RESUMO
Regulatory authorities have a crucial role in communicating about the vaccines they license. In terms of content and timing, their communication to the public is usually driven by data on quality, safety and efficacy. However, concerns over safety and vaccine hesitancy have emerged in some communities in various countries, and this demands a new approach to communication, starting with listening to the public debate. Reviewing communication research findings, coming in particular from the cognitive, decision-making and media sciences, constitutes one mechanism of listening and has led the European Union (EU) regulatory network to developing guidance about which common concerns and information needs of the public to address through proactive and prepared communication. The guidance has been welcomed by EU and international fora. The current article summarizes the recommendations and shares the underlying research findings, as well as a proof of concept that communication research can be valuable for regulators. It is critical that regulators integrate the communication process with product risk assessment in the framework of pharmacovigilance, to ensure that public concerns are addressed in the assessments and that information about evidence and uncertainty relating to safety is provided to the public and vaccination policy makers in a specific, clear and accurate manner. Additionally, information from regulatory authorities should support healthcare professionals in their communication with patients. Meeting the information interests of the public is the principal prerequisite for informed decisions as well as safe and effective use of vaccines and medicines overall. This is also fundamental for trust in the authorities' commitment to patient and population health.
Assuntos
Participação da Comunidade , Tomada de Decisões , Disseminação de Informação , Vacinação/legislação & jurisprudência , Comunicação , União Europeia , Guias como Assunto , Pessoal de Saúde , Humanos , Vacinação/efeitos adversos , Vacinação/métodos , Vacinas/administração & dosagem , Vacinas/efeitos adversosRESUMO
Diffuse sclerosing osteomyelitis of the mandible is now considered a local manifestation of SAPHO syndrome. This rare condition is thought to be of auto-inflammatory origin. The myriad of treatments shown in the literature, are basically empirical and reflect its unknown origin. We present a clinical case of refractory DSO treated with an anti-TNF drug (etanercept) with complete clinical remission. We advise against radical surgery and an interdisciplinary approach is recommended. A systematic literature review was also conducted.