Recommendations

The CIOMS recommendations for the case criteria for expedited reporting of a foreign ADR were defined as follows:

* Serious

* Medically substantiated

* Unlabelled (unexpected)

* Suspected to be product related

* Occurring with a marketed product

* In an identifiable patient

Such reports were to be submitted in English on the prescribed CIOMS form within 15 working days of receipt. The subsequent amendments to these recommendations are mentioned later in this chapter.

CIOMS reports were, and still are, restricted to ADRs and not "events". This implies that a physician or other professional healthcare worker has judged it a reasonable possibility that the observed clinical occurrence was caused by the drug. In addition, it was emphasised that manufacturers should not select cases for reporting based on their own causality assessment. All spontaneous reports of serious unlabelled reactions made by a medical professional should be considered as CIOMS reports. Submission of such a report does not necessarily constitute acceptance of causality by the manufacturer.

As product labelling differs from country to country it was suggested that manufacturers should review all serious reports and then decide on a country-by-country basis, either centrally or at affiliate level, whether the reported ADR is labelled or not. It was also agreed that there should be a minimum of four pieces of information before a report is considered to have reached the standard threshold for reporting. These are an identifiable report source; a patient (even if not precisely identified by name and date of birth); a suspect drug; and a suspect reaction.

CIOMS reports should be submitted to regulatory authorities as soon as they are received and in no case later than 15 working days after receipt. The 15-day period begins as soon as a company, or any employee in any part or affiliate of a company, receives the report.

The CIOMS I report was published in 1990 (CIOMS, 1990).

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