Cold medication rescheduling
October 12, 2010
THE TGA is seeking submissions
on proposed amendments to the
Standard for the Uniform
Scheduling of Medicines and
Poisons which would see changes
to the scheduling of a wide range
of cough and cold medicines.
The changes would see
medicines containing any of the 19
substances move into Schedule 4
for use in children less than 2 years
of age; Schedule 3 for use in
children aged from 2 to 6 years of
age and Schedule 2 for use in
children and adults aged over six.
The substances included in the
line-up are: brompheniramine,
carbetapentane, chlorpheniramine,
codeine, dexchlorpheniramine,
dextromethorphan, dihydrocodeine,
diphenhydramine, doxylamine,
ipecacuanha, oxymetazoline
(excluding for nasal spray use),
pheniramine, phenylephrine,
pholcodine, promethazine,
pseudoephedrine, senega,
triprolidine and xylometazoline
(excluding for nasal spray use).
The rescheduling move is based
on recommendations put forward
during the June 2010 meeting of
the NDPSC, with other proposals
being considered including the
deletion of the current Appendix H
entry for pseudoephedrine.
The NDPSC is also seeking
feedback on a proposal to include
preparations containing 3% or
more of diclofenac for the
treatment of solar keratoses in S4.
The deadline for submissions is
29 October, and they can be sent to
SMP@health.gov.au.
MEANWHILE rescheduling is also
in the news in the UK, where the
Medicines and Healthcare products
Regulatory Agency has advised that
oral liquid cough medicines
containing codeine should not be
used in children and young people
under 18 years of age.
The MHRA says a UK review of
scientific evidence “has concluded
that the risks associated with overthe-
counter oral liquid cough
medicines containing codeine
outweigh the benefits in children
and young people under 18 years”.
The MHRA has ordered that all
of the medicines be restricted to
adult use, and has also mandated
that all OTC oral liquid codeine
medicines should be supplied in
child-resistant containers.
All products containing codeine
indicated for cough in the UK are
already sold or supplied under the
supervision of a pharmacist.
The above article was sent to subscribers in Pharmacy Daily's issue from 12 Oct 10To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 12 Oct 10
