What you need to know

1 in 7 Scots are on an antidepressant. Some Scottish academics have argued that this is “appropriate prescribing” for “recurrent” and “chronic” conditions.

Antipsychotic prescribing, in all age-groups, has risen year-on-year since the Scottish Government started measuring such prescribing. Last week NHS Scotland was struggling to source one such antipsychotic, namely haloperidol. Intramuscular haloperidol may not be available for 14 months. I do not know if this is a supply or demand issue, however this medication is being most extensively used in NHS hospitals in Scotland despite generally being prescribed “off-label”.

With this in mind I present a pattern that emerged from reading the current British Medical Journal alongside my weekend newspapers.  Here is what they both suggested that “you need to know”:

All the other children are on it, 21 Nov 2015, Guardian Andrew Lansley, Roche 20 Nov 2013 Disney and McDonald's staple, 21 Nov 2015, Guardian Generation meds, 21 Nov 2015, Guardian Long term effects on oor children, Guardian, 21 Nov 2015 Now you are my friend, Nov 21, 2015, Guardian Pharmacological mission creep, BMJ, 20 Nov 2015 What you need to know, Bmj, 21 Nov 2015

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

A letter to Professor Jason Leitch

Image

In this post I reply to Professor Jason Leitch, whose letter of the 2nd June 2015 on Haloperidol prescribing to Scotland’s elderly can be read here:

Jason Leitch Delirium

This is the link to my summary on Delirium Screening written March 2014 at the request of one of those involved with improvement work in delirium. I shared this with Healthcare Improvement Scotland, the Scottish Delirium Association and OPAC (Older People in Acute Care Improvement programme). I had no replies.

Recently this automated e-mail arrived:

Jason Leitch, unread letter deleted

I thus contacted Professor Leitch to clarify. This is the response I received:

e-mail: 25 September 2015 

Dr Gordon, I can assure you that not only did I receive and read 
your email of 8th June, I still have it. I noted its content and 
following our earlier correspondence didn’t feel it required a 
response. I also read our correspondence which you published 
on your blog. 

Professor Jason Leitch, National Clinical Director.

The following behind-the-scene communications were recently released as a result of a Data protection request. The communications indicate a tone of disdain for those who may write regularly to DG Health and Social care.

director-general-of-nhs-scotland-e-mail-to-jason-leitch-national-clinical-director-who-is-not-registered-with-the-gmc

I had asked if Professor Jason Leitch might confirm if he is registered with the General Medical Council. Again there is clear evidence of a most disparaging tone made by two of the most senior figures in the DG Health and Social care. One has to worry for other correspondents who write with legitimate concerns about patient wellbeing and safety.

communications-between-deputy-director-nhs-scotland-and-national-clinical-director-25-sept-2016

Professor Leitch chose not to answer my question about registration with the General Medical Council however he did kindly supply a most abbreviated CV which would indicate that he is not medically trained and qualified. Professor Leitch’s qualifications are in Dentistry and he is registered with the General Dental Council. This is important in that Professor Leitch gives advice as National Clinical Director for NHS Scotland yet he is governed by a regulatory body that is not for general medicine.

national-clinical-director-and-director-general-25-sept-2016

 

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Haloperidol prescribing to Scotland’s elders

In a previous post the FOI returns on Haloperidol prescribing in NHS Scotland were shared.  This followed on from my consideration of a BMJ report regarding the scale and potential harms of  such “off-label” prescribing to our elderly in hospital.

Since that time I have had a response from Professor Jason Leitch, National Clinical Director, Healthcare Quality, Scottish Government:

Letter from Prof Leitch

Today I have sent this reply to Professor Leitch:

To: Professor J. Leitch,
National Clinical Director, Healthcare Quality,
Healthcare Quality and Strategy Directorate
Planning and Quality Division
St Andrew’s House,
Regent Road,
Edinburgh EH1 3DG

8th June 2015

Dear Professor Leitch,
I was most grateful to receive your letter of reply dated 2nd June 2015.

I thought it best to reply to you to clarify the focus of my concerns. I wish to try and keep my reply short and focussed on the points you raise.

Point ONE:
You state that the Scottish Clinical Advisor for Dementia informed you that the “off-label use of Haloperidol for dementia is not especially unusual”. This would seem to diverge from  this BMJ change page made by NHS England’s National Clinical Director for Dementia, Professor Alastair Burns (I attach the full paper)

Dont use

You cite SIGN 86 guidelines on Dementia. These guidelines were issued 9 years ago when it was stated that “they will be considered for review in three years.” SIGN 86 is specifically for dementia and not delirium. The SIGN website indicates that there is no current plan to update SIGN 86 nor to introduce a Guideline on Delirium:

SIGN 86 was criticised in this research: Knűppel H, Mertz M, Schmidhuber M, Neitzke G, Strech D (2013) Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis. PLoS Med 10(8): e1001498. doi:10.1371/journal.pmed.1001498. I find it disappointing that an outdated and flawed guideline is still the basis for prescribing in dementia.

Ethical issues

Point TWO:
Haloperidol prescribing is part of the “Comprehensive Delirium pathway” introduced across NHS Scotland by the Scottish Delirium Association (SDA) and Healthcare Improvement Scotland (OPAC). You will be aware of this as I note that you are giving the key-note talk this week at the conference: Transforming delirium care in the real world”. Over a year ago the Secretary of the Scottish Delirium Association asked me to summarise my views on delirium improvements happening in Scotland. I did so and shared these with the SDA and with OPAC. I am disappointed to note that no reply has been forthcoming. I attach this summary for you with this letter.

Transforming delirium care in the real world

Conclusion:
It is welcome to hear that the Scottish Government are taking actions here. It is the case, by Scottish Government figures, that antipsychotic prescribing is increasing year-on-year in NHS Scotland. I seek improved care for individuals with delirium and dementia. I am concerned that current approaches, along with staff shortages and increased demands on staff time, are making it more rather than less likely that our elders may receive antipsychotic medication that can result in significant harms.

Yours sincerely,
Dr Peter J. Gordon

Included with letter:

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

“OPAC tools are working”

It is over a year since I last wrote about delirium. Being aware that the new Care Standards for older people in hospital were to be published this month I had a look on the Healthcare Improvement Scotland web platform for these new standards. As yet these standards have not been published, but I did notice the news that “OPAC tools are working”. I followed the links, read the supporting material, and watched all the associated films:

[The costs of films commissioned from the private sector by NHS 
Healthcare Improvement Scotland has been over £51,000 from 
January 2014 to February 2015]

027Tools

A lot has happened in acute care settings for Scotland’s elders since I last wrote. It is wonderful to see in these films such compassion and dedication to care amongst the healthcare teams: from allied health professionals, nurses and doctors. I agree with Professor Jason Leitch that this demonstrates a caring culture.

It was some years ago that I heard Professor MacLullich give a talk about delirium. I was inspired by his thoughtful presentation which outlined the distressing symptoms that can come with states of delirium and the associated increased risk of mortality.

In this post I will not be considering improvement work undertaken on “frailty”. In what follows I intend to further explore the Healthcare Improvement Scotland strapline: “OPAC tools are working” with particular reference to delirium.

In terms of “working”, only two key figures are given by Healthcare Improvement Scotland. The first confirms that there has been 95% “compliance” with “assessment tools” for delirium.

025Tools

The other key figure demonstrates that length of hospital stay in orthopaedics for older people has been reduced since the introduction of “frailty and delirium assessment tools”:

043Tools

In what follows the OPAC tools currently being used in hospitals across Scotland to “identify” delirium will be considered. Two specific issues continue to concern me:

(1) the risk of too great a reliance on any “brief” “tool” rather than this being part of an overall assessment; and
(2) the marginalisation of consent.

(1) Reliance on a “brief” “tool”:032Tools

The 4AT has been revised since I last wrote. It was previously described by its developers as “a new screening tool for delirium and cognitive impairment” (see below):

006Tools

The latest version (at time of writing) is version 1.2. The developers “have decided to describe” the 4AT now as an “assessment test”:

Version 1.2 4AT

As an “assessment test” the 4AT requires:

011tools

The 4AT “assessment test” is also noted for its:

009Tools

The 4AT:

008tools

The four questions that comprise the AMT4 are as follows:

052Tools

It is important to appreciate that the 4AT test is different from other tools for delirium as it incorporates the AMT4. The AMT4 is a screening tool for cognitive impairment alone. To explain further this test is in effect used to screen for dementia. This is an important point because there has been very wide debate about cognitive screening. Cognitive screening is recommended by neither the UK National Screening Committee nor NICE. Another point is that using brief tests for delirium and cognitive impairment at the same time is an approach novel to the 4AT.

Given that the 4AT test incorporates a test of cognition it is relevant to consider whether our cognitive function can so easily be encapsulated in a “very brief” test. The 95 year old philosopher, Mary Midgley, has said this about “tests”:

031Tools

Mary Midgley then goes on to say:

022Tools

Cognitive ageing has become an area of great interest since Professor Lawrence Whalley of Aberdeen University began research in this area and some of his findings are summarised in his book, the Ageing Brain.

Professor Whalley reminds us that the brain is such an incredible biological wonder. Each of us have 100 billion neurons in our brains, and whilst this may change with ageing, it is still the case that our neurons, even on our last day in life, amount to:

The shock of the fall (9)

Recently this lead Editorial was published in the Lancet:

004Tools

It repeats the reminder of Professor Whalley that:

003Tools

To many it appears counter-intuitive that something so complex as human brain function can be reliably assessed in a test that takes less than 2 minutes. In a follow-up post I will look at the work currently being undertaken to evaluate the 4AT.

(2) Marginalisation of consent:
“Compliance” with the 4AT “assessment test” is being measured in Scotland by Healthcare Improvement Scotland. My concern here, that I have expressed before, is that such an approach marginalises the right of the individual to consent or otherwise to this assessment.

I have become aware through my own clinical practice that even brief cognitive tests can be distressing to patients and can leave them fearful (the following quote is from a patient undergoing a short cognitive screening test but not the 4AT):

039Tools

Another reason to be concerned about consent is that our cognitive abilities tend to follow a parabolic distribution through life. It would be a mistake to disregard this when undertaking complex diagnostic considerations.

In March of this year the UK Supreme Court judged that it was for patients to decide whether the risks, benefits and alternative options of assessments or medical interventions have been adequately communicated:

014Tools

Treatments may bring harms as well as benefits. This is why explanation of risk should be an ethical underpinning in our interactions with a patient.

The Scottish Delirium Association (SDA)  has issued delirium pathways for use across NHS Scotland. The “OPAC tools” are generally the starting point in these pathways. The SDA Comprehensive pathway states very clearly:

040tools

This pathway outlines environmental and general measures, alongside medical and nursing approaches to manage delirium which has been identified using the 4AT test. If these measures are not in themselves sufficient to improve the state of delirium, the Comprehensive Pathway outlines further interventions:

041Tools

A recent audit of Haloperidol prescribing in NHS Scotland has confirmed the findings of the Scottish Government that in our acute hospitals prescribing of antipsychotics has been rising year on year.

To try to identify how much of this rise comes from prescribing for those aged 65 years and over, the 0.5mg capsules and 1mg/ml liquid haloperidol are likely to be indicative.

In one Scottish NHS Board (see table below), we find that haloperidol prescribing in those aged 65 years and over in the acute hospital has nearly doubled since cognitive screening was introduced and monitored at NHS Board level.

042Tools

This is a recent study published in the Lancet:

045Tools

The authors of this study argued that:044Tools

Summary:
In these films Healthcare Improvement Scotland outlines that “OPAC assessment tools work, and are working in hospitals across Scotland”. There is no doubt that delirium is a condition associated with significant morbidity and mortality. It is also clear that we have a long way to go in understanding such a complex condition. Given this, my concerns about the over-reliance on brief tools used at outset and the marginalisation of consent are unchanged.

In a follow-up post I will look at the work currently being undertaken to evaluate the 4AT.

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

“In pursuit of marketing approval” [antidepressants for anxiety]

This is a report in the current BMJ:  Publication bias01This was the result of the pursuit of the market:Publication bias02The US Food and Drug Administration failed to ensure scientific objectivity:Publication bias03Robert K Merton would weep at this.

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Haloperidol in Scotland

At the start of November 2014 I wrote to all 14 regional NHS Boards in Scotland regarding the prescribing of the antipsychotic medication generically called HALOPERIDOL.

The 14 regional NHS Boards are responsible for “the protection and the improvement of their population’s health and for the delivery of frontline healthcare services”.

In this post you will find the prescribing figures and the link to the full reply by each NHS Board.

Each NHS Board area generally provided the extant protocols/guidelines that include Haloperidol as part of any treatment pathway. These may include protocols for Dementia, Delirium, Rapid Tranquilisation and alcohol withdrawal. To access these please click on NHS Board heading (in dark blue)

glasgowQuantity of haloperidol issued in Greater Glasgow NHS Board area:NHS Glashow haloperidolThe Excel spreadsheet can be accessed here. Greater Glasgow NHS Board confirmed that “the system used to extract this data was established in April 2010 and data prior to this is not included”.

 

LothianQuantity of haloperidol issued in Lothian NHS Board area:NHS Lothian HaloperidolNHS Lothian protocols can be accessed here

 

Grampian Quantity of haloperidol issued in Grampian NHS Board area:NHS Grampian HaloperidolNHS Grampian protocols can be accessed here 

 

Forth VQuantity of haloperidol issued in NHS Forth Valley Board area:NHS Forth Valley HaloperidolNHS Forth Valley protocols can be accessed here

 

TaysideQuantity of haloperidol issued in Tayside NHS Board area:NHS tayside, HaloperidolTayside NHS protocols can be accessed here

 

Ayr

Ayrshire and Arran NHS have listed all rather than tabulated in yearly summaries.

For haloperidol use 2011 – 2012 in Ayrshire & Arran NHS, click here

For haloperidol use 2013 – 2014 in Ayrshire & Arran NHS, click here

For Ayrshire & Arran NHS protocols, click here

 

BordersQuantity of haloperidol issued in Borders NHS Board area:Borders NHS HaloperidolBorders NHS protocols can be accessed here

 

highlandQuantity of haloperidol issued in Highland NHS Board area:NHS Highland haloperidolHighland NHS protocols can be accessed here and here

 

Western IQuantity of haloperidol prescribed in Western Isles NHS Board area:Western Isles HaloperidolWestern Isles NHS protocols can be accessed here

 

FifeQuantity of haloperidol prescribed in Fife NHS Board area: NHS Fife Haloperidol

NHS Fife Haloperidol communityNHS Fife protocols can be accessed here

 

dumfrQuantity of haloperidol prescribed in Dumfries and Galloway NHS Board area:Dumfries & Galloway NHS HaloperidolDumfries and Galloway NHS protocols can be accessed here

 

ShetlandQuantity of Haloperidol prescribed in Shetland NHS Board area:NHS Shetland, HaloperidolShetland NHS protocols can be accessed here 

 

OrkneyQuantity of haloperidol prescribed in Orkney NHS Board area:Orkney NHS Haloperidol

 

 

 

 

LanarksQuantity of haloperidol prescribed in Lanarkshire NHS board area:NHS lanarkshire Haloperidol Lanarkshire NHS protocols can be accessed here

 

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

“Doing damage in delirium the hazards of antipsychotic treatment in elderly people”

This paper was published in the Lancet in late last year. It is a two page article that is worth reading in full. All screenshots below are from this paper:001

The authors commented that002

The authors were of the view that003

Scottish Government figures confirm that prescribing of antipsychotics is rising in our elderly. It thus seems important to consider why this may be. The authors continue:004

There is always the risk in times of austerity, and when staffing levels are not ideal, that:005

The authors state:006

The promotion of off-label use of antipsychotic medication was instrumental in my petition to the Scottish parliament for a Sunshine Act:007

The authors continue:

008

But what does the evidence have to say? The authors state:009

The authors continue:011

The authors ask:012

The authors conclude with Dr William Osler:013

I am also of the view that there is a risk that “brief screening tools” may result in “pathways” being followed that, despite good intentions, lead to greater prescribing of antipsychotics in our elderly. I am aware that currently “brief screening tools” are being promoted in Scottish NHS hospitals.

I wish to conclude with one recent example of many: an elderly woman, with terminal cancer returned to her GP after a recent period in hospital. She asked her GP “But why am I on this anti-schizophrenic drug?”

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Hospital prescribing of Haloperidol in your NHS Health Board area

I have sent the following as a Freedom of Information request to 14 NHS Boards in Scotland. When I receive replies I will post them on Hole Ousia.

7 November 2014.

Dear NHS Board,
I am writing as part of a Freedom of Information request regarding statistical details of the prescribing of the antipsychotic medication generically called HALOPERIDOL. It may be that the all of the information that I request is already available through a publicly accessible database and if so could you please direct me to this.

The reason I write is that I am aware that Hospital Guidelines/Protocols for acute agitation, psychosis, behavioural or psychological disturbance generally seem to include Haloperidol as the first-line pharmacological treatment of choice, given either orally or intramuscularly.

This week in the British Medical Journal the following paper has been published: “Change Page:Don’t use antipsychotics routinely to treat agitation and aggression in people with dementia” This refers to individuals who may be diagnosed with dementia, but I am aware that prescribing of Haloperidol, as part of Hospital Guidelines/Protocols is also part of management of Delirium.

I am aware that prescribing of Haloperidol is also routinely part of protocols in those aged under 65 for acute or chronic agitation, psychosis, behavioural or psychological disturbance.

Could you please answer the following questions as completely as possible:

1. For the last 5 years (2009 to 2013 inclusive) could you confirm the quantity of Haloperidol issued to cover all acute and community hospitals in your NHS Board area as per each strength:

ORAL TABLET HALOPERIDOL
0.5mg,
1.5mg,
5mg
10mg
20mg

ORAL LIQUID HALOPERIDOL
1mg/ml
2mg/ml

INJECTABLE HALOPERIDOL
5mg/ml

2. Can you supply any protocols/guidelines in place for your NHS Board area that include Haloperidol as part of a treatment pathway.

  • Can you confirm if you have a protocol for Delirium and if it includes recommendation of Haloperidol?
  • Can you confirm if you have a protocol for Dementia and if it includes Haloperidol as a treatment option for “BPSD” (Behavioural and Psychological Symptoms of Dementia)
  • Can you confirm when each protocol was first issued?
  • Can you confirm if Haloperidol is ever prescribed in those under 16 years of age?

I am grateful for your help.
Yours faithfully,

Peter J Gordon

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Don’t use antipsychotics routinely to treat agitation and aggression in people with dementia

The following “Change Page” was published in the British Medical Journal on the 3rd November 2014. The authors were: Anne Corbett, Professor Alistair Burns and Professor Clive Ballard.

1

This is what the British Medical Journal would like be achieved from the “Change Page”:

2

The following box gives the “bottom line” for this change page:

3

In response to this “Change Page” I submitted the following to the British Medical Journal:

My reply to Burns & Ballard

And here is my response in html form with a few images added:

I welcome this “change page”.[1]

The authors describe the routine prescription, off-label, of antipsychotics to our most vulnerable elderly. At a recent international conference one presentation referred to the estimate that “2/3rds of current UK prescriptions for antipsychotics in people with dementia are inappropriate”.[2] These reports remind us that those living with dementia are often considered to lack “capacity” and their voice is easily lost.

6

My previous correspondence to the BMJ has demonstrated my view that our profession should not be “educated” by commerce or industry.[3]

In 1999, as a doctor in training, I was handed a document by my trainer. This I was told was “the way forward”. The document had an acronym: “BPSD”. I had not heard of “BPSD”. I learned that this acronym stood for “Behavioural & Psychological Symptoms in Dementia”. I accepted it with little thought. The comprehensive BPSD document was produced by Pharma: though at the time, and for almost a decade thereafter, I was not aware of this fact.

I am aware that a number of NHS guidelines are in existence for the treatment of “BPSD”.[4] Haloperidol, in lowest possible dose, is generally the drug recommended. My concerns over prescribing of antipsychotic drugs like Haloperidol in a frail elderly population, led me to raise a petition for a “Sunshine Act” with the Scottish Government.[5]

It has been my experience that marketing activity by the pharmaceutical industry, and also “education” by key opinion leaders paid for by the pharmaceutical industry, have in the past encouraged the off-label use of antipsychotic drugs. Until we acknowledge this mechanism, we risk losing the opportunity to minimise the harm of such an approach.

Why I no longer consult for drug companies from omphalos on Vimeo.

4

[1] Ballard,, Burns & Corbett. Change Page [PRACTICE] Don’t use antipsychotics routinely to treat agitation and aggression in people with dementia. BMJ 2014;349:g6420 Published 3 Nov 2014

[2] Saad, K. UK Chair ALCOVE Steering Group. Presentation to Alzheimer’s Europe Conference, Glasgow, 21 Oct 2014 “Preventing behavioural problems reducing inappropriate use of antipsychotics in dementia”

[3] Gordon, P, J. Letters: Drug industry sponsorship BMJ 2011;343:d7375. Published 15 Nov 2011 and Letters Clinical guidelines BMJ 2014;348:f7699 Published 6 Jan 2014

[4] Acute Hospital Guidelines and pathways: NHS Lothian and NHS Forth Valley

[5] Gordon, P, J. PE01493: A Sunshine Act for Scotland http://www.scottish.parliament.uk/GettingInvolved/Petitions/sunshineact

A Sunshine Act for Scotland from omphalos on Vimeo.

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.