Communicating information to users of medicinal products is a vital step in the process of handling a safety issue with a marketed medicine. The distribution of safety information may be targeted at specialists or generalists or both, other relevant health professionals and at patients. A particularly important aim in communications about drug safety is to ensure that essential information is clearly conveyed and not obscured by other less important information. Every effort is therefore made to word the key facts and recommendations unambiguously.
The key principles with patient information are that it should, in substance, be the same as the information provided to health professionals and it should be presented in language that the patient can understand. Good patient information adds to and reinforces the main issues that should be discussed between health professionals and patients, and does not make statements which could interfere with that relationship.
An important consideration is how quickly information needs to be made available to users.
A new life-threatening adverse reaction requires immediate communication, whereas the addition of information relating to a non-serious ADR could be added at the next routine revision of the product information. In the EU there is a mechanism for an immediate (i.e. within 24 hours) measure to restrict use or provide essential additional information on urgent safety grounds (Commission Regulation (EC) No. 541/95; Commission Regulation (EC) No. 542/95). Subsequently such changes are followed by a variation using standard procedures.
Any change to the marketing authorisation and product information which has significant safety implications is actively drawn to the attention of the relevant health professionals, usually by circulating the new product information under cover of a "Dear Doctor/Pharmacist'' letter. When the changes being made are vital for ensuring patient safety they are implemented very quickly, and it is normal practice to make information available to the media and general public through press releases and/or the internet.
The EU competent authorities recognise that successful communication about drug safety is a vital component of the pharmacovigilance process. This is a particular challenge because of the need to translate messages into all the official languages used in the EU (currently 11) and considerable attention is being paid to improving this aspect of the process.
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