Hypochlorous solution
I recently received an email from a colleague asking this question. Clinisept+ Podiatry (Clinical Health Technologies, Leicestershire) is a hypochlorous solution (HOCl) product well known to podiatrists and used widely in clinics around the UK. Professional social media forums have been littered with discussions, many erroneous, around whether it can or can’t be used on broken skin or ulcers by UK podiatrists.
To this end, I consulted with Professor Alan Borthwick for some clarity on the issue. For those of you unfamiliar with Prof. Borthwick, he is an Emeritus Professor at the University of Southampton and during his career has worked extensively with the Medicines and Healthcare products Regulatory Agency (MHRA), playing a key part in attaining independent prescribing rights for podiatrists and physiotherapists in 2014. He received an OBE shortly afterwards for his contributions to non-medical prescribing. He is also a former chair of the Medicines Committee at the Royal College of Podiatry in London.
I outlined the issue to Alan, and he wrote the following reply, which I believe clearly sets out the current position on this question.
Professor Borthwick’s response:
In response to a number of largely erroneous assumptions expressed across social media relating to the use of hypochlorous solution in the form of Clinisept+ Podiatry, we felt it timely and appropriate to help set the record straight.
"Off Label" or "Off Licence" Use
One particular concern appears to be the ‘off-label’ (sometimes referred to as ‘off licence’) use of Clinisept+ Podiatry in the management of wounds, such as those following nail surgery. The basis of the concern is that it presumes that podiatrists are prohibited from using Clinisept+ Podiatry to help manage wounds, when the labelling of the product specifies only a “cleansing antimicrobial” use. Part of the assumption is that Clinisept+ Podiatry is a medicinal product and that podiatrists should not use such products in an off-label way.
There are two key points to be addressed here. One relates to the status of Clinisept+ Podiatry as a medicinal product, and the other relates to ‘off-label’ use of medicinal products by podiatrists.
First, let’s address the issue of Clinisept+ Podiatry and its status in terms of legislation and regulations. The body which regulates medicines in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA). It regulates medicinal products and medical devices, including making decisions about whether or not a product is to be classified as a medicinal product. There are a number of products that sit close to the boundary between a medicine and other classifications, such as ‘biocides’, and these are known as “borderline” agents; the MHRA will look at them and decide on which category best fits the agent in question.
Medicinal products are legislated in the Medicines Act (1968), and the Human Medicines Regulations (2012). As far as podiatrists are concerned, these pieces of legislation outline which medicines podiatrists are able to access, supply, sell, administer and prescribe (depending on the level of qualifications the podiatrists possess i.e. the rights are different for an independent prescriber [IP] podiatrist than for a non-IP podiatrist).
However, not all agents that podiatrists use are classified as medicinal products. Our best example is liquified phenol. For many years it was considered to be a medicinal product by the MHRA, but one without any product licence/marketing authorisation. This made it an ‘unlicenced medicine’, and podiatrists are not permitted to use unlicenced medicines within the terms of the medicines legislation/regulations. The MHRA solved the problem by reclassifying liquified phenol so that it was no longer regarded as a medicinal product. As a result, the medicines legislation/regulations no longer applied to its use. This enabled podiatrists to continue to use liquified phenol without breaching the terms of the legislation/regulations. This is an important example to cite, as Clinisept+ Podiatry is presently not classed by the MHRA as a medicinal product either.
When it was first launched, it was classified as a ‘biocide’ under the biocide regulations [1], as a product type 1 disinfectant. A later change in these regulations meant that Clinisept+ Podiatry no longer sat comfortably in that category, and so the company (Clinical Health Technologies) had to consider the remaining options, which were to seek to have it classified as a medicinal product, a medical device or a cosmetic. Following consultation with a number of regulatory experts, the company was guided towards cosmetic status, given the Cosmetic Regulations [1] had recently been broadened to encompass borderline agents like Clinisept+ Podiatry. Notably, it allowed the company to claim both skin compatibility and antimicrobial functions, hence the title “cleansing antimicrobial”. Needless to say, these properties would clearly be useful in helping wounds to heal, and the company is in the process of seeking regulatory approval for use as a wound healing agent (presumably to do so would mean it would then be classified as a medicinal product or medical device). Indeed, it has already done so in Nigeria and the United Arab Emirates. It is well worth noting that there is a considerable literature supporting the use of Clinisept+ Podiatry for this purpose.
Clinisept+ Podiatry is not a medicine
This allows us to answer the first point of concern. Clinisept+ Podiatry is regulated under the Cosmetic Regulations [2], and is therefore not subject to the medicines legislation/regulations at present.
On the second point, the question is whether or not podiatrists are able to use medicines or cosmetics in an off-label capacity. There are already a number of examples where podiatrists do use medicines in an off-label capacity. Using the local anaesthetic mepivacaine hydrochloride in children is one such example. The licenced indications include reference to use in adults, but do not specifically mention use in children. It is nevertheless permissible for podiatrists to administer it in children, albeit that it is in an ‘off-label’ /‘off licence’ capacity. The terms ‘off-label’ and ‘off licence’ are synonymous. It is a matter of professional judgement.
Some time ago the issue of off-label use of flucloxacillin (related to specific dosages) by independent prescriber podiatrists was raised. Advice from the MHRA again reiterated that the Human Medicines Regulations (2012) ‘do not prevent’ podiatrist prescribers from using it in an off-label way.
So, podiatrists are able to use medicines (to which they have legal access) off-label, but in the case of Clinisept+ Podiatry it is presently hypothetical, as Clinisept+ Podiatry is not classified as a medicine or medical device at all, and the Human Medicines Regulations therefore do not apply to it. If in future it does become a medicinal product, its use in managing wounds will not be ‘off-label’, as this feature would be added to the product labelling (and product licence/marketing authorisation).
Clinisept+ Podiatry can be used "off label"
Podiatrists are therefore presently able to use Clinisept+ Podiatry in an off-label capacity, as a matter of professional judgement. That judgement should be informed by the available scientific literature, and there is an abundance of it.
[1] (EU Regulation 528/2012)
[2] (EU 2009/1223, as amended by the Product Safety and Metrology etc (Amendments etc) (EU Exit) Regulations 2019)
Summary
In summary, as it stands, the product can be used in wound care by podiatrists in the UK as they deem fit. The use of hypochlorous solution in wound care is well documented and safe . Moreover, hypochlorous solutions have been used safely and effectively over the years in many healthcare specialities [1-9]. I would recommend you read the reference below by podiatrist, Prof David Armstrong who undertook a review of HOCL in the management of the diabetic foot ulcerations in 2015 – the document can be accessed and downloaded in full, from here. Also, an article I wrote and published in Podiatry Now reviewing hypochlorous solution that can be found here.
Both authors declare that this article was written independently of, and without any financial incentive from the manufacturers, distributors or any retailers of hypochlorous products.
References
1. Selkon, J.B., et al., Evaluation of hypochlorous acid washes in the treatment of chronic venous leg ulcers. J Wound Care, 2006. 15(1): p. 33-7.
2. Wang, L., et al., Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds, 2007. 6: p. e5.
3. Sakarya, S., et al., Hypochlorous Acid: an ideal wound care agent with powerful microbicidal, antibiofilm, and wound healing potency. Wounds, 2014. 26(12): p. 342-50.
4. Taharaguchi, M., et al., Effect of weak acid hypochlorous solution on selected viruses and bacteria of laboratory rodents. Exp Anim, 2014. 63(2): p. 141-7.
5. Hiebert, J.M. and M.C. Robson, The Immediate and Delayed Post-Debridement Effects on Tissue Bacterial Wound Counts of Hypochlorous Acid Versus Saline Irrigation in Chronic Wounds. Eplasty, 2016. 16: p. e32.
6. Ishihara, M., et al., Stability of Weakly Acidic Hypochlorous Acid Solution with Microbicidal Activity. Biocontrol Sci, 2017. 22(4): p. 223-227.
7. Ragab, I.I. and K. A, The Effectiveness of Hypochlorous Acid Solution on Healing of Infected Diabetic Foot Ulcers. Journal of Education and Practice, 2017. 8(8): p. 58-71.
8. Odom, E.B., et al., The Utility of Hypochlorous Acid Wound Therapy in Wound Bed Preparation and Skin Graft Salvage. Plast Reconstr Surg, 2018.
9. Block, M.S. and B.G. Rowan, Hypochlorous Acid: A Review. J Oral Maxillofac Surg, 2020. 78(9): p. 1461-1466.
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