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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 [1–4] and some regulatory authorities (e.g. [5–8]). However, application of these documents in everyday pharmacovigilance has been a challenge. An issue of Drug Safety not long ago, dedicated to the theme of risk communication, discussed barriers to implementation and proposals for improving communication practices from worldwide experience [9–17]. There is much more research on medical information, communications and risk perception available, but every time a major safety concern arises with a medicine, designing a communication strategy and materials for avoiding and mitigating risks is perceived as a complex new challenge by both industry and regulatory authorities, and either the available evidence from the communication sciences is not fully applied or specific research to guide them is lacking. With rapidly changing communication tools, landscape and behaviour, it is not easy for research to catch up. However, communicating must be a paramount consideration whenever new safety information becomes available. Independently from which communication modalities are chosen, the content must be useful and understandable for those that should benefit from it (patients and healthcare providers), but also for other possible recipients like the general public and those in mediating roles such as drug information pharmacists and journalists. This On behalf of the ISoP CommSIG.

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