Topical Anaesthetic and the Law
Updated: Sep 8, 2019
Day by day I see posts popping up all over Facebook by trained therapists asking which numbing cream they should use. What is equally worrying are those that go on to suggest an array of illegal and banned products within the UK who have no idea that they are putting their clients at serious risk of harm. Many therapists are using these products because they were trained to do so by trainers with little industry knowledge, causing a cascade of therapists slapping on illegal products to client’s skin without a care in the world!
Recently an article by Professional Beauty claimed that several councils are now contacting local salons to advise they should no longer sell, supply or apply anaesthetic to their clients for the purposes of microneedling treatments. Many of us would have been trained in the use of anaesthetic prior to treatment due to old and crude methods of needling, all of which have now been replaced with new and less painful techniques, negating the need for anaesthetic at all.
Companies such as ACTFast popped up a few years ago to offer a prescription service to those wishing to comply with legislation, however the prescribed anaesthetic contained epinephrine which just isn’t needed in our line of work. Whilst many permanent makeup academies sell an arsenal of illegal anaesthetic under the counter to their students.
So, what is the law on anaesthetics and why are so many therapists knowingly breaking the law? What will happen when someone has a serious reaction or dies due to negligence? Do these therapists really care about their clients or do they just care about profits?
There are only a few topical anaesthetics available over the counter for our clients, these include, EMLA, LMX-4 and Ametop. These products are 'P' medicines, which mean Pharmacy Only Medicine, and should be given under direction of the pharmacist direct to the user (client). It was always believed that professionals could purchase topical anaesthetic for application on their clients prior to any invasive procedure. Over the last year, acquiring such products have proved more difficult as pharmacists refuse to sell to aesthetic practitioners.
Every council also have their own stance on the use of topical anaesthetics. Some are ok with us purchasing and using the product on our clients after a patch test, whilst others prefer the client to purchase and apply the product themselves. The MHRA also state that it is down to individual councils and our insurers to use the product safely and legally. However, the issue of using 'P' products only becomes an issue, when a client has a reaction or subsequently dies from the use of such.
So, what happens when a client presents with a reaction to a medical professional? The client is usually asked what they have had done or what they may have used recently on their skin. If they are directed to hospital, blood, urine and stool samples may also be taken. Local councils and MHRA do prosecute individuals where they have not complied with the law with devastating consequences to the therapist’s business. As an independent witness for local councils, I have witnessed first-hand the wrath of the councils when it comes to prosecution. Using illegal anaesthetics will land you horrendous fines (up to £20,000) and that’s before you are charged with negligence or grievous bodily harm. Using legal anaesthetics pose lesser risks but can still land you in hot water although following specific protocols can protect you and your business.
Can we use OTC (over the counter) topical anaesthetics legally? The law around this is simple, no we cannot. 'P' medicines should only be sold to the intended user. Whilst some councils and the MHRA turn a blind eye, it is a risk not worth taking. The best and safest solution is to speak to your client about pain tolerance and discomfort that may be associated with your treatment. If you have a prescriber, then they can prescribe cream specifically for them to use or the client can go and purchase this direct at their local pharmacy. The client should apply this to themselves 20-30 minutes prior to their appointment. The client should also sign to state that they purchased and applied the anaesthetic themselves and/or are happy for you to apply it, if it is for use on eyelids or other areas where they may struggle with the application.
For more information on the legal OTC anaesthetics please follow the below links:
Illegal anaesthetics are often imported in and have had no clearance within the UK for their safety. Their ingredients are often unknown and can contain various compounded anaesthetics such as higher than permitted levels of Lidocaine, Tetracaine, Benzocaine, Prilocaine and Epinephrine (an adrenaline). TKTX cream for example can contain 5% Lidocaine, 5% Prilocaine and 1% epinephrine, however some TKTX creams contain even higher concentrations. Compared to the likes of Emla which contains just 2.5% Lidocaine & 2.5% Prilocaine and LMX-4 which contains just 4% Lidocaine, these are seriously strong products that could cause long term side effects. Other illegal brand names include, Dr Numb, NumQuick, Tag45, Sustain and Blue Ice to name just a few.
Not only are these high doses of anaesthetic illegal, so is the use of epinephrine, an adrenaline that is often added to help block nerve sensors as well as control blood flow through vasoconstriction. Epinephrine can be highly dangerous and even a small amount can cause long term or life-threatening issues for a client. Here are some reactions caused by the topical use of epinephrine:
Some commercially available formulations of epinephrine hydrochloride contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals. The overall prevalence of sulphite sensitivity in the general population is unknown but probably low; such sensitivity appears to occur more frequently in asthmatic than in non-asthmatic individuals. [American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2926] **PEER REVIEWED**
Ophthalmic use of epinephrine occasionally causes systemic sympathomimetic effects such as palpitation, tachycardia, extrasystoles, premature ventricular contractions, hypertension, occipital headaches, pallor, trembling, faintness, and increased perspiration. Systemic sympathomimetic effects occur very rarely after application to the conjunctiva but are more likely to occur if the drug is instilled after the corneal epithelium has been damaged or permeability is increased by tonometry, surgery, inflammation, or topical application of a local anaesthetic. [American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2919] **PEER REVIEWED**
Epinephrine may cause fear, anxiety, tenseness, restlessness, headache, tremor, dizziness, light-headedness, nervousness, sleeplessness, excitability, and weakness. In patients with parkinsonian syndrome, the drug increases rigidity and tremor. Epinephrine may aggravate or induce psychomotor agitation, disorientation, impaired memory, assaultive behaviour, panic, hallucinations, suicidal or homicidal tendencies, and psychosis characterized by clear consciousness with schizophrenic-like thought disorder and paranoid delusions in some patients. Nausea, vomiting, sweating, pallor, respiratory difficulty, or respiratory weakness and apnoea may also occur. [American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 1392] **PEER REVIEWED**
Ophthalmic use of epinephrine may cause allergic reactions characterized by diffuse vascular engorgement, follicular hypertrophy, chemosis, conjunctivitis, and/or iritis. Allergic contact dermatitis of the eyelids, producing such symptoms as oedema of the lower lids, thick yellow discharge, and crusting and fissuring of the skin of the eyelids, may also occur. In some instances, allergic reactions may be caused by the preservatives in the preparations. [American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2919] **PEER REVIEWED**
A prospective study where topical epinephrine was used on burn and non-burn patients and five patients served as controls without epinephrine usage. Catecholamine concentrations were measured and to estimate the systemic effects of epinephrine, serum lactate and pyruvate concentrations were analysed, and perioperative haemodynamic changes recorded. Compared to the baseline values, there was a significant increase in the heart rate, serum epinephrine and lactate concentrations and LP-ratios in the burn patients and an increase in the epinephrine concentrations in the non-burn patients at 1 and 2 h. Epinephrine and lactate concentrations and LP-ratios were also higher in the burn patients compared to the other groups. Altogether, there were no changes in the control group. This study showed that the use of topical epinephrine has systemic effects on hemodynamic and serum epinephrine concentrations. Increased epinephrine concentrations in burn patients suggest increased absorption properties in these patients. The increased lactate concentrations and LP-ratios suggest tissue ischaemia, likely in skin. [Papp AA et al; Burns 35 (6): 832-9 (2009). Available from, as of October 13, 2009:] **PEER REVIEWED** PubMed Abstract
/ALTERNATIVE and IN VITRO TESTS/ Effects of catecholamines on skin necrosis /were examined independently/ of their vasoactive effects. Human breast skin was excised, pinned flat, and incubated at 37 deg C for 6 hours in a buffered salt solution containing catecholamine. At 0.1 and 6 hr the lactate dehydrogenase released from the skin and appearing in the buffer was determined spectrophotometrically. Total tissue lactate dehydrogenase levels were not significantly different at 0.1 or 6 hr. The toxic effect of epinephrine was eliminated by the addition of propranolol or selective beta-2 blockade, but not by alpha- or beta-1 blockade. Therefore, this effect appears to be mediated largely by beta-2 receptors. Similar toxic effects were seen in human breast skin treated with 1:200,000 epinephrine and were blocked with propranolol ... These studies indicate that addition of catecholamine to ischemic human skin accelerates skin death within 6 hr, but that the toxicity can be reversed with beta-blockade. [Burk RW et al; Plast Reconstr Surg 85 (1): 92-9 (1990)] **PEER REVIEWED** PubMed Abstract
There are many more side effects and risks, and I have included the link at the bottom of this blog for you to read through separately.
Epinephrine is not required for any procedure within the industry. Some claim the use of epinephrine enables pigment retention in permanent makeup, but in 10 years I have seen no evidence of this. Good permanent makeup artists should be able to undertake a procedure with minimal blood loss and minimal pigment loss during healing. Epinephrine will not create better retention as once the drug has worn off, a rush of fresh blood and lymph to the area can actually cause more healing and thus more removal of pigment deposits through the lymphatic system.
During procedures like microneedling, we want to encourage blood flow (not to be confused with bleeding) to stimulate the wound healing process. The use of anaesthetics and epinephrine will reduce the overall effect of the treatment for the client.
Whilst some procedures require the use of anaesthetics, the safe use of such must be taken into consideration. Telling the MHRA, council officials and trading standards that ‘you didn’t know’ the products were illegal will not mean they will go easier on you.
5 Steps to Protect your Business
1. Make sure you only purchase legal OTC anaesthetics.
2. Speak to your local council and insurers to ensure that you are within your legal rights to supply and apply anaesthetic on your client.
3. Where possible ask the client to purchase and apply their own anaesthetic and get them to sign a form stating that they are using anaesthetic on their own free will.
4. Always patch test anaesthetic 24 hours prior to any treatment to check for allergies.
5. Stick to the recommended dosage and keep records of the amount applied, length of time applied and the products batch number for future reference. Ensure the clients signs to state they are happy to use anaesthetic and are aware of all associated risks of doing so.
In the event of any allergic reaction seek urgent medical attention and ensure your client is aware of any potential risks and when they should be concerned.
For common side effects to using topical lidocaine and its safe use please visit the following link: https://www.everydayhealth.com/drugs/lidocaine-topical
The following article is about two deaths in the United States linked to the use of topical anaesthetics: https://www.reuters.com/article/us-skin-warning/overuse-of-skin-numbing-creams-can-cause-death-fda-idUSN0626472920070206
Link to all risks of epinephrine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4676230/
Compounded topical anaesthetics pose serious risks to health: https://journals.lww.com/ajnonline/Citation/2007/10000/COMPOUNDED_TOPICAL_ANESTHETICS_POSE_SERIOUS_RISKS.19.aspx
Systemic Toxicity From Topically Applied Lidocaine in Conjunction With Fractional Photothermolysis: https://jamanetwork.com/journals/jamadermatology/fullarticle/407139
MHRA’s a guide to what is a medicinal product: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/759581/012__GN8_-_final_2018_combined_doc_Oct.pdf
New topical anaesthetic rules threaten to push therapists out of skin needling: https://professionalbeauty.co.uk/site/newsdetails/new-topical-anaesthetic-rules-are-pushing-therapists-out-of-skin-needling
Epinephrine Human Health Effects: https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+4289