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1.
An. pediatr. (2003. Ed. impr.) ; 91(4): 237-243, oct. 2019. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-186744

RESUMO

Objetivo: Evaluar la prevalencia de prescripciones en condiciones no autorizadas (off-label y unlicensed) en una Unidad de Cuidados Intensivos Neonatales (UCIN) y definir qué características de los neonatos se asocian a un mayor uso de fármacos en estas condiciones. Material y métodos: Estudio observacional prospectivo en una UCIN nivel III-C durante un periodo de 6 meses. Se evaluó la condición de uso de cada fármaco, tomando como referencia su ficha técnica. Se utilizó un algoritmo secuencial para la clasificación de las prescripciones en: aprobadas, unlicensed u off-label (por edad, por indicación, por vía de administración, y por dosis). Resultados: Se incluyeron 84 pacientes y 564 prescripciones. Un total de 127 prescripciones fueron consideradas off-label y 45 unlicensed; lo cual supuso el 22,5% y el 8% del total, respectivamente. El 59,5% de los pacientes recibieron al menos un fármaco en una de estas condiciones, ascendiendo este porcentaje al 100% en los grandes prematuros y en los pacientes quirúrgicos (p < 0,001). Se encontró una correlación lineal positiva entre la estancia en UCIN y el número de prescripciones off-label (coeficiente de correlación 0,6 p < 0,001). Conclusiones: La prescripción de fármacos en condiciones no autorizadas es habitual en UCIN, siendo especialmente frecuente en los pacientes con mayor vulnerabilidad. Estos resultados ponen de manifiesto la necesidad de avanzar en la investigación y homogeneizar la información existente sobre los fármacos en neonatología, con el objetivo de realizar una prescripción eficaz y segura


Objective: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. Materials and methods: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). Results: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P < .001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P < .001). Conclusions: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription


Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Rotulagem de Medicamentos , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Terapia Intensiva Neonatal/estatística & dados numéricos , Uso Off-Label/estatística & dados numéricos , Algoritmos , Medicamentos sob Prescrição/administração & dosagem , Prevalência , Estudos Prospectivos , Tempo de Internação
2.
Pharm. pract. (Granada, Internet) ; 17(2): 0-0, abr.-jun. 2019. ilus, tab, graf
Artigo em Inglês | IBECS | ID: ibc-184684

RESUMO

Background: United States pharmacies repackage medications into multi-dose vials, enabling customized dosing for prescription drugs. Investment in infrastructure has made this the predominant approach to packaging for US prescriptions. Although recent changes to labeling now discourage the use of auxiliary labels (small stickers highlighting information germane to the safe and effective use), they are still allowed by USP<17>, provided their use comes from an evidence-based perspective. Objectives: Evaluate how 'interactive,' placements of auxiliary labels (placement requiring physical manipulation of the warning to accomplish a task (e.g. opening)) garner attention as compared to those placed vertically or horizontally. Methods: Ninety-six participants were eye tracked while opening three prescription vials (each with an auxiliary warning label with a different placement: vertical, horizontal and interactive). Recall and recognition were tested subsequently. Linear mixed models were used to analyze the continuous variables while the binary response variables were analyzed using generalized linear mixed models. The effect of auxiliary labels was fitted as a fixed effect and the subject-to-subject variation was considered as a random effect in the model. Participants' age, health literacy and sex were added to the models if their effect was statistically significant at alpha=0.05. Results: The placement of the warnings significantly impacted the time spent viewing the information they contained at alpha=0.05; people spent significantly longer on interactive placements (0.96; SD 0.13 seconds) than either, horizontal placements (0.27; SD 0.037 seconds) or those placed vertically (0.18 seconds; SD 0.035). Participants were equally as likely to see information presented in an interactive placement (90%; SD 3.8) or horizontal placement (78%; SD 05.5) but less likely to view warnings placed vertically (60%; SD 6.9). Free recall responses also supported the use of interactive placement (62%; SD 6.8 recall) as compared to horizontal placements which were 29%; SD 3.0 and 20%; SD 6.0 for vertical placements. Conclusions: Data provides evidence which suggests that interactive and horizontal placements out-perform auxiliary labels placed vertically on prescription vials with regard to garnering patient attention


No disponible


Assuntos
Humanos , Masculino , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Erros de Medicação/prevenção & controle , Rotulagem de Medicamentos/métodos , Armazenamento de Medicamentos/métodos , Rememoração Mental , Percepção Visual , Boas Práticas de Dispensação , Assistência Farmacêutica/organização & administração , Conhecimentos, Atitudes e Prática em Saúde , Estratégias Locais
4.
Reumatol. clín. (Barc.) ; 13(5): 287-293, sept.-oct. 2017. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-165226

RESUMO

No cabe duda de que los productos biológicos aportan un valor añadido a los sistemas de salud, aunque también plantean grandes interrogantes debido a su especial naturaleza, lo que obliga a ser muy rigurosos y exigentes en su control de calidad y seguimiento. Este hecho se ha visto reforzado por la entrada en escena de los fármacos biosimilares, cuyo menor coste está permitiéndoles alcanzar un mayor protagonismo en el mercado mundial. El propósito de este artículo es revisar en profundidad los principales interrogantes que se plantean en su producción, distribución y control, así como los aspectos más importantes relacionados con su seguridad en la práctica clínica. En este trabajo revisamos lo que representa la farmacovigilancia de estos productos, prestando especial atención a su trazabilidad, como herramienta fundamental para la detección precoz de acontecimientos adversos (AU)


There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events (AU)


Assuntos
Humanos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/uso terapêutico , Terapia Biológica/métodos , Farmacovigilância , Preparações Farmacêuticas/síntese química , Terapia Biológica , Terapia Biológica/efeitos adversos , Resultado do Tratamento , Rotulagem de Medicamentos/normas , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico
7.
Pharm. pract. (Granada, Internet) ; 14(2): 0-0, abr.-jun. 2016. graf, ilus
Artigo em Inglês | IBECS | ID: ibc-153714

RESUMO

Background: Inadequacies of drug labeling have been frequently reported among Malaysian healthcare institutes, in which the Hospital Information System (HIS) is used. Objective: To identify potential areas to improve the existing labels used for pediatric liquid medications. Methods: This study was qualitative in nature, whereby focus group discussions (FGDs), face-to-face interviews (FTFIs), and onsite observation were used for data collection. Pharmacists stationed at three units (outpatient, inpatient and clinical pharmacy) of a tertiary hospital were targeted. Both FGDs and FTFIs were facilitated using a semi-structured interview guide, video-recorded and transcribed verbatim. All transcripts were thematically analyzed using content analysis approach. Results: Thirteen pharmacists participated in FGDs, while five were approached for FTFIs. Data analysis resulted in four major themes: format of labels, presentation of medication instructions, insufficiency of information, and the need for external aids and education. Participants unanimously agreed on the need for enlarging font sizes of key information. Suggestions were made to use more specific instructions for administration times and pictograms to illustrate important directions. The absence of information about storage, stability and handling of liquid medications was also highlighted. While discussion mainly focused on improving drug labeling, participants consistently stressed the need for an instruction sheet and pharmacist-based, one-to-one education regarding medication instructions. Conclusion: This study provides important insights into critical shortcomings in current labeling practice, underlying the need for developing a new label that incorporates a new format, additional information and pictograms for pediatric liquid medications (AU)


No disponible


Assuntos
Humanos , Masculino , Feminino , Criança , Hidratação/métodos , Sistemas de Informação Hospitalar/organização & administração , Formas de Dosagem/normas , Soluções Farmacêuticas/administração & dosagem , Erros de Medicação/prevenção & controle , Erros de Medicação/estatística & dados numéricos , Rotulagem de Medicamentos/ética , Sistemas de Informação Hospitalar/tendências , 25783/estatística & dados numéricos , 25783/métodos , Malásia/epidemiologia , Assistência Farmacêutica/organização & administração , Uso Off-Label/normas
8.
Pharm. pract. (Granada, Internet) ; 14(2): 0-0, abr.-jun. 2016. tab, graf
Artigo em Inglês | IBECS | ID: ibc-153715

RESUMO

Background: Information in society and in health care is currently undergoing a transition from paper to digital formats, and the main source of information will probably be electronic in the future. Objective: To explore patients’ use and perceptions of the patient information leaflet included in the medication package, and their attitude towards a transition to an electronic version. Methods: The data was collected during October to November 2014 among individuals in South-Eastern Sweden, using a questionnaire (n=406, response rate 78%) and interviews (n=15). Results: The questionnaire showed that the majority of the respondents (52%) occasionally read the patient information leaflet, 37% always read it, and 11% never read it. Almost half of the patients (41%) were positive towards reading the patient information leaflet electronically while 32% were hesitant and 26% neutral. A majority of the patients would request to get the patient information leaflet printed at the pharmacy if it was not included in the package. There were differences in attitude related to age and gender. The interviews showed that patients had mixed views on a transition to an electronic patient information leaflet. The patients perceived several positive aspects with an electronic patient information leaflet but were concerned about elderly patients. Conclusion: Although many were positive towards reading the patient information leaflet electronically, the majority prefer the patient information leaflet in paper form. Providing appropriate and useful eHealth services for patients to access the patient information leaflet electronically, along with education, could prepare patients for a transition to electronic patient information leaflet (AU)


No disponible


Assuntos
Humanos , Masculino , Feminino , Informação de Saúde ao Consumidor/métodos , Informação de Saúde ao Consumidor/organização & administração , Competência em Informação , Rotulagem de Medicamentos/instrumentação , Rotulagem de Medicamentos/métodos , Rotulagem de Medicamentos/normas , Educação de Pacientes como Assunto/métodos , Telemedicina/métodos , Telemedicina , Entrevistas como Assunto , Folhetos , Serviços de Informação sobre Medicamentos/organização & administração , Farmácias/organização & administração , Inquéritos e Questionários , Pesquisa Qualitativa
9.
Farm. hosp ; 40(2): 79-89, mar.-abr. 2016. graf, tab
Artigo em Inglês | IBECS | ID: ibc-151765

RESUMO

Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors (AU)


Objetivo: Evaluar la calidad de las etiquetas de muestras para ensayos clínicos mediante la normativa vigente y analizar su posible correlación con las características específicas de cada muestra. Método: Estudio transversal multicéntrico en el que se analizaron las muestras de ensayos clínicos de dos hospitales de tercer nivel. Se estudió la presencia de los once ítems de la Directiva 2003/94/CE, el nombre del ensayo y la dosis en la portada de la etiqueta como variables de calidad del etiquetado. Se analizó la influencia de las características propias de la muestra con la calidad del etiquetado. Resultado: Se analizaron un total de 503 muestras de 220 ensayos. La calidad media del etiquetado, entendido como el porcentaje de ítems del Anexo 13, fue del 91,9%. El 6,6% no contenía el nombre de la muestra en la cara externa de la etiqueta, mientras que a un 9,7% les faltaba la dosis. Las muestras con presentación de tipo ensayo clínico presentaron mayor calidad (p < 0,049), el enmascaramiento disminuía la calidad (p = 0,017) y la identificación por número de kit o por paciente la aumentaban (p < 0,01). La variable promotor fue la que más variabilidad introdujo en el análisis. Conclusiones: La calidad media del etiquetado es adecuada en la mayoría de las muestras del ensayo clínico. Resulta preocupante la ausencia de información esencial, como el código del ensayo clínico y el período de validez, en algunas muestras que pueden ser fuente potencial de errores de dispensación o de administración (AU)


Assuntos
Humanos , Rotulagem de Medicamentos/normas , Ensaios Clínicos como Assunto/normas , Drogas em Investigação/provisão & distribução , Erros de Medicação/prevenção & controle , Conduta do Tratamento Medicamentoso/normas , Estudos Transversais
10.
Pharm. pract. (Granada, Internet) ; 14(1): 0-0, ene.-mar. 2016. tab
Artigo em Inglês | IBECS | ID: ibc-150377

RESUMO

Background: It has been estimated that 10,000 patient injuries occur in the US annually due to confusion involving drug names. An unexplored source of patient misunderstandings may be medication salt forms. Objective: The objective of this study was to assess patient knowledge and comprehension regarding the salt forms of medications as a potential source of medication errors. Methods: A 12 item questionnaire which assessed patient knowledge of medication names on prescription labels was administered to a convenience sample of patients presenting to a family practice clinic. Descriptive statistics were calculated and multivariate analyses were performed. Results: There were 308 responses. Overall, 41% of patients agreed they find their medication names confusing. Participants correctly answered to salt form questions between 12.1% and 56.9% of the time. Taking more prescription medications and higher education level were positively associated with providing more correct answers to 3 medication salt form knowledge questions, while age was negatively associated. Conclusions: Patient misconceptions about medication salt forms are common. These findings support recommendations to standardize the inclusion or exclusion of salt forms. Increasing patient education is another possible approach to reducing confusion (AU)


No disponible


Assuntos
Humanos , Masculino , Feminino , Adulto , Erros de Medicação/prevenção & controle , Erros de Medicação/estatística & dados numéricos , Segurança do Paciente/normas , Rotulagem de Medicamentos/métodos , Rotulagem de Medicamentos/normas , Avaliação de Medicamentos/métodos , Medicamentos sob Prescrição/uso terapêutico , Letramento em Saúde/métodos , Preparações Farmacêuticas/administração & dosagem , Letramento em Saúde/organização & administração , Segurança do Paciente/legislação & jurisprudência , Estados Unidos/epidemiologia , Estudos Prospectivos , Análise Multivariada , Projetos Piloto , Letramento em Saúde/tendências , Segurança do Paciente/estatística & dados numéricos
12.
Farm. hosp ; 39(5): 309-313, sept.-oct. 2015. tab
Artigo em Espanhol | IBECS | ID: ibc-143215

RESUMO

Objetivo: determinar la causa de la diferencia constante entre las unidades teóricas de trastuzumab consumidas y las reales en una unidad de mezclas intravenosas. Métodos: se realizó un estudio del procedimiento completo manual y electrónico de la preparación de mezclas con trastuzumab mediante observación visual y revisión de los datos de control cuantitativo proporcionados por el sistema electrónico de preparación asistida y segura de la aplicación Farmis-Oncofarm. Resultados: se encontró diferencia entre el volumen óptimo del vial de trastuzumab que informa la ficha técnica del producto y el contenido en la ficha del medicamento de la aplicación. Además se encontró un defecto del volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución del vial. Conclusiones: el defecto de volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución es la causa del mayor número de viales reales consumidos en la preparación de mezclas con trastuzumab. Esto produce un impacto económico muy importante, estimando un sobrecoste anual de aproximadamente 46.508 Euros, sin provocar consecuencias negativas en el paciente (AU)


Objective: determine the cause of the constant difference between the theoretical and real number of trastuzumab units consumed in an Intravenous Mixtures Unit. Methods: was studied the manual and electronic full procedure about preparing mixtures with trastuzumab. Was performed by visual observation and review of quantitative monitoring data from the electronic preparation support and safe system of the application Farmis-Oncofarm. Results: difference between the optimum volume of trastuzumab contained in the summary of product characteristics and the same included in Farmis_Oncofarm was found. Also found a defect of the optimum volume of 10ml syringes used in the reconstitution vials process. Conclusions: the default in the optimal volume of 10ml syringes used in the reconstitution process increases the real consumed units of trastuzumab. This produces a significant economic impact calculated in an annual additional cost in approximately 46.508 Euros without negative consequences for the patient (AU)


Assuntos
Humanos , Erros de Medicação , Anticorpos Monoclonais/administração & dosagem , Causalidade , Anticorpos Monoclonais/efeitos adversos , Rotulagem de Medicamentos , Seringas , Composição de Medicamentos , Custos de Medicamentos/estatística & dados numéricos
13.
Pharm. pract. (Granada, Internet) ; 13(2): 0-0, abr.-jun. 2015.
Artigo em Inglês | IBECS | ID: ibc-141531

RESUMO

Background: Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined with the generalizations of the current risk category system (A, B, C, D, X) makes risk versus benefit assessment difficult. Discussion: In response to these concerns, the U.S. Food and Drug Administration (FDA) has decided to implement a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers; this rule is set to take effect in June of 2015. This change is designed to provide clear and detailed information for both patients and healthcare providers pertaining to three main categories: pregnancy, lactation, and females and males of reproductive potential. The new labeling rule also removes the previous letter risk categorization system. Conclusion: The upcoming changes regarding pregnancy and lactation safety labeling are going to have a vast impact on drug safety interpretation and prescribing practices. While this rule will provide practitioners with more detailed information pertaining to pregnancy, lactation, and reproduction, it will also place more responsibility on the practitioners to ensure the safety of their patients. This review will summarize these changes and discuss their potential effect on clinical practice (AU)


Antecedentes: Muchos medicamentos pueden ser utilizados con seguridad y efectividad para mejorar la salud en la gestión de enfermedades durante el embarazo con mínimo riesgo para la madre o el feto. Hoy, 9 de cada 10 mujeres toman al menos un medicamento durante el embarazo, y el número de ellas que toma 4 o más medicamentos se ha más que doblado en los últimos 30 años. Sin embargo, la falta de datos de seguridad, combinada con las generalizaciones de la actual categoría de riesgos (A, B, C, D, X) hace difícil la evaluación riesgo contra beneficio. Discusión: En respuesta a estas preocupaciones, la U.S. Food and Drug Administration (FDA) ha decidido implantar una nueva regla de información en embarazo y lactación diseñada para mejorar la evaluación riesgo contra beneficio de los medicamentos usados em madres embarazadas o lactando; esta regla entrará en vigor en junio de 2015. Este cambio está diseñado para proporcionar una información clara y detallada tanto para pacientes como para profesionales de la salud comprendiendo 3 apartados principales: embarazo, lactación, y potencial reproductivo masculino y femenino. La nueva información elimina el anterior sistema de categorización por letras. Conclusión: Los próximos cambios en la información de seguridad de embarazo y lactación van a producir un gran impacto en la interpretación de la seguridad en las prácticas de prescripción. Mientras esta regla proporcionará a los facultativos una información más detallada sobre embarazo, lactación y reproducción, también les dará más responsabilidad para asegurar la seguridad de sus pacientes. Esta revisión resume estos cambios y discute sus efectos potenciales sobre la práctica clínica (AU)


Assuntos
Feminino , Humanos , Masculino , Gravidez , Disseminação de Informação/métodos , Serviços de Informação sobre Medicamentos/organização & administração , Serviços de Informação sobre Medicamentos/normas , Produtos e Serviços de Informação , Gravidez , Gravidez/fisiologia , Lactação , Conhecimentos, Atitudes e Prática em Saúde , Rotulagem de Medicamentos/instrumentação , Rotulagem de Medicamentos/métodos , Disseminação de Informação/legislação & jurisprudência , Serviços de Informação sobre Medicamentos/ética , Serviços de Informação sobre Medicamentos/estatística & dados numéricos , Serviços de Informação sobre Medicamentos/tendências , Avaliação de Eficácia-Efetividade de Intervenções , Rotulagem de Medicamentos/legislação & jurisprudência , Rotulagem de Medicamentos/estatística & dados numéricos , Rotulagem de Medicamentos/tendências
14.
Rev. esp. salud pública ; 88(5): 613-627, sept.-oct. 2014. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-124324

RESUMO

Fundamentos: El término Patient Reported Outcomes (PRO) es definido como el resultado de la evaluación de un medicamento por el paciente y basada en su percepción de la enfermedad y su(s) tratamientos(s). El objetivo del estudio es determinar la utilización de PRO y compararla con otros tipos de variables de la eficacia contenidas en las fichas técnicas (FT) de medicamentos. Métodos: Revisión y análisis descriptivo de las variables de eficacia utilizadas en los ensayos clínicos de principios activos aprobados en España durante el período 2000-2012, descritas en las fichas técnicas clasificándolas en las siguientes categorías: PRO, resultados informados por el clínico (CRO) y resultados finales basados en pruebas de laboratorio (ML). Para las comparaciones se realizaron la prueba chi2 o la prueba exacta de Fisher, y se calcularon odd ratios para valorar la intensidad de la asociación Resultados: De las 330 FT estudiadas se incluyeron PROs en 65 (19,7%), los CRO en 188 (57%) y los ML en 128 (38,7%). Los PRO se utilizaron como único resultado final de eficacia en 6 medicamentos. Se observó una tendencia creciente de la significación estadística en la utilización de PRO a lo largo del tiempo estudiado (R2=0,525; p=0,079). Conclusiones: La frecuencia de utilización de PRO en FT es claramente inferior a la de las otras medidas de la eficacia, siendo la diferencia significativamente mayor en el caso de su inclusión como variable única final. La utilización de PROs fue más frecuente en medicamentos del sistema nervioso, agentes inmunomoduladores, sistema respiratorio y sistema musculoesquelético (AU)


Background: The term "Patient Reported Outcomes" (PRO) is defined as any result assessed directly by the patient and based on his perception of the illness and its treatment. The scope of the study is to determine and compare the use of PRO measures with other types of effectiveness endpoints in the summary of the products characteristics (SPC) of medicines with active substances approved by first time from 2000 to 2012 in Spain. Methods: A review and descriptive analysis of the effectiveness endpoints used in the clinical trials described in the SPCs studied, classifying them into the following categories: PRO, clinician-reported outcomes (CROs), and laboratory test/device measurement endpoints (ML). Chisquare and Fisher exact texts were used for comparative purposes, and odds ratio to determine the strongest of association. Results: PROs were included in 65 (19.7%) of the SPCs studied. CRO were the most frequently reported 188 (57%) cases, followed by ML: 128 (38,7%). PROs were included as only effectiveness endpoint in 6 medicines. A growing trend toward statistical significance (R2=0.525; p=0.079) has been observed in reporting PROs during the period of time studied. Conclusion: The use frequency of PRO in SPCs is clearlyminor compared to other efficacy endpoints considered, being the difference significantly higher in case of its use as only efficacy endpoint. The therapeutic areas where PROs were most reported were nervous system medicines, immunologic system modulator medicines, respiratory system, muscle and skeleton system (AU)


Assuntos
Humanos , Avaliação de Medicamentos/métodos , Avaliação de Processos e Resultados em Cuidados de Saúde/estatística & dados numéricos , Autorrelato , Aprovação de Drogas , Rotulagem de Medicamentos , Satisfação do Paciente/estatística & dados numéricos
15.
Med. paliat ; 21(3): 105-112, jul.-sept. 2014. tab
Artigo em Espanhol | IBECS | ID: ibc-124736

RESUMO

JUSTIFICACIÓN: El dolor oncológico irruptivo se define como una exacerbación transitoria de dolor que aparece con un dolor basal adecuadamente controlado. Una nueva generación de fármacos (fentanilo) de absorción transmucosa mimetizan las características del dolor irruptivo, proporcionando un perfil analgésico ideal. Una correcta educación del paciente sobre las características del dolor y el modo de titulación de estos fármacos es esencial para un abordaje satisfactorio. OBJETIVO: Evaluar el grado de comprensión y utilidad que los pacientes otorgan a una hoja de información y soporte a la titulación (HIT) creada para facilitar la comprensión del empleo y titulación del fentanilo nasal en pectina. MATERIAL Y MÉTODO: Inclusión consecutiva de pacientes que ya habían completado el proceso de titulación y a los que se les había entregado la hoja informativa (HIT) para evaluar mediante encuesta su grado de comprensión y satisfacción. RESULTADOS: De los 20 pacientes incluidos, 2 no la habían utilizado como material de consulta. De los restantes, todos la consultaron al menos en una ocasión, el 85% la consideró muy útil y el 80% muy comprensible. El 33% sugirió modificaciones menores


JUSTIFICATION: Breakthrough cancer pain is defined as a transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain. Anew generation of drugs (fentanyl) with transmucosal absorption mimic the characteristics of breakthrough pain by providing an ideal analgesic profile. Good patient education on pain characteristics and the mode of titration of these drugs is essential for a successful approach. OBJECTIVE: To evaluate the degree of understanding and usefulness that patients given to a titration sheet created to facilitate the use and titration of nasal fentanyl pectin. METHODS: Twenty consecutive patients who had completed the titration and had received the titration sheet were included. A survey was used to assess their satisfaction. RESULTS: Of the 20 patients enrolled, 2 had not consulted the titration sheet because they were happy enough with the verbal instructions given. Of the rest, all had consulted it at least once, 85% considered it very useful and 80% very understandable and 33% suggested minormodifications


Assuntos
Humanos , Dor/tratamento farmacológico , Manejo da Dor/métodos , Neoplasias/complicações , Rotulagem de Medicamentos/estatística & dados numéricos , Cuidados Paliativos/métodos , Fentanila/uso terapêutico , Satisfação do Paciente/estatística & dados numéricos , Administração Intranasal , Compreensão
16.
Ars pharm ; 55(2): 11-17[2], abr.-jun. 2014. tab
Artigo em Espanhol | IBECS | ID: ibc-125916

RESUMO

Objetivo: Determinar las similitudes y las diferencias del concepto científico de medicamento genérico en Europa y en Estados Unidos a partir de un estudio comparado de la legislación vigente en ambas regiones. Material y Método: Análisis de la legislación vigente en Europa y en Estados Unidos relativa al concepto de medicamento genérico, analizando detalladamente cada aspecto de la definición del mismo, composición (principio activo y excipientes), forma farmacéutica, características de calidad, bioequivalencia y concepto de medicamento de referencia. Estudio comparado de los resultados para concluir similitudes y diferencias en el ámbito conceptual. Resultados: Se observan similitudes y diferencias en cuanto al concepto científico de medicamento genérico en Europa y en Estados Unidos. En concreto, se observan diferencias al concepto de "mismo principio activo", "misma forma farmacéutica", al uso de excipientes con respecto al medicamento de referencia y a la elección del propio medicamento de referencia. También se observan diferencias en cuanto a cómo demostrar bioequivalencia con respecto al medicamento de referencia. Se observan similitudes en cuanto al concepto de "misma dosis", características de calidad, etiquetado e indicaciones con respecto al medicamento de referencia. Conclusiones: Estas diferencias van a tener un impacto en el desarrollo, registro y comercialización del medicamento genérico que desee comercializar una compañía farmacéutica de forma global en estas regiones


Aim: The objective is to determine the similarities and differences between Europe and the United States on the scientific concept of generic medicine. The study is based on a comparative study of the current legislation in both regions. Materials and Methods: Analysis of the current legislation in Europe and the United States in reference to the concept of generic medicine, analyzing each aspect of the definition in detail: composition (active substance and excipients), pharmaceutical form, quality characteristics, bioequivalence and the concept of reference medicinal product. Comparative study of the results obtained to conclude similarities and differences on the conceptual scope. Results: Similarities and differences are observed on the scientific concept of generic medicine between Europe and the United States. In particular, differences on the concept "same active substance" and "same pharmaceutical form", the use of excipients versus the reference medicinal product and the election of the reference medicinal product are observed. Moreover, differences on how to demonstrate bioequivalence with the reference medicinal product are also observed. Similarities on the concept of "same strength", quality characteristics, labelling and indications versus the reference medicinal product are observed. Conclusions: These differences will have an impact on the development, registration and marketing of a generic medicine by a company which decides to market a generic medicine globally in these regions


Assuntos
Humanos , Medicamentos Genéricos/análise , Indústria Farmacêutica/tendências , Avaliação de Medicamentos , Legislação Farmacêutica/tendências , Comercialização de Medicamentos , Cálculos da Dosagem de Medicamento , Rotulagem de Medicamentos/normas
18.
Pharm. pract. (Granada, Internet) ; 12(1): 0-0, ene.-mar. 2014. tab
Artigo em Inglês | IBECS | ID: ibc-121064

RESUMO

Objective: To understand whether underserved populations attend to prescription warning label (PWL) instructions, examine the importance of PWL instructions to participants and describe the challenges associated with interpreting the information on PWLs. Methods: Adults from an underserved population (racial and ethnic minorities, individuals with low income, older adults) who had a history of prescription medication use and were able to understand English took part in semi-structured interviews. Participants were presented with eight different prescription bottles with an attached PWL. Participants were asked, "If this prescription was yours, what information would you need to know about the medicine?" The number of participants who attended to the warning labels was noted. Other questions assessed the importance of PWLs, the challenges with understanding PWLs, and ways a pharmacist could help participant understanding of the PWL. Results: There were 103 participants. The mean age was 50.25 years (SD=18.05). Majority attended to the PWL. Participants not currently taking medications and who had limited health literacy were likely to overlook the warning labels. Majority rated the warning instructions to be extremely important (n=86, 83.5 %), wanted the pharmacist to help them understand PWLs by counseling them on the information on the label (n=63, 61.2%), and thought the graphics made the label information easy to understand. Conclusions: PWLs are an important method of communicating medication information, as long as they are easily comprehensible to patients. In addition to placing PWLs on prescription bottles, health care providers need to counsel underserved populations on medication warnings, especially individuals with limited health literacy who are not currently using a prescription medication (AU)


Objetivo: Entender si las poblaciones marginadas prestan atención a indicaciones de las etiquetas de advertencia de los medicamentos (PWL), examinar la importancia de las indicaciones de las PWL para los participantes y describir los riesgos asociados a la interpretación de la información de las PWL. Métodos: Adultos de una población marginada (minorías raciales y étnicas, individuos de ingresos bajos, y ancianos) que tenían histórico de uso de medicamentos y eran capaces de entender inglés, tomaron parte en unas entrevistas semi-estructuradas. Se presentó a los participantes 8 frascos de medicamentos con un PWL anexado. Se preguntó a los participantes: "Si este medicamento fuese suyo, ¿qué información necesitarías conocer sobre el medicamento?" Se registró el número de participantes que obedecía las etiquetas de advertencia. Otras preguntas evaluaban la importancia de las PWL, los riesgos de entender las PWL, y los modos en que un farmacéutico podría ayudar al participante a entender las PWL. Resultados: Hubo 103 participantes. La media de edad fue de 50,25 años (DE=18,05). La mayoría obedeció las PWL. Los participantes que no usaban actualmente medicamentos y que tenían una literacía en salud más limitada tenían mayor probabilidad de saltarse las etiquetas de advertencia. La mayoría consideró que las instrucciones de avisos era extremamente importantes(n=86; 83,5%), quería que el farmacéutico le ayudase a entender las PWL aconsejándoles sobre las etiquetas de advertencias /n=63; 61,2%) y pensaba que los dibujos hacían que la información de la etiqueta fuese más fácil de entender. Conclusiones: Las PWL son un método importante de comunicar información médica, ya que son fáciles de comprender por los pacientes. Además de colocar las PWL sobre los frascos de medicamentos, los profesionales de la salud deben aconsejar a las poblaciones marginadas sobre las etiquetas de advertencia, especialmente a los individuos con literacía en salud limitada y que no toman actualmente medicamentos (AU)


Assuntos
Humanos , Rotulagem de Medicamentos , Compreensão , População Suburbana , Educação de Pacientes como Assunto , Segurança do Paciente , Populações Vulneráveis
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