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1.
J Oncol Pharm Pract ; 26(1): 133-140, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31117914

RESUMO

PURPOSE: The aim of this study was to test the feasibility and the usefulness of an intensive safety monitoring program to identify adverse drug reactions for medicines under additional monitoring that are used to treat cancer patients within a Portuguese oncology hospital. METHODS: This pilot intensive safety monitoring program was a three-month prospective, observational study. Patients undergoing treatment with one of the following medicines were included: nivolumab, olaparib, palbociclib, pembrolizumab, pertuzumab, ramucirumab, ribociclib, trastuzumab emtansine, or trifluridine/tipiracil. Potential eligible patients were identified by pharmacists based on prescription data. Clinicians used proper paper-based reporting forms to record adverse drug reactions. Clinical secretariats sent those reports through an electronic platform to the pharmacovigilance department for analysis. RESULTS: Seventy-five patients were on treatment with selected medicines. Of those, 33 (44%) experienced adverse drug reactions: 23 (69.7%) cases were serious and 5 (15.2%) unexpected. Considering the number of patients exposed to each medicine and the number of patients experiencing adverse drug reactions, trifluridine/tipiracil (72.7%; 8/11) was associated with the highest rate of toxicity, followed by olaparib (66.7%; 2/3), trastuzumab emtansine (50.0%; 3/6), pertuzumab (47.8%; 11/23), pembrolizumab (45.5%; 5/11), palbociclib (25.0%; 1/4), and nivolumab (18.8%; 3/16). A total of 59 adverse drug reactions were identified (i.e. 1.8 adverse drug reactions/patient), mainly gastrointestinal disorders (n = 15; 25.4%), and blood and lymphatic system disorders (n = 14; 23.7%). CONCLUSION: This intensive safety monitoring program was feasible and allowed identifying serious and unexpected adverse drug reactions, adding value to pharmacovigilance and therefore contributing to improve patient safety. Further research is needed to confirm the findings of this pilot study.


Assuntos
Antineoplásicos/efeitos adversos , Institutos de Câncer/normas , Monitoramento de Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Segurança do Paciente/normas , Farmacovigilância , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Monitoramento de Medicamentos/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Projetos Piloto , Portugal/epidemiologia , Estudos Prospectivos
2.
N Z Med J ; 132(1488): 28-37, 2019 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-31851659

RESUMO

AIM: Incomplete and incorrect documentation of adverse drug reactions (ADRs) can restrict prescribing choices resulting in suboptimal pharmaceutical care. This study aimed to examine the quality of information held within electronic systems in a hospital setting, to determine the preciseness of ADR documentation, and identify discrepancies where multiple electronic systems are utilised. METHOD: Over a four-week period, consecutive patients admitted to the general medical ward at the study hospital had their electronic profiles reviewed. Patient demographic information (de-identified), ADR history and discrepancies between information sources (as recorded in all electronic systems utilised at initial prescribing) were recorded and analysed. RESULTS: Over the four-week period, 332 patient profiles were reviewed, and over 1,200 alerts were identified and analysed (including duplicates of ADR reactions). Of these patients, 151 (45.5%) had at least one documented allergy or intolerance which generated 585 reactions, relating to 526 unique events. A further 151 (45.5%) were classified as having no known (drug) allergies or intolerances; however, 20 (15%) of these patients did have at least one allergy documented in at least one other electronic system. The remaining 30 (9%) patients were classified as having an unknown allergy status and of those nine had allergies documented in at least one other electronic system. Further, most systems contained information duplication, which had not been addressed during the admission process. CONCLUSION: ADR information was both imprecise and inaccurate, as multiple discrepancies between ADR information recorded in different electronic patient management systems were found to exist. Information sharing between systems needs to be prioritised in order to allow full, accurate and complete ADR information to be collected, stored and utilised; both to reduce current inadequacies and to allow optimal pharmaceutical care.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Documentação/normas , Troca de Informação em Saúde/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Centros de Atenção Terciária , Adulto Jovem
3.
Int J Med Inform ; 132: 103971, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31630063

RESUMO

CONTEXT: Adverse events in healthcare are often collated in incident reports which contain unstructured free text. Learning from these events may improve patient safety. Natural language processing (NLP) uses computational techniques to interrogate free text, reducing the human workload associated with its analysis. There is growing interest in applying NLP to patient safety, but the evidence in the field has not been summarised and evaluated to date. OBJECTIVE: To perform a systematic literature review and narrative synthesis to describe and evaluate NLP methods for classification of incident reports and adverse events in healthcare. METHODS: Data sources included Medline, Embase, The Cochrane Library, CINAHL, MIDIRS, ISI Web of Science, SciELO, Google Scholar, PROSPERO, hand searching of key articles, and OpenGrey. Data items were manually abstracted to a standardised extraction form. RESULTS: From 428 articles screened for eligibility, 35 met the inclusion criteria of using NLP to perform a classification task on incident reports, or with the aim of detecting adverse events. The majority of studies used free text from incident reporting systems or electronic health records. Models were typically designed to classify by type of incident, type of medication error, or harm severity. A broad range of NLP techniques are demonstrated to perform these classification tasks with favourable performance outcomes. There are methodological challenges in how these results can be interpreted in a broader context. CONCLUSION: NLP can generate meaningful information from unstructured data in the specific domain of the classification of incident reports and adverse events. Understanding what or why incidents are occurring is important in adverse event analysis. If NLP enables these insights to be drawn from larger datasets it may improve the learning from adverse events in healthcare.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Registros Eletrônicos de Saúde/tendências , Processamento de Linguagem Natural , Gestão de Riscos/classificação , Gestão de Riscos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Registros Eletrônicos de Saúde/normas , Humanos
5.
Drugs Aging ; 36(Suppl 1): 145-159, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-31073927

RESUMO

BACKGROUND: There is strong evidence of under-reporting of harms in manuscripts on randomized controlled trials (RCTs) compared with the volume of raw data retrieved from these trials. Many guidelines have been developed to tackle this, but they have failed to address some important issues that would allow for standardization and transparency. As a consequence, harms reporting in manuscripts remains suboptimal. OBJECTIVE: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) aimed to deliver accurate recommendations for better reporting of harms in clinical trials manuscripts on anti-osteoarthritis (OA) drugs. These could help to better inform clinicians on harms recorded in RCTs and further help researchers conducting meta-analyses. METHODS: Using the outcomes of several systematic reviews on the safety of anti-OA drugs, we summarized the ways in which harms have been reported in OA RCT manuscripts to date. Next, we drafted some recommendations and initiated a modified Delphi process that involved a panel of clinicians and clinical researchers to build an expert consensus on recommendations from the ESCEO for the reporting of harms in future manuscripts on RCTs assessing anti-OA drugs. RESULTS: These recommendations emphasize that all treatment-emergent adverse events (AEs) should always be taken into account for harms reporting, with no frequency threshold, and describe how specific AEs should be reported; they also provide a list of the most relevant organ systems to be considered according to each class of drug for reporting of harms within the results section of a manuscript. Irrespective of the drug, the ESCEO recommends that total, severe and serious AEs and withdrawals due to AEs should always be reported; guidance on the reporting of specific events pertaining to each category is provided. The ESCEO also recommends the reporting of information on drug effect on biological parameters, with specific guidance. CONCLUSIONS: These recommendations may contribute to improve transparency in the field of safety of anti-OA medications. Pharmaceutical companies developing drugs for OA, and researchers conducting clinical trials, are encouraged to comply with them when reporting harms-related results in manuscripts on RCTs. The ESCEO also encourages journals to refer to the ESCEO recommendations in their instructions to authors for the publication of manuscripts on trials of anti-OA medications.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Analgésicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Osteoartrite/tratamento farmacológico , Osteoporose/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Analgésicos/análise , Analgésicos/uso terapêutico , Consenso , Europa (Continente) , Guias como Assunto , Humanos , Osteoartrite/economia , Osteoporose/economia , Sociedades Médicas
6.
Drug Saf ; 42(4): 477-489, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30911975

RESUMO

Over a period of 3 years, the European Union's Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/ ) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety. Recommendations relating to the use of mobile apps for PV are summarised in this paper. There is a presumption amongst at least some patients and healthcare professionals that information ought to be accessed and reported from any setting, including mobile apps. WEB-RADR has focused on the use of such technology for reporting suspected adverse drug reactions and for broadcasting safety information to its users, i.e. two-way risk communication. Three apps were developed and publicly launched within Europe as part of the WEB-RADR project and subsequently assessed by a range of stakeholders to determine their value as effective tools for improving patient safety; a fourth generic app was later piloted in two African countries. The recommendations from the development and evaluation of the European apps are presented here with supporting considerations, rationales and caveats as well as suggested areas for further research.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Coleta de Dados/normas , Aplicativos Móveis/normas , Preparações Farmacêuticas/normas , África , Comunicação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Europa (Continente) , União Europeia , Pessoal de Saúde/normas , Humanos , Farmacovigilância , Mídias Sociais/normas
7.
BMC Bioinformatics ; 20(Suppl 2): 97, 2019 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-30871458

RESUMO

BACKGROUND: Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern. RESULTS: This study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents. In detail, 466/3819 (12.0%) PTs were in BW, 2023/3819 (53.0%) were in WP, and 2961/3819 (77.5%) were in AR sections. We also found a higher overlap of top 20 occurring BW PTs with WP sections compared to AR sections. Within the MedDRA System Organ Class levels, serious ADRs (sADRs) from BW were prevalent in Nervous System disorders and Vascular disorders. A Hierarchical Cluster Analysis (HCA) revealed that drugs within the same therapeutic category shared the same ADR patterns in BW (e.g., nervous system drug class is highly associated with drug abuse terms such as dependence, substance abuse, and respiratory depression). CONCLUSIONS: This study demonstrated that combining MedDRA standard terminologies with data mining techniques facilitated computer-aided ADR analysis of drug labeling. We also highlighted the importance of labeling sections that differ in seriousness and application in drug safety. Using sADRs primarily related to BW sections, we illustrated a prototype approach for computer-aided ADR monitoring and studies which can be applied to other public health documents.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Mineração de Dados/métodos , Rotulagem de Medicamentos/instrumentação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Humanos
8.
J Med Internet Res ; 21(2): e11016, 2019 02 06.
Artigo em Inglês | MEDLINE | ID: mdl-30724742

RESUMO

BACKGROUND: Adverse drug reactions (ADRs) are common and are the underlying cause of over a million serious injuries and deaths each year. The most familiar method to detect ADRs is relying on spontaneous reports. Unfortunately, the low reporting rate of spontaneous reports is a serious limitation of pharmacovigilance. OBJECTIVE: The objective of this study was to identify a method to detect potential ADRs of drugs automatically using a deep neural network (DNN). METHODS: We designed a DNN model that utilizes the chemical, biological, and biomedical information of drugs to detect ADRs. This model aimed to fulfill two main purposes: identifying the potential ADRs of drugs and predicting the possible ADRs of a new drug. For improving the detection performance, we distributed representations of the target drugs in a vector space to capture the drug relationships using the word-embedding approach to process substantial biomedical literature. Moreover, we built a mapping function to address new drugs that do not appear in the dataset. RESULTS: Using the drug information and the ADRs reported up to 2009, we predicted the ADRs of drugs recorded up to 2012. There were 746 drugs and 232 new drugs, which were only recorded in 2012 with 1325 ADRs. The experimental results showed that the overall performance of our model with mean average precision at top-10 achieved is 0.523 and the rea under the receiver operating characteristic curve (AUC) score achieved is 0.844 for ADR prediction on the dataset. CONCLUSIONS: Our model is effective in identifying the potential ADRs of a drug and the possible ADRs of a new drug. Most importantly, it can detect potential ADRs irrespective of whether they have been reported in the past.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Humanos
9.
Am J Health Syst Pharm ; 76(5): 312-319, 2019 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-30753290

RESUMO

Purpose: Adverse drug events (ADEs) in the U.S. Department of Veterans Affairs (VA) were evaluated, and differences in age group report rates and reported medications in different age groups were assessed. Methods: We utilized the VA Adverse Drug Event Reporting System (ADERS) to assess 10-year age groups regarding ADE reporting rates, event severity, and associated reported medications. Data were derived from 484,351 ADE reports from 395,703 patients included in VA ADERS from 2009 through 2016. Results: Reported rates of ADEs per 10,000 unique users demonstrated a nonlinear relationship with age, peaking in the group aged 60-69 years (148.6 reports/10,000 unique users) and declining thereafter. However, the percentage of adverse events reported as severe consistently rose with age group (3% in patients age 20-29 years versus 6% in patients older than 90 years). The types of medications reported as causative agents shifted over time from predominantly mental health and pain medications in younger veterans (e.g., age 20-29 years) to medications for chronic diseases in older cohorts (e.g., age 60-69 years). Conclusion: An analysis of VA ADE reports revealed a nonlinear relationship between age and events, with events peaking at age 60-69 years. Rates of severe ADEs increased in older age groups. Drugs commonly associated with ADEs tended to be those primarily used for mental health and pain treatment in younger patients and those used to address chronic disease states in older patients.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitais de Veteranos/normas , Índice de Gravidade de Doença , United States Department of Veterans Affairs/normas , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Feminino , Hospitais de Veteranos/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Polimedicação , Estudos Retrospectivos , Estados Unidos/epidemiologia , United States Department of Veterans Affairs/estatística & dados numéricos , Veteranos/estatística & dados numéricos , Adulto Jovem
11.
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
12.
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 , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Aprendizado Profundo/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos
14.
Expert Opin Drug Saf ; 18(1): 59-68, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29883236

RESUMO

BACKGROUND: Although China's adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. RESEARCH DESIGN AND METHODS: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April-December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. RESULTS: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities. CONCLUSIONS: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , China/epidemiologia , Estudos Transversais , Bases de Dados Factuais , Humanos , Inquéritos e Questionários
15.
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
16.
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
18.
J Am Assoc Nurse Pract ; 31(3): 206-213, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30589757

RESUMO

BACKGROUND AND PURPOSE: Older adults continue to take nonsteroidal anti-inflammatory drugs (NSAIDs) to manage chronic pain. The study's purpose was to identify predictors of gastrointestinal (GI) bleeding in older adults taking NSAIDs. METHODS: A secondary analysis of the 2016 Food and Drug Administration's Adverse Events Reporting System data was conducted with 1,347 cases aged 65 years and older with an NSAID as the primary suspect for an adverse drug event (ADE). Data included age, sex, NSAID, multiple NSAID use, rivaroxaban, warfarin, clopidogrel, cardiovascular drug (proxy for cardiovascular disease), diabetes drug (proxy for diabetes mellitus), and primary adverse drug response. CONCLUSIONS: Aspirin was the primary suspect NSAID in 72.5% of cases. Rivaroxaban was taken in 67.9% of cases. Logistic regression was conducted to predict GI bleed versus other NSAID-related ADEs with age, sex, cardiovascular medication, diabetes medication, warfarin, clopidogrel, concurrent NSAID use, aspirin, and rivaroxaban as predictors. Aspirin, rivaroxaban, and concurrent NSAID were significant predictors of GI bleed. Gastrointestinal bleed risk versus other ADE risk increased by 39.77 times when taking aspirin, rivaroxaban, and another NSAIDs concurrently. IMPLICATIONS FOR PRACTICE: Results support reduced NSAID use by older adults, especially aspirin, and avoidance of rivaroxaban in older persons taking NSAIDs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Anti-Inflamatórios não Esteroides/efeitos adversos , Hemorragia Gastrointestinal/diagnóstico , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios não Esteroides/uso terapêutico , Feminino , Hemorragia Gastrointestinal/epidemiologia , Humanos , Modelos Logísticos , Masculino , Estados Unidos/epidemiologia , United States Food and Drug Administration/organização & administração , United States Food and Drug Administration/estatística & dados numéricos
19.
Drug Saf ; 42(5): 649-655, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30569267

RESUMO

INTRODUCTION AND OBJECTIVE: Adverse event reports from industry-sponsored programs, such as patient support programs, have contributed to a rise in the number of individual case safety reports in the US Food and Drug Administration Adverse Event Reporting System database. This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection. METHODS: Individual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, outcomes, data completeness, and usefulness. The 'usefulness' of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative (e.g., temporality, comorbidities). RESULTS: Compared with non-industry-sponsored program reports, more industry-sponsored program reports were associated with a serious outcome (51.4% vs. 58.8%, p = 0.02) and were reported by consumers (35.5% vs. 50.4%, p < 0.01). Industry-sponsored program reports tended to contain more data elements than non-industry-sponsored program reports (i.e., age, sex, indication for use), but completeness was variable across products. No significant difference in usefulness was identified between non-industry-sponsored program and industry-sponsored program individual case safety reports (30.6% vs. 28.5%, p = 0.42). Useful reports that contained at least one serious, unlabeled adverse event represented only 4% and 6.2% of the non-industry-sponsored program and industry-sponsored program report cohorts, respectively. CONCLUSIONS: Our study suggests that reports obtained from industry-sponsored programs in the Food and Drug Administration Adverse Event Reporting System database contain more data elements but are similar to non-industry-sponsored program reports with regard to 'usefulness' in signal detection.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Indústria Farmacêutica , Vigilância de Produtos Comercializados/normas , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Produtos Biológicos/efeitos adversos , Produtos Biológicos/uso terapêutico , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/uso terapêutico , Fármacos Hematológicos/efeitos adversos , Fármacos Hematológicos/uso terapêutico , Humanos
20.
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
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