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[e-drug] Labelling of essential medicines is essential (cont)


  • Subject: [e-drug] Labelling of essential medicines is essential (cont)
  • From: Anthony Cox <RX@blacktriangle.org>
  • Date: Tue, 8 Oct 2002 01:49:57 -0400 (EDT)

E-drug: Labelling of essential medicines is essential (cont)
---------------------------------------------

In article <200210070116.VAA00282@satellife.healthnet.org>,
Stein  Lyftingsmo <stein@lyftingsmo.no> writes
>Patientpacks.com has had a positive impact on the
>development on the problematic labelling situation on the British medicines
>market.

I was lucky enough to sit on the group that looked at this interesting
and important issue in the UK. The report of the group is at:

http://www.mca.gov.uk/inforesources/publications/mlx275report.pdf

quote:

"The working group acknowledged that safe use of all medicines relies on
all users reading the label carefully and accurately and being able to
assimilate and act on the information presented. It was apparent to
members that although compliant with regulatory requirements, many
medicines are labelled in a manner that does not aid legibility and
identification of the medicine, its uses and any relevant warnings.
Having reviewed the general concepts of the current labelling requirements and
some specific examples of labelling implicated in medication errors, 
the  group believes that potentially more could be done to improve 
the  clarity and effectiveness of medicines labelling with the 
objective of  reducing medication errors. The primary purpose of 
labelling and  packaging should be for the clear, unambiguous 
identification of drugs and not for  promotional or marketing 
purposes.

The pharmaceutical industry needs to treat labelling and packaging
safety in the same manner in which it treats the safety of the medicine
itself and must develop expertise to enable it to do so. The WGLPM
commends this report to the CSM and asks that the recommendations be
taken forward
to produce guidelines for the pharmaceutical industry.

In addition the WGLPM recognised that some of the issues which they
discussed were also encompassed in the wider remit of other groups
involved in the implementation of OWAM. Members commend the outcome of
their discussions to those considering the wider aspects of the
issue of safe use of medicines."

Abbreviations
CSM Committee on Safety of Medicines
WGLPM Working Group on Labelling and Packaging of Medicines
OWAM Organisation with a Memory
http://www.doh.gov.uk/orgmemreport/
(This document was in part why the look at labelling occurred in the UK)

This report led to some CSM principles which are currently in the
process of being fleshed out into a guidance document for manufacturers.

Regards
-- 
Anthony Cox     ADR Pharmacist
West Midlands Centre for Adverse Drug Reaction Reporting
City Hospital NHS Trust, Dudley Road, Birmingham, B18 7QH.
http://www.csmwm.org
Anthony Cox <RX@blacktriangle.org>
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