Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of Sao Paulo, Brazil

Oliveira, Danise Senna; Lara, Amanda Nazareth; Luíz, André; Miyaji, Karina Takesaki; Sartori, Ana Marli Christovam; Lopes, Marta Heloísa

doi:10.1590/0037-8682-1265-2013

Cited by 3 publications

(3 citation statements)

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“…To further develop pharmacovigilance capabilities, Europe has initiated an online platform called European Union Adverse Drug Reactions (EU-DR). The aim is to facilitate data access, data management, and data search to enable more in-depth examinations of ADR risks ( Oliveira et al, 2013 ). The Netherlands, Denmark, Italy, and France have also developed online reporting systems ( Herxheimer et al, 2010 ).…”

Section: Use Of Ehealth Tools To Facilitate Patient Participation In mentioning

confidence: 99%

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance

2016

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In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e., Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects). This article describes these advances and highlights their respective contributions.

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Section: Use Of Ehealth Tools To Facilitate Patient Participation In mentioning

confidence: 99%

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance

2016

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“…Some CRIE have developed studies in specific populations immunizations and adverse events following immunizaiton 3 , 6 , 10 - 12 , 17 , 18 , 20 - 23 . The CRIE that comprise the two most well-structured profiles could further develop teaching and research activities, counting on greater support and encouragement of the SES and the Ministry of Health/PNI.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Reference Centers for Special Immunobiologicals implementation

2016

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OBJECTIVE To describe the Reference Centers for Special Immunobiologicals and evaluate their implementation considering formal regulations.METHODS We conducted a program evaluation, of evaluative research type. From August 2011 to January 2012, a questionnaire was applied to the 42 Reference Centers for Special Immunobiologicals existing in the Country, approaching the structure, human resources, and developed activities dimensions. We conducted a descriptive analysis of data and used a clustering for binary data with the squared Euclidean distance, by the farthest neighbor method, to aggregate services with similar features.RESULTS We observed great diversity among the services in the three dimensions. The clustering resulted in five service profiles, named according to their characteristics. 1) Best structure: 12 Reference Centers for Special Immunobiologicals with the highest proportion of services with the minimum of rooms recommended, purpose-built vaccine refrigerators, preventive maintenance of the cold chain, and oxygen source. 2) Immunobiologicals distributor: six Reference Centers for Special Immunobiologicals that distributed more than applied immunogens; no doctor present for more than half of the working hours and no purpose-built vaccine refrigerators . 3) Incipient implementation: five Reference Centers for Special Immunobiologicals with inadequate structure, such as absence of purpose-built vaccine refrigerators, preventive maintenance of the cold chain and oxygen source; none had computer. 4) Vaccination rooms: 13 Reference Centers for Special Immunobiologicals, everyone did routine immunization, most participated in vaccination campaigns. 5) Teaching and research: six services, all inserted into teaching hospitals, developed researches and received trainees; most had doctors in more than half of the working hours.CONCLUSIONS The evaluation of the Reference Centers for Special Immunobiologicals implementation was based on the profiles found and considered the official regulations: services categorized as “better structure” and “teaching and research” were considered implemented; “immunobiologicals distributor” and “vaccination room” services, partially implemented, and the ones with the “incipient implementation” profile, not implemented. The results of this evaluation can contribute to the reformulation of the services, considering the current context.

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“…Uma parte deles apresenta relatos de casos de eventos adversos raros [59][60][61][62][63][64][65][66] temporalmente associados à vacinação contra o subtipo pandêmico de 2009, tais como casos de Síndrome de Guillain-Barré, narcolepsia, paralisia oculomotora e rabdomiólise. Há também estudos transversais e de coorte, que incluíram os eventos adversos na investigação de razões para a não vacinação [67][68][69] e estudos em clientelas específicas, [70][71][72][73][74][75] além de estudos realizados entre profissionais de saúde 76 e indivíduos de 60 anos ou mais. 77,78 Discussão O propósito desta revisão foi buscar na literatura científica a resposta à pergunta se a estratégia brasileira de vacinação contra influenza vem logrando o seu objetivo de "reduzir a mortalidade, as complicações e as internações decorrentes das infecções pelo vírus da influenza, na população alvo".…”

Section: Figura 4 -Estudos De Efetividade E Cobertura Vacinal Da Vaci...unclassified