Numbing Creams and Anaesthetics
Numbing Creams and Anaesthetics.
FIRST PUBLISHED BACK IN 21/07/2017
We have been asked lots of questions about the use of anaesthetics being advertised as illegal without a specific certificate, so I thought I would write a little something on this subject for you in order to clarify a few points which seem to be causing concern and confusion.
I have done my due diligence on this subject and therefore I am extremely confident in the current techniques and instructions on this, but should anyone still be in any doubt please do not hesitate to message me and I can provide you with the evidence I have gathered. info@dermace.co.uk
Ok so, as we are all acutely aware, there is no governing body for Micropigmentation within the UK. This means we fall under the legislation of trading standards, more specifically the Local Authority. Each local authority has its own set of bylaws to follow and so please use your own for reference as they can differ. One of the biggest confusions on this topic is regarding the status of certain anaesthetic creams.
All medicines are licensed by the Medicines and Healthcare products Regulatory Agency. MHRA.
Let's look at the MHRA guidance on each of the main options for the purpose of this blog post.
There are three main ways that medicines are categorised by MHRA licensing:
POM (Prescription Only Medicine (self explanatory)
P (Pharmacy Only Medicine - meaning you can get it from a pharmacy without a prescription)
GSL (General Sales Licence, you can purchase in a supermarket!)
The three main anaesthetics many technicians use are:
Emla
LMX4
Xylocaine spray
So what's the big fuss about?
Well let's go back to the local authority. Most LA’s now require the client to purchase and apply their own numbing cream. If your LA has this guidance, then, where possible, you must follow it. This guidance is in place so the client can read the information leaflet and documentation that comes with the product (which, of course, they all do!). The reason for this is because they are not registered for use in micropigmentation.
Does this mean we are not allowed to use them?
The simple answer is NO. I have contacted the MHRA regarding this and have received confirmation back from them that although the information leaflet does not identify Micropigmentation as a specific use for the product, they are aware of it being used “off label” meaning although it is not on the information leaflet it is recognised as being used in the industry and therefore falls under Trading Standards. Ultimately, meaning it reverts to the local authority.
This is the response I received:
Thank you for your enquiry. Topical anaesthetics are licensed and indicated for their medical uses and not for cosmetic purposes, which are effectively “off-label”. Consequently cosmetic use falls outside of medicines regulations and guidelines and the MHRA could only recommend following the advice provided in the patient information leaflets provided with the products. The cosmetic industry and practice falls within the regulatory remit of the Trading Standards Service and I can only suggest that you seek clarification from your local authority.
Regards.
Simon Parker
Classifier
Medicines Borderline Section
Inspection, Enforcement and Standards Division
— MHRA
I am aware that some councils are not happy about Xylocaine spray being used and that’s absolutely fine. LMX 4 is perfectly good on its own. Other than that, the only specific guidance from the LA is that clients purchase and apply their own pre-numb. If this is the case, wait until the client arrives and advise them how to apply. This is easy for lips just slightly tricky for eyes, and I have yet to have a council take issue with the technician guiding the client more closely himself or herself in this instance.
Am I insured to use Emla, LMX4 etc?
Short answer: Yes!
Now let's address the topic of insurance companies now requiring (or in the future requiring) a certificate. This is completely untrue. Please contact your own specific insurance company to clarify this, but insurance brokers only require you to ensure you use a UK licensed anaesthetic. As long as it can be obtained without a prescription and has a UK licence, you are covered if you have selected a suitable insurer. We recommend Holistic Insurance, but there are many others too - including ABT.
Again, I have spoken to many insurance companies regarding this but I have in fact also had insurance companies contact me regarding this subject. They have all confirmed the same thing; that all they require is for the numbing agent to have a UK licence.
Lastly we need to talk about Adrenaline (epinephrine) a Prescription only medicine.
You cannot go through this industry without coming across Tag45, no matter how long ago you trained at some point someone will mention it to you. This is an American secondary numbing agent and although no one will argue its ability to do an amazing job for client comfort, unfortunately it is not licensed in the UK hence it no longer being readily available or used within the industry.
One of the main reasons this numbing agent was said to be great was the combination of anaesthetics, but with the addition of epinephrine.
So what does this mean for the client in regards to pain control?
You only have to google "epinephrine as a numbing agent" to see that it has NO numbing action at all. None! Yes it can have a numbing effect when the body produces vast quantities naturally during the “fight or flight” action but, in the quantities available to technicians through a prescriber, it simply reduces the blood flow to the area on a temporary basis, and we all know the less a client bleeds the better colour retention in the final result.
There is no need or legal requirement for any technician to be getting products prescribed for clients as they are purchasable legally at a pharmacy. Whilst I acknowledge the benefits of adrenaline in relation to being a vasoconstrictor (minimising blood flow) it has no benefit as an anaesthetic.
In short Emla, LMX4 or Xylocaine spray are not prescription only, and if your local pharmacy supply them to you or your clients there are no insurance issues.As long as you are using a UK licensed (P) Pharmacy-Supplied anaesthetic, and following your Local Authority guidelines regarding client purchasing their own you are legally insured to do so. Please know that should this ever become a legal requirement Dermace will notify students and endeavour to assist them in any way we can</strong> but there is no sign of this happening and the insurance brokers I have spoken to are just as adamant that they will not be taking any steps towards making this a requirement in the future.
Dermace would be happy to work with any company offering a really great anaesthetic product, and we’re committed to supporting our students in this area.
I hope this clarifies thing for you but if you do have any more questions or would like to have a chat about it all please get in touch.
*******UPDATE***********July 2019 - Dawn Cragg and Tracey Simpson have also been adding their years of experience to this subject. Here’s a excerpt of Dawn Craggs email with MHRA Contact:
