When a drug safety hazard has been identified and sufficient information is available on which to base a judgement about the implications for users, the overall aim of promoting the safest possible use of the agent becomes foremost. A plan is required for providing appropriate information to health professionals and patients, so as to minimise the risk of the hazard. The urgency of implementation of this plan will vary depending upon the frequency and seriousness of the adverse reaction and the place of the drug in clinical practice. An important principle is that whenever the actions proposed may significantly alter prescribing, the necessary information needs to be made available rapidly. Rarely, there is a need to withdraw the drug from the market on safety grounds. This invariably requires immediate actions by both company and regulatory authority in order to ensure users are informed and to recall distributed supplies of the drug.
The nature of the action taken in reaction to a drug safety issue will depend on several factors, which are listed in Table 9.7. In terms of the hazard, the influencing factors here are much the same as the underlying issues in the initial assessment phase (see Table 9.3) but also included here should be consideration of the benefits of the drug in relation to alternatives and the nature of the disease being treated (CIOMS Working Group IV, 1998).
An important aim is the provision of clear product information. Several sections of the
Table 9.7. Factors influencing the type of action taken and timing in relation to a drug safety issue.
Seriousness of the hazard (i.e. its potential for a fatal outcome, or to lead to hospitalisation or disability)
Nature of the disease being treated Benefits of treatment with the drug Availability of alternative treatments product information may include vital information for safe use. These are listed in Table 9.8, with examples. Changes to product information need to be tailored to specific issues and placed in the context of the existing information. Key safety information should come first within a particular section and may need to be highlighted. The amount of information added should be proportionate to the importance of the issue and care must be taken to avoid duplication (cross-referencing between sections is preferable to repetition) or adding excessive information which does not aid the prescriber. Non-contributory information dilutes important messages and may increase the likelihood of the key facts being missed. The principles of how to address safety aspects of product information have been reviewed in detail by the CIOMS Working Group III (1995).
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