ABSTRACT
En el presente artículo se revisa los cambios realizados en el proceso de producción normativa de la Autoridad Nacional de Salud (ANS), durante una década, como expresión del ejercicio de la Función de Regulación en Salud. Hasta antes de los cambios implantados, la producción normativa era a libre iniciativa de los órganos proponentes, lo que conlleva a un mayor riesgo de errores, y a no tener una metodología estandarizada ni una estructura ordenada de los Documentos Normativos (DN) que aprobaba el Ministerio de Salud. Ante ello, se tomó la decisión de ordenar el proceso, estandarizarlo y hacer que tenga menores riesgos de fallas en el transcurso del mismo. Se revisa la producción legal y normativa en salud del Ministerio de Salud en el periodo 2006 - 2015, publicada en las separatas de Normas Legales del diario oficial El Peruano, se incluyen las normas legales aprobadas (decretos supremos, resoluciones supremas) y los documentos normativos (normas técnicas de salud, directivas y otros) aprobados por resolución ministerial. El análisis estadístico de la producción permite distribuirla por clasificación temática del contenido, del tipo de documento probado y año, con fines comparativos. La experiencia muestra que se aprobaron 88 Normas Técnicas de Salud, 64 Directivas Sanitarias, 151 Directivas Administrativas, 89 Guías Técnicas (incluidas 40 Guías de Práctica Clínica) y 156 Documentos Técnicos. Además el proceso de producción normativa de la ANS fue más ordenado, seguro, con menores riesgos de errores, con el respaldo técnico científico que permita fortalecer el ejercicio de la Rectoría Sectorial.
This paper discusses the changes to the rulemaking process performed by the National Health Authority (ANS) during a decade, as an expression of the exercise of its health-related regulatory function. Before the implementation of said changes, the initiative for rulemaking was freely taken by the proposing entities. This situation led to an increased risk of mistakes, and the lack of a standardized methodology and an organized structure of the Regulatory Documents (DN) to be approved by the Ministry of Health. As a result, the National Health Authority decided to organize and standardize the process, in order to reduce the risk of mistakes during such rulemaking process. Based on the revision of the health-related rulemaking performed by the Ministry of Health for the period 2006 - 2015, which was published on the Legal Standards supplement of El Peruano official gazette, the legal standards (supreme decrees, supreme resolutions) and regulatory documents (health-related technical standards, directives, among others) approved by ministerial resolution are included herein. The statistical analysis of the rulemaking allows its classification by subject, document type and year for comparison purposes. The experience shows that 88 health-related technical standards, 64 health-related directives, 151 administrative directives, 89 technical guidelines (including 40 clinical practice guidelines) and 156 technical papers were approved. Besides, the rulemaking process performed by the ANS was more organized and safer, presented less risk of mistakes, and had a scientific technical support that strengthened the exercise of the sectorial stewardship.
ABSTRACT
Magnesium is an important intracellular cation [1], actually the second most abundant cation after Potassium, which has gained an essential role in normal human homeostasis. Low serum magnesium has been detected commonly in around 12% hospitalized patients and even more commonly in Intensive Care Patients as high as 60 to 65%. The link of low serum magnesium with acute coronary syndrome is being discussed widely and its actual role is being scrutinized [2,3]. Recently, Hypomagnesaemia has also been found to play an important role in the pathogenesis of a variety of clinical disorders including Hypertension, Diabetes Mellitus, Atherosclerosis and Acute Coronary Syndromes [4-8]. Acute coronary syndrome (ACS) has been defined as a group of conditions due to decreased blood flow in the coronary arteries. Acute coronary syndrome includes a vast spectrum like: ST elevation myocardial infarction (STEMI / 30%), non ST elevation myocardial infarction (NSTEMI / 25%), or unstable angina (U.A. / 38%).These are described according to ECGs and Cardiac Biomarkers of myocardial necrosis (troponin T, troponin I, and CK MB), in patients presenting with acute cardiac chest pain (Medscape). Aim: To look for any association between Hypomagnesaemia and Acute Coronary Syndrome. Materials and Methods: It’s a retrospective study involving 1198 patients who presented to the Accident and Emergency department (A & E), Trauma Center, Rashid Hospital, Dubai, with Acute Coronary Syndrome (ACS) between April 2010 and May 2013. We reviewed the records of all patients including their clinical history and presentation. The Magnesium levels of all the patients in the ACS pathway were checked along with, Cardiac biomarkers - Troponin, CPK and CK MB and Lipid profiles were also analyzed. A Chi-Square test was performed at 5% level of significance to test the null hypothesis of no association between cardiac markers, lipid profile and magnesium level. Inclusion Criteria: All new patients presenting to A & E Department at Rashid Hospital with an acute coronary syndrome (both NSTEMI & STEMI). All new patients presenting with non-specific chest pain who test positive for cardiac markers. All the age groups presenting to A & E Department at Rashid Hospital from 11/04/2010- 30/05/2013 were included. Both the genders were included. Exclusion Criteria: Patients diagnosed initially with acute coronary syndrome that eventually had negative cardiac markers. Results: Out of 1198, 1087(91%) patients were male. 49% were between 50 and 75 years of age group whereas 46% were between 25 years and 50 years of age. 77% patients were Asians and 17% belonged to Arabic peninsula. The Magnesium level was normal in 1097(92%), low in 63(5.3%). Troponin was negative in 431(36%) and positive in 767(64%) patients with low, medium and high levels in 338(28.2%), 426(35.5%) and 03(0.3%) respectively. These results indicate that there is no statistically significant association between Magnesium levels and Troponin groups (positive and negative) (chi-square with two degree of freedom = 3.30, p = 0.192). Conclusion: Our study proves that there is no significant association between Hypomagnesaemia and Acute Coronary Syndrome.
ABSTRACT
Los medicamentos huérfanos son aquellos requeridos para diagnosticar, prevenir o tratar enfermedades poco frecuentes, pero que pueden ser graves y debilitantes. Este trabajo tiene como objetivo proponer la implementación de una normativa de registro sanitario específica para los medicamentos huérfanos en la República Bolivariana de Venezuela, considerando la situación actual de salud y las necesidades de la población, a fin llegar a todos los niveles, facilitando la disponibilidad del mayor número de medicamentos que son requeridos por un grupo reducido de pacientes. Es necesario que las autoridades sanitarias en Venezuela fortalezcan el sistema de salud pública estableciendo políticas para satisfacer las necesidades de la población en general pero que también incluya a las minorías. Se plantean las consideraciones técnicas, legales, fiscales y regulatorias necesarias para la implementación de esta normativa, así como los criterios de inclusión para clasificar un medicamento dentro la categoría de "huérfanos". La metodología utilizada fue de tipo documental, haciendo énfasis en el análisis teórico y conceptual del material a fin de elaborar la propuesta de la normativa para medicamentos huérfanos en la República Bolivariana de Venezuela. Se realizó un análisis teórico de la información obtenida para determinar la situación actual nacional e internacional a fin de obtener los resultados que sirvieron de base para desarrollar la propuesta.
Orphan drugs are those required to diagnose, prevent or treat rare diseases but that may be severe and debilitating; besides, reduce the quality of life of patients and their families. This project aims to propose a special regulation for Orphan Drugs in the Bolivarian Republic of Venezuela taking into account the current health situation and needs of the population in order to reach all levels by facilitating the availability of a bigger amount of drugs required by a small group of patients. It is necessary for health authorities in Venezuela to strengthen the public health system by establishing policies to meet the needs of general population but also include minorities. Technical, legal and regulatory considerations arise for the implementation of this normative, as well as the inclusion criteria for drugs within the category of "orphans". The methodology used is documentary, as it emphasizes the theoretical and conceptual analysis of the material for the proposed regulation for orphan drugs in the Bolivarian Republic of Venezuela. A theoretical analysis of the information was made to determine the current national and international situation in order to obtain the results as a basis to develop the proposal.
Subject(s)
Humans , Orphan Drug Production , Rare Diseases , Drug Industry , Products Registration , Pharmaceutical TradeABSTRACT
La Rectoría Sectorial de Salud es una función propia del Estado, y que se ejerce a través del Ministerio de Salud, que es la Autoridad de Salud Nacional (ASN). La Rectoría tiene tres funciones que son exclusivas de la ASN: (a) conducción sectorial, (b) regulación y fiscalización, y (c) medición de la funciones esenciales de la Salud Pública; y tres funciones que son compartidas con la Autoridad de Salud de nivel regional: (d) armonización de la provisión de servicios, (e) modulación del financiamiento y (f) garantía del aseguramiento en Salud. La Rectoría en Salud es un medio para poder asumir responsabilidad por la salud de la población y la defensa del bien público en salud. Para ello la función de Regulación tiene especial importancia para el adecuado y eficiente desempeño de la rectoría de parte de la ASN, porque tiene el rol cimentador de políticas públicas sanitarias y el rol articulador de las demás funciones de la Rectoría en Salud. Para el Ministerio de Salud, en tanto ASN, la función de Regulación y Fiscalización es un valioso e importante recurso para cumplir con su responsabilidad de velar por la salud de la población y de mejorar las condiciones sanitarias con equidad.
Health Sector Stewardship is an eigenfunction of the state, and is exercised in Peru and in most Latin countries through a Ministry of Health, which embodies the National Health Authority (NHA). Stewardship has three functions that are unique to the NHA: (a) steering, (b) regulation and enforcement, and (c) measurement of Public Health essential functions; and three functions which are shared with the regional Health Authority: (d) harmonization of service provision, (e) financing modulation, and (f) Health insurance guarantee. Stewardship in Health is a state power for taking responsibility for both population health and defense of health public good. Regulation and Enforcement become particularly important for proper and efficient performance of the authority because it has the role of cementing public health policies and coordinating the other functions of Stewardship. In view of this, the Ministry of Health, as the NHA, has the Regulation and Enforcement function as a valuable and important resource to meet its responsibility for population health safeguard and to improve sanitary conditions with equity.