Dr Jürgen Beckmann, Germany

The whole system of pharmacovigilance begins with risk identification and assessment. Any drug then has to be evaluated in terms of its benefits against its risks, and in comparison with alternatives. These considerations eventually give rise to regulatory measures. Ideally, a feedback system should be linked to the initial stage to monitor the outcome and evaluate the effectiveness and appropriateness of the measures.

In exercising self-regulation, the pharmacovigilance officer should detect drug-related hazards, assess the risk, eliminate or reduce the hazard, inform health care professionals and consumers on the regulatory measures, and assess the outcome of the measures.

Different sentinels and indicators should be devised and put in place in various sectors of the health care system to obtain feedback on the effects of the regulatory decision. Cooperation among drug regulatory authorities should be encouraged and enhanced, with WHO serving as a facilitator.

Moreover, regulators should give attention to improving their sources of information, the interaction among regulators, and the quality of information exchanged, and consider particular difficult situations with which the feedback system might have to cope.

A number of measures to improve the feedback loop were discussed at the pre ICDRA workshop on The Impact of Regulation on the Safe Use of Drugs. These are:

• Improvement of regulators’ sources of information.
• Improvement in mutual interaction between regulators.
• Improvement in quality of information exchanged.

Some examples of particularly difficult, though relevant, situations with which any feedback based system will have to cope were presented.