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1.
Farm. comunitarios (Internet) ; 15(3): 25-30, 12 jul. 2023.
Artigo em Espanhol | IBECS | ID: ibc-223200

RESUMO

El Servicio de Indicación Farmacéutica (SIF) es el servicio profesional a través del cual el farmacéutico atiende la consulta de los pacientes sobre un síntoma menor con el fin de obtener un remedio adecuado. Requiere de una actuación protocolizada y conlleva una elevada responsabilidad por parte del farmacéutico. INDICA+PRO es un proyecto realizado desde 2017 para evaluar el impacto y la implantación del SIF en la farmacia comunitaria española. Este artículo evalúa la implantación del SIF en una única farmacia.En la etapa de implantación del SIF a través de INDICA+PRO se detectaron factores de implantación (barreras y facilitadores) para los que se utilizaron una serie de estrategias. Como parte de la implementación se propusieron estrategias como destacar las ventajas del SIF para la farmacia, realizar incentivos por la prestación del servicio o la distribución de tareas dentro del equipo. Entre los facilitadores se encontró la disponibilidad de la zona de atención personalizada, la buena relación con los centros de salud cercanos y la realización de otros servicios profesionales en la farmacia.Las ventajas obtenidas por la realización del SIF obtenidas siguiendo el procedimiento protocolizado, dentro del programa SEFAC eXPERT®, establecido fueron, entre otras, la mejora en el seguimiento del paciente, el incremento en la comunicación del equipo y con el paciente facilitado por el historial farmacoterapéutico de la farmacia y la elaboración de informes estandarizados. (AU)


Assuntos
Humanos , Serviços Comunitários de Farmácia/organização & administração , Medicamentos de Venda Assistida , Administração Farmacêutica
2.
Indian J Pediatr ; 89(11): 1126-1128, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35867272

RESUMO

The frequency, risk factors, and prognosis of antitubercular drug-induced liver injury (TB-DILI) was assessed in this prospective observational study. All consecutive children < 18 y put on antitubercular therapy (ATT) for pulmonary or extrapulmonary tuberculosis between July 2019 and December 2020 were included. Liver function tests (LFTs) were done at baseline and at 2, 4, 6 wk, and then 2 monthly after initiation of therapy till completion of ATT regimen. A total of 81 children [14.27 ± 3.38 y, 34 (42%) males] were included. Out of the patients enrolled, 10 (12.3%) developed TB-DILI at a median of 8.5 (3-18) d of starting ATT. All patients were symptomatic with the most common symptoms being anorexia and nausea (80%). A higher baseline ALT was independently associated with DILI with adjusted OR 2.1 (95% CI 1.3-3.4), p = 0.01. Eight patients tolerated reintroduction of ATT in a sequential manner, 9-24 d after discontinuation.


Assuntos
Antituberculosos , Medicamentos de Venda Assistida , Antiplatelmínticos/uso terapêutico , Antituberculosos/efeitos adversos , Criança , Inibidores da Colinesterase , Feminino , Fármacos para a Fertilidade Feminina , Humanos , Masculino
3.
Pharm. pract. (Granada, Internet) ; 19(1): 0-0, ene.-mar. 2021. tab
Artigo em Inglês | IBECS | ID: ibc-201710

RESUMO

BACKGROUND: The provision of information by pharmacy staff is a key factor to ensure patients' understanding and quality use of medications, including antibiotics. However, little is known regarding the transmission of information between pharmacy staff and patients in Indonesia. OBJECTIVE: This study aimed to identify information on antibiotics provided by pharmacy staff and recalled by patients in an Indonesian outpatient setting. METHODS: The study was conducted in a hospital outpatient clinic in Malang, Indonesia, in 2019. A checklist was used to obtain the data on information provided by pharmacy staff, while interviews were conducted to determine information recalled by patients (only presenting patients were included); a total of 15 information items - i.e. 14 essential and one secondary - were observed. Descriptive analysis was used to summarise data on the checklists ('given' versus 'not given') as well as responses from the interviews ('recalled' versus 'missed'). RESULTS: Eleven pharmacy staff (two pharmacists and nine pharmacy technicians) were involved in providing information for patients obtaining oral antibiotics during the study period. Of 14 essential information items, only about half was given by pharmacy staff, with pharmacists significantly providing on average more information items than pharmacy technicians (7.96 versus 7.67 respectively; p < 0.001). The most frequently information items provided (>90%) included "antibiotic identification", "indication", administration directions (i.e. "dosage", "frequency", "hour of administration", "administration before/after meal", "route of administration"), and "duration of use". A total of 230 patients consented to the study, giving 79.9% response rate. The average number of information items recalled by patients was 7.09 (SD 1.45). Almost all patients could recall information on administration directions [i.e. "route of administration" (97.0%), "frequency" (95.2%), "dosage" (92.6%), "hour of administration" (85.7%), "administration before/after meal" (89.1%)] and "duration of use" (90.9%). Fewer patients were able to recall "antibiotic identification" (76.5%) and "indication" (77.0%). CONCLUSIONS: Pharmacy staff provided antibiotic information in a limited fashion, while patients showed adequate ability to recall the information given to them. Further study is needed to better understand the effective process of information transmission between pharmacy staff and patients, especially if more information was provided, to better optimise the use of antibiotics in outpatient settings in Indonesia


No disponible


Assuntos
Humanos , Masculino , Feminino , Adulto Jovem , Adulto , Prescrições de Medicamentos/estatística & dados numéricos , Antibacterianos/uso terapêutico , Medicamentos de Venda Assistida/uso terapêutico , Indonésia/epidemiologia , Ambulatório Hospitalar/estatística & dados numéricos , Estudos Transversais , Boas Práticas de Dispensação , Assistência Farmacêutica/organização & administração
4.
Farm. hosp ; 44(6): 288-296, nov.-dic. 2020. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-197697

RESUMO

OBJETIVO: Dar a conocer los resultados referentes a características generales, recursos humanos, materiales y sistemas de información de la encuesta nacional de la Sociedad Española de Farmacia Hospitalaria (SEFH) 2019 sobre la situación de los Servicios de Farmacia Hospitalaria españoles. MÉTODO: Se envió un cuestionario on line a los responsables de los 368 Servicios de Farmacia Hospitalaria españoles registrados en el directorio de socios de la SEFH. El cuestionario incluía 77 preguntas agrupadas en ocho dimensiones. La información se recogió entre marzo y septiembre de 2019. RESULTADOS: La tasa global de respuesta fue del 54,3%. El 69% de los hospitales eran de titularidad pública y el tamaño más representado de 101-250 camas. El 9% permanecía abierto durante las 24 horas y el 57,5% no disponía de ninguna modalidad de atención continuada. La dispensación a pacientes externos durante la tarde se realizaba en el 41,9% de los centros. El 52,7% de los Servicios de Farmacia estaban acreditados por una norma de calidad. La media de farmacéuticos especialistas por Servicio de Farmacia fue 5,34 (desviación estándar [DE]: 6,22). El 47% de los farmacéuticos trabajaban al menos media jornada en las unidades clínicas. En cuanto a los sistemas automatizados rotativos de almacenamiento y dispensación, de media los Servicios de Farmacia disponían de 0,3 (DE: 0,7) y 0,9 (DE: 1,4) según fueran de tipo horizontal o vertical, respectivamente. El 16,1% de las camas hospitalarias estaban asistidas por sistemas automatizados de dispensación, llegando al 33,5% en hospitales con > 1.000 camas. El 3% de los Servicios de Farmacia Hospitalaria disponía de un sistema robotizado para la preparación de quimioterapia y el 24,8% de un sistema de trazabilidad y seguridad. Las bombas de infusión inteligentes se utilizaban en el 21,4% de los centros. La prescripción electrónica estaba implantada en el 98,8% de los hospitales para pacientes ingresados y en el 62% para pacientes ambulantes. CONCLUSIONES: En los Servicios de Farmacia Hospitalaria españoles existe una infradotación de farmacéuticos especialistas, a pesar de haberse duplicado su incorporación a las unidades clínicas. Destaca un crecimiento en la automatización de las actividades logísticas de dispensación, pero existe un importante margen de mejora en sistemas robotizados y de trazabilidad de las preparaciones. Conocer estos resultados puede resultar de gran utilidad para establecer planes de actuación


OBJECTIVE: To publicize the results regarding the general characteristics, human resources, materials and information systems of Spanish hospital pharmacy departments arising from SEFH's 2019 Survey on the Situation of Spanish Hospital Pharmacy Departments. METHOD: An online questionnaire was sent to the heads of the 368 hospital pharmacy departments affiliated to SEFH. The questionnaire included 77 questions grouped into 8 dimensions. The information was collected between March and September 2019. RESULTS: The overall response rate was 54.3%. Sixty-nine percent of hospitals were public and the most commonly reported hospital size was 101-250 beds. Nine percent of responding hospitals remained open round the clock and 57.5% did not offer a continued care service. A total of 41.9% of hospitals dispensed medications to outpatients in the afternoon and 52.7% of hospital pharmacy departments were accredited to some quality standard. The mean number of specialist pharmacists per pharmacy Department was 5.34 (SD: 6.22); 47% of pharmacists spent at least half their working day in a clinical unit. Hospital pharmacy departments had a mean of 0.3 (SD: 0.7) or 0:9 (SD: 1.4) automated storage and dispensing carousels, depending on whether they were horizontal or vertical, respectively. A total of 16.1% of beds were assisted by automated dispensing systems, a figure that reached 33.5% in hospitals with more than 1,000 beds. Three percent of hospital pharmacy departments had a robotized system for compounding chemotherapy medications and 24.8% had a traceability and safety system. Smart infusion pumps were used by 21.4% of hospitals. Electronic prescriptions were implemented in 98.8% of hospitals for inpatients and in 62% for outpatients. CONCLUSIONS: Spanish hospital pharmacy departments face a shortage of specialist pharmacists, although incorporation of such professionals to clinical units has doubled in the last few years. There has been an increase in the level of automation of the logistic processes involved in medication dispensing, but there is still significant room for improvement in the area of robotized dispensing and compounding traceability systems. This data could play an invaluable role in the design of future action plans


Assuntos
Humanos , Serviço de Farmácia Hospitalar , Inquéritos e Questionários/normas , Sistemas de Informação/organização & administração , Sistemas de Informação/normas , Sociedades Médicas/normas , Robótica , Prescrição Eletrônica , Medicamentos do Componente Especializado da Assistência Farmacêutica , Medicamentos de Venda Assistida/normas
5.
Rev. habanera cienc. méd ; 19(5): e2954, sept.-oct. 2020. tab, graf
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1144692

RESUMO

RESUMEN Introducción: Los farmacéuticos enfrentan conflictos éticos en la dispensación de medicamentos. La resolución de estos asegura un servicio eficaz, seguro, digno y de calidad. Objetivo: Caracterizar desde una perspectiva ética-deontológica la dispensación de medicamentos en las farmacias de Cuenca-Ecuador, 2018. Material y Métodos: La investigación tuvo un diseño no experimental, descriptivo y transversal. La muestra no probabilística fue de 65 dependientes. Se aplicó un cuestionario para identificar la resolución de conflictos éticos y el nivel de conocimientos sobre Ética y Deontología Farmacéutica. Las respuestas fueron codificadas y analizadas con SPSS 23.0. Resultados: Los conflictos más frecuentes fueron el consentimiento informado (83 por ciento), prescripción médica (95 por ciento) y conflicto de intereses (84 por ciento). La resolución ética de los conflictos fue superior en dependientes capacitados en Ética y Deontología, con una correlación de 0,34 (p= (0,009) con el nivel de conocimientos en Deontología Farmacéutica. El nivel de conocimiento sobre Ética y Deontología Farmacéutica fue bajo en 60 por ciento de la muestra, con asociación inversa a la autopercepción de conocimiento (ρ=-0,259; p≤ 0,001). Conclusiones: La resolución empírica de los conflictos éticos durante el ejercicio de la profesión se realiza sin un fundamento ético-deontológico. El nivel de conocimiento en Ética y Deontología requiere una intervención desde la capacitación institucional y formación profesional de modo que se revierta en la adopción de decisiones acertadas que garanticen la seguridad del paciente como persona(AU)


ABSTRACT Introduction: Pharmacists face ethical conflicts related to the dispensing of medications. Their resolution ensures an effective, safe, dignified, and quality service. Objective: To characterize the dispensing of medications from an ethical-deontological perspective in pharmacies of Cuenca-Ecuador in 2018. Material and methods: A non-experimental, descriptive and cross-sectional study was conducted. The non-probability sample consisted of 65 pharmacists. A survey was applied to identify the resolution of ethical conflicts and the level of knowledge of Pharmaceutical Ethics and Deontology. Data were coded and analyzed with SPSS 23.0. Results: The most frequent conflicts included informed consent (83 percent), medical prescription (95 percent) and conflict of interests (84 percent).The resolution of ethical conflicts was higher in pharmacists with training in Ethics and Deontology, with a correlation of 0.34 (p =0.009) with the level of knowledge of Pharmaceutical Deontology. The level of knowledge of Pharmaceutical Ethics and Deontology was low in 60 percent of the sample, with an inverse association with the self-perception of knowledge (ρ= -0.259; p≤ 0.001). Conclusions: Empirical resolution of ethical conflicts while exercising the profession is carried out without ethical-deontological foundation. The level of knowledge of Ethics and Deontology requires intervention from institutional and professional training so that it is reverted to make the right decisions to guarantee the safety of the patient as a person(AU)


Assuntos
Humanos , Assistência Farmacêutica/ética , Teoria Ética , Medicamentos de Venda Assistida , Epidemiologia Descritiva , Estudos Transversais , Equador
6.
Pharm. pract. (Granada, Internet) ; 18(3): 0-0, jul.-sept. 2020. tab, graf
Artigo em Inglês | IBECS | ID: ibc-194195

RESUMO

BACKGROUND: Antibiotics are the most frequently used medicines worldwide with most of the countries defining these as prescription-only medicines. Though, dispensing non-prescribed antibiotics represent one of the chief causal factors to the irrational use of antibiotics that paves the way to the development of antimicrobial resistance. OBJECTIVE: We aimed at describing the practices and the enablers for non-prescribed antibiotic dispensing in Maputo city, Mozambique. METHODS: A qualitative study was conducted, between October 2018 and March 2019, in nine private pharmacies randomly selected across Maputo city. Eighteen pharmacists were contacted and seventeen enrolled through snowball sampling. In-depth interviews were conducted, audiotaped, and transcribed verbatim. Transcripts were coded and analysed though thematic analysis with guidelines from Braun and Clark. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist by (Tong, 2007) was performed. RESULTS: Out of seventeen, fifteen pharmacists admitted non-prescribed dispensing of antibiotics. Common antibiotic dispensing practices included; dispensing without prescription, without asking for a brief clinical history of patients, without clear explanation of the appropriate way of administering, without advising on the side effects. Reasons for non-prescribed antibiotic dispensing are linked to patients' behaviour of demanding for non-prescribed antibiotics, to the patients expectations and beliefs on the healing power of antibiotics, to the physicians' prescribing practices. Other reasons included the pressure for profits from the pharmacy owners, the fragile law enforcement, and absence of accountability mechanisms. CONCLUSIONS: The practices of non-prescribed antibiotic dispensing characterize the 'daily life' of the pharmacists. On the one hand, the patient's demand for antibiotics without valid prescriptions, and pharmacist's wish to assist based on their role in the pharmacy, the pressure for profits and on the understanding of the larger forces driving the practices of self-medication with antibiotics - rock. On the other hand, pharmacists are aware of the legal status of antibiotics and the public health consequences of their inappropriate dispensing practices and their professional and ethical responsibility for upholding the law - hard place. Highlighting the role of pharmacists and their skills as health promotion professionals is needed to optimizing antibiotic dispensing and better conservancy in Mozambique


No disponible


Assuntos
Humanos , Masculino , Feminino , Adulto , Prática Profissional , Medicamentos sem Prescrição/normas , Antibacterianos/uso terapêutico , Medicamentos de Venda Assistida/normas , Boas Práticas de Dispensação , Moçambique , Assistência Farmacêutica/normas , Saúde Pública
8.
Pharm. pract. (Granada, Internet) ; 17(3): 0-0, jul.-sept. 2019. tab
Artigo em Inglês | IBECS | ID: ibc-188127

RESUMO

Background: In Germany over-the-counter medications (OTC) - which since 2004 are no longer subject to binding prices - can only be purchased in pharmacies. Pharmacy owners and their staff therefore have a special responsibility when dispensing, advising on and setting the prices of medications. Objective: The aim of this study was to assess medication dispensing, additional therapeutic recommendations and pricing practices for acute diarrhoea in adults and to evaluate the role of the patient's approach (symptom-based versus medication-based request) in determining the outcome of these aspects. Methods: A cross-sectional study was conducted from 1 May to 31 July 2017 in all 21 community pharmacies in a medium-sized German city. Symptom-based and medication-based scenarios related to self-medication of acute diarrhoea were developed and used by five simulated patients (SPs) in all of the pharmacies (a total of 84 visits). Differentiating between the different test scenarios in terms of the commercial and active ingredient names and also the prices of the medications dispensed, the SPs recorded on collection forms whether the scenario involved generic products or original preparations as well as whether recommendations were made during the test purchases regarding an additional intake of fluids. Results: In each of the 84 test purchases one preparation was dispensed. However, a preparation for oral rehydration was not sold in a single test purchase. On the other hand, in 74/84 (88%) of test purchases, medications with the active ingredient loperamide were dispensed. In only 35/84 (42%) of test purchases, the patient was also recommended to ensure an 'adequate intake of fluids' in addition to being dispensed a medication. In symptom-based scenarios significantly more expensive medications were dispensed compared to the medication-based scenarios (Wilcoxon signed rank test: z = -4.784, p < 0.001, r = 0.738). Also within the different scenarios there were enormous price differences identified - for example, in the medication-based scenarios, even for comparable loperamide generics the cheapest preparation cost EUR 1.99 and the most expensive preparation cost EUR 4.53. Conclusions: Oral rehydration was not dispensed and only occasionally was an adequate intake of fluids recommended. There were also enormous price differences both between and within the scenarios investigated


No disponible


Assuntos
Humanos , Assistência Farmacêutica/organização & administração , Dispensários de Medicamentos , Medicamentos de Venda Assistida/provisão & distribuição , Diarreia/tratamento farmacológico , Alemanha/epidemiologia , Boas Práticas de Dispensação , Loperamida/uso terapêutico , Antidiarreicos/uso terapêutico , Serviços Comunitários de Farmácia/estatística & dados numéricos , Preço de Medicamento , Automedicação/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Estudos Transversais
9.
Farm. hosp ; 43(3): 82-86, mayo-jun. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-183009

RESUMO

Objetivo: Analizar la situación y la posible variabilidad de la prestación farmacéutica a centros sociosanitarios residenciales públicos incluidos en un proyecto piloto vinculados a un servicio de farmacia de hospital del Servicio Andaluz de Salud. Método: Estudio multicéntrico transversal. Se diseñó un cuestionario que incluye preguntas englobadas en: características del centro, legislación, guía farmacoterapéutica y prescripción, preparación y transporte, dispensación, administración, actividad farmacéutica y datos asistenciales. Resultados: Se incluyeron los 13 centros del proyecto piloto; todos respondieron las 36 preguntas del cuestionario. Todos disponían de depósito de medicamentos. Todos dispensaban en dosis unitaria individualizada. Tres centros sociosanitarios no disponían de puesto de trabajo para el farmacéutico. El farmacéutico no se desplazaba al centro en tres de ellos. Conclusiones: Aunque existe cierta variabilidad en la prestación farmacéutica a los centros sociosanitarios del pilotaje, se han identificado tanto fortalezas (por ejemplo, dispensación de medicamentos en dosis unitaria), como puntos de mejora (como el aumento de la presencia del farmacéutico en los centros)


Objective: To analyse the situation and the possible variability of pharmaceutical provision to public nursing homes included in the "Project pilot" from hospital pharmacy services of the Andalusian Health Service. Method: Cross-sectional multicenter study. A questionnaire of 36 questions including: nursing homes characteristics, legislation, pharmacotherapeutic guide and prescription, preparation and transport, dispensation, administration, pharmaceutical activity and healthcare data. Results: We included 13 nursing homes. Everyone had a medicines store. All dispensed in individualized unit dose. Three nursing homes did not have a work space for the pharmacist. The pharmacist did not move to the nursing home in three of them. Conclusions: Although there is variability in the pharmaceutical provision to nursing homes included in the "Pilot Project", we have identified strengths (unit dose system of medication distribution) and opportunities to improve (increase of the time of presence of the pharmacist in the nursing homes)


Assuntos
Humanos , Casas de Saúde , Serviço de Farmácia Hospitalar/organização & administração , Projetos Piloto , Medicamentos do Componente Especializado da Assistência Farmacêutica , Serviços Públicos de Saúde , Estudos Transversais , Inquéritos e Questionários , Medicamentos de Venda Assistida
10.
Pharmacoeconomics ; 37(8): 1049-1064, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31069781

RESUMO

BACKGROUND AND OBJECTIVE: Unplanned pregnancies can lead to poorer maternal and child health outcomes. The Australian Therapeutic Goods Administration committee rejected reclassifying a range of oral contraceptive pills (OCPs) from prescription to pharmacist-only medicines in 2015, mainly based on safety concerns. Improving access to OCPs may encourage some women to use contraceptives or switch from other contraceptive methods. However, some adverse events may increase and some women may stop using condoms, increasing their risk of sexually transmitted infections. This study aimed to estimate the cost effectiveness of reclassifying OCPs from prescription to pharmacist-only. PERSPECTIVE: Healthcare system. SETTING: Australian primary care. METHODS: A Markov model was used to synthesise data from a variety of sources. The model included all Australian women aged 15-49 years (N = 5,644,701). The time horizon was 35 years. Contraceptive use before reclassification was estimated using data from the Household, Income and Labour Dynamics in Australia (HILDA) survey, while survey data informed use after reclassification. Health outcomes included pregnancies, pregnancy outcomes (live birth, miscarriage, stillbirth, ectopic pregnancy and abortion), sexually transmitted infections, adverse events (venous thromboembolism, depression, myocardial infarction and stroke), ovarian cancer cases and quality-adjusted life-years. Costs included those related to general practitioner and specialist consultations, contraceptives and other medicines, pharmacist time, hospitalisations and adverse events. All costs were reported in 2016 Australian Dollars. A 5% discount rate was applied to health outcomes and costs. RESULTS: Reclassifying OCPs resulted in 85.70 million quality-adjusted life-years experienced and costs of $46,910.14 million over 35 years, vs. 85.68 million quality-adjusted life-years experienced and costs of $50,274.95 million with OCPs remaining prescription-only. Thus, reclassifying OCPs was more effective and cost saving. However, a sensitivity analysis found that more research on the probability of pregnancy in women not using contraception and not trying to conceive is needed. CONCLUSION: Reclassifying OCPs is likely to be considered cost effective by Australian decision makers.


Assuntos
Medicamentos de Venda Assistida/classificação , Anticoncepcionais Orais/classificação , Assistência Farmacêutica/organização & administração , Farmacêuticos/organização & administração , Adolescente , Adulto , Austrália , Medicamentos de Venda Assistida/administração & dosagem , Medicamentos de Venda Assistida/economia , Anticoncepcionais Orais/administração & dosagem , Anticoncepcionais Orais/economia , Análise Custo-Benefício , Feminino , Acesso aos Serviços de Saúde , Humanos , Pessoa de Meia-Idade , Assistência Farmacêutica/economia , Farmacêuticos/economia , Medicamentos sob Prescrição/administração & dosagem , Medicamentos sob Prescrição/classificação , Medicamentos sob Prescrição/economia , Atenção Primária à Saúde/economia , Anos de Vida Ajustados por Qualidade de Vida , Inquéritos e Questionários , Adulto Jovem
12.
Farm. hosp ; 43(1): 19-23, ene.-feb. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-182582

RESUMO

Objetivo: El objetivo de nuestro estudio fue analizar las características de los medicamentos sujetos a seguimiento adicional. Para ello, estudiamos: los criterios aplicados para su designación, los criterios de dispensación autorizados, los grupos farmacológicos a los que pertenecen y su seguridad postcomercialización. Método: Se analizó la lista publicada por la Agencia Europea de Medicamentos en enero de 2017 (EMA/245297/2013 Rev.41). La información para el análisis se extrajo de las páginas web de la Agencia Europea de Medicamentos y la Agencia Española de Medicamentos y Productos Sanitarios. Resultados: Se estudiaron 316 medicamentos sujetos a seguimiento adicional. El criterio de designación más común fue ser un nuevo principio activo (n = 197 [62,3%]). Otros criterios de designación comunes fueron: requerir un estudio postautorización de seguridad (n = 52 [16,5%]) y ser un medicamento biológico, aunque no un nuevo principio activo (n = 49 [15,5%]). Con respecto a las condiciones de dispensación, casi el 66% de estos medicamentos se autorizaron con criterios de dispensación restringidos. Hasta enero de 2017, la Agencia Española de Medicamentos y Productos Sanitarios había publicado 14 notas informativas de seguridad referidas a los medicamentos sujetos a seguimiento adicional. Conclusiones: Los medicamentos sujetos a seguimiento adicional incluyen mayoritariamente nuevas sustancias activas. El grupo farmacológico más frecuente es el de los fármacos antineoplásicos e inmunomoduladores. La revisión postcomercialización de su seguridad ha generado ya alguna información publicada por la Agencia Española de Medicamentos y Productos Sanitarios


Objective: The objective of this study was to analyse the characteristics of medicines subject to additional monitoring. We assessed the following aspects: the criteria applied to approve a medicine as being subject to additional monitoring; the authorized dispensing conditions; the pharmacological groups to which they belong; and their post-authorisation safety. Method: We analysed the list published by the European Medicines Agency in January 2017 (EMA/245297/2013 Rev.41). Information for the analysis was obtained from the web sites of the European Medicines Agency and the Spanish Agency of Medicines and Medical Devices. Results: We assessed 316 medicines subject to additional monitoring. The most common criterion used to assign a medicine as being subject to additional monitoring was it being a new active substance (n = 197 [62.3%]). Other common criteria were requiring a post-authorisation safety study (n = 52 [16.5%]) and being a biologic medicine but not a new active substance (n = 49 [15.5%]). Regarding dispensing conditions, nearly 66% of these medicines were authorized under restricted conditions. Until January 2017, the Spanish Agency of Medicines and Medical Device published 14 safety reports related to medicines subject to additional monitoring. Conclusions: The group of medicines subject to additional monitoring mainly includes new active substances. The most common pharmacological group is antineoplastic and immunomodulating agents. The postauthorisation safety study has already produced information published by the Spanish Agency of Medicines and Medical Devices


Assuntos
Humanos , Monitoramento de Medicamentos/normas , Medicamentos de Venda Assistida/normas , Medicamentos Biossimilares , Aprovação de Drogas , Monitoramento de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , União Europeia , Farmacovigilância
14.
Lima; Perú. Ministerio de Salud. Dirección General de Medicamentos, Insumos y Drogas. Dirección de Farmacovigilancia, Acceso y Uso de Medicamentos. Unidad Funcional de Uso Racional de Medicamentos; 1 ed., 1 reimp; Dic. 2017. 32 p. ilus.
Monografia em Espanhol | LILACS, MINSAPERÚ | ID: biblio-1290669

RESUMO

La presente publicación describe un conjunto de normas, establecido con el objetivo de asegurar un uso adecuado de los medicamentos, estableciendo criterios, metodologías y requisitos para el cumplimiento de las buenas prácticas de dispensación de productos farmacéuticos establecidas en el Reglamento de Establecimientos Farmacéuticos aprobado por Decreto Supremo Nº 021-2001-SA


Assuntos
Assistência Farmacêutica , Qualidade dos Medicamentos Homeopáticos , Atenção à Saúde , Boas Práticas de Dispensação , Dispensários de Medicamentos , Medicamentos de Venda Assistida
15.
Lima; Perú. Ministerio de Salud; 1 ed; 20171200. 32 p. ilus.
Monografia em Espanhol | MINSAPERÚ, LILACS | ID: biblio-965595

RESUMO

El manual describe un conjunto de normas, establecido con el objetivo de asegurar un uso adecuado de los medicamentos, estableciendo criterios, metodologías y requisitos para el cumplimiento de las buenas prácticas de dispensación de productos farmacéuticos establecidas en el Reglamento de Establecimientos Farmacéuticos aprobado por Decreto Supremo Nº 021-2001-SA.


Assuntos
Boas Práticas de Dispensação , Atenção Primária à Saúde , Medicamentos de Venda Assistida
16.
Pharm. pract. (Granada, Internet) ; 14(3): 0-0, jul.-sept. 2016.
Artigo em Inglês | IBECS | ID: ibc-156632

RESUMO

Background: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. Objectives: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription. Methods: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning. Results: The recommendations were eventually endorsed by the BMG in consultation with the BfArM. Conclusions: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists (AU)


No disponible


Assuntos
Humanos , Masculino , Feminino , Medicamentos sem Prescrição/farmacologia , Medicamentos sem Prescrição/uso terapêutico , Anticoncepcionais Orais/farmacologia , Anticoncepcionais Orais/uso terapêutico , Formulários como Assunto/normas , Anticoncepcionais Pós-Coito/classificação , Anticoncepcionais Pós-Coito/farmacologia , Anticoncepcionais Pós-Coito/uso terapêutico , Alemanha/epidemiologia , Boas Práticas de Dispensação , Postos de Medicamentos , Medicamentos de Venda Assistida/normas
17.
Braz. j. pharm. sci ; 52(1): 151-162, Jan.-Mar. 2016. tab, graf
Artigo em Inglês | LILACS | ID: lil-789080

RESUMO

ABSTRACT The objective was to describe and evaluate a model of drug dispensing developed and implemented in a community pharmacy in Brazil. This was a descriptive, observational, quasi-experimental study performed in the period between 21 January 2013 and 20 April 2013. The model was evaluated and described in terms of three parameters: structure, process and outcome. The description and assessment of each parameter was performed as follows: (I) Structure: profile of patients, pharmacist's professional profile, physical facility, informational material; (II) Process: drug-related problems, pharmaceutical interventions performed, results of pharmaceutical interventions; (III) Outcome: patient knowledge of medications. Dispensing service improved patient knowledge of medications (p < 0.05), which was associated with pharmacotherapy complexity (p < 0.05). The main problems identified were related to lack of patient knowledge regarding their medication (52.9%). Pharmaceutical interventions were mostly performed directly to the patients (86.3%) by verbal (95.4%) and written (68.2%) information, and most of the problems were completely solved (62.7%). The medicine dispensing model was able to identify and solve drug-related problems and promote an improvement in patient knowledge about medication.


RESUMO O objetivo foi descrever e avaliar um modelo de serviço de dispensação de medicamentos desenvolvido e implantado em uma Farmácia Comunitária no Brasil. Trata-se de restudo descritivo, observacional e quase-experimental, realizado no período de 21 de janeiro a 20 de abril de 2013. A descrição e avaliação do modelo foi realizada segundo os parâmetros: estrutura, processo e resultado.Os aspectos descritos e avaliados foram: 1. Estrutura: perfil dos pacientes, perfil profissiográfico dos farmacêuticos, estrutura física, material de informação; 2. Processo: problemas relacionados ao medicamento detectados, intervenções farmacêuticas realizadas, resultados das intervenções farmacêuticas; 3. Resultado: conhecimento do pacientes sobre os medicamentos utilizados. A dispensação proporcionou melhora do conhecimento do paciente sobre os medicamentos (p < 0,05), que demonstrou-se associada à complexidade da farmacoterapia (p < 0,05). Foram identificados majoritariamente problemas relacionados à falta de condições do paciente em utilizar o medicamento (52,94%). As intervenções farmacêuticas foram realizadas predominantemente junto ao paciente (86,27%) através do fornecimento de informações verbais (95,4%) e escritas (68,2%) e, em sua maioria, o problema que originou a intervenção foi totalmente resolvido (62,75%).O serviço foi capaz de identificar e resolver os problemas relacionados ao medicamento e contribuiu para a melhoria do conhecimento dos pacientes relativo aos medicamentos utilizados.


Assuntos
Educação de Pacientes como Assunto/classificação , Aconselhamento Diretivo/métodos , Medicamentos de Venda Assistida , Farmácias , Uso de Medicamentos
18.
Farm. comunitarios (Internet) ; 7(3): 23-41, sept. 2015. tab
Artigo em Espanhol | IBECS | ID: ibc-142854

RESUMO

Revisión sistemática de las fichas técnicas (apartados 4.6 y 5.3) de los medicamentos más consumidos en España, según el Sistema Nacional de Salud, y revisión bibliográfica a través de PubMed, según un patrón de búsqueda estándar, con respecto a la influencia de éstos sobre la fertilidad masculina. Como resultado a esto nos encontramos con que de 29 principios activos estudiados, 15 no presentan datos referentes a la fertilidad masculina en su ficha técnica, para 18 no se recuperó información al respecto en la búsqueda en PubMed y 9 no disponen de material de información que provenga de ninguna de las dos fuentes de las que utilizamos. En 3 medicamentos los resultados de las dos fuentes coinciden y en 2 encontramos discrepancias. En 13 de los 29 fármacos estudiados se ha encontrado información de efectos adversos sobre la fertilidad masculina en alguna de las 2 fuentes de información revisadas. Se demuestra con esto una falta de información clara, concisa y contrastada (AU)


Systematic review of the technical specifications (4.6 and 5.3 paragraph) of the most frequently used drugs in Spain, from NHS, and the information provided by PubMed according to a standard search pattern with respect to their influence on male fertility. As a result of this we find that 15 of 29 active substances studied have no data about male fertility in their technical data sheets, 18 of this 29 have no data about male fertility from PubMed and 9 don’t have any information coming from either source we used. 3 medicines have matching results from the two sources and other 2 found discrepancies. In 13 of the 29 drugs studied the information about adverse effects on male fertility was found in one of the two sources of information reviewed. It’s demonstrated that it’s necessary clear, concise and contrasted information (AU)


Assuntos
Adulto , Humanos , Masculino , Fármacos para a Fertilidade/uso terapêutico , Infertilidade Masculina/induzido quimicamente , Infertilidade Masculina/tratamento farmacológico , Infertilidade Masculina/fisiopatologia , Farmácias/organização & administração , Farmácias/provisão & distribuição , Serviços Comunitários de Farmácia/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/complicações , Fármacos para a Fertilidade/efeitos adversos , Esteroides/efeitos adversos , Esteroides , Infertilidade Masculina/genética , Boas Práticas de Dispensação , Medicamentos de Venda Assistida/normas , Saúde Reprodutiva/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
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