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2.
Farm Hosp ; 44(7): 17-20, 2020 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-32533663

RESUMO

COVID crisis has abruptly broken into our hospitals, and many difficulties have  emerged, including those related to supply logistics. A huge number of new  patients, a fast internal reorganization process and many other changes were  suddenly established. These circumstances revealed the need to increase stocks  of drugs, both for basic treatment as well as for specific SARS-CoV-2 infection  management. At the same time, other problems (shortages, new and complex  purchasing procedures, etc.) surfaced, so they could risk safety along the  pharmacotherapeutic process. The main objective was to develop and implement all the necessary measures within the logistics circuit in order to ensure the  availability of medicines for patients, as safely and effectively as possible, during the Coronavirus crisis. Firstly, two pharmacists were appointed to coordinate the whole process, and a preliminary analysis of the following aspects was carried  out an estimation of needs to make an initial drug provisioning, a storage  feasibility study and a global analysis of the logistics process to detect critical  points. Three different circuits for medicines supply were established as some  drugs were operated by Agencia Española de Medicamentos y Productos  Sanitarios (AEMPS) or Servicio Madrileño de Salud (SERMAS), and others were  under no restrictions. For stocks control, inventory was frequently reviewed and  monitoring of prescription trends was implemented. For all new medicinal  products, compliance with security standards was reviewed and relabeling was  carried out if necessary. Criteria were defined for the storage of overstocks and  it was placed an isolated area for quarantined drugs. Shortages inevitably  occurred but their effects were partly mitigated by AEMPS and SERMAS. After  all, we consider that the implemented procedure for logistics management may  be reproducible, and the key points we have identified are the following: to  enhance our quality management system, to develop an Action Plan for  Healthcare Emergencies and to ensure the adequate training for all pharmacy  staff. Furthermore, we also should address other aspects: to establish storage  optimization strategies, to focus on a more advanced logistics management  model, as well as to take advantage of the extraordinary multidisciplinary  network, which has been consolidated during this COVID pandemic.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Pandemias , Preparações Farmacêuticas/provisão & distribução , Serviço de Farmácia Hospitalar/organização & administração , Pneumonia Viral , Antivirais/provisão & distribução , Antivirais/uso terapêutico , Infecções por Coronavirus/complicações , Infecções por Coronavirus/tratamento farmacológico , Planejamento em Desastres , Rotulagem de Medicamentos , Prescrições de Medicamentos/estatística & dados numéricos , Armazenamento de Medicamentos , Educação Continuada em Farmácia , Necessidades e Demandas de Serviços de Saúde , Humanos , Comunicação Interdisciplinar , Inventários Hospitalares , Pneumonia Viral/complicações , Pneumonia Viral/tratamento farmacológico , Gestão da Qualidade Total
4.
N Engl J Med ; 382(22): 2129-2136, 2020 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-32459923

RESUMO

BACKGROUND: The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use. METHODS: In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval. RESULTS: The results for performance on six primary end points met or exceeded thresholds, including the steps "Check for a suspected overdose" (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and "Give the first dose" (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of "Call 911 immediately," but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of "Check, give, and call 911 immediately" (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9). CONCLUSIONS: Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.


Assuntos
Analgésicos Opioides/envenenamento , Compreensão , Rotulagem de Medicamentos , Overdose de Drogas/tratamento farmacológico , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Medicamentos sem Prescrição/uso terapêutico , Adolescente , Adulto , Rotulagem de Medicamentos/legislação & jurisprudência , Overdose de Drogas/terapia , Regulamentação Governamental , Humanos , Entrevistas como Assunto , Estados Unidos , United States Food and Drug Administration
5.
Psychother Psychosom ; 89(4): 200-214, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32289791

RESUMO

Using Richardson and Davidson's model and the sciences of pharmacokinetics and clinical pharmacopsychology, this article reviewed the: (1) poor life expectancy associated with treatment-resistant schizophrenia (TRS), which may be improved in patients who adhere to clozapine; (2) findings that clozapine is the best treatment for TRS (according to efficacy, effectiveness and well-being); and (3) potential for clozapine to cause vulnerabilities, including potentially lethal adverse drug reactions such as agranulocytosis, pneumonia, and myocarditis. Rational use requires: (1) modification of the clozapine package insert worldwide to include lower doses for Asians and to avoid the lethality associated with pneumonia, (2) the use of clozapine levels for personalizing dosing, and (3) the use of slow and personalized titration. This may make clozapine as safe as possible and contribute to increased life expectancy and well-being. In the absence of data on COVID-19 in clozapine patients, clozapine possibly impairs immunological mechanisms and may increase pneumonia risk in infected patients. Psychiatrists should call their clozapine patients and families and explain to them that if the patient develops fever or flu-like symptoms, the psychiatrist should be called and should consider halving the clozapine dose. If the patient is hospitalized with pneumonia, the treating physician needs to assess for symptoms of clozapine intoxication since halving the dose may not be enough for all patients; consider decreasing it to one-third or even stopping it. Once the signs of inflammation and fever have disappeared, the clozapine dose can be slowly increased to the prior dosage level.


Assuntos
Antipsicóticos/efeitos adversos , Clozapina/efeitos adversos , Pneumonia/induzido quimicamente , Esquizofrenia/tratamento farmacológico , Antipsicóticos/administração & dosagem , Antipsicóticos/farmacocinética , Grupo com Ancestrais do Continente Asiático , Clozapina/administração & dosagem , Clozapina/farmacocinética , Infecções por Coronavirus/epidemiologia , Rotulagem de Medicamentos , Humanos , Pandemias , Pneumonia Viral/epidemiologia , Psiquiatria
6.
Life Sci ; 251: 117631, 2020 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-32251635

RESUMO

Initially, the selective COX-2 inhibitors were developed as safer alternatives to the conventional NSAIDs, but later on, most of them were withdrawn from the market due to the risk of heart attack and stroke. Celecoxib, the first selective COX-2 inhibitor, was approved by the Food and Drug Administration (FDA) in December 1998 and was taken back from the market in 2004. Since then, many coxibs have been discontinued one by one due to adverse cardiovascular events. United States (US), Australian and European authorities related to Therapeutic Goods Administration (TGA) implemented the requirements to carry the "Black box" warning on the labels of COX-2 drugs highlighting the risks of serious cardiovascular events. These facts encouraged the researchers to explore them well and find out the biochemical basis behind the cardiotoxicity. From the last few decades, the molecular mechanisms behind the coxibs have regained the attention, especially the specific structural features of the selective COX-2 inhibitors that are associated with cardiotoxicity. This review discusses the key structural features of the selective COX-2 inhibitors and underlying mechanisms that are responsible for the cardiotoxicity. This report also unfolds different strategies that have been reported in the last 10 years to combat the problem of selective COX-2 inhibitors mediated cardiotoxicity.


Assuntos
Cardiotoxicidade/etiologia , Inibidores de Ciclo-Oxigenase 2/efeitos adversos , Cardiotoxicidade/fisiopatologia , Cardiotoxicidade/prevenção & controle , Celecoxib/administração & dosagem , Celecoxib/efeitos adversos , Inibidores de Ciclo-Oxigenase 2/administração & dosagem , Inibidores de Ciclo-Oxigenase 2/química , Rotulagem de Medicamentos , Humanos
7.
Pediatrics ; 145(4)2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32127360

RESUMO

BACKGROUND: Orphan drug development is crucial for children, who are disproportionately affected by rare diseases. Data are lacking on the number, nature, and benefit of recently approved pediatric orphan indications. METHODS: We classified the 402 orphan indications the US Food and Drug Administration approved between 2010 and 2018 as "pediatric" if they were approved for children only or targeted pediatric diseases. We determined the number of unique diseases targeted by pediatric orphan indications and calculated the proportion that were for (1) novel drugs, (2) non-novel drugs approved to treat ≥1 common disease, and (3) non-novel drugs approved only to treat rare diseases. Among pediatric orphan indications eligible for US Food and Drug Administration breakthrough designation (granted to drugs potentially representing major therapeutic advances), we calculated the proportion receiving this designation. RESULTS: Of the 402 orphan indications, 136 (33.8%) were pediatric. These 136 indications targeted 87 unique diseases; 21 diseases were targeted by ≥1 indication. Of the 136 pediatric orphan indications, 60 (44.1%) were for novel drugs, 45 (33.1%) were for non-novel drugs approved to treat ≥1 common disease, and 31 (22.8%) were for non-novel drugs approved only to treat rare diseases. Among 97 indications eligible for breakthrough designation, 20 (20.6%) received this designation. CONCLUSIONS: Recent orphan drug development has increased the availability of treatments for pediatric rare diseases. Most pediatric orphan indications expanded use of existing drugs, and many targeted the same disease. Some indications may represent breakthroughs, but substantial unmet need for treatments remains for most pediatric rare diseases.


Assuntos
Aprovação de Drogas/estatística & dados numéricos , Produção de Droga sem Interesse Comercial/estatística & dados numéricos , Doenças Raras/tratamento farmacológico , Criança , Rotulagem de Medicamentos/estatística & dados numéricos , Humanos , Produção de Droga sem Interesse Comercial/classificação , Estados Unidos
10.
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
11.
PLoS One ; 15(1): e0227687, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31935254

RESUMO

BACKGROUND: Data on off-label and unlicensed prescribing in children in Indonesia is limited. The aims of this study were to determine the prevalence of off-label and unlicensed prescribing for paediatric patients in a public hospital, Indonesia. METHOD: A retrospective cross-sectional study of 200 randomly selected paediatric patients admitted to hospital between August and October 2014, collected patient details and all drugs prescribed. Licensed drugs were classified as off-label if there was a non-compliance with the Product Information for age, weight, indication, dose, frequency and route of administration, if there was a contraindication, special precautions or not recommended for children. Unlicensed drugs were those not approved for use in Indonesia. The main outcome was the prevalence of off-label or unlicensed prescribing to infants, children and adolescents and the impact of age group on off-label prescribing. RESULTS: A total of 200 patients received 1961 medicines of which 1807/1961 (92.1%) were licensed and 154/1961 (7.9%) were unlicensed. There were 1403/1961 (71.5%) drugs prescribed off-label. More than half of the total drugs (n = 1066; 54.4%) were administered parenterally. Every patient was prescribed at least one off-label drug. Indication (n = 810; 34.6%) was the most common reason for off-label prescribing. Ranitidine was the most frequent drug prescribed off label. Darplex® (dihydroartemisinin and piperaquine), although manufactured in Indonesia, was unlicensed. There was a significant difference between age group and off-label prescribing in that children were prescribed significantly less off-label drugs (p<0.0003). CONCLUSION: This study revealed a high prevalence of off-label and unlicensed drug use in paediatric patients in this hospital, exposing them to drug treatments or regimens that had not been approved by regulatory authorities. The high incidence of invasive parenteral prescribing is of concern for paediatric patients. Incentives are needed to encourage specific drug evaluation in paediatric populations.


Assuntos
Prescrição Inadequada/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Adolescente , Criança , Pré-Escolar , Estudos Transversais , Aprovação de Drogas , Rotulagem de Medicamentos , Feminino , Hospitais , Humanos , Prescrição Inadequada/ética , Incidência , Indonésia , Lactente , Recém-Nascido , Masculino , Uso Off-Label/ética , Preparações Farmacêuticas , Prevalência , Estudos Retrospectivos
12.
Expert Opin Pharmacother ; 21(5): 517-522, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31971450

RESUMO

Introduction: Current therapies of postoperative nausea and vomiting (PONV) are based on a combination of antiemetics from different pharmacological classes. Dopamine receptor antagonists are one of the cornerstones of such multimodal antiemetic approach, with droperidol being the best studied representative of this group. Droperidol's use has significantly declined after the FDA's black-box warning in 2001 due to its QT-prolonging properties. Amisulpride is a promising antiemetic agent which could fill this gap.Areas covered: In this review, the authors discuss the pharmacological profile as well as clinical safety and efficacy of intravenous amisulpride and its relevance in the management of PONV. The article is based on a Medline, ClinicalTrials.gov, and Cochrane Library search for studies on amisulpride conducted so far.Expert opinion: Promising clinical results on Barhemsys®, an intravenous formulation of amisulpride, make it a potential future drug of choice from the dopamine receptor antagonist group, replacing droperidol after its safety concerns. Amisulpride's success on the market will mostly be determined by its cost-effectiveness and it will likely find a brighter use on the US-market, where the black-box warning led to droperidol's withdrawal, while in many European countries, droperidol is still being used as an antiemetic.


Assuntos
Amissulprida/uso terapêutico , Antieméticos/uso terapêutico , Antagonistas de Dopamina/uso terapêutico , Náusea e Vômito Pós-Operatórios/tratamento farmacológico , Administração Intravenosa , Amissulprida/administração & dosagem , Amissulprida/efeitos adversos , Antieméticos/administração & dosagem , Antieméticos/efeitos adversos , Análise Custo-Benefício , Antagonistas de Dopamina/administração & dosagem , Antagonistas de Dopamina/efeitos adversos , Droperidol/administração & dosagem , Droperidol/efeitos adversos , Droperidol/uso terapêutico , Rotulagem de Medicamentos , Humanos , Náusea e Vômito Pós-Operatórios/prevenção & controle , Estados Unidos , United States Food and Drug Administration
13.
Acta Haematol ; 143(1): 73-77, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31167178

RESUMO

The prevalence of safety-related postmarketing label modifications of medications for hematological malignancies is unknown. We identified 35 new drugs indicated for hematological malignancies approved by the US Food and Drug Administration between January 1999 and December 2014. Characteristics of supporting trials and safety-related label modifications from approval to December 2017 were collected from drug labels. Regulatory review and approval pathways were also collected. New drug approvals were supported by trials with a median of 167 patients (interquartile range 115-316). All drugs were approved based on surrogate endpoints. Twenty-seven drug approvals (77%) were not supported by randomized controlled trials. All drugs received orphan drug designation, and most were granted fast track designation, priority review, and accelerated approval (83, 74, and 60%, respectively). A total of 28 drugs (80%) had postmarketing safety-related label modifications. Additions to black box warnings, contraindications, warnings and precautions, and common adverse reactions were identified in 31, 11, 77, and 46% of drugs, respectively. Five drugs (14%) were permanently or temporarily withdrawn from the US market. Drugs for hematological malignancies are often approved based on limited evidence through expedited regulatory pathways with incomplete safety profiles. Hematologists should be vigilant for unrecognized side effects when prescribing newly approved drugs.


Assuntos
Antineoplásicos/efeitos adversos , Rotulagem de Medicamentos/legislação & jurisprudência , Neoplasias Hematológicas/patologia , Antineoplásicos/uso terapêutico , Biomarcadores , Aprovação de Drogas , Neoplasias Hematológicas/tratamento farmacológico , Humanos , Vigilância de Produtos Comercializados , Estados Unidos , United States Food and Drug Administration
14.
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
16.
Pharmacol Res Perspect ; 7(6): e00541, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31844524

RESUMO

Clinically relevant adverse drug reactions differ between men and women. The underlying physiological and pharmacological processes contributing to these differences are infrequently studied or reported. As gene expression, cellular regulatory pathways, and integrated physiological functions differ between females and males, aggregating data from combined groups of men and women obscures the ability to detect these differences. This paper summarizes how genetic sex, that is, the presence of sex chromosomes XY for male or XX for female, and the influence of sex hormones affect transporters, receptors, and enzymes involved in drug metabolism. Changing levels of sex steroids throughout life, including increases at puberty, changes with pregnancy, and decreases with age, may directly and indirectly affect drug absorption, distribution, metabolism, and elimination. The direct and indirect effects of sex steroids in the form of exogenous hormones such as those used in hormonal contraceptives, menopausal hormone treatments, transgender therapy, and over-the-counter performance enhancing drugs may interfere with metabolism of other pharmaceuticals, and these interactions may vary by dose, formulation, and mode of delivery (oral, injection, or transdermal) of the steroid hormones. Few drugs have sex-specific labeling or dosing recommendations. Furthermore, there is limited literature evaluating how the circulating levels of sex steroids impact drug efficacy or adverse reactions. Such research is needed in order to improve the understanding of the impact of sex hormones on pharmacological therapies, particularly as medicine moves toward individualizing treatments.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Hormônios Esteroides Gonadais/metabolismo , Medicina de Precisão/normas , Projetos de Pesquisa/normas , Interações Medicamentosas , Rotulagem de Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/metabolismo , Feminino , Regulação da Expressão Gênica/fisiologia , Hormônios Esteroides Gonadais/sangue , Humanos , Masculino , Processos de Determinação Sexual/fisiologia , Fatores Sexuais
17.
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 , Redes Neurais de Computação , Estados Unidos , United States Food and Drug Administration
19.
Indian J Med Ethics ; 4(3): 183-193, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31727614

RESUMO

This paper provides a review of Purdue Pharma, LP's development and marketing of the long-acting oral narcotic OxyContin®. Within five years of the drug's launch, OxyContin® became the number-one prescribed Schedule II narcotic in the United States. This commercial success was in part the result of a marketing campaign that promoted questionably "distinctive" benefits and minimised the very real dangers of OxyContin®, which include abuse, addiction, overdose, and death. The marketing was based on scientifically invalid or unproven claims of safety and efficacy, inappropriate, off-label marketing, and inadequate warnings. When the FDA belatedly asked for changes to some of the marketing language, Purdue exploited these changes to further marketing objectives and misled healthcare practitioners. This case highlights questions of industry and governmental/regulatory accountability and responsibility for the production, marketing and sale of pharmaceutical products that increase risk while driving enhanced profits.


Assuntos
Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/economia , Rotulagem de Medicamentos/ética , Marketing/ética , Oxicodona/efeitos adversos , Oxicodona/economia , Decepção , Rotulagem de Medicamentos/legislação & jurisprudência , Humanos , Marketing/legislação & jurisprudência , Transtornos Relacionados ao Uso de Opioides/complicações , Responsabilidade Social , Transtornos Relacionados ao Uso de Substâncias/complicações , Estados Unidos , United States Food and Drug Administration
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