for pharmaceutical alternatives (PA) that would avoid the observed EC. RESULTS: 197 patients were recruited. Almost half of them were triggered by EC from 84 standardized drugs. 48 patients met the inclusion criteria. 28 adverse drug reactions, 01 therapeutic ineffectiveness, and 29 medication errors were identified. EC as a trigger tool showed a PPV value of 0.38. Only 24 drugs have PA available in the market, which could avoid one third of all observed EC. CONCLUSION: It was possible to detect potentially HI in one of two patients with enteral feeding tubes using EC as a trigger tool. The use of EC as a trigger tool contributes to identifying potential HI arising from drugs, which have not gotten pharmaceutical alternatives to be administered via enteral feeding tube.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Erros de Medicação , Estudos Transversais , Composição de Medicamentos , Humanos , Erros de Medicação/prevenção & controle , Preparações Farmacêuticas
4.
Rev. colomb. nefrol. (En línea) ; 7(supl.2): 21-41, jul.-dic. 2020.
Artigo em Espanhol | LILACS, COLNAL | ID: biblio-1251578

RESUMO

Resumen Introducción: hasta el momento, no se ha demostrado la efectividad de ningún tratamiento para afrontar la emergencia sanitaria por COVID-19. Objetivo: presentar la evidencia disponible respecto a la eficacia y seguridad del uso de cloroquina, hidroxicloroquina y azitromicina en la profilaxis y el manejo de pacientes con COVID-19. Materiales y métodos: se realizó una revisión de la literatura en las bases de datos MEDLINE, Scopus y PubMed sobre publica- ciones que registraran el uso de cloroquina, hidroxicloroquina y azitromicina en pacientes con COVID-19. Resultados: se seleccionaron 12 publicaciones que incluyeron revisiones rápidas de literatura, estudios observacionales y ensayos clínicos. No se encontró información sobre la profilaxis con cloroquina, hidroxicloroquina ni azitromicina para SARS-CoV-2. Los eventos adversos reportados incluyeron emesis, dolor abdominal, náuseas, diarrea, erupción cutánea y picazón. Conclusiones: según la evidencia recopilada el uso de hidroxicloroquina o de cloroquina sola o en combinación con azitromicina en pacientes con COVID-19 no ha mostrado beneficio. Además, cada uno de estos esquemas de tratamiento se asocia con un mayor riesgo de muerte y de episodios de arritmias. En síntesis, la efectividad de estos medicamentos sigue sin estar esclarecida, por lo cual se sugiere evitar su uso en el tratamiento de personas con infección por SARS-CoV-2/COVID-19.


Abstract Introduction: The COVID-19 disease is a health emergency; treatment has not yet been proven. Objective: To present the available evidence of efficacy and safety of the use of hydroxychloroquine and azithromycin in the prophylaxis and management of patients with COVID-19. Methods: A rapid literature review was performed; we consulted Medline, scopus and pubmed databases. Results: Eleven publications were included including rapid literature reviews, observational studies, and clinical trials. No data were found studying prophylaxis with hydroxychloroquine and azithromycin for SARS-CoV-2. Reports of adverse events include episodes of emesis, abdominal pain, nausea, diarrhea, rash, and itching. Conclusions: The evidence collected suggests that the use of hydroxychloroquine and azithromycin in patients with COVID-19, could abnormal electrocardiogram and increased risk of mortality in-hospital. The effectiveness remains unclear.


Assuntos
Humanos , Masculino , Feminino , Terapêutica , COVID-19 , Pacientes , Cloroquina , Colômbia , Azitromicina , Hidroxicloroquina
5.
Front Pharmacol ; 11: 752, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32508660

RESUMO

BACKGROUND: Brazilian patients have legal right to access unlicensed medicines undergoing clinical research, if there is evidence of efficacy and safety. This study investigated the occurrence of serious adverse events related to very high-cost medicines from clinical studies, expanded access and compassionate use programs, obtained by patients though health litigation. METHODS: A descriptive study using secondary data investigated unlicensed medicines obtained through lawsuits from 2010 to 2017, costing more than 1 million Brazilian reais (BRL), adjusted by the Brazilian Consumer Index to July 2017. Data sources were the Brazilian Health Surveillance Agency Registry (DATAVISA) and Adverse Events in Clinical Studies (NotivisaEC) Databases. Medicines were categorized by the Anatomical Therapeutic Chemical classification to level 03 and events by the WHO Adverse Drug Reaction Terminology. The study received ethical approval by the University of Brasilia Institutional Research Board. RESULTS: In the period, 812 drugs were obtained through litigation, and of these, 78 exceeded cost of 1 million BRL; 44 of them presented reports of 1,248 serious adverse events. Total Brazilian Government expenditure with these drugs was 3.2 billion BRL. Class L04A (n=7) showed greater expenditures (over 1.8 billion BRL). One hundred ninety-six deaths occurred and L01X was the most involved category (49.5%). Most other serious events (n=419) and sequelae (n=10) were related to L01X. CONCLUSION: Very high-cost drugs paid for by the government and obtained through health litigation presented deaths and serious adverse events in expanded access and compassionate use programs in Brazil.

6.
Artigo em Português | LILACS | ID: biblio-1095354

RESUMO

Objetivos: identificar as evidências científicas existentes até o presente momento sobre a efetividade do uso da cloroquina, da hidroxicloroquina associada (ou não) à azitromicina para tratamento da afecção pelo coronavírus e seus possíveis efeitos adversos e tóxicos aos seres humanos. Métodos: a revisão narrativa utilizou-se das bases de dados PubMed, LILACS, SciElo e Google Acadêmico. Nessas, buscaram-se estudos, utilizando-se dos descritores "covid", "coronavirus", "SARS-CoV-2", "chloroquine", "hydroxychloroquine", "azithromycin" e "adverse effects" junto com os operadores booleanos "AND" e "OR". Resultados: sete artigos, das trinta publicações encontradas, atenderam aos critérios de inclusão, sendo utilizados para compor a presente revisão. Dos sete ensaios clínicos analisados, cinco apresentaram resultados de cura e/ou remissão dos sintomas e/ou redução da carga viral dos pacientes, no entanto apresentaram muitas limitações. Conclusão: a literatura científica é escassa e divergente quanto à efetividade dos medicamentos cloroquina e hidroxicloroquina associada (ou não) à azitromicina no tratamento da COVID-19, pela rápida disseminação e instalação da pandemia na esfera global. É necessário a realização de ensaios clínicos pragmáticos, envolvendo um número maior de pacientes, para que seja possível analisar a efetividade no combate ao coronavírus, bem como a segurança do uso desses fármacos.(AU)


Objective: to identify the scientific evidence existing to date on the effectiveness of the use of chloroquine, hydroxychloroquine associated (or not) to azithromycin for the treatment of COVID-19 disease and its possible adverse drug events and toxicity to human health. Methods: the narrative review was performed using the PubMed, LILACS, SciElo and Google Academic databases. In these, studies were sought, using the descriptors "covid", "coronavirus", "SARS-CoV-2", "chloroquine", "hydroxychloroquine", "azithromycin", "adverse effects" and "toxicity", together with the Boolean operator "AND" and "OR". Results: seven studies of thirty publications met the inclusion criteria and were used in the present review. Of the seven clinical trials analyzed, five showed results of cure and/or remission of symptoms and/or reduction of patients' viral load, however these studies had many limitations. Conclusion: scientific literature is scarce and divergent as to the effectiveness of the drugs chloroquine and hydroxychloroquine associated (or not) with azithromycin in the treatment of COVID-19, due to the rapid spread and installation of the pandemic in the global sphere. It is necessary to carry out pragmatic clinical trials, involving a larger number of patients, so that it is possible to analyze the effectiveness in combating the coronavirus, as well as the safety of the use of these drugs.(AU)


Assuntos
Humanos , Cloroquina/toxicidade , Infecções por Coronavirus/tratamento farmacológico , Azitromicina/toxicidade , Hidroxicloroquina/toxicidade , Cloroquina/efeitos adversos , Azitromicina/efeitos adversos , Hidroxicloroquina/efeitos adversos
7.
Rev. Soc. Bras. Med. Trop ; Rev. Soc. Bras. Med. Trop;53: e20190443, 2020. tab
Artigo em Inglês | LILACS | ID: biblio-1101452

RESUMO

Abstract INTRODUCTION: Herein, we aimed to identify the factors associated with adverse drug events (ADEs) in chronic Chagas disease (CD) patients. METHODS: We analyzed 320 medical notes from 295 patients. The Naranjo algorithm was applied to determine the cause of ADEs. Mixed effects logistic regression was performed to evaluate the factors associated with ADEs. RESULTS: ADEs were described in 102 medical notes (31.9%). Captopril was most frequently associated with ADEs. Age (RR 0.96; 95%CI 0.94-0.99) and cardiac C/D stages (RR 3.24; 95%CI 1.30-4.58) were the most important clinical factors associated with ADEs. CONCLUSIONS: Close follow-up is warranted for CD patients.


Assuntos
Humanos , Masculino , Feminino , Idoso , Doença de Chagas/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Fatores Socioeconômicos , Índice de Gravidade de Doença , Algoritmos , Brasil/epidemiologia , Doença Crônica , Pessoa de Meia-Idade
8.
Am J Health Syst Pharm ; 75(14): 1064-1068, 2018 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-29987060

RESUMO

PURPOSE: The pharmacist-led implementation of a smart pump-electronic medical record (EMR) interoperability program at a hospital within a regional health system is described. SUMMARY: Smart pump-EMR interoperability involves a wireless, bidirectional connection by which infusion information transmitted by the EMR prepopulates infusion devices, reducing keystokes and opportunities for manual programming errors. The smart pumps transmit time-stamped infusion data to the EMR for nurse documentation. Use of interoperability technology forces the use of dose-error reduction software so that 100% of prepopulated infusions and dosage adjustments are protected. To improve i.v. medication safety and documentation at a 286-bed hospital within an 8-hospital health system, pharmacists led an initiative to implement smart pump-EMR interoperability as a first step toward systemwide implementation. The hospital's smart pump-EMR interoperability initiative resulted in patient safety and revenue-generation gains in the first 8 months after implementation. The mean number of keystrokes needed to program an infusion was reduced from 15 to 2 (an 86% decrease). Pump alerts, alert overrides, and reprogrammed or cancelled infusions were decreased. In addition, the program improved outpatient charge capture, resulting in $370,000 in incremental revenue. CONCLUSION: A pharmacist-led implementation of smart pump-EMR interoperability led to measurable, data-based improvements in i.v. medication safety and improved accuracy, timeliness, and efficiency of i.v. infusion documentation. Revenue was increased due to improved charge capture for outpatient i.v. infusions.


Assuntos
Registros Eletrônicos de Saúde/organização & administração , Bombas de Infusão , Farmacêuticos/organização & administração , Serviço de Farmácia Hospitalar/organização & administração , Tecnologia sem Fio , Registros Eletrônicos de Saúde/economia , Segurança de Equipamentos , Humanos , Segurança do Paciente , Farmacêuticos/economia , Serviço de Farmácia Hospitalar/economia , Fatores de Tempo
9.
J Pediatr ; 190: 236-240.e2, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-29144250

RESUMO

OBJECTIVE: To assess the prolonged impact of computerized physician order entry (CPOE) on medication prescription errors in pediatric intensive care patients. STUDY DESIGN: This observational study was conducted at a pediatric intensive care unit in which a CPOE (Metavision, iMDsoft, Israel) with a limited clinical decision support system was implemented between 2004 and 2007. Since then, no changes were made to the systems. We analyzed 2500 electronic prescriptions (1250 prescriptions from 2015 and 1250 prescriptions from 2016). Prescription errors were identified by a pediatric intensive care physician and classified as potential adverse drug events, medication prescription errors, or rule violations. Their prevalence was compared with the rate in 2007, reported in a previous study from the same unit. A randomly selected 10% of the prescriptions were also analyzed by the pediatric intensive care unit pharmacist, and the level of agreement was determined. RESULTS: The rate of prescription errors increased from 1.4% in 2007 to 3.2% in 2015 (P = .03). Following revision of the clinical decision support system tools, prescription errors decreased to 1% in 2016 (P < .0001). The potential adverse drug event rate dropped from 2% in 2015 to 0.7% in 2016 (P = .006), and the medication prescription error rate, from 1% to 0.2% (P = .01). The agreement between the 2 reviewers was excellent (k = 0.96). CONCLUSIONS: The rate of prescription errors may increase with time from implementation of a CPOE. Repeated surveillance of prescription errors is highly advised to plan strategies to reduce them. This approach should be considered in quality improvement of computerized information systems in general.


Assuntos
Sistemas de Apoio a Decisões Clínicas , Unidades de Terapia Intensiva Pediátrica/tendências , Sistemas de Registro de Ordens Médicas , Erros de Medicação/tendências , Adolescente , Criança , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Seguimentos , Humanos , Lactente , Unidades de Terapia Intensiva Pediátrica/normas , Unidades de Terapia Intensiva Pediátrica/estatística & dados numéricos , Masculino , Erros de Medicação/prevenção & controle , Erros de Medicação/estatística & dados numéricos , Garantia da Qualidade dos Cuidados de Saúde
10.
Geriatr Gerontol Int ; 17(10): 1515-1521, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27726265

RESUMO

AIM: Studies examining the association between mortality and anticholinergic burden in the geriatric population are conflicting and are absent in the Mexican American population. The present study aimed to determine whether higher anticholinergic burden increases mortality in a cohort representative of community-based older Mexican Americans in the USA. METHODS: This retrospective cohort database study used the Hispanic Established Populations for the Epidemiologic Study of the Elderly cohort. The primary outcome, mortality, was assessed beginning at the second interview in 1995 until the fifth interview in 2005. Medications were classified for anticholinergic burden according to the modified-Anticholinergic Drug Scale and were summed across all reported medications creating a measure of total anticholinergic burden. Anticholinergic burden was tested for association with mortality using survival analysis. RESULTS: The 1497 older adults reporting medication usage were included. Survival analysis showed a statistically significant (P < 0.05) relationship between anticholinergic burden and increased mortality. CONCLUSIONS: Anticholinergic burden is associated with increased mortality in Southwestern Mexican American older adults who report taking prescription or non prescription medications. These findings suggest that anticholinergic burden might be a risk factor for mortality in this selected population, with additional studies required to further define the risk. Geriatr Gerontol Int 2017; 17: 1515-1521.


Assuntos
Antagonistas Colinérgicos/uso terapêutico , Americanos Mexicanos , Fatores Etários , Idoso , Feminino , Humanos , Estudos Longitudinais , Masculino , Estudos Retrospectivos , Fatores de Risco , Fatores Socioeconômicos , Sudoeste dos Estados Unidos , Análise de Sobrevida , Taxa de Sobrevida
11.
J Clin Pharm Ther ; 40(1): 41-7, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25346459

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Use of cisplatin can induce type I hypersensitivity reactions that may also be linked to the quality of the drug utilized. We observed cases of hypersensitivity that appeared to be associated with the brand of cisplatin used. The aim of this study was to compare two different brands of cisplatin in relation to type I hypersensitivity reactions. METHODS: Brand A was used in a tertiary care teaching hospital until 2012, and use of brand B started from January 2013, when the first hypersensitivity cases were observed. Patients were categorized based on symptom. Cisplatin of both brands was analysed by high-performance liquid chromatography (HPLC) and high-resolution electrospray ionization mass spectrometry (ESI-(+)-MS) and characterized according to US Pharmacopeia. RESULTS AND DISCUSSION: There were no cases of hypersensitivity associated with the use of cisplatin brand A, whereas four of 127 outpatients that used cisplatin brand B were affected. The two brands were in accordance with the US Pharmacopeia parameters, and there was no significant difference in the total platinum levels between the two brands when analysed by HPLC. However, high-resolution ESI-(+)-MS analyses show that brand B contains approximately 2.7 times more hydrolysed cisplatin than brand A. WHAT IS NEW AND CONCLUSION: The increase in the hydrolysed form of cisplatin found in brand B may be the cause of the hypersensitivity reaction observed in a subset of patients. We present the first study of the quality of drugs by high-resolution ESI-(+)-MS. Drug regulatory agencies and manufacturers should consider including measurement of hydrolysed cisplatin as a quality criterion for cisplatin formulations.


Assuntos
Cisplatino/efeitos adversos , Cisplatino/química , Composição de Medicamentos/métodos , Hipersensibilidade a Drogas/etiologia , Platina/química , Antineoplásicos/efeitos adversos , Antineoplásicos/química , Química Farmacêutica/métodos , Cromatografia Líquida de Alta Pressão/métodos , Hipersensibilidade a Drogas/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espectrometria de Massas por Ionização por Electrospray/métodos
12.
J Clin Pharm Ther ; 39(6): 609-20, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25219403

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Studies in a number of countries have shown that adverse drug events (ADE) occur frequently among hospital inpatients. The objective of this study was to conduct a systematic review of observational studies of the frequency of ADE in adult inpatients and to examine factors associated with observed heterogeneity in the reported results. METHODS: The systematic review included observational studies, which identified and analysed ADE during hospitalization of adult inpatients. The literature search was conducted on MEDLINE, Embase, Lilacs and Google Scholar (January of 2000 to June of 2013). Article selection, quality assessment and information extraction were performed by two of the authors, working independently. Using the random-effects model, the proportion of patients with adverse events was used as an outcome measure. Proportion was estimated for subgroups based on event identification method: stimulated reporting (SR), retrospective monitoring (RM) and prospective monitoring (PM). For the latter group, meta-regression was used to identify sources of heterogeneity in the estimates. RESULTS AND DISCUSSION: Twenty-eight articles from the 7550 identified met our inclusion criteria. The articles were heterogeneous in terms of quality, outcome definition and event identification method and in the corresponding descriptions. Of the 28 articles selected, 25 were included in the corresponding quantitative summary: four used SR, six RM and 15 PM, returning incidences of 2·3% (CI 95%: 1·6-4·5), 8·7% (CI 95%: 4·8-15·3) and 21·3% (CI 95%: 15·7-28·3), respectively, and I(2) greater than 95%. There were other sources of heterogeneity, including the use of combined strategies within each subgroup. In the PM subgroup, using multivariate meta-regression model, no variables were found to associate with proportion. WHAT IS NEW AND CONCLUSION: Event frequency seems to associate with the event identification method. PM returned the highest estimates. This subgroup used a greater diversity of approaches for event identification and more diverse data sources. Improved recording of information on the event identification method, the characteristics of the events and the conduct of the study would enable more reliable and precise estimates of the frequency of ADE among hospital inpatients.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Pacientes Internados , Adulto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização , Humanos , Reprodutibilidade dos Testes
13.
J Pediatr ; 163(6): 1638-45, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23910978

RESUMO

OBJECTIVE: To evaluate the effectiveness of a hospital-wide initiative to improve patient safety by implementing high-reliability practices as part of a quality improvement (QI) program aimed at reducing all preventable harm. STUDY DESIGN: A hospital wide quasi-experimental time series QI initiative using high-reliability concepts, microsystem-based multidisciplinary teams, and QI science tools to reduce hospital acquired harm was implemented. Extensive error prevention training was provided for all employees. Change concepts were enacted using the Institute for Healthcare Improvement's Model for Improvement. Compliance with change packages was measured. RESULTS: Between 2010 and 2012, the serious safety event rate decreased from 1.15 events to 0.19 event per 10 000 adjusted hospital-days, an 83.3% reduction (P < .001). Preventable harm events decreased by 53%, from a quarterly peak of 150 in the first quarter of 2010 to 71 in the fourth quarter of 2012 (P < .01). Observed hospital mortality decreased from 1.0% to 0.75% (P < .001), although severity-adjusted expected mortality actually increased slightly, and estimated harm-related hospital costs decreased by 22.0%. Hospital-wide safety climate scores increased significantly. CONCLUSION: Substantial reductions in serious safety event rate, preventable harm, hospital mortality, and cost were seen after implementation of our multifaceted approach. Measurable improvements in the safety culture were noted as well.


Assuntos
Mortalidade Hospitalar , Hospitalização/economia , Hospitais Pediátricos , Dano ao Paciente/prevenção & controle , Segurança do Paciente/normas , Melhoria de Qualidade , Criança , Controle de Custos , Humanos , Reprodutibilidade dos Testes
14.
J Pediatr ; 163(2): 477-83, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23465404

RESUMO

OBJECTIVE: To review and describe the current literature pertaining to the incidence, classification, severity, preventability, and impact of medication-related emergency department (ED) and hospital admissions in pediatric patients. STUDY DESIGN: A systematic search of PubMED, Embase, and Web of Science was performed using the following terms: drug toxicity, adverse drug event, medication error, emergency department, ambulatory care, and outpatient clinic. Additional articles were identified by a manual search of cited references. English language, full-reports of pediatric (≤18 years) patients that required an ED visit or hospital admission secondary to an adverse drug event (ADE) were included. RESULTS: We included 11 studies that reported medication-related ED visit or hospital admission in pediatric patients. Incidence of medication-related ED visits and hospital admissions ranged from 0.5%-3.3% and 0.16%-4.3%, respectively, of which 20.3%-66.7% were deemed preventable. Among ED visits, 5.1%-22.1% of patients were admitted to hospital, with a length of stay of 24-72 hours. The majority of ADEs were deemed moderate in severity. Types of ADEs included adverse drug reactions, allergic reactions, overdose, medication use with no indication, wrong drug prescribed, and patient not receiving a drug for an indication. Common causative agents included respiratory drugs, antimicrobials, central nervous system drugs, analgesics, hormones, cardiovascular drugs, and vaccines. CONCLUSION: Medication-related ED visits and hospital admissions are common in pediatric patients, many of which are preventable. These ADEs result in significant healthcare utilization.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Erros de Medicação/estatística & dados numéricos , Admissão do Paciente/estatística & dados numéricos , Criança , Humanos
15.
São Paulo; s.n; 2010. 154 p. ilus, tab, graf.
Tese em Português | LILACS | ID: lil-639139

RESUMO

O estudo caracterizou o perfil biodemográfico e clínico dos pacientes internados na clínica médica do Hospital Universitário da USP e os fármacos prescritos, avaliou as prescrições médicas em relação à ocorrência ou não de interações medicamentosas potenciais (IMP) e os fatores relacionados a elas para elaboração de instrumento educativo para auxiliar a atuação da equipe multidisciplinar na detecção de eventos adversos evitáveis potenciais de relevância clínica. Foram extraídos dos prontuários médicos os dados referentes à internação, identificação e estado clínico dos pacientes internados na clínica médica, entre março e agosto de 2006. Coletou-se ainda o diagnóstico principal no resumo de alta e o tempo de internação. Os fármacos prescritos foram coletados das prescrições médicas para análise da ocorrência de interações medicamentosas potenciais e classificação, empregando-se o banco de monografias Micromedex® DrugReax®. Empregou-se estatística descritiva e regressão logística multivariada na análise dos dados. Analisaram-se 5.666 prescrições médicas, a média de idade foi de 56,7±19,8 anos e o tempo médio de internação 10,7±9,4 dias. Os diagnósticos mais freqüentes foram broncopneumonia (138; 21,3%) e infarto agudo do miocárdio (57; 8,8%). Os grupos anatômicos mais freqüentemente prescritos, segundo o Anatomical Therapeutical Chemical, foram C (21,2%), A (17,5%), N (15,6%), B (15,0%) e J (13,6%). O número médio de fármacos por prescrição foi 5,7±2,9. Para a análise de IMP foram consideradas somente as prescrições com dois ou mais fármacos prescritos (5.336), das quais 3.097 (58,0%) apresentavam IMP. O número médio de fármacos entre essas prescrições foi 6,2±2,3. Observou-se associação significativa com as IMP identificadas no estudo: idade (p<0,001), tempo de internação (p<0,001), doenças cardiovasculares (p=0,0059) e número de fármacos (p<0,001). Tanto hipertensão arterial sistêmica quanto diabetes mellitus foram fatores de risco para ocorrência de IMP...


The study characterized the demographic and clinical profile of patients admitted to the internal medicine unit of the USP University Hospital and the drugs prescribed, the prescriptions evaluated in relation to the occurrence of potential drug interactions (PDI) and factors related to them for developing educational tool to assist the performance of the multidisciplinary team in the detection of preventable adverse drug events of clinical relevance. Data were extracted from medical records regarding the identification and clinical status of patients from March to August 2006. It was still collected the main diagnosis in the discharge summary and the time of admission. The drugs prescribed were obtained from medical prescriptions for analysis of the occurrence of potential drug interactions and classification, using the database monographs Micromedex® DrugReax®. Descriptive statistics and logistic regression were used in data analysis. From 5.666 prescriptions evaluated, the average age was 56.7 ± 19.8 years and mean length of stay was 10.7 ± 9.4 days. The most common diagnoses were pneumonia (138, 21.3%) and heart infarct (57, 8.8%). The anatomical groups most frequently prescribed were C (21.2%), A (17.5%), N (15.6%), B (15.0%) and J (13.6%) according Anatomical Therapeutical Chemical. The average number of drugs per prescription was 5.7 ± 2.9. For the analysis of PDI were considered only the prescriptions with two or more drugs (5.336), and 3.097 (58.0%) presented PDI. The average number of drugs per prescription was 6.2 ± 2.3. There was a significant association the PDI identified in the study with: age (p <0.001), length of stay (p <0.001), cardiovascular diseases (p = 0.0059) and number of drugs prescribed (p <0.001). Both hypertension and diabetes mellitus were risk factors for the occurrence of PDI, with odds ratios 4.93 and 2.79, respectively. The frequency of major and well-documented drug interactions was 26.5%. From 9.951 PDI observed in 2.637.


Assuntos
Humanos , Masculino , Feminino , Adulto , Idoso , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/organização & administração , Interações Medicamentosas , Hospitais Universitários/estatística & dados numéricos , Pacientes Internados/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Avaliação de Medicamentos/estatística & dados numéricos , Brasil , Interpretação Estatística de Dados , Avaliação de Eficácia-Efetividade de Intervenções
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