Wybrane elementy informowania o ryzykach związanych z farmakoterapią
Selected elements of communication about pharmacotherapy related risks

Author(s): Dagmara Mirowska-Guzel, Magdalena Niedzielko, Marcin Kruk
Subject(s): Media studies, Communication studies, Theory of Communication, ICT Information and Communications Technologies
Published by: Wydawnictwa Uniwersytetu Warszawskiego
Keywords: adverse events; pharmacovigilance; pharmacotherapy; summary of product characteristic; patient’s leaflet; black triangle; risk management plan
Summary/Abstract: The risks associated with the occurrence of adverse reactions are inseparable elements of pharmacotherapy. When a drug receives marketing authorization, the knowledge about its safety is always incomplete and needs constant improvement while the medicinal product is already on the market. This requires appropriate systems of control and monitoring and ensuring effective communication routes between patients, healthcare professionals, pharmaceutical companies employees and representatives of national and international organizations responsible for the supervision of medicines safety. The chapter discusses the role of the most important documents in the field of pharmacovigilance. These include: the summary of product characteristics with a risk management plan, patient’s information leaflet, safety communications, periodic safety update reports and communications from the Chief Pharmaceutical Inspectorate. Raising awareness of the need to report adverse drug reactions and promoting knowledge about the sources of most up to date information on their occurrence and prevention poses a major challenge for those responsible for and involved in the education of medical staff.

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