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1.
Artigo em Inglês | MEDLINE | ID: mdl-32536336

RESUMO

Background: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018. Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described. Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association. Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Imunização/efeitos adversos , Imunização/estatística & dados numéricos , Farmacovigilância , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Previsões , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Vigilância da População , Estudos Retrospectivos , Vitória/epidemiologia , Adulto Jovem
2.
Artigo em Inglês | MEDLINE | ID: mdl-32536339

RESUMO

Introduction: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine-preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2017 and 2018. Methods: Specialist nurses screened hospital admissions, emergency department (ED) records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia to identify children with the conditions under surveillance. In 2017 and 2018 these included acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal, and invasive Group A streptococcus diseases. An additional social research component was added to evaluate parental attitudes to vaccination. Results: PAEDS captured 1,580 and 925 cases for 2017 and 2018, respectively, across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets; identification of a third human parechovirus outbreak among other infectious diseases linked to ACE; demonstration of variable influenza activity between 2017 and 2018, with vaccine effectiveness (VE) analysis demonstrating that the protection offered through vaccination is season-dependent. All IS cases associated with vaccine receipt were reported to the relevant state health department. Varicella and herpes zoster case numbers remained unchanged, with vaccine uptake found to be suboptimal among eligible children under the NIP. Enhanced pertussis surveillance continues to capture controls for VE estimation. Surveillance for invasive meningococcal disease showed predominance for serotype B at 57% over 2 years among 77 cases where serotyping was available, and surveillance for invasive group A streptococcus captured severe disease in children. Conclusion: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Pediatria/estatística & dados numéricos , Pediatria/tendências , Vigilância da População , Doenças Preveníveis por Vacina/epidemiologia , Adolescente , Austrália/epidemiologia , Criança , Pré-Escolar , Feminino , Previsões , Humanos , Lactente , Recém-Nascido , Masculino , Estudos Prospectivos
3.
Rev. Pesqui. (Univ. Fed. Estado Rio J., Online) ; 12: 468-475, jan.-dez. 2020. ilus, tab
Artigo em Inglês, Português | LILACS, BDENF - Enfermagem | ID: biblio-1087433

RESUMO

Objetivo: a avaliação da cultura de segurança do paciente permite aos hospitais identificar e gerir prospectivamente questões relevantes de segurança em suas rotinas de trabalho. Método: estudo quantitativo, transversal e descritivo, ocorrida no ano de 2017 na Unidade de Terapia Intensiva Adulta em um hospital privado, localizado em Niterói/RJ. A população foram os profissionais médicos e equipe de enfermagem, utilizando análise estatística por meio de programa R, com a interface Rcmdr. Resultados: baseados nas respostas às perguntas sobre notificação de eventos aplicada com a Pesquisa de Cultura de Segurança do Paciente a 97 profissionais, com uma taxa de resposta de 85,6%, correspondendo a 83 profissionais. Menos de 45% dos participantes da pesquisa sempre notificam um erro, engano ou falha, que afete ou não o paciente, 59,0% não fizeram nenhuma notificação nos últimos 12 meses antecedentes à pesquisa e não houve diferença significativa na quantidade de notificação que destacasse uma categoria profissional, graduados ou não. Discussão: houve maior adesão à notificação de eventos pelos com maior tempo de hospital e com maior tempo naquela terapia intensiva. Não se encontrou correlação do número de notificações relatadas com o tempo de profissão e com a carga horária de trabalho. Conclusão: no que tange à conscientização de incrementar a adesão à notificação de eventos, a análise realizada contribuiu para a melhoria da segurança do paciente


Objective: ealuating the patient's safety culture allows hospitals to identify and manage relevant safety issues prospectively in their work routines. Method: a quantitative, transversal and descriptive study, carried out in 2017 at the Adult Intensive Care Unit in a private hospital, located in Niterói / RJ. The population were medical professionals and nursing staff, using statistical analysis through program R, with the Rcmdr interface. Results: based on responses to questions about event notification applied with the Patient Safety Culture Survey to 97 professionals, with a response rate of 85.6%, corresponding to 83 professionals. Less than 45% of respondents report an error, deception, or failure, affecting the patient, 59.0% did not report in the last 12 months prior to the survey, and there was no significant difference in the amount of notification that stood out a professional category, graduates or not. Discussion: there was greater adherence to the notification of events by those with longer hospital time and with more time in that intensive therapy. There was no correlation between the number of reports reported with the time of profession and the workload. Conclusion: with regard to the awareness of increasing adherence to event notification, the analysis performed contributed to the improvement of patient safety


Objetivo: la evaluación de la cultura de seguridad del paciente permite a los hospitales identificar y gestionar prospectivamente cuestiones relevantes de seguridad en sus rutinas de trabajo. Método: estudio cuantitativo, transversal y descriptivo, ocurrido en el año 2017 en la Unidad de Terapia Intensiva Adulta en un hospital privado, ubicado en Niterói / RJ. La población fueron los profesionales médicos y equipo de enfermería, utilizando análisis estadístico por medio del programa R, con la interfaz Rcmdr. Resultados: basados en las respuestas a las preguntas sobre notificación de eventos aplicada con la Encuesta de Cultura de Seguridad del Paciente a 97 profesionales, con una tasa de respuesta del 85,6%, correspondiendo a 83 profesionales. En la mayoría de los casos, la mayoría de las personas que sufren de la enfermedad de Alzheimer, una categoría profesional, graduados o no. Discusión: hubo mayor adhesión a la notificación de eventos por los con mayor tiempo de hospital y con mayor tiempo en aquella terapia intensiva. No se encontró correlación del número de notificaciones relatadas con el tiempo de profesión y con la carga horaria de trabajo. Conclusión: en lo que concierne a la concientización de incrementar la adhesión a la notificación de eventos, el análisis realizado contribuyó a la mejora de la seguridad del paciente


Assuntos
Humanos , Monitoramento de Medicamentos/instrumentação , Segurança do Paciente/estatística & dados numéricos , Estudos Transversais , Fatores de Risco , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Medição de Risco , Unidades de Terapia Intensiva
4.
Pediatrics ; 144(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31740498

RESUMO

BACKGROUND AND OBJECTIVES: Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink. METHODS: Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses. RESULTS: During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events. CONCLUSIONS: After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Monitoramento Epidemiológico , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Adolescente , Adulto , Apendicite/induzido quimicamente , Apendicite/epidemiologia , Criança , Hipersensibilidade a Drogas/epidemiologia , Feminino , Humanos , Masculino , Pancreatite/induzido quimicamente , Pancreatite/epidemiologia , Estados Unidos/epidemiologia , Adulto Jovem
5.
Pediatrics ; 144(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31740500

RESUMO

BACKGROUND: The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions. RESULTS: VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings. CONCLUSIONS: No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Adolescente , Adulto , Criança , Bases de Dados Factuais/tendências , Tontura/induzido quimicamente , Tontura/epidemiologia , Feminino , Cefaleia/induzido quimicamente , Cefaleia/epidemiologia , Humanos , Masculino , Estados Unidos/epidemiologia , Adulto Jovem
6.
Therapie ; 74(6): 557-567, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31623850

RESUMO

The discovery and quantification of adverse drug reactions has long relied on the careful analysis of spontaneously reported cases. Causality assessment (imputation) was a fundamental feature of individual case report analysis. This was complemented by analysis of aggregated cases, and of disproportionality analyses in spontaneous reports databases. In the absence of more specific information sources, these have resulted in the discovery of many new adverse reactions, altering drug information. It has led to the withdrawal from the market of many drugs, but its use for risk quantification remains fraught with uncertainty. The recent access to population-wide claims or electronic health records databases have confirmed for spontaneous reporting a predominant role in hypothesis generation for serious adverse drug reactions, notably those that result in hospital admission or death. In these cases, the events are identifiable at the population level, and can be quantified precisely using the tools of modern pharmacoepidemiology, to generate specific benefit-risk analyses. Spontaneous reporting remains irreplaceable in signal and alert generation in drug safety, despite its inherent limitations. For signal strengthening and assessment, more systematic and quantitative methods should be sought, such as claims databases for reactions resulting in hospital admissions.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Coleta de Dados/métodos , Coleta de Dados/normas , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Registros Eletrônicos de Saúde/organização & administração , Registros Eletrônicos de Saúde/estatística & dados numéricos , Humanos , Segurança do Paciente , Farmacoepidemiologia/métodos , Farmacoepidemiologia/tendências
7.
Expert Opin Drug Saf ; 18(6): 477-484, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31030578

RESUMO

INTRODUCTION: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the patient reporting scheme and to compare experiences with other countries. The aim of this article is to summarize our 15-year experience of working with direct patient reporting in pharmacovigilance and to discuss necessary steps in order to optimize the use of patient reports in the future. AREAS COVERED: This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, the impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting. EXPERT OPINION: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharmacovigilance is a way to improve pharmacovigilance, enhancing the general public's trust in medicines.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Humanos , Países Baixos , Autorrelato
8.
PLoS One ; 14(2): e0212905, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30817781

RESUMO

Therapeutic ineffectiveness involves drug-related therapeutic failure, inefficacy or resistance and has not been sufficiently studied. Objective of our study was to evaluate reporting trends in therapeutic ineffectiveness by year and describe factors affecting therapeutic ineffectiveness using the Korea Adverse Event Reporting System. Proportion of therapeutic ineffectiveness reports was based on total submitted reports between 2000 and 2016. Utilizing 2016 alone, we compared the characteristics of therapeutic ineffectiveness with age group and gender matching by random extraction. We conducted a logistic regression analysis to estimate reporting odds ratios (ROR) and its 95% confidence intervals (CI) for reports by type of reporters, e.g., doctors, pharmacists, or consumers. We presented most frequent reports by the anatomical main groups and therapeutic subgroups according to the Anatomical Therapeutic Chemical (ATC) classification system. For the 17-years, the proportion of therapeutic ineffectiveness adverse drug reactions reporting ranged from 0.0% to 3.7% between 2000 and 2016. Of 228,939 reports, 2,797 (1.2%) were submitted in 2016. Consumers accounted for 6.92% of reports and doctors accounted for 45.49%, in which, consumers were more likely to report therapeutic ineffectiveness than doctors (adjusted ROR 3.98; 95% CI, 2.92 to 5.41). According to the ATC classification system, "nervous system" was the most frequently reported anatomical group (18.7%) and "parathyroid hormones and analogues" was reported most frequently in the pharmacological subgroup (23.7%). Teriparatide, a drug used to treat osteoporosis, had the most reports (11.0%). Therapeutic ineffectiveness reports may be used as a scientific tool for the reevaluation of respective drugs in order to confirm of its therapeutic effects.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Resistência a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Modelos Logísticos , Masculino , República da Coreia/epidemiologia , Falha de Tratamento , Resultado do Tratamento
10.
Drug Saf ; 42(1): 147-156, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30649737

RESUMO

INTRODUCTION: Identifying occurrences of medication side effects and adverse drug events (ADEs) is an important and challenging task because they are frequently only mentioned in clinical narrative and are not formally reported. METHODS: We developed a natural language processing (NLP) system that aims to identify mentions of symptoms and drugs in clinical notes and label the relationship between the mentions as indications or ADEs. The system leverages an existing word embeddings model with induced word clusters for dimensionality reduction. It employs a conditional random field (CRF) model for named entity recognition (NER) and a random forest model for relation extraction (RE). RESULTS: Final performance of each model was evaluated separately and then combined on a manually annotated evaluation set. The micro-averaged F1 score was 80.9% for NER, 88.1% for RE, and 61.2% for the integrated systems. Outputs from our systems were submitted to the NLP Challenges for Detecting Medication and Adverse Drug Events from Electronic Health Records (MADE 1.0) competition (Yu et al. in http://bio-nlp.org/index.php/projects/39-nlp-challenges , 2018). System performance was evaluated in three tasks (NER, RE, and complete system) with multiple teams submitting output from their systems for each task. Our RE system placed first in Task 2 of the challenge and our integrated system achieved third place in Task 3. CONCLUSION: Adding to the growing number of publications that utilize NLP to detect occurrences of ADEs, our study illustrates the benefits of employing innovative feature engineering.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Registros Eletrônicos de Saúde/tendências , Processamento de Linguagem Natural , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Registros Eletrônicos de Saúde/normas , Humanos
11.
Drug Saf ; 42(1): 135-146, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30649738

RESUMO

BACKGROUND AND SIGNIFICANCE: Adverse drug events (ADEs) occur in approximately 2-5% of hospitalized patients, often resulting in poor outcomes or even death. Extraction of ADEs from clinical narratives can accelerate and automate pharmacovigilance. Using state-of-the-art deep-learning neural networks to jointly model concept and relation extraction, we achieved the highest integrated task score in the 2018 Medication and Adverse Drug Event (MADE) 1.0 challenge. METHODS: We used a combined bidirectional long short-term memory (BiLSTM) and conditional random fields (CRF) neural network to detect medical entities relevant to ADEs and a combined BiLSTM and attention network to determine relations, including the adverse drug reaction relation between medication and sign or symptom entities. Using these models, we conducted three experiments: (1) separate and sequential modeling of entities and relations; (2) joint modeling where relations between medications and sign or symptoms determined ADE and indication entities; (3) use of information from external resources such as the US FDA's adverse event database as additional input to the second method. RESULTS: Joint modeling improved the overall task accuracy from 0.62 to 0.65 F measure, and the additional use of external resources improved the accuracy to 0.66 F measure. Given the gold-standard medical entity labels, the joint model plus external resources method achieved F measures of 0.83 for ADE-relevant medical entity detection and 0.87 for relation detection. CONCLUSION: It is important to use joint modeling techniques and external resources for effectively detecting ADEs from clinical narratives in electronic health record (EHR) systems. While the extraction of entities and relations individually achieved high accuracy, the integrated task still has room for further improvement.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Aprendizado Profundo/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Redes Neurais de Computação , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Aprendizado Profundo/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos
12.
Curr Drug Saf ; 14(1): 53-56, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30411692

RESUMO

BACKGROUND: The Colombian National Food and Drug Surveillance Institute (INVIMA) is responsible for monitoring the safety and efficacy of medicines circulating the Colombian market. DISCUSSION: This article summarizes the three key strategies the institution has implemented to strengthen the National Pharmacovigilance Program: improving the interaction and working relationship with regional health authorities, expanding the National Pharmacovigilance Network and implementing the electronic submission of adverse events. CONCLUSION: The number of adverse events reported in Colombia increased from 5,447 in 2013 to 95,658 in 2017, reaching a population-based reporting ratio within international standards (563 in 2016).


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Colômbia/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos
13.
Drug Saf ; 42(3): 365-387, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30343418

RESUMO

Drug-induced liver injury (DILI), herbal-induced liver injury, and herbal and dietary supplement (HDS)-induced liver injury are an important aspect of drug safety. Knowledge regarding responsible drugs, mechanisms, risk factors, and the diagnostic tools to detect liver injury have continued to grow in the past year. This review highlights what we considered the most significant publications from among more than 1800 articles relating to liver injury from medications, herbal products, and dietary supplements in 2017 and 2018. The US Drug-Induced Liver Injury Network (DILIN) prospective study highlighted several areas of ongoing study, including the potential utility of human leukocyte antigens and microRNAs as DILI risk factors and new data on racial differences, the role of alcohol consumption, factors associated with prognosis, and updates on the clinical signatures of autoimmune DILI, thiopurines, and HDS agents. Novel data were also generated from the Spanish and Latin American DILI registries as well as from Chinese and Korean case series. A few new agents causing DILI were added to the growing list in the past 2 years, including sodium-glucose co-transporter-2 inhibitors, as were new aspects of chemotherapy-associated liver injury. A number of cases reported previously described hepatotoxins confirmed via the Roussel Uclaf Causality Assessment Method (RUCAM; e.g., norethisterone, methylprednisolone, glatiramer acetate) and/or the DILIN method (e.g., celecoxib, dimethyl fumarate). Additionally, much work centered on elucidating the pathophysiology of DILI, including the importance of bile salt export pumps and immune-mediated mechanisms. Finally, it must be noted that, while hundreds of new studies described DILI in 2017-2018, the quality of such reports must always be addressed. Björnsson reminds us to remain very critical of the data when addressing the future utility of a study, which is why it is so important to adhere to a standardized method such as RUCAM when determining DILI causality. While drug-induced hepatotoxicity remains a diagnosis of exclusion, the diverse array of publications that appeared in 2017 and 2018 provided important advances in our understanding of DILI, paving the way for our improved ability to make a more definitive diagnosis and risk assessment.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Doença Hepática Induzida por Substâncias e Drogas , Suplementos Nutricionais/efeitos adversos , Preparações de Plantas/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Humanos , Medição de Risco
14.
Drug Saf ; 42(1): 85-93, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30066315

RESUMO

INTRODUCTION: Lawyer-submitted reports may have unintended consequences on safety signal detection in spontaneous adverse event reporting systems. OBJECTIVE: Our objective was to assess the impact of lawyer-submitted reports primarily for one adverse event (AE) on the ability to detect a signal of disproportional reporting for another AE for the same drug in the US FDA Adverse Event Reporting System (FAERS). METHODS: FAERS reports from January 2004 to September 2015 were used to estimate yearly cumulative proportional reporting ratios (PRRs) for three known drug-AE pairs-isotretinoin-birth defects, atorvastatin-rhabdomyolysis, and rosuvastatin-rhabdomyolysis-with and without lawyer-submitted reports. Isotretinoin and atorvastatin have been the subject of high-profile tort litigation regarding other AEs. A lower bound of the 95% confidence interval (CI) of one or more based on three or more reports defined a signal. RESULTS: Cumulative PRRs met signaling criteria in all analyses. For isotretinoin, lawyer-submitted reports increased PRRs for birth defects before 2008, with the largest increase in 2006 (2.9 [95% CI 2.4-3.5] to 3.3 [95% CI 2.8-3.9]); lawyer-submitted reports decreased PRRs for birth defects after 2011, with the largest decrease in 2013 (2.2 [95% CI 2.0-2.5] to 1.9 [95% CI 1.7-2.1]). For atorvastatin, lawyer-submitted reports reduced PRRs for rhabdomyolysis after 2013, with the largest decrease in 2015 (18.0 [95% CI 17.1-19.1] to 15.4 [95% CI 14.5-16.2]). Lawyer-submitted reports had little impact on PRRs for rosuvastatin and rhabdomyolysis. CONCLUSIONS: Inclusion of lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two drugs subject to high-profile tort litigation for other AEs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/legislação & jurisprudência , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Advogados/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Atorvastatina/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Isotretinoína/efeitos adversos , Advogados/normas , Rosuvastatina Cálcica/efeitos adversos , Estados Unidos/epidemiologia , United States Food and Drug Administration/normas
15.
Drug Saf ; 42(1): 35-43, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30284215

RESUMO

INTRODUCTION: Surveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear. AIM: The aim of this study was to provide insight into current activities, future intentions and need for support of national PV centres in the field of drug safety during pregnancy. METHOD: A web-based questionnaire was used to ask PV centres about their current activities concerning the surveillance of drug safety during pregnancy, their intentions to implement or improve activities and need for support. For these three main topics, questions were posed about spontaneous adverse drug reaction (ADR) reporting, additional activities to obtain information, signal detection and informing healthcare professionals and the public. RESULTS: The questionnaire was sent to PV centres of 172 countries. Response was 40%. In general, the PV centres received limited numbers of reports of ADRs in the (unborn) child, related to drug exposure during pregnancy. Signal detection in pregnancy cases is carried out by 8 out of 58 PV centres (13.5%). Most PV centres mention they have intentions to implement or improve activities, mainly for spontaneous reporting (69.4%) and methods for signal detection (67.2%). Support was needed for all topics of the questionnaire. CONCLUSION: Current activities of national PV centres concerning drug safety during pregnancy are limited. The majority of PV centres are, however, willing to improve or implement activities. Programmes should be set up in order to support and stimulate PV centres with these activities. The aim of all these activities is to increase knowledge about the safety of drugs during pregnancy.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Internacionalidade , Farmacovigilância , Complicações na Gravidez/induzido quimicamente , Complicações na Gravidez/epidemiologia , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Feminino , Previsões , Humanos , Gravidez , Complicações na Gravidez/prevenção & controle , Estudos Retrospectivos , Inquéritos e Questionários/normas
16.
Drug Saf ; 42(1): 27-34, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30121742

RESUMO

INTRODUCTION: Some adverse drug reactions (ADRs) may involve direct social issues, such as impaired quality of life, work productivity, or social functioning, as opposed to being social consequences of medical adverse events. Data on ADRs with a direct social impact remain scarce in the literature. OBJECTIVE: Our objective was to describe the ADRs consisting of direct social issues that have been recorded in the Canadian national spontaneous reporting system (Canada Vigilance). METHODS: We conducted an analysis of the online Canada Vigilance spontaneous reporting database from 1 January 1965 (inception) to 31 December 2015 (last date available). We manually examined all Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) found in the Canada Vigilance database to identify those that involved direct social issues. We then used those PTs to search for relevant individual case safety reports (ICSRs). We conducted a descriptive analysis of the following ICSR characteristics: patient and reporter characteristics, type of ADR, seriousness (as assessed by the reporter and according to the International Conference on Harmonisation criteria of seriousness), and suspected drug(s). We compared the characteristics of ADRs with and without direct social impact. RESULTS: Among the 11,946 MedDRA PTs recorded in Canada Vigilance, we retained 40 that had a direct social impact. Using these PTs, we identified 9557 relevant ICSRs (corresponding to 6670 patients). The proportion of ADRs consisting of direct social issues increased over time, with a sharp transient peak in 2008. The majority were reported by healthcare professionals and consumers (56.7 and 37.8%, respectively). The mean age of patients was 45.4 years, and 53.3% were females. Direct social issues consisted of personality disorders and behaviour disturbances (41.6%) followed by neurological disorders (34.2%). The majority of ADRs were considered serious by reporters (76.5%), with 26.8% resulting in hospitalization. Commonly suspected health products included nervous system drugs (63.3%) and antineoplastic and immunomodulating agents (23.6%). Compared with other ADRs, those with a direct social impact were more often reported by consumers, involved patients who were on average 5 years younger, and were more frequently assessed as being serious by the reporters. CONCLUSIONS: Findings from this study support the consideration of direct social issues as ADRs in the detection of drug safety signals.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Bases de Dados Factuais/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/psicologia , Farmacovigilância , Mudança Social , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Canadá/epidemiologia , Bases de Dados Factuais/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
17.
Clin Pharmacol Ther ; 105(6): 1471-1476, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30588617

RESUMO

We investigated impacts of increased generic drug use on spontaneous adverse event reports (SAERs), because SAERs have been a major source of data for drug safety assessment at the postmarket stage. Reporting proportion of SAERs for the generic drugs was consistently and significantly lower than that for the original branded drugs. The reporting proportion targeting for 55 active product ingredients, which had the longest follow-up period after generic drug marketed, gradually decreased for the original branded drugs and increased for the generic drugs. However, these transitions did not parallel the changes in market share over the same period. These results suggest that the reporting proportion of SAERs for generic drugs may not keep pace with growth in market share. When generic drugs account for the majority of market share, utilization of multiple sources of information and data, in addition to SAERs, may be a key to assuring drug safety at the postmarket stage.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Medicamentos Genéricos/efeitos adversos , Vigilância de Produtos Comercializados/tendências , Fármacos Cardiovasculares/efeitos adversos , Fármacos do Sistema Nervoso Central/efeitos adversos , Seguimentos , Humanos , Japão/epidemiologia , Vigilância de Produtos Comercializados/métodos
18.
Pharmaceut Med ; 33(2): 145-157, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-31933250

RESUMO

BACKGROUND: Adverse drug reactions (ADRs) are a source of concern in healthcare as they negatively affect patients. Serious adverse drug reactions (SADRs) have an even greater impact on patients and the system in terms of morbidity and financial burden. The establishment of National Pharmacovigilance Centers (NPCs) has enhanced ADR reporting in Africa. The Nigerian Pharmacovigilance Centre has been collecting ADR reports using VigiFlow since 2004. OBJECTIVE: The aim of this study was to identify and analyze SADR reports in the Nigerian VigiFlow database in order to profile the patients with SADRs, the medicines most implicated, system organ classes (SOCs) affected, outcome of such reactions, including fatalities, and ADR reporting trends over the years. We also looked at the data elements provided in the reports as a proxy measure of report quality. METHOD: We retrospectively assessed all individual case safety reports (ICSRs) received by the NPC in Nigeria and entered into VigiFlow as SADR reports between September 2004 and December 2016. We defined SADR as any untoward reaction to any medicine dose that resulted in death, required in-patient hospitalization or prolongation of existing hospitalization, resulted in congenital anomaly, persistent or significant disability/incapacity or was life-threatening. The suspected SADRs were analyzed at the Medical Dictionary for Regulatory Activities SOC and Preferred Term levels. RESULTS: A total of 11,222 ICSRs were entered into VigiFlow during the study period, of which 298 (3%) were classified as SADR reports. Adults were the most affected (244/282; 87%). The median number of medicines per report was 3 (interquartile range = 2-4.75). Nevirapine (36/336; 11%), as a single entity, was the most reported medicine. Human immunodeficiency virus (HIV) infection affected 128/232 (55%) of those with SADRs. There was no statistically significant association between the number of reactions per report and sex of the patients (p = 0.280), their age groups (p = 0.670), or the number of medicines per report (p = 0.640). Hospitalization was the most frequently cited reason for classifying a report as serious (151/276; 53%) and death was reported in 48 cases (48/283; 17%). Based on the SOC, skin and subcutaneous tissue disorders (139/550; 25%) was the most affected, while anemia (55/550; 10%) was the most reported specific reaction. A substantial number of patients (107/256; 42%) either recovered fully or were recovering from the SADRs. The number of SADR reports received varied by year with no consistent trend. CONCLUSION: There is under-reporting of ADRs in the Nigerian VigiFlow® database, particularly SADRs and those involving pediatric and geriatric age groups. Given that over half of the SADR reports involved antiretroviral drugs, it is imperative to increase the surveillance of ADRs related to this class of drugs through regular clinical assessment of reports and provision of feedback on the findings to healthcare providers. Direct consumer reporting should also be encouraged as a means of increasing ADR reporting.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Pessoal de Saúde/estatística & dados numéricos , Adulto , Idoso , Anemia/induzido quimicamente , Anemia/epidemiologia , Fármacos Anti-HIV/efeitos adversos , Antirretrovirais/efeitos adversos , Causas de Morte/tendências , Criança , Anormalidades Congênitas/epidemiologia , Bases de Dados Factuais , Pessoas com Deficiência/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Nevirapina/efeitos adversos , Nigéria/epidemiologia , Segurança do Paciente/estatística & dados numéricos , Farmacovigilância , Estudos Retrospectivos , Dermatopatias/induzido quimicamente , Dermatopatias/epidemiologia
19.
PLoS One ; 13(11): e0208087, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30496243

RESUMO

OBJECTIVE: To assess the reproducibility of adverse event evaluation by a medical record review committee. DESIGN: Cross-sectional reanalysis of medical records. INTERVENTION: Reviewers re-examined fifty medical records of deceased patients regarding the presence of adverse events, their potential preventability and their possible contribution to death. Also we investigated the root causes of the preventable AEs. Differences between the first and second assessment were calculated. RESULTS: The Kappa on the presence of an adverse event was 0.64 and 0.32 for the potential preventability. The intrarater agreement showed a Kappa of 0.61 on the adverse event presence and 0.64 for the potential preventability. Interrater agreement showed a Kappa of 0.66 for the adverse event presence and 0.03 for the potential preventability. CONCLUSION: We found a fair reproducibility for the detection of adverse events, but a poor reproducibility for the potential preventability. Possibly this was caused by lack of a definition for the preventability of adverse events. We think giving feedback to professionals using the results of medical record review remains valuable, but an improvement of its reproducibility is essential. To our opinion an international consensus on what exactly constitutes preventability of adverse events and agreement on a definition is necessary. This would result in more comparable studies in this field and could then be more informative on the ideal procedure to avoid certain potentially preventable adverse events in the future.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Erros Médicos/efeitos adversos , Erros Médicos/tendências , Registros Médicos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
20.
Drug Saf ; 41(12): 1397-1410, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30167992

RESUMO

INTRODUCTION: Adverse drug reactions (ADRs) are associated with significant health-related and financial burden, and multiple sources are currently utilized to actively discover them. Social media has been proposed as a potential resource for monitoring ADRs, but drug-specific analytical studies comparing social media with other sources are scarce. OBJECTIVES: Our objective was to develop methods to compare ADRs mentioned in social media with those in traditional sources: the US FDA Adverse Event Reporting System (FAERS), drug information databases (DIDs), and systematic reviews. METHODS: A total of 10,188 tweets mentioning adalimumab collected between June 2014 and August 2016 were included. ADRs in the corpus were extracted semi-automatically and manually mapped to standardized concepts in the Unified Medical Language System. ADRs were grouped into 16 biologic categories for comparisons. Frequencies, relative frequencies, disproportionality analyses, and rank ordering were used as metrics. RESULTS: There was moderate agreement between ADRs in social media and traditional sources. "Local and injection site reactions" was the top ADR in Twitter, DIDs, and systematic reviews by frequency, ranked frequency, and index ranking. The next highest ADR in Twitter-fatigue-ranked fifth and seventh in FAERS and DIDs. CONCLUSION: Social media posts often express mild and symptomatic ADRs, but rates are measured differently in scientific sources. ADRs in FAERS are reported as absolute numbers, in DIDs as percentages, and in systematic reviews as percentages, risk ratios, or other metrics, which makes comparisons challenging; however, overlap is substantial. Social media analysis facilitates open-ended investigation of patient perspectives and may reveal concepts (e.g. anxiety) not available in traditional sources.


Assuntos
Adalimumab/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Bases de Dados de Produtos Farmacêuticos/normas , Estudo de Prova de Conceito , Mídias Sociais/normas , United States Food and Drug Administration/normas , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Anti-Inflamatórios/efeitos adversos , Bases de Dados de Produtos Farmacêuticos/tendências , Humanos , Mídias Sociais/tendências , Revisões Sistemáticas como Assunto , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
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