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1.
Rio de Janeiro; s.n; 20190000. 131 p. tab, graf, ilus.
Tese em Português | LILACS, BDENF - Enfermagem | ID: biblio-1025709

RESUMO

Objetivo: Desenvolver uma proposta educativa sobre segurança do paciente no uso de medicamentos de alta vigilância (MAV) para profissionais de saúde de unidades de terapia intensiva. Método: Estudo quantitativo, descritivo, quase-experimental, do tipo antes e depois, que foi realizado em um hospital privado de grande porte localizado em Niterói/RJ. Foi utilizada amostragem não-probabilística por conveniência. Participaram do estudo médicos, enfermeiros e técnicos de enfermagem. Analisaram-se as variáveis utilizando o teste do Qui-quadrado para avaliar os resultados. Resultados: A pesquisa antes e depois da proposta educativa apresentou aumento estatisticamente significativo de respostas com conotação negativa em 29,5% das perguntas. A notificação de incidentes relacionados a medicamento aumentou 28%, sendo que a classe dos opioides apresentou um incremento de 50%. Discussão: Atribui-se ao resultado da pesquisa a melhoria na compreensão dos aspectos sobre segurança do paciente, à falta de divulgação das ações promotoras da segurança do paciente incentivadas pela direção da instituição, e as ações de capacitação pontuais que são insuficientes aos profissionais. O aumento das notificações sobre medicamentos é bastante esperado, tendo em vista que erros os envolvendo são frequentes em pacientes internados, que quando em terapia intensiva utilizam rotineiramente opioides. Conclusão: Houve contribuição no aprimoramento do senso crítico relacionado à segurança do paciente e no aumento das notificações relativas ao tema abordado


Assuntos
Humanos , Masculino , Feminino , Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Materiais Educativos e de Divulgação , Segurança do Paciente , Pessoal de Saúde/educação , Unidades de Terapia Intensiva , Erros de Medicação/prevenção & controle
2.
BMJ Open ; 9(1): e025185, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30782751

RESUMO

OBJECTIVES: Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online system developed to support patient care during cancer treatment by improving the detection and management of treatment-related symptoms. Patients can complete symptom reports from home and receive severity-based self-management advice, including notifications to contact the hospital for severe symptoms. Patient data are available in electronic records for staff to review. Prior to the commencement of a randomised controlled trial (RCT), field testing of the intervention was undertaken to troubleshoot practical issues with intervention integration in clinical practice. DESIGN: Observational clinical field testing. SETTING: Medical oncology breast service in a UK cancer centre. PARTICIPANTS: 12 patients receiving chemotherapy for early breast cancer and 10 health professionals (oncologists and specialist nurses). INTERVENTION: Patients were asked to use the eRAPID intervention and complete weekly online symptom reports during four cycles of chemotherapy. Clinical staff were invited to access and use patient data in clinical assessments. ANALYSIS: Descriptive data on the frequency of online symptom report completion and severe symptom notifications were collated. Verbal and written feedback was collected from patients and staff and semistructured interviews were conducted to explore patient experiences. Interviews were transcribed and analysed thematically. RESULTS: The testing ran from January 2014 to March 2014. Feedback from patients and staff was largely positive. Patients described eRAPID as 'reassuring' and 'comforting' and valued the tailored management advice. Several changes were made to refine eRAPID. In particular, improvement of the clinical notification, patient reminder systems and changes to patient and staff training. CONCLUSIONS: The field testing generated valuable results used to guide refinement of eRAPID prior to formal intervention evaluation. Feedback indicated that eRAPID has the potential to improve patients' self-efficacy, knowledge and confidence with managing symptoms during treatment. A large-scale RCT is underway with data collection due to finish in October 2018.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Antineoplásicos/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Eletrônica Médica , Adulto , Idoso , Antineoplásicos/uso terapêutico , Feminino , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Autoeficácia , Autogestão/métodos , Reino Unido
3.
Hum Vaccin Immunother ; 15(5): 1048-1059, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30648923

RESUMO

Influenza is a major public health burden, mainly prevented by vaccination. Recommendations on influenza vaccine composition are updated annually and constant benefit-risk monitoring is therefore needed. We conducted near-real-time enhanced passive surveillance (EPS) for the influenza vaccine, Fluarix Tetra, according to European Medicines Agency guidance, in 10 volunteer general practices in England using Fluarix Tetra as their principal influenza vaccine brand, from 1-Sep to 30-Nov-2016. The EPS method used a combination of routinely collected data from electronic health records (EHR) and a customized adverse events reporting card (AERC) distributed to participants vaccinated with Fluarix Tetra. For participants vaccinated with a different influenza vaccine, data were derived exclusively from the EHR. We reported weekly and cumulative incidence of pre-defined adverse events of interest (AEI) occurring within 7 days post-vaccination, adjusted for clustering effect. Of the 97,754 eligible participants, 19,334 (19.8%) received influenza vaccination, of whom 13,861 (71.7%) received Fluarix Tetra. A total of 1,049 participants receiving Fluarix Tetra reported AEIs; 703 (67%) used the AERC (adjusted cumulative incidence rate 4.96% [95% CI: 3.92-6.25]). Analysis by individual pre-specified AEI categories identified no safety signal for Fluarix Tetra. A total of 62 individuals reported an AEI with a known brand of non-GSK influenza vaccine and 54 with an unknown brand (adjusted cumulative incidence rate 2.59% [1.93-3.47] and 1.77% [1.42-2.20], respectively). In conclusion, the study identified no safety signal for Fluarix Tetra and showed that the AERC was a useful tool that complemented routine pharmacovigilance by allowing more comprehensive capture of AEIs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Coleta de Dados , Registros Eletrônicos de Saúde , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
4.
Pharmaceut Med ; 33(2): 109-120, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-31933254

RESUMO

INTRODUCTION: Pharmacovigilance (PV) detects, assesses, and prevents adverse events (AEs) and other drug-related problems by collecting, evaluating, and acting upon AEs. The volume of individual case safety reports (ICSRs) increases yearly, but it is estimated that more than 90% of AEs go unreported. In this landscape, embracing assistive technologies at scale becomes necessary to obtain a higher yield of AEs, to maintain compliance, and transform the PV professional work life. AIM: The aim of this study was to identify areas across the PV value chain that can be augmented by cognitive service solutions using the methodologies of contextual analysis and cognitive load theory. It will also provide a framework of how to validate these PV cognitive services leveraging the acceptable quality limit approach. METHODS: The data used to train the cognitive service were an annotated corpus consisting of 20,000 ICSRS from which we developed a framework to identify and validate 40 cognitive services ranging from information extraction to complex decision making. This framework addresses the following shortcomings: (1) needing subject-matter expertise (SME) to match the artificial intelligence (AI) model predictions to the gold standard, commonly referred to as 'ground truth' in the AI space, (2) ground truth inconsistencies, (3) automated validation of prediction missing context, and (4) auto-labeling causing inaccurate test accuracy. The method consists of (1) conducting contextual analysis, (2) assessing human cognitive workload, (3) determining decision points for applying artificial intelligence (AI), (4) defining the scope of the data, or annotated corpus required for training and validation of the cognitive services, (5) identifying and standardizing PV knowledge elements, (6) developing cognitive services, and (7) reviewing and validating cognitive services. RESULTS: By applying the framework, we (1) identified 51 decision points as candidates for AI use, (2) standardized the process to make PV knowledge explicit, (3) embedded SMEs in the process to preserve PV knowledge and context, (4) standardized acceptability by using established quality inspection principles, and (5) validated a total of 126 cognitive services. CONCLUSION: The value of using AI methodologies in PV is compelling; however, as PV is highly regulated, acceptability will require assurances of quality, consistency, and standardization. We are proposing a foundational framework that the industry can use to identify and validate services to better support the gathering of quality data and to better serve the PV professional.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Inteligência Artificial/tendências , Cognição/fisiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Algoritmos , Bases de Dados Factuais , Tomada de Decisões/fisiologia , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Aprendizado de Máquina , Segurança do Paciente/normas , Farmacovigilância , Carga de Trabalho/estatística & dados numéricos
5.
Trials ; 19(1): 174, 2018 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-29523169

RESUMO

BACKGROUND: The reporting of adverse drug reactions (ADR) by patients represents an interesting challenge in the field of pharmacovigilance, but the reporting system is not adequately implemented in France. In 2015, only 20 MS patients in France reported ADR due to first-line disease-modifying drugs (DMD), while more than 3000 patients were initiated on DMD. The aim of this study is to validate a proof-of-concept as to whether the use of a mobile application (App) increases ADR reporting among patients with relapsing-remitting multiple sclerosis (RR-MS) receiving DMD. METHODS/DESIGN: We designed a multi-centric, open cluster-randomized controlled trial, called the Vigip-SEP study (NCT03029897), using the App My eReport France® to report ADR to the appropriate authorities in E2B language, in accordance with European regulations. RR-MS patients who were initiated on, or switched, first-line DMD will be included. In the experimental arm, a neurologist will introduce the patient to the App to report ADR to the appropriate French authorities. In the control arm, the patient will be informed of the existence of the App but will not be introduced to its use and will then report ADR according to the usual reporting procedures. Primary assessment criteria are defined as the average number of ADR per patient and per center. We assume that the App will increase patient reporting by 10-fold. Therefore, we will require 24 centers (12 per arm: 6 MS academic expert centers, 3 general hospitals, 3 private practice neurologists), allowing for an expected enrollment of 180 patients (alpha risk 5%, power 90% and standard deviation 4%). DISCUSSION: Increasing patient reporting of ADR in a real-life setting is extremely important for therapeutic management of RR-MS, particularly for monitoring newly approved DMD to gain better knowledge of their safety profiles. To increase patient involvement, teaching patients to use tools, such as mobile applications, should be encouraged, and these tools should be tested rigorously. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT03029897 . Registered on 20 January 2017.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Computadores de Mão , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Fatores Imunológicos/efeitos adversos , Aplicativos Móveis , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Feminino , França/epidemiologia , Humanos , Masculino , Estudos Multicêntricos como Assunto , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Farmacovigilância , Estudo de Prova de Conceito , Ensaios Clínicos Controlados Aleatórios como Assunto , Smartphone , Fatores de Tempo
6.
Artigo em Inglês | MEDLINE | ID: mdl-29417762

RESUMO

It is difficult to determine adverse drug reactions (ADRs) in daily complicated clinical practice in which many kinds of drugs are prescribed. We evaluated how well the Naranjo Algorithm (NA) categorized ADRs among suspected ADRs. The Japan Adverse Drug Events (JADE) study was a prospective cohort study of 3459 inpatients. After all suspected ADRs were reported from research assistants, a single physician reviewer independently assigned an NA score to each. After all NA score of suspected ADRs were scored, two physician reviewers discussed and determined ADRs based on the literature. We investigated the sensitivity and specificity of NA and each component to categorize ADRs among suspected ADRs. A total of 1579 suspected ADRs were reported in 962 patients. Physician reviewers determined 997 ADRs. The percentage of ADRs was 94% if the total NA score reached 5. The modified NA consisted of 5 components that showed high classification abilities; its area under the curve (AUC) was 0.92 for categorizing ADRs, the same as the original. When we set the total NA score cut-off value to 5, specificity was 0.95 and sensitivity was 0.59. When we reclassified NA components as binary variables, the specificity increased to 0.98 with a cut-off value of 4 and yielded an AUC of 0.93. In conclusion, we showed that both NA and modified NA could categorize ADRs among suspected ADRs with a high likelihood in daily clinical practice.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Algoritmos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização/estatística & dados numéricos , Medicamentos sob Prescrição/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Feminino , Humanos , Incidência , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sensibilidade e Especificidade
7.
J Chem Inf Model ; 58(1): 8-11, 2018 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-29206457

RESUMO

Application of structure-activity relationships (SARs) for the prediction of adverse effects of drugs (ADEs) has been reported in many published studies. Training sets for the creation of SAR models are usually based on drug label information which allows for the generation of data sets for many hundreds of drugs. Since many ADEs may not be related to drug consumption, one of the main problems in such studies is the quality of data on drug-ADE pairs obtained from labels. The information on ADEs may be included in three sections of the drug labels: "Boxed warning," "Warnings and Precautions," and "Adverse reactions." The first two sections, especially Boxed warning, usually contain the most frequent and severe ADEs that have either known or probable relationships to drug consumption. Using this information, we have created manually curated data sets for the five most frequent and severe ADEs: myocardial infarction, arrhythmia, cardiac failure, severe hepatotoxicity, and nephrotoxicity, with more than 850 drugs on average for each effect. The corresponding SARs were built with PASS (Prediction of Activity Spectra for Substances) software and had balanced accuracy values of 0.74, 0.7, 0.77, 0.67, and 0.75, respectively. They were implemented in a freely available ADVERPred web service ( http://www.way2drug.com/adverpred/ ), which enables a user to predict five ADEs based on the structural formula of compound. This web service can be applied for estimation of the corresponding ADEs for hits and lead compounds at the early stages of drug discovery.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Internet , Rotulagem de Medicamentos , Coração/efeitos dos fármacos , Cardiopatias/induzido quimicamente , Humanos , Rim/efeitos dos fármacos , Fígado/efeitos dos fármacos , Valor Preditivo dos Testes , Software , Relação Estrutura-Atividade
8.
BMC Cancer ; 17(1): 318, 2017 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-28482877

RESUMO

BACKGROUND: eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation. METHODS: The trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients. Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504. The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff. DISCUSSION: The pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88520246 . Registered 11 September 2014.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Antineoplásicos/efeitos adversos , Eletrônica Médica , Neoplasias/tratamento farmacológico , Antineoplásicos/uso terapêutico , Feminino , Humanos , Internet , Estudos Prospectivos , Qualidade de Vida
9.
Stud Health Technol Inform ; 225: 840-1, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27332369

RESUMO

Nurse used to be the first one to be investigated in a drug adverse event. Our newly hospital-wide implemented home-made mobile chemotherapy medication support system, which has released our nurses from the traditional heavy 2-nurse-double-checking loading, was unexpectedly used to protect our nurses from being suspected in a recent event of over delivery of infusion. The outcome turned us to reexamine the device maintenance and test protocols.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Terapia por Infusões no Domicílio/enfermagem , Erros de Medicação/prevenção & controle , Sistemas de Medicação no Hospital/organização & administração , Telemedicina/instrumentação , Cálculos da Dosagem de Medicamento , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/enfermagem , Terapia por Infusões no Domicílio/instrumentação , Terapia por Infusões no Domicílio/métodos , Recursos Humanos de Enfermagem no Hospital/organização & administração , Taiwan , Telemedicina/métodos
10.
Rev Saude Publica ; 50: 14, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27143614

RESUMO

OBJECTIVE: To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS: We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS: All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS: We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/economia , Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Monitoramento de Medicamentos/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Análise Custo-Benefício , Pessoal de Saúde , Humanos , Farmacovigilância , Portugal
11.
Pharmacoepidemiol Drug Saf ; 25(3): 238-50, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26521865

RESUMO

BACKGROUND: The PROTECT Benefit-Risk group is dedicated to research in methods for continuous benefit-risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods. METHODS: A comprehensive review was performed to identify visuals used for medical risk and benefit-risk communication. The identified visual displays were grouped into visual types, and each visual type was appraised based on five criteria: intended audience, intended message, knowledge required to understand the visual, unintentional messages that may be derived from the visual and missing information that may be needed to understand the visual. RESULTS: Sixty-six examples of visual formats were identified from the literature and classified into 14 visual types. We found that there is not one single visual format that is consistently superior to others for the communication of benefit-risk information. In addition, we found that most of the drawbacks found in the visual formats could be considered general to visual communication, although some appear more relevant to specific formats and should be considered when creating visuals for different audiences depending on the exact message to be communicated. CONCLUSION: We have arrived at recommendations for the use of visual displays for benefit-risk communication. The recommendation refers to the creation of visuals. We outline four criteria to determine audience-visual compatibility and consider these to be a key task in creating any visual. Next we propose specific visual formats of interest, to be explored further for their ability to address nine different types of benefit-risk analysis information.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Apresentação de Dados , Farmacoepidemiologia/métodos , Medição de Risco/métodos , Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Comunicação , Tomada de Decisões , Farmacoepidemiologia/instrumentação
12.
BMC Health Serv Res ; 14: 655, 2014 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-25527905

RESUMO

BACKGROUND: Little is known about adverse events (AEs) in pediatric patients. Record review is a common methodology for identifying AEs, but in pediatrics the record review tools generally have limited focus. The aim of the present study was to develop a broadly applicable record review tool to identify AEs in pediatric inpatients. METHODS: Using a broad literature review and expert opinion with a modified Delphi process, a pediatric trigger tool with 88 triggers, definitions, and descriptions including AE preventability decision support was developed and tested in a random sample of 600 hospitalized pediatric patients admitted in 2010 to a single university children's hospital. Four registered nurse-physician teams performed complete two-stage retrospective reviews of 150 records each from either neonatal, surgical/orthopedic, medicine, or emergency medicine units. RESULTS: Registered nurse review identified 296 of 600 records with triggers indicating potential AEs. Records (n = 121) with only false positive triggers not indicating any potential AEs were not forwarded to the next review stage. On subsequent physician review, 204 (34.0%) of patients were found to have had 563 AEs, range 1-27 AEs/patient. A total of 442 preventable AEs were found in 161 patients (26.8%), range 1-22. Overall, triggers were found 3,598 times in 417 (69.5%) records, with a mean of 6 (median 1, range 0-176) triggers per patient. The overall positive predictive value of the triggers was 22.9%, (range 0.0-100.0%). The final pediatric trigger tool, developed with a second Delphi round, required 29 triggers. CONCLUSIONS: AEs are common in pediatric patients and most are preventable. The main contributions of this study are to further develop and adapt trigger definitions, including AE preventability decision support, to introduce new triggers in pediatric care, as well as to apply pediatric triggers in different clinical specialties. Our findings resulted in a national pediatric trigger tool, and might also be adapted internationally. The pediatric trigger tool can help healthcare organizations to measure and analyze the AEs occurring in hospitalized children in order to improve patient safety.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Erros Médicos/efeitos adversos , Segurança do Paciente , Pediatria , Criança , Criança Hospitalizada , Feminino , Hospitais Pediátricos , Humanos , Lactente , Masculino , Fatores Desencadeantes , Reprodutibilidade dos Testes , Estudos Retrospectivos
13.
Int J Risk Saf Med ; 26(1): 1-8, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24796346

RESUMO

BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting form is a vital tool for collecting information about ADRs, which helps in establishing the causal assessment and generating a signal. This is feasible if quality information is translated into the reporting form by health care professional (HCPs). Hence, present study was carried out to compare efficiency of HCPs in translating suspected ADR information in the spontaneous reporting forms and to compare the ADR reporting forms of different countries and their duration of training in pharmacovigilance. METHODS: In a cross-sectional study, 50 doctors, 50 Nurses and 50 Pharmacists were asked to fill different reporting forms (CDSCO form, Medwatch, Yellow card and the Blue form) using different simulated ADR case reports. Filled forms were analysed for their contents, information captured and time taken to fill these forms. They were also asked about their training and exposure to pharmacovigilance related activities. RESULTS: All the spontaneous ADR reporting forms had 24-26 data elements to furnish information. Information regarding dechallenge was lacking in the Yellow card and Blue form. Blue form also lacked the information on rechallenge. Overall nurses took longer time to fill all the ADR reporting forms as compared to the doctors and pharmacists. Majority of HCPs missed to fill reporter's information in all the forms. CONCLUSION: Study suggested that the quality of information translated by the HCPs needs improvement for which they should be sensitized periodically on the basic elements of pharmacovigilance.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Documentação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Enfermeiras e Enfermeiros/normas , Farmacêuticos/normas , Médicos/normas , Austrália , Competência Clínica/normas , Estudos Transversais , Documentação/métodos , Documentação/normas , Humanos , Índia , Farmacovigilância , Qualidade da Assistência à Saúde , Relatório de Pesquisa , Análise e Desempenho de Tarefas , Reino Unido , Estados Unidos
14.
J Nurs Manag ; 22(3): 331-49, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23701013

RESUMO

AIM: This paper reports on the development of an instrument for nurse-led medication monitoring, the West Wales Adverse Drug Reaction profile for respiratory medicines, as part of a strategy to reduce avoidable adverse drug reactions. BACKGROUND: Preventable adverse drug reactions account for 3.7% hospital admissions. Nurse-led medication monitoring may reduce drug-related harm. However, development of medication monitoring strategies is not reported elsewhere. METHODS: The profile was developed by: (1) cognitive interviews (n = 4), (2) the content validity index (n = 10) involving academics, clinicians and service users prescribed respiratory medicines, (3) inter-rater reliability (n = 48) and clinical gains in a nurse-led outpatient clinic. RESULTS: Cognitive interviews prompted more profile changes than either the content validity index or inter-rater reliability testing. Cohen's κ for inter-rater reliability for each item ranged from 0.73-1.00 (good to complete agreement). The profile identified previously unsuspected problems in all participants, including muscular weakness, skin and mouth problems. CONCLUSIONS: The West Wales Adverse Drug Reaction profile was valid and reliable, and helped to detect and ameliorate drug-related harm. IMPLICATIONS FOR NURSING MANAGEMENT: The West Wales Adverse Drug Reaction profile offers opportunities to improve care. Medication monitoring provides the structure to concurrently monitor known adverse drug reactions. Practice-based adverse drug reaction profiles benefit from cognitive, content validity and inter-rater reliability testing.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Monitoramento de Medicamentos/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Enfermeiras e Enfermeiros , Desenvolvimento de Programas/métodos , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/enfermagem , Humanos , País de Gales
15.
Stud Health Technol Inform ; 192: 903-7, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23920689

RESUMO

The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Documentação/métodos , Registros Eletrônicos de Saúde/organização & administração , Armazenamento e Recuperação da Informação/métodos , Registro Médico Coordenado/métodos , Software , França , Semântica , Design de Software , Interface Usuário-Computador , Carga de Trabalho
16.
Farm Hosp ; 36(5): 351-5, 2012.
Artigo em Espanhol | MEDLINE | ID: mdl-22484103

RESUMO

OBJECTIVE: To describe the development of a tool to automate detection of adverse drug-related events (ADRE) in all patients in a hospital. METHOD: We selected the ADRE that we wished to detect (administering drugs to patients with kidney failure and/or by enteral feeding tube) We designed software to record, process and integrate analytical results from SELENE(®) clinical history programme, treatment prescribed using Farmatools(®), and the information included in the tables we designed. RESULTS: The programme allows us to automatically detect patients likely to experience the ADRE we defined, and recommends a modified treatment to the pharmacist. This new tool enables us to search for all patients who might have a specific ADRE. CONCLUSIONS: The software we designed may be a useful drug validation tool.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Software , Hospitais , Humanos , Farmacêuticos , Serviço de Farmácia Hospitalar , Reprodutibilidade dos Testes
17.
Zhongguo Zhong Yao Za Zhi ; 37(18): 2695-7, 2012 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-23285911

RESUMO

OBJECTIVE: To provide analytical data and automatic method for more quickly and accurately discovering warning signals of adverse reactions of traditional Chinese medicine (TCM) injections from a large number of adverse reaction data. METHOD: Constructed the TCM injection adverse reaction monitoring system, integrated of multiple mining algorithms of warning signals of adverse reactions and automatically generate early warning analysis, and extended the algorithm to achieve better effect of warning and analysis. RESULT: By data validation, the system can provide consistent warning results with the actual situation. CONCLUSION: The established system has good scalability, it can provide warning analysis of adverse reaction data from multiple sources, and provide a basis for decision making to experts in the field.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Algoritmos , Medicamentos de Ervas Chinesas/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Hipersensibilidade a Drogas/epidemiologia , Medicamentos de Ervas Chinesas/administração & dosagem , Humanos
18.
Health Technol Assess ; 15(20): 1-234, iii-iv, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21545758

RESUMO

BACKGROUND: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety issues can be detected. While previous studies have shown differences between patient and health-care professional (HCP) reports for the types of drugs and reactions reported, relatively little is known about the pharmacovigilance impact of patient reports. There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs. OBJECTIVES: To evaluate the pharmacovigilance impact of patient reporting of ADRs by analysing reports of suspected ADRs from the UK YCS and comparing reports from patients and HCPs. To elicit the views and experiences of patients and the public about patient reporting of ADRs. DESIGN: (1) Literature review and survey of international experiences of consumer reporting of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with patient reporters to the scheme; (7) qualitative analysis of focus groups and usability testing of the patient YCS; and (8) national omnibus telephone survey of public awareness of the YCS. PARTICIPANTS: Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports from October 2005 to September 2007. Respondents to questionnaire survey (n = 1362). Participants at focus groups and usability testing sessions (n = 40). National omnibus telephone survey (n = 2028). SETTING: The literature review included studies in English from across the world. All other components included populations from the UK; the omnibus survey was restricted to Great Britain. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Characteristics of patient reports: types of drug and suspected ADR reported; seriousness of reports; and content of reports. The relative contributions of patient reports and of HCP reports to signal generation. Views and experiences of patient reporters. Views of members of the public about the YCS, including user-friendliness and usability of different ways of patient reporting. Public awareness of the YCS. Suggestions for improving patient reporting to the YCS. RESULTS: Compared with HCPs, patient reports to the YCS contained a higher median number of suspected ADRs per report, and described reactions in more detail. The proportions of reports categorised as 'serious' were similar; the patterns of drugs and reactions reported differed. Patient reports were richer in their descriptions of reactions than those from HCPs, and more often noted the effects of ADRs on patients' lives. Combining patient and HCP reports generated more potential signals than HCP reports alone; some potential signals in the 'HCP-only' data set were lost when combined with patient reports, but fewer than those gained; the addition of patient reports to HCP reports identified 47 new 'serious' reactions not previously included in 'Summaries of Product Characteristics'. Most patient reporters found it fairly easy to make reports, although improvements to the scheme were suggested, including greater publicity and the redesign of web- and paper-based reporting systems. Among members of the public, 8.5% were aware of the YCS in 2009. CONCLUSIONS: Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients' lives. These findings suggest that further promotion of patient reporting to the YCS is justified, along with improvements to existing reporting systems. In order of priority, future work should include further investigation of (1) the pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs in terms of impact on patients' lives; (4) the knowledge and attitudes of HCPs towards patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other patients and HCPs who are seeking information on patient experiences of ADRs; and (6) the impact of increasing publicity and/or enhancements to reporting systems on the numbers and types of Yellow Card reports from patients. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Autorrelato , Adulto , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Estudos de Avaliação como Assunto , Feminino , Grupos Focais , Pessoal de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Gestão da Segurança , Inquéritos e Questionários , Reino Unido/epidemiologia
19.
BMJ Qual Saf ; 20(5): 416-23, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21242527

RESUMO

OBJECTIVE: To describe the process of developing and validating the Canadian Association of Paediatric Health Centres Trigger Tool (CPTT). METHODS: Five existing trigger tools were consolidated with duplicate triggers eliminated. After a risk analysis and modified Delphi process, the tool was reduced from 94 to 47 triggers. Feasibility of use was tested, reviewing 40 charts in three hospitals. For validation, charts were randomly selected across four age groups, half medical/half surgical diagnoses, from six paediatric academic health sciences centres. 591 charts were reviewed by six nurses (for triggers and adverse events (AEs)) and three physicians (for AEs only). The incidence of trigger- and AE-positive charts was documented, and the sensitivity and specificity of the tool to identify charts with AEs were determined. Identification of AEs by nurses and physicians was compared. The positive predictive value (PPV) of each trigger was calculated and the ratio of false- to true-positive AE predictors analysed for each trigger. RESULTS: Nurses rated the CPTT easy to use and identified triggers in 61.1% (361/591; 95% CI 57.2 to 65.0) of patient charts; physicians identified AEs in 15.1% (89/ 591, 95% CI 0.23 to 0.43). Over a third of patients with AEs were neonates. The sensitivity and specificity were 0.88 and 0.44, respectively. Nurse and physician AE assessments correlated poorly. The PPV for each trigger ranged from 0 to 88.3%. Triggers with a false/true-positive ratio of >0.7 were eliminated, resulting in the final 35-trigger CPTT. CONCLUSIONS: The CPTT is the first validated, comprehensive trigger tool available to detect AEs in children hospitalised in acute care facilities.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Erros Médicos/estatística & dados numéricos , Pediatria/instrumentação , Gestão da Segurança/métodos , Canadá , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
20.
J Gen Intern Med ; 23 Suppl 1: 41-5, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18095043

RESUMO

BACKGROUND: Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. OBJECTIVES: To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software ("smart pump") and to suggest potential improvements in smart-pump design. DESIGN: Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 hospitals replaced conventional pumps with smart pumps. The smart pumps alerted users when programmed to deliver duplicate infusions or continuous-infusion doses outside hospital-defined ranges. PARTICIPANTS: 4,604 critically ill adults at 1 academic and 1 nonacademic hospital. MEASUREMENTS: Preventable IV-ADEs matching smart-pump features and errors involved in preventable IV-ADEs. RESULTS: Of 100 preventable IV-ADEs identified, 4 involved errors matching smart-pump features. Two occurred before and 2 after smart-pump implementation. Overall, 29% of preventable IV-ADEs involved overdoses; 37%, failures to monitor for potential problems; and 45%, failures to intervene when problems appeared. Error descriptions suggested that expanding smart pumps' capabilities might enable them to prevent more IV-ADEs. CONCLUSION: The smart pumps we evaluated are unlikely to reduce preventable IV-ADEs in ICUs because they address only 4% of them. Expanding smart-pump capabilities might prevent more IV-ADEs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Quimioterapia Assistida por Computador , Bombas de Infusão/normas , Erros de Medicação/prevenção & controle , Adulto , Idoso , Estado Terminal , Desenho de Equipamento , Segurança de Equipamentos , Feminino , Humanos , Bombas de Infusão/tendências , Bombas de Infusão Implantáveis/normas , Bombas de Infusão Implantáveis/tendências , Unidades de Terapia Intensiva , Masculino , Registros Médicos , Pessoa de Meia-Idade , Probabilidade , Estudos Retrospectivos , Gestão de Riscos , Sensibilidade e Especificidade
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