Introduction

In this chapter we take a practical look at the handling of post-marketing drug safety issues. The process of handling such issues is shown in Figure 9.1 and this forms the basis on which this chapter is structured.

There may be differences in the way issues are handled, and in perceptions, depending on whether one is coming from a regulatory or industry perspective. However, in both cases the goal is to protect patients and the means of achieving this should coincide from both directions. The broad aims of pharmacovigilance personnel are that any medicine should be used as safely as possible and that, where necessary, steps should be taken to improve its safety and users informed promptly (Waller et al., 1996).

In order to meet the above aims, both regulatory authorities and companies need to identify safety issues proactively. With proper use of the systems available, many potential issues will be identified but only some of them will turn out to be real and/or important. Judgements will need to be made, sometimes based on limited information, as to whether there is an issue in need of attention. When this is considered to be the case, it will be necessary to investigate it by assembling all the relevant evidence available and, sometimes, by designing specific new studies. Consideration will need to be given at an early stage to the possible outcomes and specifically as to how safety might be improved. The output of the process will usually be a risk-benefit analysis with proposals for changes in the recommendations for use of a medicine, withdrawal on safety grounds being relatively unusual (Jefferys et al., 1998). Communicating any necessary changes is a key issue in determining the effectiveness of the measures that are ultimately taken.

The first stage is the identification of a possible hazard. What you find depends on where and how

Figure 9.1. Process of handling a drug safety issue.

you look, and this is our starting point for considering how to respond to a drug safety issue.

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