Base de dados : MEDLINE
Pesquisa : I01.880.604.605.250.625 [Categoria DeCS]
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  1 / 105 MEDLINE  
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[PMID]:27673458
[Au] Autor:Rubin R
[Ti] Título:EpiPen price hike comes under scrutiny.
[So] Source:Lancet;388(10051):1266, 2016 Sep 24.
[Is] ISSN:1474-547X
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Anafilaxia/tratamento farmacológico
Custos de Medicamentos
Epinefrina/administração & dosagem
Epinefrina/economia
Injeções/instrumentação
[Mh] Termos MeSH secundário: Agonistas Adrenérgicos/administração & dosagem
Agonistas Adrenérgicos/economia
Anafilaxia/economia
Broncodilatadores/administração & dosagem
Broncodilatadores/economia
Comércio
Recall de Medicamento
Seres Humanos
Estados Unidos
Vasoconstritores/administração & dosagem
Vasoconstritores/economia
[Pt] Tipo de publicação:NEWS
[Nm] Nome de substância:
0 (Adrenergic Agonists); 0 (Bronchodilator Agents); 0 (Vasoconstrictor Agents); YKH834O4BH (Epinephrine)
[Em] Mês de entrada:1610
[Cu] Atualização por classe:170816
[Lr] Data última revisão:
170816
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:160928
[St] Status:MEDLINE


  2 / 105 MEDLINE  
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[PMID]:27592833
[Au] Autor:Yamamoto C; Ishida T; Osawa T; Naito T; Kawakami J
[Ad] Endereço:Department of Hospital Pharmacy, Hamamatsu University School of Medicine.
[Ti] Título:Trends in Non-prescription Drug Recalls in Japan.
[So] Source:Yakugaku Zasshi;136(9):1307-12, 2016.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.
[Mh] Termos MeSH primário: Recall de Medicamento/estatística & dados numéricos
Recall de Medicamento/tendências
Medicamentos sem Prescrição
[Mh] Termos MeSH secundário: Indústria Farmacêutica
Órgãos Governamentais
Japão
Legislação de Medicamentos
Medicamentos sem Prescrição/normas
Automedicação
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Nonprescription Drugs)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171016
[Lr] Data última revisão:
171016
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160906
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.15-00287


  3 / 105 MEDLINE  
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[PMID]:27154940
[Au] Autor:Ramsey I; Roberts E; Spence S
[Ad] Endereço:University of Glasgow Small Animal Hospital, 464 Bearsden Road, Bearsden, Glasgow G61 1QH, e-mail: ian.ramsey@glasgow.ac.uk.
[Ti] Título:Management of Addison's disease in dogs.
[So] Source:Vet Rec;178(19):478, 2016 May 07.
[Is] ISSN:2042-7670
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Doença de Addison/veterinária
Desoxicorticosterona/uso terapêutico
Doenças do Cão/tratamento farmacológico
[Mh] Termos MeSH secundário: Doença de Addison/tratamento farmacológico
Animais
Cães
Recall de Medicamento
Fludrocortisona/análogos & derivados
Reino Unido
[Pt] Tipo de publicação:LETTER
[Nm] Nome de substância:
40GP35YQ49 (Desoxycorticosterone); U0476M545B (Fludrocortisone); V47IF0PVH4 (fludrocortisone acetate)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160508
[St] Status:MEDLINE
[do] DOI:10.1136/vr.i2520


  4 / 105 MEDLINE  
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[PMID]:27023487
[Au] Autor:Handley S; Patel MX; Flanagan RJ
[Ad] Endereço:a Toxicology Unit, Department of Clinical Biochemistry , King's College Hospital NHS Foundation Trust , London , UK ;
[Ti] Título:Antipsychotic-related fatal poisoning, England and Wales, 1993-2013: impact of the withdrawal of thioridazine.
[So] Source:Clin Toxicol (Phila);54(6):471-80, 2016 Jul.
[Is] ISSN:1556-9519
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:CONTEXT: Use of second generation antipsychotics in England and Wales has increased in recent years whilst prescription of first generation antipsychotics has decreased. METHODS: To evaluate the impact of this change and of the withdrawal of thioridazine in 2000 on antipsychotic-related fatal poisoning, we reviewed all such deaths in England and Wales 1993-2013 recorded on the Office for National Statistics drug poisoning deaths database. We also reviewed antipsychotic prescribing in the community, England and Wales, 2001-2013. Use of routine mortality data: When an antipsychotic was recorded with other drug(s), the death certificate does not normally say if the antipsychotic caused the death rather than the other substance(s). A second consideration concerns intent. A record of "undetermined intent" is likely to have been intentional self-poisoning, the evidence being insufficient to be certain that the individual intended to kill. A record of drug abuse/dependence, on the other hand, is likely to have been associated with an unintentional death. Accuracy of the diagnosis of poisoning: When investigating a death in someone prescribed antipsychotics, toxicological analysis of biological samples collected post-mortem is usually performed. However, prolonged attempts at resuscitation, or diffusion from tissues into blood as autolysis proceeds, may serve to alter the composition of blood sampled after death from that circulating at death. With chlorpromazine and with olanzapine a further factor is that these compounds are notoriously unstable in post-mortem blood. Deaths from antipsychotics: There were 1544 antipsychotic-related poisoning deaths. Deaths in males (N = 948) were almost twice those in females. For most antipsychotics, the proportion of deaths in which a specific antipsychotic featured either alone, or only with alcohol was 30-40%, but for clozapine (193 deaths) such mentions totalled 66%. For clozapine, the proportion of deaths attributed to either intentional self-harm, or undetermined intent was 44%, but for all other drugs except haloperidol (20 deaths) the proportion was 56% or more. The annual number of antipsychotic-related deaths increased from some 55 per year (1.0 per million population) between 1993 and 1998 to 74 (1.5 per million population) in 2000, and then after falling slightly in 2002 increased steadily to reach 109 (1.9 per million population) in 2013. Intent: The annual number of intentional and unascertained intent poisoning deaths remained relatively constant throughout the study period (1993: 35 deaths, 2013: 38 deaths) hence the increase in antipsychotic-related deaths since 2002 was almost entirely in unintentional poisoning involving second generation antipsychotics. Clozapine, olanzapine, and quetiapine were the second generation antipsychotics mentioned most frequently in unintentional poisonings (99, 136, and 99 deaths, respectively). Mentions of diamorphine/morphine and methadone (67 and 99 deaths, respectively) together with an antipsychotic were mainly (84 and 90%, respectively) in either unintentional or drug abuse-related deaths. Deaths and community prescriptions: Deaths involving antipsychotics (10 or more deaths) were in the range 11.3-17.1 deaths per million community prescriptions in England and Wales, 2001-2013. Almost all (96%) such deaths now involve second generation antipsychotics. This is keeping with the increase in annual numbers of prescriptions of these drugs overall (<1 million in 2000, 7 million in 2013), largely driven by increases in prescriptions for olanzapine and quetiapine. In contrast, deaths involving thioridazine declined markedly (from 40 in 2000 to 10 in 2003-2013) in line with the fall in prescriptions for thioridazine from 2001. CONCLUSIONS: The removal of thioridazine has had no apparent effect on the incidence of antipsychotic-related fatal poisoning in England and Wales. That such deaths have increased steadily since 2001 is in large part attributable to an increase in unintentional deaths related to (i) clozapine, and (ii) co-exposure to opioids, principally diamorphine and methadone.
[Mh] Termos MeSH primário: Antipsicóticos/envenenamento
Recall de Medicamento
Envenenamento/mortalidade
Tioridazina/envenenamento
[Mh] Termos MeSH secundário: Antipsicóticos/sangue
Benzodiazepinas/sangue
Benzodiazepinas/envenenamento
Clorpromazina/sangue
Clorpromazina/envenenamento
Clozapina/sangue
Clozapina/envenenamento
Inglaterra/epidemiologia
Heroína/sangue
Heroína/envenenamento
Seres Humanos
Metadona/sangue
Metadona/envenenamento
Morfina/sangue
Morfina/envenenamento
Envenenamento/etiologia
Fumarato de Quetiapina/sangue
Fumarato de Quetiapina/envenenamento
Tioridazina/sangue
País de Gales/epidemiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antipsychotic Agents); 12794-10-4 (Benzodiazepines); 2S3PL1B6UJ (Quetiapine Fumarate); 70D95007SX (Heroin); 76I7G6D29C (Morphine); J60AR2IKIC (Clozapine); N3D6TG58NI (Thioridazine); N7U69T4SZR (olanzapine); U42B7VYA4P (Chlorpromazine); UC6VBE7V1Z (Methadone)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170922
[Lr] Data última revisão:
170922
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:160330
[St] Status:MEDLINE
[do] DOI:10.3109/15563650.2016.1164861


  5 / 105 MEDLINE  
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[PMID]:26843501
[Au] Autor:Hall K; Stewart T; Chang J; Freeman MK
[Ad] Endereço:Walmart Pharmacy, Louisville, KY.
[Ti] Título:Characteristics of FDA drug recalls: A 30-month analysis.
[So] Source:Am J Health Syst Pharm;73(4):235-40, 2016 Feb 15.
[Is] ISSN:1535-2900
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed. METHODS: All FDA-issued recalls for drugs (prescription and nonprescription, including dietary supplements) and biological products issued from June 20, 2012, to December 31, 2014, were included in this retrospective analysis. Data for all drug recalls were downloaded and sorted by the inclusion criteria from weekly FDA enforcement reports. The following data were analyzed: product type, recall firm, type of recall firm (compounding or noncompounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription or nonprescription), reason for recall, recall initiation date, and recall report date. RESULTS: A total of 21,120 products were recalled during the 30-month study period. Of these, 3,045 drug products (14.4%) met the inclusion criteria and were analyzed. A total of 348 total manufacturers were associated with recalled drug products. The 5 firms most frequently involved in recalls accounted for 299, 273, 212, 118, and 112 recalls. The most common reasons for recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. There was a significant association between FDA recall classification and the following outcomes: reasons for recall, product availability, type of recall firm, and form of communication. CONCLUSION: An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms.
[Mh] Termos MeSH primário: Recall de Medicamento/estatística & dados numéricos
Medicamentos sem Prescrição/normas
Medicamentos sob Prescrição/normas
Retirada de Medicamento Baseada em Segurança/estatística & dados numéricos
[Mh] Termos MeSH secundário: Produtos Biológicos/normas
Contaminação de Medicamentos
Rotulagem de Medicamentos/normas
Seres Humanos
Estudos Retrospectivos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biological Products); 0 (Nonprescription Drugs); 0 (Prescription Drugs)
[Em] Mês de entrada:1610
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160205
[St] Status:MEDLINE
[do] DOI:10.2146/ajhp150277


  6 / 105 MEDLINE  
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[PMID]:26553801
[Au] Autor:Siramshetty VB; Nickel J; Omieczynski C; Gohlke BO; Drwal MN; Preissner R
[Ad] Endereço:Structural Bioinformatics Group, ECRC Experimental and Clinical Research Center, Charité - University Medicine Berlin, 13125 Berlin, Germany.
[Ti] Título:WITHDRAWN--a resource for withdrawn and discontinued drugs.
[So] Source:Nucleic Acids Res;44(D1):D1080-6, 2016 Jan 04.
[Is] ISSN:1362-4962
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Post-marketing drug withdrawals can be associated with various events, ranging from safety issues such as reported deaths or severe side-effects, to a multitude of non-safety problems including lack of efficacy, manufacturing, regulatory or business issues. During the last century, the majority of drugs voluntarily withdrawn from the market or prohibited by regulatory agencies was reported to be related to adverse drug reactions. Understanding the underlying mechanisms of toxicity is of utmost importance for current and future drug discovery. Here, we present WITHDRAWN, a resource for withdrawn and discontinued drugs publicly accessible at http://cheminfo.charite.de/withdrawn. Today, the database comprises 578 withdrawn or discontinued drugs, their structures, important physico-chemical properties, protein targets and relevant signaling pathways. A special focus of the database lies on the drugs withdrawn due to adverse reactions and toxic effects. For approximately one half of the drugs in the database, safety issues were identified as the main reason for withdrawal. Withdrawal reasons were extracted from the literature and manually classified into toxicity types representing adverse effects on different organs. A special feature of the database is the presence of multiple search options which will allow systematic analyses of withdrawn drugs and their mechanisms of toxicity.
[Mh] Termos MeSH primário: Bases de Dados de Produtos Farmacêuticos
Retirada de Medicamento Baseada em Segurança
[Mh] Termos MeSH secundário: Recall de Medicamento
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Seres Humanos
Internet
Preparações Farmacêuticas/química
Polimorfismo de Nucleotídeo Único
Proteínas/efeitos dos fármacos
Transdução de Sinais/efeitos dos fármacos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Pharmaceutical Preparations); 0 (Proteins)
[Em] Mês de entrada:1606
[Cu] Atualização por classe:160108
[Lr] Data última revisão:
160108
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:151111
[St] Status:MEDLINE
[do] DOI:10.1093/nar/gkv1192


  7 / 105 MEDLINE  
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[PMID]:26552336
[Au] Autor:Ebbers HC; de Tienda NF; Hoefnagel MC; Nibbeling R; Mantel-Teeuwisse AK
[Ad] Endereço:Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, The Netherlands; Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Department of Pharmaceutics, Utrecht, Th
[Ti] Título:Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA.
[So] Source:Drug Discov Today;21(4):536-9, 2016 Apr.
[Is] ISSN:1878-5832
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Compared with chemically synthesized small-molecule drugs, the manufacturing process of biopharmaceuticals is more complex. Unexpected changes to product characteristics following manufacturing changes have given rise to calls for robust systems to monitor the postauthorization safety of biopharmaceuticals. We compared quality-related product recalls in the USA of biopharmaceuticals and of small molecules. Although the reasons for recalls for biopharmaceuticals differed from those for small molecules, adverse events were rarely reported. The relative contribution of recalls that could cause serious adverse health consequences was not greater for biopharmaceuticals than for small molecules. Therefore, these data do not give rise to concerns that biopharmaceuticals are more frequently associated with unexpected safety concerns.
[Mh] Termos MeSH primário: Recall de Medicamento
[Mh] Termos MeSH secundário: Produtos Biológicos
Preparações Farmacêuticas
Controle de Qualidade
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biological Products); 0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1701
[Cu] Atualização por classe:170119
[Lr] Data última revisão:
170119
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:151111
[St] Status:MEDLINE


  8 / 105 MEDLINE  
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[PMID]:26119714
[Au] Autor:Vijayakumar R; Saleh Al-Aboody M; Sandle T
[Ad] Endereço:Department of Medical Laboratory, College of Science AlZulfi, Majmaah University, AlZulfi, Saudi Arabia.
[Ti] Título:A review of melanized (black) fungal contamination in pharmaceutical products--incidence, drug recall and control measures.
[So] Source:J Appl Microbiol;120(4):831-41, 2016 Apr.
[Is] ISSN:1365-2672
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The aim of this study was to describe the incidence of contamination of pharmaceutical products by melanized fungi and to consider control measures in relation to bioburden and cleanrooms. This study reviews and analyses pharmaceutical product recalls and offers incidence rates of fungal detection from a typical cleanrooms. The recalls include some serious cases which resulted in the loss of life. Of different types of fungal contamination incidences some of the most damaging have been due to melanized fungi ('black mould'), such as Exserohilum rostratum. The focus of the article is with melanized fungi. The study concludes that, from the review of recent pharmaceutical product recalls, fungal contamination is either increasingly common within cleanroom environments or the accuracy of sampling and the level of reporting has risen. The prevalence of melanized fungi in pharmaceutical facilities rests on specific virulence factors particular to these types of fungi, which are outlined. The article identifies a gap in the way that such fungi are screened for using available cultural methods. The article provides some control strategies, including assessing the suitability of disinfectants and biocides, for reducing the risk of melanized fungal incidences within the pharmaceutical facility. Understanding the fungal risk to pharmaceutical products remains a poorly understood and often overlooked aspect of pharmaceutical microbiology. This article helps to identify this risk and offer some guidance to those involved with pharmaceutical products manufacture in relation to bio-contamination control strategies.
[Mh] Termos MeSH primário: Contaminação de Medicamentos/prevenção & controle
Contaminação de Medicamentos/estatística & dados numéricos
Indústria Farmacêutica/instrumentação
Recall de Medicamento
Fungos/isolamento & purificação
[Mh] Termos MeSH secundário: Indústria Farmacêutica/normas
Fungos/classificação
Fungos/genética
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1612
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150630
[St] Status:MEDLINE
[do] DOI:10.1111/jam.12888


  9 / 105 MEDLINE  
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[PMID]:26960848
[Au] Autor:Beer AM
[Ti] Título:[Phytotherapy for control of nausea and vomiting].
[Ti] Título:Pflanzliches gegen Übelkeit und Erbrechen..
[So] Source:MMW Fortschr Med;157(21-22):26, 2015 Dec 14.
[Is] ISSN:1438-3276
[Cp] País de publicação:Germany
[La] Idioma:ger
[Mh] Termos MeSH primário: Náusea/tratamento farmacológico
Fitoterapia
Extratos Vegetais/uso terapêutico
Plantas Medicinais
Vômito/tratamento farmacológico
[Mh] Termos MeSH secundário: Recall de Medicamento
Substituição de Medicamentos
Seres Humanos
Metoclopramida/efeitos adversos
Metoclopramida/uso terapêutico
[Pt] Tipo de publicação:NEWS
[Nm] Nome de substância:
0 (Plant Extracts); L4YEB44I46 (Metoclopramide)
[Em] Mês de entrada:1605
[Cu] Atualização por classe:160310
[Lr] Data última revisão:
160310
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160311
[St] Status:MEDLINE
[do] DOI:10.1007/s15006-015-7592-z


  10 / 105 MEDLINE  
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[PMID]:26693573
[Ti] Título:Banned in one name, allowed under another.
[So] Source:J Am Vet Med Assoc;247(8):862, 2015 Oct 15.
[Is] ISSN:1943-569X
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Doenças do Gato/tratamento farmacológico
Doenças do Cão/tratamento farmacológico
Nefropatias/terapia
[Mh] Termos MeSH secundário: Animais
Gatos
Suplementos Nutricionais
Cães
Recall de Medicamento
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:NEWS
[Em] Mês de entrada:1607
[Cu] Atualização por classe:151222
[Lr] Data última revisão:
151222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:151224
[St] Status:MEDLINE



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