Background: The use of herbal medicines in children and adolescents is continually on the rise. Contrary to popular belief, herbal products (HPs) are not always a safe alternative to conventional drugs and can cause a variety of adverse events such as severe and fatal allergic reactions. In regards to herbal medicine use in children, a recently published systematic review that searched PubMed, Embase, PsycINFO and AMED included 58 studies from 19 countries and found overall herbal lifetime use to be between 0.8-85.5 % and 2.2-8.9 % for current use. Unlike most synthetically produced drugs, the adverse event profile of such "natural" preparations in children has rarely been studied. To this date, effective systems that monitor adverse drug events (ADRs) and long term side effects associated with HPs are either non-existent or still developing in many countries. Due to insufficient and inconsistent ADR reporting, little is known about the ADR spectrum of herbals in pediatric patients. Awareness of the potential of HPs to cause ADRs, particularly in children and adolescents, needs to be increased and reporting to national pharmacovigilance centers (PVCs) reinforced. Objectives: This project analyzed the worldwide adverse event data for herbal drugs related to hypersensitivity reactions as recorded in...

>Magister Scientiae - MSc / Pharmacovigilance involves the management of sub-standard drugs, medication errors, ―off-licence‖ drugs, abuse and misuse, lack of efficacy, poisoning, adverse drug reactions (ADRs), drug interactions, expired stock destruction and drug-related mortality. Regulators and the pharmaceutical industry rely on healthcare professionals, including pharmacists, to report ADRs. The majority of pharmacists work in retail community pharmacies and they are often the first point of contact when ADRs are experienced, since self-medication, misuse of over-the-counter (OTC) medicines, vitamins and traditional medicines, increase the probability of ADRs. In South Africa (SA) ADRs have been known to cause adult deaths and hospital admissions. In first-world communities, pharmacovigilance is more common among pharmacists, however in South Africa, ADR reporting compares poorly. Studies in the public sector have found that pharmacists lack pharmacovigilance knowledge and underreport ADRs. In comparison the pharmacovigilance knowledge and practice patterns among retail community pharmacists is poorly documented.

Os eventos adversos, devido à grande ocorrência, são considerados um importante problema de saúde pública além de elevarem os custos com a saúde. Dessa forma, existe a necessidade de um sistema eficiente de farmacovigilância para prevení-los sendo a monitorização intensiva uma excelente estratégia para se alcançar este objetivo, pois permite a identificação e o conhecimento dos eventos adversos, além de medir sua incidência e melhorar as notificações voluntárias. Por esta razão, o presente estudo propôs a avaliação deste método em eventos adversos relacionados ao antimicrobiano vancomicina. As informações coletadas, provenientes dos bancos de dados e dos prontuários do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP-USP), são referentes aos pacientes internados no hospital em tratamento com vancomicina no período de 01/09/2008 a 31/08/2009. Identificou-se 1719 tratamentos de 1302 usuários. Destes tratamentos, 521 foram excluídos por serem profiláticos. A idade média dos 1198 pacientes monitorados foi de 39,33 (± 27,66) anos e 58,68% pertenciam ao gênero masculino. Os diagnósticos infecciosos prevalentes para o tratamento com vancomicina foram pneumonia (18,95%), sepse (11,19%) e infecção relacionada a cateter (10,27%) com período médio de duração do tratamento de 11,47 (±7,79) dias geralmente na dose de 2000 mg ao dia (35,98%). Foram identificados indicadores de eventos adversos em 85,81% dos tratamentos, sendo a incidência de eventos adversos de 7,18%. A incidência de reações adversas (RAM) foi de 5,93% e de erros de medicação 2,57%. A causalidade das RAM foi prevalentemente provável (49,29%) e a gravidade moderada (54,93%). As RAM foram essencialmente do tipo B (81,69%) e os erros de medicação relativos à prescrição (87,10%). A comparação entre os grupos controle e estudo não apresentou diferenças significativas, demonstrando a necessidade de monitorização de todos os parâmetros relacionados a eventos adversos com a vancomicina. Dessa forma, fica evidente a importância da monitorização intensiva e da presença dos farmacêuticos clínicos na equipe de saúde para melhorar a eficiência da farmacovigilância, como demonstrado por este estudo. Diante dos resultados, conclui-se que o método de monitorização intensiva utilizando base de dados e prontuários, além da participação de um farmacêutico clínico, promove o conhecimento, a avaliação e a compreensão dos eventos adversos presentes em uma instituição, permitindo a esquematização de estratégias para a sua prevenção. / Adverse events, due to the high occurrence, are considered an important public health problem in addition to driving up health care costs. There is therefore a need for an efficient system of pharmacovigilance to prevent them being the intensive monitoring an excellent strategy for achieving this goal because it allows the identification and knowledge of the adverse events, in addition to measuring its incidence and improve spontaneous reports. For this reason, the present study evaluated this method in adverse events related to antibiotic vancomycin. The informations collected from databases and records of the Hospital of the Medical School of Ribeirão Preto-SP (USP-HCFMRP), refers to hospital patients treated with vancomycin for the period 01/09/2008 to 31/08/2009. We evaluated 1719 treatments in 1302 users, of which 521 were excluded because they were prophylactic. The average age of 1198 patients was 39.33 years (±27.66) and 58.68% were males. Prevalent infectious diagnoses for treatment with vancomycin were pneumonia (18.95%), sepsis (11.19%) and catheter-related infection (10.27%) with mean duration of treatment of 11.47 days (± 7.79) usually at a dose of 2000 mg daily (35.98%). We identified indicators of adverse events in 85.81% of treatments, and the incidence of adverse events was 7.18%. The adverse drug reactions (ADR) incidence was 5.93% and 2.57% of medication errors. The causality of ADR was probable (49.29%) and severity was moderate (54.93%). The ADR were mainly of type B (81.69%) and medication errors related to prescription (87.10%). Comparisons between the study and control groups showed no significant differences, demonstrating the need for monitoring of all parameters related to adverse events with vancomycin. Thus, it is clear the importance of the intensive monitoring and the presence of clinical pharmacists in the health team to improve the efficiency of pharmacovigilance, as demonstrated by this study. Before the results, we conclude that the method of intensive monitoring using the database and records, plus the involvement of a clinical pharmacist, promotes knowledge, assessment and understanding of adverse events presents in an institution, enabling the layout of strategies to prevention.

OBJETIVOS: Os objetivos da presente pesquisa são (i) identificar os fármacos prescritos aos pacientes idosos matriculados em ambulatório didático de geriatria; (ii) estudo da possibilidade de ocorrência de interações medicamentosas nos pacientes ambulatoriais; e (iii) proposta de modelo de rotina de intervenção preventiva para evitar interações medicamentosas prejudiciais de significância clínica antes do aviamento da receita, respeitando a rotina e os recursos disponíveis em um ambulatório de geriatria. CASUÍSTICA e MÉTODO: Ensaio aberto observacional descritivo prospectivo realizado no Ambulatório Didático de Geriatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, por meio da análise dos prontuários dos pacientes, acima de 60 anos de idade, na hora da consulta. RESULTADO: Neste Ambulatório foram feitos 380 atendimentos para 124 pacientes, prescrito 211 fármacos e 7 associações fixas, havendo a polimedicação e apenas 8 receitas continham um medicamento. Foram encontradas 65,3% receitas com interações medicamentosas e destas, 63,6% no sexo feminino e 70,1% no sexo masculino. CONCLUSÃO: Houve a identificação dos fármacos prescritos para os idosos, onde a possibilidade de ocorrência de interações medicamentosas foi alta. A proposta de modelo de rotina de intervenção para evitar interações medicamentosas foi aprovada. / OBJECTIVES: The objectives of the research are: (i) identify the drugs prescribed to the elderly enrolled in didatic ambulatory of geriatry; (ii) study of the possibility of ocorrence of drug-drug interactions in these outpatients; e (iii) propose a pattern of routine of intervention to avoid drug-drug interactions harmful of clinical significance before the prescription, respecting the routine, and the resources available in a ambulatory of geriatry. CASUISTIC and METHOD: A prospective descritive observational open assay realized in the Didatic Ambulatory of Geriatry at the Hospital of the Clinics of the Faculty of Medicine of the University of San Paul, by means of the analysis of the promptuary of the outpatients, older than 60 years of age, during the consultation. RESULTS: In these Ambulatory were done 380 attendances for 124 outpatients, prescribed 211 drugs, and 7 fixed association, having polypharmacy and just 8 recipes contained one drug. There were 65,3% recipes with drug-drug interactions, and of these, 63,6% in female, and 70,1% in male. CONCLUSION: The drugs prescribed to the outpatients were identified, and the possibility of ocorrence of drug-drug interactions was high. The purpose of pattern of routine of intervention to avoid the drug-drug interactions was approved.

nÃo hà / A farmacovigilÃncia à a ciÃncia relativa à detecÃÃo, avaliaÃÃo, compreensÃo e prevenÃÃo de reaÃÃes adversas ou quaisquer outros possÃveis problemas relacionados a medicamentos. No Brasil, a farmacovigilÃncia encontra-se em desenvolvimento. Ainda nÃo està completamente disseminada a cultura da notificaÃÃo espontÃnea, principalmente na oncologia, onde a ocorrÃncia de reaÃÃo adversa passa muitas vezes despercebida por ser considerada como um evento esperado, e, portanto, sem importÃncia significativa. Este estudo avaliou as aÃÃes de farmacovigilÃncia desenvolvidas numa instituiÃÃo hospitalar da cidade de Teresina-PI, atravÃs da monitorizaÃÃo de pacientes portadores de cÃncer de mama submetidos à terapia antineoplÃsica com o regime de combinaÃÃo FEC. Para isso, foi realizada uma investigaÃÃo baseada em uma revisÃo dos prontuÃrios desses pacientes para detectar o registro: de reaÃÃes adversas decorrentes da quimioterapia antineoplÃsica vigente e da distinÃÃo das mesmas, segundo os graus de severidade estabelecidos pelo National Cancer Institute (NCI); de intercorrÃncias clÃnicas devido à RAM ocorridas durante a terapia e de possÃveis alteraÃÃes no plano do tratamento protocolado (atrasos na realizaÃÃo dos ciclos de quimioterapia ou suspensÃo temporÃria da terapia, reduÃÃes das doses preconizadas) relacionadas com reaÃÃes adversas. De todas as reaÃÃes adversas observadas durante a investigaÃÃo, 2,07% foram registradas em nÃo conformidade com a terminologia qualitativa adotada pelo NCI e 15,06% nÃo foram graduadas quanto à severidade; alÃm disso, 100% das RAMs nÃo foram notificadas à autoridade sanitÃria competente (ANVISA) e nÃo existe um banco de dados institucional com essas reaÃÃes adversas. Foram ainda identificadas 17 (70,83%) intervenÃÃes clÃnicas devido à RAM realizadas em nÃvel ambulatorial e 7 (29,17%) intervenÃÃes clÃnicas devido à RAM que exigiram a hospitalizaÃÃo do paciente; atrasos ou suspensÃo temporÃria da realizaÃÃo dos ciclos de quimioterapia, com 8,70% decorrentes de causas clÃnicas, entre estas reaÃÃes adversas; e 8 (5,84%) casos de reduÃÃo das doses protocoladas devido à presenÃa e severidade de reaÃÃes adversas. Conclui-se que as aÃÃes de farmacovigilÃncia da instituiÃÃo hospitalar ainda sÃo incipientes, com falhas organizacionais que diminuem a confiabilidade das informaÃÃes registradas; alÃm disso, houve a comprovaÃÃo da importÃncia da farmacovigilÃncia em oncologia, onde a toxicidade dos fÃrmacos utilizados pode ser considerada fator limitante primÃrio para uma prÃtica terapÃutica ideal. / Pharmacovigilance is the science concerning the detection, assessment, understanding and prevention of adverse reactions or any other possible drug-related problems. In Brazil, pharmacovigilance is in the developmental stage. The culture of spontaneous reporting not yet fully spread, especially in oncology, where the occurrence of adverse reaction is often unnoticed because it is considered as an expected event, and therefore immaterial. This study evaluated the pharmacovigilance actions carried out at a hospital in the city of Teresina, PI, through the monitoring of patients with breast cancer undergoing anticancer therapy with the FEC protocol. An investigation was undertaken based on a review of the medical records of these patients to detect the registry: of adverse reactions resulting from cancer chemotherapy and the distinction of them according to the degrees of severity established by the National Cancer Institute (NCI); of clinical interventions due to ADR that occurred during therapy and possible changes in the plan of treatment protocol (delays in the achievement of cycles of chemotherapy or temporary suspension of therapy, reductions in the recommended doses) related with adverse reactions. Of all the adverse reactions observed during the investigation, 2,07% were not registered in accordance with the terminology adopted by NCI qualitative and 15,06% were not graded as to severity. In addition, 100% of ADRs were not reported to the recognized health authority (ANVISA) and there is not an institutional database with these adverse reactions. There were also 17 identified (70,83%) clinical interventions due to ADR performed on an outpatient basid and 7 (29,17%) clinical interventions due to ADR that required hospitalization of the patient; delays or temporary suspension of achievement of cycles of chemotherapy with 8,70% due to clinical causes among these adverse reactions; and 8 (5,84%) cases of dose reduction due to the presence and severity of adverse reactions. It is concluded that the pharmacovigilance actions of the hospital are still preliminary, with organizational flaws that reduce the reliability of the information recorded. In addition, there was evidence of the importance of pharmacovigilance in oncology, where the toxicity of drugs used may be considered a limiting factor necessary for an ideal therapeutic practice.

OBJETIVOS: Os objetivos da presente pesquisa são (i) identificar os fármacos prescritos aos pacientes idosos matriculados em ambulatório didático de geriatria; (ii) estudo da possibilidade de ocorrência de interações medicamentosas nos pacientes ambulatoriais; e (iii) proposta de modelo de rotina de intervenção preventiva para evitar interações medicamentosas prejudiciais de significância clínica antes do aviamento da receita, respeitando a rotina e os recursos disponíveis em um ambulatório de geriatria. CASUÍSTICA e MÉTODO: Ensaio aberto observacional descritivo prospectivo realizado no Ambulatório Didático de Geriatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, por meio da análise dos prontuários dos pacientes, acima de 60 anos de idade, na hora da consulta. RESULTADO: Neste Ambulatório foram feitos 380 atendimentos para 124 pacientes, prescrito 211 fármacos e 7 associações fixas, havendo a polimedicação e apenas 8 receitas continham um medicamento. Foram encontradas 65,3% receitas com interações medicamentosas e destas, 63,6% no sexo feminino e 70,1% no sexo masculino. CONCLUSÃO: Houve a identificação dos fármacos prescritos para os idosos, onde a possibilidade de ocorrência de interações medicamentosas foi alta. A proposta de modelo de rotina de intervenção para evitar interações medicamentosas foi aprovada. / OBJECTIVES: The objectives of the research are: (i) identify the drugs prescribed to the elderly enrolled in didatic ambulatory of geriatry; (ii) study of the possibility of ocorrence of drug-drug interactions in these outpatients; e (iii) propose a pattern of routine of intervention to avoid drug-drug interactions harmful of clinical significance before the prescription, respecting the routine, and the resources available in a ambulatory of geriatry. CASUISTIC and METHOD: A prospective descritive observational open assay realized in the Didatic Ambulatory of Geriatry at the Hospital of the Clinics of the Faculty of Medicine of the University of San Paul, by means of the analysis of the promptuary of the outpatients, older than 60 years of age, during the consultation. RESULTS: In these Ambulatory were done 380 attendances for 124 outpatients, prescribed 211 drugs, and 7 fixed association, having polypharmacy and just 8 recipes contained one drug. There were 65,3% recipes with drug-drug interactions, and of these, 63,6% in female, and 70,1% in male. CONCLUSION: The drugs prescribed to the outpatients were identified, and the possibility of ocorrence of drug-drug interactions was high. The purpose of pattern of routine of intervention to avoid the drug-drug interactions was approved.

Reproduction de : Thèse d'exercice : Médecine : Nancy 1 : 2005. / Titre provenant de l'écran-titre.

Objetivo: A segurança no uso de medicamentos tem constituído importante indicador na assistência prestada em nível hospitalar. Para tanto, este estudo propõe avaliar o impacto clínico e econômico da implantação de um programa de farmacovigilância (PFV) intensiva em um hospital geral, através do monitoramento de reações adversas à vancomicina. Delineamento: Coorte. Amostra: 689 pacientes constituíram a amostra, sendo 151 acompanhados antes do PFV e 538 depois PFV. Principais Medidas: Ocorrência de reação adversa a medicamento (RAM) baseado no algoritmo de Naranjo e estimativa de custos hospitalares. Resultados: Houve redução na ocorrência de RAM após a implementação do PFV (19,9% vs. 13,4%; P < 0,05). O PFV foi um fator independente relacionado a uma diminuição da RAM, especialmente naqueles pacientes em uso de vancomicina inferior a 12 dias e em pacientes pediátricos, com um NNT de 15. Não houve diferença nos custos antes e após o programa, entretanto aqueles pacientes com RAM apresentaram um custo adicional de R$ 12.676,47, sendo que a atividade de vigilância representou um custo estimado de R$ 19,23 por caso acompanhado. Conclusão: Um PFV implementado ativamente, com busca e monitoramento de RAM, e com estratégias pró-ativas para minimizá-las, tem impacto positivo nos resultados clínicos e econômicos hospitalares. / Proper drug safety monitoring is a central aspect and an important quality indicator of hospital care. This study was carried to evaluate the clinical and economic impact of the implementation of an Intensive Phamacovigilance Program (IPP) in a general hospital. We selected the occurrence of Adverse Drug Reactions (ADR) related to the antimicrobial drug vancomycin to evaluate the program. Study design: Cohort. Methods: 689 patients were included, 151 of them were followed before the implementation of the IPP and 538 patients were followed after this. Main determinants: The occurrence of ADR was measured and classified based in the ‘Naranjo’ algorithm. All the hospital costs were estimated using the register of the financial department of the hospital. Results: There was a significant reduction in the ADR rates after the implementation of the IPP (19.9% versus 13.4%; P-value<0.05). The IPP was an independent factor for the reduction of the ADR rates; it was more important in those that used vancomycin for a period of time ≤ 12 days, and in pediatric patients, in this case the number needed to treat (NNT) estimated was 15. There was no difference between the costs comparing the period before and after the IPP implementation, but those patients that has ADR represented an additional cost of R$ 12,676.47. The cost of the IPP program was R$ 19.23 per individual case followed. Conclusion: The implementation of an IPP that monitored ADR and the strategies that were simultaneously developed to minimize them, had a positive impact in the clinical and economic aspects analized.

Charles University, Faculty of Pharmacy in Hradci Králové Department of: Social and Clinical Pharmacy Author: Roman Vorel Supervisor: PharmDr. Jan Kostřiba, Ph.D. Title of Diploma Thesis: Pharmacovigilance of active substance zolpidem Introduction: Drug safety became very important topic in the second half of 20th century, even beyond pharmacy. It relates to increasing impact on testing of drugs before launch onto the market, but also following monitoring, so the benefit and risk ratio of drug can be determined. Pharmacovigilance takes care of monitoring of drug use risk. Zolpidem is active substance from class hypnotics and it is used for short-term treatment of insomnia. Most professionals recommend zolpidem as first line treatment of acute insomnia. That is why it can be considered as one of the most important hypnotic drugs. Objectives: The aim of this diploma thesis is to analyze spontaneous reports for adverse drug reaction for zolpidem from years 2004 to 2017. The thesis focus on reports from the Czech republic but also from the whole world. The information in SPC of medicinal products containing zolpidem which were distributed from 2004 to 2017 are compared. Methods: Following data from years 2004 to 2017 were used: 1) List of spontaneous reports for adverse reaction from the Czech republic...

Resumo: Reações Adversas a Medicamentos (RAM) são um importante problema de saúde pública, pois reduzem a qualidade de vida do paciente e geram gastos desnecessários aos hospitais. Por isso, o presente estudo estimou a prevalência de internações hospitalares por possível RAM, identificou o perfil demográfico dos pacientes acometidos, bem como os fármacos e as possíveis RAM mais frequentemente relacionadas com as internações hospitalares. Para tanto, realizou-se um estudo observacional e transversal na clínica médica de um hospital de ensino, entre os meses de agosto a dezembro de 2008. Os pacientes foram entrevistados sobre os sintomas/queixas/motivos de internação que os levaram ao hospital e quais medicamentos utilizaram nos 15 dias prévios à internação. Durante o período do estudo, observou-se que a internação hospitalar estava relacionada com possível RAM em 115 pacientes (46,4%), sendo a maioria mulheres e não-idosos. Os fármacos mais frequentemente relacionados com a internação foram os que atuam nos sistemas: cardiovascular (48,7%), digestório (22,9%) e nervoso central (14,1%). Quanto ao tipo de receituário dos medicamentos responsáveis por RAM, 90,9% eram sob prescrição, sendo que 9,4% eram sujeitos a controle especial e 9,1% eram isentos de prescrição. Dos medicamentos responsáveis pelas internações, 58% pertenciam à lista RENAME. Em relação aos idosos, 43,9% utilizaram medicamentos impróprios, os quais foram possivelmente responsáveis pela internação de 29,2% pacientes. As manifestações clínicas das RAM mais comuns foram: do aparelho digestório (23,0%), dos aparelhos respiratório (20,2%) e circulatório (14,6%), além de sintomas, sinais e achados anormais de exames clínicos e laboratoriais (20,2%). Apenas a polimedicação foi detectada como fator de risco para internações por possível RAM. Estudos farmacoepidemiológicos como este... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract : Adverse Drug Reaction (ADR) is an important public health concern, because they decrease the patient's quality of life and raise the unnecessary expenditure for the hospital. The purpose of this study was to: 1) assess the prevalence of ADR-related admission; 2) identify the demographic characteristics of the patients with ADR; 3) identify the main drugs and the ADR more often associated with hospitalization. A cross-sectional observational study was performed. It was conducted in an internal medicine ward in a teaching hospital and the data was collected from August 2008 to December 2008. The patients were interviewed about their symptoms, complaints, and causes of hospitalization, which were responsible to the hospital admission and what were the drugs used 15 days prior the hospitalization. During the period of the study, it was observed ADR-related admission in 115 (46.4%) patients; the majority was woman and no-elderly. Medications that were commonly involved in these cases were those acting on the cardiovascular (48.7%), gastrointestinal (22.9%) and nervous system (14.1%). Regarding the type of prescription medicines, 90.6% were under prescription, of these 9.4% still were subjected to special control, and 9.1% were non-prescription drugs. 58.0% medicines ADR-related admission belonged to RENAME's list. Considering the elderly people, 43.9% of them used inappropriate drugs, which were possibly responsible for hospitalization in 29.2% patients. The clinical manifestations of RAM most commonly associated with the hospitalization were: gastrointestinal system (23.0%), abnormal findings in clinical and laboratory tests (20.2%), respiratory system (20.2%) and circulatory system (14.6%). Only polipharmacy was detected as a risk factor for ADR-related admission. The present pharmacoepidemiological study shows the need of patient's therapeutic monitoring in the first... (Complete abstract click electronic access below) / Orientador: Cleópatra da Silva Planeta / Coorientador: Patrícia de Carvalho Mastroianni / Banca: Cleópatra da Silva Planeta / Banca: Regina Célia Garcia de Andrade / Banca: Leonor de Castro Monteiro Loffredo / Mestre