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1.
PLoS One ; 15(7): e0232966, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32645019

RESUMO

OBJECTIVE: To assess the importance of ensuring medicine quality in order to achieve universal health coverage (UHC). METHODS: We developed a systems map connecting medicines quality assurance systems with UHC goals to illustrate the ensuing impact of quality-assured medicines in the implementation of UHC. The association between UHC and medicine quality was further examined in the context of essential medicines in low- and middle-income countries (LMICs) by analyzing data on reported prevalence of substandard and falsified essential medicines and established indicators for UHC. Finally, we examined the health and economic savings of improving antimalarial quality in four countries in sub-Saharan Africa: the Democratic Republic of the Congo (DRC), Nigeria, Uganda, and Zambia. FINDINGS: A systems perspective demonstrates how quality assurance of medicines supports dimensions of UHC. Across 63 LMICs, the reported prevalence of substandard and falsified essential medicines was found to be negatively associated with both an indicator for coverage of essential services (p = 0.05) and with an indicator for government effectiveness (p = 0.04). We estimated that investing in improving the quality of antimalarials by 10% would result in annual savings of $8.3 million in Zambia, $14 million in Uganda, $79 million in two DRC regions, and $598 million in Nigeria, and was more impactful compared to other potential investments we examined. Costs of substandard and falsified antimalarials per malaria case ranged from $7 to $86, while costs per death due to poor-quality antimalarials ranged from $14,000 to $72,000. CONCLUSION: Medicines quality assurance systems play a critical role in reaching UHC goals. By ensuring the quality of essential medicines, they help deliver effective treatments that lead to less illness and result in health care savings that can be reinvested towards UHC.


Assuntos
Preparações Farmacêuticas/normas , Garantia da Qualidade dos Cuidados de Saúde , Assistência de Saúde Universal , África ao Sul do Saara , Antimaláricos/normas , Medicamentos Essenciais/normas , Humanos , Garantia da Qualidade dos Cuidados de Saúde/economia
2.
Ceska Slov Farm ; 69(2): 59-66, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32545984

RESUMO

Colour is an important indicator of the quality of pharmaceuticals, medicinal products and pharmaceutical excipients. The paper summarizes advances in the use of instrumental colour measurement in synthetic medicines and medicines of non-natural origin, their dosage forms and excipients published in 2013-2019.


Assuntos
Cor , Excipientes/normas , Preparações Farmacêuticas/normas , Controle de Qualidade
4.
PDA J Pharm Sci Technol ; 74(4): 468-494, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32467176

RESUMO

This article reviews currently available scientific literature related to the epidemiology, infectivity, survival, and susceptibility to disinfectants of Coronaviruses, in the context of the controls established to meet good manufacturing practice (GMP) regulations and guidance, and the public health guidance issued specifically to combat the COVID-19 pandemic. The possible impact of the COVID-19 pandemic on the pharmaceutical supply chain is assessed and recommendations are listed for risk mitigation steps to minimize supply disruption to pharmaceutical drug products. Areas addressed include a brief history of the COVID-19 viral pandemic, a description of the virus, the regulatory response to the pandemic, the screening of employees, the persistence of the virus on inanimate surfaces, cleaning and disinfection of manufacturing facilities, the use of GMP-mandated personal protective equipment to counter the spread of the disease, the role of air changes in viral clearance, and approaches to risk assessment and mitigation. Biological medicinal products have a great record of safety, yet the cell cultures used for production can be susceptible to viruses, and contamination events have occurred. Studies on SARS-CoV-2 for it ability to replicate in various mammalian cell lines used for biopharmaceutical manufacturing suggests that the virus poses a low risk and any contamination would be detected by currently used adventitious virus testing. The consequences of the potential virus exposure of manufacturing processes as well as the effectiveness of mitigation efforts are discussed. The pharmaceutical supply chain is complex, traversing many geographies and companies that range from large multinationals to mid- and small-size operations. This paper recommends practices that can be adopted by all companies, irrespective of their size, geographic location, or position in the supply chain.


Assuntos
Infecções por Coronavirus/prevenção & controle , Desinfecção/métodos , Pandemias/prevenção & controle , Preparações Farmacêuticas/provisão & distribução , Pneumonia Viral/prevenção & controle , Animais , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Desinfetantes/química , Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica/normas , Contaminação de Equipamentos/prevenção & controle , Humanos , Preparações Farmacêuticas/normas , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Gestão de Riscos/métodos , Replicação Viral
5.
Artigo em Inglês | MEDLINE | ID: mdl-32455918

RESUMO

Many web-based pharmaceutical e-commerce platforms allow consumers to post open-ended textual reviews based on their purchase experiences. Understanding the true voice of consumers by analyzing such a large amount of user-generated content is of great significance to pharmaceutical manufacturers and e-commerce websites. The aim of this paper is to automatically extract hidden topics from web-based drug reviews using the structural topic model (STM) to examine consumers' concerns when they buy drugs online. The STM is a probabilistic extension of Latent Dirichlet Allocation (LDA), which allows the consolidation of document-level covariates. This innovation allows us to capture consumer dissatisfaction along with their dynamics over time. We extract 12 topics, and five of them are negative topics representing consumer dissatisfaction, whose appearances in the negative reviews are substantially higher than those in the positive reviews. We also come to the conclusion that the prevalence of these five negative topics has not decreased over time. Furthermore, our results reveal that the prevalence of price-related topics has decreased significantly in positive reviews, which indicates that low-price strategies are becoming less attractive to customers. To the best of our knowledge, our work is the first study using STM to analyze the unstructured textual data of drug reviews, which enhances the understanding of the aspects of drug consumer concerns and contributes to the research of pharmaceutical e-commerce literature.


Assuntos
Comércio , Comportamento do Consumidor , Indústria Farmacêutica , Preparações Farmacêuticas , Humanos , Internet , Preparações Farmacêuticas/normas , Publicações
12.
JAMA ; 323(2): 164-176, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935033

RESUMO

Importance: US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks. Objective: To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018. Evidence: Sources of evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic drugs (1970-2018), biologics (1984-2018), and vaccines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priority Review and its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-2018]); expanded access (2010-2017) and Risk Evaluation and Mitigation Strategies (2008-2018); and user fees paid to the FDA by industry (1993-2018). Findings: From 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA. The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018. The median annual number of generic drugs approved was 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984; 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012; and 588 from 2013-2018. Prescription drug user fee funding expanded from new drugs and biologics in 1992 to generic and biosimilar drugs in 2012. The amount of Prescription Drug User Fee Act fees collected from industry increased from an annual mean of $66 million in 1993-1997 to $820 million in 2013-2017, and in 2018, user fees accounted for approximately 80% of the salaries of review personnel responsible for the approval of new drugs. The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304) in 1984-1995, to 22% (82/379) in 1996-2007, to 41% (154/380) in 2008-2018. Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period. Conclusions and Relevance: Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged. The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Regulamentação Governamental , Legislação de Medicamentos/tendências , Preparações Farmacêuticas/normas , United States Food and Drug Administration , Aprovação de Drogas/economia , Aprovação de Drogas/estatística & dados numéricos , História do Século XX , Legislação de Medicamentos/história , Estados Unidos
13.
Anal Bioanal Chem ; 412(1): 203-222, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31802178

RESUMO

This study examines an improved and simplified method for solid-phase extraction (SPE), which offers rapid and accurate determination and identification of 44 pharmaceutically active compounds using ultra-performance liquid chromatography (UPLC) and tandem mass spectrometry (MS/MS). The common active compounds include four macrolides, seventeen sulfonamides, four quinolones, chloramphenicol, eight ß-lactams, four tetracyclines, lincomycin, amantadine, 4-acetamidophenol, phenylbutazone, trimethoprim, clenbuterol, and hydrocortisone in water samples. We optimized crucial parameters of MS/MS, UPLC, and SPE and studied the matrix effect related to the modified analytical process from water samples. The matrix-matched calibration curves were accomplished at seven concentration levels and a satisfactory linear relationship (r2 > 0.994) was observed within the range of 0.1-500 ng/mL. Results show varying limits of detection (0.0111-0.966 ng/L for different analytes based on signal-to-noise (S/N) = 3) and limits of quantitation (0.0382-3.26 ng/L). Recoveries of the spiked samples ranged from 75.7 to 108% with relative standard deviation lower than 9.6%. The proposed method was successfully applied to the analysis of real samples.


Assuntos
Cromatografia Líquida/métodos , Preparações Farmacêuticas/análise , Extração em Fase Sólida/métodos , Espectrometria de Massas em Tandem/métodos , Poluentes Químicos da Água/análise , Limite de Detecção , Preparações Farmacêuticas/normas , Padrões de Referência , Reprodutibilidade dos Testes
14.
Am J Trop Med Hyg ; 102(2): 262-267, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31746313

RESUMO

A vicious circle links lack of equitable access to health to the supply of poor-quality medicines, which amount to one-tenth of medicines available in low- and middle-income countries. The WHO introduced a new, public health-focused definition of substandard and falsified (SF) medicines, which offers opportunities for governments to broaden the scope of interventions to combat poor-quality medicines. At the same time, translating it into legal and regulatory measures may be challenging because this definition is not free of ambiguity (in that, there is a gray area between intentionally falsified and unintentional substandard medicines), and some countries may not have appropriate regulatory mechanisms/jurisdictions in place. The focus of the article is to consider what a public health-informed legal and regulatory environment could look like in light of WHO's SF definition and propose appropriate measures to put it into effect. We present a "legal levers matrix" that may assist legislators and policymakers evaluate the adequacy of measures (i.e., criminal, civil, and administrative mechanisms) to address the problem of poor-quality medicines, particularly in terms of their configuration. In addition, this matrix underscores the importance of fostering dialogue between medical/public health and the legal/regulatory communities and to develop alternative/complementary solutions, including regulatory strengthening and nonpunitive actions. Substandard and falsified medicines arise from the interplay between societies, economies, and behaviors: effective regulation is necessary to disincentivize the production and/or supply of SF medicines, whereas health systems should strive to provide affordable medicines to all levels of society.


Assuntos
Medicamentos Falsificados , Países em Desenvolvimento , Legislação de Medicamentos , Preparações Farmacêuticas/normas , Saúde Pública/normas , Medicamentos Fora do Padrão , Humanos
15.
J Infus Nurs ; 43(1): 12-14, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31876768

RESUMO

EDITOR'S NOTE: The Infusion Nurses Society (INS) and the Journal of Infusion Nursing (JIN) editors are pleased to debut Pharmacology Report, a recurring bimonthly column authored by Susan Kleppin, RPh, FASHP. Susan is an accomplished pharmacist in health-system pharmacy with significant experience in infusion therapy. Her column will discuss relevant pharmacology topics, including medications new to market, safe handling for hazardous drugs, and managing drug shortages. INS and JIN extend Susan a warm welcome.


Assuntos
Substâncias Perigosas/normas , Recursos Humanos de Enfermagem/normas , Exposição Ocupacional/prevenção & controle , Preparações Farmacêuticas/normas , Guias de Prática Clínica como Assunto , Antineoplásicos , Antivirais , Hormônios , Humanos
16.
Spectrochim Acta A Mol Biomol Spectrosc ; 224: 117407, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31404760

RESUMO

As expired medical products can be repackaged and sold by unscrupulous counterfeiters, it is essential to find a rapid and convenient method for distinguishing expired and unexpired drugs. Standard detection methods such as high-performance liquid chromatography (HPLC) and thin-layer chromatography are complex, time-consuming, and require organic solvents (that are environmentally unfriendly). Additionally, the Pharmacopoeia publications do not include information about identifying expired drugs. In this study, we proposed a novel method for identifying expired medications based on Raman spectra and verified it using >20 types of expired (Old) and unexpired (New) drugs, each type from the same manufacturer. A portable Raman spectrometer was used to collect Raman spectra of all samples and the similarities between the Old and New drugs (SN-O) were evaluated. Drugs with SN-O values <0.9 were classified directly as expired drugs. For drugs with SN-O values >0.9, the content of active pharmaceutical ingredient (API) might be so low (below or around 10 wt%) that its Raman signal is largely obscured by that of the excipients. In such cases, changes in the API content are undetectable using the portable instrument. Therefore, we adopted Raman mapping technology and established a virtual imaging map to locate areas of high API content. The similarities between the Old or New spectrum and that of the API (SO-A and SN-A, respectively) were calculated after removing the signal from the excipients. Our novel methods provide a precise, rapid, convenient, and environmentally friendly way to identify expired drugs that is more effective than the standard HPLC assay.


Assuntos
Preparações Farmacêuticas/análise , Análise Espectral Raman/métodos , Química Farmacêutica , Cromatografia Líquida de Alta Pressão , Cromatografia em Camada Delgada , Preparações Farmacêuticas/química , Preparações Farmacêuticas/normas , Processamento de Sinais Assistido por Computador , Comprimidos/análise , Comprimidos/química , Comprimidos/normas
17.
Artigo em Inglês | MEDLINE | ID: mdl-31810208

RESUMO

Medicine is the main means to reduce cancer mortality. However, some medicines face various risks during transportation and storage due to the particularity of medicines, which must be kept at a low temperature to ensure their quality. In this regard, it is of great significance to evaluate and select drug cold chain logistics suppliers from different perspectives to ensure the quality of medicines and reduce the risks of transportation and storage. To solve such a multiple criteria decision-making (MCDM) problem, this paper proposes an integrated model based on the combination of the SWARA (stepwise weight assessment ratio analysis) and CoCoSo (combined compromise solution) methods under the probabilistic linguistic environment. An adjustment coefficient is introduced to the SWARA method to derive criteria weights, and an improved CoCoSo method is proposed to determine the ranking of alternatives. The two methods are extended to the probabilistic linguistic environment to enhance the applicability of the two methods. A case study on the selection of drug cold chain logistics suppliers is presented to demonstrate the applicability of the proposed integrated MCDM model. The advantages of the proposed methods are highlighted through comparative analyses.


Assuntos
Antineoplásicos/normas , Antineoplásicos/uso terapêutico , Técnicas de Apoio para a Decisão , Assistência à Saúde/organização & administração , Neoplasias/tratamento farmacológico , Preparações Farmacêuticas/normas , Refrigeração/normas , Tomada de Decisões , Humanos , Modelos Logísticos
18.
Ceska Slov Farm ; 68(4): 157-160, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31822108

RESUMO

In the European Pharmacopoeia (Ph. Eur.) there is no prescribed number of parallel determinations of the content of active substances and excipients. The authors suggest adding at least three determinations. The results of parallel determinations suggest to test for outliers before using test based on the ratio of the range of results (p = 0.95) and not to compare individual results with the tolerance limits given in Ph. Eur., but with their arithmetic mean. Furthermore, they propose to extend the Chapter 5.3. of the European Pharmacopoeia so as to be applicable not only to bioassays, but also to chemical, physicochemical and physical assays and tests, starting with the content of active substances and excipients.


Assuntos
Excipientes/normas , Preparações Farmacêuticas/normas , Europa (Continente) , Farmacopeias como Assunto
19.
Recurso na Internet em Português | LIS - Localizador de Informação em Saúde, LIS-bvsms | ID: lis-46906

RESUMO

A partir do próximo ano, o Governo do Brasil deve passar a oferecer um novo medicamento para tratar a tuberculose latente, aquela em que há a presença da bactéria adormecida, mas sem doença, ou seja, não há os sintomas como tosse prolongada e febre. A estimativa é de que há 30 mil pessoas nestas condições no país e que, caso contraiam doenças como o HIV/aids, quando o sistema imunológico está mais fragilizado, podem vir a desenvolver a forma ativa da tuberculose.


Assuntos
Tuberculose Latente , Brasil , Preparações Farmacêuticas/normas
20.
Ethiop J Health Sci ; 29(6): 727-736, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31741643

RESUMO

Background: Patients' care when dispensing of Medicines could be ensured through the delivery of drug information either orally or in written form. Pharmacists are expected to ascertain that patients or caregivers have gained clear and complete information. The objective of this study was to assess patient counseling during dispensing of medicines and associated factors in Tikur-Anbessa Specialized Hospital. Method: A cross sectional study was conducted to assess patients' counseling and a convenient sampling technique was employed to select study participants. Data was collected using a structured questionnaire and observation checklist and, analyzed by using SPSS version 20. Descriptive statistics and odds ratio were used to present study results. Results: A total of 286 respondents were included in this study. Most (93.7%; 94.4%; 91%) of the respondents were told the drug unit dose, frequency of administration and duration of therapy respectively. Less than a third of the patients received information on drug-drug interactions, storage of medications and side -effects. None of the patients were told what to do on missed dose and, none were asked back to repeat their understanding. Three fourth of the patients reported that they were satisfied with the counseling services provided. Females were more likely to be satisfied than males whereas, level of education showed a negative association with pharmacist counseling services. Conclusion: Drug dose, frequency of administration and duration of therapy were the most frequently delivered information to patients. Gender and level of education have significant association with medication counseling service in the study setting.


Assuntos
Aconselhamento/normas , Prescrições de Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Guias como Assunto , Adesão à Medicação , Educação de Pacientes como Assunto/normas , Preparações Farmacêuticas/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Etiópia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmácias , Inquéritos e Questionários
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