Discontinuation of two different depot antipsychotics

Posted on June 22, 2017 by Snow-Leavis

This week, UK medical professionals were alerted of the permanent discontinuation of the supply of MODECATE (fluphenazine decanoate) injection by the end of 2018:

In October 2014, UK medical professionals were informed of permanent discontinuation of PIPORTIL Depot (pipothiazine palmitate):

Advice is given with these notifications of alternative depot medications. In changing patients from one depot to another I have found that there can be severe deterioration in mental health and that this can endure far beyond the transition phase.

My concern is that patients may be started on long-term medication without realising (being informed) that the medication they are taking may not be available at a future time and that this may have consequences for them. We must also consider that depot antipsychotics can be given without consent if certain criteria of mental health legislation are met.

To seek balance in the appreciation of where expertise rests: my submission on PE01651

Posted on June 4, 2017 by Snow-Leavis

Submission on PE01651: Prescribed drug dependence and withdrawal

Made by Dr Peter J Gordon

Date of submission: 3rd June 2017.

Submission made in a personal capacity.

I am writing in support of this petition. I am an NHS Consultant Psychiatrist who has worked in this specialty in Scotland for almost 25 years now. My wife has worked as a General Practitioner in Scotland over the same period. I have an interest in ethics, human rights and the medical humanities generally. One of the areas I have taken much interest in is informed consent.

I would argue that this backdrop may mean that I can add some thoughts and reflections that might help the Committee in the consideration of this particular petition.

I should make it clear that as an NHS psychiatrist I do prescribe antidepressants and other psychotropic medications. I try to do so following the best available evidence as considered as relevant or not to my professional understanding of each unique patient and their life circumstances.

I wish to keep this summary short as I am aware that the Committee receives a great deal of evidence. So I offer a few points of evidence that I would be willing at a future date to expand upon if that were felt to be helpful:

• Antidepressant prescribing In Scotland (ISD figures) has been rising year-on-year in Scotland for at least the last ten years (this is also true of all other prescribed psychotropic medications). It is estimated that 1 in 7 Scots are now taking antidepressants and many of these in the long-term.

• At a recent Parliamentary Cross Party Meeting on Mental Health and older adults an invited speaker stated that: “depression is under-recognised across all age groups” and that “maintenance treatment has a good risk-benefit ratio.”

• A key opinion leader and Government advisor has previously argued that prescribing of antidepressants in Scotland is “conservative” and “appropriate”.

• Many of the key opinion leaders “educating” doctors prescribing antidepressants in Scotland appear to have significant financial interests with the makers of these medications. Across the UK, £340 million was paid by the pharmaceutical industry in the last recorded year to healthcare workers and academics for such “promotional activities”.

• “Informed Consent” will not be possible if the information that doctors base prescribing on follows such promotion rather than independent, and more objective, continuing medical education. This issue is now at the fore of the Mesh Inquiry.

A few questions that need to be considered:

When patients are prescribed antidepressants are they informed that as many as 1 in 2 will be taking antidepressants long-term?

Are patients informed that there may be a significant risk of pharmacological dependence on antidepressants?

Do patients know that their experience of antidepressants may be considered less valid than the experts (who may have been paid by the pharmaceutical industry) who educate other doctors (who may be unaware of this potential financial bias)?

Summary:

My view is that antidepressants are over-prescribed in Scotland.

My view is that patients have not been properly informed of benefits and risks.

My view is that appropriate prescribing has not been realised due to a number of factors: the lack of access to psychological therapies or other meaningful supports; the wide promotion of antidepressants where marketing is routinely conflated with education; and a culture of increasing medicalisation generally.

I would suggest that this petition might be considered in light of the Chief Medical Officer’s Realistic Medicine campaign. It is time for balance to be re-established between “medical paternalism” and the valued, vital and real-world experiences of patients who are taking medications like antidepressants. I am particularly disappointed in my own College, the Royal College of Psychiatrists for not making greater effort to facilitate such balance. Without such, I fear more harm will result from inappropriate and costly prescribing in NHS Scotland.

Finally, due to widespread “off-label” promotion of antidepressants in Scotland, patients may experience withdrawal syndromes which can be most severe and precipitate mental states far more serious than the mental state for which they may have originally been prescribed.

I would urge the committee to consider this petition most carefully and to seek balance in their appreciation of where expertise rests.

‘Informed consent is a fundamental principle underlying all healthcare’

Posted on May 17, 2017 by Snow-Leavis

A recent Independent Review for NHS Scotland stated that: “Informed consent is a fundamental principle underlying all healthcare”

The Cabinet Secretary for Health and Sport, Shona Robison stated to the Scottish Parliament (17 March 2017): “Informed consent and shared decision making are expected prior to any procedure being carried out.”

On the 20th April 2017, I wrote to Healthcare Improvement Scotland 
about Patient consent in NHS Scotland:

I have just completed my annual Appraisal which is a General Medical Council requirement as part of 5 yearly Revalidation. As part of this I was informed by my Appraiser that I must comply with all the LearnPro modules which I have now done.

The following screenshot comes from the NHS Lothian mandatory LearnPro module on Capacity and Consent:

I apologise as the text is small, so I have reproduced verbatim what it states to me as an NHS Lothian employee:

“Consent is both a legal requirement and an ethical principle and requires to be obtained by healthcare professionals, prior to the start of any examination, treatment, therapy or episode of care.”

“In Scotland, everyone over the age of 16 is an adult. The law assumes that adults can make their own decisions and can sign legal documents, such as consent to medical treatment (in some circumstances this also can apply to children under the age of 16) provided they have the capacity. This means that they are able to understand what is involved in the proposed treatment, retain the information, be able to weigh up the information needed to make the decision and then communicate that decision. Treatment might be delivered in a hospital, clinic or in someone’s home.”

In years past I have written about consent for older adults in hospital in NHS Scotland:

Do we care enough about consent?

‘OPAC tools are working’

I am writing to Healthcare Improvement Scotland as I find myself confused.

Do I follow the mandatory requirements of my employers on consent? Or do I follow the National Improvement requirements of OPAC-HIS where consent is not required for assessments such as the 4AT assessment test? (formerly called “4AT screening tool”)

I know, from the re-drafted Care Standards, that Healthcare Improvement Scotland take consent very seriously.

I should state that I am writing in my own capacity and in my own time.

12 May 2017 - I sent this update to Healthcare Improvement Scotland:

Forgive me for this further correspondence but I felt that I should update you on the learning that I received as part of my attendance for Continuing Medical Education (CME) yesterday.

This CME event was for the Royal College of Psychiatrists in Scotland – Faculty of Old Age Psychiatry and was held in Falkirk.

At this event the Chair of Old Age Psychiatry for the Royal College of Psychiatry was giving a talk and when the time came for questions I asked about the wide use of haloperidol in older adults in hospitals in NHS Scotland. Dr Thompsell replied “evidence has found that Haloperidol actually worsens the outcome of delirium”.

Another lecturer at this meeting, who was giving a talk on her area of expertise: anti-psychotics and older adults, was Dr Suzanne Reeve. She replied: “Haloperidol does increase mortality in older people compared with other antipsychotics. That message has been out for a while but has not really got across.”

The next talk was entitled “Successes of Old Age Psychiatry Liaison team” and one of the slides shown had the headline “Compliance with 4AT”. The impressive “compliance” figures then followed. The dictionary definition of compliance is “the act of yielding”.

My concern here is for patient harm and indeed increased patient mortality. National Improvement work undertaken by HIS has been instrumental in increasing “compliance” with tools such as the 4AT and it is clear that no consent is deemed necessary. I have argued that this is not ethical as these tools are often the beginning of “pathways” and “protocols” that may result in the administration of haloperidol.

I am genuinely worried that National Improvement work undertaken by Healthcare Improvement Scotland has not properly considered ethics, available evidence and the potential for unforeseen consequences. You will understand that I am also nervous about writing this letter given the consequences for me when I first “spoke up” three years ago:

I would very much value your advice. I am not sure that I can work in a profession if it loses sight of Hippocrates and “first do no harm”.

This is the response from Healthcare Improvement Scotland,
dated 17th May 2017:

“Thank you for your letter of the 20th April and your letter of 12th May, in which you raise the interesting issue of taking consent in relation to cognitive screening.

I understand from staff involved in the inspections of older people’s care in hospital that taking of written consent prior to initial assessment for frailty is not routinely undertaken. Assessment at the point of admission, or where a change in a patient’s cognitive presentation is giving cause for concern, can alert staff to possible increased risk and enables planning of care for the patient. In these circumstances staff adopt a proportionate approach such as asking, for example, if they may ask some questions.

For absolute clarity though, as an employee of NHS Lothian, the requirements set out in the Board’s policies and mandatory training are those that you should follow.”

Submission on PE1517: Polypropylene Mesh Medical Devices

Posted on May 17, 2017 by Snow-Leavis

Submission on PE1517 on Polypropylene Mesh Medical Devices

Made by Dr Peter J Gordon

Date of submission: 17th May 2017
Submission made in a personal capacity.

The Agenda for the Public Petitions Committee meeting of the 18th May 2017 includes a most helpful summary “Note by the Clerk” on PE1517: Polypropylene Mesh Medical Devices (Document PPC/S5/17/10/1). Having read this carefully, and in accordance with the first suggested “Action” (point 45, page 8), I would like to offer evidence. Before doing so I have listed below the most relevant sections of PPC/S5/17/10/1 in relation to the points of evidence that I wish to make.

In Annexe B of PPC/S5/17/10/1 the Interim and Final Conclusions of the Independent Review are listed side-by-side.

Conclusion 1, both Interim and Final, was that “Robust clinical governance must surround treatment”

Conclusion 3, both Interim and Final, was that “Informed consent is a fundamental principle underlying all healthcare”

In Annexe C: Parliamentary Action (page 21 of PPC/S5/17/10/1) the Cabinet Minister for Health, Shona Robison answered question S5W-07749 by Neil Findlay, MSP on the 17 March 2017, by stating:

“Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.”

The Clerk, in point 7, (page 2 of PPC/S5/17/10/1) confirms that:

“The Scottish Government does not have the power to regulate what medical devices are licensed for use in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK”

The Clerk, in point 12 (page 3 of PPC/S5/17/10/1) includes quotations from the Preface of the Review’s Independent Report:

“We found some concerning features about how new techniques are introduced into routine practice” and that

“We are aware that some of our conclusions have wider implications and see the need to embed this in patient Safety and Clinical Governance strands of the NHS”

Points of Evidence by Dr Peter J Gordon  (GMC number 3468861)

• HDL62:  the Scottish Government has acknowledged that this 
Guidance is not being followed by NHS Boards

• There have been media reports that NHS professionals working in 
Scotland, who are involved in educating NHS staff about Mesh
procedures, have been paid by commercial sectors who have 
financial interest in Mesh products. 

• PE1493, A Sunshine Act for Scotland, was closed in February 2016 

• A Public Consultation on PE1493 was undertaken by the Scottish 
Health Council. The Scottish  public, in majority, were of the view 
that it should be mandatory for  all financial payments made to 
healthcare workers and academics to be declared in a publically 
accessible form 

• No meaningful update has been provided by the Scottish Government 
since this Public Consultation was published more than a year ago.

• I  fully support the Chief Medical Officer’s “Realistic Medicine” 
initiative and I have suggested that Sunshine legislation should be 
considered an essential part of this development  

• I agree with the Independent Review that “robust clinical 
governance must surround treatment”. I am concerned that if the 
current situation continues, where “education” of health 
professionals may be significantly based on marketing, further 
examples of iatrogenic harm may occur in NHS Scotland.

• The Independent Review concluded that “informed consent is a 
fundamental principle underlying all healthcare”. If the advice 
given to patients is based on marketing, either partially or wholly, 
then informed consent may be denied patients. Further examples of 
Iatrogenic harm may then  unfortunately occur and healthcare 
in Scotland may risk being considered as  unrealistic 
rather than “realistic”.

Update, 22 May 2017:

Public Petitions Committee – Scottish Parliament: 18 May 2017 (click on image below to watch the full meeting)

The official report of the Public Petitions Committee of 18 May 2017

Sunday Post, 21 May 2017: ‘Probe to examine possible conflicts of interest in troubled mesh implant inquiry’