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Introdução: O uso extensivo de medicamentos não padronizados causa aumento de custos em saúde, além de potencial redução de segurança e uso racional de medicamentos. A Comissão de Farmácia e Terapêutica orienta a prescrição de medicamentos, por meio da avaliação e seleção de medicamentos a serem incluídos no formulário de medicamentos padronizados, com base nas melhores evidências científicas disponíveis e no perfil dos pacientes locais, promovendo o uso racional de medicamentos. O objetivo deste trabalho foi analisar as solicitações de fornecimento de medicamentos não padronizados na instituição. Métodos: Trata-se de um estudo observacional e descritivo onde foram analisadas as solicitações de medicamentos não padronizados realizadas entre fevereiro de 2016 e dezembro de 2021, identificando os medicamentos envolvidos e seus respectivos custos. Resultados: Foram realizadas 203 solicitações no período, sendo 174 incluídas no estudo. Os medicamentos que tiveram mais solicitações foram o rituximabe (41), a imunoglobulina humana (31), o sucralfato (23), a nitazoxanida (12) e o eltrombopague (7). As solicitações com maior custo foram as de imunoglobulina humana (US$ 799,702.38), rituximabe (US$ 717,320.26), eltrombopague (US$ 281,062.50), ruxolitinibe (US$ 167,867.46) e bortezomibe (US$ 149,033.52). As principais clínicas que solicitaram medicamentos não padronizado foram a neurologia (47), a hematologia (30), as moléstias infecciosas e parasitárias (17), e a anestesiologia (12). As solicitações de maior custo foram realizadas pela neurologia (US$ 145,519.08), hematologia (US$ 120,980.25), transplante de medula óssea (US$ 51,635.11) e dermatologia (US$ 44,813.40). Conclusão: O estudo demonstrou que há um fluxo estruturado de solicitação de medicamentos não padronizados na instituição, sendo uma importante ferramenta de gerenciamento dessas solicitações, evitando a aquisição desnecessária de itens que não compõem o elenco terapêutico do hospital.
Introduction: Widespread use of non-formulary drugs (NFD) increases cost and may reduce safety and rational use of medicines. The Pharmacy and Therapeutics Committee provides guidance on drug prescription by evaluating and selecting medications to be included in a hospital's formulary based on best scientific evidence available and local patients' profile, promoting rational use of medicines. The objective of this study was to assess non-formulary drugs prescriptions at a tertiary hospital. Methods: This was a retrospective study. NFD prescribed and its associated costs were assessed through NFD request forms received from February 2016 to December 2021. Results: A total of 203 NFD request forms were received, from which 174 were included in this study. The most frequently prescribed NFD included rituximab (n = 41), immunoglobulin (31), sucralfate (23), nitazoxanide (12), and eltrombopag (7), with the highest costs being with immunoglobulin (US$ 799,702.38), rituximab (US$ 717,320.26), eltrombopag (US$ 281,062.50), ruxolitinib (US$ 167,867.46), and bortezomib (US$ 149,033.52). The most frequent requesting specialties were neurology (n = 47), hematology (30), infectious disease (17) and anesthesiology (12), and highest costs requests were from neurology (US$ 145,519.08), hematology (US$ 120,980.25), bone marrow transplant unit (US$ 51,635.11), and dermatology (US$ 44,813.40). Conclusion: This study showed that a structured request flow for NFD prescription is a critical procedure in order to better manage drug prescription within the hospital, promoting rational use of medicines and preventing unnecessary spending with drugs for which the clinical indication may be covered by a drug already in the hospital's formulary.
Subject(s)
Pharmacy and Therapeutics Committee/organization & administration , Pharmaceutical Preparations/supply & distribution , Drug Utilization/legislation & jurisprudence , Costs and Cost Analysis/statistics & numerical dataABSTRACT
Background:The term “medical device” includes a broad classification of production ranging from therapeutic medicinal devices withlocal uses tohighlyadvanced electronic medicalequipmentandindicativemedicaldevices. These devices vary widely in their production, type and are highly essential for patients’ care. Thus, their manufacturing, distribution, and sales must be managed to ensure their quality, safety, and efficacy. They play a major role in to detection, assessment and management and treatment of many different diseases. That being said, the quality of devices can very different and even the perfectly articulated products can fail in clinical practice. Post-market surveillance istherefore essential to ensure the quality and evaluate the safety and performance of medical devices. Despite the importance placed on surveillance of drug safety, the need for better monitoring of medical device-associated adverse events receives less attention. A well-structured vigilance system is the backbone of a robust regulatory framework to ensure the quality and promote the safe use of medical devices. The regulation of medical devices, however, is a complex and constantly evolving area that is often complicated by legal technicalities. Although the regulations may differ from one country to another.
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Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.
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Introducción: actualmente muchas personas sobrepasan las barreras cronológicas situadas como etapa de vejez, y esto puede transformarse en un problema si no se es capaz de brindar soluciones adecuadas a las consecuencias que del mismo se derivan. Objetivo: evaluar el proceso de atención a los adultos mayores con afecciones respiratorias tratados con fitofármacos. Materiales y métodos: se realizó un estudio observacional descriptivo de corte transversal en los 861 adultos mayores con diagnóstico de infección respiratoria aguda tratados con fitofármacos en los consultorios pertenecientes al Policlínico Dr. "Francisco Figueroa Véliz", del municipio Colón, provincia Matanzas, en el período comprendido entre julio y diciembre del 2015. Se analizaron los indicadores: adultos mayores con infección respiratoria aguda tratados con fitofármacos registrados en el consultorio, seguimiento médico a dichos pacientes, indicaciones correctas de fitofármacos, indicación de complementarios, inter-consultas realizadas y comportamiento de la certificación de calidad emitida a las producciones realizadas. Para la recolección de información se utilizó un instrumento que fue validado en su funcionamiento. Resultados: de los seis indicadores evaluados no alcanzaron los estándares establecidos el seguimiento médico a los adultos mayores con infección respiratoria aguda tratados con fitofármacos pues solo en el 95 % de las historias clínicas había constancia y la certificación de calidad ya que de los 220 lotes elaborados solo fueron analizados por control de la calidad el 81 % de ellos, por lo tanto el componente Proceso no es adecuado. Conclusiones: todas las unidades organizativas del área de salud presentan problemas con el proceso que se desarrolla (AU).
Background: currently many people surpass the chronological barriers limiting the old age stage, and this can become a problem if adequate solutions are not given to the consequences derived from it. Objective: to evaluate the health care processes of elder people treated with herbal medical products. Materials and methods: a cross-sectional, observational, descriptive study was carried out in 861 elder people with acute respiratory infection (ARI) treated with herbal medical products in the medical consultations belonging to the Policlinic "Dr. Francisco Figueroa Véliz" of the municipality of Colon, province of Matanzas, in the period July-December 2015. The indicators analyzed were elder people with acute respiratory infection treated with herbal medical products registered in the consultations, their medical follow-up, correct indication of herbal medical products, indication of complementary tests, inter- consultations and behavior of the quality certifications emitted for the elaborated production. For collecting information, it was used an instrument validated in its functioning. Results: of the six indicators evaluated, the follow-up to elder people with ARI treated with herbal medical products did not reach the average standards because in only 95 % of the clinical records it was registered; the quality certification was also deficient, because only the 81 % of the 220 lots elaborated was analyzed by quality control, therefore the component Process is not suitable. Conclusions: all the organizational units of the health area have problems with the developed process (AU).
Subject(s)
Humans , Aged , History, 21st Century , Primary Health Care , Respiratory Tract Diseases , Respiratory Tract Infections/drug therapy , Aging , Health Status Indicators , Process Assessment, Health Care , Patient Outcome Assessment , Patient Care , Phytotherapy , Quality Assurance, Health Care , Quality of Life , Respiratory Tract Infections/diagnosis , Epidemiology, Descriptive , Cross-Sectional Studies , Interviews as Topic , Community Health Services , Cuba/ethnology , Observational Study , Health Services ResearchABSTRACT
In 2008, the Global strategy and plan of action on public health, innovation and intellectual property (GSPA-PHI) was launched by the World Health Organization, to stimulate fresh thinking on innovation in, and access to, medicines and to build sustainable research on diseases disproportionately affecting low- and middleincome countries. As part of the activities of the GSPA-PHI, Sri Lanka has been the first country to date to assess the national environment for medical technology and innovation. This year-long, multistakeholder, participative analysis facilitated identification of clear and implementable policy recommendations, for the government to increase its effectiveness in promoting innovation in health products through institutional development, investment and coordination among all areas relevant to public health. The assessment also highlighted areas for priority action, including closing the technology gap in development of health products, facilitating technology transfer, and building the health-research and allied workforces. The Sri Lankan experience will inform the ongoing independent external evaluation of the GSPA-PHI worldwide. The assessment process coincided with the passing of the National Medicines Regulatory Authority Act in 2015. In addition, there is growing recognition that regional cooperation will be critical to improving access to medical products in the future. Sri Lanka is therefore actively promoting cooperation to establish a regional regulatory affairs network. Lessons learnt from the Sri Lankan assessment may also benefit other countries embarking on a national GSPA-PHI assessment.
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Background of research work: Background of our research work is that requirement arises to study structure of medicine and medical products which included in tender documents prepared by cus- tomer, as well as evaluate and conclude procurement and supply operation of customer and supplier. Material and methodology of research work: In the research, Central hospitals and medical cent ers in 9 provinces including Tuv, Arkhangai, Zavkhan, Bayan-Ulgii, Khuvsgul, Darkhan-Uul, Dorno- govi, Bulgan, Uvs, tender documents of years between 2013 and 2014 were studied by retrospective and mathematic statistics methodology. Conclusion: Number of package to purchase medicine, medical products, reagent diagnosing de- vice, disinfection substance, blood and blood products and oxygen of hospitals included are different and it shows that index of III phases hospital is greatly high. Typology of medicine of hospitals included in tender package by ATC category, A,B,C,J, and N cat- egories’ medicines are greatly high. Keywords: state property, local property, purchase, medicine, and medical products
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OBJECTIVE: To provide references for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.METHODS: FDA's CGMP Warning Letters on medical products issued by the USA during 2002～2006 were analyzed statistically,and FDA's emphasis and intent on quality management system of medical products was discussed.RESULTS & CONCLUSIONS: The contents stated in FDA Warning Letters are of great importance for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.Chinese enterprises can probe into the problems and solutions of quality management of medical products by analyzing FDA's emphasis and intent on quality management system of medical products as well as field investigation.