Current progress in pharmacovigilance is marked by increasing use of databases and by attempts to make the process more proactive and organized.
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).
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