The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance

• Published in: Drug safety Vol. 38; no. 7; pp. 621 - 627
• Main Authors: Bahri, Priya, Dodoo, Alexander N., Edwards, Brian D., Edwards, I. Ralph, Fermont, Irene, Hagemann, Ulrich, Hartigan-Go, Kenneth, Hugman, Bruce, Mol, Peter G.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01-07-2015; Springer Nature B.V
• Subjects: Adverse Drug Reaction Reporting Systems; Behavior; Collaboration; Communication; Consumer Product Safety; Cooperative Behavior; Drug Safety and Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drug-Related Side Effects and Adverse Reactions - etiology; Experts; From the ISoP; Health risk assessment; Humans; International Cooperation; Medicine; Medicine & Public Health; Patient Safety; Patients; Pharmacology/Toxicology; Pharmacovigilance; Product safety; Program Development; Risk Assessment; Risk Factors; Societies, Medical; Society; Studies
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-015-0301-0

Communicating to patients and healthcare providers about the risks of harm with medicines and how to use medicines safely is vital to pharmacovigilance for fulfilling its objectives -- there is no or little risk avoidance/mitigation or patient safety without risk communication. Communication about risk characteristics and factors should also enable patients and healthcare providers to make informed therapeutic choices. This requires discussing risks of medicines in the context of their benefits as well as the risks of deciding against medication. Usually medicines are meant to benefit the individuals taking them. In the area of infectious diseases, however, vaccines are aimed at protecting the vaccinee and also, through repressing or eradicating the disease, protecting vulnerable individuals who cannot be vaccinated. For a considerable time, guidance documents on communications have been available from international pharmacovigilance specialists and some regulatory authorities. However, application of these documents in everyday pharmacovigilance has been a challenge.