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[PMID]:28453819
[Au] Autor:Cheen MHH; Goon CP; Ong WC; Lim PS; Wan CN; Leong MY; Khee GY
[Ad] Endereço:Department of Pharmacy, Singapore General Hospital, Singapore.
[Ti] Título:Evaluation of a care transition program with pharmacist-provided home-based medication review for elderly Singaporeans at high risk of readmissions.
[So] Source:Int J Qual Health Care;29(2):200-205, 2017 Apr 01.
[Is] ISSN:1464-3677
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Objective: This study aimed to determine whether pharmacist-provided home-based medication review (HBMR) can reduce readmissions in the elderly. Design: Retrospective cohort study. Setting: Patient's home. Participants: Records of patients referred to a care transition program from March 2011 through March 2015 were reviewed. Patients aged 60 years and older taking more than 5 medications and had at least 2 unplanned admissions within 3 months preceding the first home visit were included. Intervention: Pharmacist-provided HBMR. Main outcome measures: Primary outcome was readmission rate over 6 months after the first home visit. Secondary outcomes included emergency department (ED) visits, outpatient visits and mortality. Drug-related problems (DRPs) were reported for the HBMR group. Multivariate incidence rate ratios (IRR) and hazard ratio (HR) were calculated with adjustments for covariates. Results: The study included 499 patients (97 HBMR, 402 no HBMR). Pharmacist-provided HBMR reduced readmissions by 26% (IRR = 0.74, 95% CI: 0.59-0.92, P = 0.007), reduced ED visits by 20% (IRR = 0.80, 95% CI: 0.66-0.98, P = 0.030) and increased outpatient visits by 16% (IRR = 1.16, 95% CI: 0.95-1.41, P = 0.150). There were 8 and 44 deaths in the HBMR and no HBMR groups respectively (HR = 0.73, 95% CI: 0.29-1.81, P = 0.492). Pharmacists identified 464 DRPs, with 169 (36.4%) resolved within 1 month after the home visit. Conclusions: The study suggests that pharmacist-provided HBMR is effective in reducing readmissions and ED visits in the elderly. More studies in the Asian population are needed to determine its long term benefits and patient's acceptability.
[Mh] Termos MeSH primário: Reconciliação de Medicamentos/métodos
Alta do Paciente
Readmissão do Paciente/estatística & dados numéricos
Farmacêuticos
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Estudos de Coortes
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle
Serviço Hospitalar de Emergência/utilização
Feminino
Seres Humanos
Masculino
Meia-Idade
Mortalidade
Serviço de Farmácia Hospitalar/métodos
Estudos Retrospectivos
Singapura
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/intqhc/mzw150


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[PMID]:28743244
[Au] Autor:Bazargan M; Smith J; Yazdanshenas H; Movassaghi M; Martins D; Orum G
[Ad] Endereço:Charles R. Drew University of Medicine & Science, 1731 East 120th Street, Los Angeles, CA, 90005, USA. mobazarg@cdrewu.edu.
[Ti] Título:Non-adherence to medication regimens among older African-American adults.
[So] Source:BMC Geriatr;17(1):163, 2017 Jul 25.
[Is] ISSN:1471-2318
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Despite concerns about racial differences on adherence to prescribed medication rigimens among older adults, current information about nonadherence among underserved elderly African Americans with co-morbidities is limited. This study examines the association between adherence to drug regimens and an array of medication-related factors, including polypharmacy, medication regimen complexity, use of Potentially Inappropriate Medications (PIM), and knowledge about the therapeutic purpose and instructions of medication use. METHODS: Four-hundred African Americans, aged 65 years and older, were recruited from South Los Angeles. Structured, face-to-face interviews and visual inspection of participants' medications were conducted. From the medication container labels, information including strength of the drug, expiration date, instructions, and special warnings were recorded. The Medication Regimen Complexity Index (MRCI) was measured to quantify multiple features of drug regimen complexity. The Beers Criteria was used to measure the PIM use. RESULTS: Participants reported taking an average of 5.7 prescription drugs. Over 56% could not identify the purpose of at least one of their medications. Only two-thirds knew dosage regimen of their medications. Thirty-five percent of participants indicated that they purposely had skipped taking at least one of their medications within last three days. Only 8% of participants admitted that they forgot to take their medications. The results of multivariate analysis showed that co-payment for drugs, memory deficits, MRCI, and medication-related knowledge were all associated with adherence to dosage regimen of medications. Participants with a higher level of knowledge about therapeutic purpose and knowledge about dosage regimen of their medications were seven times (CI: 4.2-10.8) more likely to adhere to frequency and dose of medications. Participants with a low complexity index were two times (CI: 1.1-3.9) more likely to adhere to the dosage regimen of their medications, compared with participants with high drug regimen complexity index. CONCLUSIONS: While other studies have documented that non-adherence remains an important issue among older adults, our study shows that for underserved elderly African Americans, these issues are particularly striking. A periodic comprehensive assessment of all medications that they use remains a critical initial step to identify medication related issues. Assessment of their disease and medication related knowledge (e.g., therapeutic purposes, side-effects, special instructions, etc.) and their ability to follow complicated medication regimens and modification of their drug regimens requires inter-professional collaboration.
[Mh] Termos MeSH primário: Afroamericanos/psicologia
Conhecimentos, Atitudes e Prática em Saúde
Alfabetização em Saúde/métodos
Adesão à Medicação/psicologia
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Estudos Transversais
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle
Feminino
Hospitalização/tendências
Seres Humanos
Masculino
Educação de Pacientes como Assunto/métodos
Polimedicação
Lista de Medicamentos Potencialmente Inapropriados/tendências
Medicamentos sob Prescrição/efeitos adversos
Estados Unidos/epidemiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Prescription Drugs)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170727
[St] Status:MEDLINE
[do] DOI:10.1186/s12877-017-0558-5


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[PMID]:29425084
[Au] Autor:Sponsler KC; Mixon AS
[Ad] Endereço:Assistant Professor, Department of Medicine, Division of General Internal Medicine and Public Health, Section of Hospital Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. kelly.sponsler@vanderbilt.edu.
[Ti] Título:Finding balance: Optimizing medication prescribing in older patients.
[So] Source:Cleve Clin J Med;85(2):136-137, 2018 02.
[Is] ISSN:1939-2869
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Prescrições de Medicamentos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
[Mh] Termos MeSH secundário: Seres Humanos
Erros de Medicação
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180302
[Lr] Data última revisão:
180302
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180210
[St] Status:MEDLINE
[do] DOI:10.3949/ccjm.85a.17087


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[PMID]:29212082
[Au] Autor:Phaibulvatanapong E; Srinonprasert V; Ithimakin S
[Ad] Endereço:Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
[Ti] Título:Risk Factors for Chemotherapy-Related Toxicity and Adverse Events in Elderly Thai Cancer Patients: A Prospective Study.
[So] Source:Oncology;94(3):149-160, 2018.
[Is] ISSN:1423-0232
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: To assess factors predisposing to severe chemotherapy-related toxicity and adverse events (AEs) and dose modification in aging cancer patients. METHODS: Cancer patients aged ≥70 years scheduled to receive the first cycle of a new chemotherapy regimen were enrolled. On the day of starting chemotherapy, demographic data, performance status (PS), and geriatric parameters were recorded. AEs and chemotherapy modification were recorded. Quality of life (QOL) was assessed at baseline and 3 months after starting chemotherapy or at the end of chemotherapy. RESULTS: We included 151 patients (mean age, 76.4 years) with gastrointestinal (47%), lung (24%), breast (9%), or genitourinary (6%) cancer. All-grade and severe AEs occurred in 83 and 42% of patients, respectively; 51.6% of patients required chemotherapy modification due to toxicities. A higher incidence of severe AEs (71% vs. 39%, p = 0.01) and poorer QOL was found in patients with PS 2 than in those with PS 0-1. Patients with PS 2 or who received palliative-intent chemotherapy or had multiple comorbidities were more likely to discontinue chemotherapy because of toxicity. CONCLUSIONS: PS remains a key predictor of chemotherapy-related toxicity in elderly patients. PS 2 was correlated with higher incidence of severe AEs, premature treatment discontinuation, and worsening QOL after treatment.
[Mh] Termos MeSH primário: Antineoplásicos/administração & dosagem
Antineoplásicos/efeitos adversos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Feminino
Seres Humanos
Masculino
Estudos Prospectivos
Qualidade de Vida
Fatores de Risco
Tailândia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180302
[Lr] Data última revisão:
180302
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171207
[St] Status:MEDLINE
[do] DOI:10.1159/000485078


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[PMID]:29372930
[Au] Autor:Allen EN; Chandler CI; Mandimika N; Leisegang C; Barnes K
[Ad] Endereço:Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, K45, Old Main Building, Groote Schuur Hospital, Observatory, Cape Town, Western Cape, South Africa, 7925.
[Ti] Título:Eliciting adverse effects data from participants in clinical trials.
[So] Source:Cochrane Database Syst Rev;1:MR000039, 2018 01 16.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Analysis of drug safety in clinical trials involves assessing adverse events (AEs) individually or by aggregate statistical synthesis to provide evidence of likely adverse drug reactions (ADR). While some AEs may be ascertained from physical examinations or tests, there is great reliance on reports from participants to detect subjective symptoms, where he/she is often the only source of information. There is no consensus on how these reports should be elicited, although it is known that questioning methods influence the extent and nature of data detected. This leaves room for measurement error and undermines comparisons between studies and pooled analyses. This review investigated comparisons of methods used in trials to elicit participant-reported AEs. This should contribute to knowledge about the methodological challenges and possible solutions for achieving better, or more consistent, AE ascertainment in trials. OBJECTIVES: To systematically review the research that has compared methods used within clinical drug trials (or methods that would be specific for such trials) to elicit information about AEs defined in the protocol or in the planning for the trial. SEARCH METHODS: Databases (searched to March 2015 unless indicated otherwise) included: Embase; MEDLINE; MEDLINE in Process and Other Non-Indexed Citations; Cochrane Methodology Register (July 2012); Cochrane Central Register of Controlled Trials (February 2015); Cochrane Database of Systematic Reviews; Database of Abstracts of Reviews of Effects (January 2015); Health Technology Assessment database (January 2015); CINAHL; CAB Abstracts; BIOSIS (July 2013); Science Citation Index; Social Science Citation Index; Conference Proceedings Citation Index - Science. The search used thesaurus headings and synonyms for the following concepts: (A): Adverse events AND measurement; (B): Participants AND elicitation (also other synonyms for extraction of information about adverse effects from people); (C): Participants AND checklists (also other synonyms as for B). Pragmatic ways were used to limit the results whilst trying to maintain sensitivity. There were no date or sample size restrictions but only reports published in English were included fully, because of resource constraints as regards translation. SELECTION CRITERIA: Two types of studies were included: drug trials comparing two or more methods within- or between-participants to elicit participant-reported AEs, and research studies performed outside the context of a trial to compare methods which could be used in trials (evidenced by reference to such applicability). Primary outcome data included AEs elicited from participants taking part in any such clinical trial. We included any participant-reported data relevant for an assessment of drug-related harm, using the original authors' terminology (and definition, where available), with comment on whether the data were likely to be treatment-emergent AEs or not. DATA COLLECTION AND ANALYSIS: Titles and abstracts were independently reviewed for eligibility. Full texts of potentially eligible citations were independently reviewed for final eligibility. Relevant data were extracted and subjected to a 100% check. Disagreements were resolved by discussion, involving a third author. The risk of bias was independently assessed by two authors. The Cochrane 'Risk of bias' tool was used for reports comparing outcomes between participants, while for within-participant comparisons, each study was critically evaluated in terms of potential impact of the design and conduct on findings using the framework of selection, performance, detection, attrition, reporting, and other biases. An attempt was made to contact authors to retrieve protocols or specific relevant missing information. Reports were not excluded on the basis of quality unless data for outcomes were impossible to compare (e.g. where denominators differed). A narrative synthesis was conducted because differences in study design and presentation meant that a quantitative meta-analysis was not possible. MAIN RESULTS: The 33 eligible studies largely compared open questions with checklist-type questions or rating scales. Two included participant interviews. Despite different designs, populations and details of questioning methods, the narrative review showed that more specific questioning of participants led to more AEs detected compared to a more general enquiry. A subset of six studies suggested that more severe, bothersome, or otherwise clinically relevant AEs were reported when an initial open enquiry was used, while some less severe, bothersome, or clinically relevant AEs were only reported with a subsequent specific enquiry. However, two studies showed that quite severe or debilitating AEs were only detected by an interview, while other studies did not find a difference in the nature of AEs between elicitation methods. No conclusions could be made regarding the impact of question method on the ability to detect a statistically significant difference between study groups. There was no common statistical rubric, but we were able to represent some effect measures as a risk ratio of the proportion of participants with at least one AE. This showed a lower level of reporting for open questions (O) compared to checklists (CL), with a range for the risk ratios of 0.12 to 0.64. AUTHORS' CONCLUSIONS: This review supports concerns that methods to elicit participant-reported AEs influence the detection of these data. There was a risk for under-detection of AEs in studies using a more general elicitation method compared to those using a comprehensive method. These AEs may be important from a clinical perspective or for patients. This under-detection could compromise ability to pool AE data. However, the impact on the nature of the AE detected by different methods is unclear. The wide variety and low quality of methods to compare elicitation strategies limited this review. Future studies would be improved by using and reporting clear definitions and terminology for AEs (and other important variables), frequency and time period over which they were ascertained, how they were graded, assessed for a relationship to the study drug, coded, and tabulated/reported. While the many potential AE endpoints in a trial may preclude the development of general AE patient-reported outcome measurement instruments, much could also be learnt from how these employ both quantitative and qualitative methods to better understand data elicited. Any chosen questioning method needs to be feasible for use by both staff and participants.
[Mh] Termos MeSH primário: Lista de Checagem
Ensaios Clínicos como Assunto
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Sujeitos da Pesquisa
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180127
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.MR000039.pub2


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[PMID]:29386436
[Au] Autor:Komada F
[Ad] Endereço:Faculty of Pharmaceutical Sciences, Himeji Dokkyo University.
[Ti] Título:[Analysis of Time-to-onset of Interstitial Lung Disease after the Administration of Small Molecule Molecularly-targeted Drugs].
[So] Source:Yakugaku Zasshi;138(2):229-235, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: The aim of this study was to investigate the time-to-onset of drug-induced interstitial lung disease (DILD) following the administration of small molecule molecularly-targeted drugs via the use of the spontaneous adverse reaction reporting system of the Japanese Adverse Drug Event Report database. DILD datasets for afatinib, alectinib, bortezomib, crizotinib, dasatinib, erlotinib, everolimus, gefitinib, imatinib, lapatinib, nilotinib, osimertinib, sorafenib, sunitinib, temsirolimus, and tofacitinib were used to calculate the median onset times of DILD and the Weibull distribution parameters, and to perform the hierarchical cluster analysis. The median onset times of DILD for afatinib, bortezomib, crizotinib, erlotinib, gefitinib, and nilotinib were within one month. The median onset times of DILD for dasatinib, everolimus, lapatinib, osimertinib, and temsirolimus ranged from 1 to 2 months. The median onset times of the DILD for alectinib, imatinib, and tofacitinib ranged from 2 to 3 months. The median onset times of the DILD for sunitinib and sorafenib ranged from 8 to 9 months. Weibull distributions for these drugs when using the cluster analysis showed that there were 4 clusters. Cluster 1 described a subgroup with early to later onset DILD and early failure type profiles or a random failure type profile. Cluster 2 exhibited early failure type profiles or a random failure type profile with early onset DILD. Cluster 3 exhibited a random failure type profile or wear out failure type profiles with later onset DILD. Cluster 4 exhibited an early failure type profile or a random failure type profile with the latest onset DILD.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Bortezomib/efeitos adversos
Carbazóis/efeitos adversos
Bases de Dados como Assunto
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Doenças Pulmonares Intersticiais/induzido quimicamente
Piperidinas/efeitos adversos
Quinazolinas/efeitos adversos
[Mh] Termos MeSH secundário: Análise por Conglomerados
Dasatinibe/efeitos adversos
Conjuntos de Dados como Assunto
Seres Humanos
Japão/epidemiologia
Doenças Pulmonares Intersticiais/epidemiologia
Terapia de Alvo Molecular/efeitos adversos
Tamanho da Partícula
Pirazóis/efeitos adversos
Piridinas/efeitos adversos
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (CH5424802); 0 (Carbazoles); 0 (Piperidines); 0 (Pyrazoles); 0 (Pyridines); 0 (Quinazolines); 41UD74L59M (afatinib); 53AH36668S (crizotinib); 69G8BD63PP (Bortezomib); RBZ1571X5H (Dasatinib)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180202
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00194


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[PMID]:29386432
[Au] Autor:Uesawa Y
[Ad] Endereço:Department of Clinical Pharmaceutics, Meiji Pharmaceutical University.
[Ti] Título:[Adverse Effect Predictions Based on Computational Toxicology Techniques and Large-scale Databases].
[So] Source:Yakugaku Zasshi;138(2):185-190, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: Understanding the features of chemical structures related to the adverse effects of drugs is useful for identifying potential adverse effects of new drugs. This can be based on the limited information available from post-marketing surveillance, assessment of the potential toxicities of metabolites and illegal drugs with unclear characteristics, screening of lead compounds at the drug discovery stage, and identification of leads for the discovery of new pharmacological mechanisms. This present paper describes techniques used in computational toxicology to investigate the content of large-scale spontaneous report databases of adverse effects, and it is illustrated with examples. Furthermore, volcano plotting, a new visualization method for clarifying the relationships between drugs and adverse effects via comprehensive analyses, will be introduced. These analyses may produce a great amount of data that can be applied to drug repositioning.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Computadores
Bases de Dados como Assunto
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Toxicologia/métodos
[Mh] Termos MeSH secundário: Reposicionamento de Medicamentos
Valor Preditivo dos Testes
Vigilância de Produtos Comercializados
Relação Estrutura-Atividade
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180202
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00174-4


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[PMID]:29386431
[Au] Autor:Ohashi Y
[Ad] Endereço:Quality & Regulatory Compliance Unit, Chugai Pharmaceutical Co., Ltd.
[Ti] Título:[Safe Use of Recent New Drugs-Current Status and Challenges].
[So] Source:Yakugaku Zasshi;138(2):177-183, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.
[Mh] Termos MeSH primário: Bases de Dados de Produtos Farmacêuticos
Serviços de Informação sobre Medicamentos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Preparações Farmacêuticas
Farmacovigilância
Gestão de Riscos
[Mh] Termos MeSH secundário: Biofarmácia
Tomada de Decisões Gerenciais
Indústria Farmacêutica
Seres Humanos
Farmacêuticos
Medicina de Precisão/tendências
Segurança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180202
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00174-3


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[PMID]:29320302
[Au] Autor:Joffe S; Lynch HF
[Ad] Endereço:From the Department of Medical Ethics and Health Policy, Perelman School of Medicine, and the Leonard Davis Institute of Health Economics, University of Pennsylvania (S.J., H.F.L.), and the Children's Hospital of Philadelphia (S.J.) - all in Philadelphia.
[Ti] Título:Federal Right-to-Try Legislation - Threatening the FDA's Public Health Mission.
[So] Source:N Engl J Med;378(8):695-697, 2018 Feb 22.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas/legislação & jurisprudência
Drogas em Investigação
Regulamentação Governamental
Acesso aos Serviços de Saúde/legislação & jurisprudência
Legislação de Medicamentos
Segurança do Paciente/legislação & jurisprudência
United States Food and Drug Administration/legislação & jurisprudência
[Mh] Termos MeSH secundário: Ensaios Clínicos Fase I como Assunto
Estado Terminal
Avaliação de Medicamentos/legislação & jurisprudência
Indústria Farmacêutica/legislação & jurisprudência
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Seres Humanos
Responsabilidade Legal
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Investigational)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1714054


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[PMID]:29311458
[Au] Autor:Sasaoka S; Hatahira H; Hasegawa S; Motooka Y; Fukuda A; Naganuma M; Umetsu R; Nakao S; Shimauchi A; Ueda N; Hirade K; Iguchi K; Nakamura M
[Ad] Endereço:Laboratory of Drug Informatics, Gifu Pharmaceutical University.
[Ti] Título:[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database].
[So] Source:Yakugaku Zasshi;138(1):123-134, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:OTC combination cold remedies are widely used in Japan. In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database. The JADER database contained 430587 reports between April 2004 and November 2016. 1084 adverse events associated with the use of OTC combination cold remedy were reported. Reporting odds ratio (ROR) was used to detect safety signals. The ROR values for "skin and subcutaneous tissue disorders", "hepatobiliary disorders", and "immune system disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 9.82 (8.71-11.06), 2.63 (2.25-3.07), and 3.13 (2.63-3.74), respectively. OTC combination cold remedy containing acetaminophen exhibited a significantly higher reporting ratio for "hepatobiliary disorders" than OTC combination cold remedy without acetaminophen. We demonstrated the potential risk of OTC combination cold remedy in a real-life setting. Our results suggested that the monitoring of individuals using OTC combination cold remedy is important.
[Mh] Termos MeSH primário: Acetaminofen/efeitos adversos
Sistemas de Notificação de Reações Adversas a Medicamentos
Mineração de Dados
Bases de Dados Factuais
Uso de Medicamentos/estatística & dados numéricos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Medicamentos sem Prescrição/efeitos adversos
[Mh] Termos MeSH secundário: Acetaminofen/administração & dosagem
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos
Doenças Biliares/induzido quimicamente
Doenças Biliares/epidemiologia
Doença Hepática Induzida por Substâncias e Drogas/epidemiologia
Doença Hepática Induzida por Substâncias e Drogas/etiologia
Combinação de Medicamentos
Doenças do Sistema Imune/induzido quimicamente
Doenças do Sistema Imune/epidemiologia
Japão/epidemiologia
Medicamentos sem Prescrição/administração & dosagem
Razão de Chances
Risco
Dermatopatias/induzido quimicamente
Dermatopatias/epidemiologia
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drug Combinations); 0 (Nonprescription Drugs); 362O9ITL9D (Acetaminophen)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180110
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00172



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