Outcomes in diabetes

Wow – this was posted over two years ago!

The MMP Blog

It’s funny when you start a discussion on outcomes in a condition such as diabetes. The usual tripe comes out – HbA1c and then some idiot talks about cost-effectiveness and then those silly QIPP indicators and QoF points. I can even get angry when someone adds medicines safety and adherence. My heart sinks and I really know that the NHS has problems.

So – let’s start from a different place. The person with diabetes wants to feel confident that they can manage their condition over a long period of time. They want to feel that they are in control and they are on top of things. They want to feel well. I even highlighted the key words to make it simple.

Hmmm – the room has now gone totally silent.

I now have to stop the ones that are trying to tell me that they do this, by reading…

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Antiseptics – a must read

Over the years I have heard some strange views about antiseptics. I am usually stunned by the sincerity in which they are said. It demonstrates a total blind spot in knowledge and belief. Here are a few – with the answer I might have given if my jaw hadn’t hit the ground…..

Antiseptics are important, but washing hands and wearing a mask is more important during surgery.

Well I can’t disagree with the importance of handwashing and need to prevent transmission by wearing a mask, but the truth is that most bacteria infecting a wound have come from the skin – so the appropriate selection and use of antiseptics is important. Although there are few studies that are head to head, some do show a significant difference from one antiseptic to another and all guidance that I am aware of recommends using chlorhexidine 2% as a first line choice.

We are quite happy using an unlicensed medicine as our pre-operative antiseptic of choice.

Unfortunately there is no such thing as an antiseptic unlicensed medicine. It is either a medicine regulated by the MHRA or a biocide controlled by the HSE. They are two complimentary sets of regulations that form UK law – it is either one or the other. Any product containing an antiseptic that is not a medicine or a medical device is a biocide and controlled under the biocide regulations. It is an offence to use a biocide outside of its label. There is no legal framework to use a biocide in the place of a licensed medicine.

Where there is a possibility of confusion the MHRA has insisted on a label which tells the user that it is a biocide and not for a therapeutic application.

Patients are not informed – it is accepted as part of the operative procedure, but not specified on the consent form

This isn’t quite how I see it. As a patient I think it is part of the duty of care that I am owed to be treated with proper medicines. Actually I don’t even think that a hospital would use look-alike medicines that they have bought because they look the same, but are cheaper. However, I can just see the conversation –

Nurse or surgeon: ‘We use antiseptics to reduce the chance of you having an infection after your operation. I could use a proper licensed and evidence based medicine that is sterile and comes in a single use container, but I have one that is a bit cheaper and contains the same ingredients. Unfortunately it isn’t sterile and it isn’t in a single use container, but we will be very careful and try not to set you or the theatre on fire. Is that OK?

Me: Is it the same.

Nurse or surgeon: probably, we have no published studies to say it is, but the good thing is that there are no published studies to say that it isn’t.

Me: So there is nothing published at all

Nurse or surgeon: no, but I am sure it will be OK- would you sign here?

We use 0.5% chlorhexidine for our hip operations and use two coats.

OK firstly 0.5% chlorhexidine is a licensed medicine, but the indication is for minor surgery – so you are planning to use the product off-label. If you know that applying one coat is insufficient and off-label – how do you come to the conclusion that two coats is OK?

We add a little bottle of dye to the bulk bottles of chlorhexidine to show the surgeon the area of skin that has been prepared.

There is nothing on the label that says that this is an acceptable action. It is not included within the license of the bulk bottle and therefore the MHRA has not approved this. There is little evidence published to support this process except a small article which suggests that adding the red dye reduces the antimicrobial effectiveness of the antiseptic. A basic knowledge of chemistry would question the sense of adding an ionic dye to a cationic antiseptic.

It doesn’t matter what strength of chlorhexidine you use.

Chlorhexidine has the special property of substantivity. It adheres to tissue, preventing antimicrobial colonisation over time. The time appears to be concentration dependent so you should expect that the stronger the chlorhexidine the longer it works for. This has been demonstrated in two clinical studies.

We use alcoholic povidone iodine and this is more effective than aqueous

Can’t fault that thinking – but do you really use an alcoholic product. The product that you are actually using has only a small concentration of alcohol. At that concentration it is there to support evaporation, but would need to be 50% plus to have an antiseptic effect. You should not expect better results than with an aqueous product.

You don’t get resistance to chlorhexidine

This is not completely true. We have known for many years that bacteria, particularly gram negative bacteria like Klebsiella activate a pump mechanism which allows then to survive in increasing concentrations of chlorhexidine – it is adaption rather than resistance, but the end is the same – the bacteria survive apparently without harm. What is worse is that we have known for some time that this process caused the upregulation of genes associated with antimicrobial resistance, but now we know that in Klebsiella it is associated with colistin resistance.

Resistance to chlorhexidine is not important

That is very hard to say – we don’t really know the extent of chlorhexidine adaption in gram negative bacteria. We continue to slop varying concentrations of chlorhexidine around in a wide range of situations with very limited control – some would say an ideal situation for adaption and growing Klebsiella resistance. We have not properly considered recommendations to use sterile and single use antiseptics in surgery.

What we do know is that resistance to Klebsiella is a worldwide issue and there is an absolutely urgent need to try to reduce resistance within this and other bacteria. The UK may not be in big trouble yet, but European colleagues such as those in Italy are and we are following hot on their heels.

And just remember – when the antiseptics don’t work and cause bacteria to be resistance to antibiotics – we have no chance.

Don’t worry there are other antiseptics

Yes well – we have had one new antiseptic medicine launched this century – It can’t have been easy to get through the regulations and produce a sterile product in a single use container. Just when was the last new antiseptic chemical entity was launched in the UK as a medicine – can anyone remember? No I thought not- I can’t either. It is a serious problem- that demands governmental action.


What do we have to do

This is undoubtedly the easiest and most sensible question. Two things are necessary:

  1. Implement the existing law
  2. Initiate an antiseptic guardian program as part of the wider antibiotic guardian program and start talking about it