E-drug: WHO's Information Exchange System
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Hi,
This message comes from the Quality Assurance and Safety of
Medicines (QSM) team of the department of Essential Drugs and
Medicines Policy (EDM) in WHO, Geneva to inform e-drug users
about WHO's Information Exchange System. It is a mechanism
operated by QSM to disseminate current and urgent information
related to the use of medical products. The last message that was
sent out through this system was on the suspension of manufacturing
licence held by Pan Pharmaceuticals in Australia. The following text
summarises the concept.
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WHO's Information Exchange System
WHO issues a "rapid alert" whenever a serious problem in the safety
of any medicinal product arises. A description of how this operates is
provided below.
Background
WHO through the Quality Assurance and Safety: Medicines (QSM)
team within EDM operates an Information Exchange System for the
rapid dissemination to all Member States of any untoward medical
occurrence that arises in a medicinal product (including drugs,
vaccines, biologicals, plasma derived medicinal products, medical
devices and herbal medicines) in any Member State that results in
death, is life-threatening, requires inpatient hospitalisation or
prolongation of existing hospitalisation, results in persistent or
significant disability / incapacity or in a congenital anomaly or birth
defect. The system is based on the 16th World Health Assembly
resolution (WHA16.36) that 'reaffirms the need for early action in
regard to rapid dissemination of information on adverse drug
reaction'. Cross-cutting WHO initiative Focal points from different
departments within WHO constitute the Alert Committee. On
receiving information on a 'potential' alert a rapid, ad hoc meeting of
the Alert Committee is arranged to validate the information for its
source and authenticity, to check for any causality relationship that
might have been established, to assess the extent of distribution of
the product etc. If the material warrants rapid and worldwide
distribution, an 'Alert' is composed and mailed to the regulatory
officers and nominated Information Officers in the Member States.
Web posting
The alerts are also posted on the WHO EDM website
(http://www.who.int/medicines/organization/qsm/activities/drugsafety/
orgqsmalerts.shtm
So far 108 alerts have been issued. Most of them have dealt with
drug safety issues, (for example, the withdrawal of cerivastatin due to
risks of rhabdomyolysis); a few have related to quality
non-compliance of drugs and diagnostics. Efforts are also underway
to establish a central email - system, to send these alerts
electronically, for greater efficiency. It is hoped that this system will be
in place by the year-end.
Dr Shanthi Pal
Technical Officer
HTP/EDM/QSM
World Health Organization
1211 Geneva 27
Switzerland
Tel: 41-22-7911318
Fax: 41-22-7914730
e-mail: pals@who.int
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