SPEAKER_02 0:00

You're listening to Confidence2Prides podcast for Fitzgare Healthcare Practitioners and brought to you by Alex Prime. Welcome to Confidence2Prides, the podcast helping failure practitioners and healthcare entrepreneurs navigate the challenges of risk and regulation while building brands that matter. Every episode, we tackle a different issue facing healthcare practitioners and we interview a guest who's worked on the leading age of private healthcare, building something that matters in their sector or profession. My name is Jody Rainsford, and on today's episode I'll be discussing with Christopher Cloakbound of Roger Houston, Director to Our Listy, the challenges of off-label prescribing and what functional medicine practitioners need to do to ensure they are sufficiently protected. Welcome, Christopher and Roger. Off-label prescribing is something we have discussed in a number of previous episodes, but I thought it'd be worth delving into this on its own dedicated episode. What is off-label prescribing?

SPEAKER_00 0:59

So it's uh medications are licensed in the UK through the British National Formulary, but they are licensed for a particular use in a particular dose. So it's literally the uses of the medication are absolutely specified. So off-license is a use of that medication for something other than has already been approved by the British National Formulary. Now the medication is known to be safe for human consumption, it's been through clinical trials and all those things, but it isn't known to be effective or it isn't deemed to be effective for the particular use that it's put to. It can be if you absolutely take the sort of down to the absolute letter, if you have a pill of 100 milligrams and you break it in two and give 50 milligrams, that can be off-license because the specification in the British National Formulary is for 100 milligrams now. That's probably one of the least serious uh cases of off-license. And what we really mean by off-license is where approved medications are deemed or seem to be effective for other purposes and used for the treatment of other conditions.

SPEAKER_02 2:12

And where does this become an issue for practitioners in areas where there is greater innovation or leading edge? Why is this a particular challenge?

SPEAKER_00 2:25

The challenge really comes down in it's really an indemnity and sort of moving on to the whole sort of professional standing kind of issues. So if you are a practitioner, if you are like using something off license, then you are, first of all, in terms of your indemnity, your indemnity might well have a clause saying that you know all medication needs to be according to its license. So therefore, if you are giving off license medication with that clause in your indemnity, you are uninsured. And insurance is a statutory requirement. We'll talk in another episode about a poor doctor who ended up giving treatments about for which he wasn't qualified, and it's ended up ended her up in a whole world of hurt. So if you are giving off-license treatments and it invalidates your insurance, it is a very fast path to a whole world of hurt.

SPEAKER_02 3:14

And is that quite common? Is that quite common that the people in this area simply not have the cover that they have because there are clauses like that in most contracts?

SPEAKER_00 3:24

Yeah, it's very common. Yeah, so we have developed an indemnity specifically for functional medicine which has clear and specific cover for off-license treatments. So it specifically says that the use of these medications for these purposes is approved. General insurance contracts will have clauses which will basically limit everything to what is approved by the NHS. As you can imagine, the insurance industry is very conservative. Most medical indemnity underwriters know not a huge amount about medicine. So the whole sort of idea of fairly conservative people who are not expert in medications, the whole idea of them being happy with something that isn't approved by the NHS is fairly out there. So you need to be careful on that if you are looking to prescribe off license, and especially on the more marginal medications.

SPEAKER_01 4:12

I've noticed an evolution in terms of underwriters relying on things to avoid claims. So there's a general condition which means that you have to sort of comply and act as a doctor, and implicit in that or explicit, depending on the wording, is that you have to follow GMC guidelines and those of your Royal College. There's been an evolution to more particular underwriting in terms of what is the range of things that you have declared to be. So practitioners will be familiar with a document called the statement of facts, where they go into detail as to what they do by way of their practice. And if what's going on is not being specifically declared, there's a breach of an express condition. So, in terms of insurance contract law, the more specific the breach in terms of the declaration on a contract, the easier it is to land in exclusion. So it happens through two ways, and there's been an evolution to more specific underwriting in terms of the shopping list, the things you do, and if what has happened to cause a claim is not on your shopping list, that's a problem. More general underwriting, there's a breach of what they call general conditions, but either way, there is a lack of contract certainty, which is as far as we need take it for today.

SPEAKER_02 5:32

Is there just from an insurer provider perspective? Why is there such a gap? Is it because the sector moves much faster than they want it, or is it a little bit more uh willful than that?

SPEAKER_00 5:49

That's a very delicate way of putting it. I don't think it's willful, I think it is uh it's a lack of willingness to put resource in and not really knowing where to start most of the time. I mean, again, and we can talk about the process by which we've started to get comfortable with off-license uses of medications. So it's not the same as a full new medication, clinical trials, and so on. We always talk about this idea of informed consent.

SPEAKER_01 6:22

Yeah.

SPEAKER_00 6:22

So the risks must outweigh the benefits. So you must know what the benefits and risks are. Well, this is good for this, but um I'm I think it might be good for that, so you know, have a bit. There's still a certain level of trial in there. There's other reasons why people think that it might be good for that. And there's a number of people who might have tried it before in other bodies of evidence. So, in fact, you know, it might sound all sort of wild west that we'll just do off-license, we won't just do off-license, we work really quite hard. Um we work with somebody I've known for years who's he's a pharmacist by background, and he helps us with all the research. Now, interestingly, the whole sort of way medicine's gone is these RCTs, randomized controlled trials, are seen as the pinnacle. And so to get a classic drug approved, you have to go up through the sort of pyramid of approvals, and then you have to get through all the human RCTs to get it approved. Now, if you think about integrative functional and personalized medicine, it's very hard to do a whole randomized controlled trial on personalized medicine. So you have to start to think about the world in a different way. So we've actually based it on a very good paper by a South African lady, which has more of a wheel, so she has different factors with different levels of evidence. So you can work out biochemically that you think it should work, you can work out anecdotally that it has worked, you can report your own tests and trials as to how it has worked, and a number of different factors, and where we see different elements pointing in the same direction, we draw quite a lot of comfort that that is effective. So it is it is a little bit experimental, it is a little bit testing, but done well. It's can it can produce good results now. Both ourselves and in fact, when I went to the Nordic Labs conference, they highly encourage all of their practitioners. Nordic Labs, they do medications, all of their stuff is supplements and tests. But again, they massively encourage all of the people who use their products to publish results because that body of evidence is all supportive of these new techniques that we distribute to our 138 countries. So there's quite a lot of stuff going on around the world, so it's not just UK, there's quite a broad body of evidence to draw from.

SPEAKER_01 8:50

So I'm just gonna offer two small anecdotes on that. One is there's an instrument that is allegedly medical negligence underwriting in the broad market. So there's still this disproportionate reliance on income as a proxy for risk on the basis that if you do more procedures and earn more, you're somehow more risky, or there is a direct correlation between underwriting treatment and income. And one of the things that functional medicine demonstrates in space is that that isn't a reliable proxy, you know, you need to get to the detail as to what's going on. My second example is that we work very well with a well-known functional medicine clinic in London, and the relationship is such that there's a dialogue when they want to do something new by way of a procedure. And one of the things that really triggers me is you know, when the doctor will tell you that there's a cohort of treatment, and then that triggers an enhanced monitoring program, Dr. E. Yes, and he knows he doesn't know all the answers, so a patient will have two or three times the amount of monitoring in terms of consultations, but also the scope of what they monitor is increased or honed. And that to me is a very different risk to saying, well, yeah, this you know is turnovers X, and therefore the printing must be Y.

SPEAKER_00 10:15

We've talked about these headlines and all these new magic treatments that get talked about in the headlines, and one of the things that was really emerging now is a set of substances called peptides. Peptides are very short-chain amino acids, and amino acids are the building box of proteins in your body. Peptides are these uh signaling molecules, so they basically tell your body what's going on and what it needs and what to do, and so on. So they can be enormously powerful in all sorts of ways. Now, one of the most popular is something called BPC157, and that simulates recovery. So if you've moved into the gym and torn your shoulder or whatever, if you take this stuff, then it can massively enhance your recovery time. The problem with it is you don't know what else it does. It's signals in if you think of the body as all these biochemical loops that then interrelate to each other and so on and so forth. And so BPC 157, you know, it enhances that recovery, you don't know what other things it affects, and then even from there, all the things it affects will affect other things and other things and other things. So you you don't know what he's doing. The guy who was out with all this stuff, I need to pharmacist. I actually know him from the time when I program computers very badly for a short period of time. And he's described peptides as the machine code of medications, basically. So what I do know from the time when I program very badly is machine code is the most fundamental level of programming. You're directly telling the processor inside the computer what to do. Uh it's enormously powerful, but if you get it slightly wrong, it's in the computer just dies basically, and you can think of peptides in that context. So you have to be enormously careful, and that's why we're happy to work with our best practitioners because they know that they don't know the story, as Roger says. So they will try things on the basis that they know so much, and they'll try it on the basis of, well, I think I know what else it might affect, and I'll have to watch that, I'll give it in small doses, and I will watch all of these factors very carefully. And if anything's going remotely off track, I'll stop it and I will only do it for a fairly short period of time. It's exciting because you are helping people push forward the boundaries of medication, which we're really excited to do. But it's interesting if you can work with the right practitioners, you can help them to do that. Clearly, those peptides are very powerful and very exciting and quite unregulated. And I fear that there's going to be a less scrupulous end of the market who are going to be selling all this stuff as wonder drugs for huge amounts of money and not knowing what they're doing. Our plan is to keep well away from that end of the market.

SPEAKER_01 12:51

Or you'll be able to buy it on Amazon or something. So I think the other thing I would say on that is that for us, then that feeds through into how you deal with informed consent in those circumstances. So one of the things that we can, and I'm going to use the word guarantee, bear in mind I'm a claims guy, don't use the word guarantee lightly, is that if you come and inshore with us for functional medicine and something goes wrong, whilst you're feeling flat on the floor over someone suing you, what you will not have to contend with is the fact that your underwriter will be wanting to withdraw a policy cover based on a lack of a proper presentation in terms of what you were doing, etc. etc. A breach of reporting or policy condition in terms of underwriting disclosure. I think we can offer that as a guarantee, which is quite an important, which is quite a stern test to set ourselves. But I will guarantee that when things are that black, we will not add the icing on the cake of saying, oh, by the way, your insurer would like to withdraw cover. That's the first point. Second point is that if you've got this leading edge, almost quasi clinical trial thing, which is perhaps a poor analogy, it's not quite that, is that that has to be reflected in the honesty and informed consent. So if you don't know what all the battery of side effects will be, never mind being able to quantify them, you have to say that. There's this interesting dynamic with doctors in my experience is that they feel under pressure to know all the answers, and by definition, you can't. So the clever practitioners don't even try to do that. They will tell you what their clinical experience is and what they're certain of and what they're less certain of and what they know nothing of. And it doesn't mean that you can't have informed consent, it means that you have to place an extra risk on the patient to say, I really don't know what the consequences are, but that's why we're going to monitor them this way, and that's why the consent will say, I'm I'm certain and you know, I'm confident on this, less competent on that, don't know anything about the other. And that isn't a sign of professional weakness, quite the opposite. And those doctors that get themselves into a pickle generally want to try and answer all the questions, and it's another feature of not being able to say no. You can't know all the answers, and don't pretend to, and be honest with your patient. Informed consent is underpinned by professional honesty, and I don't mean that disrespectfully to doctors, but don't pretend that you know all the answers when no one does. Um, functional medicine is right at that edge.

SPEAKER_02 15:24

One of the other things which reminds me of an earlier discussion around uh the uh GMC complaints of procedure is uh understanding that you know when you are working in an area that is really forward thinking and you're pushing forward, that actually the rest of the medical profession isn't. And so you know, a GP will not know the particular use of certain off-label prescribing, will take a look at what you've done and immediately say that that that is incorrect or that that's not how it should happen. But that comes as a little bit of a surprise to uh some of the people who are so deep in this and so uh knowledgeable. And of course it helps that you have a uh if you've got a body of evidence as well, like you talked about the Nordic level things, but you also have a number of other practitioners who uh are very clear that you know this is even though this is uh off label, you know, prescribing that this is a well-known uh way of dealing with a particular issue or or treating something. What how do you help people avoid that issue? How do you help you know practitioners who are working so far ahead understand that that they there is this like extra burden on them to uh show what the you know to it particularly when a if a complaint comes along and they've got to put it to a layperson, got to put it to a sort of a general medical practitioner, exactly what it is that that they're doing.

SPEAKER_00 16:52

That's a very difficult area. And it's you see, even in in certain things and between certain professionals, just this huge split, and it depends, you know, all your training and your knowledge. To me, the the most salient case that I've seen is within women's health as you get to the menopause, you can think about hormones and hormone replacement and all that sort of stuff now. The most central hormone is ultimately the thyroid. Women's menopause quite often have some kind of thyroid imbalances and thyroid problems. Uh just talking about what I've learned from chatting to a few people. But again, the classic NHS treatment is to give a substance called T4, which is the end result, so it's what the body produces, but that's actually quite toxic and uh it's not particularly good. It's just what people have discovered on the way. And in fact, what's quite often better is to uh give the precursor a substance called T3, which is the building blocks for T4, and then that uh gives the body what it needs to go and produce what it needs for itself, and that's a better way of doing it. And then there's desiccated thyroid, which is is pink thyroids, which again boosts all that process. Now, if you talk to a range of doctors, and I did a sort of poll. Now, no doctor would really say publicly about it. Um I put it out on LinkedIn, a bit of a poll, and I got a number of personal messages back, and that was everything from I've been doing this for 25 years, it's the most straightforward thing under the sun, to I wouldn't go near that with a barge poll, I have no idea what I'm doing. Um it could knock the body completely out of balance, and here are all the consequences, and so it's a little bit of partly what we do is and partly what the insurers trust us to do is the risk is down to the knowledge and skill of the doctor to a large extent, and that knowledge and skill varies doctor to doctor. Now, as you say, the problem that you got is the doctors have been doing this for 25 years, and for them it is just every day they've been doing it successfully without complaint for 25 years. They probably see it as absolutely normal and low risk. If they get a complaint and it goes to another doctor who is in the, you know, that's crazy. I need to leave that to an endocrinologist, the experts. This is the riskiest thing under the sun. The first thing they're going to say is, Well, what the hell is this doctor doing using that stuff? So you've had to deal with that kind of issue.

SPEAKER_01 19:20

Yeah, so I think the touchstone for me is is there a body of a supportive opinion from colleagues? And the risk you always run is that question being asked to an echo chamber because those that would be broadly supportive are on message with what functional medicine is trying to achieve, and they're already halfway in the room, if not in the room. So to me, the benchmark is if there is a broad consensus or a consensus amongst functional medicine colleagues. And I told Chris this before when I worked for one of the medical defence organizations and we did a lot of defence work for general practitioners, it always made me smile when a claimant lawyer would, as a way of demonstrating how poor they'd been through an orthopedic procedure, sent me a breach of duty report from a consultant orthopedic surgeon. So then I did just send it back saying, I don't know why you're sending me this, our chap's a GP. Why are you seeking to judge him by the standard of an orthopedic consultant? And I think if there's an opinion that's broadly supportive, if someone is literally trailblazing out and they are only in a cohort of one, that will require Chris and I to have some particular underwriting treatment with the underwriter, we can do, but we need to know that we're in that position as opposed to a consensus. So within the functional medicine community, this whole T3 T4 thing is not really a discussion, but it's a whole life issue compared with conventional medicine. Now that's fine in terms of a negligence claim because, in terms of litigation, risk, and evidence, that has a way of coming out in the wash. Where it's more problematic is where the GMC insists on the conventional burden of proof and will consider a functional medicine doctor as a little more than a snake oil salesman. So that's where it becomes slightly more difficult. And there's a difference between a defensible position ultimately at a GMC hearing and one that we can be confident at dismissing at what we call the committee stage, and that may be something for a subsequent episode, but there are various hierarchies of decision making based on a reasonable prospect of success within the GMC and the GDC. And the problem is that for a functional medicine practitioner, if there's insufficient number Gravitative supportive opinion. That's not to say that you won't succeed, but you will get higher up the hierarchy of decision and tribunals before you're ultimately let out. So, again, if people are worried about that, that's part of the overall conversation we have with them. Our third agenda item for today will get into precisely one example of how that's played out. So, candidly, if you're thinking about disciplinary proceedings, you're more likely to get to what we're called an interim orders tribunal quicker, which can have consequences. So, again, rather than scrambling around for supportive evidence, once a complaint's been made, we're very keen on saying to people, well, where is the body of opinion within functional medicine, whichever particular area of medicine that you're dealing with, and how does that relate to what we think the GMC are going to use by way of a benchmark on terms of conduct? Don't forget the GMC is an odd organization. Is that in functional medicine? I've had more complaints via the GMC triggered by a fellow medical practitioner than the patient, right? So you need to understand that the GMC is one of these very odd sort of Edwardian type organizations that give credence to third-party complaints. Yeah because it holds a torch for professional standards and how the public perceive the profession. So it's perfectly logical in their mind to receive a complaint and investigate and administer whatever disciplinary process or retraining or whatever they think is appropriate based on a complaint by a fellow medical practitioner. And the motivations for a complaint from another practitioner are wise and varied. But you need to understand that. And again, we're attuned to that in terms of where we think these cases need to be evidenced before these treatments take place.

SPEAKER_02 24:04

So for anyone who is in the process of uh undertaking off-label prescriptions on a regular basis, uh, there are a number of things to immediately look at. Firstly, that uh there is no clause in your insurance provision that uh explicitly excludes any kind of off-licence or off-label uh medication. Also, then to have a conversation uh with yourselves or with your insurance provider about uh where you sit within uh functional medicine versus uh general medicine as well, and whether you will need to have this additional burden of proof or you will need to look at these things in case an issue like that comes up, and then also your processes in place to make sure that there is that element of informed consent and honesty around that. Is there is that broadly speaking, the number of action they should take? Is there anything more than that?

SPEAKER_01 24:59

Yeah, I think just one final example, then I will be quiet. Is that one of the things that's a common pitfall on the cover is that you know there's a levels of cover in terms of supplements and wellness, and the tipping point is prescription of medication. That's quite an important policy coverage tipping point where so many of the kind of wellness therapy policies that include medics and non-medics have an exclusion on prescribing.

SPEAKER_02 25:32

Right.

SPEAKER_01 25:33

And then we get into the definition of what's a prescription, which again is something we may need to cover, but it's not just writing a script that you take to the pharmacy, it's broader than that. So again, that's a pitfall that lots of people fall into.

SPEAKER_00 25:50

One thing to keep in mind is insurance is only effective at the end of the day if what you have done is defensible in court. So if if the insurer cannot see any path to a defence, some kind of defensibility, that's when they are very likely to withdraw cover. They just see that they're throwing money down the drain, basically. So it is all about uh you know what evidence and what support can you draw on for your actions. Now, you know, we will really go that mile to find that kind of evidence and that support, and we've built networks and communities and discussions to you know, we really want to support people who are driving those boundaries. We spend a lot of time out at the conferences and out talking to people in some of our original clients have been very kind with their time in terms of just explaining how it is and what they do and how it works. So we will put in insurance to say, yeah, we can insure that. If we say we can insure that, that's because we are very confident that we can put up a defence. I think if you're just a general insurer, then again it's down to something we covered in a previous episode of, you know, ask your insurer what happens if I get a claim. Do you really think you could defend me for this action?

SPEAKER_02 27:09

So it requires you, if you're working in this area, you need to be proactive around firstly checking that you have that cover, but also that you have the grounds for defensibility.

SPEAKER_00 27:19

You need to understand what it takes to defend your actions. And that's brought back to your previous question in some ways of really understanding what backs you up in terms of doing what you do. You have to put it into that context of defensibility. And again, we will work with our practitioners on what is it you want to do, what is the evidence to support it, and do we think that's defensible? And if we do, we can generally get it insured.

SPEAKER_02 27:45

That's a great place to wrap that up, uh, this whole area of labor prescription. And we'll probably come back to this in another episode as well, because I think there's so many other aspects to this that probably need looking at. And if you're listening to this and you have further questions, you can of course get in touch with us and we will have ideas for future episodes and anything else that you want to hear. But for the meantime, thank you very much, and we'll see you on another episode. Thanks, Greg. Thank you for listening to Confidence to Thrive. Before you go, please rate, review, and subscribe to Confidence to Thrive on your preferred podcast platform to help us spread our message to others who are making a difference in private healthcare. This podcast was brought to you by Our Litity, a Twitter advisor to support your business ambitions. Our City Advisor Practitioners own to not know how healthcare practices are mitigating risks so your business can thrive. Learn more about how Alicity can support you by finding the link in the show notes or visiting our t.co.uk.