Conclusions

The data resources and processes for identifying and responding effectively to drug safety issues have been reviewed above. Pharmaceutical companies and regulatory authorities have clear obligations to use them in order to recognise and address safety concerns promptly so that marketed medicines can be used as safely as possible. To achieve this objective organisations must be proactive in identifying and investigating issues, and responsive to a moving target. Most important, drug safety issues are unpredictable and an open-minded approach is necessary to ensure that significant changes in the evidence lead to appropriate actions. Once action has been taken there is invariably a need for continued monitoring.

The methodologies underpinning pharmaco-vigilance have been developed over the last 30 years to a level that affords patients a reasonable degree of protection against the unwanted effects of medicines. However, these still need to become more sophisticated to meet the challenges of the changing world of therapeutics. Innovative methodologies are also needed in order to enhance the capabilities of drug safety personnel to respond quickly to important issues. Technological advances, and the increasingly availability of computerised databases which can be used to research drug safety issues, are providing new opportunities for better investigation and communication about drug safety.

Consumer expectations of drug safety have recently increased and are likely to continue to do so (Asscher et al., 1995). The primary consideration in this field must always be the patients using the medicine. When making decisions based on risk-benefit analysis, a fine line often has to be drawn between restricting availability and choice, and minimising the risks that inevitably accompany the use of any pharmacological agent. Improving the quality of the evidence on which such judgements are based is a clear priority for all working in the field of drug safety.

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