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Abstract On the increasing prevalence of using mAbs (monoclonal antibodies) in cancer therapy and the severe risk of hyperglycemia, we aimed to analyze the main clinical ADRs of mAbs, with a focus on adverse hyperglycemic events associated with currently clinically used mAbs. mAbs as well as target information were selected from Martinadale book and published articles. Drug approving information was collected from each government website, and ADR statistic data were collected from VigibaseR, comparing with Adverse Event Reporting System of US FDA. Top 10 mAbs were classified within listing in total ADR records, ADRs per year, hyperglycemic ADR records. Vigibase data were updated onto 15 Feb 2019. 20 mAbs were analyzed with 263217 ADR reports, wherein 16751 records on Metabolism and nutrition disorders and 1444 records on Glucose metabolism disorders. The geographic, age, gender distributions and annual ADR report numbers were listed respectively. Of the top 10, Rituximab, Bevacizumab and Nivolumab were on the top 3 in total ADR record and hyperglycemic record. Top 3 record results were similar in Vigibase and FDA database. It is of increasing importance for clinicians to be aware of early detection, patient management, or drug selection strategies when using mAbs, particularly within the high glycemic risk-reported mAbs, to improve the efficacy and tolerability of mAbs regiment and optimize patient outcomes.

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Tamoxifen (TAM), a selective oestrogen receptor modulator, is one of the most used treatments in oestrogen receptor-positive (ER+) early and metastatic breast cancer (BC) patients. The response to TAM has a high degree of inter-individual variability. This is mainly due to genetic variants in CYP2D6 gene, as well as other genes encoding proteins involved in the TAM pharmacokinetic and/or pharmacodynamic. Therefore, prediction of the TAM response using these genetic factors together with other non-genetic variables may be relevant to improve breast cancer treatment. Thus, in this work, we used genetic polymorphisms and clinical variables for TAM response modelling. One hundred sixty-two ER + BC patients with 2 years of TAM treatment were retrospectively recruited, and the genetic polymorphisms CYP2D6*4, CYP3A4*1B (CYP3A4*1.001), CYP3A5*3, UGT2B7*2, UGT2B15*2, SULT1A1*2, and ESRA V364E were analyzed by PCR-RFLP. Concomitantly, the therapeutic response was obtained from clinical records for association with genotypes using univariate and multivariate biostatistical models. Our results show that UGT2B15*1/*2 genotype protects against relapse (OR = 0.09; p = 0.02), CYP3A5*3/*3 genotype avoids endometrial hyperplasia (OR = 0.07; p = 0.01), SULT1A1*1/*2 genotype avoids vaginal bleeding (OR = 0.09; p = 0.03) and ESRA 364E/364E genotype increases the probability of vaginal bleeding (OR = 5.68; p = 0.02). Logistic regression models, including genomic and non-genomic variables, allowed us to obtain preliminary predictive models to explain relapse (p = 0.010), endometrial hyperplasia (p = 0.002) and vaginal bleeding (p = 0.014). Our results suggest that the response to TAM treatment in ER + BC patients might be associated with the presence of the studied genetic variants in UGT2B15, CYP3A5, SULT1A1 and ESRA genes. After clinical validation protocols, these models might be used to help to predict a percentage of BC relapse and adverse reactions, improving the individual response to TAM-based treatment.

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Butyrate is a short-chain fatty acid derived from the metabolism of indigestible carbohydrates by the gut microbiota. Butyrate contributes to gut homeostasis, but it may also control inflammatory responses and host physiology in other tissues. Butyrate inhibits histone deacetylases, thereby affecting gene transcription, and also signals through the metabolite-sensing G protein receptor (GPR)109a. We produced an mAb to mouse GPR109a and found high expression on podocytes in the kidney. Wild-type and Gpr109a-/- mice were induced to develop nephropathy by a single injection of Adriamycin and treated with sodium butyrate or high butyrate-releasing high-amylose maize starch diet. Butyrate improved proteinuria by preserving podocyte at glomerular basement membrane and attenuated glomerulosclerosis and tissue inflammation. This protective phenotype was associated with increased podocyte-related proteins and a normalized pattern of acetylation and methylation at promoter sites of genes essential for podocyte function. We found that GPR109a is expressed by podocytes, and the use of Gpr109a-/- mice showed that the protective effects of butyrate depended on GPR109a expression. A prebiotic diet that releases high amounts of butyrate also proved highly effective for protection against kidney disease. Butyrate and GPR109a play a role in the pathogenesis of kidney disease and provide one of the important molecular connections between diet, the gut microbiota, and kidney disease.-Felizardo, R. J. F., de Almeida, D. C., Pereira, R. L., Watanabe, I. K. M., Doimo, N. T. S., Ribeiro, W. R., Cenedeze, M. A., Hiyane, M. I., Amano, M. T., Braga, T. T., Ferreira, C. M., Parmigiani, R. B., Andrade-Oliveira, V., Volpini, R. A., Vinolo, M. A. R., Mariño, E., Robert, R., Mackay, C. R., Camara, N. O. S. Gut microbial metabolite butyrate protects against proteinuric kidney disease through epigenetic- and GPR109a-mediated mechanisms.

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Understanding the potential for adverse drug reactions (ADRs), from herb-drug interactions, is a key aspect of medicinal plant safety, with particular relevance for public health in countries where medicinal plant use is highly prevalent. We undertook an in-depth assessment of extracts of Hyptis verticillata Jacq., via its impact on activities of key cytochrome P450 (CYP) enzymes (CYPs 1A1, 1A2, 1B1, 3A4 and 2D6), its antioxidant properties (determined by DPPH assays) and chemical characterisation (using LC-MS). The dried plant aqueous extract demonstrated potent inhibition of the activities of CYPs 1A1 (7.6 µg/mL), 1A2 (1.9 µg/mL), 1B1 (9.4 µg/mL) and 3A4 (6.8 µg/mL). Further analysis of other crude extracts demonstrated potent inhibition of CYP1A2 activity for a dried plant ethanol extract (1.5 µg/mL), fresh plant ethanol extract (3.9 µg/mL), and moderate activity for a fresh plant aqueous extract (27.8 µg/mL). All four extracts demonstrated strong antioxidant activity, compared to the positive control (ascorbic acid, 1.3 µg/mL), with the dried plant ethanol extract being the most potent (1.6 µg/mL). Analysis of the dried plant aqueous extract confirmed the identity of seven phytochemicals, five lignans and two triterpenes. Individual screening of these phytochemicals against the activity of CYP1A2 identified yatein as a moderate inhibitor (71.9 µM), likely to contribute to the plant extract's potent bioactivity. Further analysis on the impact of this plant on key drug metabolizing enzymes in vivo appears warranted for likely ADRs, as well as furthering development as a potential chemopreventive agent.

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INTRODUCCIÓN: La reacción a drogas con eosinofilia y síntomas sistémicos (DRESS) es una rara enfermedad que puede ser letal. OBJETIVOS: Describir los hallazgos clínicos, de laboratorio e histopatológicos en pacientes con DRESS. MATERIALES Y MÉTODOS: Estudio retrospectivo de fichas clínicas de pacientes con DRESS entre los años 2007 y 2017 con score regiSCAR mayor o igual a caso probable. RESULTADOS: Se estudiaron 24 pacientes: 14 fueron mujeres (58,3%), 2 tuvieron enfermedad autoinmune (8,3%), la edad promedio fue 45,04 años DS 17,2 (16-78). Los medicamentos frecuentemente implicados fueron Lamotrigina (33,3%) y Carbamazepina (20,8%). La latencia fue 28 días DS 17,7 (10-90). La clínica más frecuente fue prurito 87,5%, fiebre 75%, edema facial 62,5% y adenopatías 45,8%. En laboratorio lo más alterado fueron pruebas hepáticas (70,8%) y eosinofilia (45,8%). 11 pacientes (45,8%) presentaron eosinófilos en la histopatología y 21 pacientes (87,5%) fueron tratados con corticoides. La mortalidad fue 11,1% (2 pacientes, por causas distintas a DRESS). DISCUSIÓN: DRESS es una reacción adversa a medicamentos severa con variados hallazgos clínicos y analíticos que requieren de su conocimiento para no retrasar el diagnóstico y su tratamiento.

INTRODUCCIÓN: Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare disease that can be lethal. OBJECTIVE: To describe the clinical, laboratory and histopathological findings in patients with DRESS. MATERIALS AND METHODS: Retrospective study of clinical records of patients with DRESS between 2007 and 2017 with RegiSCAR score greater than or equal to probable case. RESULTS: 24 patients were studied: 14 were women (58.3%), 2 had autoimmune diseases (8.3%), the average age was 45.04 ± 17.2 years (16-78). The medications frequently implicated were Lamotrigine (33.3%) and Carbamazepine (20.8%). The latency was 28 ± 17.7 days (10-90). The most frequent symptoms were 87.5% pruritus, fever 75%, facial edema 62.5% and lymphadenopathies 45.8%. In the laboratory, the most disturbed were liver tests (70.8%) and eosinophilia (45.8%). 11 patients (45.8%) presented eosino-phils in histopathology and 21 patients (87.5%) were treated with corticosteroids. Mortality was 11.1% (2 patients) due to other causes than DRESS. DISCUSSION: DRESS is an adverse reaction to severe medications with a varied clinical and la-boratory finding, requiring knowledge in order to not to delay diagnosis and treatment.Key words: DRESS; Eosinophilia; ADR, Drug rash

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Realizou-se este estudo com o objetivo de avaliar níveis de milheto híbrido ADR 8010(r) nas dietas de suínos em crescimento e terminação sobre o desempenho e características quantitativas de carcaça. Foram utilizados 48 animais, machos castrados, geneticamente similares, com peso inicial de 30,0±2,9kg. Os animais foram distribuídos em delineamento experimental de blocos casualizados, com quatro níveis de inclusão de milheto na dieta (0; 25; 50; e 75%), seis repetições, sendo cada unidade experimental constituída por dois animais. Foram analisados os parâmetros de desempenho (consumo de ração, ganho de peso e conversão alimentar) e as características de carcaça (peso e comprimento de carcaça, espessura de toucinho, profundidade de músculo, percentual e quantidade de carne magra). Os níveis de milheto não influenciaram (P>0,05) nos parâmetros de desempenho e características de carcaça dos suínos. O milheto ADR 8010(r) pode substituir o milho em até 75% nas dietas de suínos em crescimento e terminação, sem prejudicar o desempenho e características de carcaça dos animais.

The aim of this study was to evaluate levels of millet hybrid ADR 8010(r) in the diets of pigs in growing and finishing on performance and carcass quantitative characteristics. It was used 48 barrows, genetically similar c, with initial weight around 30.0±2.9kg. The animals were distributed in a randomized block design, with four levels of inclusion of millet in the diet (0; 25; 50 and 75%), six replicate of two animals each. It was analyzed the parameters of performance (feed intake, weight gain and feed conversion) and carcass traits (weight and height of carcass, back fat thickness, depth of muscle, percentage and amount of lean meat). The level of inclusion of millet do not influence (P>0.05) the parameters of performance and characteristics of carcass of pigs. The millet ADRR 8010(r) can replace the corn up to 75% on diets of pigs in growth and finishing without impacting performance and carcass characteristics of animals.

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Realizou-se este estudo com o objetivo de avaliar níveis de milheto híbrido ADR 8010(r) nas dietas de suínos em crescimento e terminação sobre o desempenho e características quantitativas de carcaça. Foram utilizados 48 animais, machos castrados, geneticamente similares, com peso inicial de 30,0±2,9kg. Os animais foram distribuídos em delineamento experimental de blocos casualizados, com quatro níveis de inclusão de milheto na dieta (0; 25; 50; e 75%), seis repetições, sendo cada unidade experimental constituída por dois animais. Foram analisados os parâmetros de desempenho (consumo de ração, ganho de peso e conversão alimentar) e as características de carcaça (peso e comprimento de carcaça, espessura de toucinho, profundidade de músculo, percentual e quantidade de carne magra). Os níveis de milheto não influenciaram (P>0,05) nos parâmetros de desempenho e características de carcaça dos suínos. O milheto ADR 8010(r) pode substituir o milho em até 75% nas dietas de suínos em crescimento e terminação, sem prejudicar o desempenho e características de carcaça dos animais.(AU)

The aim of this study was to evaluate levels of millet hybrid ADR 8010(r) in the diets of pigs in growing and finishing on performance and carcass quantitative characteristics. It was used 48 barrows, genetically similar c, with initial weight around 30.0±2.9kg. The animals were distributed in a randomized block design, with four levels of inclusion of millet in the diet (0; 25; 50 and 75%), six replicate of two animals each. It was analyzed the parameters of performance (feed intake, weight gain and feed conversion) and carcass traits (weight and height of carcass, back fat thickness, depth of muscle, percentage and amount of lean meat). The level of inclusion of millet do not influence (P>0.05) the parameters of performance and characteristics of carcass of pigs. The millet ADRR 8010(r) can replace the corn up to 75% on diets of pigs in growth and finishing without impacting performance and carcass characteristics of animals.(AU)

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O objetivo deste trabalho foi avaliar níveis de milheto na alimentação de suínos na composição lipídica e de colesterol da gordura subcutânea e da carne. Foram utilizados 48 animais, machos castrados, distribuídos em um delineamento experimental de blocos casualizados, com quatro níveis de milheto na dieta (0; 25; 50 e 75%), seis repetições, sendo cada unidade experimental constituída por dois animais. Foram analisados os perfis lipídicos da gordura e da carne através de cromatografia gasosa e a quantidade de colesterol nas amostras de carne foi determinada seguindo a metodologia de extração. O aumento do nível de milheto na dieta dos suínos reduziu (P<0,05) a concentração dos ácidos mirístico, palmítico, palmitoleico, heptadecanoico e aumentou a concentração do ácido linoleico na gordura subcutânea. O nível de inclusão de 50,82% de milheto na dieta possibilita máxima deposição do ácido linolênico na gordura. Os níveis de milheto não modificam o perfil de ácidos graxos e o teor de colesterol na carne suína. O nível de 42,09% de inclusão de milheto na dieta resulta no maior índice trombogênico da carne.

The aim of this study was to evaluate the replacement of corn by millet in the diets of pigs on the lipid composition and cholesterol from subcutaneous fat and meat. It was used 48 castrated males, distributed on randomized experimental blocks design, with four levels of millet in the diet (0; 25; 50 and 75%), six replicate of two animals each. It was analyzed the lipid profiles of fat and meat by gas chromatography and the amount of cholesterol in the meat samples was determined following the extraction methodology. The increased level of millet in the diet of pigs reduced (P<0.05) the concentration of myristic, palmitic, palmitoleic and heptadecanoic acids and increased the concentration of linoleic acid in subcutaneous fat. The inclusion level of 50.82% of millet in the diet allowed maximum deposition of linolenic acid in fat. Levels of millet did not change the fatty acid profile and cholesterol content in pork. The level of 42.09% inclusion of millet in the diet results in the highest rate thrombogenic meat.

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O objetivo deste trabalho foi avaliar níveis de milheto na alimentação de suínos na composição lipídica e de colesterol da gordura subcutânea e da carne. Foram utilizados 48 animais, machos castrados, distribuídos em um delineamento experimental de blocos casualizados, com quatro níveis de milheto na dieta (0; 25; 50 e 75%), seis repetições, sendo cada unidade experimental constituída por dois animais. Foram analisados os perfis lipídicos da gordura e da carne através de cromatografia gasosa e a quantidade de colesterol nas amostras de carne foi determinada seguindo a metodologia de extração. O aumento do nível de milheto na dieta dos suínos reduziu (P<0,05) a concentração dos ácidos mirístico, palmítico, palmitoleico, heptadecanoico e aumentou a concentração do ácido linoleico na gordura subcutânea. O nível de inclusão de 50,82% de milheto na dieta possibilita máxima deposição do ácido linolênico na gordura. Os níveis de milheto não modificam o perfil de ácidos graxos e o teor de colesterol na carne suína. O nível de 42,09% de inclusão de milheto na dieta resulta no maior índice trombogênico da carne.(AU)

The aim of this study was to evaluate the replacement of corn by millet in the diets of pigs on the lipid composition and cholesterol from subcutaneous fat and meat. It was used 48 castrated males, distributed on randomized experimental blocks design, with four levels of millet in the diet (0; 25; 50 and 75%), six replicate of two animals each. It was analyzed the lipid profiles of fat and meat by gas chromatography and the amount of cholesterol in the meat samples was determined following the extraction methodology. The increased level of millet in the diet of pigs reduced (P<0.05) the concentration of myristic, palmitic, palmitoleic and heptadecanoic acids and increased the concentration of linoleic acid in subcutaneous fat. The inclusion level of 50.82% of millet in the diet allowed maximum deposition of linolenic acid in fat. Levels of millet did not change the fatty acid profile and cholesterol content in pork. The level of 42.09% inclusion of millet in the diet results in the highest rate thrombogenic meat.(AU)

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OBJECTIVE: To review and describe the current literature pertaining to the incidence, classification, severity, preventability, and impact of medication-related emergency department (ED) and hospital admissions in pediatric patients. STUDY DESIGN: A systematic search of PubMED, Embase, and Web of Science was performed using the following terms: drug toxicity, adverse drug event, medication error, emergency department, ambulatory care, and outpatient clinic. Additional articles were identified by a manual search of cited references. English language, full-reports of pediatric (≤18 years) patients that required an ED visit or hospital admission secondary to an adverse drug event (ADE) were included. RESULTS: We included 11 studies that reported medication-related ED visit or hospital admission in pediatric patients. Incidence of medication-related ED visits and hospital admissions ranged from 0.5%-3.3% and 0.16%-4.3%, respectively, of which 20.3%-66.7% were deemed preventable. Among ED visits, 5.1%-22.1% of patients were admitted to hospital, with a length of stay of 24-72 hours. The majority of ADEs were deemed moderate in severity. Types of ADEs included adverse drug reactions, allergic reactions, overdose, medication use with no indication, wrong drug prescribed, and patient not receiving a drug for an indication. Common causative agents included respiratory drugs, antimicrobials, central nervous system drugs, analgesics, hormones, cardiovascular drugs, and vaccines. CONCLUSION: Medication-related ED visits and hospital admissions are common in pediatric patients, many of which are preventable. These ADEs result in significant healthcare utilization.

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A asma brônquica é uma doença inflamatória crônica das vias aéreas inferiores que resulta da interação entre fatores genéticos e ambientais.Teve como objetivo estudar o polimorfismo Arg16Gly e Gln27Glu do Gene β2-ADR e a sensibilização fúngica associada ao controle e gravidade da asma. Trata-se de um estudo observacional analítico caso controle em portadores de asma, assistidos no “Programa de Assistência ao Paciente Asmático do Hospital Universitário Presidente Dutra” (PAPA-HUPD). Foram incluídos no estudo 83 pacientes com asma brônquica e 46 não asmáticos como controles. Os participantes coletaram duas amostra de 5ml de sangue, para genotipagem do gene β2AR-16 e β2AR-27 por PCR-RFLP e teste de sensibilização Elisa específico para fungos. Os dados de controle foram obtidos através do Teste de Controle da Asma (ACT) e os dados clínicos dos prontuários. As análises de polimorfismo não apresentaram associação com o estado de controle da asma para o gene β2-ADR-16 e β2-ADR-27. Entre asmáticos e não asmáticos foi observado diferença estatisticamente significante (p<0,05) com maior expressão do alelo Glu (74%) entre os não asmáticos. O homozigoto Glu/Glu também foi mais frequentes entre os não asmáticos, sugerindo que o alelo Glu-27 pode estar associado ao risco diminuído para asma. Quanto à sensibilização fúngica, não houve associação significante com os genótipos estudados. O estudo mostrou que, asmáticos graves são mais sensibilizados que não asmáticos e asmáticos moderados. Não houve diferença estatisticamente significante entre controle da asma e sensibilização fúngica, no entanto houve associação significativa com a gravidade. Associações isoladas entre sensibilização fúngica e asma, assim como entre polimorfismo e asma ficou evidente neste estudo...

Asthma is a chronic inflammatory disease of the lower airways, and is a result of the interaction between genetic and environmental factors. Aimed to study polymorphism and Arg16Gly Gln27Glu Gene β2-ADR and fungal sensitization associated with asthma severity and control. It is an observational, analytic case-control study involving asthmatic subjects of the Assistance Program to the Asthmatic Patient - APAP, in the Presidente Dutra University Hospital, Maranhão, Brazil. Eighty-three asthmatic patients and 46 non-asthmatic controls were included in the study. PCR-RFLP genotyping of the β2AR-16 and β2AR-27 genes, and fungal-specific enzyme-linked immunosorbent assay (ELISA) were made in two 5 ml blood samples collected from the participants. Control data were gathered from the Asthma Control Questionnaire (ACQ) and clinical data from the medical records. The analysis of the polymorphism has not demonstrated association between the asthma control status and the β2AR-16 and β2AR-27 genes. There was statistically significant difference (p < 0,05) between asthmatics and non-asthmatics, with higher expression (74%) of the Glu allele in non-asthmatic subjects. The Glu/Glu homozygote was also more frequent between non-asthmatics, and it suggests that the Glu-27 allele might be associated with a lower risk to develop asthma. Regarding fungal sensitization, there wasn't significant association with the studied genotypes. The study demonstrated that severe asthmatics are more sensitized than non-asthmatics and moderate asthmatics. There wasn't statistically significant difference between asthma control and fungal sensitization; nevertheless, there was significant association with the severity level. Isolated associations between fungal sensitization and asthma, as well as associations between polymorphisms and asthma were evident in this study...

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La hiperplasia prostática benigna, enfermedad común en hombres a partir de los 50 años de edad, consiste en el crecimiento benigno e incontrolado de la glándula prostática y produce diversos síntomas del tracto bajo urinario. Su agente causal multifactorial involucra fundamentalmente el incremento de la conversión de testosterona en dihidrotestosterona por acción de la 5 a-reductasa prostática, lo cual desencadena eventos que propician el incremento en el tamaño de la próstata (componente estático) y el aumento del tono del músculo liso de vejiga y próstata (componente dinámico) regulado por los adrenoreceptores (ADR)-a1. El tratamiento farmacológico de la hiperplasia prostática benigna incluye los inhibidores de la 5a-reductasa, antagonistas de ADR-a1, su terapia combinada y la fitoterapia. El objetivo del presente trabajo fue presentar los aspectos más relevantes de la farmacología de los fármacos utilizados en el tratamiento de la hiperplasia prostática benigna y brindar elementos de su eficacia, seguridad y tolerabilidad. Para ello, se realizó una reseña de los diferentes fármacos utilizados en el tratamiento de esta afección, los que fueron clasificados de acuerdo con su mecanismo de acción. Se incluyeron productos de origen natural como los extractos lipídicos del Serenoa repens y Pygeum africanum, así como el D-004, extracto lipídico de los frutos de la Roystonea regia, que ejerce efectos beneficiosos sobre los principales factores causales de la hiperplasia prostática benigna, ya que es un inhibidor de la 5 a-reductasa prostática, un antagonista de los ADR-a1, un inhibidor de la 5-lipooxigenasa y tiene acción antioxidante, lo que evidencia un mecanismo multifactorial. Los resultados hasta el presente indican que el D-004 es seguro y bien tolerado

Benign prostatic hyperplasia is a common disease in over 50 years-old men consisting in uncontrolled and benign growth of prostatic gland that leads to lower urinary tract symptoms. The etiology of benign prostatic hyperplasia is multifactoral involving the increased conversion of testosterone in dihydrotestosterone by the prostatic 5a-reductase action, which brought about events that encourage the prostate growth (static component) and the increase of the bladder and prostate smooth muscle tone (dynamic component) regulated by the a1 -adrenoceptors (ADR). The pharmacological treatment of the benign prostatic hyperplasia includes the prostatic 5a-reductase inhibitors, the a1-adrenoreceptor blockers, their combined therapy and the phytotherapy. This paper was aimed at presenting the most relevant aspects of the pharmacology of drugs used for treating the benign prostatic hyperplasia, and providing elements to analyze their efficacy, safety and tolerability. To this end, a review was made of the different drugs for the treatment of this pathology and they were grouped according to their mechanism of action. Natural products were included as lipid extracts from Serenoa repens and Pygeum africanum as well as D-004, a lipid extract from Roystonea regia fruits, with proved beneficial effects on the main etiological factors of benign prostatic hyperplasia. D-004 is a prostatic 5a-reductase inhibitor, an a1-adrenoceptor antagonist, a 5-lipooxygenase inhibitor and has antioxidant action, all of which reveals a multifactoral mechanism. The results achieved till now indicate that D-004 is a safe and well-tolerated product

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Considerando la necesidad de conocer los efectos de los medicamentos en nuestra población, el Instituto de Salud Pública, creó el Centro Nacional de Información de Medicamentos y Farmacovigilancia–CENIMEF, responsable de planificar, evaluar y desarrollar el Programa Nacional de Farmacovigilancia (FV), que fue aceptado en programa de la Organización Mundial de la Salud (OMS) en 1996. Adopta el sistema de notificación espontánea de RAM en una ficha tipo, pueden notificar todos los profesionales de la salud y utiliza las definiciones de la OMS sobre la materia. Se hace extensivo a todos los hospitales del país en 1998. Los resultados del Programa señalan un aumento continuo de las notificaciones de RAM, lo que se refleja internacionalmente en la publicación Uppsala Reports April 2006, que analiza estadísticamente la base de datos del the Uppsala Monitoring Centre de la OMS, mostrando que Cuba y Chile están entre los 20 países mejores notificadores del Programa de FV de la OMS, en número de casos correctos en el año 2005, por 100.000 habitantes. El desafío del Programa es mantener y aumentar la promoción de la FV para contar con una base de datos de RAM lo suficientemente grande, de modo que no se vea afectada por eventos puntuales, permita detectar riesgos en forma oportuna, lograr un uso racional de los medicamentos por los profesionales de la salud, introducir la FV en la malla curricular de pre-grado de las profesiones de la salud y crear conciencia respecto a que notificar una reacción adversa es su obligación moral y profesional.

National Drug Information and Pharmacovigilance Centre (CENIMEF) is part of the Public Health Institute, the official regulatory agency on medicines. Chilean Pharmacovigilance Programme was established in April 1995 and was accepted in the WHO Drug Monitoring Centre in March 1996. Is on a voluntary basis by a reporting form/card, reporters are all health care professionals. WHO causality terms and definitions are used for adverse drug reaction (ADR) evaluation. From 1998 CENIMEF has organized and dictated workshops on pharmacovigilance for hospitals health care professionals all over the country. The challenge is keep improving the promotion of ADR reporting from health care professionals and include the pre-grade Pharmacovigilance teaching.

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