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INSIDE HEALTH

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Programme 6.

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TX:Ìý 06.10.15Ìý 2100-2130

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PRESENTER:Ìý MARK PORTER

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PRODUCER:Ìý FIONA HILL

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Porter

Coming up today:Ìý Caesarean sections - and new guidelines for women having another baby that should help allay concerns that they will probably need to go under the knife again.

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And auto-injectors - over 200,000 people in the UK are thought to carry adrenaline injections for treating life threatening allergy to things like wasp stings and peanuts. But how effective are they?

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Clip – Robert Boyle

Some of us press harder than others when we’re pressing the needle into our thigh, some of us have more fat under our skin than others and the devices available have varying needle lengths.Ìý And studies have shown that in some people that’s not long enough to get it into the muscle.Ìý So if you inject adrenaline just under the skin or into the fat it’s absorbed very slowly, it’s probably not a good treatment for a severe allergic reaction.

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Porter

More on auto-injectors later in the programme, but first we take a closer look at the latest arrivals to the murky world of drug abuse.

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Pregabalin and gabapentin are prescription only medicines designed to help with a number of problems, but it’s their painkilling properties - in particular in nerve related pain - that has resulted in an explosion in their use.Ìý The number of prescriptions for the drugs in the UK has risen dramatically in recent years and an increasing number of pills are finding their way on to the black market. Patrick – that’s not his real name - abused pregabalin while in prison, but his habit started well before that, along with many others.

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Patrick

Do you wanna buy any gabas, do you want some pregabs?Ìý Basically you can be walking through a town and someone will stop you asking if you want to buy them, so they’ve become that popular.Ìý I was taking them outside but when I went to prison they become top of the list for people to take because you’ve got nothing to do but think in there and when you take them they seem to take away all your problems and the day seems to go really quick.Ìý Just gives you a feeling of euphoria and energy and it feels like all your problems just go away.Ìý You just tell the doctor you’ve got a bad back or you’ve got severe back problems and stuff and eventually he’ll put you on them, do you know what I mean, it’s that easy really.Ìý They queue up for the healthcare and they’re just hiding them under their tongue and then just spitting them out and selling them on because it’s only a little pill, so it’s easy to get out.Ìý They’re very… and as soon as you get them they’re gone.Ìý An ounce of tobacco you can get one for.Ìý People are getting them like you know on tick and they’re getting further and further into debt, they’re getting loads and they end up with owing loads of ounces and they end up going down the block for protection because they can’t pay the debts off.Ìý There’s beatings, there’s people basically with serious problems because of it.

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Porter

It is estimated that one in 35 prisoners in England is now prescribed pregabalin or gabapentin - a situation likely to be mirrored across the rest of the UK.Ìý Dr Iain Brew is a prison doctor concerned about misuse of the drugs - so does Patrick’s experience sound familiar?

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Brew

Oh it certainly does yeah.Ìý I mean for the last six or seven years we’ve been seeing more and more patients coming to see us asking for pregabalin and very often they’ve been prescribed it outside and I’ve spent a lot of my working life working with people to try and help them to get off the drug.

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Porter

How are people in prison getting them – I presume there’s two ways, I mean there’s the type of prisoner who comes in who’s already being prescribed them but then there are other people who try and get you to prescribe them to start them.

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Brew

A surprising number of people come in already taking them and if they’re on pregabalin we’ll also seek to wean patients of it unless it’s absolutely essential.Ìý But you’re quite right – we see an awful lot of people complaining of I broke my leg 10 years ago or there’s a plate in my arm and it’s really hurting and they’ve learnt the terms like shooting pains that make you think of nerve pain for which gabapentin and pregabalin are prescribed.

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Porter

How much pressure did you come under as a prescribing doctor when you were in prison, did you feel threatened at any stage?

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Brew

I’ve come under quite a lot of verbal pressure and I’ve been threatened with legal action when I wouldn’t agree to prescribe.Ìý But there are cases where doctors have been taken hostage even or physically threatened.Ìý I’m fortunate that nobody’s physically threatened me but I am aware that that’s a problem and clearly that’s a problem to GPs outside of prison.

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Porter

If a person stops these medicines, I mean say they go into prison and you refuse to supply them anymore, can they stop them suddenly, do they get withdrawal symptoms?

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Brew

Yeah they certainly do.Ìý The doctors’ bible, the British National Formulary, says that the drugs can be stopped over the course of one week but we’ve found that people have really unpleasant effects, rebound anxiety, they can’t sleep, they do feel restless and agitated.Ìý And we’ve found that reducing them gradually over four to six weeks seems to work quite well.

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Porter

What’s happening outside of prison?

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Brew

Well we know that the number of prescriptions has skyrocketed over the last few years.Ìý Speaking to colleagues and community drug treatment services they describe patients who are getting on it much more easily and unfortunately we’ve seen an increase in the number of drug related deaths where pregabalin has been mentioned as a causative drug.Ìý Very often patients are taking a number of sedating drugs and sometimes sadly pregabalin can be the straw that broke the camel’s back as it were.Ìý But we’ve also heard of gangs breaking into pharmacies and targeting pregabalin, leaving the other drugs that you might expect to be stolen on the shelf and just taking pregabalin.

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Porter

Do you think the problem’s going to get worse?

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Brew

If the current trajectory gets followed then there’s no doubt it will get worse and unfortunately with the increase in drug related deaths I suspect that that is the tip of the iceberg, I suspect that if pregabalin was sought as one of the problems in toxicology testing after a drug related death it would be many more deaths.Ìý I’m very worried about it.

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Porter

Dr Iain Brew.

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Public Health England has been so worried about the problem that it wrote to prescribers highlighting the abuse potential of pregabalin and gabapentin, and reminding doctors to prescribe appropriately. Dr Cathy Stannard, a consultant in Pain Medicine at Southmead Hospital in Bristol, chaired the expert group behind the PHE letter.

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Cathy, Iain is obviously concerned about abuse of these drugs - and not only in prison. Do you think they represent a big problem in the community too?

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Stannard

I think they do, we know not only from prisons but from people working in drug and alcohol services in the community that gabapentin and pregabalin are emerging as a very common drug choice, particularly in the context of polysubstance misuse.Ìý Certainly since about 2006 the misuse of pregabalin has emerged in the medical literature.

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Porter

The Public Health England letter that went out to dispensers talked about pregabalin and gabapentin but when you talk about these talks it’s often pregabalin that comes to the fore, is this a more popular drug for abuse?

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Stannard

I think it is.Ìý I mean there are a number of properties of pregabalin in terms of how the body handles it that would make it a more intuitive drug as choice for misuse.Ìý So it is, as we say, more bio-available, which means that most of the dose you take by mouth actually gets into the system.Ìý Whereas with gabapentin there gets to be a sort of ceiling whereby if you take more you don’t get more on board as it were.

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Porter

How addictive are these drugs?

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Stannard

Well it’s quite interesting because the properties of the drugs one wouldn’t expect it to be a particularly addictive drug.Ìý However, the emerging literature does suggest that it has some interaction with other substances in the reward pathway, if you will.Ìý So there does seem to be a biological rationale for the observation that people find it difficult to stop these drugs.

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Porter

Does that apply to people who are taking them for therapeutic purposes as well, say I’m prescribing it to somebody who has pain following their shingles for instance?

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Stannard

As far as we know for patients who take these drugs therapeutically in sensible doses they are unlikely to come to harm, or certainly that’s what the observational literature tells us to date.Ìý What we do know however is that if somebody has a current or past history of addiction they are more likely – statistically more likely to run into harm with these drugs.

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Porter

The letter sent out by Public Health England asked prescribers, like myself, to use these drugs appropriately, do you think we’re using them appropriately at the moment or are we overusing them?

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Stannard

This is a general comment that might relate to lots of classes of drugs used particularly for pain, persistent pain is inherently very, very difficult to treat and there’s probably no drug that helps more than a third of patients.Ìý And the sorts of benefits that people get are modest but important in terms of allowing people to improve their quality of life and get on with things that they maybe couldn’t do before.Ìý I think though that this leaves a population of patients who have pain that is untreated and it’s very tempting then to try drugs even if they’re outside their licensed indications.Ìý So certainly in the clinic I will often see gabapentin or pregabalin used as an add on drug, say for a difficult back pain or for a pain that is not clearly of nerve damage origin which is the indication for the drug.

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Porter

How effective are these drugs?Ìý There’s a general perception in the community that these work very well, does the science back that up?

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Stannard

Not really, they work no less well than other classes of drugs used in pain and they have sufficient evidence to support their effectiveness, that it is definitely worth trying these for the management of neuropathic pain which is a very difficult and disabling condition.Ìý I think it’s quite important for people being prescribed the drugs to understand that there is no guarantee that they’ll work and they’re unlikely to take people’s pain away completely.Ìý But for those patients in whom they do work they can get a benefit which does make a difference to quality of life.

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Porter

Experts like you that I’ve spoken to in this field seem very worried by this problem whereas a lot of my colleagues seem blissfully unaware of it, do you think there’s enough awareness out there?

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Stannard

I would say that there isn’t and I think it’s a well-trodden path.Ìý Many drugs that we now know to be worrisome took a long time to get on people’s radar as being problematic drugs.Ìý Certainly when I talk to pain clinicians there’s not a great awareness.

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Porter

Dr Cathy Stannard. But let’s leave the last word to Patrick, who has managed to kick his habit.

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Patrick

I guess I just put my mind to it and I just gradually slowed down on them.Ìý Instead of taking 10 I took eight, then seven, then I went down on them like a pyramid thing and eventually it was just one a day and then I stopped.Ìý It’s been a lot better, I’ve felt like the old person, the old me coming back again.Ìý You see I lost my family and everything because of them so people need to be aware.

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Porter

And there is a link to the Public Health England letter warning prescribers about the problem on the Inside Health page of the Radio 4 website.

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Now some reassuring news for women who have had a Caesarean section. Many of whom have, in the past, been made to feel that if they get pregnant again they are almost bound to end up having another Caesar. Which is what happened to Sara.

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Sara

When I said I didn’t want a C section and that if I did have a C section then I at least wanted to go to my due date and a few days over, I wanted to give this baby a chance to come naturally and if we have to have a C section then I will, I will always listen to the doctors and I’m going to take your professional advice.Ìý And the answer was yeah okay we could maybe give you a few days, as long as you know the risk you’re taking and what could happen to your baby.Ìý This was quite early on, about 20 weeks, and they just planted a seed of fear in me, which at first I was – I was annoyed with them at first, I was like how dare they say to me that I’m risking my baby.Ìý But then I thought about it and I thought well am I risking my baby?Ìý And it just – that just sits with you.Ìý I felt disappointed in myself that I wasn’t strong enough to say to them, come on let’s go to 41 weeks and see if she can come naturally.Ìý You feel undermined and that there’s no confidence in you to do what’s totally natural and I thought very empowering because the women I know that have done it it’s a brilliant start to motherhood.

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Porter

Sara who had a Caesarean section eight weeks ago when she was delivered of a bonny baby girl. And talking of bonny, listening to that in our Glasgow studio is Dr Margaret McCartney. Margaret, the Royal College of Obstetricians and Gynaecologists have just issued new guidance on natural births after a previous Caesarean. What do they say?

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McCartney

This is brand new guidance, just out from the Royal College of Obstetrics and Gynaecology.Ìý And what they’re now saying is there should be a very clear pathway when a lady has had a Caesarean section in the past that she has a proper discussion with an obstetrician as to what she would like to do in the future, it should not automatically be another Caesarean section, she should be given good information and given the options and be allowed to choose for herself what the best means will be for her.

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Porter

Because traditionally if you’ve had a previous Caesar it’s often accepted that you’re probably going to need to have another one, but is that the case?

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McCartney

It’s very interesting.Ìý So in the 1950s only about 3% of births in England were by Caesarean section.Ìý By 1980 it was up to about 9%, in 1990 up to 12% and in the year 2000 it was 21%.Ìý In 2013 26.5% and it’s elective sections that seem to be picking up rather than emergency sections, that’s when you plan to do a Caesarean section rather than suddenly needing to find that you have to do something quickly in an emergency.Ìý So something has been happening.Ìý The rate of Caesarean section has been going up.Ìý And the concern is, really raised by the World Health Organisation, NICE and the Royal College, is that some of these Caesarean sections are not necessary, for some women they would have been able to go on and have a vaginal birth after Caesarean section without any more risk to them, compared with having a Caesarean.

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Porter

So what happens if you’ve had one Caesarean section and you want to try again, as many women do, what are your chances of having a normal vaginal birth next time?

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McCartney

Well the Royal College say that after one Caesarean section you will have a success rate of about 75% of giving birth vaginally, which is around the same as first time mothers.Ìý If you’ve previously had a vaginal birth and a Caesarean as well your success rate is up to 90% and if you’ve had to two previous Caesarean sections your chances of a vaginal birth are around 71%.

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Porter

So how’s that likely to change current practice?Ìý I mean that suggests that – I mean you’re likely to be okay.

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McCartney

Well Just over half of women who have had a previous Caesarean section will go on to try a vaginal birth next in the UK and I think what the Royal College are trying to do is make sure that that option is offered as standard to every woman, so they have a chance to make an informed choice about it.Ìý What’s really good I think about the guidance is that there’s no blame or guilt attached to it, it’s very much about saying to women look if you would like to go on and have a vaginal birth and as long as you don’t appear to have any increased risk compared with anyone else there’s really no reason why that shouldn’t be attempted, you can start talking about it, they suggest, after your 20 week scan to start having a discussion about it and by 36 weeks to have tried to have made a good decision.

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Porter

But the point is of course here that it varies from individual case to individual case but generally it’s fine to try for a normal vaginal birth but there will be some women in who it’s not suitable.

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McCartney

Yeah absolutely and I think that’s what’s really good about the tone and the language and the guidance.Ìý And what the Royal College have told me is that for women considering a vaginal birth after a previous Caesarean section they can be assured that it is a clinically safe choice for the majority of women, not for everyone but for most women.Ìý So I think it’s definitely an option that’s good to have.

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Porter

And if you are planning to have another baby after a previous Caesarean there is link to the revised guidance from the RCOG on our website.

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Listener Jessica e-mailed insidehealth@bbc.co.uk to ask about how to take family history into consideration when you don’t know anything about your family:

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Jessica

I recently had a heart health check which suggested I was at very low risk of a stroke or heart attack - just 2.2% over the next decade – hooray - but I couldn’t answer the family history question, because I was adopted. What if I do have a strong family history of heart attack or stroke, would it alter my risk much?

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Porter

Margaret not knowing your family history is surprisingly common and you don’t need to be adopted like Jessica to struggle do you?

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McCartney

Absolutely, so people might often have perhaps an early death through a non-health related event like an accident or something like that in their family history and it’s a problem not just in cardiovascular risk assessment but also say, for example, in cancer or genetic risk assessment where perhaps you’re not aware of a certain branch of your family or perhaps you were an only child and don’t know what your sibling history would have been when it comes down to diseases.

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Porter

So our default position in such situations would have to be that we don’t think there’s a family history, no evidence of a family history, so we’d leave the box unticked.Ìý Looking at Jessica’s case with regards to her heart, 2.2% very good, what difference might it have made if she’d had a strong family history of heart disease?

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McCartney

So what I did was – and it’s something that Jessica could do as well or any other listener – is I went on to the qrisk.org website where you can input the data that you know and that will work out your chances of a heart attack or stroke over the next 10 years.Ìý And I basically played about with numbers.Ìý So on one set of information I put in the data that would generate Jessica’s risk of 2.2% and then I put in the same data but I added in a positive family history of cardiovascular disease.Ìý And that brought up Jessica’s risk to 3.5%, so still pretty low.Ìý And just to flag up that the people without a family history that data set, that group of people, these will include people who perhaps have a family history but don’t know it.Ìý So there’ll be people like Jessica who’ve been in that data set to make up the numbers when they were generated.

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Porter

Thank you Margaret. And there is a link to that QRisk calculator on our website.

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This worried father wrote in to Inside Health with a question about adrenaline auto-injections - like Epipen and Jext - carried by over 200,000 people in the UK with severe allergies.

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Father

My teenage daughter carries an adrenaline auto-injector for her peanut allergy and I’ve been discovering that there are serious concerns about how these devices work in an emergency. For example whether the needle is long enough and also whether the adrenaline reaches the muscle properly.Ìý Our GP just said I was worrying unnecessarily. Am I?Ìý How can I find out for sure if the pen will work when she needs it to? I have helped her use the device in the past and thankfully, she didn't die...but I don't recall seeing any dramatic improvement until the paramedics arrived and injected her with their own supply, by which time she couldn’t stand or speak and that was really scary.

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Porter

Well the serious concerns about auto-injectors mentioned there relate to an investigation by the Medicine and Healthcare Products Regulatory Authority, following a coroner’s recommendation after a 19 year student died of anaphylactic shock caused a by a nut allergy – despite her using her auto-injector. And they have also been reviewed by the European Medicines Agency.

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The devices go back to the sixties when they were developed for soldiers to use during nerve gas attacks allowing them to self-administer the antidote. But is a device designed to be used by fit trained young men, just as suitable for use in children and adults of widely varying size and weight?

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Dr Robert Boyle is an allergy specialist at St Mary’s Hospital and Director of the Paediatric Research Unit at Imperial College, London.

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Boyle

Adrenaline auto-injectors such as Epipen or Jext or Emerade are meant to be lifesaving devices. They’re quite simple devices and they’ve had essentially relatively little innovation in terms of changing their design over the last 40 years.Ìý The bottom line is that they’re not absolutely perfect as a lifesaving device to use in the community.Ìý The drug they contain is the best drug, as far as we know, for treating severe allergic reactions but the recent European Medicines Agency review of adrenalin auto-injectors was sparked by concerns that they really may not be appropriately designed, they might not be doing the right thing when we use in the community to treat people having severe allergic reactions.

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Porter

And the concerns seem to centre around the fact that the medicine that they contain, the adrenaline that they contain, wasn’t getting into the right place.Ìý So perhaps you can explain where it should have gone and where it was going.

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Boyle

Yeah, well the adrenaline’s meant to get into the muscle and then be absorbed into the bloodstream which should happen within a handful of minutes if it’s gone straight into the muscle.Ìý And severe allergic reactions can progress very, very fast, so getting the drug into your system within a few minutes is important.Ìý So it’s meant to get into the muscle, the concern is that we’re all different shapes and sizes and the distance between our skin through the fat into the muscle varies a lot between individuals.Ìý So it’s quite hard to make a device that will reliably get into the muscle instantly in an emergency situation for everybody.Ìý Some of us press harder than others when we’re pressing the needle into our thigh, some of us have more fat under our skin than others and the devices available have varying needle lengths, generally between one and two centimetres or thereabouts in length.Ìý And studies have shown that in some people that’s not long enough to get it into the muscle.Ìý So if you inject adrenaline just under the skin or into the fat it’s absorbed very slowly, it’s probably not a good treatment for a severe allergic reaction.

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Porter

What did the European Medicine Agency find, was there cause for concern?

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Boyle

Well what they found was an evidence gap really, there are very limited studies in this area and that’s partly because severe allergic reactions are unpredictable, they often happen in the community, hard to study them.Ìý And people haven’t really been brave enough to do a lot of studies where they induce severe allergic reactions in people and watch what happens, treat them, see what happens to the drug, they are generally considered high risk studies and haven’t really been prioritised.Ìý But that was one of the EMA’s recommendations was that we should really be doing more of those sorts of studies because we really do need to find out what happens to people during allergic reactions and how best to treat them.

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Porter

You’ve done your own study with parents of children who’ve been recently diagnosed with a food allergy, what did you do – tell us what you found.

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Boyle

Well what we were concerned about was the problem we see often in the clinic which is that people aren’t really confident in how to use their Epipen or other adrenaline auto-injector device and we just wondered how good is our training and how good are these devices in terms of the human factor side of things.Ìý So we took 200 mothers of children who’ve just been diagnosed with food allergy and given one of these devices for the first time and we trained them on one of two different devices, we trained them very thoroughly, much more thoroughly than might usually be done in a clinic because we had extra time, extra resources as part of the research project.Ìý And six weeks later we brought the mums back and we put them through what we called a simulated anaphylaxis scenario.Ìý So a scenario which felt a little bit like the real thing – we had a dummy the size of their child on a bed, we gave them a story about their child having an allergic reaction during lunchtime and we played an audiotape with sounds that the child might make if they’re having a severe allergic reaction and then we asked the mothers to go ahead and treat the dummy as if it were their child and video recorded them doing this.Ìý Now the mothers found this quite stressful and in that respect it was more akin to a real life allergic reaction than other ways of assessing this.Ìý But we really disappointed that six weeks after training the mothers less than half of them could actually do it.Ìý So the majority of the mothers were failing to administer adrenaline using their Epipen.

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Porter

And the sort of common mistakes they were making were what?

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Boyle

They would use the wrong end of the device, they failed to take the safety caps off, not press hard enough, some of them would have injected their own thumb and which is something we see in clinical practice not infrequently.Ìý So the usual sorts of mistakes and I think what they’re telling us that their devices they’re not optimally designed for the purpose we’re using them for now, so that more innovation is needed there in terms of making the devices easier to use in the field.

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Porter

But if your study’s representative and I suspect that the real world study might get even worse results than yours 60% of Epipens out there or the equivalent are being used by people who don’t know how to use them properly, so it doesn’t matter how effective the ingredient is it’s not going to help very much is it?

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Boyle

That’s right.Ìý But I think the important thing to bear in mind and just to keep the situation in context, especially in view of the particular details of your listener’s question, is that really very severe allergic reactions, dying from an allergic reaction, is fortunately extremely rare, it’s surprisingly rare really considering how common allergy is and how common allergic reactions are.Ìý If you have a food allergy your chance of succumbing from your food allergy in the next year is about the same as your chance of being murdered.Ìý And that is age specific.Ìý But the problem is that we don’t know – we can’t predict who’s going to have those very severe allergic reactions, they happen out of the blue and that’s absolutely terrifying for everyone involved and unfortunately totally unpredictable.Ìý And that’s why most people with food allergy are offered one of these pens, so people can have the confidence that there’s some sort of backup there if something really bad did happen.Ìý Now the problem you’re raising today in your programme is that is that peace of mind really real or how much peace of mind will it give you to have a device that only some people can remember how to use, and it may not have a needle that’s quite long enough for the particular person, one shot may not be enough for somebody who’s having a really severe allergic reaction.Ìý But I think in general it is the right drug and some people can give it properly and I think that’s why most people would prefer to have one.

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Porter

Since these have been around have they had a noticeable impact on the number of people who die from this sort of serious allergy?

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Boyle

Well it’s hard to judge that but we looked at the numbers of people dying from food allergy in the UK, we’ve got the most comprehensive database in the world here, the number of people on that database is small but the death rate has essentially stayed exactly the same over the last 20 years in the UK.Ìý And that’s in the context where we think that food allergy has been getting more common and certainly the number of people coming to hospital with allergic reactions to food is increasing.Ìý So it suggests that something about what we’re doing is working, whether it’s ambulances responding better, paramedics giving drugs faster, people using their Epipens more promptly it’s difficult to say.

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Porter

What would you say to a parent then who’s concerned about their young child, how should they be using their Epipen and where should they be injecting?Ìý I presume the first thing is they need to get someone to show them who knows what they’re doing and that’s not always – I’m embarrassed to say that’s not always their GP or practice nurse either in the community.

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Boyle

Well I think – I mean the first recommendation that the European Medicines Agency made and it’s very sensible is that the manufacturers need to make better training materials and health practitioners need to make sure that their patients know how to use their devices.Ìý And people who are carrying these devices need to inform themselves so there are now much better written materials and online materials, apps, etc., from the manufacturers, so that you can remind yourself how to use one.Ìý The best way to remind yourself how to use your pen is to get a trainer pen, they’re free from the manufacturers and practise with it from time to time.Ìý If you’re leaving your child with somebody show them with the trainer pen, make sure they know how to use the pen.

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Porter

Dr Robert Boyle. And there are links to the official reports on auto-injectors on our website along with more information on serious food allergy.

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That is it for this programme, and for this series. Inside Health will be back in the New Year so please do get in touch if there is something you think we should be covering. ÌýUntil then goodbye.

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ENDS