Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 6.998
Filtrar
1.
Am J Nurs ; 121(3): 22-23, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33625005

RESUMO

The boxed warning for drugs in the benzodiazepine class has been strengthened to further emphasize the risk of overdose and death, especially if combined with opioids, alcohol, or illicit drugs, and the risk of abuse, misuse, addiction, physical dependence, and withdrawal.


Assuntos
Benzodiazepinas/efeitos adversos , Rotulagem de Medicamentos , Overdose de Drogas/prevenção & controle , Uso Indevido de Medicamentos sob Prescrição/prevenção & controle , Humanos , Padrões de Prática Médica , Insuficiência Respiratória/etiologia
2.
J Ethnopharmacol ; 272: 113957, 2021 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-33631276

RESUMO

ETHNOPHARMACOLOGICAL RELEVANCE: The novel coronavirus disease (COVID-19) outbreak in Wuhan has imposed a huge influence in terms of public health and economy on society. However, no effective drugs or vaccines have been developed so far. Traditional Chinese Medicine (TCM) has been considered as a promising supplementary treatment of this disease due to its clinically proven performance in many severe diseases, like severe acute respiratory syndrome (SARS). Meanwhile, many reports suggest that the side-effects (SE) of TCM prescriptions cannot be ignored in treating COVID-19 as it often leads to dramatic degradation of the patients' physical condition. Systematic evaluation of TCM regarding its latent SE becomes a burning issue. AIM: In this study, we used an ontology-based side-effect prediction framework (OSPF) developed from our previous work and Artificial Neural Network (ANN)-based deep learning, to evaluate the TCM prescriptions officially recommended by China for the treatment of COVID-19. MATERIALS AND METHODS: The OSPF developed from our previous work was implemented in this study, where an ontology-based model separated all ingredients in a TCM prescription into two categories: hot and cold. A database was created by converting each TCM prescription into a vector which contained ingredient dosages, corresponding hot/cold attribution and safe/unsafe labels. This allowed for training of the ANN model. A safety indicator (SI), as a complement to SE possibility, was then assigned to each TCM prescription. According to the proposed SI, from high to low, the recommended prescription list could be optimized. Furthermore, in interest of expanding the potential treatment options, SIs of other well-known TCM prescriptions, which are not included in the recommended list but are used traditionally to cure flu-like diseases, are also evaluated via this method. RESULTS: Based on SI, QFPD-T, HSBD-F, PMSP, GCT-CJ, SF-ZSY, and HSYF-F were the safest treatments in the recommended list, with SI scores over 0.8. PESP, QYLX-F, JHQG-KL, SFJD-JN, SHL-KFY, PESP1, XBJ-ZSY, HSZF-F, PSSP2, FFTS-W, and NHSQ-W were the prescriptions most likely to be unsafe, with SI scores below 0.1. In the additional lists of other TCM prescriptions, the indicators of XC-T, SQRS-S, CC-J, and XFBD-F were all above 0.8, while QF-Y, XZXS-S, BJ-S, KBD-CJ, and QWJD-T's indicators were all below 0.1. CONCLUSIONS: In total, there were 10 TCM prescriptions with indicators over 0.8, suggesting that they could be considered in treating COVID-19, if suitable. We believe this work could provide reasonable suggestions for choosing proper TCM prescriptions as a supplementary treatment for COVID-19. Furthermore, this work introduces a novel and informative method which could help create recommendation list of TCM prescriptions for the treatment of other diseases.


Assuntos
/tratamento farmacológico , Medicina Tradicional Chinesa/efeitos adversos , China , Bases de Dados Factuais , Aprendizado Profundo , Rotulagem de Medicamentos , Medicamentos de Ervas Chinesas/farmacologia , Humanos , Redes Neurais de Computação , Padrões de Referência
3.
BMC Health Serv Res ; 21(1): 89, 2021 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-33499869

RESUMO

BACKGROUND: The indication for prescribing a particular medication, or its reason for use (RFU) is a crucial piece of information for all those involved in the circle of care. Research has shown that sharing RFU information with physicians, pharmacists and patients improves patient safety and patient adherence, however RFU is rarely added on prescriptions by prescribers or on medication labels for patients to reference. METHODS: Qualitative interviews were conducted with 20 prescribers in Southern Ontario, Canada, to learn prescribers' current attitudes on the addition of RFU on prescriptions and medication labels. A trained interviewer used a semi-structured interview guide for each interview. The interviews explored how the sharing of RFU information would impact prescribers' workflows and practices. Interviews were recorded, transcribed and thematically coded. RESULTS: The analysis yielded four main themes: Current Practice, Future Practice, Changing Culture, and Collaboration. Most of the prescribers interviewed do not currently add RFU to prescriptions. Prescribers were open to sharing RFU with colleagues via a regional database but wanted the ability to provide context for the prescribed medication within the system. Many prescribers were wary of the impact of adding RFU on their workflow but felt it could save time by avoiding clarifying questions from pharmacists. Increased interprofessional collaboration, increased patient understanding of prescribed medications, avoiding guesswork when determining indications and decreased misinterpretation regarding RFU were cited by most prescribers as benefits to including RFU information. CONCLUSIONS: Prescribers were generally open to sharing RFU and clearly identified the benefits to pharmacists and patients if added. Critically, they also identified benefits to their own practices. These results can be used to guide the implementation of future initiatives to promote the sharing of RFU in healthcare teams.


Assuntos
Rotulagem de Medicamentos , Prescrições de Medicamentos , Humanos , Ontário , Equipe de Assistência ao Paciente , Segurança do Paciente , Medicamentos sob Prescrição
6.
Zhongguo Zhong Yao Za Zhi ; 45(17): 4277-4284, 2020 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-33164415

RESUMO

To introduce current literature reporting situations of the off-label drug use(OLDU) by analyzing relevant literatures published in China, this study comprehensively focused on literatures about OLDU in China in seven Chinese and English databases, then extracted and analyzed the data by different literature types. A total of 667 papers were analyzed. The number of literatures about OLDU data analyzed in hospitals was 325, and the number of clinical studies relating to OLDU was 329, in which case series and case reports were the majority(69.91%). In addition, there were 13 expert consensuses of OLDU and another 56 studies about drug use based on the real-world data characteristics and influencing factors. The number of OLDU data studies has increased year by year. Based on the existing studies, there were more western medicine reports than traditional Chinese medicines, and OLDU types were mainly for over-dosage use. The literatures from OLDU data in hospital were mostly limited to one or several tertiary hospitals in a certain area, and the OLDU types were not uniform. Clinical studies were mainly clinical control trials and case series/reports, but with contradictory reporting results. There were fewer OLDU consensus, and the recommended classification was not uniform. The characteristics and analysis of influencing factors of drug using data in real-world focused on traditional Chinese medicine injections, and the results were not the same. In the future, we shall pay more attention to and strengthen reporting and analysis of OLDU, define study objectives, and unify the content and reporting standards, so as to promote the integrated utilization of OLDU data and reflect real situations in our country.


Assuntos
Rotulagem de Medicamentos , Uso Off-Label , China , Consenso , Medicina Tradicional Chinesa
11.
Anesth Analg ; 131(4): 1193-1200, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925340

RESUMO

BACKGROUND: While US Food and Drug Administration (FDA) black box warnings are common, their impact on perioperative outcomes is unclear. Hydroxyethyl starch (HES) is associated with increased bleeding and kidney injury in patients with sepsis, leading to an FDA black box warning in 2013. Among patients undergoing musculoskeletal surgery in a subset of hospitals where colloid use changed from HES to albumin following the FDA warning, we examined the rate of major perioperative bleeding post- versus pre-FDA warning. METHODS: The authors of this article used a retrospective, quasi-experimental, repeated cross-sectional, interrupted time series study of patients undergoing musculoskeletal surgery in hospitals within the Premier Healthcare Database, in the year before and year after the 2013 FDA black box warning. We examined patients in 23 "switcher" hospitals (where the percentage of colloid recipients receiving HES exceeded 50% before the FDA warning and decreased by at least 25% in absolute terms after the FDA warning) and patients in 279 "nonswitcher" hospitals. Among patients having surgery in "switcher" and "nonswitcher" hospitals, we determined monthly rates of major perioperative bleeding during the 12 months after the FDA warning, compared to 12 months before the FDA warning. Among patients who received surgery in "switcher" hospitals, we conducted a propensity-weighted segmented regression analysis assessing differences-in-differences (DID), using patients in "nonswitcher" hospitals as a control group. RESULTS: Among 3078 patients treated at "switcher" hospitals (1892 patients treated pre-FDA warning versus 1186 patients treated post-FDA warning), demographic and clinical characteristics were well-balanced. Two hundred fifty-one (13.3%) received albumin pre-FDA warning, and 900 (75.9%) received albumin post-FDA warning. Among patients undergoing surgery in "switcher" hospitals during the pre-FDA warning period, 282 of 1892 (14.9%) experienced major bleeding during the hospitalization, compared to 149 of 1186 (12.6%) following the warning. In segmented regression, the adjusted ratio of slopes for major perioperative bleeding post- versus pre-FDA warning was 0.98 (95% confidence interval [CI], 0.93-1.04). In the DID estimate using "nonswitcher" hospitals as a control group, the ratio of ratios was 0.93 (95% CI, 0.46-1.86), indicating no significant difference. CONCLUSIONS: We identified a subset of hospitals where colloid use for musculoskeletal surgery changed following a 2013 FDA black box warning regarding HES use in sepsis. Among patients undergoing musculoskeletal surgery at these "switcher" hospitals, there was no significant decrease in the rate of major perioperative bleeding following the warning, possibly due to incomplete practice change. Evaluation of the impact of systemic changes in health care may contribute to the understanding of patient outcomes in perioperative medicine.


Assuntos
Albuminas/uso terapêutico , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Rotulagem de Medicamentos , Derivados de Hidroxietil Amido/uso terapêutico , Sistema Musculoesquelético/cirurgia , Substitutos do Plasma/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Bases de Dados Factuais , Feminino , Hospitais , Humanos , Análise de Séries Temporais Interrompida , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
13.
Artigo em Inglês | MEDLINE | ID: mdl-32751393

RESUMO

(1) Background: The harm of misusing over-the-counter (OTC) codeine-containing medicines among university students in England is being increasingly recognized. Based on English university students, this paper aims to study the importance of information design on information communication, explore methods for effective warning design, and investigate university students' perception of OTC codeine. (2) Methods: The effective warning design is addressed through case studies, answering correctness by the heat map generated from the eye-tracking experiment (ETE), and the total time spent on the tasks. User perceptions are made though online surveys. (3) Results: Information design significantly affects the way user processes information. Therefore, two emphasized warnings displayed in the headline, and the "possible side effect (PSE)" sections and warning signs of addiction presented under the PSE are suggested as effective ways to display warnings. For students' perception of OTC codeine, 80% of university students are unfamiliar with the substance. After reading the patient information leaflets (PILs), 47% recommended tight regulation on codeine. (4) Conclusions: The misuse of OTC codeine could be a potential problem among English university students. The design of the PIL significantly influences the chance of unintentional medicine misuse. The display of warnings on the PILs of OTC codeine should be redesigned for better understanding.


Assuntos
Analgésicos Opioides , Codeína , Rotulagem de Medicamentos , Medicamentos sem Prescrição , Analgésicos Opioides/efeitos adversos , Codeína/efeitos adversos , Inglaterra , Humanos , Estudantes , Universidades
14.
Br J Anaesth ; 125(6): 962-969, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32859363

RESUMO

BACKGROUND: Penicillin allergy is associated with a range of poor health outcomes. Allergy testing can be made simpler by using a direct drug provocation test in patients at low risk of genuine allergy. This approach could allow population-level 'de-labelling'. We sought to determine the incidence and nature of penicillin allergy labels in UK surgical patients and define patient and anaesthetist attitudes towards penicillin allergy testing. METHODS: A prospective cross-sectional questionnaire study was performed in 213 UK hospitals. 'Penicillin allergic' patients were interviewed and risk-stratified. Knowledge and attitudes around penicillin allergy were defined in patients and anaesthetists. RESULTS: Of 21 219 patients, 12% (n=2626) self-reported penicillin allergy; 27% reported low-risk histories potentially suitable for a direct drug provocation test; an additional 40% reported symptoms potentially suitable for a direct drug provocation test after more detailed assessment. Of 4798 anaesthetists, 40% claimed to administer penicillin routinely when they judged the label low risk. Only 47% of anaesthetists would be happy to administer penicillin to a patient previously de-labelled by an allergy specialist using a direct drug provocation test; perceived lack of support was the most common reason for not doing so. CONCLUSIONS: At least 27% of patients with a penicillin allergy label may be suitable for a direct drug provocation test. Anaesthetists demonstrated potentially unsafe prescribing in patients with penicillin allergy labels. More than half of anaesthetists lack confidence in the results of a direct drug provocation tests undertaken by a specialist. Our findings highlight significant barriers to the effective implementation of widespread de-labelling in surgical patients.


Assuntos
Antibacterianos/efeitos adversos , Hipersensibilidade a Drogas/epidemiologia , Rotulagem de Medicamentos/métodos , Procedimentos Cirúrgicos Eletivos , Penicilinas/efeitos adversos , Adolescente , Adulto , Idoso , Estudos Transversais , Hipersensibilidade a Drogas/prevenção & controle , Rotulagem de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários , Reino Unido/epidemiologia , Adulto Jovem
16.
PLoS One ; 15(6): e0234541, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32584835

RESUMO

Erythropoisis stimulating agent (ESA) use was addressed in Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings between 2004 and 2008. FDA safety-focused regulatory actions occurred in 2007 and 2008. In 2007, black box warnings advised of early death and venous thromboembolism (VTE) risks with ESAs in oncology. In 2010, a Risk Evaluation Strategies (REMS) was initiated, with cancer patient consent that mortality and VTE risks were noted with ESAs. We report warnings and REMS impacts on ESA utilization among Veterans Administration (VA) cancer patients with chemotherapy-induced anemia (CIA). Data were from Veterans Affairs database (2003-2012). Epoetin and darbepoetin use were primary outcomes. Segmented linear regression was used to estimate changes in ESA use levels and trends, clinical appropriateness, and adverse events (VTEs) among chemotherapy-treated cancer patients. To estimate changes in level of drug prescription rate after policy actions, model-specific indicator variables as covariates based on specific actions were included. ESA use fell by 95% and 90% from 2005, for epoetin and darbepoetin, from 22% and 11%, respectively, to 1% and 1%, respectively, among cancer patients with CIA, respectively (p<0.01). Following REMS in 2010, mean hematocrit levels at ESA initiation decreased from 30% to 21% (p<0.01). Black box warnings preceded decreased ESA use among VA cancer patients with CIA. REMS was followed by reduced hematocrit levels at ESA initiation. Our findings contrast with privately- insured and Medicaid insured cancer patient data on chemotherapy-induced anemia where ESA use decreased to 3% to 7% by 2010-2012. By 2012, the era of ESA administration to VA to cancer patients had ended but the warnings remain relevant and significant. In 2019, oncology/hematology national guidelines (ASCO/ASH) recommend that cancer patients with chemotherapy-induced anemia should receive ESAs or red blood cell transfusions after risk-benefit evaluation.


Assuntos
Anemia/epidemiologia , Antineoplásicos/efeitos adversos , Hematínicos/efeitos adversos , Neoplasias/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/induzido quimicamente , Anemia/patologia , Anemia/prevenção & controle , Antineoplásicos/uso terapêutico , Rotulagem de Medicamentos , Feminino , Hematínicos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Neoplasias/patologia , Estados Unidos/epidemiologia , United States Department of Veterans Affairs , Tromboembolia Venosa , Adulto Jovem
18.
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
20.
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
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...