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1.
Neuropsychiatr ; 34(1): 1-4, 2020 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-31974929

RESUMO

Given an indication for pharmacological treatment, prescribers can only draw from a rather limited number of substances with a label for the treatment of children and adolescents suffering from psychiatric disorders. In order to capture the currently available substances with such a label in Austria and to thus provide one element of informed patient education, the Austrian medicinal product index of the Austrian Federal Office for Safety in Health Care has been systematically searched. The resulting tables are being presented.


Assuntos
Rotulagem de Medicamentos/legislação & jurisprudência , Transtornos Mentais/tratamento farmacológico , Psicotrópicos/uso terapêutico , Adolescente , Áustria , Criança , Humanos
2.
J Pharm Biomed Anal ; 177: 112877, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31568967

RESUMO

The present study aimed to design, develop, and optimize an analytical procedure to perform the quantitative determination of ecdysterone in commercially available dietary supplements. The newly developed procedure is based on the extraction of ecdysterone from the supplements and the subsequent analysis by an optimized UHPLC-MS/MS method. Chromatographic separation was performed on an Agilent Eclipse Plus C18 column (2.1 mm x 100 mm, particle size 1.8 µm). The mass spectrometer was operated in positive ionization mode (ESI+) with acquisition in dynamic multiple reaction monitoring (dMRM) mode. Using the protonated molecular ion [M+H]+ ecdysterone (target) and cortisol (internal reference) were detected at m/z 481 and 363, respectively. The assay was fully validated according to ICH guidelines and the method resulted to be fit for purpose in terms of accuracy and precision (CV% and RE% <15). Time-different intermediate precision was found within the reported range according to AOAC guideline for dietary supplements and botanicals. Quantitation has been performed using an external calibration considering the minimal matrix influences, preliminarily assessed following a cross comparison with an elaborate and time consuming standard addition method. The method was successfully applied to 12 different dietary supplements labelled to contain ecdysterone, showing an actual content generally much lower than the labelled one.


Assuntos
Suplementos Nutricionais/análise , Rotulagem de Medicamentos/normas , Ecdisterona/análise , Controle de Qualidade , Cromatografia Líquida de Alta Pressão/métodos , Suplementos Nutricionais/normas , Reprodutibilidade dos Testes , Espectrometria de Massas por Ionização por Electrospray/métodos , Espectrometria de Massas em Tandem/métodos
3.
BMC Bioinformatics ; 20(Suppl 21): 707, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31865904

RESUMO

BACKGROUND: Use of medication can cause adverse drug reactions (ADRs), unwanted or unexpected events, which are a major safety concern. Drug labels, or prescribing information or package inserts, describe ADRs. Therefore, systematically identifying ADR information from drug labels is critical in multiple aspects; however, this task is challenging due to the nature of the natural language of drug labels. RESULTS: In this paper, we present a machine learning- and rule-based system for the identification of ADR entity mentions in the text of drug labels and their normalization through the Medical Dictionary for Regulatory Activities (MedDRA) dictionary. The machine learning approach is based on a recently proposed deep learning architecture, which integrates bi-directional Long Short-Term Memory (Bi-LSTM), Convolutional Neural Network (CNN), and Conditional Random Fields (CRF) for entity recognition. The rule-based approach, used for normalizing the identified ADR mentions to MedDRA terms, is based on an extension of our in-house text-mining system, SciMiner. We evaluated our system on the Text Analysis Conference (TAC) Adverse Drug Reaction 2017 challenge test data set, consisting of 200 manually curated US FDA drug labels. Our ML-based system achieved 77.0% F1 score on the task of ADR mention recognition and 82.6% micro-averaged F1 score on the task of ADR normalization, while rule-based system achieved 67.4 and 77.6% F1 scores, respectively. CONCLUSION: Our study demonstrates that a system composed of a deep learning architecture for entity recognition and a rule-based model for entity normalization is a promising approach for ADR extraction from drug labels.


Assuntos
Rotulagem de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Aprendizado de Máquina , Mineração de Dados , Aprendizado Profundo , Estados Unidos , United States Food and Drug Administration
5.
Pediatrics ; 144(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31767714

RESUMO

Aluminum has no known biological function; however, it is a contaminant present in most foods and medications. Aluminum is excreted by the renal system, and patients with renal diseases should avoid aluminum-containing medications. Studies demonstrating long-term toxicity from the aluminum content in parenteral nutrition components led the US Food and Drug Administration to implement rules for these solutions. Large-volume ingredients were required to reduce the aluminum concentration, and small-volume components were required to be labeled with the aluminum concentration. Despite these rules, the total aluminum concentration from some components continues to be above the recommended final concentration. The concerns about toxicity from the aluminum present in infant formulas and antiperspirants have not been substantiated but require more research. Aluminum is one of the most effective adjuvants used in vaccines, and a large number of studies have documented minimal adverse effects from this use. Long-term, high-concentration exposure to aluminum has been linked in meta-analyses with the development of Alzheimer disease.


Assuntos
Alumínio/efeitos adversos , Soluções/química , Adjuvantes Farmacêuticos/química , Alumínio/análise , Alumínio/farmacocinética , Doença de Alzheimer , Antiperspirantes/química , Criança , Soluções para Diálise/química , Contaminação de Medicamentos/legislação & jurisprudência , Rotulagem de Medicamentos/legislação & jurisprudência , Regulamentação Governamental , Humanos , Lactente , Fórmulas Infantis/química , Recém-Nascido , Recém-Nascido Prematuro , Rim/metabolismo , Nefropatias/metabolismo , Nutrição Parenteral , Soluções/normas , Estados Unidos , United States Food and Drug Administration , Vacinas/química
10.
Artigo em Inglês | MEDLINE | ID: mdl-31547245

RESUMO

New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends and issues is a necessity. The objective of this study was to identify issues and future trends impacting drug safety using foresight methodologies. The study started by identifying global megatrends, trends in safety management of medicines, and key issues in drug safety. A total of 25 global megatrends were selected by extracting and clustering keywords from 26 reports concerning the future. Using the text-mining method, 10 trends in drug safety were identified from 3593 news articles. This study derived 60 issues which can arise from the trends, and finally, the 20 key issues with the highest urgency and impact scores were selected. Some examples of issues with high scores were as follows: illegal distribution of medicines, lack of technology for managing and utilizing big data, change in the pharmaceutical trade environment, lack of education and safety management for specific populations, lack of artificial intelligence-based technology for the safety management of medicines, and the prevalence of drug advertisements through social network services. The key issues could be used to establish plans for medication safety management.


Assuntos
Rotulagem de Medicamentos/métodos , Rotulagem de Medicamentos/normas , Guias como Assunto , Medicamentos sob Prescrição/normas , Gestão da Segurança/métodos , Gestão da Segurança/tendências , Previsões , Humanos , República da Coreia
11.
Am J Health Syst Pharm ; 76(19): 1521-1531, 2019 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-31532502

RESUMO

PURPOSE: Common bacterial infections in pediatric patients that the hospital pharmacist may encounter are reviewed, and guidance on the safe and effective use of antibiotics to treat those infections is provided. SUMMARY: Pharmacists play a key role in evaluating and creating antibiotic treatment plans for patients with infections. Bacterial infections are a common reason for hospital admission in pediatric patients, and pharmacists working in hospitals may be consulted to provide treatment and monitoring recommendations. It is important for pharmacists to be aware of similarities and differences in adult and pediatric populations with regard to presenting signs and symptoms of bacterial infections, common causative pathogens, and antibiotic selection, dosing, and monitoring. This article reviews current approaches to treatment of common bacterial infections in pediatric patients and also provides general suggestions for antibiotic use. CONCLUSION: Pharmacists have an opportunity to positively impact the care of pediatric patients with bacterial infections. Especially at facilities where pediatric patients are not regularly treated, pharmacists can potentially improve care through provision of recommendations for optimal antibiotic selection, dosing, and monitoring.


Assuntos
Antibacterianos/administração & dosagem , Infecções Bacterianas/tratamento farmacológico , Farmacêuticos/organização & administração , Serviço de Farmácia Hospitalar/organização & administração , Papel Profissional , Adulto , Fatores Etários , Antibacterianos/efeitos adversos , Infecções Bacterianas/diagnóstico , Criança , Relação Dose-Resposta a Droga , Cálculos da Dosagem de Medicamento , Rotulagem de Medicamentos/normas , Monitoramento de Medicamentos/normas , Humanos , Conduta do Tratamento Medicamentoso/organização & administração , Conduta do Tratamento Medicamentoso/normas , Serviço de Farmácia Hospitalar/normas , Guias de Prática Clínica como Assunto , Encaminhamento e Consulta
12.
BioDrugs ; 33(5): 447-451, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31388968

RESUMO

The status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians.


Assuntos
Produtos Biológicos , Aprovação de Drogas , Insulinas , Produtos Biológicos/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Rotulagem de Medicamentos , Humanos , Insulinas/uso terapêutico , Patient Protection and Affordable Care Act , Estados Unidos , United States Food and Drug Administration
13.
BMC Public Health ; 19(1): 1037, 2019 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-31375089

RESUMO

BACKGROUND: Patient package inserts (PPIs) should provide accurate, sufficient, and clear information for patients as well as health care professionals. The goal of this study was to evaluate and compare the PPIs of local and imported anti-diabetic agents in the Palestinian market. METHODS: Eighteen leaflets were collected and analysed based on the completeness of 31 criteria using a scoring method, then the quantity of information was assessed by applying word counting of 17 headings and subheadings. Statistical comparisons of the word count for all products were performed using the Mann-Whitney U test with mean ranks. Then the mean ranks for differences in word counts were adjusted to calculate the fold-difference statistic by dividing the higher mean rank by the lower mean rank. RESULTS: In general, the PPIs of imported agents scored better than local PPIs, but none of the inserts fulfilled the whole criteria. Thirteen out of thirty-one criteria were available in all products. None of these agents had provided any information about duration of use, instructions to convert tablets into liquids forms, pharmacokinetics, or shelf life. Moreover, mechanism of action and maximum dose were deficient in all local PPIs (0.0%), while they were included in 37.5 and 62.5% of imported PPIs, respectively. Furthermore, 90.0% of local PPIs lacked information about drug dose, 80.0% didn't mention any instructions regarding effects on ability to drive or possibility of tablet splitting, and 60.0% didn't involve orders about possibility of tablet crushing. Local PPIs provided inadequate and less detailed instructions regarding many aspects, since the estimated mean rank of local and imported PPIs demonstrated a range of difference from 1.04-fold for missing dose to 2.64-fold for warning and precautions. CONCLUSIONS: Significant differences were being identified, with excellence being assigned to imported PPIs. So, it is worth suggesting some necessary modifications in PPI topography and sequence structure of local diabetic agents. Experts in Palestinian Ministry of Health should implement regulatory guidelines to improve the quality and quantity of information provided by local PPIs. This optimisation could become a step forward toward optimal health practice in our society.


Assuntos
Rotulagem de Medicamentos/normas , Hipoglicemiantes , Administração Oral , Comércio/estatística & dados numéricos , Humanos , Hipoglicemiantes/administração & dosagem , Oriente Médio
14.
Expert Rev Clin Pharmacol ; 12(10): 1003-1007, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31437412

RESUMO

Introduction: The choice of the proper intrathecal drug to treat neuropathic pain has been subject to much debate in recent years. Areas Covered: Currently, the United States Food and Drug Administration (USFDA) has approved two drugs for chronic intrathecal use for the treatment of pain; however, there has been substantial growth in the development of other intrathecal drugs that can be used for neuropathic pain. We performed a PubMed literature search looking at intrathecal drug research for neuropathic pain between January 2005 to May 2019 and discuss current practices and mechanisms in treating these complex patients. Expert Opinion: On-label intrathecal drugs are recommended if efficacious with acceptable side effects. In those suffering from neuropathic pain, clinical evidence suggests additional drug algorithms for treating these patients are necessary. There is ample room for growth in the development and approval of novel drugs for intrathecal delivery to manage neuropathic pain.


Assuntos
Analgésicos/administração & dosagem , Desenvolvimento de Medicamentos/métodos , Neuralgia/tratamento farmacológico , Analgésicos/efeitos adversos , Animais , Aprovação de Drogas , Rotulagem de Medicamentos , Humanos , Injeções Espinhais , Estados Unidos , United States Food and Drug Administration
15.
Adv Exp Med Biol ; 1145: 133-141, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31364076

RESUMO

Two different labelling conventions for the contents of colistin methanesulfonate (i.e. colistin base activity [CBA] and international unit [IU]) are used in different parts of the world, and have caused prescribing errors and patient safety issues. This chapter discusses the key issues on the conversion between CBA and IU, and highlights that in pharmacokinetic analyses only the absolute mass of the chemical colistin methanesulfonate should be employed, but not the CBA or IU values. The scientific evidence is unknown for the limits specified for the pharmacopeial standards of the major components of colistin methanesulfonate and polymyxin B. The package information of parenteral colistin methanesulfonate in Europe has now been significantly improved by incorporating the latest pharmacokinetic/pharmacodynamic data. However, the current package information of almost all different brands of parenteral polymyxin B products is substantially out of date without solid pharmacological data. Updating the package information of different products of both polymyxins requires the coordination between major regulatory authorities and will significantly facilitate the optimisation of their use in patients.


Assuntos
Antibacterianos , Rotulagem de Medicamentos/normas , Erros de Medicação , Polimixinas , Europa (Continente) , Humanos
16.
J Clin Psychopharmacol ; 39(5): 494-498, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31425464

RESUMO

PURPOSE/BACKGROUND: Long-acting injectable antipsychotics (LAIAs) are used in the management of schizophrenia, bipolar disorder, and related psychiatric conditions. The efficacy of LAIAs has been established in randomized controlled trials; however, usage of LAIAs outside of randomized controlled trials may not correlate to naturalistic prescribing habits. The purpose of this analysis was to evaluate the prescribing patterns of LAIAs within our health system and identify any inconsistencies between medications' published labeling information and clinical practice. METHODS/PROCEDURES: All patients who received a LAIA at the time of the analysis were included for review. Areas of inconsistency between the prescribed LAIA and each medication's published labeling information were targeted and assessed. Frequency statistics were used to review the following areas for inconsistencies: indication, trial of oral therapy, dose, frequency, and titration method. FINDINGS/RESULTS: This analysis included 427 patient cases who received a combined 1480 injections during the analysis period. Overall consistency rates between labeling information and prescribed LAIAs within the analysis period were as follows: 71.2% for indication, 67.4% for trial of oral therapy, 94.4% for dose of LAIA, 84.5% for injection frequency, and 93.9% for titration method. IMPLICATIONS/CONCLUSIONS: Inconsistencies were observed between labeling information and clinical practice for LAIAs prescribed within the community health system. Patients who are more symptomatic and have additional psychological comorbidities are commonly excluded from clinical trials. Alternative dosing may be clinically necessary to obtain an adequate response, and this may have been captured in this review. This analysis may be hypothesis generating for future studies on LAIAs.


Assuntos
Antipsicóticos/uso terapêutico , Serviços de Saúde Comunitária , Transtornos Mentais/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Preparações de Ação Retardada , Rotulagem de Medicamentos , Feminino , Humanos , Injeções , Masculino , Estudos Retrospectivos
18.
Clin Cardiol ; 42(10): 873-880, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31317562

RESUMO

BACKGROUND: Rivaroxaban is a non-vitamin K oral anticoagulant and has been approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). Current labeling recommends 20 mg once a day (q.d.) as a standard dose and a reduced dose of 15 mg q.d. in patients with renal impairment. HYPOTHESIS: The aim of this study was to analyze the adherence to current labeling concerning initial rivaroxaban dosing and to determine whether potential lack of such adherence is medically justified. METHODS: Patients with AF initiated on rivaroxaban between January 1, 2016 and January 31, 2017, were identified in the Heart Center Leipzig database. Health records were screened to identify prescribed rivaroxaban dose, presence or absence of renal impairment, patient characteristics, further dosing-relevant diagnoses and co-medication with antiplatelet drugs and non-vitamin K oral anticoagulants (NOACs). RESULTS: We identified a total of 378 consecutive patients. In 282 cases (74.6%), rivaroxaban was prescribed in a standard dose and in 96 (25.4%) in a reduced dose. Out of 96 patients receiving a reduced dose, 50 (52.1%) did not meet labeling criteria for dose reduction. In uni- and multivariate regression analysis, estimated glomerular filtration rate (eGFR) (odds ratio [OR] 0.34, 95% confidence interval [CI] 0.12-0.95, P = .04) was the only independent predictor of rivaroxaban underdosage. CONCLUSIONS: In clinical practice, rivaroxaban dosing is frequently incoherent with labeling. In this study, rivaroxaban was often administered underdosed. Potentially inappropriate dose reduction was significantly associated with eGFR, the same factor that is used as criterion for dose adjustment.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Rivaroxabana/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Fibrilação Atrial/complicações , Relação Dose-Resposta a Droga , Rotulagem de Medicamentos/métodos , Inibidores do Fator Xa/administração & dosagem , Feminino , Seguimentos , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/etiologia
19.
Clin Drug Investig ; 39(11): 1057-1066, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31325111

RESUMO

BACKGROUND AND OBJECTIVE: Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures. METHODS: In Belgium, France, Germany, Spain, and the UK, surveys were conducted to assess physicians' knowledge on the updated domperidone labeling information, and a drug-utilization study (DUS) was conducted using healthcare databases to assess domperidone prescribing patterns before and after the RMM. Four DUS sensitivity analyses (scenarios) evaluated uncertainty regarding domperidone treatment duration and indication. RESULTS: Among 1805 physicians participating in the survey, most were aware of the approved indication (nausea and vomiting, 80%), treatment duration (≤ 7 days, 70%), and maximum adult daily dose (10 mg three times daily, 84%). Only 33% selected the on-label indication from a list of indications for which they would prescribe domperidone. Awareness was low for medications contraindicated for concomitant use (26%) and contraindicated conditions (4%). In the DUS, under the optimistic scenario, a large improvement in labeling compliance from pre- to post-implementation period was observed in France (27% vs. 69%), while Belgium, Germany, Spain, and the UK showed small improvements (< 10%). In the other scenarios, there was little to no improvement in compliance with the revised labeling from the pre- to post-implementation periods in most countries. CONCLUSIONS: The survey findings documented that most physicians in all five countries were aware of the main aspects of the revised labeling. Results of the DUS were inconclusive regarding the effect of the RMM and compliance with the revised labeling for all countries except France.


Assuntos
Antieméticos/uso terapêutico , Domperidona/uso terapêutico , Rotulagem de Medicamentos/normas , Uso de Medicamentos/normas , Médicos/normas , Adulto , Antieméticos/efeitos adversos , Arritmias Cardíacas/induzido quimicamente , Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/prevenção & controle , Doença do Sistema de Condução Cardíaco/induzido quimicamente , Doença do Sistema de Condução Cardíaco/epidemiologia , Doença do Sistema de Condução Cardíaco/prevenção & controle , Estudos Transversais , Morte Súbita Cardíaca/etiologia , Domperidona/efeitos adversos , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Náusea/tratamento farmacológico , Náusea/epidemiologia , Estudos Retrospectivos , Medição de Risco , Inquéritos e Questionários , Vômito/tratamento farmacológico , Vômito/epidemiologia
20.
Skin Therapy Lett ; 24(4): 1-4, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31339678

RESUMO

The interleukin (IL)-17 inhibitors have proven to be highly effective in the treatment of psoriasis. The most recently approved agent, brodalumab, had few cases of suicidal behavior, including completed suicide, in the phase 3 clinical program leading both the US FDA and Health Canada to add a boxed warning to its label. This raises the importance of identifying the psychiatric comorbidities associated with psoriasis. It is also necessary to critically examine the data from the brodalumab clinical trial program to determine whether there is enough information to establish causality and whether other factors, other than the drug, could be playing a role.


Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Psoríase/tratamento farmacológico , Ideação Suicida , Suicídio/estatística & dados numéricos , Anticorpos Monoclonais Humanizados/administração & dosagem , Canadá , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Rotulagem de Medicamentos , Humanos , Interleucina-17/imunologia
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