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Introduction: the World Health Organization recommended the countries, the establishment of a National Committee of Experts to identify the necessary measures and plans to formulate a national policy on traditional medicine. The Cuban Drug Regulatory Authority named Center for State Control of Drugs, Equipment and Medical Devices (CECMED) was created in December 2011 by the Committee of Experts on Natural and Traditional Medicine to replace the Quality Committee of Drugs of Natural Origin created in 2002. Objectives: to present the structure and internal regulations of the committee as an advisory organ of CECMED to evaluate specific issues and make recommendations that contribute to collegial decision process of CECMED. Methods: the Internal Regulations of Committee of Experts on Natural and Traditional Medicine (Approved as Appendix 1 in the 134-2008 Resolution, Regulations for the selection and management of experts of CECMED) was developed using the methodology of literature review of different committees of experts, mainly the Committee on Herbal Medicinal Products of the European Medicines Agency. Results: the composition of the Committee of Experts on Natural and Traditional Medicine is identified as well as the organization and function of its parts and its responsibilities, among other aspects. Conclusions: the implementation of the internal regulations will allow a better organization and performance of the functions of the committee in each of the activities and tasks planned for the development of traditional medicine. Source

Garcia Farinas A.,Escuela Nacional de Salud Publica ENSAP | Felix Garcia Rodriguez J.,Juarez Autonomous University of Tabasco | Galvez Gonzalez A.M.,Escuela Nacional de Salud Publica ENSAP | Jimenez Lopez G.,Centro Para El Control Estatal Of Medicamentos
Revista Cubana de Salud Publica

Objective: To determine the methodical quality of complete economic evaluations published in Cuban medical journals from 1999 to 2014. Methods: Observational, descriptive and cross-sectional study of articles classified by their authors as complete economic evaluations and published from 1999 to 2014 in 47 Cuban medical journals authorized by the Ministry of Science, Technology and Environment. The applied evaluation guide included year of publication, journal, objective, problem, options, time frame, prospects, cost, health effects and estimation of the cost/effectiveness ratio. Results: Twenty one papers were found, but in the last three years no paper has been published. These papers were mainly published in eight journals, being the first Revista Cubana de Farmacia, followed by Revista Cubana de Salud Publica and MEDISAN. None of the aspects was correctly addressed in over 80 % of revised papers. The worst results were found in statement of perspective present in less than 20 % of papers in addition to sensitivity analysis in less than 30 % of them. Almost 50 of papers adequately dealt with the submission of research problems, objectives, time frame, costs and the incremental cost/effectiveness ratio. Conclusions: Published economic evaluations are still scanty and most of them exhibit methodological faults. There is insufficient development in this area nationwide, which points to the importance of insisting once again on the dissemination of the basic methodological aspects of these evaluations aimed at researchers who act as reviewers and as editors of scientific journals. © 2016, Editorial Ciencias Medicas. All rights reserved. Source

Diaz M.F.,Sociedad Medica Terapeutica LTDA | Garcia K.,CSIC - National Center for Metallurgical Research | Meneau R.I.,Centro Para El Control Estatal Of Medicamentos | Sanchez Y.,Centro Para El Control Estatal Of Medicamentos | Garcia G.,Institute Farmacia y Alimentos
Journal of Pharmacy and Pharmacognosy Research

Context: Ozonized vegetable oils present germicidal effects which can be used as active principle in different cosmetological compositions. The thematic about of the corporal massage advantage have been very treatment by aesthetics, dermatologic and consumers. OLEOMASAJE formulation content ozonized sunflower oil OLEOZON as active principle active which present moisturizer and conditioner effects. Aims: To determine the possible dermal and ophthalmic irritability effects of the OLEOMASAJE. Methods: The trial was conducted in rabbits and the techniques described in the standardized procedures of the work established by the Center of Biological Research and Evaluations from Pharmacy and Food Institute of Havana University were used according to Norma ISO 10993-10. The ethical principles of the Good Practices of Laboratory were fulfilled to avoid suffering to the animals during the experimentation. Male rabbits with body weight between 2.05 and 2.48 kg were used. In the skin and the ocular structures the effects were observed immediately after of the application at 1, 24, 48 and 72 hours. Draizés scale was applied to evaluate skin and ocular structures lesions. Results: The OLEOMASAJE formulation does not irritate de skin of the assayed rabbits. However, the ocular structures irritability index was of 4.5 after of first hour to apply of product. These wounds were missing before of 24 hours to apply of product. Conclusions: The OLEOMASAJE formulation obeys the indispensable requirements for the acceptance as cosmetic product and for it is used in corporal massage. © 2015 Journal of Pharmacy & Pharmacognosy Research,. Source

Alfonso Orta I.,Centro Para El Control Estatal Of Medicamentos | Toledo Romani M.E.,Institute Medicina Tropical Pedro Kouri IPK | Coutin Marie G.,University of Habana | Garcia Farinas A.,Escuela Nacional de Salud Publica ENSAP La Habana | And 2 more authors.
Revista Cubana de Salud Publica

Introduction: Availability and irrational consumption of antimicrobials prompt their inadequate use and sometimes give rise to adverse reactions. At present, these reactions represent a clinical and epidemiological problem. It is necessary to deepen into the knowledge about their characteristics in Cuba and the behavior in the course of time for the decision making process. Objectives: To characterize the adverse antimicrobial reactions reported in Cuba and to analyze the behavior of tendencies, seasonality and prognosis for 2013 and 2014. Methods: Longitudinal and descriptive study of case series in a ten-year period (2003-2012). Data were taken from national pharmacovigilance databases. Results: There were registered 40 391 reports of adverse antimicrobial reactions accounting for 86.5 % of the total number of adverse reactions. They prevailed in females (64.3 %) and in under one-year old infants. The skin illnesses represented 47.9 % and digestive ones 26.8 %. Penicillin G was the most reported drug. Moderate adverse reactions prevailed (58.2 %). Tendency was growing, seasonality was observed and prognosis was on the rise. Conclusions: The increase in the number of reports of adverse antimicrobial reactions and the anticipated rise of them is an alert to the health care system. © 2016, Editorial Ciencias Medicas. All rights reserved. Source

Garcia Milian A.J.,Escuela Nacional de Salud Publica ENSAP | Alonso Carbonell L.,Centro Nacional Coordinador Of Ensayos Clinicos Cencec | Jimenez Lopez G.,Centro Para El Control Estatal Of Medicamentos | Alfonso Orta I.,Centro Para El Control Estatal Of Medicamentos
Revista Cubana de Plantas Medicinales

Introduction: increase in the consumption of natural products is largely due to the perception that being “natural” can only be beneficial and without risk to health. Objective: To characterize the adverse reactions associated with the use of herbal medicines sold in Cuba for the period 2003-2010. Methods: Observational, descriptive and transversal study. Was eligible for the study all reports of suspected adverse drug reactions (ADRs) herbal medicines produced by the National Coordinator of Pharmacovigilance Unit during the study period. Results: Most of the reports of suspected adverse reactions were distributed in females (67.3 %) and in the age group of 31-60 years (52.5 %). Predominant gastrointestinal disorders such as epigastria pain (17.9) and vomiting (10.5). Garlic tincture and syrup (14.0 %) and Aloe Vera L (7.7) were the most commonly reported herbal medicines. The organ most affected by adverse reactions was the tract. Most of them were classified probable mild. Conclusions: Adverse reactions, for herbal medicines, reported the Cuban system of pharmacovigilance are mostly mild, occur in adult women and Digestive and skin more often. © 2015, Editorial Ciencias Medicas. All rights reserved. Source

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