prescriptions

A Miracle Migraine Machine?

Cefaly. No, it's not a village in Wales, nor is it a type of cheese (actually, it might be for all I know, but nevermind.) It is instead a new all singing, all dancing miracle cure for migraines, according to its manufacturers anyway. So, in our usual fashion, let's take a look at the evidence and see what on earth it is, and whether it is worth spending money on.

It's a medical headband device that you wear on your noggin, around your forehead. This means that you can easily pretend to be the Empress from the Never Ending Story. The downside is that you'll have to pay somewhere in the region of £250 to do so, plus electrodes and batteries. So, for that amount of money, you want to know that what you're getting is going to provide you with a bit more than simply cosplaying as a child-like film character.

What I love about pictures like this is that it's always perfectly made-up women in them. As if anyone can be arsed to think about makeup when they're vomiting everywhere and their head feels like its being crushed. 

What I love about pictures like this is that it's always perfectly made-up women in them. As if anyone can be arsed to think about makeup when they're vomiting everywhere and their head feels like its being crushed. 


It is essentially a TENS machine, which applies an electric current to the middle of the forehead via self adhesive electrodes. Anyone who has ever used one of those godawful Slendertone thingies on their stomach is probably right now recoiling in horror at the idea of having to endure such torture right between their eyes- I know I am. But first I suppose we need to see if it works- after all, migraines are horrible things which can massively impact on the quality of life of sufferers. Those who are desperate may be quite happy to have their foreheads electrocuted.

Its been approved by the FDA, which is nice. What isn't quite so nice is the fact that this approval is based on one trial- the one and only trial in existence, despite what the manufacturers would have you believe.

This trial included 67 patients who suffered at least 2 migraine attacks per month. Although small, this trial is well designed, with an identical sham stimulator being used as a comparison to the test product. After three months of daily 20 minute usage, the mean number of migraine days in users of Cefaly was significantly reduced (6.94vs 4.88, p=0.023), but were not significantly changed in the sham group. But here's the thing: the difference between groups was not significant (p=0.054).

There was significantly higher percentage of responders (defined as ≥ 50% reduction in no of migraine days per month) in the Cefaly group compared to the sham group (38.24% vs 12.12%, p=0.023).

There was no significant difference in severity of migraine.

Although some of the results in this trial are encouraging, it is limited by its very small size. It is worth noting that the authors and manufacturers claim that this trial proves that the product is effective at preventing migraine, despite the lack of a significant between-group difference in the primary outcome of migraine days.
Other papers have been published in the literature regarding this product, and the manufacturers try their best on their website to make them look like they are real trials. However, these range from letters, conference abstracts, experiments in healthy adults, and case studies- not robust clinical trials.

An uncontrolled survey of 2313 Cefaly rental users found that roughly just over half of patients were satisfied with the treatment and would be willing to buy the device. The rest of the patients stopped therapy- that's a pretty high number of people. There are a number of methodological and confounding problems with this study, so the conclusions drawn from it should be considered unreliable.

Being a rental user is one thing- at least they were able to try it out before taking the plunge and handing over a rather large wad of cash. In the UK, though, it seems that the rental option isn't readily available. £250 is an awful lot of money to spend on a product, especially when, for roughly half of its purchasers, its going to be used a couple of times then lie in a cupboard, forlorn and forgotten about. 

Let's have a think about compliance. To get the best results, you are supposed to use it for 20 minutes per day. Now, initially that might not sound like too big a deal, but if you work, have a social life, go to the gym, or spend every waking minute building a house in Minecraft, finding 20 minutes a day for something that could be, in most cases, painful, is probably pretty unappealing, and impractical. I can't see too many people who will be able to religiously use this product exactly as intended in the long term. I'm guessing that in most cases its going to go the way of that bit of exercise equipment that you bought 5 years ago and that you've used twice and now only trip over on occasion.

So to summarise: there is a little bit of encouraging data, though it's not as compelling as the manufacturers would like us to think. It's extremely expensive, impractical, and probably pretty unpleasant to use. Its an interesting device, but one that I am placing firmly in the "Yet to be convinced by larger trials" pile.

Hxxx
 

Water in a can now available on prescription. No, really.

No, its not a homeopathic sort of magic water this time, but instead Magicool.

Yep, remember when there were cheesy adverts on the TV all the time advertising this breakthrough, world's first spray? The website for Magicool even goes so far as to call it "heaven-sent". What in it? Well, water it would seem. I can't find any of the other ingredients listed on the website, save for a rambling explanation of how they still manage to get away with putting fragrance into it whilst claiming that it is an "unscented" product. Presumably it will have some sort of propellant in it too.


The theory is simple, and to be honest pretty good. When its warm, water on your skin evaporates, drawing out the heat. You feel cooler. So that's good. But its fairly impractical to keep having a cold shower every two seconds if you're at work or out and about, so Magicool is a nice portable option. Fine so far. 

However, Magicool have decided to go one step further, and start making medical claims with their Magicool Plus range. They're classed as medical devices (sound familiar?) so don't need to go through the rigorous clinical trials that licensed medical lotions or potions have to. But they're now apparently available on prescription, so there must be some evidence that they work, right?

The Magicool website is frankly appalling. But what I'm looking for is a plausible mechanism of action for why their products work, and some good evidence that they do work. Let's have a lookie, shall we?

Kinetic pulses? anaesthetizing? Vital deep cell hydration? adjusting pH? Despite its claims to be unscented, I am smelling pseudoscience at work. And what is with the text speak?! I've had emails from Nigerian princes asking for my bank details so that they can send me millions of pounds that are better written than this supposedly medical resource.

The evidence section appears to be a badly scraped together list of links from places like Trip Advisor and Yahoo Answers, where people have vaguely mentioned in passing that the product worked. But, dear readers, as we know by now, testimonials and reviews certainly do not constitute robust medical evidence, especially when lots of them are merely spam adverts posted on forums etc, as they are here. Again, there's no indication of what the ingredients actually are, so I have no idea whether or not there is even any plausibility in the claims above and beyond the fact that it might make you feel a little bit cooler.

So, if the manufacturer's aren't being forthcoming with any evidence, let's turn to the medical literature. This is made difficult, of course, by fact that I have no idea what is in it, other than water. Searching for the brand name brings up nothing at all, so it would appear that there is a grand total of no evidence whatsoever that this stuff actually works more than ordinary Magicool, or a shower, or standing next to a fan. The manufacturers are claiming that the product has "maximum therapeutic efficacy" on the basis of thin air. 


According to Chemist and Druggist, the availability on prescription is coinciding with a large advertising campaign. This means two things:We'll have to sit through more daft adverts filled with smug thin people on holiday cooling themselves down despite not even looking remotely hot (where's the red face and frizzy hair, eh?!) and that some patients will inevitably rock up to their doctors and demand it on prescription. 

The cost price to the NHS is £5.77. That doesn't seem like its going to break the bank, but I don't care how small an amount it is, frankly. There is a finite pot of money in the NHS, and we need to use every single penny of it wisely. If £5.77 is being spent on water in a can, that £5.77 can no longer be used to pay for something life saving.

Hxxx 

Prescription exemptions and the bloody Mail on Sunday.

Today, I feel ranty. So ranty, in fact, that I can't even think of a clever title for this post.

Why? because the Mail on Sunday has riled me up with this story about how pharmacies are failing to check exemption statuses of patients. I have been weak, dear readers, and I have allowed the Mail to affect my emotions.

As a pharmacist, my job is to make sure that patients get the right medicines, can use them safely, and have all the information that they need. My ultimate goal is to make sure that my patients stay as healthy as they can for as long as they can, and to improve their quality of life.

My role is not as a fraud investigator, but as a healthcare professional. Its up to the patient to ensure that their exemption is correct and up to date, and its up to me to ask to see proof of exemption, and to train my staff to do likewise. So that's what I- and many, many other pharmacies- do, day in, day out.

What if a patient says they don't have any proof of exemption? I go right ahead and give them their prescription anyway. What am I supposed to do? Say no, sorry, you can't have this inhaler until you go home and get your exemption certificate and bring it back to me. And then what happens when the patient has an asthma attack on the way back to the pharmacy, and without their medication dies? Funnily enough, I suspect newspapers like the Mail on Sunday would just as gleefully report on my failure as a pharmacist to supply life- saving medicine to a patient, and how I was just being evil and money-grabbing instead of thinking about patient care. So we are literally damned if we do, and damned if we don't.

Of course, we can cross the box on the back of the prescription, which means that a small, random selection of prescriptions may be investigated. But this process is pretty murky, and the details of it are unclear to the majority of patients, pharmacists, and pharmacy staff. We get little to no feedback of any cases which are identified as fraud through this method, so it ends up seeming pretty pointless. You spend years and years of dutifully crossing the box, and you never see it making any difference. Perhaps if this process were clearer, and we could more clearly see some results from it, this would spur pharmacists on to continue with the box ticking exercise.

Ever tried to confront someone about the fact that they may be committing fraud? Ever tried to do so over a counter, when you're working on your own and have a queue of about twenty people behind the person you are accusing? A pharmacy is certainly not the correct place for such things to happen in- the personal security of the staff, the workload, and the potential for a patient to have to go without their medicines all mean that its practically something that we cannot do well, without a massive overhaul of staffing and how pharmacies are designed.

I suspect the reporters at the Mail on Sunday haven't ever had to stand on one side of a pharmacy counter whilst a patient asks which of their medicines is the most important because they can't afford to buy all of them. I have, and its heart breaking. Prescription medicines in the UK are £7.85 right now. We're currently in a time when Atos are merrily declaring- sometimes on very shaky grounds- that people who are crippled by a variety of medical and psychiatric problems are fit for work, and are stopping their benefits. There are people out there who cannot afford to pay £7.85 per prescription item, through no fault of their own, and these are the people who are likely to be taking a variety of different medicines. Do I therefore withhold their prescription, or tell them which is the most important drug for them to take and send them off on their way with a sub-therapeutic drug regime that is going to make them even less able to work and find means of paying for their medicines? I can't imagine the hurt and shame that a patient must have to go through to admit that they can't afford their medicines, but I know I don't want to have to put an already unwell patient through that.

I've had a friend worry how he was going to pay for his prescriptions because of problems with his benefits, problems that he had no control over and were to do with mistakes at Atos. Do you know what I told him? Go to your usual pharmacy, tick the box, and don't say anything. I know that's wrong, but given the options: he becomes very unwell vs a small risk he gets a fine of £100 at a later date when he would hopefully be able to pay it, I'm sorry dear readers, but I'm always going to opt for the former. That may be, as the Mail so charmingly puts it "scandalously careless" of me, but it doesn't feel like it. It feels like I am caring for my friend's health, and that's my job, and my personality. What would feel "scandalously careless" would be to force someone with no income through no fault of their own to choose between food or essential drugs. 

Forgive me if I would rather give patients their drugs and keep them as healthy as I can. Do forgive me if I put the quality of my patients' lives ahead of the fear of prescription fraud, which I can do very little about anyway.

This whole system of exemptions and payment is outdated and needs an overhaul. In the meantime, branding pharmacists as lazy debt collectors and desperate patients as robbing prescription cheats doesn't help. As a healthcare professional, my need to provide vital medicines to my patients transcends petty demonisation by a scaremongering newspaper. 

Here's an extract of the Mail on Sunday's report:

 

"Dr Clare Gerada, chairman of the Royal College of GPs, called for a ‘fundamental review of prescriptions’. But a spokesman for the Royal College of Pharmacists said it was ‘not their job to police the Government’s prescription exemption system’, adding: ‘Guidance is very clear that pharmacists must put the clinical needs of a patient first, and not deny someone access to lifesaving medicines because they haven’t got proof of exemption."

Interesting, really, given that the "Royal College of Pharmacists" doesn't actually exist. This is lazy, crappy reporting, if they don't even bother to get the Royal Pharmaceutical Society's name right. You can read how the RPS have responded to this article here. Its a perfectly reasonable response, and in my opinion reflects what actually happens in daily practice.

Hxxx