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Vinca alkaloids

Labelling issues

From Mr R. J. S. Shaw, MRPharmS

Following a death in a London hospital in 1998, the London regional office of the NHS Executive drew up principles of safe practice to eliminate the chance of patients ever again being administered vinca alkaloids by the spinal route.

In essence, the approach is to take a variety of measures including dilution of these injections to at least 10ml and to include a cautionary label stating: “For intravenous use only. Potentially fatal if given by any other route.” These guidelines were also promoted in this (Eastern) region and no doubt elsewhere.

Since then, however, a commercial licensed product of a “patient ready” vincristine injection has continued to be marketed. This product has a 2ml volume and is labelled to include the words, “Fatal if given intrathecally”. More than two years on and with another recent death (no direct association alleged) a lot of hospital pharmacies are still, I believe, supplying this product.

A particular concern is with the label which, while intended to draw attention to the dire consequences of maladministration, could in fact do the opposite. It is known that the eye can see what it wants to see and the presence of the word “intrathecally” can be picked up in a subliminal way.

The manufacturer does in fact have a registration application pending for a 10ml syringe presentation, thereby addressing one of the issues. However, it is understood that the perpetuation of the “Fatal if given intrathecally” wording has been requested by the Medicines Control Agency based on the precedent for the innovator product (a vial presentation normally handled in hospital pharmacy departments only).

I would strongly urge the MCA to reconsider its stance on this. I would also recommend that hospital pharmacists consider their own potential culpability in supplying this injection with the suspect wording.

Bob Shaw Regional Specialist — Quality Assurance (Eastern Region)
Academic Pharmacy Practice Unit
University of East Anglia, Norwich

J. MacDONALD (head, product information and advertising, post licensing division, Medicines Control Agency) replies:

The MCA is unable to comment on specific cases. However, we are concerned that a contributing factor in medication errors is the labelling of the medicine itself. We have already begun a policy review to agree a strategy for labelling which will help minimise errors and will be liaising with professional colleagues as part of this review.

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