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1.
Expert Opin Drug Saf ; 19(1): 99-106, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31661986

RESUMO

Objectives: Biological drugs have been successfully tested in asthma, especially in the most severe forms of the disease. The goal of this study was to characterize the safety profile of biologicals used in asthma.Methods: Retrospective and descriptive analysis of spontaneous reports (SRs) involving omalizumab and mepolizumab, sent to the Portuguese Pharmacovigilance System, since market launch until October 2018.Results: A total of 127 SRs for omalizumab and 10 SRs mepolizumab were found. Most patients were female (75.6% omalizumab and 90.0% mepolizumab), and aged 18-64 years (61.4% and 50.0%, respectively). 71.7% of the reports for omalizumab were serious, with 2 cases of anaphylaxis, 12 malignant neoplasms and 2 abortions. Only 20.0% of the reports for mepolizumab were considered serious. A total of 391 adverse drug reactions (ADRs) for omalizumab and 20 ADRs for mepolizumab were found. Most reported ADRs belonged to System organ class (SOC) groups: 'respiratory, thoracic and mediastinal disorders' and 'investigations', for omalizumab; 'musculoskeletal and connective tissue disorders' and 'general disorders and administration site conditions' for mepolizumab.Conclusion: Over the years, there was an increasing trend of SRs with these biological drugs. However, it is necessary to continue to develop educational programs in order to get a better reporting system.


Assuntos
Antiasmáticos/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Asma/tratamento farmacológico , Omalizumab/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Antiasmáticos/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Terapia Biológica/efeitos adversos , Terapia Biológica/métodos , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Omalizumab/administração & dosagem , Farmacovigilância , Portugal/epidemiologia , Estudos Retrospectivos , Adulto Jovem
2.
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
4.
Zhongguo Zhong Yao Za Zhi ; 44(21): 4751-4755, 2019 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-31872674

RESUMO

Taking the Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,Shiyi Materia Medica,Harmful Benefits of Materia Medica as representative works in Qing Dynasty,this paper extracts text information from four aspects: drug identification,drug use,drug prevention and detoxification,constructs a drug pharmacovigilance information table of Qing Dynasty herbal works,and summarizes the drug pharmacovigilance of Qing Dynasty. Thought,in the Qing Dynasty,there were many recordings of drug pharmacovigilance. In the aspect of drug awareness,the main representative was Shi Yi Materia Medica which added many new drugs and introduced more new uses of drugs. In addition,in the aspect of drug use and prevention,the main representatives were Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,and Harmful Benefits of Materia Medica. In the aspect of taboo of disease and syndrome,attention should be paid to the integration of medicine so as to make drugs closely related to clinical use. Although there is no special introduction on detoxification,it has been introduced in various medicines in the De Pei Materia Medica,Shiyi Materia Medica,which has a relatively systematic and complete drug warning ideology system of " drug identification-use-drug prevention-detoxification".This study found that the traditional pharmacovigilance thought of Qing Dynasty had the characteristics of attaching importance to the clinical application of toxic traditional Chinese medicine and the combination of medicine,which had certain guiding significance for modern clinical medication. This paper aims to explore the traditional drug pharmacovigilance knowledge in representative works of the Qing Dynasty,analyze the characteristics of the drug pharmacovigilance thought in the Qing Dynasty,and lay a foundation for clarifying the traditional drug pharmacovigilance system.


Assuntos
Medicamentos de Ervas Chinesas , Materia Medica , Medicina Tradicional Chinesa , China , Sistemas de Liberação de Medicamentos , Farmacovigilância , Registros
5.
Medicine (Baltimore) ; 98(50): e18369, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31852144

RESUMO

RATIONALE: Anaphylaxis is a serious allergic reaction which could be life-threatening. To date, it could be diagnosed by causality between clinical manifestations and triggers. But it is not always easy to find out the clue. Chlorpheniramine maleate (peniramin) is known to safe and it is an antihistamine commonly used to treat almost the whole allergic disease, including urticaria and allergic rhinitis. We recently experienced 2 cases of chlorpheniramine induced anaphylaxis. To document suspected cases of chlorpheniramine-induced adverse reactions, we analyzed a database spontaneously reported adverse drug reactions in the Ajou Regional Pharmacovigilance Center from 2011 to 2017. PATIENT CONCERNS: Two female patients presented urticaria and abdominal pain right after chlorpheniramine injection. DIAGNOSES: Both patients were diagnosed with symptoms. One patient confirmed by assistance with tryptase level and another one confirmed cross-reactivity by skin tests. INTERVENTIONS: One patient was instructed to avoid future administration of chlorpheniramine. The other patient was advised not to take chlorpheniramine, and piperazine derivatives including cetirizine/levocetirizine, but piperidine derivatives such as fexofenadine, loratadine, and ebastine can be available. OUTCOMES: The patients fully recovered after prompt treatment for anaphylaxis. After that, no recurrences were observed at the following. Among 54 patients with chlorpheniramine-induced adverse drug reactions from the Pharmacovigilance Center database, 17 (31.5%) were reported as anaphylaxis. LESSONS: Physicians should be aware chlorpheniramine could be a cause for allergic reaction. In addition, we suggest that serum tryptase level, skin prick test, and intradermal test could be considered as a supplementary test for diagnosing chlorpheniramine anaphylaxis and cross-reactivity should also be considered.


Assuntos
Anafilaxia/induzido quimicamente , Clorfeniramina/efeitos adversos , Antagonistas dos Receptores Histamínicos H1/efeitos adversos , Bases de Dados de Produtos Farmacêuticos , Feminino , Humanos , Pessoa de Meia-Idade , Farmacovigilância , República da Coreia , Triptases/sangue , Urticária/induzido quimicamente
6.
Adv Clin Exp Med ; 28(11): 1525-1530, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31693316

RESUMO

BACKGROUND: With emerging new therapeutic concepts including renal denervation (RDN), there is a renewed interest in resistant hypertension (ResH). Among patients suspected of having ResH, a definitive diagnosis needs to be established. OBJECTIVES: This study presents observations from a standardized single-center screening program for RDN candidates, including medical therapy modification and reassessment. MATERIAL AND METHODS: All patients referred to our center for RDN underwent a standardized screening protocol. Candidates were recruited from among patients receiving no less than 3 antihypertensive drugs, including diuretics with office blood pressure (BP) >140/90 mm Hg. The assessment included 2 measurements of BP and ambulatory BP monitoring (ABPM). If needed, pharmacotherapy was intensified and the diagnosis of ResH was reconfirmed after 6 weeks. If ResH was persistent, patients were hospitalized with repeated ABPM on day 4. Further, renal CT-angio was performed and a multidisciplinary team discussed the patients' suitability for RDN. RESULTS: A total of 87 patients with a ResH diagnosis were referred for RDN. Mean office BP was 159/92 (±7.0/6.5) mm Hg and mean ABPM was 154/90 (±9.0/4.8) mm Hg. The initial medication included angiotensin convertase inhibitors (ACE-I, 78%), angiotensin receptor blockers (12%), ß-blockers (85%), calcium channel blockers (36%), and diuretics (93%). During the 18 months of the RDN program, 5 patients underwent RDN and 2 further had ineligible renal anatomy. A new diagnosis of secondary hypertension was made in 21 patients. However, in 59 patients, BP control was achieved after optimization of medical therapy, with a mean ABPM of 124/74 mm Hg. The final treatment included ACE-I (100%), ß-blockers (92%), indapamide (94%), amlodipine (72%), and spironolactone (61%). Medication in most of these patients (88%) included single-pill triple combination (52.5%) or double combination (35.6%). CONCLUSIONS: Patients with elevated BP screened for RDN require a rigorous diagnostic workup. Up to 2/3 of patients can be managed with strict pharmacotherapy compliance and pharmaceutical intensification, including single-pill combinations and improved drug compliance. Hasty use of RDN may be a result of poor drug optimization and/or compliance. It does remain a viable treatment option in thoroughly vetted ResH patients.


Assuntos
Denervação , Hipertensão/cirurgia , Farmacovigilância , Artéria Renal/cirurgia , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Monitorização Ambulatorial da Pressão Arterial , Humanos , Hipertensão/tratamento farmacológico , Rim/inervação , Rim/cirurgia , Artéria Renal/inervação , Simpatectomia , Resultado do Tratamento
8.
Medicine (Baltimore) ; 98(48): e18205, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770278

RESUMO

BACKGROUND AND OBJECTIVES: This meta-analysis was to investigate the efficacy and safety of new oral anticoagulant (NOAC) in atrial fibrillation (AF) patients with renal function insufficiency, and to explore whether renal decline occurs in AF patients with NOAC and its impact on outcomes. METHODS AND RESULTS: In AF patients with mild renal insufficiency, the NOAC was associated with significantly lower rates of stroke (odds ratio [OR], 0.78; 95% confidence interval [CI], 0.67-0.91; P < .05). Lower rates of bleeding were significantly observed in NOAC group (OR, 0.85; 95% CI, 0.75-0.97; P < .05). In AF patients with moderate renal impairment, similar results were revealed (OR for stroke or systemic embolism, 0.80; 95% CI, 0.67-0.95, P < .05; OR for major bleeding, 0.78; 95% CI, 0.59-1.03; P = .07). During the follow-up, pooled data revealed that NOAC showed a less renal toxicity, but the difference did not reach statistical significance (creatinine clearance decline: -0.12 mL/min [-0.84, 0.61 mL/min]). We have revealed that the NOACs were associated with significantly lower rates of stroke or systemic embolism (hazard ratio [HR], 0.66; 95% CI, 0.42-0.89; P < .05) and lower rates of bleeding (HR, 0.93; 95% CI, 0.70-1.16; P = .153) in AF patients with worsening renal function. CONCLUSIONS: NOAC may have the potentiality to be at least as effective as warfarin and may equal safety outcomes in AF patients with renal impairment. Renal decline during therapeutics may be less likely happened in NOAC than warfarin dose. NOAC may reveal good efficacy and safety outcomes in these scenarios. Further detailed research is needed to gain more clear profile on this new anticoagulant.


Assuntos
Anticoagulantes , Fibrilação Atrial , Insuficiência Renal/complicações , Anticoagulantes/classificação , Anticoagulantes/farmacologia , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Humanos , Farmacovigilância , Resultado do Tratamento
9.
Expert Opin Drug Saf ; 18(12): 1245-1253, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31580740

RESUMO

Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of potentially unresolved outcomes for gustatory, olfactory and auditory (GOA) suspected ADRs associated with antibiotics for systemic use.Methods: 'Overall' and 'GOA' suspected ADRs were extracted from Eudravigilance to estimate the distribution of their outcomes among different antibiotic groups. Then, the authors identified the drugs contributing to at least 15% of all suspected GOA ADRs observed for the antibiotic groups, and evaluated the expectedness.Results: The frequency of persistent/permanent outcomes was higher for GOA suspected ADRs, as compared to the overall ones. Unresolved and undetermined outcomes for antibiotic-associated GOA ADRs in Eudravigilance might hide a large number of events with underestimated clinical consequences. Several persistent/permanent antibiotic-associated GOA reactions could be classified as serious and unexpected.Conclusion: Potential long-lasting or irreversible GOA reactions are often reported for all antibiotics drugs. Further studies are warranted to clarify whether this is an actual safety issue or simply it reflects a general difficulty in outcomes assessment for such reactions.


Assuntos
Antibacterianos/efeitos adversos , Audição/efeitos dos fármacos , Olfato/efeitos dos fármacos , Paladar/efeitos dos fármacos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Antibacterianos/administração & dosagem , Bases de Dados Factuais , Humanos , Farmacovigilância
10.
Expert Opin Drug Saf ; 18(11): 1099-1108, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31519110

RESUMO

Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporting odds ratio (ROR)] for gliptins. Secondly, the authors performed linear regression analyses to explore the association between DPP-4i signals for BP and their affinities toward different target enzymes (DPP-2, DPP-4, DPP-8, and DPP-9) and their volume of distribution (Vd). Results: A significant BP signal was found for DPP-4i. The ROR for pooled DPP-4i was 179.48 (95% CI: 166.41-193.58). The highest ROR was found for teneligliptin 975.04 (801.70-1185.87) and lowest for saxagliptin 18.9 (11.5-30.9). Linear regression analyses showed a considerable trend to significance for the linear correlation between the BP signal and gliptin affinity at DPP-4 (slope = 1.316 [-0.4385-3.21], p = 0.067, R2 = 0.40) but not the other enzyme targets, nor for Vd. Conclusion: The findings suggest a clinical relevance of gliptins selectivity for DDP-4 in the development of BP as a result of exposure to these drugs. Future preclinical and clinical studies are needed for a better understanding of this correlation.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Penfigoide Bolhoso/induzido quimicamente , Farmacovigilância , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais/estatística & dados numéricos , Inibidores da Dipeptidil Peptidase IV/farmacocinética , Inibidores da Dipeptidil Peptidase IV/farmacologia , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Penfigoide Bolhoso/epidemiologia , Distribuição Tecidual
11.
Washington, D. C.; PAHO; 2019-09-20. (PAHO/HSS/19-004).
em Inglês | PAHO-IRIS | ID: phr-51558

RESUMO

The aim of this document is to highlight the progress made with regard to advanced therapy products, the risks associated with such products, and the regulatory challenges they pose for Member States with a view to strengthening regulatory systems. The document is also a call to action for governments to consider the development of standards and rules for regulating these products in order to control the use of unapproved therapies and prevent risks to the population. As discussed, there are cross-cutting regulatory principles that should be implemented by any regulatory body that plans to undertake the regulation and oversight of advanced therapy products.


Assuntos
Assistência Farmacêutica , Sistemas de Saúde , Farmácia , Farmacovigilância , Células-Tronco Hematopoéticas , Sistema Imunitário , Sistemas Sanguíneo e Imunológico
12.
Washington, D. C.; OPS; 2019-09-20. (OPS/HSS/19-004).
em Espanhol | PAHO-IRIS | ID: phr-51557

RESUMO

Este documento pretende resaltar los avances y riesgos de los productos de terapias avanzadas y los desafíos regulatorios que enfrentan los estados miembros respecto a estos productos, a fin de promover el fortalecimiento de los sistemas regulatorios. Igualmente, es un llamado para que los gobiernos consideren el desarrollo de normas y reglamentos que regulen estos medicamentos a fin de controlar el uso de terapias no aprobadas y prevenir el riesgo de la población. Como se menciona en este documento existen principios regulatorios transversales que deben estar implementados por un ente regulatorio que prevé hacerse cargo de la regulación y fiscalización de productos de terapia avanzada.


Assuntos
Sistemas de Saúde , Farmácia , Assistência Farmacêutica , Farmacovigilância , Células-Tronco Hematopoéticas , Sistema Imunitário , Sistemas Sanguíneo e Imunológico
13.
BMC Public Health ; 19(1): 1166, 2019 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-31455314

RESUMO

BACKGROUND: Vaccine safety surveillance is an essential requirement in vaccination programmes. It supports signal identification, hypothesis generation, and the identification and rectification of gaps in vaccine pharmacovigilance systems. The objectives of this study were to determine the characteristics and trends of adverse events following immunisation (AEFI) and to assess the performance of the Zimbabwe Expanded Immunisation Programme safety surveillance system. METHODS: We carried out a descriptive study of passively collected vaccine-related Individual Case Safety Report (ICSR) data submitted to the World Health Organization global adverse drug reaction database (VigiBase®) from Zimbabwe during the period 1997 to 2017. We extracted AEFI/ICSR data using VigiLyze® for analysis with respect to the demographic distribution, AEFI characteristics, reporting trends over time, ICSR timeliness and case completeness. RESULTS: A total of 272 vaccine-related ICSRs were included in the analyses with a median completeness score of 0.90 interquartile range, IQR (0.63; 0.90). The overall annual reporting rate was 0.58 per 100,000 vaccine doses and the AEFI reporting ratio ranged between 0 and 30.2 AEFI reports per 100,000 surviving infants. The majority of ICSRs were male (55.3%; p value = 0.641) and the median age was 12 (0-168) months. The majority of ICSRs were reported in children who had received measles (n = 133; 48.9%) and OPV/DTP-Hib-HepB (n = 107; 39.3%) vaccines. Of the 387 observed AEFIs, 301 (77.8%) were systemic events and 86 (22.2%) were local reactions. Systemic events were more frequently reported with doses containing the measles antigen (n = 190; 49.1%) while local events were associated with the multiple antigen OPV/DTP-Hib-HepB (n = 62; 16.0%). The multiple antigen OPV/DTP-Hib-HepB was associated with higher rates for injection site abscess (n = 57), pyrexia (n = 27), diarrhea (n = 15), vomiting (n = 12), and seizures (n = 6). The measles antigen was associated with higher rates for rash (n = 44), ocular disorders (n = 26), pyrexia (n = 26), urticaria (n = 22), diarrhea (n = 8), and vomiting (n = 12). CONCLUSIONS: Most of the ICSRs were associated with measles and OPV/DTP-Hib-HepB vaccines. Zimbabwe's vaccine safety surveillance system is still developing and is not yet fully functional. However, the current system provides a reference point for the monitoring of the ongoing AEFI reporting trends and characteristics.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Imunização/efeitos adversos , Vigilância da População , Vacinas/efeitos adversos , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Programas de Imunização/organização & administração , Lactente , Recém-Nascido , Masculino , Farmacovigilância , Zimbábue/epidemiologia
14.
Sci Total Environ ; 696: 134007, 2019 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-31465919

RESUMO

The "targeted ecopharmacovigilance (EPV)" strategy emphasizes the control of environmental pollution by high-priority hazardous pharmaceuticals from principal pollution sources especially in areas that are high risk as a result of drug administration. We conducted a prospective empirical study to explore the possibility of using a targeted EPV intervention as an optimized management tool for the control of aquatic pollution by antibiotics, a common type of pharmaceutical residue, in a rural area in China. Because of the notably high levels of ofloxacin in the studied aquatic environment and the well-accepted environmental risks posed by fluoroquinolone residues, ofloxacin was selected as the targeted high-priority antibiotic pollutant. Based on the main sources of antibiotic pollution in the studied rural aquatic environment, which had been traced previously, a five-step targeted EPV intervention was designed and conducted from Feb 2018 to Jan 2019. The results showed that the residual levels of ofloxacin in the studied Chinese rural aquatic environment significantly decreased during the targeted EPV intervention. Importantly, the EPV measures targeting ofloxacin were found to effectively reduce the environmental pollution by other non-targeted antibiotics. The data from a survey of 45 participants (42 residents and 3 clinicians) and 12 program committee members revealed that the targeted EPV intervention was acceptable to both participants and organizers and could be used as an economical and feasible solution for addressing antibiotic pollution in aquatic environments.


Assuntos
Antibacterianos/análise , Monitoramento Ambiental/métodos , Farmacovigilância , Poluentes Químicos da Água/análise , Poluição da Água/prevenção & controle
15.
Stud Health Technol Inform ; 264: 45-49, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31437882

RESUMO

The aim of the study was to build a proof-of-concept demonstratrating that big data technology could improve drug safety monitoring in a hospital and could help pharmacovigilance professionals to make data-driven targeted hypotheses on adverse drug events (ADEs) due to drug-drug interactions (DDI). We developed a DDI automatic detection system based on treatment data and laboratory tests from the electronic health records stored in the clinical data warehouse of Rennes academic hospital. We also used OrientDb, a graph database to store informations from five drug knowledge databases and Spark to perform analysis of potential interactions betweens drugs taken by hospitalized patients. Then, we developed a machine learning model to identify the patients in whom an ADE might have occurred because of a DDI. The DDI detection system worked efficiently and computation time was manageable. The system could be routinely employed for monitoring.


Assuntos
Interações de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Registros Eletrônicos de Saúde , Automação , Big Data , Humanos , Farmacovigilância
16.
Stud Health Technol Inform ; 264: 60-64, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31437885

RESUMO

We report initial experiments for analyzing social media through an NLP annotation tool on web posts about medications of current interests (baclofen, levothyroxine and vaccines) and summaries of product characteristics (SPCs). We conducted supervised experiments on a subset of messages annotated by experts according to positive or negative misuse; results ranged from 0.62 to 0.91 of F-score. We also annotated both SPCs and another set of posts to compare MedDRA annotations in each source. A pharmacovigilance expert checked the output and confirmed that entities not found in SCPs might express drug misuse or unknown ADRs.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacovigilância , Mídias Sociais , Coleta de Dados , Humanos
17.
Stud Health Technol Inform ; 264: 213-217, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31437916

RESUMO

Medical terminologies are the basis of interoperability in medicine. They allow connecting the various systems and data and facilitate searches in databases. An example is the MedDRA terminology, used in particular for coding drug adverse events. However, these terminologies are often complex and involve a huge number of terms. Consequently, it is difficult to browse them or find the desired terms. Traditional approaches consist of lexical search, with the problems of synonymy and polysemy, or tree-based navigation, but the user often gets "lost" in the tree. Here, we propose a new approach for browsing medical terminologies: the use of pictograms and icons, for formulating the query in complement to a textual search box, and for displaying the search results. We applied this approach to the MedDRA terminology. We present both the methods and search algorithms and the resulting browsing interface, as well as the qualitative opinions of two pharmacovigilance experts.


Assuntos
Farmacovigilância , Systematized Nomenclature of Medicine , Algoritmos , Fissura , Bases de Dados Factuais
18.
Stud Health Technol Inform ; 264: 452-456, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31437964

RESUMO

Misspellings in clinical free text present potential challenges to pharmacovigilance tasks, such as monitoring for potential ineffective treatment of drug-resistant infections. We developed a novel method using Word2Vec, Levenshtein edit distance constraints, and a customized lexicon to identify correct and misspelled pharmaceutical word forms. We processed a large corpus of clinical notes in a real-world pharmacovigilance task, achieving positive predictive values of 0.929 and 0.909 in identifying valid misspellings and correct spellings, respectively, and negative predictive values of 0.994 and 0.333 as assessments where the program did not produce output. In a specific Methicillin-Resistant Staphylococcus Aureus use case, the method identified 9,815 additional instances in the corpus for potential inaffective drug administration inspection. The findings suggest that this method could potentially achieve satisfactory results for other pharmacovigilance tasks.


Assuntos
Preparações Farmacêuticas , Farmacovigilância , Algoritmos , Linguagem , Staphylococcus aureus Resistente à Meticilina
19.
Stud Health Technol Inform ; 264: 964-968, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438067

RESUMO

Social media are proposed as a complementary data source for detection and characterisation of adverse drug reactions. While signal detection algorithms were implemented for generating signals in pharmacovigilance databases, the implementation of a graphical user interface supporting the selection and display of algorithms' results is not documented in the medical literature. Although collecting information on the chronology and the impact of adverse drug reactions is desirable to enable causality and quality assessment of potential signals detected in patients' posts, no tool has been proposed yet to consider such data. We describe here two approaches, and the corresponding tools we implemented for: (1) quantitative approach based on signal detection algorithms, and (2) qualitative approach based on expert review of patient's posts. Future work will focus on implementing other statistical methods, exploring the complementarity of both approaches on a larger scale, and prioritizing the posts to manually evaluate after applying appropriate signal detection methods.


Assuntos
Mídias Sociais , Tiofenos/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos , Humanos , Farmacovigilância
20.
Stud Health Technol Inform ; 264: 1007-1011, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438076

RESUMO

Even though Adverse Drug Reactions (ADRs) constitute a significant public health issue, there is a lack of Information & Communication Technologies (ICT) tools supporting Pharmacovigilance activities at the point of care. In this paper, we present the rationale of a Web-based platform to address this need. The driving user scenario of the proposed platform refers to a clinician who investigates information for a possible ADR as part of a specific patient treatment. The goal is to facilitate this assessment through appropriate tools for searching various relevant data sources, analysing the acquired data, aggregating the obtained evidence, and offering follow-up ADR monitoring over time in a systematic and user-friendly way. In this regard, we describe the adopted user requirements engineering methodology and illustrate the use of Knowledge Engineering (KE) as the platform's main technical paradigm to enable heterogeneous data integration and handle the complexity of the underlying information processing workflow.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Sistemas Automatizados de Assistência Junto ao Leito , Sistemas de Notificação de Reações Adversas a Medicamentos , Humanos , Armazenamento e Recuperação da Informação , Bases de Conhecimento , Farmacovigilância
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