Friday, 31 May 2013

My Fantasy Pharmacy

People are allowed fantasy football teams, so why shouldn't I be allowed my own little fantasy pharmacy?

Now people, I want you to contribute to this post. So let me know if I haven't included your desert Island drug and why you think my pharmacy should stock it, and I shall put it on the shelves if I deem it worthy. Tweet me @SparkleWildfire, leave a comment, or drop me an email at inthecityofthefuture@gmail.com. I'm going to start off small with this post, and add to it gradually.

With all this talk of pharmacy as a quack trade, and the lack of evidence base for many OTC products, my pharmacy is going to have the bare minimum. Only the drugs I want to sell, ad that I think are necessary, with none of the extraneous, shiny combination packs that are purely there for profit. 

So, welcome into my emporium of evidence-base, and help yourself to some expert advice, a healthy dose of skepticism, and a pinch of thriftiness.

Shelf One: Pain Relief
Paracetamol: because it is an effective painkiller and antipyretic with few side effects. 
Ibuprofen: again, an effective painkiller and antipyretic. Needs more caution because of side effects, but still useful to have over the counter.
Sumatriptan: a good shout, thanks for your comment, Joanne. This is actually a really useful product to have OTC, in my opinion- its for migraines, so its great for regular sufferers to have easy access to if they don't have their usual meds to hand. But it does needs to be sold very carefully, with good questioning and counselling. 

Shelf Two: Coughs and Colds
Sudafed: just the plain old pseudoephedrine variety. Its the most effective decongestant over the counter (phenylephrine has much less of an effect orally) and can be combined with paracetamol or ibuprofen if there is pain associated with blocked sinuses.
Lemons and Honey: for combining with hot water for soothing throats and coughs. About as effective as any other cough mixture.
Glycerin, Lemon and Honey Mixture: as above, but ready made for when you don't have access to a kettle. Also: its quite delicious. 
I would include a night time product too, but I'm not sure which one yet. I don't want to include Night Nurse because its got far too many ingredients in it, and no one should have to take medicines they don't need. My product would just have diphenhydramine and paracetamol in it, probably, just something to help you sleep when you have that awful achey can't breathe feeling that comes with colds. 
Menthol crystals: for adding to steam inhalations. Inhaling the vapours of a  couple of those bad boys in boiling water will have your mucus cowering and crying in a corner. 
Xylometazoline nasal spray: an option for people with bad congestion who can't take pseudoephedrine.
Pholcodine cough medicine: As voted for by Kev. Its cheap enough, and acts to suppress a dry, tickly cough. Shouldn't be used in chesty coughs though. 

Shelf Three: Ear problems
Olive oil: there is no reason whatsoever for any of the other products to exist. Plain old cheap olive oil will do the job just as well as anything else.
Dropper: for administering the olive oil. 

Shelf Four: Allergies
Generic beclomethasone nasal spray: cheap, works if used in advance of the hayfever season.
Antihistamine tablets (generic): Chlorphenamine, loratadine, and cetirizine. Exactly the same as the hugely expensive branded varieties. chlorphenamine can cause drowsiness, the other two tend to be much of a muchness- some people find one works for them, some the other.
Cheap anti-allergy eye drops: great for people that have predominantly eye symptoms.


That's a little start, and I shall add to it when I think of anything else or get a chance.

Hxxx

Dermalex: a superficial skin miracle?

I've written before about the guttate psoriasis which suddenly appeared at the start of this year and the impact it has had on my life.

I'm pleased to report that, after 9 weeks of phototherapy, it is much better. It has virtually gone on my top half, but the plaques on my legs are still stubbornly visible, although much better. The fact that it hasn't gone away entirely yet means its probably not going to clear up. Without wanting to sound over-dramatic, it actually feels like quite a bit to deal with- I've never had any long-term health conditions before, and although I've become slightly more confident, I'm still really conscious and nervous of having to expose any affected skin.

A while ago, my Mum rang me. "There's this new product out that says its for psoriasis, shall I buy you it so you can try it and see if it works?". To be honest, it was tempting, but when she told me the price £29.99 for just 150g, I declined. Skin diseases really can have an enormous impact on your life, and leave you desperate to try anything to find that one miracle that will get rid of it once and for all. Since then, I've seen it prominently displayed in quite a few pharmacies, hailed on shelf-edges as a 'breakthrough in psoriasis treatment'. So the big question is, is there any evidence that it works?

The product is Dermalex, and it is made by Omega Pharma. If their name sounds familiar to you, that may be because they also produce Prevalin, the overpriced, overcomplicated, under-evidenced Vaseline substitute for hayfever. This leaves me with a slight prickling of my skepticism, but lets keep an open mind for now.

This poor chap obviously has some practical joker friends who like to write words of skin conditions in his sun tan lotion when he is sleeping in the sun.

How is it supposed to work? Well, the fact that the website itself titles this section "How its works?" (sic) begins to worry me slightly. I know this blog is liberally sprinkled with typos and spelling errors, but at least I have the courtesy of being shameful about it. In a professional website selling a quality medicinal product, I don't think spelling errors are acceptable, and there are a few dotted around the whole website. Nowhere on the website does it actually tell you what is in the product. Its said to:

"Reduce Psoriasis symptoms by: Normalising skin cell production and Acceleration of the recovery of the skin barrier 

and


Fortify the skin barrier through: The creation of a protective shield on the skin by means of Alumino silicates against outside to inside insults (bacterial superantigens & toxins) through the non-intact skin barrier.
Providing a barrier to water loss"

This is helpfully illustrated by a diagram of the skin, which has labels that don't correspond to any numbers at all- either they're deliberately trying to make it look all science-like and confusing, to make the patient think "this is too complicated for me, so it must work", or its just sloppy oversight. Either way is bad enough.

Some labels on those numbers would be nice. Unless there really are little blue circles with random number in them floating about in the layers of our skin.

We can pretty much entirely discount the claims for "fortifying the skin barrier". All this means is moisturing the skin, and a plain old (cheaper) emollient will do just as good a job at that. Once again, this seems to be Omega Pharma reinventing the Vaseline-greased wheel. As for the former claims, well, I need to see some evidence to corroborate them and decide if they are reasonable or not. So let's have a little lookie, shall we?

Having had a bit of a dig about on the website, I could see no clinical evidence. So of course I emailled the manufacturers, and got back a curt response after several days telling me to look at this page for references. So, here it is, the grand total of the evidence that Dermalex Psoriasis works:

"PASI based clinical efficacy study of Dermalex Psoriasis cream for the treatment of Psoriasis Vulgaris symptoms in a mono application therapy, Józsefváros Health Center, Budapest, Hungary; Open Label Clinical Study into the overall efficacy of Dermalex Psoriasis Cream, 2008, Dermatology and Psoriasis Clinics Laudau and Kandel, Germany"

For some reason, Omega Pharma seem to want to throw away the usual format of referencing- the one that is accepted and good enough for use in the rest of the medical profession. These references do not give me enough information to find the original studies, so what use are they? I've emailled them back to ask for standard reference formats, including where the studies are published, and have been greeted with a loud silence. I've tried googling the titles, and this brings up nothing, suggesting that they haven't even been published.

Why isn't the evidence published anywhere? How many patients were involved? What are the study designs? What were the results, and the statistical analysis of the results? Without answers to any of these questions, all I can do is discount this as evidence at the moment. 

Of course I didn't just leave my research there, in the hands of the manufacturers. I've also had a look myself at the medical literature. And could I find anything at all for whether Dermalex works for psoriasis? Not a sausage. 

You're supposed to apply this stuff  three times a day. 150 grams will not last you long at that rate. That makes this a whoppingly expensive product. The national minimum wage in the UK is £6.31, meaning one pack would be equivalent to just under 5 hours work. I simply don't think that a couple of unpublished trials that may or may not say it works is a good enough reason to justify the expense. They're either being deliberately evasive about the evidence, or remarkably blase with people's hard earned cash.  

They say beauty is only skin deep. It would seem that the evidence that Dermalex is even more shallow than that.

Hxxx

Update: I was contacted by the manufacturers of Dermalex, who promised to provide me with the references I asked for above. Here is the response I've gotten, with my response to the points they have raised below. .

Thank you for your enquiry regarding Dermalex.

As you may be aware, the Dermalex range contains a number of different products to treat the following conditions; atopic eczema, contact eczema, psoriasis, rosacea, atopic eczema for babies and children. Please rest assured that all Omega Pharma products have been produced under strict guidelines and regulations.

A range of proprietary studies have been conducted across the Dermalex product portfolio and as medical devices, these products have undergone statutory trials to ensure they meet the safety and efficacy standards required by regulatory bodies to demonstrate an impact on skin pathologies.

Medical devices are designed, engineered and formulated, in compliance with the UNI EN ISO 14971:2009 and 13485 guidelines. This means that each step of development and marketing has been strictly regulated to ensure the safety and efficacy of the products.  All testing is carried out by medical device status certified organizations, which include leading dermatology research centres. In addition, all studies were conducted by practicing clinicians. Please note that these studies include varying number of participants and study designs.

The research behind the Dermalex range is ongoing - we are working towards publishing data on the product range this year to ensure we are able to communicate the efficacy and safety of these products to healthcare professionals. We are working closely with the University of Amsterdam and are looking to publish the first set of results in the International Journal of Contact Eczema. We will also be presenting this data at the upcoming conference on ‘impaired skin barrier in the pathogenesis of atopic and contact dermatitis’ in Amsterdam in June.

To date, we have conducted six trials across the product portfolio involving nearly 200 patients. The products have also been used in in Belgium, France, The Netherlands, UK, Italy, Portugal, Austria, Switzerland, Ukraine, Czech Republic, Slovakia, Turkey and Australia, among nearly 3 million sufferers.

All Dermalex products are well tolerated and have been clinically proven to work. In summary, the trials showed:
·         Dermalex Contact Eczema produces symptom improvement comparable to prescription drug treatments
·         Dermalex Atopic Eczema (Babies & Children and Adult formulations) effectively relieves both objective and subjective symptoms of contact or atopic eczema
·         Dermalex Psoriasis is effective against objective and subjective symptoms of psoriasis
·         Dermalex Rosacea & Couperose is effective against objective and subjective symptoms of rosacea

We hope that this information is useful and thank you for taking the time to contact us."

Firstly: I was aware that Dermalex is being sold as a medical device, but only because of those telltale words "Clinically proven!" and based on knowledge of Omega Pharma's other product, Prevalin. the fact it is classed as a medical device (and therefore not subject to the rigorous clinical testing of a real medicine) is even less prominent on the Dermalex website than it is on the Prevalin website. 

The rest of the e-mail appears to be a lengthy way of saying "We don't have any trials published yet, and no, you can't have any results in order to make up your own mind whether or not it works, you'll just have to take our word for it.". 

What's particularly interesting is that the International Journal of Contact Eczema doesn't appear to actually exist, as nothing at all is coming up for it on a Google search.

They say they have conducted six trials, which initially sounds reasonable. But this is across the product range, which includes at least four products and also children's versions. 200 people over six trials is not a lot- if shared equally that is only 33 patients per trial, and assuming they're placebo controlled, that would only mean that 16 patients per trial are actually exposed to the product- nowhere near enough to claim clinical significance of any results. Stating that the product has been used in other countries is meaningless, unless it is backed up by good, robust clinical trials. Its a logical fallacy- an appeal to popularity. Just being used doesn't mean it works- people might just try it once, or use it on the basis of advertising alone, but the product could still be ineffective.

So here's my main problem. How do Dermalex justify charging such an enormous price for a product before they have proven its efficacy. If good quality research had been undertaken prior to marketing, and robust results said that it worked, then that's one thing. But charging people £29.99 for "We think it might work, but we don't know yet because we're still doing research now, and the trials we've done so far that haven't been published yet in a non-existent journal are too small to decide" is, to my mind, entirely unjustified.


Bad Pharmacy: An example

This morning, I needed to go and buy some medicines.

So, on my way into work, I popped into the nearest pharmacy to my route into work: a branch of a very large chain of chemists. Here's what I bought:



This turned out to be a particularly disappointing example of what I wrote about in my last post- a very lackadaisical, dangerous attitude to OTC sales. And this comes merely a few weeks after publication of the latest Which? report into pharmacy, and about a week after pharmacy was referred to, by Ben Goldacre and Andy Lewis no less, as a "quack profession".

Now, I'm demonstrably not a parent, but you know when you tell off a child for doing something naughty? The usual response is to stop doing the naughty thing, and act extra-specially well-behaved for a period of time until the original naughty thing is forgotten about, then you start doing it again. On second thought, I know some adults that exactly the same thing applies to. The pharmacy profession as a whole should be in that well-behaved phase right now. We should be pulling together, and ensuring that everyone involved- including counter staff- pulls their socks up, shakes off bad habits, and works to the highest quality, to prove a point, but also just because this is how we should be operating all the time.

So, this morning I shuffled into this particular pharmacy (which I'm sure you have no idea which one it is, given I have so cleverly covered the brand in the picture) and asked for "Some Piriton and some co-codamol". The lady who served me appeared to be an experienced member of the pharmacy counter-staff. Here's how the conversation went:

Pharmacy Lady: "Do you want a pack of 30 or 60 Piriton?
Me: 30
Her: And you wanted paracetamol?
Me: No, co-codamol.
Her: Soluble?
Me: No.
Her: have you got a loyalty card?
Me: No
Her: that'll be £5.34
Me: *pays and leaves*

Here is how the conversation *should* have gone, as a bare minimum:

Pharmacy Lady: "Do you want a pack of 30 or 60 Piriton?"
Me: 30
Her: We've got a cheaper generic version, if you want that?"
Me: "lovely, yes please"
Her: "These can cause drowsiness, mind, so make sure you don't drive or anything when you've taken them"
Me: okay, I wont.
Her: And you said you wanted co-codamol?
Me: Yes.
Her: soluble or tablets?
Me: just tablets is fine
Her: Have you used these before? Do you take them regularly
Me: No, just when i have a headache now and again.
Her: Because of the codeine content, they should be used for no more than 3 days at a time. If you feel you still need to use them after that, see your doctor. They also contain paracetamol, so make sure you don't take any other paracetamol products with them, and no more than 8 tablets in a day.
Me: okay
Her: Do you take any other medication at all?
Me: no, just the contraceptive pill
Her: have you got a loyalty card?
Me: No
Her: That'll be £5.34
Me: *pays and leaves*

That extra counselling would have added on about 20 extra seconds, which might have seemed like a minor inconvenience to myself, but lets have a look at the theoretical consequences of not saying them:

Piriton: Causes drowsiness. I take one, get in my car, fall asleep at the wheel, and have an accident.
Co-codamol: I don't realise it has paracetamol in, and take 2 co-codamol tablets and 2 paracetamol tablets four times a day for a while. I get liver failure, and die a slow, painful, unpleasant death because a suitable liver isn't available for transplant.
Also: I take co-codamol regularly for a week. I then try to stop taking co-codamol, and start getting headaches, and generally feeling awful, so I restart taking it. I am now dependent on the codeine content of it.

Yes, I am a pharmacist, so I already know the potential risks and consequences of taking these drugs. But I wasn't wearing an "I'm a pharmacist" T-shirt this morning, so its not like the member of staff knew this. Just because I asked for the products by name does not instantly mean that I know all about them and do not require full counselling on how to use them appropriately. And yes, I do also know that there is no good evidence that co-codamol is more effective than paracetamol alone, and I know I'm daft to be buying them, before anyone starts with the "aren't you supposed to be a skeptical pharmacist?"- sometimes even skeptical pharmacists like to utilize the placebo effect the promise of a tiny opioid hit provides.

Any of these theoretical problems can-and do- happen to people. We simply cannot go on providing such poor service over the counter and yet at the same time expecting the profession to be taken seriously. This is not safe selling of medicines- this is irresponsible and dangerous, and unacceptable. It makes me pretty angry because it not only gives a bad name to myself, and all the other great, conscientious pharmacists I know, but more importantly because it endangers patients on a minute-by-minute basis.

Friday, 24 May 2013

Are we selling our souls Over The Counter?

There's something beautifully logical and satisfying about a good Over The Counter consultation.

I know what you're thinking, and yes, I should get out more. But it is true. The way I think of it is in a stepwise approach, using a systematic series of questions to eliminate products leaving you with a limited number of options to recommend. I suspect the way a patient views it may vary somewhat from "hey! I'm really being listened to!" to "oh for goodness sake shut up, I'm going to be late for the bus.".

A good consultation goes like this:

Step One: Establish the symptoms and check diagnosis.
Fairly self explanatory: to decide what medicine to select, I need to know what I am trying to treat in the first place. I'm also finding out if the patient has any danger symptoms which might be suggestive of a serious illness, so I can signpost them appropriately to the right services.
Once I know what the problem is, I think about what products are available to treat it over the counter

Step Two: Find out about the patient's medical history.
I'm looking for anything that means the patient is at high risk of complications of the problem, meaning they need to be referred. I'm also thinking of the cautions and contra-indications of the available products to treat the problem and eliminating any products that these apply to.

Step Three: Find out about the patient's drug history.
I'm thinking about what drug interactions each of the available products has, and whether or not they are relevant to what the patient is already taking. I'm also thinking about whether or not any of the patient's medicines contain the same or similar ingredients to any of the OTC products- i don't want to risk an overdose. I then eliminate any products that have relevant drug interactions.

Step Four: Consider the evidence.
At this point, there may be only a couple of products that are suitable for the patient. If there aren't any left, I refer them to their GP or other appropriate healthcare provider.Out of the ones that are left, I think about which ones the evidence says are more effective and safe and I'll steer the patient towards that one. If there's no good evidence for at treatment, I'm always clear with the customer about it. Sometimes they listen, sometimes they don't, but its an obligation that I think needs to be done in order to sell medicines honestly and with integrity.

Step Five: Consider the price. 
Where two products are equally efficacious, I always recommend the cheapest. Because I don't want to waste a patient's hard earned cash, and I think patients appreciate that.

Step Six: Counsel the patient.
This involves giving them all the useful little snippets of information about how to use the product effectively and -crucially- safely. It might be pointing out that the product contains paracetamol, or that it causes drowsiness, or that it works best taken at a particular time of day.

Hopefully all pharmacists will recognize this process, although everyone does-and should- have their own style to go about it with. These sorts of encounters can be really satisfying for both pharmacist and patient, and its often in these moments that I have the most amount of pride in my role. Here I am, giving the patient trusted, evidence based advice which will hopefully bmake the patient feel better. However, you also need a willing patient, and I'm finding more and more often that patients are unwilling to engage in such exchanges. I've also noticed through personal experience as a customer, that some pharmacies are using what i consider to be a cop-out approach to OTC sales. An offhand "you should read the leaflet" whilst I'm handing over my money does not, in my opinion, constitute provide expert advice on medicines.

So why am I on about this at the moment? Well, there's the Which? report, which has found a disappointing quality of over-the-counter information being provided in some pharmacies. Others have given a more detailed analysis of this report, so I won't go into it too much, except to say that yes, there are methodological problems with it. However, it may well be indicative that in a world where pharmacists are under massive pressure to deliver services and dispense ever-increasing numbers of prescriptions whilst working longer hours for less pay, some are starting to lose pride in the basics. Its understandable. In the rush to get everything done, its easy to start seeing the patient as an inconvenience, who we need to get in and out of the door  as quickly as possible. I'm not saying this is what is happening in every pharmacy or in every case, but based on how I used to feel when I managed a pharmacy, I suspect it is a factor.

The other reason I've been thinking about this is the issue of self-selection of pharmacy medicines. In my humble opinion, this is a giant backwards step for the pharmacy profession. Self selection reduces the process I described above down to a bare minimum, and reduces the possibility of introducing quality into it. Sure, we can say there will be information on the packs, but lets be realistic about this. Patients very rarely read the leaflets before purchasing, and if they have to do so in the middle of an aisle in a high street pharmacy or supermarket, i think it becomes even more unlikely. In my experience, if a patient has a preconceived idea of the product they want to buy, its very difficult to persuade them otherwise, even when there is a safety concern with their chosen product.

I remember one customer asking for Sudafed, when she was also taking phenelzine. A combination of these drugs could provoke a potentially fatal hypertensive crisis, but no matter how much I explained this, the customer was adamant that she still wanted it. It turned out her daughter, a medical student, had advised her to use this product, but when I spoke to the daughter it turned out she thought that Sudafed just had paracetamol in it.

Now imagine this situation in a self-selection age. The customer picks up the pack, wanders to the pharmacist, who then has to try to wrangle it from their fingertips in order to ensure their safety. Okay, maybe not that dramatic, but the fact that the customer has the product in their hand, and has been able to "choose" it themselves, reinforces to them that it is their right to buy it. But in pharmacy, the fact of the matter is that the customer isn't always right, and its poor customer service- and downright dangerous- to always allow them to think so.

Imagine that self-selection scenario is also coupled with a curt "read the information leaflet first" as the only form of counselling. Why would the patient bother reading the leaflet, when she already thinks its safe for her to use? And so, what appeared to be a quick, convenient shop for the customer could so easily turn into a fatal drug interaction.

The shopping experience is becoming more and more depersonalised. With chip and pin and contactless payments, you barely even have to glance at the cashier during a transaction- if you're even in contact with a cashier at all. This may be fine when you're buying groceries, but medicines are not commodities. We're different to other shops in that the wares we sell can have fatal effects if they're not used in accordance with expert knowledge and instruction. We simply cannot safely reduce the over the counter consultation to the bare minimum of words required to take money from people as quickly as possible. 

Of course, its not like we pharmacists, will get that much say in the matter, and we'll carry on regardless if self selection goes ahead. Indeed it seems to be a near certainty, despite support from "very few" pharmacists. And it may even be the case that such scenarios never happen in real life. But all I want to do is make medicines safer for people, and to do so we have to identify areas of risk before they happen, and take action to minimise them. 

When it comes to patient care, just hoping the worst doesn't happen isn't good enough.

Hxxx