Reporting CIOMS

Reporting Forms. FDA form 3500/3500A (see Figure 20.1) is the standard form for notifying expedited reports and can also be used by companies to submit IND safety reports. Foreign cases may be reported on the CIOMS I form. 

There is at least one MedWatch form or CIOMS I form for each report. 

CIOMS is associated with safety, providing various forms such as the form normally used to report SAEs (CIOMS 1) but also many other types of forms, for example, CIOMS 11 for the international reporting of periodic drug-safety update reports. The council is active as a medium for international discussion on safety and bioethics (see Chapter 15). 

CIOMS Working Group. International Reporting of Adverse Drug Reactions. Geneva QOMS, 1990 45-7. 

CIOMS. Basic requirements for the use of terms for reporting adverse drug reactions. Pharmacoepidemiol Drug Safety 1992 1 39-45. 

CIOMS. Working Group II Final Report. Geneva Coimdl for International Organisations of Medical Sciences, 1992. 

CIOMS. International reporting of adverse drug reactions (Report of CIOMS Working Group I). Geneva Counsil for International Organizations of Medical Sciences 1990. 

Gordon AJ, editor. Benefit-risk balance for marketed drugs evaluating safety signals. Report of CIOMS Working Group IV. Geneva WHO Press 1998. 

The AZT trials triggered the revision and elaboration of documents such as the Declaration of Helsinki, the CIOMS-WHO Guidelines, a new report of the NBAC of the U.S. The battlefields of the standard of treatment debate were research ethical codes. The revision of the Declaration of Helsinki (WMA 2000) at the end of the 1990s is an... 

Penicillin-induced hepatotoxicity may not be as uncommon as has been thought. There have been three reviews. The first was a comparison of the assessment of drug-induced liver injury obtained by two different methods, the Council for International Organizations of Medical Sciences (CIOMS) scale and the Maria Victorino (M V) clinical scale (66). Three independent experts evaluated 215 cases of hepatotoxicity reported using a structured reporting form. There was absolute agreement between the two scales in 18% of cases, but there was no agreement in cases of fulminant hepatitis or death. The authors concluded that the CIOMS instrument is more likely to lead to a conclusion compatible with the specialist s empirical approach. 

The MA holder has to keep records on all severe ADRs that en-e reported to him by a healthcare professional in Belgium or outside the European Union. Within 15 days he or she has to report ADRs to the Minister (pharmaceutical inspection). It is recommended to use the CIOMS document to indicate the clinical data it also has to be indicated whether the ADR is already mentioned in the approved leeiflet. For products approved by the central procedure, these data have to be reported immediately to the EMEA within 15 days. 

The periodic reporting should include all reports of both serious and non-serious M)Rs worldwide. The reporting should respect the CIOMS II format. The MA holder can take the international birth date as the registration date. 

The bases for all expedited, but also cumulative or periodic reports are individual case reports. The accepted reporting format for individual case reports is the Council of International Organizations of Medical Sciences (CIOMS) form. However, all other forms are acceptable in principle, as long as they contain the necessary information. Cases must fulfill minimum requirements to qualify for reporting a reporter, an event, a drug and a patient must be identifiable. In the EU, the reporter can only be a healthcare professional, unlike in the United States, where the Food and Drug Administration (FDA) accepts reports from consumers. 

CIOMS IV form for reporting of serious unexpected suspected adverse drug reactions www.cioms.ch. ABPI Code of Practice 2003. 

The CIOMS I working party s efforts were highly effective. Today, every regulatory authority in the developed world has endorsed expedited SAE reporting, usually within 15 working days of receipt by the company. The CIOMS form, in its later editions, is also now ubiquitous. 

The CIOMS VII working group is currently discussing development periodic safety reporting recommendations. 

CIOMS Working Group II. 1992. International Reporting of Periodic Drug-safety Update Summaries. CIOMS Geneva. 

Faich GA, Castle W, Bankowski Z, and the Council for International Organizations of Medical Sciences (CIOMS) ADR Working Group. 1990. International adverse drug reporting. The CIOMS project. J. Clin. Res. Pharmacoepidemiol. 4 83-90. 

Stephenson WP. 2005. FDA Public Hearing Reporting of Adverse Events to Institutional Review Boards, CIOMS VI Working Group Proposals. US Food and Drug Administration, 21 March 2005 16 May 2006 (http //www.fda.gov/ohrms/dockets/dockets/ 05n0038/05n-0038-ts00015-02-Stephenson.pdf). 

CIOMS. Standardisation of definitions and criteria of causality assessment of adverse drug reactions - drug-induced cytopenia. Int J Clin Pharmacol Ther Toxicol 1991 29 75-81. CIOMS. Basic requirements for the use of terms for reporting adverse drug reactions. Pharmacoepidemiol Drug Safety 1992 1 39-45. 

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