Patients – Consumers – Citizens

Wednesday 19th November 2003 The Resource Centre 356 Holloway Road, London N7 6PA 10am -4pm

What sort of relationship do want to see between the population and the health service? Will an extension of patient choice encourage involvement or generate unrealistic expectations and more unproductive complaints? If choice is not restricted to fit healthy people what relationship can people who have chronic conditions expect with the health service? And what will happen when people do not get what they want?

Dr Peter Smith, Chair of The National Association of Primary Care

Adrian Harvey Fabian Society

Prof. John Spiers, University of Glamorgan, – Patients, Power and Responsibility

Millie Kieve Adverse Psychiatric Reactions Information Link

Catherine Needham, Queen Mary College, London, Research Associate Catalyst

Professor John Peysner Professor of Civil Justice Nottingham Law School

Peter Walsh Action for Victims of Medical Accidents

Intended audience: anyone interested in the Individual or collective rights of patients: Clinical Negligence, complaints, advocacy and ICAS. Board members, managers, organisations of users or patients, Scrutiny Committees, PALS staff

Fair for All Personal to You – Patient Choice Consultation

Message from Harry Cayton about the consultation:

Emerging themes are:

  • 1. Access choices including language and disability, stigma (around mental health for instance) opening access by creating different routes into services
  • 2. Treatment choices, patients more in control of their treatment and patient journey, able to make decisions for them selves including not to be treated.
  • 3. Information – without good information about the NHS and about conditions none of this is possible.

We have had a lot of discussion about equity; disability, ethnicity, economic disadvantage, as barriers to choice. As so about the expert patient programe and supporting self-management as promoting equity. The task groups have met three times – two to go. We have had over 600 responses on the website, been in touch with 180 voluntary organisations. We are expecting more than 3000 responses in total.

The sick can’t shop around Roy Hattersley November 14, 2003 The Guardian

Equity Choice Capacity and Culture John Reid New Health Network Conference 7 November 2003

Choice Tom Baldwin and Alice Miles The Times 7/8/02

Picker Institute

A deeper democracy: Challenging market fundamentalism Angela Eagle MP

What is the Real Cost of More Patient Choice? Kings Fund 2003

Report of proceedings:

Report of the day

What does Choice mean to us (From the flip chart):

Choice = Self-determination; Choice is empowerment; Choice is being taken seriously; Allopathic v. Complementary; Choice for me is going to my health provider who can give me my options; Be honest about what they don’t know; and give me the performance data of the clinicians I may be referred to so that I can choose who locally gives me care.

Adrian Harvey, Fabian Society: The Politics of Choice and Consumption

Floor contributions:

Unlike other sectors of the economy increasing the consumption of medication or surgery is not necessarily a good thing.

Some sorts of choice is pointless – like the proliferation of directory enquiry services. Does choice improve quality?

If money follows the patient will unpopular services close?

Choice is impractical without the provision of balanced information.

Patients have got to want to challenge what is provided.

The lay agenda is important.

We have to cater for minorities of all sorts.

Professionals can be very defensive.

Choice and fear do not go well together. People who are terminally ill often don’t want to choose. Some patients are too afraid to ask questions.

Will the working class get choice?

Adrian’s responses: The working class are not effective complainers. The provision of information is related to the maintenance of professional control. More choice makes people more demanding. Meaningful political engagement is important. Choice can stimulate innovation and responsiveness.

Dr Peter Smith, Chair of The National Association of Primary Care: Choice at the Sharp End

– perspective as a member of the Inequalities Reference Group.

Relevant information is critical. New GP contract will generate public information about practices, and the possibility of league tables.

People who are involved in the political debate, esp the media and including those attending the conference, do not use health services as much as the average person. Satisfaction with GPs is very high, and UK only country where poorer patients are significantly more satisfied with the care they get than richer people. However it is important to keep the middle classes on board.

Will more choice lead to higher cost?

Are patients sufficiently involved? The NHS has less patient involvement than other European health systems. Demanding consumers can be informed participants.

We need to solicit more complaints from poorer people. Otherwise we get a better service for the more vocal.

Patient/doctor relationship is still crucial.

Older people are less keen on choice.

Redefining the GP role will mean more teamwork.

Do we give choices about vaccination?

Questions – What happens if there is, for example, conflict between the information given by your doctor and that available from the pharmacist, who may for example be aware that you are being treated for cancer when you have not been told?

What is choice for?

The NHSIA is working on an internet based project – My health space – a web based health record.

We are moving towards pharmacist prescribing.

How does choice rank as an issue?

Problems of psychiatric diagnosis, which may not be accepted by the patient, and may not be right. What do we do about bad patient experiences?

What does choice mean to us?

Will GPs still strike off people who complain?

Prof. John Spiers, University of Glamorgan, – Empowering the silent patient? (Prof Spiers talk is here – what follows are rough notes)

Choices are made every day. Society has become more diverse. Healthcare is uniquely personal.

What is involvement about? After all the pig is involved in the bacon sandwich.

Importance of solidarity, equity – which is better in Europe, and access.

Many health choices are not about life and death, but about lifestyle choices.

Both old and disabled people are capable of making choices.

Negroponte’s Being digital shows us possibilities for delivering services in very different ways – diagnosis through your TV.

What happens to choice for children?

Work of Prof Robert G. Evans in Canada shows choice can lead to more effective care. Making people feel in charge has a therapeutic effect. Medicalisation of problems is not generally helpful.

A&E Departments have a profound effect on local health economies.

Does involvement make any difference? (see bacon sandwich above).

Doctors know which of their colleagues they would not wish to be treated by, but they don’t tell us because of the quasi-masonic medical culture.

The class gradient has not improved.

Beggar my neighbour rationing.

Political or economic influence.

Activism is not a feasible solution for most patients. Involvement leads to informed and trained users, who can see things from the manager’s point of view.

I already own 1/60,000,000 of the NHS. What I want is a legally enforceable core guarantee of care. Funding should be allocated on an individual-biased basis and then taken to a mutual purchasing organisation – under community ownership. That would lead to sensitised purchasing. Choice has to affect the flow of money if it is to make a difference.

Spending money on self-care reduces demand on services. Most NHS spending goes on chronic care.

Most knowledge is tacit. I won’t know what I want until I get there.

Direct payments work very well in social care. Perhaps they could work in health. Look at the provision of spectacles. In Europe if you have money you can buy better clinical care.

If there are to be changes they must be introduced incrementally, so we can learn from experience.

Questions: What would we do about self-imposed illness? Need to encourage change with incentives, and use purchasing power.

How honest are audits and evaluations? Customer satisfaction surveys should include follow up and payment should not be made until later. CHI cannot enforce change.

Investment should be in primary care, where there are many silent patients.

Millie Kieve, Adverse Psychiatric Reactions Information Link:

Importance of long- term follow up of patients from clinical trials as Adverse drug reactions (ADRs) and withdrawal effects may be delayed. Many hospital admissions are iatrogenic. GPs know little about pharmacology, pharmacists could be involved in reviewing medication and ADRs. The MHRA yellow card system for reporting ADRs is ineffective.

Can we have choice without information? Not all licensed drugs are safe.

We need withdrawal protocols and support for safe medication withdrawal and to tackle the widespread addiction to prescribed drugs. Psychiatric adverse drug reactions are often treated as new illness.”

Patients and Carers’ views should be listened to.

Patient choice would be fine thing if we had the ability, knowledge and understanding needed to make the informed choices we so desire. Partnerships and patient choice is currently a fashionable topic. Will it ever be a reality?

In the area of drug treatment and anaesthesia, the patients have little opportunity to make an informed choice. We are given too little information about the risks versus benefits of treatment.

Psychiatric Adverse Drug Reactions (ADRs) to non-psychiatric medication, or to psychotropic drugs, are often mistaken for new illness resulting in cascades of new drugs instead of withdrawal of the causation. Drugs can save lives and some medication can make living with long-term conditions possible. The same drugs, if inappropriately prescribed or given to a patient unable to cope with the dose or the drug, may cause severe ADRs.

Some of us have chosen the path of researching for available information, and have gained knowledge about the way drugs work or don’t work. Together with the knowledge of our own and our family’s normal condition and behaviour we may be alerted to early warning signs of ADRs.

Involvement in treatment reduction or withdrawal decisions for a family member is sometimes unwelcome. Ignoring the concerns of family and patient about the adverse effects of medication has unfortunately resulted in possibly avoidable crisis and even death. Many carers complain that doctors ignore their requests for medication review or reduction.

I am constantly hearing from people denied any say in the drugging of their elderly parents in care homes. The parents of autistic or Asperger syndrome young adults who have had serious adverse reactions to psychotropic drugs, are desperately seeking a review of the harms caused by this kind of treatment. Long term iatrogenic (treatment induced) illness, emergency hospital admissions, long stays in psychiatric units and deaths by suicide or accident are reported to me every day.

Personal story

For 8 years since the untimely death of my daughter Karen, I have done research, and founded a charity helping thousands of individuals. I have organised an International conference, tried to create awareness among the public and contributed to many government health inquiries.

My daughter had severe reactions to a number of drugs prescribed for non-psychiatric conditions and to anaesthesia. Karen then suffered from the debilitating adverse effects of the psychiatric drugs used to treat the original ADRs. We had no written information or verbal warnings of risks and no way of reporting the ADRS.

Only since 1999 has EU law required Patient Information Leaflets (PILs) to be provided with all medication. Some of these still omit warnings about the danger of sudden withdrawal, or clear information about the risk of psychiatric ADRs.

Patient Reports of adverse drug reactions from patients are still not accepted in the UK. The submission of reports by health professionals, of a maximum of 10% of serious ADRs does not give a realistic picture of the extent of the problems occurring in the community.

Millions of pounds are spent due to emergency admissions and treatment for ADRs and illness caused by sudden withdrawal from addictive medication in hospitals as well as in primary care. The immense personal cost of devastated family life, wrecked careers, and the emotional effect on families, friends and work colleagues is rarely evaluated.

Official statistics of 10,000 serious ADR incidents in NHS hospitals included in the Department of Health (D of H) report “An Organisation with a Memory” maybe just the tip of the iceberg.

The Government are spending millions on new D of H agencies. There is much talk about improving patient safety, compliance and involvement, yet still the problem of ADRs is not being addressed by such agencies as the NPSA (National Patient Safety Agency).

The remit of the NPSA is only to investigate unusual adverse incidents and they say the responsibility for monitoring ‘expected’, even serious ADRs belongs to the MHRA (Medicines and Healthcare products Regulatory Agency) which in April 2003 replaced the MCA (Medicines Control Agency). Drug safety monitoring and regulation, is the responsibility of the MHRA, an organisation most of whose work is funded by the industry it regulates.

Following a BBC Panorama programme highlighting the adverse effects and withdrawal problems of the SSRI antidepressant Seroxat, (also known as Paxil or paroxetine), many of the over 1300 people who e-mailed Panorama after the programme, were asked to submit detailed information on special Yellow Cards designed by Mind, to be submitted to the MHRA.

A recent study by experts Dr Andrew Herxheimer and Charles Medawar, examined the MHRA monitoring and evaluation of all reports for the drug Seroxat. They concluded that “miscoding and flawed analysis of the Yellow Card reports has led to underestimation of the risk of suicidal behaviour on these drugs.” The full report in the International Journal of Risk & Safety in Medicine can be accessed via the web site www.socialaudit.org.uk

Akathisia (mental and physical agitation) is an ADR that may lead to self harm, thoughts of suicide, suicide attempts, death by suicide or accident, violence or homicide The National Suicide Prevention Strategy for England does not include a warning, or even mention the need to monitor suicidal patients for the possibility that they may be suffering from akathisia.

The Oxford Centre for Suicide Research has no plans to include medication-induced suicide or problems due to akathisia in their research. The D of H National Service Framework does not include warnings for health professionals to be aware of the possibility that ADRs to medication may be causing depression, agitation, mania, violence, akathisia, suicidal ideation, anorexia, or confusion and dementia in the elderly.

Off Licence Prescribing

Many drugs are prescribed ‘off licence’, that is they have never been tested in clinical trials for the condition, or possibly for a particular group of patients. Clinicians frequently prescribe ‘off licence’ for children, drugs that have not been tested on young people. Due to the lack of guidelines, the dose prescribed for a child is left to the individual judgement of the clinician. ‘Off licence’ prescriptions are unregulated and information about them is not collected.

Soon after the publicity surrounding the Panorama programme, ‘off licence’ prescribing of two specific antidepressants Seroxat and Effexor for people under 18 was banned. Statistics from pharmaceutical company clinical trials in children and adolescents had suddenly come to light, which showed evidence of a higher suicide risk for those under 18 when taking these drugs.

Sarah Boseley, in an article in the Guardian September 20th 2002 stated

” There are around 50,000 children, some as young as six, on antidepressants in the UK, the Guardian has learned. Last year, doctors wrote 170,000 prescriptions of the drugs for children under 18, even though many experts say counselling and talking therapies work better. Just as with Seroxat, the GlaxoSmithKline drug banned in June, studies have shown that Efexor can cause children to have suicidal thoughts or to become hostile, a word which in the context of clinical trials can mean homicidal. Experts at the Medicines and Healthcare products Regulatory Agency (MHRA), which licenses drugs in the UK, are urging that children should not stop taking either drug suddenly, but should consult their doctor.

The announcement raises a number of serious and urgent questions about the conduct of the pharmaceutical industry, the use of drugs in children and the ability of the MHRA to police the drug companies and safeguard public health.

Data which suggests the drugs could be causing children to feel murderous and suicidal has been in drug company hands for several years. The studies on these two drugs and others were carried out in the mid to late-1990s, after the Food and Drug Administration in the United States asked for efficacy and safety data because of the rapidly increasing number of children being prescribed antidepressants.

Glaxo is already under investigation by the UK regulators for failing to hand over data showing the suicide risks earlier. One of Wyeth’s four studies in depressed and anxious children was published in 1997. Yesterday a spokesman for the company refused to give the dates of the other unpublished trials. ” end of quote from ‘The Guardian’

A November 2002 ‘Early Day Motion’ in the House of Commons was concerned about ‘off licence’ prescribing to children. It read as follows:

“That this House welcomes the publication of ‘Surveillance for fatal suspected adverse drug reactions in the United Kingdom’ by A. Clarkson and I. Choonara which aimed to determine the nature and number of suspected adverse drug reactions associated with children reported through the yellow card scheme; is concerned that there were 331 deaths with 390 suspected medicines; notes that overall the benefits of all the drugs listed are likely to be far greater than risks; but hopes most earnestly that paediatricians will learn from the prime message of the paper that they should make themselves aware of guidelines which recommend avoiding certain medication in high risk groups; and further calls on the Medicines Control Agency to recognise, as the report states in its opening sentence, that the toxicity of medicines in children is clearly different from that in adults by introducing new and specific testing procedures for medicines prescribed to children.”

The MHRA should be regulating the safety of drugs, yet only acted on the evidence of the risks to children after it set up a working group to review the antidepressants following the Panorama expose. MHRA officials apparently see only a summary of the trial results from the manufacturers and only when the company is seeking a licence.

Dr David Healy, Dr Andrew Herxheimer and Mr Charles Medawar, have been voicing their concerns for years, about the risk of suicide for patients suffering adverse effects and withdrawal effects of SSRI antidepressants. If not for their tireless work and the efforts of the BBC Panorama programme, the increase in prescribing antidepressants, often for conditions unrelated to clinical depression and for children as young as six would have continued.

Hopefully the message will get through now to the many psychiatrists and GPs who have previously increased the dose for patients suffering from akathisia and other obvious ADRs in the belief that their ‘condition’ would be helped by the very drug that was causing the problems.

No investigation into the way these drugs were licensed would be taking place if it were not for the efforts of just a few concerned people. To all those afraid of stepping on toes, I would say “We cannot bring back the dead children but we can make more of an effort to protect the living”. Please make your voices heard.

We should be demanding as a right for patients and for the overstretched medical profession, that the ‘Safety of Medicines’ should be regulated by an independent body with no connections to the pharmaceutical industry and that clinical trials should be scrutinised by people who care more about safety than profits. Serious Adverse Events (SAEs) and withdrawal problems during and after clinical trials should not be surrounded by secrecy as is currently the case.

Following the announcement of an investigation in the UK, the American Food and Drug Administration (FDA) announced a meeting to hear evidence from the public about SSRI antidepressants, to be held in New York in Feb 2004.

Pharmacogenetics

Some people who lack certain enzymes needed to break down and inactivate the medication, will quickly have toxic levels in their body, even when taking normal (therapeutic) doses. An enzyme in the cytochrome P50 group known as CYP2D6 is known to be lacking in some 4 – 5 million people in the UK and is needed for 50 of the most commonly prescribed drugs, including cardiovascular and antidepressant drugs among others. There are no Department of Health plans yet in the pipeline for testing people thought to be vulnerable, let alone the whole population. These tests, however, are being used to identify suitable and unsuitable people for drug trials. If you want to find out more about pharmacogenetics go to www.nuffieldbioethics.org

It is important to understand that psychological adverse effects of medication can affect anyone. Many people who have never had any psychiatric illness or appeared vulnerable or likely to suffer from mental illness will suffer from psychiatric adverse reactions to medication prescribed for physical complaints or anaesthesia.

It may not touch you today but could in the future. If you look back, there may have been someone in your circle of family and friends who had been affected. Awareness now may prevent a future catastrophe.

WARNING: NEVER STOP ANY MEDICATION SUDDENLY WITHOUT CONSULTING A CLINICIAN. Stopping steroids, antidepressants, bezodiazepine (muscle relaxants, tranquillisers and sleeping pills) and some pain killers too quickly can be a danger to life.

2pm Professor John Peysner, Professor of Civil Justice Nottingham Law School: Disputes and negligence

If the NHS is a collective, and it damages you, then what? Is Social Security sufficient?

No fault schemes, such as New Zealand, are very sensitive to government interference, and vulnerable to excessive responses to beneficiary fraud. However they remove lawyers from that area so there is no easy way back down that road.

Cerebral palsy needs to be treated separately.

In the UK the post-Woolf scheme of civil litigation is faster. Costs are disproportionate in most clinical negligence cases because damages for pain and suffering are low. Home Office v Lownds (2002) acts as a check on lawyers who run up disproportionate costs. There is now budgeting of cases and the appointment of agreed experts acting for both parties. Conditional fee arrangements with insurance against the award of costs are established.

We need a complaint system which is responsive, permits an early apology and is fair to clinicians. Future development should include much greater emphasis on early rehabilitation, a duty of candour, a move to periodical payments instead of lump sums and better adverse incident reports. The basic rule is that adverse incident reports should be available to patients.

Peter Walsh, Action for Victims of Medical Accidents: Choice and Complaints

Can choice improve safety? Choice is meaningless without information

Information needs careful analysis & explanation. Informed choice of provider and of treatment options can improve outcomes for the patient. Unwilling patients generate discontent.

Can we afford full choice?

All providers should meet minimum standards and so be up to the job anyway. No one will improve if we always use ‘the best’

Can choice be a right?

If a right or expectation, failure to provide the chosen provider will generate complaints/challenges. Without the right to challenge, choice becomes meaningless. There will inevitably be an increase in complaints

‘Choice’ & ‘Justice’

Legal redress has its limitations. Legal Aid is quite limited in coverage and scope. Access to Justice not a realistic prospect for most people who are neither rich enough to pay nor poor enough to qualify for help. Proposed reforms have potential for fairer system. Still a danger of choice = take it or leave it. Possible ‘Hobson’s choice’

Individual and collective Justice

Choice or justice for one can mean less choice or justice for others. Some choice an absolute necessity. Questionable how much choice is desirable or deliverable. There has to be a reasonable balance

Effective Consumer or Empowered Patient?

Take your choice!

Questions: We don’t want to see defensive medicine as practiced in the USA. Clinicians have to explain risks. Clinical Negligence provisions as reported to NHS Trust accounts are grossly unrealistic, and in reality the costs of negligence are under 1%. Patients need to know what questions to ask. Should the NHS have its own investigation service?

Can Foundation Hospitals opt out of the clinical negligence scheme?

Catherine Needham, Queen Mary College, London, Research Associate, Catalyst : The Patient as Consumer

Consumerism pre-supposes self interested rationalism. It is rights based, but essentially passive, and vulnerable to marketing techniques.

Under the Tories the issues between patients and producers were dealt with by the Patients’ Charter. Now the approach is to customise the NHS – putting the patient in the centre in a consumer age. Is more choice going to lead to more equality?

Consumers are essentially selfish. The model works well for non- essential services and where there is a choice between providers of similar services. But what is its effect on collective goals and the public service ethos.

What does it mean to treat someone as a consumer?

  • Choice-based model (e.g. choice between providers)
  • Rights-based model (e.g. charters specifying service standards)
  • Cultural model (consumers are passive, vulnerable, manipulated)

1980s: Patient vs Producer

  • Conservative commitment to put patient first
  • 1983 Griffiths Report called for the NHS to be responsive to consumers, like companies
  • User as an ally in fight against ‘producerism’
  • Internal market expanded competition, but was little change in patient role

1990-97: Patient’s Charter

  • Major’s Citizen’s Charter initiative promised to make users as powerful as private sector customers.
  • Information, ‘voice’ and rights would act in place of market and ‘exit’
  • Patient’s Charter blended rights with entitlements
  • Citizenship missing from the Charter

1997-2000: New NHS

  • New NHS white paper (1997) emphasised meeting patient needs and restoring patient confidence in the NHS
  • Citizenship and community played an enhanced role
  • Patient’s Charter replaced by weaker document Your NHS. Emphasised responsibilities rather than rights

2000-03: Patient-centred care

  • NHS Plan 2000: emphasis on choice, and tailoring the service to patient needs
  • Call for NHS to respond to the ‘consumer age’ and to meet expectations shaped in the private sector
  • Expansion of hospital choice for some operations
  • Foundation Hospitals initiative sees choice as driver of excellence
  • Reid: I will ‘put the patient at the centre of the NHS’

    What’s wrong with treating patients as consumers?

  • Assumes that public and private sector should operate on the same principles
  • Is based on a deterministic vision of a ‘consumer age’
  • Weakens capacity of the NHS to meet collective goals
  • Equates choice with equity
  • Threatens public service ethos