Vol. 22, No.3, May 2000
2000, Vol. 22
No. 3 (May)
..Chemistry in Slovenia
..News from IUPAC
..Reports from Symposia
..Letter to the Editor
..Reports from Commissions
Download the May
issue in pdf format.
Download the May
cover in pdf format.
Vol. 22, No. 3
Books and Publications
New Book from
the World Health Organization
Guidelines for Preparing Core Clinical-Safety
Information on Drugs, 2 nd
edition. Including New Proposals for Investigators
Brochures. Report of CIOMS Working Groups III (Revised) and V (New)
1999, 98 pages (available in English
only), ISBN 92-9036-070-4, CHF 15.-/USD 13.50; In developing countries:
CHF 10.50, Order No. 1840021.
This book is a revised and expanded edition of
the first internationally agreed guidelines covering the minimum drug
safety information that should be communicated by manufacturers to
physicians and other prescribers. Originally published as the CIOMS
Working Group III report, the "Core Safety Information"
specified in the guidelines has been widely endorsed as a standard
for the preparation of all official national data sheets, package
inserts, product labels, and other official statements issued by manufacturers.
The original guidelines were produced in response to the need to harmonize
drug safety information. As their principal objective, the guidelines
aim to ensure that data sheets contain the information most needed
to help prescribers balance a products risks against its benefits,
and thus make good therapeutic decisions. The book also includes the
new report of CIOMS Working Group V. This report extends the original
guidelines to include recommended safety information on drugs undergoing
investigation. Intended to guide the content of company investigators
brochures, this "Development Core Safety Information" then
forms the basis for the core safety information eventually issued
for the marketed product. The report of Working Group V is published
as an additional set of proposals for the assessment and presentation
of safety information in investigators brochures. Proposals,
which follow the same practical approach used to produce core clinical
safety information, are intended to provide researchers with all relevant
clinical and non-clinical information and to assist pharmaceutical
companies in meeting their reporting obligations. In addition, guidance
is provided on the global distribution to investigators of new safety
information, such as 7-day and 15-day alerts to serious, unexpected
adverse reaction. The proposals should also facilitate the work of
ethics review committees when assessing the benefits and risks to
participants in clinical trials.
The book concludes with the text of the European
Summary of Product Characteristics and a summary of the U.S. FDA Requirements,
examples of illustrative drug scenarios used by the working group,
and a model of Core Safety Information proposed for a fictitious drug.