The Pharmaceutical Journal
Vol 270 No 7239 p321
8 March 2003

This article
Reprint
Photocopy

News summary

Related websites
MCA guidance (PDF 170K)

Medicines number plate proposal comes to fruition

New guidance on medicines labelling and packaging has been published by the Medicines Control Agency. Manufacturers are asked to label packs so that the name of the medicine is visible whatever way round the box is put on a shelf. They are also asked to leave space for dispensing labels.

The guidance came into effect on 1 March. It applies to containers with a volume of greater than 10ml.

The aim of the guidance is to ensure that all critical information necessary for medicines to be used safely is legible and confusion and mistakes by users are minimised. Critical information, which must all appear in the same field of view, comprises the name of the medicine, its strength, its administration route, dosage information (for over-the-counter medicines only) and any warnings.

The name of the medicine, including its strength and pharmaceutical form and the recommended International Nonproprietary Name (rINN) if the medicine has a single active ingredient, should appear on at least three non-opposing faces of boxes. Common names are to be given due prominence. Strengths are to be in a consistent format across a range of medicines (eg, 500mg and 1,000mg, not 1g) and administration routes must be expressed positively and only as registered in the summary of product characteristics (SPC). This means, for example, that "not for intravenous use" cannot be used.

Some flexibility is allowed where warnings are concerned, with only those that are expressly required by an SPC to be included in the critical field having to be shown. Examples include "fatal if given by other routes" for vinca alkaloids and "contains paracetamol" for paracetamol products.

Manufacturers will be expected to have tested their proposed labelling for clarity among the expected user group. When conducting these tests, they are expected to bear in mind that the needs of health professionals are not the same as those of patients.

The guidelines encourage the use of innovative pack design to ensure accurate medicines identification.

Announcing the principles on 3 March, Parliamentary Under-Secretary of State for Health Lord Hunt said: "Labelling should be plain, clear and should let patients, carers and health professionals identify at a glance the information to make sure that the medicine can be used safely."

The new guidelines have the support of the Association of the British Pharmaceutical Industry. Dr Trevor Jones, ABPI director-general, said: "This is an area in which the pharmaceutical industry can make a real contribution to enhancing patient safety. Many companies are doing just that and we welcome this best practice guide."

Eighteen months ago, the Committee on Safety of Medicines recommended a "number plate" format for medicines labelling (PJ, 25 August 2001, p252, and 1 September 2001, p286). This guidance is the result of that proposal.

  * PDF files on PJ Online require Acrobat Reader 4 or later