Conclusion

CONCLUSION

Current progress in pharmacovigilance is marked by increasing use of databases and by attempts to make the process more proactive and organized. Attempts are being made to augment the spontaneous, random nature of the generation of pharmacovigilance data and to make the process more systematic and struc-tured. These changes are emphasized by the recent guidance documents for industry by both EMEA and FDA on pharmacovigilance planning and risk management. This emphasis on planning a pharma-covigilance programme for a drug and trying thought-fully to minimize risk appears constructive and, to some of us, long overdue. It is notable that the empha-sis on proactive safety planning is linked with an expectation that the suspicions arising from sponta-neous reporting will rapidly be tested by formal phar-macoepidemiological studies conducted in organized and validated databases or prospective studies.

It is in everyone’s interest to develop safe and effective medicines and provide access to patients for whom benefits will outweigh harms. Post-approval surprises, such as drug withdrawals, are not innocent of harm for the drug is precipitously denied to large numbers of patients who found it safe and effective. There has been a coming together of academic, regu-latory and industrial interests across many countries to produce the guidance documents mentioned above as well as good practice guidelines for the conduct of pharmacopepidemiology studies (International Soci-ety for Pharmacoepidemiology, 2004).