Body advises MHRA on patient information leaflets and yellow cards
A new body set up to give the Medicines and Healthcare products Regulatory Agency independent expert advice on how patient information leaflets (PILs) can be improved, met for the first time last week.
The Patient
Information Expert Advisory Group (PIEAG) is part of the
Commission on Human Medicines. Its aim is to look at ways to improve
PILs and to offer advice on how the MHRA communicates the risk/benefit
ratio of medicines to patients. The group will also advise the MHRA on
how to encourage patients to use the Yellow Card Scheme to report suspected
adverse effects.
Nicola Gray, lecturer in pharmacy practice at the University of Nottingham,
is a member of the group. She told The Journal: “This group is
extremely important. The professional and lay members are passionate
about improving information about medicines for the public. There is
a direct line to the industry and legislature in the UK and Europe through
which to co-operate on these issues.”
New legislation, introduced in July 2005, made user
testing of patient information leaflets for all new medicines mandatory in the UK (PJ, 2
July 2005, p12). At the end of 2008 the legislation will be extended
to include all existing medicines leaflets.
The MHRA has published
on its website three examples
of patient information leaflets that have been improved after the involvement
of patient groups.
The leaflets better define the likelihood of experiencing adverse events
by specifying the probable frequency of very common, common, uncommon,
rare and very rare side effects.
Patients can report any PILs that they do not understand to the MHRA
via a link on its website. |
The
Pharmaceutical Journal
Acrobat
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