Getting Started

Once a decision has been taken on the appropriate action to reduce the risk from a drug safety issue, it is essential that planning is undertaken. Planning will include how and when action is taken and the optimisation of communications to ensure all those that need to know about the action are informed in a clear and timely manner. If the safety issue represents a major hazard to the public and significant action, such as a product withdrawal is planned, then it is essential to act quickly. A project team should be formed made up of a leader to oversee the planning and execution of communications and members with the necessary knowledge and experience of drug safety, communication and distribution networks. A communication plan will be drafted which makes clear the key messages, the audiences to be targeted (and how to reach them), who is responsible for drafting documents, who should review them and who will sign them off. The plan should include dates and times for production of drafts, for initiating distribution and for communications being received. The plan should be reviewed regularly and may need to be changed in light of emerging events. The plan should also include contingency for a major change in events, such as a leak of information to the media.

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