What is a biocide?
A biocide is a chemical substance that can have a controlling effect or kill a potentially harmful organism by chemical means. These chemicals are generally disinfectants or pesticides.
How are they controlled?
They are controlled through the biocidal product directives which were converted into the biocidal products regulations in 2001 and have been subsequently updated. There regulations are under the control of the Department of Works and Pensions and are enforced by the Health and Safety Executive.
Are biocides registered and authorised?
No – the HSE is still waiting for the European Commission to approve the active ingredients before the application, registration and authorisation process can start. In effect, even though the use of biocides outside of their label is prohibited within the statutory instrument, there is no oversight and control.
Isn’t this a patient safety issue?
Yes – as long as the biocides do not fall foul of the medicines regulations in their labelling and advertising, they can be put on the UK market without challenge or monitoring. The biocidal products regulations are an important element of the patient safety legislation in the UK and they remain unenforced. There is a lot we don’t understand about their efficacy, particularly when mixed with carmoisine for skin delineation.
Are they being used widely?
Yes – biocides are in routine use within hospitals in the UK. They are used instead of licensed medicines (for example prior to surgery) and in place of medical devices (for example to disinfect medical devices). In 2014 the NHS purchased over 1,500,000 bottles of biocide.
Is this an issue?
For three main reasons, firstly that we have no published clinical evidence showing that these products are safe and effective, linked to a marketing authorisation approval by the MHRA. Secondly that many patients are being treated with a biocide, where they may reasonable expect to be treated by a licensed medicine, without their consent. And thirdly hospital managers may be directing their staff – either through policy or through not supporting choice, to use a biocide without the necessary information based on cost.
But can I use a biocide if I want to?
There are guidelines and standards in place that support the use of unlicensed medicines, but the clinician should identify the special clinical need that can only be fulfilled by the biocide and not by the licensed medicinal products available. Hospitals have good processes to deal with this situation and there are ample guidelines and standards for doctors, pharmacists and nurses to apply.
What about the wider effects?
The increased use of cheap biocides, lead to stagnation in the market place with few companies researching new products and certainly only one new product for pre-operative use launched in the last 15 years. It is OK for organisations to want sterile, single use, closed system preparations of appropriate skin preparations available, but the depressed and stagnant market hardly stimulates innovation.
What do people say?
The Royal College of Surgery are very clear in recommending that “operating theatres should be using the medicinally licensed product over those which are classed as general disinfectants. They have issued a joint statement with the MHRA with the intention of clarifying this.