Diversity, Utility, Analytical Methods and Use Implications of Aroma-active Compounds from Select Angiosperm Familie.

Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants, such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing to their complexity and variability, many EOs need to be standardized to ISO’s criteria. Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing practice (GMP). Aim: Given the immense diversities in sources, chemical structures, and bioactivities of EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their: i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical methods, in order to gain a better insight into their regulation in foods and drugs. Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs; and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished products (FPs). Results: The literature revealed scores of AACs with varying health implications. But their levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and complexities of the methods used. Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data on their levels in samples, it is recommended that their regulation in FPs should focus on: i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such RMs. Meanwhile relevant agencies should sponsor research into more cost-effective methods.

Ley Nº 29459 - Ley de los productos farmacéuticos, dispositivos médicos y productos sanitarios / Law N° 29459 of pharmaceutical products, medical devices and sanitary products

La Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios N.° 29459, publicada ennoviembre de 2009, orienta la regulación de estos productos sustituyendo al Capítulo III de la Ley General de Salud N.º 26842. A través de esta Ley se ha modificado los aspectos más cuestionados en la Ley N.° 26842, al establecer requisitos para solicitar el registro sanitario de productos farmacéuticos que son necesarios para garantizar su eficacia,seguridad y calidad, incluyendo también los plazos necesarios para su evaluación y que el costo de la tasa por registrosanitario sea en función de lo que implique otorgar dicho registro, lo cual incluye también las actividades de control y vigilancia sanitaria. Así mismo, restablece la exigencia de la autorización sanitaria de funcionamiento, previa al inicio delas actividades, previa inspección para verificar el cumplimiento de los dispositivos legales vigentes. La Ley incorpora también tres capítulos específicos sobre acceso, uso racional de productos farmacéuticos, dispositivos médicos y productos sanitarios, así como un capítulo de investigación.

The Law of Pharmaceutical Products, Medical devices and Sanitary products N°. 29459, published in November, 2009, guides the regulations of these products, substituting Chapter III of the General Law of Health N°. 26842. Through this law, the most questioned aspects of the Law N°. 26842 have been modified, establishing requisites to apply for the sanitary registry of pharmaceutical products that are necessary to guarantee their efficacy, security and quality, also including the required terms for their evaluation and the cost of the health registration fee must be according to all what implies to give the registry, including control activities and health surveillance. It also resets the requirement of the operating health approval, prior to the initiation of the activities, and having had a previous inspection to verify the accomplishment of the actual legal devices. The law also incorporates three specific chapters about access, rational use of pharmaceutical products, medical devices and health products, as well as a chapter on research.

Política de medicamentos en Estados Unidos de América / Drug policy in United States of America

La política de medicamentos de los Estados Unidos de América (EEUU) es inconsistente, regula el desarrollo,producción, comercialización y seguridad de los medicamentos en el país, por medio de mecanismos legales así como de instituciones privadas y gubernamentales. Las leyes de patente protegen a la industria farmacéutica y noexiste un mecanismo directo de control de precios ni una política que dé cobertura de acceso a los medicamentosa toda la población de EEUU. La Agencia Federal de Medicamentos y Alimentos (FDA) es el organismo que regulalos medicamentos en EEUU. Varias leyes han sido promulgadas para incrementar el control de calidad, seguridad yasegurar la eficacia de los medicamentos, tales como, la ley de honorarios por la prescripción de drogas al usuario (PDUFA) y la ley de modernización de la FDA (FDAMA). Asimismo, para aumentar el acceso de los pacientes a los medicamentos (Fast track; Orphan Drug Act; Pediatric exclusivity). Por su parte, la ley Hatch-Waxman, ha cumplido una función muy importante al estimular el desarrollo de medicamentos genéricos con mucho éxito y controlar precios en el mercado libre. Finalmente, el sistema de seguro de salud es voluntario y también inconsistente, ofrece varios planesque abarcan desde la obtención personal del seguro por el propio individuo, los seguros auspiciados por el empleador yterminan con varios seguros gubernamentales. Todos estos pueden, o no, contener un subsidio de medicamentos.

The USA federal prescription drug policies are inconsistent. The federal government regulates the development,production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US population with a prescription drug benefit. The FDA is the agency charged with regulation of medicines. Various laws have been enacted over the years to improve quality control, safety and ensure efficacy of prescription drugs as: Prescription Drug User Fee Act (PDUFA) and Food and Drug Administration Modernization Act (FDAMA), as well as increase patient access to prescription drugs (Fast Track; Orphan Drug Act, Pediatric exclusivity). The Hatch-Waxman Act, named for its authors, has played an important role in the development of generic drugs withmuch success and a significant effect on drug prices. The insurance health system is voluntary and also inconsistentoffering various forms of insurance that range from the individual applying for insurance personally, through employerfinanced health insurance, to government run health insurance systems. All health insurance may or may not have a prescription drug benefit.

Evaluación del suministro de medicamentos en los servicios de atención primaria de salud de Rosario, Argentina, 2005 / Evaluation of the drug supply in the primary health care services of Rosario, Argentina, 2005

OBJETIVO: Evaluar el sistema público de selección y adquisición de medicamentos en el municipio de Rosario, Argentina, durante el año 2005 desde la perspectiva de la gestión farmacéutica. MÉTODOS: Se utilizó una combinación de varias herramientas de gestión: análisis de Pareto para determinar el peso de los diferentes medicamentos en el presupuesto de la Secretaría de Salud Pública del municipio de Rosario; el análisis de las categorías terapéuticas para establecer posibles prioridades de sustitución terapéutica que reduzcan el gasto en los medicamentos de prescripción libre; el análisis comparativo de los precios de los medicamentos para medir el rendimiento de las compras, y el análisis de los plazos de espera para calificar a los proveedores. RESULTADOS: En 2005 se adquirieron 371 medicamentos: a 12,4 por ciento de ellos correspondió 74,9 por ciento del presupuesto total (grupo A), mientras que a 12,7 por ciento correspondió 14,9 por ciento (grupo B) y 74,9 por ciento consumió el restante 10,2 por ciento del presupuesto (grupo C). La mayor proporción del gasto correspondió a medicamentos de prescripción libre (grupo A: 82,1 por ciento; grupo B: 68,0 por ciento; grupo C: 58,0 por ciento), generalmente de primera elección y bajo costo. Los medicamentos del grupo A pertenecían a 21 subgrupos terapéuticos y se identificaron oportunidades de ahorro en 5 de ellos. El precio local abonado fue 2,0 veces superior al precio internacional de referencia. A cuatro proveedores se adjudicó 72,0 por ciento de los medicamentos licitados, no obstante, en tres de ellos se concentraron los mayores incumplimientos y las esperas más prolongadas. CONCLUSIONES: Se identificaron oportunidades para disminuir los costos y, en consecuencia, favorecer el acceso de la población a los medicamentos. Para optimizar el proceso de suministro de medicamentos se requiere un sistema de seguimiento de los plazos de espera y una metodología para la calificación y sanción ...

OBJECTIVE: To evaluate the public process for selecting and acquiring prescription drugs in the Rosario municipality, Argentina, during 2005, from the perspective of pharmaceuticals management. METHODS: A combination of management tools was used: a Pareto analysis was used to prioritize the various drugs on the budget of the Public Health Secretariat of the Rosario Municipality; therapeutic categories were reviewed to identify possible substitutions that would reduce spending on "unrestricted" prescription drugs (those not requiring proof of medical necessity); comparative analysis of drug prices was conducted and expenses were reconciled; and order fulfillment was reviewed as a means of rating suppliers. RESULTS: In 2005, a total of 371 medications were purchased: 12.4 percent of these medications (group A) absorbed 74.9 percent of the total budget; whereas 12.7 percent (group B) cost 14.9 percent and 74.9 percent (group C) used the remaining 10.2 percent. The largest proportion of the spending correlated with "unrestricted" prescriptions (group A: 82.1 percent; group B: 68 percent; group C: 58 percent), generally the first choice and most economical. The drugs in group A pertained to 21 therapeutic subgroups; savings opportunities were identified in five of them. The local price paid was 2.0 times more than the international reference price. Four suppliers received 72.0 percent of the drug orders; however, three of them were responsible for the majority of fulfillment errors and the longest delays. CONCLUSIONS: Opportunities for cost-saving were identified, and as a consequence, for improving the general public's access to prescription medications. The prescription drug supply can be improved by putting in place a procedure for tracking delays and a process for evaluating and approving suppliers.