Evaluación de la gestión del suministro de medicamentos antirretrovirales en una institución prestadora de salud Medellín-Colombia 2013 / Antiretrovirals drug supply management evaluation at a health care institution in Medellín-Colombia 2013

Introducción: existe la necesidad de impulsar el suministro racional de medicamentos, según la necesidad del paciente, desde la gestión integral de un seguimiento fármaco-terapéutico con calidad y un enfoque de riesgo al usar un fármaco. Objetivo: analizar antecedentes en perspectiva de la gestión integral del suministro de los medicamentos antirretrovirales, con el fin de contribuir a mejorar la calidad de vida del paciente. Materiales y Métodos: estudio cualitativo retrospectivo con enfoque hermenéutico, en una institución prestadora de salud de la ciudad de Medellín en el año 2013. Se realizó una revisión y análisis de los protocolos del sistema de gestión de la calidad de la institución en estudio, conforme a la normatividad vigente. A su vez, se hizo un diario de campo junto con observación no participante a los procesos que se ejecutan en las categorías de Inspección, Vigilancia y Control. Principalmente, se llevó a cabo un análisis estadístico del seguimiento fármaco-terapéutico mediante el coeficiente de Spearman. Resultados: se encontró que la gestión del suministro de los antirretrovirales en general se cumple conforme a las normas. No obstante, se halló que el seguimiento fármaco-terapéutico a cada uno de los pacientes que asisten a la institución es deficiente. Se evidenció que en el primer trimestre del año 2013 97,5% de los pacientes tratados con antirretrovirales, no le hicieron seguimiento fármaco-terapéutico en conformidad a la normatividad vigente y a lo establecido por los protocolos. Conclusión: se requiere mejorar y fortalecer el servicio de atención farmacéutico, liderado por profesionales suficientes y capacitados, que implementen otro seguimiento fármaco-terapéutico holístico, sistemático y permanente. MÉD.UIS. 2016;29(2):11-20.

Introduction: there is the need to promote rational drug supply, according to the patient's need, from the comprehensive management of drug-therapeutic monitoring quality and a perspective of risk by the use a drug. Objective: to analyze antecedents in perspective to the integrated management supply of antiretroviral drug system s in order to contribute to improving the quality of life for patients. Materials and Methods: a retrospective qualitative study was performed with hermeneutical approach, the methodological process was the review and the analysis of the protocols of the institution under the study, according to the regulations; field diary and non-participant observation processes running on the categories of Inspection, Monitoring and Control. Especially, the pharmaceutical care, this statistical analysis was performed using Spearman coefficient. Results: it was found that protocols from integrated management supply of antiretroviral drugs system are comply. Nevertheless, the pharmaceutical care to each of the patients attending the institution is poor. They showed that in the first quarter of 2013, 97.5% of the patients with antiretroviral regimens were not under pharmaceutical care in accordance with the current regulations and the provisions of the protocols. Conclusion: it is necessary to improve and strengthen the pharmaceutical care service led by a trained professional that implements other permanent, systematic, holistic and pharmaceutical care. MÉD.UIS. 2016;29(2):11-20.

Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries.

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

[Practice and exploration on clinical evaluations of hospital-made Chinese herbal formulas in the Pudong new area of Shanghai].

Chinese herbal formulas can well present the characteristics of traditional Chinese medicine (TCM) with their simple, convenient, inexpensive and effective uses. However, due to the high cost of production, manufacturing pharmacies inside the hospital closed down one after another, which rendered the difficult situation of developing preparation of Chinese herbal formulas. The Pudong New Area of Shanghai, as a pilot region for comprehensive reforms on national development of TCM, vigorously explores the standardized research on and application of hospital-made Chinese herbal formulas. The Health Bureau of the Pudong New Area, based on the Shuguang Hospital, has established a clinical evaluation center for hospital-made Chinese herbal formulas. Through screening, manufacturing, quality control, unified allocation, and standardized clinical evaluation, the clinical evaluation center has summarized its experience on these processes.

Avaliação da assistência farmacêutica básica em um município da Bahia, Brasil / Evaluation of basic pharmaceutical assistance in a city of Bahia, Brazil / Evaluación de la atención farmacéutica básica en un municipio de Bahia, Brasil

O acesso aos medicamentos e à assistência farmacêutica integra as ações de saúde e é um direito do cidadão garantido pela lei sanitária brasileira. Diante da relevância de avaliações para a gestão da assistência farmacêutica na atenção básica à saúde, este estudo objetivou avaliar aspectos relacionados à estrutura e processos da assistência farmacêutica em um município da Bahia, Brasil. Pesquisa avaliativa de abordagem quantitativa, orientada por indicadores adaptados da WHO, OPAS/MS e Consendey. Os resultados mostraram que 84,6% das unidades básicas de saúde não dispunham de local adequado para dispensação e armazenamento de medicamentos; 96,2% não tinham previsão de demanda mensal, tanto que 92,3% apresentaram falta de pelo menos um item da lista de medicamentos adotada. Três unidades tinham farmacêuticos em seus quadros que atuavam em atividades da assistência farmacêutica e a maioria dos trabalhadores envolvidos com tais atividades eram pouco capacitados. Observaram-se aspectos positivos em relação ao acesso aos medicamentos, como a descentralização da distribuição de medicamentos para as unidades de saúde. Concluiu-se que dificuldades como estrutura física inadequada, processos pouco eficientes e escassez de recursos humanos comprometem a distribuição de medicamentos e prejudicam a integralidade da atenção e a resolubilidade do SUS.

The access to medicines and pharmaceutical assistance is an integrant part of actions to health and a right of citizen that is guaranteed by the Brazilian sanitary law. Given the relevance of assessments for the management of pharmaceutical assistance in basic health care, this study aimed to evaluate different aspects related to the structure and the processes of pharmaceutical care in a city of Bahia, Brazil. Evaluative study of quantitative approach, guided by adapted from WHO, OPAS/MS and Consendey. The study showed that, 84.6% of the basic health lacked a suitable place for storage and dispensing of medicines; 96.2% had no prediction of monthly demand; 92.3% were missing at least one item from the list of medication taken. Three units had on its staff pharmacist who worked in the in the pharmaceutical care and most works involved in such activities were not sufficiently trained. Positive aspects were observed in the access to medicines such as decentralization of drug distribution to health facilities. It was concluded that difficulties such as precarious physical structure of the units, inefficient processes and lack of human resources jeopardize drug distribution and affect the comprehensive care and solvability of the SUS.

El acceso a los medicamentos y a la atención farmacéutica, integra las acciones de salud y es un derecho garantizado por la legislación sanitaria brasileña. Dada la importância de las evaluaciones para la gestión de la asistencia farmacéutica en la atención básica a la salud, este estudio tuvo como objetivo evaluar los aspectos relacionados con la estructura y losprocesos de atención farmacéutica en un municipio de Bahia, Brasil. Investigación evaluativa de enfoque cuantitativo, guiada por los indicadores adaptados de la WHO, OPAS/MS y Consendey. Los resultados mostraron que: el 84,6% de las unidades básicas de salud carecían de un lugar adecuado para el almacenamiento y despensa de medicinas; el 96,2% no tenían previsión de la demanda mensual, siendo que el 92,3% presentaron falta, por lo menos de un ítem, en la lista de medicinas adoptada. Tres unidades disponían de farmacéuticos en sus plantillas que actuaban en actividades de atención farmacéutica y la mayoría de los trabajadores involucrados en tales actividades no estaban suficientemente capacitados. Se observan aspectos positivos com respecto al acceso a las medicinas, como la descentralización de la distribución de medicinas para las unidades de salud. Se concluye, que las dificultades, tales como la infraestructura física inadecuada, procesos poco eficaces y la falta de recursos humanos, comprometen la distribución de medicinas y perjudican la integralidad de la atención y la solvencia del SUS.

[Update on the Mali Pharmacy Code: legislative section]. / Essai de mise au point d'un code de la pharmacie au Mali: partie legislative.

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

Reengineering a pharmacist intervention program.

At the beginning of a period of rapid growth in clinical pharmacy services in our integrated health system, we realized that there was no mechanism to address how pharmacist interventions were processed, evaluated, and followed up. Interventions were inconsistently documented, and the documentation served no more purpose than to record workload statistics. There was little assessment of the value or quality of interventions, no peer review, and no reporting of aggregate data to improve system-related problems. How are others handling the documentation and assessment of pharmacist interventions?

[Non-technical causes of fakes existing in Chinese medicinal material markets].

Non-technical causes of fakes existing in Chinese medicinal materials markets come from three aspects. Source of Chinese medicinal materials is complex and it is difficult to trace back to a source; lawless add impurities and use inferior goods pretending to superior quality and illegally seek for profit; supervising department lack strict blow and deterrent force is limitted.

[The status quo survey of false and inferior species in Chinese medicinal materials market in Hubei Province].

By taking a sample, unqualified varieties were investigated found in Chinese medicinal material examinatorial work near twenty years of six regional level and three countrylish level institutes for drug control and one comprehensive level-three grade-A hospital. By mail, false and inferior species and their origin of Chinese medicinal material were investigated found by sixteen institutes for drug control near ten years in Hubei province. 539 kinds of adulterants (750 cases) including 24 toxic species were found in above-mentioned investigations. Fales and inferior species are rampant in minority regions, which threatens people's health severely. It is urgent for supervising department to gorem the condition strictly.

[Technical causes of false and inferior species appearing in Chinese medicinal materials markets].

The result indicated that technical causes of false and inferior appearing in the Chinese medicinal materials markets consisted of two respects essentially. First, the men who violated the law and committed a crime used certain weak link existing in quantity analysis of country's medicinal standard. Second, it is difficult that basic units managing and using drug implement effective technical supervision.

Indicadores de calidad de la prescripción farmacológica basado en el consumo farmaceútico / Quality indicatives of hte pharmacological prescription based on pharmaceutical consumption

Objetivo: el objetivo de este trabajo es doble: por una parte sentar las bases metodológicas para el desarrollo de indicadores basados en datos de consumo farmacéutico. Por otra diseñar un conjunto de indicadores y proponer valores óptimos que puedan servir para la mejora de calidad de prescripción en atención primaria. Material y métodos: se creó un grupo de expertos que debía tomar sus decisiones por consenso. El procedimiento de trabajo se basó en la selección de los grupos farmacológicos más relevantes en atención primaria y en la propuesta inicial de un gran número de indicadores de consumo de principios activos expresados en Dosis Diarias Definidas. Tras analizar su significación y potencial utilidad y efectuar su seguimiento en diversas áreas del Insalud, se seleccionó un conjunto reducido para los que, en su mayoría, se han propuesto valores óptimos. Para la determinación de los valores óptimos se han considerado tanto los datos históricos de consumo, como datos epidemiológicos y diversos estudios internacionales. Únicamente en un grupo muy reducido de indicadores no se han establecido estos valores óptimos, por estimarse más oportuna la fijación de estándares locales, en función de las circunstancias epidemiológicas y sociosanitarias particulares. Resultados: se han propuesto indicadores de consumo para principios activos de utilidad terapéutica alta de los siguientes grupos: Antiulcerosos, antidiabéticos orales, hipolipemiantes, antiagregantes plaquetarios antihipertensivos, antiinflamatorios no esteroideos, analgésicos narcóticos, tratamiento de la hiperplasia benigna de próstata, tranquilizantes e hipnóticos, antidepresivos, antibióticos y antiasmáticos. Además, se proponen otra serie de indicadores seleccionados por completar la aproximación a la calidad desde perspectivas complementarias a la estricta relevancia farmacológica. Entre ellos se encuentran indicadores de eficiencia, de utilización de genéricos, de adhesión a la guía farmacológica, de novedad terapéutica sin aportación relevante y de alerta. Conclusiones: el análisis del consumo farmacéutico puede ser una herramienta muy útil para evaluar la calidad en la prescripción farmacológica, ya que permite detectar con facilidad consumos excesivos y/o ineficientes, puede identificar el uso de medicamentos ineficaces y permite comparaciones sencillas y fáciles de interpretar, a partir de una toma de datos sencilla y fiable. Sin embargo, tiene como limitaciones la dificultad de relacionar de relacionar el diagnóstico con la indicación y el hecho de que no siempre lo consumido es igual a lo prescrito. Se espera que este primer grupo de indicadores propuestos sean discutidos, mejorados y ampliados por todo el colectivo de profesionales interesados en el tema (AU)

Soporte técnico para la evaluación de la calidad de los productos farmacéuticos (USP 23 - NF 18) / Support for the evaluation of the quality of pharmaceuticals (USP 23 - NF 18)

Documento elaborado por el Programa de Administración Compartida de Farmacias (PACFARM). Su patrón de referencia es la Farmacopea de los Estados Unidos (USP-23) que establece en cada monografía las pruebas, ensayos y rangos tolerables necesarios para asegurar la calidad de los medicamentos(AU)

Soporte técnico para la evaluación de la calidad de los productos farmacéuticos (USP 23 - NF 18) / Support for the evaluation of the quality of pharmaceuticals (USP 23 - NF 18)

Documento elaborado por el Programa de Administración Compartida de Farmacias (PACFARM). Su patrón de referencia es la Farmacopea de los Estados Unidos (USP-23) que establece en cada monografía las pruebas, ensayos y rangos tolerables necesarios para asegurar la calidad de los medicamentos