Statins form part of the PAGB's draft OTC advertising guidance
Advertising of statins to the public is included in draft guidance on advertisements for non-prescription medicines in new therapeutic indications, issued by the Proprietary Association of Great Britain this week.
Last year, the Government proposed
to revoke regulations preventing advertising
to the public of medicines for 13 serious conditions, including cardiovascular
diseases (PJ, 9 November 2002, p665). It said at the time that this would
be accompanied by updated guidance from the PAGB. The regulations have
not yet been revoked but this is expected to happen shortly.
The PAGB’s best practice guidance for manufacturers says that any
advertising materials need to comply with existing legal and self-regulatory
requirements and be backed by relevant evidence. In addition, for products
in new therapeutic areas, it says that they must give “clear and
unambiguous messages in language that can be understood by the average
member of the public”.
Advertisements must not encourage consumers to self-diagnose and must
encourage a responsible attitude to self-medication and that “medicines
should be treated with respect and may not be suitable for some people”.
Consumers should not be encouraged to discontinue the use of prescribed
medicines and where long-term use of a product is necessary this should
be made clear and continued use encouraged. Product launches should be
accompanied by high quality materials for health care professionals,
developed in association with relevant professional groups, that give
an overview of the therapeutic area, how the medicine is to be used and
how it fits in with nationally agreed clinical guideleines. Alternative
treatments and self-help options also need to be addressed.
With the advent of non-prescription statins imminent, the draft guidance
gives specific guidance on cardiovascular medicines. Advertisements need
to indicate the condition and the target individuals clearly, it says.
Medicines, such as statins, should be presented as an option, alongside
lifestyle changes, such as smoking cessation, exercise and weight loss.
It should be emphasised that they are designed to reduce risk and not
something to be taken in preference to such changes. Intermittent or
occasional use of statins should not be encouraged. It adds that “hyperlipidaemia” is
unlikely to be a meaningful term for the public.
The PAGB is seeking comments on its guidance by 31 December. These should
be sent to Helen Darracott, PAGB, Vernon House, Sicilian Avenue, London
WC1A 2QS (e-mail helen.darracott@pagb.co.uk). Further guidance on other
therapeutic areas will be issued in due course. |
