It is well established that continuous ADR surveil-lance is critical to assuring the safety of approved drugs in clinical practice.
CIOMS I - EXPEDITED REPORTING OF
INDIVIDUAL ADRS
It
is well established that continuous ADR surveil-lance is critical to assuring
the safety of approved drugs in clinical practice. Prior to 1984, regulatory
authorities restricted their requirements for the receipt of individual ADRs to
domestic reports only. However, between 1984 and 1987 the United King-dom,
France, the United States, Italy and Germany introduced regulatory requirements
for the submis-sion of foreign reports. That is, manufacturers were required to
report ADRs occurring in one coun-try to the regulatory authorities in other
countries where the drug was also marketed. As each regulatory authority had
different requirements regarding time frames, formats and definitions, and were
concerned about different types of ADRs, manufacturers were confronted with
many problems.
The
purpose of the CIOMS I working group was, therefore, to develop an
internationally acceptable reporting method so that manufacturers could report
post-marketing ADRs rapidly, efficiently and effec-tively to regulators.
On
the understanding that the CIOMS members would modify their own international
reporting procedures accordingly, the working group set out to define what
constituted a reportable individual reaction, the elements of a report and the
procedure and format for submitting individual reports. As most reporting
depends on legal requirements, it became clear that the regulators needed to
reach consensus. When this had been achieved a pilot test was undertaken to
demon-strate the feasibility and utility of standardised report-ing. The effort
was geared towards the international exchange of post-approval reports of
suspected, unex-pected (unlabelled) serious ADRs. The manufacturers in the
working group reported local cases according to the domestic requirements in
that country and then entered the cases on to single common forms and submitted
them to the other regulatory authorities represented on the CIOMS working
group. Reports received from a country outside the participating six were
entered on a single report and submitted to all six regulators.
The
advantages of standardisation to the manufac-turers were that it avoided a
multitude of different requirements from different regulators, eased
commu-nication of reports between international corpo-rate affiliates, and
lessened regulatory ambiguities. From the regulatory perspective,
standardisation could improve standards and reporting compliance by
manu-facturers and facilitate the exchange of information between regulators.
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; and
·
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 recom-mendations
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 assess-ment. 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 coun-try 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).
Many
of the CIOMS I criteria for expedited reporting were incorporated into ICH E2A,
Clinical Safety Data Management: Definitions and Standards for
Expe-dited Reporting, which reached final agreement in October 1994 (ICH, 1994). This document expanded on the CIOMS I
definitions and terminology. In particular, it introduced the concept of the
‘medi-cal’ seriousness category that recognised that events may not be
immediately life-threatening, or result in death or hospitalisation, but may
jeopardise the patient or require intervention to prevent such outcomes.
Although ICH E2A focused on pre-approval clini-cal trials, its definitions and
other criteria have been applied by regulators to expedited reporting of both
pre- and post-marketed products. The reporting time frame was reduced from 15
working days to 15 calen-dar days, with 7 days for the initial report on fatal
or life-threatening suspected adverse reaction cases from clinical trials. More
recently, ICH E2D, Post-approval Safety
Data Management: Definitions and Standards for Expedited Reporting, which
reached step 4 agreement in November
2003 (ICH, 2003a), formally applied the ICH E2A concepts to the post-approval
phase of the product life cycle as well as incorporating many of the good case
management practices proposed by CIOMS Working Group V.
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