Why are there no new pre-operative antiseptics on the market

Pre-operative antisepsis is an important element of any interventional procedure from insertion of a cannula to major surgery. It reflects the number of surgical site infections and the number of prescriptions issued for antibiotics. It has a role to play in reducing antibiotic resistance. The costs to both patients and the health system of infections and wound breakdown are significant.

However there has only been one new product put on the market over the last 15 years or more.

Have you asked yourself why that is? Why is there so little money spent on research and why we have so few choices when it comes to this important element of patient care?

There are a number of important factors here.

Firstly the medicines legislation in the UK clearly defines the application of an antiseptic to the skin, prior to an interventional procedure – for example surgery – in order to reduce the risk of infection – as a medicinal purpose and the product must be a medicinal product. That is good because we then know that there are standards applied to the manufacturing process and a reasonable evidence base. There is proper surveillance and manufacturer liability.

The MHRA went even further to say that new products should be single use and sterile. Fantastic – although it then introduced another level of manufacturing complexity and cost, but it is all in the aim of reducing risk and improving patient safety that the FDA is trying to emulate.

Secondly the NHS did not move. Many hospitals use biocides in place of licensed medicines or products of lower efficacy – either lower concentrations of chlorhexidine (only licenced for minor surgical procedures) – or iodine based solutions many of which have alcohol concentrations that play no active role in their antiseptic effect. NICE and the DH advised the use of medicinal products by content and assumed that everyone knew that their advice would apply to properly licensed medicines

Although familiarity is a driver, the major driver is cost. Hospitals may understand and accept the risk and simply write it down in their risk register. They know that by supplying biocides for a medicinal purpose they are in breach of UK medicines regulatory requirements and the biocidal products directives – but why should they care – enforcement is non-existent. The system to monitor surgical site infections is broken and very few GPs would even think of reporting a late presenting surgical site infection back to the hospital.

So at the end of the day there is no money in the market. While the UK heavily supports cheaper old, inferior or unlicensed products there is no point spending money on research. Why introduce an advance in therapy into a market that simply isn’t there and totally unwilling to accept innovation.

I shrug my shoulders and move on – except I will insist that any surgical procedure on me or my family will include an appropriately licensed and evidenced based medicine


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