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1.
Int J Pharm Compd ; 24(1): 21-27, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32023212

RESUMO

United States Pharmacopeia Chapter <800>, which became effective on December 1, 2019, addresses handling of hazardous drugs in facilities that make compounded preparations. The Chapter includes minimum facility, engineering controls, personal protective equipment, and other requirements under which all hazardous drugs must be handled. For certain hazardous drugs, an assessment of risk may be performed to determine alternative containment strategies or work practices. This article addresses the legal enforceability of Unites States Pharmacopeia Chapter <800>, how to determine whether a drug is eligible for an assessment of risk, and details important considerations when performing assessments of risk.


Assuntos
Fidelidade a Diretrizes , Substâncias Perigosas/normas , Farmacopeias como Assunto , Estados Unidos
2.
Artigo em Inglês | MEDLINE | ID: mdl-31936022

RESUMO

Model tools for estimating hazardous substance exposure are an accepted part of regulatory risk assessments in Europe, and models underpin control banding tools used to help manage chemicals in workplaces. Of necessity the models are simplified abstractions of real-life working situations that aim to capture the essence of the scenario to give estimates of actual exposures with an appropriate margin of safety. The basis for existing inhalation exposure assessment tools has recently been discussed by some scientists who have argued for the use of more complex models. In our opinion, the currently accepted tools are documented to be the most robust way for workplace health and safety practitioners and others to estimate inhalation exposure. However, we recognise that it is important to continue the scientific development of exposure modelling to further elaborate and improve the existing methodologies.


Assuntos
Monitoramento Ambiental/métodos , Substâncias Perigosas/análise , Substâncias Perigosas/normas , Exposição por Inalação/normas , Exposição Ocupacional/normas , Saúde do Trabalhador/normas , Medição de Risco/métodos , Europa (Continente) , Humanos , Exposição por Inalação/análise , Exposição Ocupacional/análise
3.
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
4.
J Infus Nurs ; 43(1): 15-18, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31876769

RESUMO

Safety concerns have existed for more than 40 years about how hazardous drug (HD) exposure contributes to adverse health outcomes in health care workers. Careless handling causes toxic HD residues to infiltrate hospital and ambulatory care settings and can even be tracked to patient homes. Little is known about the adverse health outcomes experienced by exposed caregivers. The December 1, 2019, release of new regulations will enforce health care organizations to minimize risk to all health care workers by implementing the US Pharmacopeia (USP) General Chapter<800>Hazardous Drugs-Handling in Healthcare Settings safety standards. Worker safety measures include wearing personal protective equipment, even in home care settings.


Assuntos
Cuidadores/normas , Resíduos de Drogas , Substâncias Perigosas/normas , Serviços de Assistência Domiciliar , Exposição Ocupacional/normas , Equipamento de Proteção Individual , Antineoplásicos/normas , Pessoal de Saúde/normas , Humanos , Gestão da Segurança/normas
5.
Int J Pharm Compd ; 23(3): 182-186, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31085785

RESUMO

United States Pharmacopeia Chapter <800>, concerned with the handling of hazardous drugs in healthcare settings, requires that any entity handling such drugs maintain a hazardous drug list. While this list must include any drug found on the latest NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, entities are expected to include other drugs and substances of concern. This article provides guidance on the creation and maintenance of such a list.


Assuntos
Substâncias Perigosas , Exposição Ocupacional , Antineoplásicos/análise , Antineoplásicos/normas , Substâncias Perigosas/análise , Substâncias Perigosas/normas , Exposição Ocupacional/análise , Exposição Ocupacional/prevenção & controle , Saúde do Trabalhador/normas , Estados Unidos
6.
Environ Pollut ; 250: 386-396, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31022644

RESUMO

This technique for setting guideline values differs from that currently used by regulatory agencies throughout the world. Data for benzene were evaluated from epidemiological studies on human populations (29 studies). Exposure durations were evaluated in terms of Long Term Exposure (LTE) and Lifetime Exposure. All data was reported as Lowest Observed Adverse Effect Levels (LOAEL) and converted into exposure doses using Average Daily Dose (ADD) and Lifetime Average Daily Dose (LADD). These values were plotted as a Toxicant Sensitivity Distribution (TSD) which was the cumulative probability of LOAEL-ADD and LOAEL-LADD. From the TSD plots, linear regression equations gave correlation coefficients (R2) ranging from 0.69 to 0.97 indicating normal distributions. Guideline Values (GVs) for LTE (8hr/day) and Lifetime (24hr/70yrs) exposure to benzene were calculated using data from human epidemiological studies as 5% level of cumulative probability (CP) of LOAEL-ADD and LOAEL-LADD from the cumulative probability distributions (CPD). The derived guideline values from the human epidemiological studies were 92 µg/kg/day for LTE and 3.4 µg/kg/day for lifetime exposure. GV for LTE is appropriate for occupational exposure and GV derived for lifetime exposure appropriate for the general population. The guideline value for occupational exposure limit was below all the guideline values developed by regulatory agencies. But the general population guideline is within the range of values formulated by European Union, ATSDR, EPAQS, USEPA and OEHHA for air quality for the general population. This is an alternative method which eliminates the application of safety factors and other sources of errors in deriving guideline values for benzene.


Assuntos
Benzeno/análise , Substâncias Perigosas/análise , Exposição Ocupacional/normas , Poluição do Ar , Benzeno/normas , Benzeno/toxicidade , Substâncias Perigosas/normas , Substâncias Perigosas/toxicidade , Humanos , Medição de Risco
7.
Am J Health Syst Pharm ; 76(9): 613-616, 2019 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-30873517

RESUMO

PURPOSE: This case study describes a multidisciplinary initiative to promote the safe use, preparation, and administration of bacillus Calmette-Guérin (BCG) in patients with bladder cancer that is in compliance with United States Pharmacopeia chapter 800. SUMMARY: After an evaluation of a hospital's medication-use process for the preparation and administration of BCG identified inconsistencies with guideline-based procedures for the safe handling and manipulation of hazardous drug products, a revised medication-use process promoting the inclusion of pharmacy services was developed by pharmacy and urology clinic leaders. Implementation of the enhanced medication-use process included (1) the shift of BCG vaccine preparation from urology clinic nurses to a pharmacy equipped with the appropriate engineering controls for the safe preparation of hazardous product, (2) greater involvement by pharmacists in BCG order justification and verification, and (3) a process that ensured just-in-time preparation and delivery of medication for enhanced patient satisfaction. After initial process changes resulted in increased turnaround time from preparation to administration, a study on time to preparation, delivery, and administration was conducted and resulted in complete reduction of turnaround times and increased patient satisfaction. CONCLUSION: Through a multidisciplinary initiative involving pharmacists, physicians, nurses, and leadership, a new process to promote the safe preparation and administration of the tuberculosis vaccine Mycobacterium bovis BCG was developed and implemented. The results of a post-implementation time study indicated that a standardized approach to scheduling, preparing, and administering BCG was effective in managing the operations of BCG through having high clinic and patient satisfaction.


Assuntos
Vacina BCG/normas , Composição de Medicamentos/normas , Farmacêuticos/organização & administração , Serviço de Farmácia Hospitalar/organização & administração , Neoplasias da Bexiga Urinária/tratamento farmacológico , Vacina BCG/administração & dosagem , Guias como Assunto , Substâncias Perigosas/administração & dosagem , Substâncias Perigosas/normas , Humanos , Comunicação Interdisciplinar , Satisfação do Paciente , Farmacopeias como Assunto , Serviço de Farmácia Hospitalar/normas , Fatores de Tempo , Estados Unidos
8.
Oncol Nurs Forum ; 46(2): 248-256, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30767961

RESUMO

OBJECTIVES: To evaluate whether a web-based educational intervention improved personal protective equipment (PPE) use among oncology nurses who handle hazardous drugs. SAMPLE & SETTING: From 2015 to 2017, the authors partnered with 12 ambulatory oncology settings in the United States to enroll 396 nurses, 257 of whom completed baseline and primary endpoint surveys. METHODS & VARIABLES: In a cluster randomized controlled trial, 136 nurses in control settings received a one-hour educational module on PPE use with quarterly reminders, and 121 nurses in treatment settings received the control intervention plus tailored messages to address perceived barriers and quarterly data gathered on hazardous drug spills across all study settings. The primary outcome was nurse-reported PPE use. RESULTS: Control and intervention sites had suboptimal PPE use before and after the intervention. No significant differences were observed in PPE use knowledge or perceived barriers. Participants reported high satisfaction with the study experience. IMPLICATIONS FOR NURSING: Hazardous drug exposure confers notable health risks to healthcare workers. To improve hazardous drug handling, occupational healthcare workers, health systems, and professional organizations should consider coordinated efforts to implement policy and practice changes.


Assuntos
Fidelidade a Diretrizes/estatística & dados numéricos , Substâncias Perigosas/normas , Substâncias Perigosas/toxicidade , Recursos Humanos de Enfermagem no Hospital/educação , Exposição Ocupacional/prevenção & controle , Gestão da Segurança/normas , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Estados Unidos
11.
Farm. hosp ; 42(5): 212-215, sept.-oct. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-174846

RESUMO

Objetivo: La administración intravesical de medicamentos peligrosos es una práctica habitual en el ámbito de la urología, con posible exposición del personal sanitario a dichos medicamentos. Se considera necesario disponer de un documento de consenso entre las sociedades científicas implicadas -Asociación Española de Urología y Sociedad Española de Farmacia Hospitalaria- que recoja la mejor evidencia disponible para el manejo, de la forma más segura posible, de medicamentos peligrosos en el ámbito de los servicios de Urología. Método: Se ha realizado una revisión de la legislación y de las recomendaciones sobre el manejo de medicamentos peligrosos tanto a nivel estatal como internacional. Resultados: Se dispone de legislación nacional y de normativas para la protección de los trabajadores que manipulen medicamentos y productos peligrosos, así como recomendaciones de manipulación para la protección tanto del producto, como de los trabajadores


Objective: The intravesical administration of hazardous drug products is a standard practice in the urology setting, which potentially exposing medical personnel to these drug products. It was deemed necessary to have a consensus document among the scientific societies involved (the Spanish Urological Association and the Spanish Society of Hospital Pharmacy) that collects the best available evidence on the safest handling possible of dangerous drug products in the setting of urology departments. Method: We reviewed the legislation and recommendations on the handling of dangerous drug products, both at the national and international level. Results: There is national legislation and regulations for protecting workers who handle dangerous drugs and products, as well as recommendations for handling to protect both the product and workers


Assuntos
Substâncias Perigosas/normas , Preparações Farmacêuticas/normas , Unidade Hospitalar de Urologia/organização & administração , Legislação de Medicamentos , Administração Farmacêutica , Espanha , Exposição Ocupacional , Administração Intravesical , Mycobacterium bovis/patogenicidade , Mitomicina
12.
Environ Int ; 120: 535-543, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30170308

RESUMO

Fundamental to regulatory guidelines is to identify chemicals that are implicated with adverse human health effects and inform public health risk assessors about "acceptable ranges" of such environmental exposures (e.g., from consumer products and pesticides). The process is made more difficult when accounting for complex human exposures to multiple environmental chemicals. Herein we propose a new class of nonlinear statistical models for human data that incorporate and evaluate regulatory guideline values into analyses of health effects of exposure to chemical mixtures using so-called 'desirability functions' (DFs). The DFs are incorporated into nonlinear regression models to allow for the simultaneous estimation of points of departure for risk assessment of combinations of individual substances that are parts of chemical mixtures detected in humans. These are, in contrast to published so-called biomonitoring equivalent (BE) values and human biomonitoring (HBM) values that link regulatory guideline values from in vivo studies of single chemicals to internal concentrations monitored in humans. We illustrate the strategy through the analysis of prenatal concentrations of mixtures of 11 chemicals with suspected endocrine disrupting properties and two health effects: birth weight and language delay at 2.5 years. The strategy allows for the creation of a Mixture Desirability Function i.e., MDF, which is a uni-dimensional construct of the set of single chemical DFs; thus, it focuses the resulting inference to a single dimension for a more powerful one degree-of-freedom test of significance. Based on the application of this new method we conclude that the guideline values need to be lower than those for single chemicals when the chemicals are observed in combination to achieve a similar level of protection as was aimed for the individual chemicals. The proposed modeling may thus suggest data-driven uncertainty factors for single chemical risk assessment that takes environmental mixtures into account.


Assuntos
Misturas Complexas/análise , Disruptores Endócrinos/análise , Exposição Ambiental/análise , Substâncias Perigosas/análise , Modelos Estatísticos , Peso ao Nascer , Pré-Escolar , Misturas Complexas/normas , Disruptores Endócrinos/normas , Exposição Ambiental/normas , Monitoramento Ambiental/métodos , Feminino , Regulamentação Governamental , Substâncias Perigosas/normas , Humanos , Recém-Nascido , Transtornos do Desenvolvimento da Linguagem/epidemiologia , Masculino , Troca Materno-Fetal , Gravidez , Medição de Risco , Incerteza
14.
Am J Health Syst Pharm ; 75(10): 627-632, 2018 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-29650727

RESUMO

PURPOSE: One academic medical center's efforts to move toward compliance with requirements of United States Pharmacopeia (USP) chapter 800 through a multidepartmental collaborative initiative are described. SUMMARY: Requirements of USP general chapter 800 (enforceable as of December 2019) address the handling of hazardous drugs (HDs) throughout the entire operational and clinical cycle, from receiving to compounding, administration, and waste disposal. Due to the variety of pharmacy operational areas in which HDs are encountered at University of North Carolina Medical Center (UNCMC), multiple pharmacy managers oversee the safe handling of HDs. To determine baseline compliance with USP chapter 800 requirements, a common assessment tool was developed to ensure a standardized approach to compliance assessment in all areas. An interdepartmental workgroup was created to ensure institutionwide support for a collaborative compliance initiative, a uniform understanding of compliance risks, and robust action planning. UNCMC has taken a number of steps toward USP chapter compliance in areas such as engineering controls, environmental quality and controls, use of personal protective equipment, hazard communication programs, personnel training, spill control, and medical surveillance. CONCLUSION: Achieving USP chapter 800 compliance presented several operational, clinical, and financial challenges for the medical center, requiring months of preparation and diligence by the hospital leadership. The pharmacy department-led compliance collaborative allowed departments to proactively align while implementing practice and quality standards to foster safety for patients, workers, and the environment.


Assuntos
Centros Médicos Acadêmicos/normas , Substâncias Perigosas/normas , Farmacopeias como Assunto , Serviço de Farmácia Hospitalar/normas , Centros Médicos Acadêmicos/organização & administração , Comportamento Cooperativo , Fidelidade a Diretrizes , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Estados Unidos
15.
J Infus Nurs ; 41(1): 12-23, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29293194

RESUMO

The term hazardous drug (HD) includes medications that have any of the following properties: carcinogenicity, teratogenicity, reproductive toxicities, genotoxicities, toxicities at low doses, and a structure that mimics other drugs meeting the criteria. Numerous studies continue to demonstrate widespread environmental contamination and human uptake of these agents. Safe handling guidelines have existed for more than 30 years but have not been routinely implemented. USP General Chapter 800 (USP <800>) represents a new enforceable standard for HD safety. Nurses will need to understand the impact of USP <800>, which is expected to be enforced beginning December 1, 2019.


Assuntos
Substâncias Perigosas/normas , Exposição Ocupacional/prevenção & controle , Guias de Prática Clínica como Assunto/normas , Gestão da Segurança/normas , Antineoplásicos/administração & dosagem , Antineoplásicos/toxicidade , Substâncias Perigosas/toxicidade , Humanos , Recursos Humanos de Enfermagem no Hospital/normas , Preparações Farmacêuticas , Roupa de Proteção , Estados Unidos
17.
PLoS Biol ; 15(12): e2002404, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29252997

RESUMO

After 40 years, the 1976 US Toxic Substances Control Act (TSCA) was revised under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Its original goals of protecting the public from hazardous chemicals were hindered by complex and cumbersome administrative burdens, data limitations, vulnerabilities in risk assessments, and recurring corporate lawsuits. As a result, countless chemicals were entered into commercial use without toxicological information. Few chemicals of the many identified as potential public health threats were regulated or banned. This paper explores the factors that have worked against a comprehensive and rational policy for regulating toxic chemicals and discusses whether the TSCA revisions offer greater public protection against existing and new chemicals.


Assuntos
Segurança Química/legislação & jurisprudência , Poluentes Ambientais/toxicidade , Poluição Ambiental/prevenção & controle , Substâncias Perigosas/toxicidade , Política Pública/história , Animais , Segurança Química/história , Segurança Química/tendências , Poluentes Ambientais/normas , Poluição Ambiental/ética , Poluição Ambiental/legislação & jurisprudência , Substâncias Perigosas/normas , História do Século XX , História do Século XXI , Humanos , Legislação de Medicamentos/ética , Legislação de Medicamentos/história , Legislação de Medicamentos/tendências , Política Pública/legislação & jurisprudência , Política Pública/tendências , Medição de Risco/história , Medição de Risco/legislação & jurisprudência , Medição de Risco/tendências , Responsabilidade Social , Estados Unidos , United States Environmental Protection Agency
20.
Am J Nurs ; 117(5): 61-64, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28448366

RESUMO

: Chemicals are ubiquitous in the food we eat, the water we drink, the air we breathe, and the products we use at work and in our personal lives. Toxic chemicals increase the risk of cognitive, behavioral, and neurodevelopmental disorders throughout the life span. The Toxic Substances Control Act of 1976 was intended to allow for the collection of data on and regulation of these chemicals but has been criticized for its significant limitations in protecting the public's health. In recognition of the scientific evidence demonstrating the connection between toxic environmental chemicals and neurodevelopmental disorders, Project TENDR (Targeting Environmental Neuro-Developmental Risks)-a collaborative initiative of scientists, health professionals, and children's health advocates-produced a call to action last July with the aim of reducing exposure to chemicals and pollutants that contribute to the development of these disorders.


Assuntos
Exposição Ambiental/prevenção & controle , Substâncias Perigosas/normas , Transtornos do Neurodesenvolvimento/prevenção & controle , Medição de Risco/métodos , Criança , Desenvolvimento Infantil/fisiologia , Saúde Ambiental , Humanos , Saúde Pública
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