The Pharmaceutical Journal Vol 267 No 7163 p286
1 September 2001

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Number plates for medicines — a new way of reducing medication errors

A new report says that the packaging of all medicines should carry a “number plate” of standardised information and that more work should be done on making medicine labels easier to read and understand. Jonathan Buisson analyses the report’s conclusions

The National Health Service plan for England contains two targets relating to medication errors: first, to reduce to zero the number of patients dying or being paralysed by incorrectly administered spinal injections by the end of 2001, and, secondly, to reduce by 40 per cent the number of serious errors in the use of prescribed drugs by the end of 2005.

In February this year, a teenager died after being given an intrathecal (instead of intravenous) injection of vincristine. This was the 14th such case since 1975, almost all of which have had fatal outcomes. The Committee on Safety of Medicines set up an expert working group, under the chairmanship of Dr Robert Calvert, FRPharmS, to examine the role of medicines packaging and labelling in medication errors.

Number plates are an idea with merit and practicality, observers say

In its report, published on 22 August (PJ, 25 August, p252), the group recommends that a number of changes be made to the way in which all medicines are labelled. Principal among these is a call for a “number plate” of information to appear in a standard format on both prescription and non-prescription medicines (see Panel).

Professor Alasdair Breckenridge, chairman of the CSM, says: “We strongly support the concept of a ‘number plate’ for all medicines. This and the other recommendations in the report will help to strengthen patient safety by ensuring that all drugs are clearly labelled and identifiable, thereby helping to reduce medication error and keeping patients better informed.”

The expert group said that colour coding should not normally be used as a specific way of identifying medicines since “colour itself can become a short cut to the identification of the medicine rather than reading the label text itself”. However, it does recommend the continuation of some conventions, such as the colouring of metered dose inhalers for asthma and of warfarin tablets. It adds that in these cases it would be helpful to co-ordinate the colouring of the packaging with the colouring of the product inside.

Text on medicine labels should be in sans serif fonts at the largest type size possible, the report says. The group expresses concern that some labels, particularly on small volume containers of injectable products, simply meet minimum standards rather than using all the space available for imparting information.

Idris Hughes is a pharmacist who has established a website (www.patientpacks.com) devoted to some of the problems with current pharmaceutical packaging. He welcomes the report and, in particular, the recommendation for medicine number plates — an idea which he says has both merit and practicality and that was floated on the website last year.

“The most significant statement in the whole report is the conclusion that the pharmaceutical industry needs to treat labelling and packaging safety in the same way that it treats the safety of the medicines themselves,” Mr Hughes says.

However, he is concerned about the absence of any reference in the report to the issue of child-resistant closures.

“Many patient packs and almost all packs of liquids for reconstitution lack these closures. I believe that the expert group should have paid some attention to this.”

Specific medications

As part of its work the expert group looked at a number of specific medicines where packaging or labelling had been implicated in medication errors.

Vinca alkaloids These products are neurotoxic and intrathecal administration normally results in death. The group wants to see standard information appearing on all packaging components: approved name, quantitative strength, route of administration and pharmaceutical form. Only positive statements should be used, it says, to avoid misreading of statements such as “Not for intrathecal use”. The statement “Fatal if given by other routes” should also appear, the group concludes. [The Medicines Control Agency is working with manufacturers to make these changes by the end of 2001.]

Methotrexate This is normally taken once a week but prescribing and dispensing errors have led to patients taking it every day with fatal results. The group want to see a statement “Check dose and frequency. Methotrexate is usually taken once a week.” on oral preparations. It also wants availability of the 10mg tablet to be restricted.

Potassium chloride Injection of concentrated potassium chloride solution can be fatal. The group recommends that all ampoules of concentrated potassium chloride should have a black cap and a large red K should appear on both ampoules and cartons. Infusion bags containing potassium chloride should also have a red K.

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Jonathan Buisson is on the staff of The Pharmaceutical Journal