Medicines labelling

Editor, – I have major concerns about Ropivacaine Sandoz, which has appeared in several private hospitals.

This product is labelled ropivacaine 150 mg/20 mL. Nowhere on the packet or the ampoule does it say that this is equivalent to 0.75% ropivacaine, or 7.5 mg/mL. When ropivacaine was first marketed about ten years ago it was marketed as 2 mg/mL, 7.5 mg/mL or 10 mg/mL strengths. More recently this was changed to percent labelling (0.2%, 0.75% and 1%) to make it consistent with all the other available local anaesthetics.

My concern is that nowhere on the packaging does it say that this is 0.75% ropivacaine or 7.5 mg/mL. It only has the total amount of milligrams in the bottle.

This is a great potential source of confusion and particularly if ropivacaine is being used on the ward. Many nurses have expressed to me their confusion when looking for the requested local anaesthetic.

I think the labelling is inadequate and unsafe. It is clearly a potential source of medication error.

Paul Herreen
Specialist anaesthetist
Calvary Wakefield Hospital
Goodwood, SA

Editor, – There are two aspects of prescriptions that can cause problems to patients, pharmacy staff and doctors.

Firstly, repeat authorisation forms are confusing – all the information is there, but there are three boxes of information for the patient. Number of repeats remaining is sometimes not interpreted correctly, perhaps because the ‘Number of supplies left’ line is overshadowed by the bar code and the patient only reads the information in the two boxes above.

Patients ask for a repeat prescription when there is still one repeat outstanding, or are occasionally directed by pharmacy staff to ask for a repeat. If the form was altered so that it stated (1) the original prescription details – and put in the total number authorised (not just repeats), and (2) the number of supplies left – and leave the space for the bar code free, I think there would be no confusion.

Secondly it is frustrating, and potentially dangerous for patients that the highlighted name on dispensed medications and the repeat prescription is the trade name, with the generic name in smaller print.

We used to know the trade names, but now there are so many it is impossible to know them all. For prescribers, it is a time consuming process to try to work out what is being requested – and the worst situation by far is the Webster pack system. It is dangerous for patients. For example, recently a patient was taking the same medication twice because of different trade names.

It would be safer and so much more logical if the large print name was the generic name and the trade name was in smaller print.

John Jackson
General practitioner
Ipswich, Qld

Daniel Lalor, author of the article ‘Medicines labelling’ ( Aust Prescr 2011;34:136-8 ), comments:

Drs Herreen and Jackson provide some excellent examples of how medicines labelling and packaging can be detrimental to the quality use of medicines.

Dr Herreen has demonstrated to us the difficulties that health professionals have when product strength is expressed in a non-standardised way. The use of ratios and percentages to express the strength of a medicine has long been known to cause confusion. Doctors make considerably more calculation errors when concentrations are expressed as ratios or percentages rather than as milligrams per millilitre (mg/mL).^1,2

Simulation studies have shown that expressing a dose as concentration (mg/mL), quantity (total mg in packaging) and volume (total volume in packaging) can improve safety.³ Standardising the way in which strength is presented should be strongly considered as a mechanism to improve safety.

I firmly support Dr Jackson’s call for an increased prominence of the active ingredient on all medicines labelling, as do many consumers and other healthcare professionals. Standardising the prominence and position of medicines names on manufacturers’ labelling as well as pharmacy applied labels, would also assist consumers in identifying their medicines and prevent medication misadventure.

These issues, and others, must be considered as part of the current Therapeutic Goods Administration medicines labelling review process.