OTC medicines

Unicough: Sadly not as good as unicorns.

Another day and another new cough medicine has mysteriously appeared on pharmacy shelves.  It’s called Unicough® (Infirst), and it claims to work by:

addressing the hypersensitivity of the cough reflex, which makes it suitable for dry, tickly and chesty coughs
— http://www.chemistanddruggist.co.uk/news/new-cough-syrup-pharmacy-only#sthash.toAK6A2l.dpuf (subscription required)
source: http://www.infirst.co.uk/were-working-on/unicough

source: http://www.infirst.co.uk/were-working-on/unicough

Riiiight. Regular readers will by now know that most cough medicines are absolute nonsense, with little to no evidence of effectiveness. I’m particularly suspicious of products (like this one and Bronchostop, for example), which claim to be able to work on any type of cough. Chesty and dry coughs happen through different mechanisms, so a product that claims to treat all types seems more likely to not work for any. An exception to this would be a simple demulcent like simple linctus, which acts just by coating the throat for a little while. 

Am I right to be suspicious about this product? Well dear friends, lets take a deep, objective breath and dive into the evidence, hoping beyond hope that maybe this time… this time… it might not be a nonsense product. 

Is it actually a medicine? Or is it just pretending? 

Unlike most new over the counter products which all turn out to be medical devices masquerading as real medicines, this product is actually, genuinely a Real Life Medicine. It even has a Real Life License, for the symptomatic relief of common coughs associated with upper respiratory tract congestion. What larks! What a time to be alive!

This means that the manufacturer will have proven three broad things in order to receive the license: safety, efficacy, and quality. We’re not out of the woods yet, by any means, but this is probably the most promising start to an OTC medicines review I’ve done so far.

It contains diphenhydramine 14 mg (an antihistamine, which as a side effect will make you sleepy), ammonium chloride 135 mg (irritates the airways, therefore is supposed to loosen up any mucus and help you cough it up- aka an expectorant), and levomenthol 1.1mg (minty, therefore feels a bit soothing and cooling). Despite Infirst’s hopes that Unicough will “reshape the approach to acute common coughs”, there are no exciting or revolutionary technologies here. All of these drugs are old as the hills, and very similar products (Benylin Chesty Cough Original) have been widely available for pretty much forever.  

Furthermore, it is a totally irrational combination of drugs. You’ve got an antihistamine, which acts to dry up secretions, nestling up alongside an expectorant, which is supposed to promote loosening up secretions. Those two actions work against each other and cancel each other out, rendering the whole thing pretty darn pointless. 

If it's licensed, that means that there is evidence that it works though, right?

Ummm… no. It seems that it’s managed to get its license on the basis of being exactly the same (save for flavouring) as another product called Histalix®. That product got its license in 1999, seemingly on the basis of thin air. It’s safe to say that back then licensing for OTC products was rather less rigorous than these days, and “but it’s been around for a while now” used to be a legitimate reason to grant a license. Now, I can’t find the information that the manufacturers of Histalix® presented at the time, but I’m guessing it’s probably not a whole suite of robust, well designed trials.

An article about the product in Chemist+Druggist magazine gave some vague details about a trial:

A randomised study of 163 patients co-ordinated by King’s College Hospital, London, found that the cocoa-based formulation was more effective at reducing the frequency of coughs and the disrupted sleep caused by coughs than simple linctus, Infirst Healthcare said
— http://www.chemistanddruggist.co.uk/news/new-cough-syrup-pharmacy-only#sthash.toAK6A2l.dpuf

This trial, however, doesn’t appear to be published anywhere. I contacted the manufacturers asking for more information about it and was, perhaps predictably, met with silence. Without knowing how the trial was designed, and what the results were, we will have to just discount it; it’s the medical equivalent of being told that no, this Rolex watch someone wants to sell you for £20 is definitely not a fake, honest guvnor. It’s worth noting too that the comparator they used, simple linctus, is no better than placebo itself. 

Searches of the medical literature found a great deal of nothing, either. I searched for both Unicough® and Histalix® too, as well as the combination of ingredients, to no avail. Yes, it might help you get to sleep at night thanks to the antihistamine side effects, but I wish they would be honest about that in their marketing. You’ll sleep because you’ve been knocked out by drugs, not because its made any difference to your cough. 

Is it safe? 

On the whole, there probably aren't any major safety concerns here. Drowsiness is going to be the main problem with it, and as with all things that can cause drowsiness there is a possibility of dependence. Other effects could be dry mouth and urinary retention. It can interact with a few different medicines. Of course there is always the potential issue of self-treatment of a persistent cough, and masking of symptoms that could suggest a more malignant cause. 

The practicalities

Any product which causes drowsiness is going to be severely limited in its usefulness through the day. If you drive, work, or even just don’t want to be asleep all day, then you’re going to have to avoid this product, or you might even end up having to buy two lots of pointless medicines; one for day and this one for night. Additionally, antihistamine-induced sleep can often leave you feeling still quite drowsy the next morning, and some people can even feel quite hungover. It’s not going to be ideal if you have to be up early for work, or if you drive early in the morning.

The unique selling point of this product is the taste. It's cocoa-based, which I'm sure is pleasant, but it aint going to make a blind bit of difference to your cough. I even wonder whether a pleasant taste might have a detrimental effect on any placebo effect: if it doesn't taste like medicine, then you might get less of a response. 

Is the cost reasonable?

Whoah, £8.85 for 150 mL? Give over! There is absolutely, categorically no way that this product is worth that amount. 

TL:DR! Is it worth a punt? 

Nope. There’s no evidence it works, and the combination of ingredients in it makes no sense. Save your money and invest in some cheap simple linctus or glycerine, honey and lemon to soothe your throat instead. The best cure for a post-infective cough is time. Look after yourself, rest, drink plenty, and eat well. If your cough doesn’t go away after about three weeks, get yourself checked over. I know that coughs can be awful, annoying, embarrassing, and exhausting, but –and I’m sorry to have to tell you this- nothing will get rid of it instantaneously, or even any quicker than using nothing at all, so you might as well save your pennies. 

A Mahoosive Thank You

Last month, in a drunken moment of possible madness, I decided to set up a Patreon page. I did so hoping that even setting the page up might work as a driver to overcome the writer's block that has been cursing me for too long. I set the target amount as a dollar, and limited paid posts to these OTC product reviews, because I think there is a real gap in the market for them, and ultimately they will hopefully help people save money. 

To my utter astonishment, four kindly patrons stepped up and made pledges. I doff my cap to you and can't thank you enough. 

Shaun Sellars
Alex Brown
Jack Wright
Bevin Flynn

If you enjoy these sorts of posts, find them useful, and have more money than sense, then I'll just leave this here

Literature Search terms:

Embase: unicough (freetext, ti.ab) Histalix (freetext, ti.ab) *Diphenhydramine AND *Menthol AND *Ammonium chloride

References: http://www.infirst.co.uk/were-working-on/unicough https://www.medicines.org.uk/emc/medicine/31365 https://www.medicines.org.uk/emc/medicine/11171 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con553668.pdf http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1445576593772.pdf

Is SoreFix a sore loser?

Cold sores truly are the devil's work. The pesky little blighters make a habit of cropping up at the worst moment, crushing your self confidence within a mere matter of hours. 

Given that cancelling everything and holing yourself up in a darkened room until it has gone away tends not to be all that practical for most of us, It's no surprise that folk are desperate for something that really works, and fast. I've already written about several other new cold sore products on this here blog, neither of which are the miracle cures they're marketed as. 

Enter Sorefix, a product selling itself as a new all-round product to both treat and prevent cold sores. Interestingly, the manufacturers claim that it even works after the cold sore has come out, which if true would make it a really useful product. 

In case you are too late to prevent a cold sore, SoreFix relieves symptoms such as itching, burning and the blisters on or around the lips and it speeds up the healing process. So prevent feeling embarrassed and choose SoreFix!
— http://www.sorefix.com/sorefix-cold-sore/

Medicine vs Medical Device? 

Once again, this product isn't a medicine. It seems that nearly every new OTC product these days is actually a medical device masquerading as a medicine, and this is no exception. It might look like a medicine, it might be sold in pharmacies, and the manufacturers might even make claims that make it sound like a medicine, but nay, it is in fact a medical device. Essentially, this means that the need for good quality, robust evidence of efficacy before marketing is virtually non-existent. Le sigh.

The evidence   

Usually, the first step in finding evidence for how a product works is to find out what is actually in the product. This is proving quite difficult for Sorefix, as all I can find is some vague statements about "two zinc salts". hmph. Ah well, I shall have to make do with what I can. What i am particularly interested in is the claim that Sorefix can reduce healing times for a cold sore once it is already out. 

The manufacturers themselves don't bother with providing any cursory clinical trial data. This is unusual, and sort of  refreshing in a way; at least they aren't trying to palm off some nonsense animal studies as irrefutable evidence. It does, however, leave me with even less of a start than I normally would have for these sorts of posts. 

A quick Google search found nothing whatsoever, so I delved into the medical literature in a Medline and Embase search to see if there is any studies looking at the effects of zinc on cold sores. As I can't find which exact zinc salts are in the product, I just did a search for zinc. I found a grand total of three results, none of which were relevant. 

I did manage to find some information about the topical use of zinc in a trusted database. It seems that there is some, very limited data which suggests that some specific zinc-containing products, none of which are Sorefix, may reduce the duration of symptoms by a grand total of 1.5 days, and that's only if used within 24 hours of onset. There is also some evidence that zinc isn't effective for recurrent infections, which is probably going to be pretty much everyone. 

So it seems that I can find nothing at all to back up any of the manufacturers claims at this point. I've contacted them to see if they have any further information, and it'll be really interesting to see if I ever get anything back. 

Safety

Safety-wise, it's very difficult to comment on without knowing what exactly is actually in it. The manufacturers say you shouldn't use it if you are very sensitive to any of the ingredients, though of course they don't tell you what they are. Helpful much :S

The practicalities

The key with cold sore treatments is that you need to start using them before they appear, and you need to use them regularly. Despite what the manufacturers seem to be saying, it would appear that this product is no different. It doesn't contain an antiviral, but the limited amount of evidence looking at the effects of zinc for cold sores suggest that it needs to used every two hours in order to have an effect. That's a lot of applications per day, and I think it's unlikely that most people will be able to keep up with it for any reasonable amount of time. It's worth noting that, because cold sores can worsen quickly, this probably does include overnight too.

I really like the idea of having something to use for prevention, but its hard to remember to apply something at the best of times.  Its even harder if you haven't got a throbbing mass of evil reminding you of its presence constantly.  Given the lack of evidence for prevention, there is no specific guidance on how often you are supposed to use it in order to prevent a cold sore, but I suspect its going to have to be very regularly. 

The cost

It costs £7.47 for a jar or tub of this stuff. Although that's quite similar to other new products for cold sores, it's waaay more expensive than generic aciclovir or plain old vaseline. 

So, is it worth a shot? 

At this time, no. I can't see anything to suggest it's any better than existing treatments. I'll be interested to see if I get anything back from the manufacturers, but I can't see any reason why this product would work, and there is certainly no evidence to back up their claims.

Unfortunately, when it comes to cold sores, time is the best healer, especially once they are out and proud.  If it hurts, then use painkillers like paracetamol or ibuprofen. If its still at the tingling stage, go for topical aciclovir, but make sure you get a cheap generic version rather than Zoivirax: its exactly the same stuff. It's not going to make much difference once its already taken hold though, and at this point you're better off just using something like vaseline to keep it as supple as possible. 

Hxxx

 

Can you really get all medicines for children free in a pharmacy?

The following message has been widely shared on Facebook over the last few days.

It could have been an accidentally wonderful way of spreading the word about minor ailments services- something that pharmacies, CCGs, and PCTs have been struggling to do for years. Sadly, however, it hasn’t quite had that effect- it’s very inaccurate and is likely to lead to a lot of disappointment for patients and pharmacists alike. As with all things, if something sounds too good to be true, then in all likelihood it is.  Hopefully, this post might clear up some of the confusion caused by the original status.

The purpose of a minor ailments service (MAS)

Far from being a free way to stock your medicines cabinet, MAS’s are in place to reduce unnecessary GP appointments. They’re a convenient way to access medicines and advice for those who would otherwise see their GP in order to get free items on prescription as they can’t afford to buy medicines. As such, it’s not about the patient asking for specific medicines. Services are designed so that the pharmacist can sit down with the patient and give them advice about a minor condition. Yes, they can provide some medicines as part of that consultation, but only where the pharmacist deems them necessary in response to symptoms.  Many of the conditions covered are self-limiting, and will go away of their own accord without you having to use any medicine at all.

Local Schemes for Local People

Unless you’re in Scotland or Wales, MASs are commissioned according to local needs, by CCGs. Not all areas with have them, and of those that do, there may be wide differences in how they are run. For example, to access some schemes, you may have to be referred by your GP. Others, you might be able to just pop into your local pharmacy and ask for the service. Some areas may stipulate that only people from that town or county can use the service, whilst others allow it for out-of-townies. There are currently 70 individually commissioned MAS across England, some of which cover multiple areas. They might all have different names and different scopes. 

 

The logo of the Think Pharmacy First scheme,  available in some areas of North East England.

The logo of the Think Pharmacy First scheme,  available in some areas of North East England.

"All" medicines?

Nope. It’s not even available for all minor ailments. There will be a selected list of things that the pharmacist can deal with under the scheme, and again these will change depending on local needs. It might be things like headlice, hay fever, sprains and strains, conjunctivitis etc. The average number of indications covered by each service is 16. 

Even if an ailment is covered by the service, not all medicines will be available under the scheme. Only evidence-based, cost-effective medicines will be available. You won’t be able to get branded medicines (like the Calpol and Piriton bandied about in the original post) because this doesn’t represent a rational use of the service. I was lucky enough to be involved in the setting up of Think Pharmacy First, the minor ailments scheme that originally covered Newcastle and which now also covers quite a few other areas in the North East, and I remember the discussions we had about what we were going to include on the formulary. We checked robust sources for primary care management and made sure to remove anything that we considered irrational or which had no evidence to back it up. The post mentions plasters, but I very much doubt that these will be widely available- it’s a minor ailments scheme, not a first aid service.

Is it just Boots, or is it all pharmacies?

Even within an area with an MAS, not all pharmacies will offer the scheme. The original post seems to suggest that this is something only Boots offer, but in actual fact any pharmacy can participate. 34 MASs require the pharmacist themselves to provide the service. in 29, the pharmacist or an appropriately trained member of staff can undertake it. Some areas will require pharmacies, or individual pharmacists, to be accredited before they can start offering the scheme. So, if you do feel that you could benefit from using an MAS, its best to phone your local pharmacy first to check if they do deliver it.

Anyone can use the scheme, right?

MASs are there primarily to help those with a low income, who struggle to pay for medicines. Depending on the local scheme, others may be entitled to use it too, for example those over 60 or all children, but this is likely to vary. To use my local as an example again, the Think Pharmacy First scheme is available only to adults who are entitled to free prescriptions on the grounds of low income and their children along with all people aged 60 or over.

They very much ARE allowed to advertise it.

I’ve no idea where this nonsense about not advertising comes from. We had four foot, bright yellow and green window stickers made up for the launch of the Think Pharmacy First scheme, and I remember spending about an hour trying to remove air bubbles from it once I put it up. I did local press stints to advertise the scheme widely, with photoshoots and everything. The scheme was advertised in local council newsletters, in schools, and goodness only knows where else. For years, even after I left community pharmacy, I would get annual phone calls from people saying “Hey, I saw you in the paper the other day!” CCG websites and pharmacy websites have plenty of information about the schemes. They aren’t a dirty secret that we pharmacists keep to ourselves because we’re mean. If anything, they help us pharmacists demonstrate our worth, and we have long been campaigning for a good quality, robust national scheme to reduce all these inequalities.

There’s one obvious reason why these schemes probably aren’t that well known, and that’s budget. It’s nothing to do with not being able to advertise, it just comes down to cold hard cash. Some of these schemes are woefully underfunded, and as such they sadly get left to limp along.

It might take a while

We pharmacists tend to be very busy, and we usually have about 30 different things to do that all need doing immediately. An MAS consultation is a lot more in depth than a usual Over the Counter sale- it usually takes 10-15 minutes, in the consultation room, discussing the problem and any possible treatment. The paperwork then takes the pharmacist a good deal of extra time. Therefore, if you do use an MAS service, please do so patiently. If you need a medicine quicker and you aren’t willing to wait for a consultation, or you don’t want to answer any questions, it is probably best to buy a medicine over the counter instead.

Misuse

We’re all constantly bombarded with Daily Mail headlines about prescription fraud and the likes. Now, I don’t buy into any of that overblown rhetoric, but I, and probably any other community pharmacist you will speak to, can reel off many an occasion where people have taken the mickey out of a minor ailments service. Some people seem to go completely wild when they realise they can get something free. I’ve had numerous people ask me to hand them the formulary list so that they can mark all the products they’ve decided they want. Others used to demand to “self-prescribe” themselves whatever they fancied that day, which used to drive me mad and which used to lead to a stern talking to from myself. It’s just not in the spirit of the thing- its about accessing the pharmacist’s expertise and skill in treating minor ailments, rather than a shopping list. I fear the wording of the FB post in question may be leading people to think otherwise.

Overall

It’s a really handy, worthwhile scheme, and more people should definitely know about it and access it when need be. But they also need to know how variable it is and its limitations.

If you have any other questions about your local scheme, try having a lookie at your local CCG’s website. If in doubt, ring your local pharmacist and they should be able to tell you what’s available. 

 

 

reference: PSNC briefing 006/15: Analysis of Minor Ailments Services in England, Feb 2015


Is Herpatch Mouth Ulcer Gel worth a shot?

Mouth ulcers can be very unpleasant little blighters. They’re often really painful and can be rather distracting, especially when eating. And, if you ask me, anything that makes eating difficult makes life more miserable. They tend to be self-limiting, but for those most painful moments, there aren’t that many treatment options available over the counter. There’s a new product available in Boots currently called Herpatch mouth ulcer gel, so I thought I’d cast an eye over it to see whether it’s worth spending your hard earned cash on.

What's in a name? Mainly confusion in this case

Its actually been quite hard to find manufacturer’s information on this product due to some brand name issues. It would seem that the Herpatch range is being marketed elsewhere in Europe as two products for cold sores, a preventer and a treatment “serum”. The same manufacturers also market a product called Aphtgel, which is for mouth ulcers.

It seems that in the UK, however, the picture is less clear. From what I’ve managed to cobble together, only two products are being marketed, and they’re both doing so under the Herpatch brand. There is a mouth ulcer gel, which appears to be the same as Aphtgel, as well as the cold sore preventer product. The serum doesn’t appear to be available over here yet. The brand name makes little sense for the mouth ulcer product- there’s no patches, it has nothing to do with herpes, and it ends up sounding gender specific, which is nonsense.

What is it?

Aphtgel Remesense is based on Sylphar’s film forming technology. Upon application, it will form a transparent, thin muco-adhesive film on the mouth ulcer. This film will protect and isolate the injured mouth area affected by the ulcer.
— http://www.sylphar.com/sites/default/files/productfiles/111085Aphtgel_Psheet_UK00.pdf

This actually seems like a very reasonable mode of action. Forming a cover over the ulcer may in theory reduce pain, as well as reducing the likelihood that a secondary bacterial infection can creep in and make itself comfortable. It’s also useful to cover over an ulcer whilst it heals, but its obviously very difficult to stick a plaster in your gob, so a product like this certainly does have an important role, at least in theory. It’s not a new concept, but refreshingly it also doesn’t seem to be marketed as such. A product called Orabase used to do a similar sort of job, though its no longer available.

The main active ingredient is hyaluronic acid, which is naturally abundant in skin and cartilage, along with a few other bits and pieces like xanthan gum and cellulose. Basically, it contains a collection of gloopy, sticky stuff that probably won’t dissolve immediately when in contact with saliva. 

Medicine vs Medical Device?

As with many new Over the Counter products, Herpatch gel isn’t actually a medicine. Instead, it is classed as a medical device- a fact that is fairly difficult to deduce unless you do a fair bit of poking about on the manufacturer’s website. This means that the product doesn’t have to go through the rigorous testing that a medicine would, and it shouldn’t have any direct pharmacological effect- in this case it forms a physical barrier, but isn’t absorbed greatly and doesn’t produce any other effects on the body.

Does it work? 

Wonders will never cease, but it seems that there is actually some half-decent evidence that this product works. There are some actual, real life trials for gingivitis, periodontitis, and a similar product is already licensed for chemotherapy-induced mucositis. There’s not much evidence, admittedly, but the published stuff seems to suggest a decent effect size. It’s worth noting that most trials and evidence include people with recurrent or more severe ulcers, which might skew the results somewhat- most of the folk buying it over the counter will be using it for the occasional ulcer rather than for a more serious, recurrent problem.

Is it safe? 

Evidence seems to suggest that topical hyaluronic acid is well tolerated and there aren’t really any safety concerns that I can see think of with this product. One problem could be indirect harm caused by lengthy self-treatment of an ongoing problem. If an ulcer persists for more than 3 weeks, there’s a possibility that it could be something more suspicious.

The practicalities

Using the product might be a bit onerous. The aforementioned Orabase used to be a claggy, gritty paste which felt pretty unpleasant in your mouth. Being a gel, I’d imagine that Herpatch might feel a bit better, but there’s still a possibility that it might feel weird. You’re supposed to wait for 30 minutes before eating and drinking and avoid rubbing the area with your tongue. That seems… unlikely. We’ve all got that little masochistic streak in us that means you can’t quite leave it alone. I’m therefore not sure how long the barrier will stay in place for.

The cost.

This product isn’t cheap, coming in at £7 a pack. That seems pretty steep to me, especially for something that is self-limiting and will probably resolve in two or three days.

To summarise

Not a medicine as such, but a product that has some prior plausibility and some evidence suggesting it may work. Pretty pricey, but I guess if you’re going out for an important curry or something, you might decide it’s worthwhile. There aren’t that many other options available that aren’t hokum or placebos, so I’d actually-for once- be fairly happy to recommend this product to some patients over the counter.

 

Vicks, Feet, and a whole load of nonsense.

Vicks Vaporub. It's a staple of our medicine cabinet, and we all reach for it at the first sign of sniffles. You may have seen (usually on a poorly made image posted on Facebook) or heard (from a friend who heard from their friend who heard from their aunt's sister's niece's dogsitter) that actually we've all be using it all wrong. 

It's logical to use Vaporub on your chest, pillow, in a steam inhalation. It makes sense, because the vapours will end up in or around your nostrils, which is where it acts. But no- according to this particular internet fraud, it is only by smearing our tootsies with it that we will get the full benefit. 

I'm going to pick apart the standard Facebook post, piece by piece, so you can see my thought processes and logical reasons why I don't believe a word. Even if you do think this works, stick with me and see whether or not you agree with any of my individual points, or if you can come up with a more robust argument for using it on your feet. 

"Some of us have used Vicks Vaporub for years for everything from chapped lips to sore toes and many body parts in between."

 Wait, What? Who uses Vicks Vaporub for chapped lips? I've never heard of anyone do this, ever. Firstly, it would sting lots, and secondly it could be highly toxic, given its essential oil content, and aspiration risk when swallowed due to petroleum. I wouldn't put the stuff anywhere near my mouth.

But I’ve never heard of this. And don’t laugh, it works 100% of the time

100% of the time? Nothing in medicine works 100% of the time, so alarm bells are ringing loudly, unless this is the single most important medical discovery that's ever happened. If a medicine had been truly found to be 100% effective for anything, it would have been ground-breaking, world-changing news- probably not something that's just shared by your cousin on FB. 

 In the interests of research, I actually tried this when I had a troublesome post-infective cough. Needless to say, it did nothing to the frequency of my cough, so we've already disproved that number straight away. Whether or not it works, it most certainly does not work 100% of the time, and if that number isn't true, then why on earth should we believe anything else in this post?

...although the scientists who discovered it aren’t sure why.

 What scientists? What were their names? Where were they working? Where did they receive their funding from? Why aren't their details given? If they aren't sure, do they have any working theories? 

The lack of detail here is really telling. It really suggests that this is a whole load of hokum, especially given that a search (see below) shows no formal records of any "scientists" or research.

To stop night time coughing in a child (or adult as we found out personally), put Vicks Vaporub generously on the bottom of the feet at bedtime, then cover with socks.

Ahh, feet. Feet really are a favourite for peddlers of quackery. I'm not sure why, but from reflexology to detox foot patches, the alt med world seems to be obsessed with them. Any time feet are suggested as therapy for anything going on elsewhere in the body, loud alarm bells start going off. 

The ironic thing is that feet are probably the worst place to apply any medicine. The skin on your feet is miles thicker that elsewhere. Absorption through the skin tends to be low and erratic at the best of times, but if you apply something onto your feet, the chances of absorbing anything useful from it are very low indeed. 

Additionally, your feet, when lying down, are very far away from your airways. The post requests that you put socks on over it. Therefore there is certainly no way that vapour could get to your airways in any clinically relevant amounts.

Even persistent, heavy, deep coughing will stop in about 5 minutes and stay stopped for many, many hours of relief. 

Coughing fits are just that- fits. They're acute- you cough a lot for a little while, then stop, then it all starts again. A more chronic cough will still follow this pattern or stopping and starting. So yes, persistent, heavy deep coughing will usually stop- albeit temporarily- in probably much less than 5 minutes. If you're coughing for longer than that, it's likely you're going to be having severe problems breathing, and you'll need urgent medical care- you wouldn't really be thinking about smearing goo on your feet. You may find that you put Vicks on your feet and your coughing stops shortly after, but the likelihood is that the coughing would have stopped even if you hadn't. This is called regression to the mean, and its one reason why we can't rely on anecdotes for deciding whether a medicine works. We need to scale up and look at robust clinical trials instead.

Works 100% of the time and is more effective in children than even very strong prescription cough medicines. 

That 100% claim raises its improbable head again. To claim that something is more effective than other medicines would suggest the existence of comparative trials, which-spoiler alert- don't actually exist. This is rather a strawman anyway, as there are very few prescription cough medicines on the whole. Even conventional cough medicines don't really work to any great degree, and are based on very shakey evidence. It would be a very, very rare occasion indeed that a doctor would prescribe a cough medicine on prescription for a child. 

 In addition it is extremely soothing and comforting and they will sleep soundly.

I can see how that tingly, cold sort of feeling you get from menthol could be pleasant, though I don't think I'd go as far as to call it soothing. To be honest, you'd have to have perfectly soft skin on your feet to feel anything at all- when I tried it I didn't even feel a tiny tingle, especially since it was covered over with socks. 

Just happened to tune in A.M. Radio and picked up this guy talking about why cough medicines in kids often do more harm than good, due to the chemical makeup of these strong drugs so, I listened.

What guy, and on which radio station? What qualifications does this guy have for making medical recommendations?  Who is even meant to be narrating this post? The only medicines now available for coughs in children in the UK are glycerol and simple linctus paediatric. Both of these essentially work on the basis of being sugary, slightly gloopy water. There's no "strong drugs" here, just some soothing "demulcents" that taste nice and are supposed to leave a soothing lining on the throat, making a cough feel less raw. They're mainly placebos. 

It was a surprise finding and found to be more effective than prescribed medicines for children at bedtime, in addition to have a soothing and calming effect on sick children who then went on to sleep soundly.

 Where is this finding published? What sort of a study was it and how was it designed? How many participants were there? Was there a control group, or a comparator group and if so, what was the comparator? As it happens, all of this is irrelevant really, as no studies exist. These statements come from the head of an internet fraudster, rather than actually being grounded in reality. 

My wife tried it on herself when she had a very deep constant and persistent cough a few weeks ago and it worked 100%! She said that it felt like a warm blanket had enveloped her, coughing stopped in a few minutes and believe me, this was a deep, (incredibly annoying!) every few seconds uncontrollable cough, and she slept cough-free for hours every night that she used it.

 We don't even know who is narrating this thing in the first place, let alone their wife. As I've explained above, this is an anecdote, and we can't derive anything from it. A person, who may or may not be mythical, had a cough, and it went away after they did a thing. It might have gone away anyway, we just can't tell. 

A warm blanket?  far from it. It actually just feels like you have some oily gunk on your feet. At best it might feel a little cold, but for most of us, it'll feel no different at all thanks to our thick skin. 

If you have grandchildren, pass this on. If you end up sick, try it yourself and you will be absolutely amazed at how it works!

Well that's just bizarre. Presumably you don't need to bother if you're simply a parent, only if you're a grandparent? What a load of nonsense. I wasn't left amazed, I was just left feeling a little silly. And I had minty-smelling feet.

So of course I have done a search for the evidence and claims included in the post and have found a grand total of Nothing At All. I will say this though: If I was the manufacturer of Vicks, and someone had done some studies which found my product to be 100% effective, I would sing it loudly from every rooftop I could find. I would be the manufacturer of The Number One Most Effective Medical Product In The World Ever, and I would make sure that I made my millions on the back of that fact, as well as collecting my Nobel prize for Medicine and probably world peace as well. What I probably wouldn't do is ignore the claims, and continue on selling my product and advising that its used in a way which has a less than 100% chance of it working. 

Direct harms from following this advice could include dermatitis and skin reactions. Indirect harms? Well, you've slathered some slippery, oily unguent onto the bottom of your feet. When you take your socks off, you may be slip-sliding all over the place.

The moral of the story is: Very rarely should you believe anything posted on Facebook. Unless its me, posting a link to my blog, of course ;)

Hxxx
 

Allergy relievers: red light nonsense

Its just about coming into allergy season again, so today I am turning my attention to a product I’ve seen for sale in a few pharmacies I’ve locumed at of late: The Allergy Reliever Device. These things are sold under some pharmacy chain’s own names, or under brand names like Kinetik.

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

It’s yet another medical device. These things seem to be hitting the pharmacy shelves more and more often these days, giving them a level of respectability which personally I don’t think they deserve. At least this device makes it clear that it is a device though, unlike things like Prevalin which pretend to be real medicine.

According to Kinetik, it uses “red light therapy to suppress the cells that release histamine, thereby relieving the symptoms of hayfever and allergic rhinitis.”

So, essentially shoving some Christmas tree lights up your nose then. Well I must admit that’s a new one on me. It’s pretty hard to sniff out (geddit?) the theory behind this one too.  The manufacturers of these things don’t give any explanation as to why red light would suppress mast cells, and several Google searches later I’m none the wiser. I have managed to dig out one published paper in rats, where the authors seem to be suggesting that red light changes the redox state of cells, which might cause some changes within the cell. Even these others say that they’re not quite sure what’s happening though, and that further investigation is required.

Armed with a few unsuccessful Google Searches, I delved into the medical literature. I tried every which way I could think of to search for evidence that this thing works, but ended up drawing a total blank. I think this may well be the least successful search for evidence I’ve done so far, and that’s saying something. Even the manufacturers can’t be bothered with listing any sources instead they go wild with the clipart, giving us a Generic Smiley White Coated Person and Happy Photostock Chef alongside some very random recipes and general lifestyle advice.

And it looks like this thing really isn't very pleasant or practical to use. You're supposed to shove the probes up your schnozz as far as you comfortably can, then keep them there for three minutes. Not the most dignified of poses. And you're supposed to do this three or four times a day. That's a lot of inconvenience. Seems like prime Use Once Then Put In A Dark Cupboard territory for me, especially since taking a one a day antihistamine tablet is no hassle at all. 

In short, I wouldn’t waste your money. There’s no basis to these things, and it saddens me that they are not only being sold in pharmacies, but are being sold under pharmacy brand names. The more we associated our profession with such nonsense, the less trustworthy we become to other healthcare professionals and patients alike.

Hxxx

Advert Annoyances Vol 1: Senokot

Welcome to the first installment in what is likely to be a very sporadic series. As you've probably guessed by now, I have a tendency to be irrationally annoyed by small things, especially when it comes to medicines. Adverts for OTC meds can be a prolific  source of cringes. Even leaving aside the requests for "you know, that one on the telly, where there is a guy and a dog and its a blue box", there will occasionally be a little phrase or image used in these adverts that makes me stop and seethe a little.

The current one at the moment, is Senokot. I can't find a link to the new advert, but when I do, I shall pop it in here so you can see for yourself.

There's all sorts of naturalistic fallacies going on, but that's not what annoys me the most. It's the phrase " works in harmony with your body" that i'm finding hard to stomach (geddit?)

Put simply, senna works by irritating your bowel. Your bowel notices that it is being hurt by something, therefore starts contracting and producing secretions to hastily get rid of the thing hurting it.  This then might make you poo, but from your bowel's point of view that's a side issue- its just trying to protect itself from harm.

That doesn't really sound to me like "working in harmony". You might as well say that fire works in harmony with human skin to make you walk faster- in actual fact, one is just out to hurt the other, meaning something else happens as an unintended- but sometimes useful- consequence. 

Hxxx

 

It's thyme to Bronchostop this nonsense

I’m sorry, I just could not resist that headline.

Whilst working a locum shift the other week, I noticed a couple of new products had leapt their way to the pharmacy shelves. “Bronchostop”. Sounds interesting, I thought, until I moved a bit closer and noticed that they are, in actual fact, a herbal cough remedy, and my vague excitement was replaced with a bit of my soul dying. Then I saw the price tag, and the anger kicked in.

Brought to us by our old friends at Omega Pharma, Bronchostop syrup contains thyme extract and marshmallow root, whilst the lozenges just contain thyme extract. Omega claim that it “relieves any type of cough”, and that it “takes the hassle out of choosing a solution”. Well, I must say, I’m pleased to hear that, because I find one of the main stressors in my life is choosing which cough remedy to use. I mean, it’s just so complicated to decide if you have a dry or a chesty cough, then realise that it makes no difference anyway as most cough medicines don't work, so you then just by a cheapo honey and lemon thing to make yourself feel placebo-ey better. 

So, given that the great all-consuming cough medicine dilemma of my life has now been sorted out by Omega, I can spend some quality time looking up the evidence to see if it works.

It turns out that there are some preliminary trials which suggest thyme might improve cough symptoms. However, these all use specific cough syrups with different combinations of ingredients compared to Bronchostop, so they’re not very helpful. Because the product is being sold as a traditional herbal remedy, the manufacturers don’t need to bother collecting any evidence that it works before it goes on sale- their claims are based entirely on “traditional use”, which means nothing at all scientifically.

One attempt at a clinical trial compared thyme syrup with a “real” expectorant, bromhexine, and found no difference over a five day period. There are a number of problems with this though- firstly, bromhexine isn’t commonly used in cough medicines. Secondly, there’s little to no good evidence that expectorants work anyway, so we’re comparing something that may or may not work with something that doesn’t.

Worryingly, the website www.bronchostop.co.uk contains absolutely no safety information whatsoever. It doesn’t tell you who can’t use it, who needs to be careful using it, or what any of the side effects might be.

What side effects could it possibly have, you’re wondering. After all, its just a herb. We eat it, so it can’t be that bad, right? Well, sort of. The amounts used in food tend to be a lot lower than when it is used as a herbal medicine.

On the whole, thyme is well tolerated, but occasional gastrointestinal effects can occur. Uncommonly, and more seriously, people can have allergic reactions to it. It can interact with drugs, including those that thin the blood, those used in Parkinson’s disease, those with anticholinergic or cholinergic effects, oestrogens (research suggests it may decrease the effects of HRT, but theoretically also the contraceptive pill), and non-steroidal anti-inflammatory drugs. It may cause problems in people with bleeding disorders, who are undergoing surgery, or who have hormone sensitive cancers. We have no idea of the effects that medicinal amounts of thyme can have in pregnant or lactating women.

It seems to me, however, that its main adverse effect will be on your bank balance. This stuff is £8.99 for a 200ml bottle or £4.99 for 20 pastilles- that’s a whole lot more than simple linctus, which is about £1.50 and which will probably do just as good a job.

Hxxx

When real science gets left out in the Coldzyme

There’s no getting away from it, folks. Its sniffle season. For the next 6 months or so, the sounds of sneezes, coughs, and millions of noses being blown will echo throughout the nation.

We all know by now that the common cold is a virus. We all know that there is no cure. We also all know that, although you feel like crawling into a small dark warm cave and dying at the time, its usually much better after a few days, and it goes away of its own accord. Cold and flu remedies do nothing to actually get rid of your cold- they are there to make you feel better during it, although many of them are actually irrational combinations of products in shiny boxes with a redonkulously high price.

It is often said that if someone did come up with a cure for the common cold, they would be millionaires. I was, therefore, surprised to read this week in Chemist + Druggist magazine that indeed, the first ever product to not only treat the symptoms but to act on the virus itself was winging its way to pharmacy shelves as we speak. Really? Because blimey charlie, if that's the case, then this product should be Big News. 

The product is ColdZyme, a mouth spray that costs £8.99 for 20mLs. Seems a pretty fair price to pay for a product which claims to cure the most prominent infectious disease in the western hemisphere. It seems odd, though, that instead of this marvellous scientific breakthrough being plastered all over the media and medical literature, the article announcing it is tucked away quietly in a barely read corner of a trade journal.

What is this breakthrough, miracle product that will powerfully break down viruses? Well, an enzyme called trypsin. An enzyme that already merrily and plentifully kicks about in your digestive system, breaking down proteins. An enzyme which, for the purposes of this product, is inexplicable being derived from cod (which has meant that I have had to resist the urge to refer to it as somewhat fishy.) An enzyme which should be stored at temperatures of between -20 and -80 degrees Celsius, to prevent autolysis. Now, I've seen some fancy medicine packaging in my time, but never a simple mouth spray bottle that can manage such cold chain storage feats. So, if trypsin really is present in this product, then it seems fairly likely that its going to be inactive, unless the manufacturers have found a way of warping room temperature. Or you happen to be in Winnipeg in the middle of winter.

Medicine vs. Medical Device

The manufacturers make some really very extraordinary claims on their website, including one textbook example of special pleading. Their product, they state, isn’t a medicine. It’s a medical device, because it has no systemic effect. They then of course go on to helpfully tell us about the systemic effect it has:

“The medicines currently on the market only treat the various symptoms of a cold. ColdZyme treats the cause of the symptoms – the virus itself – and thus works both preventively against the common cold and shortens the duration of illness if you have already been infected.”

Right. So in the same breath, they are claiming that the product only forms a barrier, no more. But then they are also claiming that this barrier affects the ability of the virus to produce illness if you are already infected- viruses which are already through that barrier and inside your body. Come on, Enzymatica, you can’t have it both ways.

The Evidence

All these claims are backed up by evidence, right? Well, there is a tiny trial performed on only 46 people, which isn’t published anywhere. I can’t say whether or not it is a well designed trial, because I can’t see it in full, so to be honest, we pretty much have to just discount it. What we can do, however, if have a look to see if there is any other decent published information looking at the effect of trypsin on the cold virus. So I turned to the medical databases Medline and Embase, to trawl through the published medical literature. 

I did find one experiment which looked at the trypsin sensitivity of several human rhinovirus serotypes(1). And this appears to have found that viruses are only really susceptible to trypsin when there have been exposed to low pH, followed by neutralization- something which wont have happened to your common or garden cold viruses. I couldn’t find much else suggestive of a clinically significant antivirus action of trypsin.

The practicalities

This isn’t a simple, one-off- couple of sprays and away flies your cold sort of product. You have to use it every two hours, as well as after you brush your teeth and before you go to bed, and you have to continue this “until your symptoms are relieved”. That’s one hell of a regime. I have difficulty remembering to use medicines twice daily, never mind every two hours. I’ve never used this product, but I’d imagine that if it really does leave a “barrier” coating in your mouth, its a pretty unpleasant sensation. I can’t imagine many people sticking closely to these dosage instructions, and if the mechanism of action is as the manufacturer’s claim, skipping doses would cause the product to fail (if, indeed, it works in the first place)

We are also directed to “Start using ColdZyme® as soon as possible when you detect symptoms of a cold.”. Now, those of use who suffer with cold sores who have ever used aciclovir cream will know that this is often easier said than done- you probably haven’t got the stuff in the house, or at work, and by the time you’ve managed to get your hands on some, its already too late- your cold sore is out loud and proud, and using the drug will be pointless. Its likely that the very same thing will apply here. And remember that the incubation period for a cold is about 2 days- so the virus will already be cosily settled into your body before you even know about it. Its therefore completely ludicrous that this product claims to be able to reduce the length of a cold simply by forming a barrier.  

I know it can be used as a cold preventative, but how many people who feel completely fine are going to remember to use the product every two hours, every day, for the entirely of the cold season?

To Summarise

So, do I think there is scientific evidence to back up the extraordinary claims being made by ColdZyme? I might do when hell freezes over. Or at least when some decent trials are published, which might take just as long.  Do I think that this product should be sold through pharmacies? Absolutely not- this isn’t, if you ask me, real medicine. This is pure pseudoscience, trying its best to fool you into buying real medicine. Do I think lots of people will buy this, use it once or twice, then leave it to languish in their bathroom cabinet? Absolutely.

Here’s the problem though: this stuff will appear on the shelves of pharmacies all over. The pharmacists wont have a clue what this stuff is, and because they are really busy and probably quite tired at the end of each day, they wont be able to do the sort of evidence review I have managed to squeeze into a quiet moment. So they’ll get asked about it, and they’ll sell it. Some people will buy it and will feel better after a few days, and will think that the spray has made them better, forgetting that colds are self-limiting anyway. A customer might come back in the pharmacy one day, and say something like “hey, that new-fangled spray got rid of my cold!”, and the pharmacy staff will end up making recommendations on the basis of customer feedback and anecdotes, rather than on the basis of rational, scientific evidence. In my eyes, this really is a shame, and by selling this sort of nonsense, we really are cheapening our profession, and we're causing our customers to waste their money. 

If patients ask me about it, when I’m working behind the counter, I’ll tell them something along the lines of: “there’s no evidence or logical way that it works. It seems to be a bit of an expensive gimmick, with no decent basis to it. You’ll feel horrible with your cold, but it will start to go away of its own accord, I promise. In the meantime, you’d be much better off looking after yourself, having plenty of fluids and rest, and taking paracetamol according to the packet.”

Hxxx


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
 

Stick a label on this...

Since before I began my career in pharmacy, there has been a drive to get pharmacists "out of the dispensary", in a bid to better utilise their medicines expertise with patients. This sounds great- we have unique clinical knowledge and skills that we have always wanted to use more to make sure medicines are used effectively, safely and efficiently.

For a patient to use a medicine effectively, they need to actually have it in their possession. There is no getting away from the fact that dispensing prescriptions remains a large part of the community pharmacy business model (leaving aside concerns about the contract and reimbursement etc for now). However, dispensing remains the frumpy friend of the drop dead gorgeous, charismatic clinical side of pharmacy. It seems that these days it is seen as repetitive drudgery: the smartie counting and label sticking that we hear so much about. It is, in short, a waste of pharmacists' time, and is something the profession as a whole seems to unquestioningly want to leave behind.

I believe, however, that it is pharmacy's unique selling point. Its only through dispensing that a prescriber's directions are translated into reality. We can prescribe and advise on the most efficient use of medicines imaginable, but if the patient doesn't physically have the right medicines and know how to use them, all of that is pointless.

Yes, there are ways to reduce the pharmacist's input in the dispensing process. There are robots, accredited checking technicians etc. But a prescription still needs to be clinically checked- and that requires the unique skills, knowledge, and abilities that only pharmacists have.

But lets say we step away from dispensing and move in a purely clinical direction. We sit in a room and do reviews of patient's medicines, answer queries, prescribe medicines, monitor and screen patients. Does this sound familiar to you? It sounds to me like the sort of thing a GP does. So, why do pharmacists exist? What do they add to the healthcare picture? Doubtless such pharmacists would be useful, but the profession would become more nebulous, the edges of our role more diluted and less defined.

In my eyes it is our practicality, our ability to supply essential medicines in a safe and effective way to patients that defines us as a separate profession. That, to me, doesn't have to just mean sticking labels on boxes, and doesn't mean that the profession has to be at a standstill. I just think that we need to stop putting ourselves down and accept and be proud of our role in supply. For years we have been declaring ourselves as able to provide new and more clinical services- and we can. But we need to make sure that we define and build on our niche to give us the solid foundations we need to start branching out.

We pharmacists are an interface. Our role is as go-between, and a bloody important role it is. We are go-between a patient and their GP or their consultant, or whoever. Or, we are a go-between the patient and complex medicines information- we can, crucially, convert difficult to understand evidence into patient friendly terms. We can explain what they read in the paper or on the internet, what the directions of a reducing dose are, help them to navigate through the overwhelming choice of medicines over the counter. We are a go-between the drug manufacturing plants and the patient's bathroom cabinet. And the thing that underpins this role is our accessibility. And the reason we are so accessible is because- wait for it- we dispense prescriptions.

If you ask me (not that anyone will), we need to stop thinking of dispensing as the poor relation and see it for just how useful it is.

Hxxx


 

Does XLS Medical Fat Binder weigh up?

Oh Omega Pharma. Once again you provide me with some juicy blog fodder.

XLS-Medical Fat Binder has been on my radar for some time, but I haven't really gotten round to writing a blog post on it or taking a proper look at the evidence. However, prompted by a bit of real-life work I've just been doing, I've been doing some digging.

So what is it? Well, it contains something called litramine, which appears to be a cactus extract. It supposedly binds onto dietary fat and stops it being absorbed. Sounds suspiciously similar in action to orlistat, a licensed medicine. However, XLS- Medical Fat Binder is instead marketed as a medical device.

Here's what the company have to say on the matter:


  
"What is a medical device and how does it differ from traditional medicine? 
  • A medical device is designed to work on or inside the body - either temporarily or permanently. Its main aim is to prevent, diagnose, monitor or treat diseases. 
  • The key difference compared to traditional medicines is that medical devices work mechanically as opposed to pharmacologically. So it works alongside or with your body rather than affecting the chemistry of the human cells."

 

I think what they've missed out here is this: "If we sell this product as a medical device we just need to fill in a form and send it to the MHRA rather than actually having to bother proving that it works so YAY LETS JUST DO THAT!!." It would seem pretty bizarre that orlistat, which is also not absorbed from the GI tract and which also prevents absorption of fat from the diet is regulated as a medicine whereas this product isn't. 

What of the evidence? Well, Omega Pharma once again provide us with a list of the most vague references ever seen, making it virtually impossible to find anything to back up the results they are shouting about. As references go, just writing: "In vivo, 2-armed, randomised, placebo-controlled, double-blind study, conducted in Germany, 2009" is, as someone so succinctly put it on Twitter, the equivalent of saying "This one time, at Band Camp...". These studies don't appear to be published in any peer-reviewed medical journals, so there is no way to verify the results from them. Oh dear.

Of course, not one to rely on the manufacturers alone, I performed a literature review to see if there was anything else out there. And there is: all of one study. And to be honest, the results are promising. Whilst there is a link to this bit of evidence on the XLS Medical website, its hidden away in the tiniest of tiny footnotes, which seems a bit odd really, given it seems to show that Litramine actually works. The trial appears well desgined (double-blind, randomized, placebo-controlled), and whilst not massive (n=123), it isn't as tiny as the usual sort of guff that can be purported as evidence. Patients who used Litramine lost an average of 3.8kg (+/- 1.8) compared to 1.4kg (+/- 2.6) in the placebo group (p<0.001), which actually seems rather encouraging. 

Hang on though, let's not all jump for joy and throw away the salad leaves just yet. Patients in the trial had a hypocaloric diet plan and exercise regimes. The trial only lasted for 12 weeks, so is pretty short- term. and of course its still quite small, and the results would need to be replicated in further, larger, well-designed trials before we could know for sure.

And here's the big problem with it. the study medication is described as:

"Litramine IQP G-002AS is a natural fiber complex derived from Opuntia ficus-indica, enriched with additional soluble fiber from Acacia spp.IQPG-002AS is standardized for its lipophilic activity and has been shown to reduce the dietary fat absorption through GI fat binding." 

- Grube B, Chong P, Lau K, and Orzechoski H. A Natural fiber complex reduces body weight in the overwieght and obese: A double blind, randomised placebo controlled study. Obesity 2013. 21: 58-64

 

The study participants were given 500mg tablets three times a day. However I can't see anywhere on the XLS-Medical website that actually tells me how much litramine is in the tablets- it could be 5mg or 500mg. . So whether or not we can apply these promising results to XLS-Medical, we simply can't say.  

 

And wahoosa are these things are expensive. £39.99 for a months supply? That's six and a half hour's work at minimum wage.

 

Hxxx

Common Community Pharmacy Annoyances

It's funny how variable working in a community pharmacy can be. Nowadays, I locum here and there, and I tend to really enjoy it. I usually do evening shifts, so you have an hour or two of bedlam, followed by several hours of blissful calm and quiet, where you get to sort out all the outstanding things, do lots of other bits and pieces like checking owings, controlled drug stock levels, and cleaning. I usually also end up having bizarrely deep and meaningful conversations about life, love and philosophy with whoever I am working with. Usually when I leave a pharmacy it is as clean and tidy as possible, I've sorted out what I can, and have left notes for anything that I haven't been able to deal with fully.

I say all this because I lately did one of *those* locum shifts. The ones where it is constantly busy, no prescription is straightforward, the fax machine isn't working, and you seem to have to deal with every problem under the sun. On this particular locum shift, I think my colleagues and I encountered every single type of category of impolite customer possible in a 4 hour shift.

So, because the only way that we can cope with such things is to laugh about them, and because I fancy a self-indulgent rant, here is my compilation of the things in pharmacy that annoy me and that happened in that locum shift.

The Mythical Taxi

Some people do get a taxi to their local supermarket. I have done it myself. But it would appear that taxi companies must have an amazingly lucrative trade in ferrying people to and from pharmacies if the frequency of use of the phrase "Can you do it quickly please, I've got a taxi waiting" is anything to go by. These are not, as far as I am aware, magic words that will somehow warp the time-space continuum so that I am able to dispense and check a twenty item prescription in a mere matter of seconds. Whether or not you actually have a taxi waiting will simply mean that your prescription gets put in the queue in the same place it would have done anyway, and you will wait the same amount of time as you would have done anyway. Needless to say, I suspect that many of these taxis don't actually exist, but merely a tactic used by some people to attempt to "hurry their prescriptions along".

The Dry Chesty Cough

"What sort of a cough is it?" "Well, its a dry, chesty cough."
No, no it isn't. It's either dry or its chesty, its not both. And either way, there is little point buying anything for it given that there is no evidence that any cough medicines work.

The Evil Eyes

Glaring at me continuously for the entire time that I am dispensing your prescription will not in any way speed up my work, and in fact may have the opposite effect as I am more likely to lumber around in a sloth-like manner just to annoy.

"I Need To Be Somewhere"

At 6:05pm, a woman handed in her prescription of 4 items. At 6:07pm, having spent all of two minutes repeatedly sighing and tapping her feet, she asked to speak to the pharmacist. Off I went, leaving a prescription half-dispensed. She demanded to know how long her prescription was going to be (the one I left to go and speak to her), because she needed to be somewhere. I gave her an estimation, told her I was doing it now, then went off to complete it. She then asked to speak to me a further three times to find out how long it was going to be, each time meaning it would take a little longer. "But I need to be somewhere at 6:15!!" she told me each time. I handed her the prescription at 6:12pm, thanking her for her patience. She then proceeded to rant for several minutes about how long the prescription had taken and how it meant she was going to be late and she had to be somewhere at 6:15. She eventually stopped complaining at exactly 6.15, and I returned to the dispensary, whereupon I noticed out of the corner of my eye that she had taken the time to hang around to complain about how long it had taken her to get her prescription to some of her friends who she just happened to bump into in the shop. Goodness only knows what time she actually left.

Invading Privacy

If you have ever picked up a prescription from a pharmacy, you will have probably been asked to confirm your address. This is so that we can make sure that you actually get the correct prescription. This is not because we are evil assassins or because we want to sit in a bush outside your house and spy on you- we really don't- and you're address is written on the prescription so if we wanted to we could anyway. On this locum shift, however, we were accused of invading someone's privacy for asking for this information. "I don't need to give you that information!" he declared. The counter assistant advised him that this is a routine question to ensure that we give out the correct prescription. But this wasn't good enough, and he wanted to speak to someone in charge. Off I went into the breach. I told him that he could come into the consultation room to give us his address so no one could overhear, but this was "an inconvenience", apparently.

By this time, he was shouting and other people in the queue were staring at him.

Again, I advised that we routinely confirm the address to ensure that the correct prescription is given out.

He decided to prove that the prescription was his instead by giving out his name, date of birth, and by telling me every item that was on the script. Loudly. One of which was sildenafil (Viagra).

Magicking Up Medicine

Me: "I'm sorry, we don't have that item in stock. There is a manufacturing problem on it, so we can't get it from our suppliers"
Patient: "But I need it" 
Me (in head): "Oh I see. Well if you can hold on a few minutes, I'll just nip round the back into our large pharmaceutical manufacturing factory, dig out the raw materials, and whip you up a batch right now then" 
Me (in real-life): "I understand, but I'm really sorry, we can't get any in at the moment."
Patient: "But I need it."
Me: "Where is the nearest wall please, so that I can bash my head against it repeatedly?"

The Expert Customer

I'm advising a patient about how to manage their child's teething problems. Another customer waiting in the queue decides to chip in with "Those Nelsons Teetha sachets are really good." (Nelsons Teetha sachets are homeopathic, therefore contain nothing of use and have no pharmacological effect). From then on, I (and my many years of training and experience) might as well not exist, as nothing I say can steer the patient away from believing that Nelsons Teetha are simply THE best thing since sliced bread, and in her eyes I'm obviously a terrible pharmacist for not recommending them immediately.

Impatient Patient Questioning

You ask the patient all the usual questions. They're all answered with a loud sigh, vacant eyes, and a disinterested "yes" or "no" at all the bits that they think are right. I could be asking anything, and I'd get the same response. So sometimes, I like to mix it up a bit and throw in a question they're not expecting. If its something like Nytol or a codeine containing medicine, I'll ask "Do you take it regularly?" to which the response is usually a bored yes. In which case, I advise them that I can't sell them any, then swiftly duck for cover when they inevitably throw things at me.

A variant You ask the patient if they are taking any other medications, to which they sigh and say "no". It's only when they're about to hand over their money that they a) ask what would happen if they were taking medicines, then confess, or b) whip out an inhaler and proceed to take a couple of puffs right in front of you after they have just told you that they don't have asthma or COPD.

Specifics

The patient can inexplicably only take one or two brands of generics for a product. You are, of course, expected to telepathically know this and dispense the right one, and woe betide anyone who doesn't. Now, I am entirely understanding of cases where a patient has specific requirements for one type of product- maybe an allergy to an excipient, say. But when there is not reason for it, and the patient is shouting at you for not giving them "the right medicine" despite them at no point telling you what "the right" one is, then I tend to feel a bit put out.

Mobile Misery

Now I am known for being attached to my mobile phone. However, one of the most annoying things when working in retail is having to deal with customers who refuse to hang up theirs whilst you are trying to have a conversation with them. Over a pharmacy counter, we often need to give detailed counselling, and of course we need to ask a lot of questions. I can't really do that if you are also listening to so-and-so discussing who was drunkest down the pub the other night. At this particular locum shift, I had to attempt to explain that there was an item owing on a prescription to a chap who was having just such a conversation. The icing on the cake was when he said to his phone-based friend "Hang on, I can't hear you, this stupid woman keeps talking about something and wont give me my prescription". Needless to say, despite me explaining the owing and handing him an owing slip, he returned a few minutes later demanding to know where the missing item was. This "stupid woman" then had to patiently and politely re-explain everything I had already told him.

How do I deal with situations like this? Politely, professionally, and with a smile on my face. I might have a bit of a rant and a laugh about it later in the back of the pharmacy, but outwardly in these situations I remain as calm as possible and attempt to be as helpful as I can. I've had many years of practice. The worst thing about this shift was that I was working with a new counter assistant and a newly qualified pharmacist, and I could see their morale slipping minute by minute. Their shoulders slumped, their smiles became more forced, and I found myself desperately trying to reassure them that this is just how some days go. Of course, we pharmacy types do make mistakes on occasion, and inconveniences do happen. I can understand that, when it comes to health, people can be scared and anxious, and that can come across as aggression. It is my firm belief, however, that a little bit of kindness and manners get you everywhere, and I am always much more likely to respond positively to calm and polite customers than those who default to outright rudeness, although I will do what I can to ensure that I help them all.

Hxxx

 

Nelson's: Suggesting that your kids need mood stabilisers from two years old.

You know of Rescue Remedy, right? You probably had an aunt who would constantly swig a drop for her nerves, or might have even taken some before a driving test or exam.

Rescue Remedy has become a pretty well known brand- so well known, in fact, that most people don't bother finding out whats in it, or what principles its based on. You wouldn't want to know the recipe of Coca-Cola before you take a refreshing swig- you'd just assume that because its a well known brand, its probably going to work.

Rescue Remedy is, however, a whole load of woo nonsense. Sorry, but there's no other way of putting it. Some dude called Edward Bach decided- apropos of nothing- a good few years ago that some flowers, if left out in the sun and dissolved in alcohol,  will be able to balance physical and emotional distress. This is interesting, really, given that its taken the entire fields of neuroscience, psychiatry, and psychology many, many years to get to a point where there are still a vast amount of unknowns regarding mood disorders.

Science is getting there- slowly- when it comes to understanding things like depression. It's a vastly complicated subject. There's no perfect cure-all drug out there for treating such things- mainly because we don't yet understand it that well yet. So forgive me if I am skeptical that some random guy years ago has just randomly (without any basis in science) decided that, for example, mustard flower:

 "is the remedy for deep gloom and depression that descends for no apparent reason out of a clear blue sky. People in this state often list all the reasons they have to feel happy and contented, but still everything looks black and hopeless to them. The remedy helps to dispel the clouds so that we can once again appreciate the joy and peace in our lives."

Rescue Remedy is a blend of some of Dr Bach's made up flower remedies, diluted in brandy. You're supposed to reach for it in times of anxiety, as a soother. Funnily enough, brandy, being alcohol and all, it might make you feel a little bit better, but similarly to homeopathic remedies, they are dilutes such that very little or no levels of active ingredient are likely to remain. So even if Dr Bach were right about the flowers (despite evidence and science suggesting otherwise), there wouldnt be enough flower-stuff in a drop of it anyway to make a difference.

I can't quite get away from the fact that this is a cynical product which Dr Bach made up in an attempt to target wealthy women ("ooh! pretty flowers!") in the days where women were considered "hysterical" and many were labelled as having "problems with their nerves" based entirely on their sex.

Anyway, why am I on about Nelsons, and why am I on about children? Well, because the Bach Rescue Remedy brand- in all of its many, varying, and just-as-cynically money-grabbing-as-Big-Pharma- forms- is sold via Nelson's homeopathic brand. That's Nelson's who the FDA discovered weren't putting magic woo water in all of their magic woo water pills, but were happy enough to put particles of glass in there. That's Nelson's who are all "ooh, we care about you and your healthcare unlike those big meanie pharmaceutical companies who only care about money" all the time.

Well, I happened to stumble across this product of theirs today. Rescue Remedy Gummy Stars- aimed at children from 2 years and onwards. According to Nelsons:


"The first day back at school is a big day so parents should have a secret weapon against tiny tears on standby in the school run bag. RESCUE® Gummy stars - The latest addition to the RESCUE brand come in fun star shapes to help turn a frown upside down at the school gates and each Gummy Star contains four drops of RESCUE, the famous soothing combination of five flower essences."

What's wrong with that? The fact the Nelsons are attempting to medicalise a perfectly normal part of childhood purely for their profit, that's what. Being nervous on your first day of school is entirely normal, especially for a little one. What they need to do is to develop normal coping mechanisms to deal with their anxiety. What they don't need to feel is that their anxiety is abnormal and something which only a medicine can fix.

When encountering the world of complementary or alternative medicine, I often like to stop for a moment and replace the names of the companies with those of Big Pharma. It gives a good indication of whether or not there really is a difference in practices between the two camps, and whether people's reactions would be different

"The first day back at school is a big day so parents should have a secret weapon against tiny tears on standby in the school run bag. PROZAC® Gummy stars - The latest addition to the PROZAC brand come in fun star shapes to help turn a frown upside down at the school gates and each Gummy Star contains 10mg of PROZAC, the famous soothing antidepressant fluoxetine."

Icky, right?

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

Customer walks into a pharmacy...

...and chooses what medicine they want to buy, before taking it to the pharmacy counter. Yes, that's right folks, instead of telling a daft joke, I'm going to witter on yet again about the self-selection of P-meds. This time I want to think about it from a patient's perspective. Some of these considerations may seem small and petty, but i just want to put my thoughts down on virtual paper and you can see what you think.

When I walk into a shop, I can be pretty easily intimidated. I'm shy, and I don't like to bother people. I also hate that uncomfortable feeling when you walk into a shop and you feel like you're being watched by someone and then you feel terrible about not buying something. I can get anxious about the smallest of things, in particular not quite knowing what you're supposed to do in a shop- if I can't find the til, or there's an empty box and i don't know who to ask, or if I can't find something, for example.Of course this is worse when I am feeling a bit poorly and I can be particularly skittish- im likely to go home without buying anything, even if i need it, because i can't be bothered to have to work out what I'm supposed to do. This brings me onto my first point about self selection

1. It could be different everywhere.

 Not all pharmacies will take up the self-selection option, so I'll need to ask at the counter as i am used to. But in some pharmacies, the packs may be out on the shelves, whilst in others, they might be in security packs or might be empty packs that I need to take to the counter, like an early nineties video rental shop. It sounds daft, but this sort of thing could be quite off-putting.
 

2. How the hell am I supposed to know what to buy?

 I tend to acknowledge people who know more than I do about a subject and listen to their opinion. If I go to the hairdressers, for example I tend to ask them what style they think would best suit my hair type and face. After all, they've done some training in cutting hair whilst I am utterly clueless about it. If I walk into a pharmacy, therefore I don't expect to have to do all the hard work of product selection myself. My product selection process for most things usually goes like this:

Its either that, or I stand around reading every single box of every single product. This would take me bloody ages, and would be pretty inconvenient.

3. What If Its The Wrong Thing?

 After I have found the shiniest product, I take it to the counter, where I am then told that I've picked up the wrong thing and I'm not allowed to buy it. This, frankly, pisses me off and adds even more inconvenience o the whole affair. I've chosen the product, and now some jobsworth glorified shop assistant is saying that I've chosen the wrong thing? how dare they! (I've lost count of the number of times I've been called a glorified shop assistant by patients-and on occasion non-pharmacist managers over the years, by the way). You know like when you're in a hurry, and you've picked something up in a shop and you take it to the counter, and they tell you that its on buy one get one free, but there is a huge queue behind and you're going to be late for your train so you just say "oh its fine, I'll just take that one". I suspect that would end up happening quite a bit as well.

4. Advice Isn't Quite So Forthcoming.

 When I ask for a specific product in a pharmacy, the counselling and advice I am given tends to be minimal (if at all), whereas if I ask what they would recommend for a particualr symptom (not that I usually have to bother doing that myself, but you know), I tend to be given fuller, more rounded advice as part of the product selection process- I've written about this before. If I want to know something about a product, I have to ask about it, and I might feel a bit stupid doing that when I'm supposed to have picked the product myself. In addition, I might not actually know that I need to ask for advice unless it is offered. With self-selection, I fear that offering routine advice would become the exception rather than the norm, and instead of being proactive in giving advice, we would instead get into a pattern of waiting to be asked.

5. Medicines Are Commodities And Its My Right To Buy Them.

 I've written before about the paracetamol problem- its so widely available that people think its safe and innocuous, and they can take extra or dismiss it because they've sort of forgotten that its a medicine. I think this may become a wider problem. If medicines are available on the shop floor for me to handle and choose myself, I assume that they're either not very good medicines, or they are so safe that I can use them how *I* like. If I want to take three times the amount of antihistamines that it says on the pack, then I can do, just like how if I want to eat peanut butter out of  a jar with a tablespoon then I should be allowed to, because its my choice to buy it and who is anyone else to judge me and tell me otherwise? this is going to be particularly problematic with codeine-containing medicines and similar.

Anyway, those are a few thoughts for now. I may add to them as time goes on. What do you think?

Hxxx 

When Z-day comes, Think Pharmacy

A little while ago, it occurred to me that I hadn't watched many zombie films in my life. I therefore made it a bit of a project to watch a whole load of them. I got myself a mentor (my friend Frankie) and together we perfected the art of walking back from the cinema in a zombie fashion whilst giggling hysterically.

 

I've watched good zombie films, bizarre zombie films, Christmas zombie films, thoughtful zombie films, and absolutely terrible zombie films starring Billy Connelly. So I sort of know the ropes when it comes to the genre. On the advice of Nancy, I started listening to the We're Alive podcast, and now extol the virtues of it to any who will listen. Although I dont recommend listening to The Archers right after it, as you find yourself waiting for zombies to jump out and ruin the Ambridge flower festival.

 

So I've just gotten back from World War Z. It was better than expected, and it managed to squeeze more entertainment than I thought may be possible out of a lab in Wales and Peter Capaldi wearing a jumper. Although I may be biased as I do have a bit of  a thing for Peter Capaldi (and Brad Pitt), so I was happy enough as soon as he arrived on screen. All that was missing was Hugh Laurie. And a better ending. And more gore. And less CGI. And less not realising that with a pen and paper and the camera he could easily get the people in the know to tell him which vial to choose. And wouldn't there be an intercom in a WHO lab with infectious diseases in it anyway?!

 

Anyway, I digress. Aside from all the problems with the film that no one else would probably notice, I did note one shining light in all of the z-day carnage. Brad Pitt, like any good citizen should, Thinks Pharmacy. In need of an emergency supply of a salbutamol inhaler, off he goes to the local, friendly community pharmacy.


I don't think this is much of a spoiler, given apparently pretty much the whole film is in the trailer, but after barging into the supermarket pharmacy (probably unlikely: in real life he would have just coughed loudly and shouted "shop!") he is greeted by a friendly professional, white coated  pharmacist who offers him an NMS consultation. Okay, maybe not. He's wearing  hoody and carrying a gun, but, ever the professional, still manages to give some health advice when handing over three inhalers. "Children grow out of asthma" he says, helpfully, which may be true, but I think is unlikely to be the case by the time the  3 inhalers are used up.


He even link sales, passing over some bottles of what I presume to be paracetamol liquid too. How very helpful.


Its nice to see a pharmacist in a film or TV show doing something other than serial killing, murdering, nearly killing orphans with poison when drunk, or merrily doling out vicodin to Dr House without a prescription. Its nice to see a pharmacist resolutely doing what he can to help. It reminds me of all those stories you see in Chemist and Druggist, where there has been horrendous flooding but the pharmacy staff still manage to open up and do their deliveries in a makeshift canoe. The ones who, despite broken shutters or six foot deep snow or pandemic Ebola still turn up to make sure all the collections are done and the order is put away.


The pharmacist in question doesn't do any WWHAM questioning though. I'm not convinced Which? Would have been very happy with him.


Hxxx

Self Selecting P-meds: searching for the evidence

The other week, the lovely folks at The Pharmacy Show Community (they are really lovely, my flattery of them is nothing whatsoever to do with the fact that they are linking to and publishing bits of my blog) held a tweet chat all about the self-selection of P meds, led by the mysterious and always entertaining @MrDispenser.

There are a few concerns that I- and it seems many other pharmacists share about the self-selection of P-meds. I've covered some of my concerns here, but the tweet chat threw up many others too. Other pharmacists have also shared their concerns, and you can find some of them in the links below:

Right now I want to look at the evidence that self-selection works. The theory is that allowing patients to choose their own medicines leads to greater adherence. As the patient feels they have more ownership over their healthcare decisions, they might use the drugs more effectively for a better outcome. But is there any cold, hard evidence that this is the case when it comes to over the counter medicines? 

As a skeptic, the words "Where's the evidence?" are often found escaping from my mouth. Sometimes the need for evidence is countered by the risk averse pharmacist side of me, where the theoretical likelihood of a risk outweighs the need for evidence. As with all things in healthcare, a balance needs to be taken into account: what are the risks vs what are the benefits?  In this case of self selection, I can see there being a real risk of fatalities. Any evidence of benefit to patients needs to be robust in order to outweigh the risks, in my opinion.

So I've made a start by looking at Embase and Medline. I've also had a look at NHS Evidence and have even googled. And I've been able to find very, very little on the subject. I found one Dutch paper about self-selection in the pharmacy, but that has no abstract.

I found this World Self-Medication Industry website which states:

"A study done in the United Kingdom showed that consumers welcome the opportunity to self-select medicines in that country's pharmacy class. Three out of four of the British consumers in the study felt that re-configured pharmacies with easier access to non-prescription medicines was a good idea, half because it would save their own time or that of their doctor, and the remainder because it offered greater choice."

But this doesn't appear to be referenced, so I can't find the study to see how reliable it is.

Have I missed anything? If you're aware of any evidence for the efficacy of self-selection of P-meds, please do let me know by dropping me an e-mail at healthydoseofskepticism@gmail.com. I would be particularly interested in any evidence that could be provided by the GPhC, and might drop them a line to see what they have to say on the matter. 

In contrast, I stumbled across a study from New Zealand, which concludes that, when purchasing a pharmacy medicine for the first time, in 62.2% of cases the sale was influence by pharmacy staff. This study has its limitations of course, but if true (and from my personal experience of many years of community pharmacy work it would appear about right), it would seem a shame to eliminate this from the medicines buying experience. 

There is also some evidence that patients who approach the pharmacy counter with a specific product in mind are given poorer advice than those who ask for a recommendation based on their symptoms- again something I have experienced both as a pharmacist and a customer. 

Of course patients can still ask for the expertise of pharmacy staff, but how many of them will know to ask, and how many will simply pick the nearest thing and hope for the best?

I'm going to hopefully write another post about my concerns about how the patient experience will be affected. If you have any thoughts on this, again do get in touch. If you're a customer in a pharmacy, I would love to know whether you think self-selection of Over-The-Counter medicines would be good for you. 

The Vaper Verdict

I seem to have gotten myself a bit of a reputation as a Vaper-hater. In truth, I'm actually really not.

I even once owned a disposable e-cigar. It was a good few years back now. Although I consider myself a non-smoker, I do smoke the odd cigar, but about one a week and only when the weather is nice (so about 4 days a year then) and only when someone has brought me some back from their holidays probably does not constitute a habit, or would be considered the world's most pathetic addiction. I would never dream of smoking indoors, and somebody thought it would make a nice stocking filler for me one year.

I used it a few times, and it was alright, in the same way that a Pot Noodle is mildly enjoyable in its own right, but bears no resemblance to a steaming hot bowl of freshly cooked spicy Szechuan chicken in udon noodles (no 69. on the menu at Nudo, my favourite restaurant in Newcastle. Its always giggle-worthy ordering it). E-cigarettes are the Smash mashed potato of the smoking world, a Cup-A-Soup to a home-made broth.

I can see how it would be good to have something vaguely resembling a cigarette if you're trying to give up smoking, and I can certainly see how a nicotine delivery method that avoids all the tar, chemicals and other gunk that smoking dumps in your lungs is more healthy.

My reservations are thus:

  1. If they're unregulated, you have no idea what's in them. It might say on the pack that it contains x mg of nicotine and chemicals y and z but there is no guarantee of this. Some have been found to contain toxic chemicals like ethylene glycol, for example. Its undoubtedly likely that they still contain less dangerous chemicals that cigarettes, but it would be very nice to have that guaranteed.

  2. There's no long term safety data. We literally don't know what the long term effects of these things are. For all we know, the seemingly safe-at-first ingredients could actually prove to be carcinogenic, say, when inhaled in this way in the long term. Admittedly its unlikely the products would be as bad or worse than smoking, but without the studies we just don't know. Theoretically they may seem like they're going to be harmless, but without the data there to back it up we just cannot make that assumption- its that sort of reasoning that lead to the thalidomide disaster, for instance. Unknown does not mean safe.

  3. There's evidence that products are often do not contain what it says on the label (if they even have a label at all). A study in the BMJ's Tobacco Control found that products contained variable and potentially dangerous amounts of nicotine- most often the product contained less than was stated. Now, if I'm paying for a product that says it contains 72mg/ml of nicotine, I expect that product to contain 72mg/ml of nicotine, just as I would expect a 500mg paracetamol tablet to contain 500mg paracetamol. If it contains less than this, I'm essentially being ripped off. The other available nicotine replacement products- patches, gums, inhalators etc- all have a license, and I don't really see why these electronic cigarettes should be any different.

  4. In smoking cessation, using a product which looks like a cigarette might be helpful in the short term, but it doesn't help to address the habits of smoking rituals, and in my experience of helping people quit, that's half the battle.

  5. The risk of serious accidental nicotine poisoning in both adults and children. 

  6. There is a risk that the ease of use of the products and ability to use them indoors might actually increase nicotine intake in some people.

  7. Even if nicotine itself were entirely safe (which it isn't), its still an addictive substance. Any addiction can lead to harmful effects in a person. For evidence of this, try speaking to me on a day when I have not had any caffeine. If I added up all the time and money I have spent in my life engaging in drug-seeking behaviour to feed my addiction (mainly desperately trying to find the nearest kettle or coffee shop), I suspect it would be very upsetting.

Today there has been, in my opinion, some good news. The MHRA have decided to start . This decision essentially eliminates concerns number 1, 3 and 5 and starts us on the road to also ruling out concerns 2,4 and 6. The BMA have responded enthusiastically to the news, stating:

“We can now build on this and press for good research which looks at the efficacy and health implications of e-cigarettes. It’s really important that we find out if the hand to mouth use of e-cigarettes either breaks or reinforces smoking behaviours. We need to know if e-cigarettes actually help smokers quit."


I'm also enthusiastic about this step. Whilst it may lead to decreased availability and choice of these products, it will hopefully lead to a smaller number of better quality products being legitimized and incorporated more formally into smoking cessation or harm reduction schemes- if they are proven to work in robust clinical trials. This is yet another case where, instead of waiting until we have good, robust data that a product works and is safe, it has been widely sold and adopted by users in lieu of risk or efficacy information. There will no doubt be an outcry from users and manufacturers, and wails that the MHRA have banned e-cigarette sales, that its a Big Pharma conspiracy to give everyone cancer so they can sell more drugs, that big evil corporations are trying to trample the little guys down, when all they are trying to do is save some lives. But none of this regulation means that.

All a manufacturer of e-cigarettes would need to do to continue selling their product is to prove its safety, efficacy and quality. It will take money and time, but if they have been already producing their wares safely and in accordance with Good Manufacturing Practice guidelines, they're already some of the way there. Gaining a license will of course cost time and money, but if these manufacturers are genuinely interested in saving lives- and not just unscrupulously making profit- they would see the value in the licensing process, and the opportunities available for a licensed product in the long run.

So here's to what could be start of a new dawn of smoking cessation or harm reduction. I really hope so, but will reserve judgement until the evidence starts piling in.

Hxxx