Pharmacovigilance: More Than Ever, an Overall Responsibility

Dainesi, Sonia Mansoldo

doi:10.1590/s1807-59322005000400002

Cited by 8 publications

(9 citation statements)

References 11 publications

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“…It is likely that this is the first study that addresses this subject, and it will certainly support the identification of different intervention areas. A few reports have discussed this problem under other circunstances 11,12 The prevalence of the NSAIDs use in the sample was 34.0% in the investigated period. Concerning the methodological differences, a study of the use of minor analgesics and NSAIDs by people over 18 in Sweden found a prevalence of 35.0%.…”

Section: Discussionmentioning

confidence: 91%

The Use of Nonsteroidal Anti-Inflammatory Drugs and the Occurrence of Gastric Lesions Among Patients Undergoing Upper Endoscopy in a University Hospital in Brazil

Ribeiro

Sevalho

César

2006

Clinics

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METHODS:The cross-sectional methodological approach was used; 533 patients aged 17 or older were interviewed, between June and December, 2000. Data were submitted to bivariate and multivariate analyses. RESULTS: More than two thirds of the interviewed population reported the use of nonsteroidal anti-inflammatory drugs in a period of 1 month before the upper endoscopy. The most used nonsteroidal anti-inflammatory drugs were acetylsalicylic acid and diclofenac. An association was clearly shown between the use of these drugs and the occurrence of the studied lesions, with the latter attaining significance. There was also a significant association between nonsteroidal anti-inflammatory drugs use for a period greater than 15 days and the occurrence of the gastric lesions, with a higher odds ratio than for the other comparisons. CONCLUSIONS:The results suggest that nonsteroidal anti-inflammatory drugs have a significant association with the occurrence of the gastric lesions and point to the need of further study of this issue in Brazil.

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Section: Discussionmentioning

confidence: 91%

The Use of Nonsteroidal Anti-Inflammatory Drugs and the Occurrence of Gastric Lesions Among Patients Undergoing Upper Endoscopy in a University Hospital in Brazil

Ribeiro

Sevalho

César

2006

Clinics

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“…This is because some clinical situations will never be reproducible in the clinical trial setting, and some questions can only be answered through real-world testing. 5 The completeness of safety reporting in randomized trials must also deserve a close look. An article published in 2001 evaluated the quality and quantity of drug safety reporting in 192 randomized drug trials in 7 different areas of drug therapy.…”

Section: Safety Firstmentioning

confidence: 99%

Current clinical research environment: focus on psychiatry

Dainesi

Elkis

2007

Rev. Bras. Psiquiatr.

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A b s t r a c tThe introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/ scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.Descriptors: Clinical research; Regulatory approval; Conflict of interest; Placebo; Clinical trial registration Resumo A introdução de diretrizes internacionais de Boas Práticas Clínicas, em 1996, imediatamente seguida pela publicação da Resolução do Conselho Nacional de Saúde 196/96, abriu uma grande oportunidade para a participação de centros de pesquisa brasileiros em estudos internacionais. Tais estudos devem ser estritamente monitorados, a fim de assegurar a adesão às legislações, assim como garantir a segurança dos pacientes envolvidos. A fim de evitar possíveis conflitos de interesse durante e após o estudo, todos os aspectos relacionados devem ser claramente definidos previamente entre o pesquisador, o patrocinador e a instituição. Aspectos operacionais, tais como tempo para aprovação regulatória do estudo, métodos de recrutamento e retenção de pacientes e a logística em geral, também são importantes. Em 2005, a Rede Nacional de Pesquisa Clínica foi criada no Brasil, somando a experiência de vários centros de pesquisa ligados a hospitais de ensino. Seu objetivo é reforçar a atividade de pesquisa clínica no país, com práticas atualizadas e adequado treinamento técnico-científico. O desenvolvimento de protocolos de pesquisa que foquem as prioridades de saúde do país é outro objetivo fundamental da Rede. Aspectos gerais da pesquisa clínica e algumas particularidades em Psiquiatria são discutidos no artigo. O objetivo final de todo o trabalho nesta área de pesquisa é, sem dúvida, a busca de melhores condições de saúde e qualidade de vida da população.

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“…The availability of independent and valid pharmacovigilance data is essential because clinical trials with medicinal products are limited in scope and do not necessarily reveal all adverse effects of a product (Dainesi, 2005). The lead time for pre-marketing tests is sometimes insufficient for adverse reactions to become manifest and drugs may also be administered to populations or for indications for which they have not been previously tested (Menard et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

Challenges of Pharmacovigilance in Brazil

Oliveira¹,

Gubert-Matos²,

Tutes³

et al. 2020

GJHS

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Pharmacovigilance encompasses the detection, evaluation, understanding, and prevention of adverse effects or any other drug-related problems. Knowledge of real and independent pharmacovigilance data is essential because clinical trials with medicinal products are limited and do not reveal all adverse effects of a product. The spontaneous notification system is one of the main tools used in pharmacovigilance. However, important remaining challenges for health professionals are the accurate recognition of adverse drug reactions and reporting routinely and systematically during their work. Once low notification rates make it harder to detect and monitor potential safety issues, it is needed risk assessment, and regulatory actions to safeguard patient safety. The objective of this study is to present the challenges of pharmacovigilance in Brazil. The implementation of computerized active search tools significantly improves the identification of possible adverse drug effects. Effective pharmacovigilance is crucial to ensure the safety and integrity of healthcare systems, to avoid lengthy hospital stays and to optimize healthcare spending. However, pharmacovigilance tools remain underused, undervalued, or even unknown in Brazil.

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Pharmacovigilance: More Than Ever, an Overall Responsibility

Cited by 8 publications

References 11 publications

The Use of Nonsteroidal Anti-Inflammatory Drugs and the Occurrence of Gastric Lesions Among Patients Undergoing Upper Endoscopy in a University Hospital in Brazil

The Use of Nonsteroidal Anti-Inflammatory Drugs and the Occurrence of Gastric Lesions Among Patients Undergoing Upper Endoscopy in a University Hospital in Brazil

Current clinical research environment: focus on psychiatry

Challenges of Pharmacovigilance in Brazil

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