The safe use of all medicines depends on users reading the label and packaging carefully and accurately and being able to assimilate and act on the information presented. The European New Medicines Legislation (NML) now covers guidance for a broad range of products. The guidance, when applied, will help to ensure that the critical information necessary for the safe use of the medicine is legible, easily accessible and that users of medicines are assisted in assimilating this information so that confusion and error are minimised. This means that Patient Information Leaflets, Track, Trace and Authenticate, Child Resistance, Compliance (with on pack storage requirements as well as patient dosing) and Waste – all have to be addressed. This will compel packaging suppliers to make changes in packaging of pharmaceuticals. They also create challenges as well as new opportunities. Some of the new legislations requirements that will be major driving force for a radical change in the packaging of pharmaceuticals are: • Braille script on a pack which is small in size for the OTC products registered after October 2005. Legislation states that medicines should be packaged with the name in Braille and that other help for visually impaired patients should be provided, by way of telephone help lines, audio versions of patient information leaflets, leaflets that can be accessed via the internet, etc. Where a medicine is available in more than one strength, the data should also appear in Braille on the label. All medicines which will be handled directly by patients, including herbal medicines, will have to comply with the new provision. Medicines such as injectable products, radiopharmaceuticals, anaesthetics and infusions, which are administered by health care professionals need not have Braille applied. However, insulin products and peritoneal dialysis fluids which are handled by the patient will have to comply. There is a significant lack of basic Braille information and knowledge (such as National characters) as well as production “dot height” limitations on packaging formats and supplier capability issues. • Late Stage Customization (LSC) technology permits businesses (particularly those dealing with pharmaceutical products or high numbers of SKUs) to have the benefits of medium to long production runs combined with the flexibility to produce low volume orders – exactly matching market’s specific needs and customisation requirements demanded by their regulatory authorities. Dynamic digital artworking systems can be used in LSC which allows for varied text and coding systems (2D datamatrix codes) as well as dynamic sequential numbering of packs. This in turn can lead to improved track and trace and product. • In the EU, the ‘Centralised Procedure’ for registering certain products often means that more than one language might be included or that the full licence holder address needs to be shown for each country that the product is marketed in the EU. This could result in 27 different addresses, unless addressed in a proper manner. • Text size and type face considerations EMEA has advocated that leaflets have the minimum font size increased from 8 point to 12 point, with headings being 14 point so that ageing population is able to both read and understand all patient information. • Implementation of RFID at pack levels occurs this will further open up communication standards. These legislation requirements would essentially mean that the current packaging size will have to increase to include all requirements. There is the potential for improving the layout of medicines labelling to aid clarity. This would assist health professionals and patients/carers to select the correct medicine and use it safely, thereby helping to minimise medication errors. (Source: www.profitthroughinnovation.com)