Labelling of medicines

The publication by the Government of new guidance on the labelling of medicines has been welcomed by the ABPI. The original proposals set out by MCA in MLX 275 in 2001 were unworkable in practical terms, and it was questionable what benefit would have been derived either by healthcare professionals or, most importantly, patients.

Although there is no evidence that labelling is a cause of errors, the new guidelines provide flexible guidance for best practice by pharmaceutical manufacturers and acknowledge the over-riding necessity that all labels currently comply with rigorously enforced UK and European legislation and at the same time be legible.

ABPI has always supported initiatives based on good evidence that improve patient safety, but it is important that these guidelines are not taken as the complete answer to a problem that has many causes.

Good labelling and packaging are among a number of factors that can help reduce medication errors, but it is essential that vigilance is maintained at all stages of the dispensing and administration process – there is no substitute for the healthcare professional verifying at the point of administration or dispensing the identity and strength of the product and the provision of the correct instructions for use.

The new guidance needs to be applied pragmatically, especially in the case of smaller containers where space on the label is limited.

The pharmaceutical industry has always co-operated with the regulatory authorities over any proposals on how to reduce the risk of errors, and will continue to do so.