"Gluten-free prescribing is in a state of flux"

Consider this off-core-topic post an extension of previous other off-topic chatter on this blog talking about the prescription of gluten-free foods here in Blighty (see here). On that previous blogging occasion, I discussed a 'head-to-head' debate on whether the prescription of gluten-free foods for conditions such as coeliac disease was still 'relevant' in an age when supermarkets have shelves loaded with gluten-free products as part of a societal fascination with 'going gluten-free'. Whether there may be other models - such as the use of a voucher scheme - that could save time and money yet still ensure that the important use of a gluten-free diet in relation to coeliac disease is maintained and supported.

Well, the recent findings reported by Alex Walker and colleagues [1] add to this debate, and their look at "long-term national trends in gluten-free prescribing, and practice and Clinical Commissioning Group (CCG) level monthly variation in the rate of gluten-free prescribing (per 1000 patients) over time." CCGs by the way, are groups here in England "responsible for the planning and commissioning of health care services for their local area."

Walker et al relied on a retrospective cohort study design that analysed prescribing and spending data from various sources, and covered various geographical areas of England in relation to gluten-free prescribing. Alongside, other potentially pertinent data were included in the statistical mix, for example: "Index of Multiple Deprivation (IMD) score; patients with a long-term health condition (%); patients over 65 (%) and whether each practice is a ‘dispensing practice’ with an in-house pharmacy service (yes or no)."

Results: including data from over 7600 medical practices, authors reported that between July 2012 and June 2013, some 1.8 million prescriptions for gluten-free products were dispensed costing around £25.4 million. Fast forward to the period July 2016 - June 2017 and fewer prescriptions were made: "1.3 million gluten-free prescriptions nationally... with a total expenditure of £18.7 million." This, bearing in mind, that rates of diagnosed coeliac disease are seemingly only going in one direction - up [2].

Researchers also reported that there was "substantial variation in prescribing rates among practices" which was captured by some other reporting on the Walker paper as per bylines such as: "Prescribing of gluten-free products in England differs largely and “without good reason”, researchers have concluded." Indeed Walker and colleagues concluded that much of the geographical discrepancy in the gluten-free prescribing rates was "driven at the CCG level, where there is also a great deal of variation." For some CCGs, the decision was to provide gluten-free prescriptions; for others, there seems to be "a partial or complete withdrawal of prescriptions." A bit of a postcode lottery if you like.

As to those other variables included in the analysis, a few other important details emerged. So: "practices in the most deprived areas had a significantly lower rate of gluten-free prescribing than those in less deprived areas." Further: "We also found that percentage of patients over 65 is strongly associated with gluten-free prescribing, which is unsurprising given that coeliac disease prevalence increases with age." That first finding in relation to deprivation *might* be linked to things like an under-diagnosis of something like coeliac disease in those areas. But it could point to other factors potentially coming into play as well...

At the time of writing / publishing this post, we are still living in the age of austerity here in Blighty. Government in particular, [still] wants to 'balance the books' yet is still expecting national services such as health to provide for the population they serve. Set within that context, and also how health budgets are having to deal with more people with more complex needs, it's probably not surprising that for some geographical areas, 'low hanging fruit' such as gluten-free prescriptions are seen as fair game when it comes to balancing the books. It shouldn't, but there you go.

I do stand by the idea that if things are seemingly 'on the downward slide' in terms of gluten-free prescribing patterns, there may be other models to look at that could help (i.e. that voucher scheme idea). Patients and their relevant organisations need to have a voice in this process to ensure that gluten-free diets are maintained and health does not unduly suffer. Food, for people with coeliac disease - gluten-free food - is medicine, and one should never forget that and the absolute requirement to provide such medical provision.

To close, and entirely unrelated to today's post, I see Belgium have some historical and/or statistical advantage when it comes to the World Cup starting soon...

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[1] Walker AJ. et al. Trends, geographical variation and factors associated with prescribing of gluten-free foods in English primary care: a cross-sectional study. BMJ Open. 2018 Apr 16;8(3):e021312.

[2] Holmes GKT. & Muirhead A. Epidemiology of coeliac disease in a single centre in Southern Derbyshire 1958-2014. BMJ Open Gastroenterol. 2017 Apr 1;4(1):e000137.

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"Should gluten-free foods be available on prescription?"

Continuing the theme of blogging outside of the core material typically included on this site, I couldn't resist a mention of the 'head-to-head' debate talked about in the article by Matthew Kurien and colleagues [1] published in the British Medical Journal (BMJ).

As per the title of this post, the name of the game was gluten-free products being available on prescription here in Blighty, and in particular, the prescribing of gluten-free products to patients diagnosed with coeliac disease. The head-to-headers were Matthew Kurien, Sarah Sleet & David Sanders* (*a name not unfamiliar to this blog) all in favour of keeping the status quo and James Cave presenting the opposing view and why prescriptions of gluten-free products to those with coeliac disease might not be the only way.

OK, first things first. A gluten-free diet is not some dietary 'fad' for people living with coeliac disease (CD); it is a clinically-indicated treatment tool for this autoimmune condition. As I've said a few times on this blog, not only are there are physiological effects linked to CD mostly 'solved' by use of a gluten-free diet, but there may be psychological effects too (see here). Gluten is most definitely the 'baddie' when it comes to CD and should not be in the diet of those with CD.

The head-to-head piece makes for interesting reading in terms of how in these days of focus on the finances of the National Health Service (NHS), the idea that removing food prescriptions as one way to "reduce costs in the short term" might have some important repercussions in the longer-term. Indeed I was taken by one quote in the 'keep gluten-free food prescriptions' camp: "Would clinical commissioning groups consider this if the treatment for coeliac disease was an immunosuppressive drug and not food?" Food as medicine? I like that sentiment (see here).

I have to say however that I did find the viewpoint from James Cave rather appealing in some aspects. Within his various facts and figures he shows how perverse it is that one can go into a supermarket and buy a gluten-free loaf of bread for one price and yet the same loaf is bought by the NHS for prescription for quite a bit more. Sorry to focus on cost and finances but this is salient point in these days of continued austerity and financial/political uncertainty. Cave also adds that gluten-free food prescriptions tend to be restricted to set items, come in bulk and generally need to be collected from a pharmacy. There are additional costs added to the supply of such goods.

The two viewpoints do however agree that slight changes could be made to the system to make it both run more efficiently and provide those with coeliac disease a little more 'opportunity' in what they select. As Cave notes: "A national voucher scheme or a personalised health budget could be provided to ensure that patients receive recompense for the extra expense of gluten-free products." As Kurien and colleagues note: "Alternative strategies to prescriptions, such as direct supply schemes from community pharmacies, or voucher allowances, may be a more efficient way of delivering NHS support." A voucher scheme for gluten-free products? Interesting.

In these days where areas of England are already seeing changes to gluten-free prescriptions (see here for example) I'm wondering if a voucher scheme might be the [inevitable] way forward, at least for the majority of patients. Not only does this offer more choice to the consumer in terms of what products they buy (and indeed, what they might prefer) but the whole process of the NHS ordering, buying and dispensing such products is also reduced. For those who perhaps do not have access to a full-range of gluten-free products as their local supermarket for example or have mobility issues, exceptions could be made but for the most part, patients are handed choice and a lot more buying power and freedom. A voucher scheme might also 'normalise' the idea of gluten-free products when it comes to CD. By 'normalise' I mean that a young adult diagnosed with CD for example, no longer has to go to their local pharmacy for their 'months supply' but rather can shop - pick and choose - from the growing range of gluten-free products that adorn supermarket shelves these days. Compliance to the gluten-free diet will no doubt benefit when there is more choice and a voucher scheme will bring choice.

Change is often difficult when it comes to the NHS and it's been over 50 years since gluten-free products were put on prescription for those with CD so this would be a big change. But gluten-free is everywhere these days and there is seemingly little to hold the NHS back from further empowering those diagnosed with CD in terms of their dietary choices...

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[1] Kurien M. et al. Should gluten-free foods be available on prescription? BMJ 2017: 356.

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Kurien M, Sleet S, Sanders DS, & Cave J (2017). Should gluten-free foods be available on prescription? BMJ (Clinical research ed.), 356 PMID: 28073799

Prescription medication use and autism: good medicines management required

"Prescription drug use and polypharmacy rates among adults with ASD [autism spectrum disorder] are substantially higher than those in an age-, sex-, and race-matched cohort of adults without ASD."

That sentence taken from the paper by Rini Vohra and colleagues [1] (open-access available here) is probably not likely to win any 'novel findings of the year' awards given the already quite voluminous data published on the medication use and autism (see here for example). What gives the Vohra data a bit of an edge is that: (a) they included data for some 1700 adults with autism "matched 1:3 with adults without autism", (b) data were derived from administrative health insurance claims databases in the United States ("Medicaid programs"), and (c) they examined "the rates of prescription drug use, general polypharmacy, and psychotropic polypharmacy among adults" thus were able to detail not just psychotropic medication use but also that for other, more general conditions too.

Their findings were stark. Accompanying that opening sentence on medication use and autism, authors reported that: "Annually, almost 75% of adults with ASD had >20 prescription drug claims compared with 33% of adults without ASD." That's more than 20 prescription medication claims per year.

Further: "Other than psychotropics, many adults with ASD used medical prescription drugs such as antimicrobials (47%), dermatologic agents (48%), respiratory agents (38%), gastrointestinal agents (31%), alternative medications (25%), antiparkinsonian agents (22.6%), antihyperlipidemics/statins (7.3%), and immunologics (2.0%)." So when we start talking about the label of autism not appearing in some sort of diagnostic vacuum, and particularly that various medical comorbidity seem to be 'over-represented' when it comes to autism (see here), this is reflected in the large burden of medication being dispensed. If readers trawl through the adjusted odds ratios (AORs) generated when those with autism were compared with controls (Table 1), you'll note that many classes of medicine were more frequently prescribed to those with autism.  And where medicines were less frequently prescribed to the autism group, there were some potentially telling signs too: analgesics (used for pain relief), antidiabetics and antimicrobials. One could argue that maybe those diagnosed with autism have less need of things like pain relief or antibiotics or less likely to need antidiabetic medicines. One might however similarly argue that their medical and healthcare screening services could perhaps be 'less rigorous' than those not diagnosed with autism too, potentially as a result of various factors (see here).

Onwards: "Adults with ASD and a psychiatric comorbidity such as an adjustment disorder (26%), mood disorder (31%), or schizophrenia (32%) had significantly high rates of psychotropic polypharmacy." I probably don't need to say much more about this sentence aside from the fact that mood disorder including things like depression are not uncommon diagnoses alongside autism (see here). The links with the schizophrenia spectrum are also not to be underestimated (see here).

Finally: "Older age, female gender, White race, and presence of three or more comorbid conditions among adults with ASD is significantly associated with using six or more prescription drug classes per year." This sentence is not a roadmap to predicting who will need what medicines when it comes to autism but does provide some important information. There is for example, a woeful lack of research on autism in a longitudinal sense (see here) despite the topic of ageing and autism being debated time and time again. Inevitably as people age, their medication requirements are likely to change (increase?); this is as true for autism as it is for the not-autism population.

I included the words 'good medicines management required' in the title of this post because, as you can see, the level of prescription medicines use when it comes to autism can be high and one needs to be careful that medicines are appropriate, monitored regularly and don't interact with one and another. Given what is also known about psychotropic medicines in particular in terms of potential side-effects (see here and see here for examples), the onus is surely on prescribers to keep an even closer eye on those with autism who are being medicated under their care.

Medication is a part of life when it comes to autism. I base that last sentence on the wealth of data, peer-reviewed and otherwise, that has been published on this topic. I'm sure nobody particularly likes the idea of medication particularly when it comes to autism and certainly nobody should like the idea that some people on the autism spectrum are receiving quite a lot of prescription medicine concurrently and over quite long periods of time. But here's the thing, medication (generally) serves an important purpose. In the case of the antiepileptics/anticonvulsants it can be life-saving. Where mood disorders such as depression are being pharmacologically treated, it can be life-saving. Until, science is able to get a better idea of why some many conditions/labels seem to be over-represented when it comes to autism, medication is often all that it can offer at the moment...

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[1] Vohra R. et al. Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. Drugs Real World Outcomes. 2016 Nov 21.

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Vohra R, Madhavan S, Sambamoorthi U, StPeter C, Poe S, Dwibedi N, & Ajmera M (2016). Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. Drugs - real world outcomes PMID: 27873285