Important Safety Information

(also on envelope)

Dear Health Professional,


1. The problem

2. The evidence

3. Conclusions drawn from the evidence

4. Practical recommendations Mention enclosures (if any)

Contact(s) for further information (phone, fax, e-mail) Signed : Senior Professional

Figure 9.7. Model letter to health professionals.

discussed between health professionals and patients, and does not make statements that could interfere with that relationship.

The Media

Most important drug safety issues will receive attention in the media. Often this will originate in medical journals with a scientific paper or news item forming the basis of subsequent television and newspaper coverage. The lay media have great potential influence on the perceptions of large numbers of users of medicines. Furthermore, healthcare professionals may first hear about a drug safety issue through the media. Therefore the media need to be handled with considerable care. It should be recognised that the immediate need of journalists is for a story that will interest their customers. The aim should be to provide them with the necessary facts and interpretation so as to give them maximum opportunity for balanced reporting. Unfortunately, a balanced perspective of risks and benefits may not lead to a newsworthy item, and journalists often tend to over-rate anecdotal evidence (e.g. in putting emphasis on the problems experienced by a particular individual). Journalists' expectations may also be unrealistic in relation to the level of safety of medicines or the quality of the evidence suggesting harm. They can be expected to highlight disagreement amongst experts in the field or any other factor that increases the newsworthiness of the item. With these considerations in mind, a basic model for providing the media with information is proposed in Table 9.11.

Professional Organisations and Patient Representative Groups

Professional organisations and patient representative groups offer both potential benefits and potential threats to a communication plan. Such organisations may be willing to input into the drafting of communication documents and in so doing improve them by offering perspectives which regulatory or company personnel do not have. They may be willing to give quotes relating to the action being taken which can then be used in

Table 9.11. Model for providing information to the media.

1. Nature of the problem: drug, hazard, precipitating factor(s)

2. Evidence for the hazard: strengths, weaknesses

3. What is being done: e.g. reviewing, investigating, new studies, changing labelling, etc.

4. What are the implications for (a) health professionals and (b) patients?

5. Overall balanced view of risks and benefits media briefing and in response to complaints. These organisations may be willing to help with the distribution of communications and, if they are adequately briefed (for example with a detailed "question and answer'' document), may be able to handle some of the enquiries that inevitably follow communication about a major safety issue. However, if the relationship with the organisation is poor prior to the safety issue emerging, then consultation can significantly complicate the communications plan and may lead to a leak to the media. Ideally, contacts with these organisations should be built proactively rather than making first contact at the time of an urgent drug safety issue.

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