Use of monitoring indicators in hospital management of antimicrobials.

BACKGROUND: According to the literature, 25% to 50% of antimicrobials prescribed in hospitals are unnecessary or inappropriate, directly impacting antimicrobial resistance. Thus, the present study aimed to evaluate the use of antimicrobials in a university hospital in Northeast Brazil, using days of therapy (DOT) and length of therapy (LOT) indicators in accordance with the latest national and international recommendations for monitoring the use of antimicrobials. METHODS: This is an observational, prospective analytical study conducted in a teaching hospital, with 94 active beds, distributed between the intensive care unit (ICU), the surgical clinic (SUR), the medical clinic (MED), the pneumology/infectology department (PNE/INF) and pediatrics (PED). The duration of the study was from the beginning of January to the end of December 2018. RESULTS: During the study period, a total of 11,634 patient-days were followed up and 50.4% of the patients were found to have received some antimicrobial, with a significant reduction in use of 1% per month throughout the year. Patients were receiving antimicrobial therapy for 376 days in every 1000 days of hospitalization (LOT = 376/1000pd). Overall, the 1st-generation cephalosporins and fluoroquinolones were the most used in respect of the number of prescriptions and the duration of therapy. The calculated global DOT/LOT ratio showed that each patient received an average of 1.5 antimicrobials during the hospital stay. The incidence of antimicrobial resistance, globally, for both methicillin-resistant Staphylococcus aureus (methicillin R), Carbapenem-resistant Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii (Carbapenem R), was 1 per 1000 patient-days. CONCLUSIONS: The results obtained from the analyses revealed that half of the patients admitted to the hospital who took part in the study were exposed to the use of antimicrobials at some point during their stay. Although moderate, it is noteworthy that there was a decline in the use of antimicrobials throughout the year. The indicators used in this study were found to be very effective for gathering data on the use of antimicrobials, and assessing the results of the initiatives taken as part of the Stewardship program.

O papel dos Determinantes Sociais da Saúde e da Atenção Primária à Saúde no controle da COVID-19 em Belém, Pará / The role of Social Determinants of Health and Primary Health Care in controlling COVID-19 in Belém

Resumo Esse estudo tem como objetivo refletir sobre os Determinantes Sociais da Saúde na cidade de Belém (PA) e a atuação da Atenção Primária à Saúde no enfrentamento à pandemia de COVID-19. A partir da utilização de dados secundários e da caracterização do município, foi possível refletir sobre os aspectos de habitação, saneamento básico e renda da população na distribuição dos casos de COVID-19 na cidade. Evidenciou-se que as desigualdades sociais entre os Distritos Administrativos são preponderantes, todavia não houve a elaboração de um plano de ação que considerasse os impactos de COVID-19 nas populações em vulnerabilidade social. Ao investigar o papel da Atenção Primária à Saúde no controle da pandemia, percebe-se que a baixa cobertura da Estratégia Saúde da Família aliada às ações desarticuladas entre município e estado podem ter contribuído para o agravamento epidemiológico da COVID-19 em Belém. O plano de contingência não conseguiu implementar políticas contundentes para o controle da doença, focando na medicalização e nas ações hospitalocêntricas para os casos graves, enquanto as unidades de saúde foram subutilizadas, faltando estabelecer um fluxo coordenado de cuidados para os pacientes com a COVID-19, uma doença fortemente atrelada às iniquidades sociais.

Abstract This study aims to reflect on the Social Determinants of Health in the city of Belém (PA) and the performance of Primary Health Care in coping with the COVID-19 pandemic. From the use of secondary data and the characterization of the municipality, it was possible to reflect on the aspects of housing, basic sanitation and income of the population in the distribution of COVID-19 cases in the city. It was evidenced that social inequalities between Administrative Districts are predominant, however there was no elaboration of an action plan that considered the impacts of COVID-19 on populations in social vulnerability. When investigating the role of Primary Health Care in pandemic control, it is perceived that the low coverage of the Family Health Strategy combined with the disjointed actions between municipality and state may have contributed to the epidemiological worsening of COVID-19 in Belém. The contingency plan failed to implement forceful policies for the control of the disease, focusing on medicalization and hospital-centered actions for severe cases, while health units were underutilized, lacking to establish a coordinated flow of care for patients with COVID-19, a disease strongly linked to social inequities.

Unlicensed and off-label prescription of drugs to children in primary health care: A systematic review.

OBJECTIVE: To evaluate unlicensed and off-label prescription and use of drugs to children in primary health care. METHODS: This is a systematic review that was written based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The studies were extracted from the databases: LILACS, PubMed/MEDLINE, and Scopus. Studies in English, Spanish or Portuguese with abstract available regarding the use and prescription of off-label and unlicensed drugs to children aged 0-18 years in primary health care were included. The evaluation of the titles, abstracts and Full-text were performed independently by two reviewers, and the divergences were resolved by a third reviewer. RESULTS: Six studies were included. The incidence of off-label prescription varied from 29.5% to 51.7% in relation to the total number of drugs prescribed. The prevalence of off-label drugs ranged from 31.7% to 93.5% in relation to the total number of drugs prescribed. It was observed a higher proportion of off-label prescription related to age and dose. For unlicensed drugs, there was a small variation in incidence between 2.4% and 3.9%, relative to the total number of prescriptions, or between 2.4% and 10.0%, relative to the sample size. It was observed a higher proportion of unlicensed prescription related to children under 2 years of age. CONCLUSIONS: The unlicensed and off-label prescription of drugs is recurring in the pediatric population of primary health care. It is necessary to have better information on these drugs by the regulatory agencies and the pharmaceutical industries for rational use of drugs in children.

Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist.

AIMS: The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices. METHODS: This study has a cross-sectional design and was carried out with hospital pharmacists in Brazil. The sample was obtained by voluntary recruitment. Pharmacists who worked at Brazilian hospitals and were registered in their respective regulatory councils were invited to participate in the present study. A personalized questionnaire was developed by the authors and was electronically filled out by the respondents on the platform 'Google forms'. The questionnaire was nationally available on the digital platform of the Pharmacy Federal Council, the Brazilian Society of Hospital Pharmacy and Health Services, four Pharmacy regional councils and the social network farmacêuticoclínico®. Quantitative variables were analyzed by mean and standard deviation. The qualitative variables were analyzed by means of absolute and relative frequency. Difficulties related to pharmacovigilance activities are presented in an Ishikawa diagram in the Supplemental Material online. RESULTS: Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% (n = 23) of them. Among the pharmacovigilance practices developed by Brazilian pharmacists, the adverse drug reaction investigation (55.4%) and notification activities (47.0%) were worthy of note. Numerous difficulties were reported by the pharmacists, highlighting the difficulty in monitoring the medication and imputation of causality (27.7%). After categorizing the difficulties reported, it was observed that the category 'people involved' (45.1%) stood out from the others. CONCLUSION: This study pointed out numerous challenges to pharmacovigilance practices involving pharmacists in Brazil. It is believed that the correction of certain difficulties may impact on the better consolidation of pharmacovigilance activities in the country. However, regulatory agencies at all hierarchical levels of pharmacovigilance must work together to make it possible. PLAIN LANGUAGE SUMMARY: Challenges to the consolidation of pharmacovigilance This is a study that seeks to present the needs of Brazilian hospital pharmacists in relation to pharmacovigilance activities. Through online interviews, pharmacists answered a questionnaire, presented the pharmacovigilance activities they develop and expressed their anxieties and difficulties for the development of these activities. With this study, it was concluded that numerous activities of active search, investigation and notification of adverse drug reaction are developed by Brazilian pharmacists. However, each pharmacist performs a different method of pharmacovigilance. In addition, it was observed that among the interviewees there was a perception of insufficient professional training and a shortage of professionals to assist in pharmacovigilance activities. These were the main difficulties reported. Therefore, the search for models or agile solutions to solve problems involving adverse drug reactions seems necessary for a better consolidation of pharmacovigilance services in Brazil.

Risk factors for adverse drug reactions in pediatric inpatients: A cohort study.

PURPOSE: The present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients. METHODS: A prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17th and November 6th, 2015, and the second one between March 1st and August 25th, 2016. We included children aged 0-14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used. RESULTS: A total of 173 children (208 admissions) and 66 ADR classified as "definite" and "probable" were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%). In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR) 2.44; 95% confidence interval (CI) 1.19-5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21-20.54), antibacterial for systemic use (HR 2.75; 95% CI 1.08-6.98) and antiepileptic drugs (HR 3.84; 95% CI 1.40-10.56) were identified risk factors for ADR. CONCLUSIONS: We identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.

Risk factors for adverse drug reactions in pediatric inpatients: a systematic review.

BACKGROUND: The main objective of the present systematic review is to identify potential risk factors for adverse drug reactions (ADRs) through prospective cohort studies in pediatric inpatients. METHODS: The data search was done in the following electronic databases PubMed/MEDLINE; Scopus; LILACS and Web of Science from the earliest record until 31 May 2015. Two reviewers independently screened each study and one of them assessed the methodological quality according to the Newcastle-Ottawa scale for cohort studies. The data extraction was conducted according to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative for cohort studies. RESULTS: The only risk factor observed in all studies was the increase in the number of prescription drugs. However, other factors were identified, such as the increase in the length of stay or the number of low- or high-risk drugs prescribed, use of general anesthesia and oncological diagnosis. The cumulative incidence of ADR was 16.4% (95% confidence interval: 15.6 to 17.2). The main professional responsible for ADR identification was the pharmacist and the dominant category among the ADRs were gastrointestinal disorders. In addition, analgesics, antibacterial agents and corticosteroids were the drug classes commonly associated with ADRs. The methodology used in this study was tried to homogenize the data extracted; however, this was not sufficient to correct the discrepancies so it was not possible to perform a meta-analysis. CONCLUSIONS: The increase in the number of prescription drugs was the main risk factor in this population. However, additional studies are required to identify the risk factors for ADRs in pediatric inpatients.

Use of herbal medicines by elderly patients: A systematic review.

OBJECTIVES: We aimed to survey the published literature for articles that describe the use of herbal supplements by elderly patients and to summarize important aspects of selected studies, including most commonly used supplements, study type, study location, and potential hazards of herbal supplement use. METHODS: Literature searches were conducted on three scientific/medical databases: Medline, Web of Science, and Scopus. Search results were examined for articles involving the use of herbal products in the elderly population that met selection criteria. RESULTS: Initial searches yielded 1297 articles. Of these original results, only 16 met specific selection criteria. Twelve (75%) of studies identified were performed in North America. Nine studies (56.25%) were conducted in the United States. Seven of the studies were cross-sectional (43.8%). The most commonly reported were gingko biloba, garlic, ginseng, aloe vera, chamomile, spearmint, and ginger. Of these, gingko and garlic are the most commonly used among community-dwelling elderly. Both of these supplements have the potential to interact with anticoagulants and produce bruising or bleeding problems. CONCLUSIONS: The use of herbal supplements is common among the elderly, a population that takes a disproportionate share of prescription medications compared to that taken by younger populations. Among the problems uncovered by these studies was a lack of dialog between medical professionals and patients about the use of herbal supplements. Prescribers need to consider the use of herbal supplements and discuss the matter with their elderly patients when making decisions about pharmacological treatments.

[Indicators for drug selection in health systems: an integrative review]. / Indicadores da seleção de medicamentos em sistemas de saúde: uma revisão integrativa.

OBJECTIVE: To produce a panel of the main drug selection indicators by performing an integrative literature review. METHODS: After the elaboration of a review protocol, searches were conducted in LILACS, MEDLINE, Embase, and SciELO databases. The following search terms were used: "indicators"; "criteria"; "drug selection"; "pharmacy and therapeutics committee"; and "medication form"; with the applicable variations in English and Spanish. Sixteen original articles published between January 1996 and March 2012 were retrieved and reviewed to compose a panel of indicators. RESULTS: Forty-five quantitative and qualitative indicators were identified. These indicators were grouped according to conceptual similarities in three categories: 1) assessment of pharmacy and therapeutics committee structure; 2) evaluation of the general processes of drug selection; and 3) evaluation of the results of drug selection. CONCLUSIONS: The indicators identified reveal relative uniformity in the established patterns for drug selection. The group of indicators established in this study should serve as reference for the development and consolidation of drug selection in public health services.

Indicadores da seleção de medicamentos em sistemas de saúde: uma revisão integrativa / Indicators for drug selection in health systems: an integrative review

OBJETIVO: Obter um painel dos principais indicadores utilizados para a seleção de medicamentos por meio da realização de uma revisão integrativa da literatura. MÉTODOS: Após elaborar um protocolo de revisão, foram realizadas buscas nas bases LILACS, MEDLINE, Embase e SciELO. Foram utilizados os descritores "indicadores", "critérios", "seleção de medicamentos", "comitê de farmácia e terapêutica" e "formulário de medicamentos", com suas variações em inglês e espanhol. Foram selecionados e revisados 16 artigos originais publicados entre janeiro de 1996 e março de 2012 para compor um painel de indicadores. RESULTADOS: Foram identificados 45 indicadores quantitativos e qualitativos. Esses indicadores foram agrupados de acordo com semelhanças conceituais em três categorias: 1) avaliação da estrutura da comissão de farmácia e terapêutica; 2) avaliação dos processos gerais de seleção de medicamentos; e 3) avaliação dos resultados da seleção de medicamentos. CONCLUSÕES: Os indicadores avaliados demonstram relativa uniformidade nos padrões estabelecidos para a seleção de medicamentos. O grupo de indicadores estabelecidos neste estudo deve servir como referência para fomento e consolidação dessa atividade nos serviços de saúde pública.

OBJECTIVE: To produce a panel of the main drug selection indicators by performing an integrative literature review. METHODS: After the elaboration of a review protocol, searches were conducted in LILACS, MEDLINE, Embase, and SciELO databases. The following search terms were used: "indicators"; "criteria"; "drug selection"; "pharmacy and therapeutics committee"; and "medication form"; with the applicable variations in English and Spanish. Sixteen original articles published between January 1996 and March 2012 were retrieved and reviewed to compose a panel of indicators. RESULTS: Forty-five quantitative and qualitative indicators were identified. These indicators were grouped according to conceptual similarities in three categories: 1) assessment of pharmacy and therapeutics committee structure; 2) evaluation of the general processes of drug selection; and 3) evaluation of the results of drug selection. CONCLUSIONS: The indicators identified reveal relative uniformity in the established patterns for drug selection. The group of indicators established in this study should serve as reference for the development and consolidation of drug selection in public health services.

A institucionalização da seleção de medicamentos em hospitais públicos por meio do planejamento estratégico situacional / Institutionalization of medicine selection in public hospitals through the situational strategic planning / La institucionalización del proceso de selección de medicamentos en los hospitales públicos a través de planificación estratégica situacional

Desde a publicação da primeira relação de medicamentos essenciais da Organização Mundial da Saúde (OMS), em 1977, essa instituição de saúde e diversas outras em todo o mundo têm fomentado a importância da promoção de políticas de medicamentos essenciais para os serviços de saúde. Apesar da inegável contribuição para a promoção do uso racional de medicamentos, a implantação de comitês que gerenciem a implantação de listas de medicamentos essenciais ainda é um desafio para os gestores do Sistema Único de Saúde (SUS). Este trabalho teve como objetivo utilizar uma ferramenta de gestão, proposta pelo economista Carlos Matus, para a superação das dificuldades de implantação de Comissões de Farmácia e Terapêutica nos serviços hospitalares do estado de Sergipe. Para isso, a equipe de pesquisadores realizou, em conjunto com os atores do serviço, a implantação do Planejamento Estratégico Situacional (PES) por meio dos momentos explicativo, normativo, estratégico e tático-operacional. Por meio deste trabalho, observou-se que o método PES caracteriza-se como uma ferramenta recomendada para a implantação de atividades fundamentais da seleção de medicamentos, agrupadas em três objetivos gerais alcançados: 1) a regulamentação de fluxos e procedimentos para a seleção de medicamentos; 2) a organização de comissões de farmácia e terapêutica e 3) a elaboração de listas de medicamentos essenciais.

Desde la publicación de la primera lista modelo de la Organización Mundial de la Salud (OMS) de medicamentos esenciales en 1977, este órgano y varias instituciones de salud en todo el mundo han promovido la importancia de la promoción de políticas de medicamentos esenciales a los servicios de salud. A pesar de la innegable contribución a la promoción del uso racional de los medicamentos, la implementación de los comités que administran la aplicación de listas de medicamentos esenciales sigue siendo un reto para los gestores en el Sistema Único de Salud de Brasil. Este estudio tuvo como objetivo utilizar una herramienta de gestión, propuesta por el economista Carlos Matus, para superar las dificultades de implantación del comité de farmacia y terapéutica en servicios hospitalarios en el estado de Sergipe. Para ello, el equipo de investigación ante los actores del servicio aplicaron la Planificación Estratégica Situacional (PES) por medio de los momentos explicativo, normativo, estratégico y táctico-operacional. A través de este trabajo, se observó que el método PES se caracteriza por ser una herramienta recomendable para la ejecución de las actividades clave de la selección de medicamentos, en este estudio, agrupadas en tres objetivos generales alcanzados: 1) la regulación de los flujos y procedimientos para selección de medicamentos, 2) la organización de comités de farmacia y terapéutica, y 3) la preparación de las listas de medicamentos esenciales.

Since the publication of the first list of World Health Organization (WHO)’s essential medicines, in 1977, this one and some health institutions around the world have encouraged the importance of promoting policies of essential medicines for health services. Despite the undeniable contribution to the promotion of rational use of medicines, the implementation of committees that manage the deployment of lists ofessential medicines is still a challenge for managers of the Brazilian health system (SUS). This study aimed to use a management tool proposed by economist Carlos Matus to overcome the difficulties of implementing pharmacy and therapeutic committees in hospital services of Sergipe, State of Brazil.To do it, the research team conducted with the stakeholders of the implementation of the SituationalStrategic Planning (PES) through explanatory, normative, strategic and tactical-operational moments. It was observed that the PES method is characterized as a recommended tool for the implementation of fundamental activities of of essential medicines’ selection, in this study, grouped into three general objectives achieved: 1) the regulation of flows and procedures for selecting medication, 2) the organization of pharmacy and therapeutic committees, and 3) the preparation of lists of essential medicines.

Evaluation of adherence to treatment by patients seen in a psychosocial care center in northeastern Brazil

In the treatment of mental disorders, nonadherence to medication, the main cause of psychiatric morbidity, is observed in about 50 percent of the cases and is responsible for numerous losses. This study evaluated adherence to drug treatment by patients seen in a Psychosocial Care Center (CAPS) in northeastern Brazil. Adherence to treatment was evaluated using the Haynes-Sackett and Morisky-Green-Levine tests. All patients registered in the CAPS were included in the study (n= 101). Only 11.88 percent of the patients adhered to drug treatment. The main reasons not to use medication were: oblivion (68.83 percent), feeling unwell after taking the medication (54.22 percent), not having money to buy the medication (43.83 percent), not finding the medication in the public health service (39.94 percent) and fear of harm that might be caused by the drug (28.90 percent). Furthermore, 85.1 percent of the patients did not know their diseases, 88.1 percent did not know their treatment, 86.4 percent did not feel good when they took their medication, and 88.1 percent took their medication incorrectly. The results revealed that the lack of information about diseases and drugs used, the nuisance posed by drug therapy and the low access to medications reduce adherence to treatment and, consequently, treatment effectiveness.

No tratamento de desordens mentais, a não-adesão ao tratamento ocorre em cerca de 50 por cento dos casos e é responsável por inúmeros prejuízos, além de ser a principal causa de morbidade psiquiátrica. O presente estudo objetivou avaliar a adesão ao tratamento medicamentoso de pacientes atendidos em um Centro de Atenção Psicossocial (CAPS) no Nordeste do Brasil. A avaliação da adesão ao tratamento foi feita através dos testes de Haynes-Sackett e Morisky-Green-Levine. Todos os pacientes cadastrados no CAPS foram incluídos no estudo (n = 101). Observou-se que apenas 11,88 por cento dos pacientes aderiram ao tratamento medicamentoso. As principais razões para o não uso dos medicamentos foram: esquecimento (68,83 por cento), sentir-se mal após a ingestão de medicamentos (54,22 por cento), não ter dinheiro para comprar medicamentos (43,83 por cento), não encontrar os medicamentos no serviço público de saúde (39,94 por cento) e medo dos danos causados pelos medicamentos (28,90 por cento). Além disso, observou-se que 85,1 por cento dos pacientes não conheciam suas doenças, 88,1 por cento não conheciam seus tratamentos, 86,4 por cento não se sentiam bem quando usavam medicamentos e 88,1 por cento usavam os medicamentos incorretamente. Os resultados demonstram que a falta de informação sobre doenças e medicamentos, os danos decorrentes da terapia medicamentosa e o baixo acesso aos medicamentos comprometem a adesão ao tratamento e, consequentemente, a eficácia do tratamento.

O lugar da farmacognosia na formação em farmácia: questões epistemológicas e suas implicações para o ensino / The place of pharmacognosy in the pharmaceutical education: epistemological issues and their implications for teaching

O presente ensaio propõe a discussão de questões epistemológicas referentes ao ensino de Farmacognosia e seu papel na formação e apropriação de uma cultura científica entre os estudantes dos cursos de Farmácia, além das possibilidades de contribuição da disciplina para o estabelecimento de um novo modelo de prática profissional. Defende que há uma estreita relação entre a crise de identidade profissional da Farmácia e incongruências epistemológicas na matriz disciplinar da Farmacognosia, o que, do ponto de vista pedagógico implica em obstáculos para o processo de ensino e aprendizagem da disciplina. Além disso, o caráter experimental da Farmacognosia comporta uma concepção de ciência e do objeto de conhecimento que influenciam na seleção de conteúdos e pode constituir obstáculos na mediação e apropriação de conhecimentos e demandas necessárias para a prática profissional da Farmácia.

This paper proposes the discussion of epistemological issues concerning the teaching of pharmacognosy and its role in training and ownership of a scientific culture among students of the courses of Pharmacy, in addition to the potential contribution of the discipline for the establishment of a new model of professional practice. It argues that there is a close link between the crisis of professional identity of Pharmacy and epistemological inconsistencies in the disciplinary matrix of pharmacognosy, which from a teaching point of view it involves obstacles to the process of teaching and learning the discipline. Moreover, the experimental nature of pharmacognosy includes a conception of science and the object of knowledge that influences the selection of content and may constitute obstacles in mediation and appropriation of knowledge and demands for the pharmacy practice.

Reflexiones epistemológicas en las Ciencias de la salud / Epistemological considerations around the Health Sciences

El artículo discute algunos apuntes epistemológicos presentes en los trabajos de Canguilhem, Foucault y Kuhn y sus implicaciones para la caracterización de la racionalidad de la medicina científica. La delimitación del concepto de enfermedad, constructo fundamental por tratarse del objeto de conocimiento de la medicina, es abordado en el análisis de Canguilhem para la formación teórica de los conceptos de lo normal y lo patológico, y en la interpretación foulcaltiana que identifica el desplazamiento epistemológico que da origen al método clínico como modelo de práctica subyacente a los procesos de intervención en salud. La perspectiva socio-constructivista de L. Fleck es representada como posibilidad de abordaje epistemológico para explicar la dinámica de transformación, instauración y extensión de los hechos científicos, atribuyendo importancia a los elementos históricos y sociales como posibilidad de interpretar la complejidad en el área de la salud(AU)

This article discusses some epistemological aspects of Canguilhem, Foucault and Kuhn's work and their implication in the characterization of Medicine's scientific rationale. The delimitation of the disease concept, which is fundamental for being Medicine's object of knowledge, is considered in Canguilhem's analysis of the theoretical formation of the concepts of what is normal or pathologic and in Foucault's interpretation that identifies the epistemological hallmark that gives origin to the clinical method as a subjacent model to all health intervention processes. Ludwik Fleck's socio constructivist perspective is presented as a possibility to epistemologically approach the dynamics of transformation, instauration and extension of scientific facts, placing special importance on the historical and social elements as a possibility to interpret health's complexity(AU)