Política industrial farmacéutica, un requisito clave para la autonomía sanitaria de Colombia

Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.

Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country's pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia's sanitary autonomy.

Review of international experience about the adjustment procedure of essential medicine list / 中国药房

In order to further consolidate the national essential medicine system and establish and improve the selection and adjustment mechanism of the national essential medicine list ，the Department of Drug Policy and Essential Medicine of the National Health Commission of the People ’s Republic of China recently has issued the Measures for the Administration of the National Essential Medicine List （Revised Draft ）. Under the background that China is in a critical period of improving the management procedures for the adjustment of the essential medicines list ，how to better design the adjustment procedure ，clarify the operation process and material requirements of each link ，ensure social participation and improve work transparency are important problems to be solved. By consulting the official websites of World Health Organization （WHO）and some typical countries with essential medicine system as well as related foreign literature ，the advanced practices of WHO and some typical countries in the adjustment procedures of the essential medicine list were summarized from 6 stages，such as start-up stage ，the material collection and summary stage ，the evaluation stage ，result publicity stage ，relief stage and application and promotion stage. It is suggested that China can learn from the relevant successful international experience ，scientifically set the adjustment cycle ，establish a normalized feedback mechanism with multi-agent participation ，design a standardized material collection process and a scientific and efficient evaluation process ，and improve the transparency and social identity of the publicity of the selection results of essential medicines ， so as to build a more scientific and perfect adjustment procedure of essential medicine list.

Importancia del cuadro básico de medicamentos en la prescripción médica / Importance of the list of essential medicines in medical prescription

Resumen La implementación en instituciones de salud de un cuadro básico permite adquirir y administrar una larga lista de medicamentos que presenta a los médicos las alternativas de tratamiento, así como la descripción académica colegiada de indicaciones, dosis, efectos secundarios, interacciones y análisis de costo-beneficio, con lo que se facilita la prescripción médica y la administración de insumos para la salud. El Comité de Ética y Transparencia en la Relación Médico-Industria emite diversas recomendaciones para la optimización de los beneficios generados por los cuadros básico de medicamentos.

Abstract The implementation of an essential medicines list in health institutions allows acquiring and administering a long list of drugs that offers treatment alternatives to physicians, as well as a collegiate academic description of indications, doses, side effects, interactions and cost-benefit analyses, thus facilitating medical prescription and administration of health products. The Committee of Ethics and Transparency in the Physician-Industry Relationship issues several recommendations for optimizing the benefits generated by essential medicines lists.

Dosage form and specification analysis on electrolytes and antipyretic analgesics in 2018 National Essential Medicines List / 药学实践杂志

Objective To provide data reference for improving the selection criteria of the dosage forms and specifications of the electrolytes and antipyretic analgesics in the Essential Medicines List, and to improve the applicability of these medicines to children and the availability of essential medicines. Methods The market and prices of electrolytes and antipyretic analgesics were retrieved by the system. The data were processed by Excel software, and the different dosage forms were compared and analyzed. Results 8 medication classes were included for adjusting water, electrolytes and acid-base balance, and another 16 classes were analgesic, antipyretic, anti-inflammatory, anti-rheumatic and anti-gout drugs. Those medications were characterized with many registered approval numbers, manufacturers and some considerations for pediatric uses. The proper prices were given for different dosage forms and specifications. There is a room for improvement regarding the specifications of potassium, glucose injections, and acetaminophen preparations. Conclusion The selection of pharmaceutical dosage forms and specifications in the Essential Medicines List should be comprehensively evaluated from the registered approval numbers of base medicines, the manufacturers and related prices in pharmaceutical procurement platforms from various provinces, and the clinical needs for special populations. It is recommended that 10 ml: 1 g potassium chloride injection, 50 ml glucose injection，acetaminophen suppositories and drops were included in the Essential Medicines List.

Libertad de prescripción médica / Freedom of medical prescription

Resumen Los médicos requieren flexibilidad para sus prescripciones. Sin embargo, algunos límites están marcados tanto por el conocimiento vigente como por las restricciones de acceso, normas y reglamentos. El Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) propone varias sugerencias para ayudar a los pacientes, que incluyen la selección de las mejores alternativas para cada caso, la protocolización de variaciones a los estándares de prescripción (dosis, indicaciones, etcétera) por escrito en el expediente y eludir modas, novedades no probadas, argumentos simplemente publicitarios o promocionales y conflictos de interés.

Abstract Doctors require flexibility for prescription. However, some limits are laid down both by current knowledge and by restrictions imposed by access and rules and regulations. The Committee for Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine proposes several suggestions to help patients, which include the selection of the best alternatives for each case, formalization of prescription standards variations (doses, drug indications, etc.) written down in the medical records, and avoidance of fashions, untested novelties, argumentations solely based on advertising or commercial promotion and conflicts of interest.

Valor terapéutico potencial de medicamentos en México: el caso de los antibióticos / Potential therapeutic value of drugs in Mexico: the case of antibiotics

Resumen Introducción: La relevancia de los medicamentos para la salud depende de su calidad, acceso y correcto uso. Objetivos: Determinar el valor terapéutico potencial de los antibióticos no incluidos en la lista de medicamentos esenciales (LME) de la Organización Mundial de la Salud pero que forman parte del Cuadro Básico de Medicamentos (CBM) de la Secretaría de Salud de México y categorizarlos por su valor intrínseco. Método: Análisis descriptivo de los antibióticos no incluidos en la LME de la Organización Mundial de la Salud 2013, revisión de la literatura para obtener evidencia de eficacia y seguridad y aplicación de escala de calidad y de valor intrínseco. Resultados: Se identificaron 452 resúmenes para 19 antibióticos, se eliminaron 56.9 %. In extenso se revisaron 195 ensayos clínicos; 37.9 % fueron de calidad y se determinó valor intrínseco; 54 % fueron estudios de superioridad y 46 % de no inferioridad o equivalencia; 32 % de los antibióticos fueron clasificados sin valor intrínseco y aproximadamente 50 % fueron dudosos. Conclusión: Una elevada proporción de antibióticos del CBM tuvo valor intrínseco dudoso o nulo, lo que favorece su uso inapropiado, resistencia bacteriana y coloca a la población en riesgo.

Abstract Introduction: The relevance of medications for health depends on their quality, accessibility and appropriate use. Objective: To determine the potential therapeutic value of antibiotics that are not included in the World Health Organization Essential Medicines List (EML) but that are part of the National Essential Medicines List (NEML) of the Mexican Ministry of Health, and categorize them according to their intrinsic value. Method: Descriptive analysis of antibiotics not included in the 2013 World Health Organization EML; literature review to obtain efficacy and safety evidence; and application of quality and intrinsic value scales. Results: Four hundred and fifty-two abstracts were identified for 19 antibiotics; 56.9 % were excluded; 195 clinical trials were reviewed in full-text articles, out of which 37.9 % were of good quality, and intrinsic value was determined; 54 % were superiority studies, whereas 46 % were non-inferiority or equivalence studies; 32 % of the antibiotics were classified without intrinsic value and nearly 50 % were inconclusive. Conclusion: An elevated proportion of antibiotics of the NEML had uncertain or no intrinsic value, which favors their inappropriate use, bacterial resistance and puts the population at risk.

Analysis of the Anticancer Drug List between the National Essential Medicines List (2018) and the WHO Model List of Essential Medicines (2017) / 中国药学杂志

OBJECTIVE: To analyze the variation of the anticancer drug list in the National Essential Medicines List (NEML-2018) and compare with the WHO Essential Model List (WHO-EML-2017) considering the epidemic characteristics and current national conditions, in order to provide the reference and advice for the revision of NEML in the future. METHODS: The category, content, formulation, dosage forms, medicines for children and indication for use of anticancer drug list between the NEML-2018 and WHO-EML-2017 were compared, and the deficiency existing in the NEML-2018 was analyzed. RESULTS: Compared with the NEML-2012, the category and content of the anticancer drug list have been improved in the 2018th edition, which is more reasonable for clinical request. However, disadvantages still exist in the aspect of the content, formulation, dosage forms, medicines for children and indication for use compared with the WHO-EML-2017. CONCLUSION: Although the rationality of the category and content has been improved in the NEML-2018, it still needs to be further improved compared with the WHO-EML-2017, which provides guidance and indication for the revision of anticancer drug list of the NEML in the future.

An in-depth study of drugs prescribing pattern in the Surgery Department of a Tertiary Care Teaching Institute in Northern India.

Background: In surgical patients, a number of drugs are prescribed to prevent post-operative infections and to relieve pain. Therefore, prescription audit should be periodically performed in Department of Surgery to analyze the present scenario of drugs prescribed for the surgical/post-operative patients. This will help us to use the medicines rationally and decrease the adverse effects in surgical patients. The main aim of the study was to evaluate the drugs prescribing pattern in the Surgery Department in Tertiary Care Teaching Institute. Methods: Patients’ prescriptions or case record forms were randomly collected over a period of 1 year from the Department of Surgery at GGS Medical College and Hospital, Faridkot, Punjab (India) for analysis and rationalization. Results: A total of 900 prescriptions was collected and analyzed for drugs used in surgical patients. Average number of drugs prescribed is 4.26. The most commonly prescribed drugs were anti-microbial agents (AMAs), gastrointestinal tract (GIT) related, non-steroidal anti-inflammatory drugs (NSAIDs) and multivitamins and trace elements, and their percentages were 37.90%, 23.36%, 14.14 %, and 9.11% respectively. About 95% drugs were prescribed by non-generic (Trade) names. Drugs prescribed from National Essential Medicines List (EML) and World Health Organization EML were 69.25% and 45.31% respectively. Average cost per prescription per day was Rs. 610/- (INR) or $10.34 USD in a surgical patient. Conclusions: There is a high tendency and frequency to prescribe four and more than four drugs to post-operative patients. Most drugs prescribed were AMAs, GIT related, NSAIDs and Multivitamins and trace elements. There is an urgent need to develop proper prescription writing skills in budding doctors regarding the use of EML/drugs list and generic medicines to reduce the cost of treatment.

Analysis on the application of antibiotics in the National Essential Drug List in Obstetric medical institutions of Western Hunan / 中国基层医药

Objective To analyze the application of antibiotics in the national essential drug list used by women in obstetric medical institutions at all levels of Western Hunan ( Basic Medical and Health Institutions Part,2009 version).Methods Medical records were reviewed respectively from May,2010 to December,2010.Results The rate of the use of antibiotics in the essential medicines list in township hospitals was more than 50％,which was higher than that of the secondary and tertiary hospitals.Conclusion The management of the use of medicine in the essential medicines list in hospitals at all levels should be strengthened to control the delivery cost.