Changes to aspirin legislation from 1 October
REVISED WORDING (4 October 2003)
New labelling and leaflet requirements recognising the possible
link between aspirin use in children and Reye’s syndrome
(PJ, 27 April
2002, p557) come into force on 1 October.
The Medicines for Human Use (Marketing Authorisations Etc) Amendment
Regulations 2003 require the inclusion of the words “Do not give
to children aged under 16 years, unless on the advice of a doctor” on
the labels of relevant medicinal products on the general sale list containing
aspirin or aloxiprin. The package leaflet included in the packaging of
such products has to include the words “There is a possible association
between aspirin and Reye’s syndrome when given to children. Reye’s
syndrome is a very rare disease, which can be fatal. For this reason
aspirin should not be given to children aged under 16 years, unless on
the advice of a doctor.”
The Society’s Code of Ethics states that a pharmacist’s prime
concern must be for the wellbeing and safety of patients and the public.
Pharmacists are advised to use their professional judgement when requests
for aspirin or aloxiprin products are made for, or by, persons under
16 years old.
On and after 1 October, all stock must carry the new wording on the label
and the package leaflet. manufacturers may instigate recalls of stock
placed on the market before that date. In the event of a recall pharmacists
should comply fully to ensure a rapid transition from the old packs to
the new packs.
At the time of going to press, details of a transitional period for all
aspirin 75mg products are still awaited. As soon as these are available,
details will be published. |
