How safe is information about medicines? A risk assessment framework

The purpose of this paper is to identify factors predisposing to risk in publications written by healthcare professionals, especially those concerned with medicines.

Observation, discussion, and analysis of production methods, standards, and written outputs produced by the UK Medicines Information network as an exemplar of a healthcare organisation producing an array of publications with an accompanying tier of pre‐publication quality assurance procedures.

The factors which affect the likelihood and impact of risk in publications can be identified: author competence, quality of information sources, transformation process, audience, provenance, intended use and subject matter. These factors can be used to score a given publication and establish its risk potential relative to other publications.

It is recommended that healthcare organisations engaged in producing written material consider carefully the risks inherent in publishing, and the factors which influence risk.

The factors identified here can be used to score relative risk and to identify the highest risk publications. Higher risk documents should attract the most stringent pre‐publication quality assurance procedures.