The UK Medicines Control Agency has published a new guidance on best practice in drug labelling and packaging which is part of a broader Department of Health programme aimed at achieving a 40 per cent cut in medication errors by 2005. Any application for assessment to the MCA with a labelling component which deviates from this guidance should be accompanied by a full justification, says the Agency.
The document, which was implemented on March 1, has been welcomed by the Association of the British Pharmaceutical Industry, albeit with some reservations. The ABPI applauds the MCA for producing what it describes as a flexible guidance, while pointing out that "labelling is rarely a cause of medication errors." However, the MCA appears to be of a somewhat different mind, noting that problems with labelling have been associated with "a high percentage of errors."
"While the ABPI supports all initiatives based on good evidence that improve patient safety, it is important that these guidelines are not taken as the complete answer to a problem that has many causes," said Andrew Curl, the Association's deputy Director General.
The guidance document sets out to make improvements to medicines labelling, within the current regulatory framework, that will add clarity to the information provided and help healthcare professionals and patients/carers to select the best medicine and use it safely.
The general considerations of the guidance state that, while all labels must comply with current European Union law (Article 54 of Council Directive 2001/83/EEC), certain critical items of information should be located together on the pack and appear in the same field of view, where practicable.
These items include the product name, which should appear in full on at least three non-opposing faces of the pack to aid accurate identification. Where the common (generic) name appears after the brand name it must be given due prominence. The strength - it may be necessary in some cases to express the strength as quantity per unit volume and also as the total quantity per total volume, notes the guidance, which points out this is particularly important for injectable products and other medicines available in solution or suspension. The route of administration, which must be set out exactly as it appears in the Summary of Product Characteristics, posology (dosing), only necessary when the product is intended for self-medication and warnings -only those specifically considered critical for inclusion on the labelling need to be listed, such as "fatal if given by other routes," dilute before use" or "contains paracetamol." This information should appear in as large a font as possible on at least one face of the presentation.
Other factors brought out in the guidance include an encouragement for the use of innovative pack design, for example through the judicious use of colour, to aid in the accurate identification of a medicine, as well as the inclusion of space for the placement of the dispensing label. Only positive statements should appear on the labelling to avoid ambiguity (e.g. "for intravenous use only" is acceptable, "not for intravenous use" is not). Manufacturers should undertake a user test to ensure the maximum clarity of the critical information.
Finally, if a container is too small to adhere to EU requirements on labelling, for traceability purposes it is recommended that it should carry the Product License number and the name of the Marketing Authorisation Holder (or a logo if it incorporates the name). Blister packs found within a container should where practicable, have the name and strength of the product visible over each blister pocket, or be oriented centrally across the pack.