[india-drug] Rapid Alert of WHO

["Dr. Shanti Pal" <pals@who.int>]

Rapid Alert of WHO
------------------


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. 

Shanthi Pal   (M.Pharm, PhD)
Technical Officer (Information Exchange on Medicines)
Quality Assurance and Safety: Medicines
Essential Drugs and Medicines Policy
Health Technology and Pharmaceuticals
WHO, Geneva


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