Adverse events are described as any untoward experience whether or not the event is thought to be drug related. All new events should be reported and also adverse changes in a pre-existing condition, abnormally changed laboratory values, pregnancy, unexpected failure of therapeutic effect, any possible interactions, accidents and all deaths. From time to time all doctors are sent "desk reminder cards'', which list the medicines being monitored and describe the type of reporting required. This latter advice is shown in Figure 27.2. Because the IMMP is primarily a method of drug surveillance designed to detect new adverse reactions early in the post-marketing phase, emphasis is given to the reporting of adverse events. However, doctors are also encouraged to report unexpected favourable events and, to this end, promotion of reporting usually refers to "events", omitting the adjective "adverse".
The Intensive Medicines Monitoring Programme is aimed at the early identification of unexpected adverse reactions with selected new medicines. To enable this practitioners are requested to report all adverse events occurring in patients on these medicines.
Events are not reactions only, but include any and all random clinical incidents. Unknown reactions cannot be identified if only recognised reactions are reported and an assessment of the significance of events can only be performed effectively on a large aggregation of reports.
• all new events, including common minor ones
• change in a pre-existing condition
• abnormal changes in laboratory tests
• all deaths and the cause
• possible interactions - remember alcohol and the "pill"
To enable accurate identification and careful epidemiological assessment please include on prescriptions:
Figure 27.2. Advice to prescribers.
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