The key requirements for a successful drug safety communication are summarised in Table 9.10, i.e. targeted, understandable, open, informative and balanced. These are the factors around which the formulation process should be built. Any proposed communication should be tested against these requirements by a review process that includes both individuals who are experts in the field and those who are generalists. Communications intended for patients should be written in plain English and reviewed by lay people. In urgent situations it is vital to spend the time that is available ensuring that these requirements are met.
It is particularly important in any communication about drug safety to ensure that essential information is clearly conveyed and not obscured by other less important information. The key facts and recommendations must be worded unambiguously and should be placed in a prominent early position, if necessary with use of highlighting.
Table 9.10. Key requirements for a successful drug safety communication.
Targeted First, consider your audience and their specific information needs
Understandable Keep it as straightforward as possible—the reader is more likely to respond appropriately if the message is simple and clear
Open Be honest about the hazard—don't hide or minimise it; make it clear what has led you to communicate now
Informative Make sure you include all the information which the reader needs to know; what should they do if they are concerned or require further information?
Balanced The final test—is it clear that you have considered both risks and benefits; is the overall message right?
A model for a written communication to healthcare professionals is shown in Figure 9.7. The numbered paragraphs are intended to describe the content of the particular section rather than to be used as headings. The model should aid making the letter open and informative, and can be tailored to the specific issue. It is important for credibility that communications to health professionals are signed by a senior professional, such as the company Medical Director. One of the key aspects is to inform healthcare professionals of any action that they need to take. Simple instructions will help prevent unnesessary consultations and minimise further enquiries. Contact points should be given for the provision of further information. This is particularly important as some individuals will not have understood the messages, some will want more information on the data leading to the action, others will want detailed advice on patient management, and some will want to complain. Contact points might include a website address, the number of a telephone helpline and an address for written correspondence.
The key principles with patient information are that it should, in substance, be the same as the information provided to healthcare professionals and it should be presented in language that they can understand. Good patient information adds to and reinforces the main issues which should be
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