Revista ConSciencia Sanitaria

Editorial

Noe García — 2025-01-10

La Revista ConSciencia Sanitaria nació en el 2022 con la finalidad de consolidarse como un espacio de referencia para la investigación científica y para divulgar información técnica reciente acerca de medicamentos, dispositivos médicos y otros productos regulados por la DNM.

En los últimos dos años, nuestra revista, se ha convertido en un espacio que fomenta el pensamiento crítico, el análisis y la investigación, basándose en un fundamento científico, con el principal objetivo de trasladarle al lector nuevos conocimientos, conceptos e ideas técnicas, y aportar al acumen de conocimiento científico necesario para fomentar una cultura de conocimiento del mundo de la ciencia.

Desde su nacimiento la Dirección ha priorizado garantizar la calidad, seguridad, y eficacia de los medicamentos, dispositivos médicos, productos químicos, cosméticos e higiénicos al alcance de la población. En nuestro proyecto institucional de modernización como instancia reguladora, no solo está generar un espacio de contenido científico; también hemos venido desarrollando una transformación completa, para seguir garantizando dichas prioridades bajo la Superintendencia de Regulación Sanitaria.

Pero esto no es todo, en la revista ConSciencia Sanitaria también hemos querido seguir innovando, y en esta nueva emisión los artículos incluyen la versión en español y en inglés. Debemos convertirnos en un reservorio de data científica de calidad y con la perspectiva de ser cada vez mejor.

En este nuevo camino, la SRS siempre velará por garantizar la calidad, la eficacia, la seguridad, disponibilidad, inocuidad, accesibilidad y uso racional de medicamentos de uso humano y animal; así como de los cosméticos, alimentos y bebidas e insumos agrícolas, esto permitirá afincar la cultura y mística, que identifican a la DNM, en otras aristas, pero igual de importantes. ¡Nuestra prioridad es la salud de todos!

Isolation of Enterobacter cloacae in a pharmaceutical matrix containing amoxicillin and clavulanic acid

Williams Alexander Flores Ortiz — 2025-01-10

Background: in recent years, clinical importance has been detected for the Enterobacter cloacae Complex due to its high resistance to various antimicrobials and its association with their inactivation and degradation, and also for its nosocomial pathogenicity.

Objective : to show the survival capacity of Enterobacter cloacae to a mixture of antimicrobial and betalactamase inhibitor.

Method: the microbiological analysis method used in the present study corresponds to the direct method described in the general chapter 〈 62 〉 (Microbiological examination of non-sterile products: tests for specific microorganisms) of the Pharmacopoeia of the United States of America, which consists in placing the sample directly in the nutrient medium as preincubation, to complete the scheme with direct passages to broth and selective agar.

Results: from the determination of objectionable microorganisms, microbial growth was obtained, which was purified to perform
preliminary tests for identification, obtaining short gram-negative bacilli in staining; in the oxidase test, no color change was obtained on the strip test, which indicates a negative result, and in miniaturized galleries the identification gave Enterobacter cloacae with a probability percentage of 100%. The results were obtained in the microbiological analysis (objectionable microorganisms) of a pharmaceutical matrix evaluated in the Microbiological Analysis Quality Control Laboratory of the National Directorate of Medicines carried out in 2022.

Conclusion: there is an evident resistance to antimicrobial drugs by Enterobacter cloacae, even when it comes to multi drugs,
intended to block the action of betalactamases (which is the nature of the studied matrix) created by resistant microorganisms.

Review of requirements for drug registration according to RTCA 11.03.59.18

Génesis Ramírez Ramírez — 2025-01-10

Medications are substances or products to diagnose, cure, mitigate, treat, or prevent diseases. For its marketing and distribution in a
country, a marketing authorization is required to ensure compliance with territorial legislation. In the case of Central American nations, there is Central American Technical Regulation (RTCA, for its Spanish acronym) 11.03.59.18. Therefore, the objective was to identify compliance with the requirements established in such guidelines by Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama. To this end, an exhaustive review of the document was made.

Then, a list of the main obligations for the registration and renewal procedures of medicines for human use that apply to the States Parties to the General Treaty of Central American Economic Integration was established. Next, other specific provisions indicated by the legislation and regulatory authorities of the states mentioned above were investigated. This search was complemented by communication with regulatory affairs officers in each nation. After their review, it was shown that, despite the countries' compliance with the aspects established in the RTCA, it is usual to find some differences in the processing linked to each territory's legislation, adding complementary elements that must be incorporated. Thus, its comparison and delimitation are a basis for analyzing which aspects could be subject to harmonization and convergence by Central American regulatory authorities.

Impact of Gender Bias in Antimicrobial Resistance

Pilar Hernández — 2025-01-10

Surveillance Activities about products, activities and establishments object to the SRS regulation

Pilar Hernández — 2025-01-10

Career Opportunities in Pharma

Pilar Hernández — 2025-01-10

Usage of opium and its derivatives in pharmacotherapies in El Salvador

José Luis Reyes Zelaya — 2025-01-10

In the Central American region and particularly in El Salvador, many technical, legal and social difficulties have historically arisen for the usage of controlled drugs (narcotics, psychotropics and chemical precursors). So, for the population in general, the access to this type of medicine has been quite difficult. For this, a series of factors have greatly influenced, such as Legal Norms that are regularly quite restrictive and that generate fear in prescribing or using them by some health professionals, especially due to ignorance of it and fear of legal consequences for the poor prescription or misuse of medications by patients. Among other influencing factors, there are the low local or regional production of medicines that declare opium or its derivatives as active substances, social factors, such as discrimination against people who use this type of medicine or fear of the risks of addiction due to the wrong use of them

New antibiotics authorized by referral agencies

Luis Alfredo Ayala Ayala — 2025-01-10

Antimicrobial Resistance (AMR) has been defined as a public health problem due to the exponential progression of its spread. It will not only cause millions of deaths, but also greater suffering and increased costs for health services, and animal production with serious repercussions on food security. The World Bank has estimated that if the problem of AMR is not addressed, the global economy may have lost almost 4% of annual Gross Domestic Product (GDP) by 2050, and that the losses will be even greater in low- and middle-income countries. In 2050, this situation could lead 28 million inhabitants to a situation of poverty, within developing countries, especially due to the effects of drug resistance on the economy, livestock industry and costs of medical services (World Health Organization, WHO , 2021)

Key considerations and stages in the development of clinical trials with medical devices: Regulatory Approach

Rafael Ramírez — 2025-01-10

Traditionally, clinical trials have primarily focused on the research of new drugs, leading to an abundance of pertinent information in the literature, far exceeding that available for medical device trials. This article delves into the essential definitions to fully understand medical device trials. It explores the general characteristics of medical devices, details the technical criteria and stages of studies, and highlights the key differences compared to drug trials. This is done by reflecting the perspective of the National Directorate of Medicines (DNM) of El Salvador, a regulatory agency, regarding these types of trials. The article also includes a description of the legal and regulatory frameworks, both local and international, supporting the regulatory work.

Bioequivalence studies: main methodologies for design

Enrique Aragón — 2025-01-10

The objective of bioequivalence studies is to demonstrate that two formulations with the same active ingredient have such a similar
pharmacokinetic profile that it can be assumed that they will behave in the same way as the reference product, ensuring their pharmacological and therapeutic equivalence, even allowing them to be exchanged.

This regulatory focus article seeks to provide general bases on the types of design of bioequivalence studies, as well as their advantages and limitations. In El Salvador, the entity in charge of clinical trials oversight and authorization, and the establishments where they are carried out is the National Directorate of Medicines.

Importance of the Regulation of Pharmaceutical Marketing

Karla Zarceño — 2025-01-10

In recent years, the world of the pharmaceutical industry has been evolving, as well as the way of advertising its products. That is why, in El Salvador since 2012, through the Promotion and Advertising Unit (UPP) of the National Directorate of Medicines, the issue of “Pharmaceutical Marketing” is treated with great importance, considering that one of its main objectives is to authorize, before its dissemination, all types of advertising of pharmaceutical products. In addition, to regulate by means of monitoring, surveillance and inspection, the advertising that is already exposed to the population.

The purpose of this is to guarantee that the message issued by the industry to the final consumer promotes the rational use of drugs, as well as the prevention of their abuse, through precise and objective communication based on the therapeutic indications previously approved by the regulatory authority.