Ensuring Action To Protect Patients Is Effective

Perhaps the most important aspect of audit is ensuring that any action taken to protect the public from a drug risk is effective. With the exception of when a drug is withdrawn from the market, all action on drug safety will aim to reduce rather than eliminate risk. If the drug in question is of proven therapeutic benefit, then this is entirely appropriate. However, simply adding warnings to product information, recommending monitoring or contraindicating an at-risk patient group may not adequately protect public health. It is therefore important to monitor that the action has been effective and to continue to monitor the safety issue on an ongoing basis. A list of possible methods of evaluation is given in Table 9.12. In the past, the number and nature of spontaneous reports received has been used as the main method of evaluating the effectiveness of action. However, for the reasons discussed above, this approach has significant limitations. Ideally, adverse reactions following use of the drug would be prospectively monitored. This might be done using a formal observational study or by monitoring prescribing

Table 9.12. Possible methods of evaluating the effectiveness of actions taken.

1. Communications—have they been received and understood (using market research techniques)?

2. Prescribing—extent to which it is consistent with revised recommendations in product information (using longitudinal patient databases)

3. Spontaneous reporting—do serious cases continue to be reported? Do reported cases reflect contraindicated use?

4. Observation/formal study of prescribing and events— has the action resulted in reduced morbidity/mortality from the ADR in practice (using longitudinal patient databases or epidemiological study)?

events in a longitudinal patient database such as the GPRD. If there is evidence that the action taken has not reduced the morbidity or mortality associated with the drug, then further action and communications will usually be necessary.

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