In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines, consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators.
CIOMS Working Group V has generated proposals for pragmatic approaches to dealing with such issues as:
• Classification and handling of individual case reports from a variety of sources (spontaneous consumer reports, solicited reports, literature, the Internet, observational studies and secondary data bases, disease and other registries, or regulatory ADR data bases).
• New approaches to case management and regulatory reporting practices - proper clinical evaluation of cases, incidental vs other events, patient and reporter identifiability, seriousness, expectedness, or case follow-up criteria, and the role and structure of case narratives.
• Improvements and efficiencies in the format, content and reporting of periodic safety update reports (PSUR) including results of an industry survey on PSUR workloads and practices, proposals for high case volume and long time-period reports, simplification of certain PSURs, summary bridging reports, addendum reports, license renewal reports for the EU and Japan, dealing with old products, and other technical details.
• Determination and use of population exposure (denominator) data, sources of data and a guide to analytical approaches for a variety of circumstances.
The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world, with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process.
In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives, the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V. Council for International Organizations of Medical Sciences (CIOMS), 2001. ISBN 92 9036 0747. Price Sw. fr. 30. - available from: World Health Organization, 1211 Geneva 27, Switzerland. http://www.cioms.ch