Labels, leaflets and cascade prescribing

When receiving a prescribed medicine for an animal, the owner needs enough information about the product to know how to use it, how to handle and store it, and about side effects that might occur. For an authorised medicine, all this information should be covered in the dispensing label together with information on the package or package leaflet (which companies must provide if the necessary information can’t be fitted on the pack).

But what if, say, tablets have been removed from the original pack and dispensed in a new container? What if the medicine is for an unlicensed use (i.e. supplied through the ‘cascade’)?  What do vets and pharmacists need to do about supplying information in these instances?

In the first case (medicines supplied in a labelled new container), a copy of the product’s summary of product characteristics (SPC) can be printed from the Veterinary Medicines Directorate website; alternatively a data sheet or SPC can be obtained from NOAH although not all authorised medicines are included in the NOAH database.

For cascade prescribing, things are a bit more tricky. The RCVS code of professional conduct says “clients should be made aware of the intended use of unauthorised medicines and given a clear indication of potential side effects. Their consent should be obtained in writing”. 

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But the law requires something different. When medicines are supplied through the cascade , vets and pharmacists are required to supply certain information, which is set out in the Veterinary Medicines Regulations. Most of the required information is straightforward, but “Any necessary warnings for the user, animal, administration or disposal of the product” is vague. For example, does this include information about side effects?There are several problems with supplying information for cascade medicines. What precisely should be supplied in the way of warnings? And where can vets and pharmacists find the relevant information quickly and easily and in a form that they can give to clients? Although the SPC (which is a summary of what is known about a medicine in relation to its authorised use) might help with the prescribing decision, it is unlikely to contain information about the dose and side effects that are relevant to the species or indication for which the medicine is being supplied through cascade. What's more, SPCs and data sheets not usually written for easy understanding by lay people.

Don't miss the next Veterinary Prescriber article (out next week) which rounds up the quick-reference sources of information that help with prescribing and dispensing veterinary medicines.