PRODUCT INFORMATION
93. Concern was expressed in our own evidence,
as well as in the MHRA consultation, about the proposals for identification
of medicines licensed for use in children. Several respondents[41]
agreed with the Government[42]
that the Commission's proposal to use the identifying letter "P"
was unsuitable in the UK where that identifying letter was already
used to denote medicines available for over-the-counter sale as
distinct from on prescription.
94. The ABPI (pp 25-26) stressed that any labelling
must be clear and unambiguous to enable medicines to be given
to children safely. They and a paediatric research consultant[43]
suggested that a pictogram of a child would be better than the
proposed letter "P".
95. We asked Professor Chantler about the need
for more clear and specific information, especially on suitability
for use in differing ages of children. He agreed that the symbol
"P" was unsuitable and saw clear risks, given the different
likely reactions of children of different ages, in using a potentially
misleading symbol denoting suitability for children. The label
should direct users to the relevant product information (QQ 29-33).
96. We put this to the Minister (Q 74). She replied
that[44] following objections
from several Member States, as well as the UK, the Council Working
Group had accepted that all medicines authorised for paediatric
use should bear an appropriate European symbol (other than the
letter "P"). That symbol would be selected by the Paediatric
Committee within one year of the Regulation coming into force.
The meaning of the symbol would be explained on the package label,
but it would not indicate suitability for a particular age group.
The Government saw no danger of over-simplification.
97. We are not satisfied that adequate consideration
has been given to this problem. We accept that a decision is not
needed until after the Directive enters into force. But, despite
the Minister's assurance, we foresee a significant risk of dangerous
confusion arising from over-simplification. Labelling a product
as "suitable for use in children" appears to overlook
the very real danger highlighted by Professor Chantler that a
product suitable for use in mature children may be highly dangerous
for use in younger ones.
98. We recommend that the Government should
give further and serious consideration to the proposal that the
products should be labelled in a way which indicates their suitability
for use in children.
99. It is abundantly clear from our evidence
that children are not just young adults: their reaction to drugs
varies considerably in relation to age and other factors and the
newly-born are particularly vulnerable. We therefore recommend
that any labelling scheme that is devised must take full account
of this and make plain the risks of using products without consulting
the relevant product information, especially for products which
are available without prescription. Product information should
also be summarised in clear, non-scientific language that leaves
no doubt whatsoever about the risks of misuse and the need to
follow carefully the dosage information.
36 
