The Veterinary Medicines Regulations…what’s new for SQPs in May 2024

We first saw the new VMR on 1st May and then an amended version of the SQP Code of Practice on 17th May.  We do recommend that all SQPs and others in the veterinary pharmaceutical industry read the updated Code of Practice and you can find the link here.

It does take a little time to digest the changes and of course it’s only been three weeks! Previously the VMD has advised us that a review of the SQP Code of Practice will follow the new regulations. This blog is just about what affects SQPs today and what’s new that SQPs need to think very carefully about for the future.

At Vetpol we believe that good point-of-sale professional advice is essential and of course it is the reason for the existence of SQPs.  It is why they need to be suitably qualified. Many of the requirements in the Code have been there for decades but as the world around us changes, much of the Code stays the same until the VMD has time to review it thoroughly.  In the short-term this can result in some situations that are a bit of an anomaly.  As the world of veterinary medicines evolves it needs to be understood that what has just been inserted into the Code on 17th May appears to be what VMD considers to be the essential changes today.  We can expect further changes.

Changes for farm animal, avian and equine SQPs

Some SQPs prescribe anthelmintics (wormers or de-wormers) for horses, cattle, sheep and birds classified POM-VPS and this is where the most significant new change in the VMR is.  The VMR used to refer to vets, pharmacists and SQPs as oral prescribers of POM-VPS medicines. The VMR now refer to verbal prescribers although it wasn’t clear what the VMD meant by that until the Code was published last Friday. The version of the Code published on Friday 17th May now says under section 32 page 7:

“Where a medicine is supplied in accordance with a prescription which is not a written prescription, the person who prescribes the product must make a record of the reason for prescribing that product; their prescribing rationale.”

The summary of the information that must be recorded when prescribing a POM-VPS is detailed in 47, p. 11. That now also includes the words: “In the case of a medicine which has been prescribed but not against a written prescription, the reason for prescribing that medicine.”

No reasons for a written prescription…and no record of it?

However, this new requirement to record the ‘rationale’ only applies to non-written prescriptions (i.e. only the verbal ones).  Section 33 on page 7 covers what a written prescription must contain.  But section 33 doesn’t include an obligation to record the reason for prescribing that POM-VPS medicine or even oblige an SQP to keep a record of everything that is on the prescription.  So at the moment, according to the Code, if SQPs write a prescription for a POM-VPS product, they don’t yet have to record the reasons for prescribing and they don’t even have to keep a record of everything that’s in section 33.  It’s worth remembering that the VMR only apply to GB and the product may well be sent from outside GB, beyond the VMD’s powers of inspection. Clearly, this is very odd indeed and needs another look.  We cannot see the VMD not reviewing this and changing this at some point.

SQPs must be aware that under section 33, if they do write written prescriptions they must now include the words “It is an offence under the Veterinary Medicines Regulations 2013 for a person to alter a written prescription unless authorised to do so by the person who signed it.”

Ensure prudent use of antmicrobials

Section 33 (written prescriptions) also requires the SQP to include “any warnings necessary to ensure the proper use, including, where relevant, to ensure prudent use of antimicrobials”. That is because many parasites are ‘microbes’, i.e. organisms that can only be viewed under the microscope. Anti-microbial resistance is a growing concern. RUMA CA&E is particularly concerned about antimicrobial resistance and is presently considering the prescription of companion animal and equine products other than antibacterials, including horse de-wormers.

Changes for farm animal, avian, equine and companion animal SQPs

Most SQPs supply dog and cat flea and worm treatments, but there are some changes that have the potential to affect all SQPs. These concern dispensing, i.e. the act of giving the product out to the customer.  The truth is that there is not much change in terms of what SQPs responsibilities are today but the changes that have just been introduced do have the potential for some risks going forward that need thinking about and managing.

The first change is that Code Section 43 on page 10 now states “An SQP may delegate to a colleague the handing over or despatch of the product, provided the SQP authorises each transaction individually before the product is supplied and is satisfied that the person handing over or despatching the product is competent to do so correctly”.  Code section 37 on page 8 also now says: “Training records for the designated person responsible for selecting and packing the product should be available at the premises. Evidence that the SQP has checked the delivery before despatch should also be retained.”

Check delivery before despatch…?

So what this means is that an SQP can now let someone else dispense (or despatch) the product but must train them first. SQPs must also keep records that they’ve done it and according to section 37, checked the ‘delivery before despatch’

In reality, an SQPs responsibilities haven’t changed much but this change does open the door to further remote, possibly internet supply.  The responsibilities are the same whether SQPs are in a shop or supplying via the internet. But overall, the changes introduced to the Code on May 17th appear to favour remote supply, possibly via the internet, rather than professional advice given close to the point of sale. 

Splitting packs…watch out!!!

The next change also concerns the management of risks while dispensing.

Code Section 46 on page 10 used to contain a section relating to splitting packs of anthelmintic bolus treatments used to treat calves for worms.  Historically there was occasionally a problem with some farmers giving these treatments to calves that were too small, resulting in these products getting stuck in the oesophagus.  Animals suffered, some calves had to be destroyed or had to have surgery to survive. It caused farmers considerable distress. Most farmers do care about their animals.  So there used to be a section in the Code to protect small calves that reminded SQPs who split packs to pass on the safety warnings each time they split a pack and supplied an individual bolus. And this reminder also served to remind SQPs to consider the weight of the animals to be treated.

Farmers are professional keepers of animals…but parents aren’t!

The specific warnings relating to calves have now been taken out and a general warning to pass on safety warnings if packs are split for dispensing has been put in.  We recommend that SQPs do read Code section 46 on page 10 and think very carefully about it. Essentially the obligations for SQPs remain the same and the safety obligations are still listed in this section in general terms. However, now the risks are not explicitly-stated. And because they are not explicit the hazards are less obvious. Farmers are professional keepers of animals, which is why we are allowed to advertise veterinary medicines differently to farmers. But these changes on dispensing affect the risk to the general public. 

If for example an SQP splits a pack of flea or worm treatments, allows somebody else to dispense the product whilst at lunch and the safety warnings don’t get passed on to somebody with a small child we have a potential horror story. Imagine yourself hearing a crying child sitting on the floor next to a torn dispensing envelope, rubbing her eye, or salivating. Picture a parent not knowing whether the veterinary medicine that’s on the floor has caused their distressed child irreversible harm.  Even if the child doesn’t, choke, suffer long-term harm, or isn’t likely to, the memory of that fear will stay with the parent and perhaps with the child.

So legally the recent amendments don’t really change much in terms of what an SQPs responsibilities are, and these are covered in section 46.  But in practice if SQPs are going to allow somebody to dispense for them then they must not only train them but also think very carefully indeed about how they do it.

The bottom line on dispensing…

The bottom line is, if SQPs need to train somebody to dispense for them then they can now do it, but it’s still the responsibility of the SQP if something goes wrong, not the responsibility of the business employing the SQP.  So SQPs need to take a lot of extra care when splitting packs. Splitting packs incurs a great deal of extra risk!