New EU medicines legislation improves patient information
Packaging labelled in Braille |
New European medicines legislation states that medicines should be packaged with the name in Braille and that other help for visually impaired patients should be provided. Examples include: leaflets with large print, telephone help lines, audio versions of patient information leaflets (PILs) made available on compact discs and tapes, or leaflets that can be accessed via the internet.
The new legislation,which came into effect on 30 October, introduces
wide ranging changes to the regulation of medicines which will give patients
access to better information about their medicines. Patients will have
direct input into the design and content of the leaflets provided with
every medicine. The Medicines and Healthcare products Regulatory Agency
(MHRA) will also be publishing public assessment reports and summaries
of clinical trial data for newly licensed medicines on the internet.
All medicines which will be handled directly by patients, including herbal
medicines, will have to comply with the new provision, and guidance on
its application has been published by the European Commission. Medicines
such as injectable products which are administered by health care professionals
need not have Braille applied. Other medicines encompassed in this exception
includes radiopharmaceuticals, anaesthetics and infusions. However, insulin
products and peritoneal dialysis fluids which are handled by the patient
will have to comply.
The MHRA says that the name of the medicine in the summary of product
characteristics must appear in Braille on the package. Where a medicine
is available in more than one strength, these data should also appear
in Braille on the label and in some cases where different pharmaceutical
forms of a medicine are available, this information should be displayed
in Braille on the label. The MHRA also states that it is not necessary
to retain PILs in a variety of formats (eg, Braille, audio and CD-rom)
because the marketing authorisation holder can contract out the provision
of these documents to third party suppliers.
For products which have already been submitted to the MHRA, are under
assessment and not yet authorised, the expectation is that these will
comply with the new legislation in relation to Braille. Medicines which
were authorised before 30 October have until 30 October 2010 to comply.
The MHRA says that the legislation strengthens its role of protecting
public health by ensuring that a risk profile is drawn up for new products.
Companies are required to submit to the MHRA any new information that
may affect the risk–benefit balance of products. This will identify
areas where more evidence may be needed.
Kent Woods, chief executive of the MHRA, said, “The new EU medicines
legislation will improve the protection of public health by enhancing
the assessment of risk-benefit during the life-cycle of the product.
Patients will be better informed through the improvement of PILs.”
|
Hospital Pharmacist