This document provides an overview of access to complementary and alternative medicine (CAM) in the NHS Scotland chronic pain service. It notes that nearly 40% of GP partnerships in England provide CAM access to NHS patients, and that chronic musculoskeletal pain is the most common reason people use CAM. Several government reports and clinical guidelines since 1994 have recommended CAM therapies like manual therapy and acupuncture for chronic pain conditions. However, access to CAM through the NHS is currently unequal, as it depends on how affluent patients are. The document proposes developing a referral pathway for GPs to refer patients to nationally-regulated CAM practitioners, and increasing dissemination of chronic pain resources, as ways to help address this inequality.
2. Background
Nearly 40% of GP partnerships in England provide
access to CAM for NHS patients*1
one in ten of the population uses complementary
healthcare*2
three-quarters of the population would choose
complementary healthcare if it were available on the
NHS*2
Chronic musculoskeletal pain is the single most cited
reason for use of CAM*3
*1 Integrated Healthcare: A Way forward for the Next Five years? Published by the Foundation for Integrated
Health
*2 A Healthy Partnership – Integrating Complementary Healthcare into Primary Care; 2005 (published by the Prince
of Wales Foundation for Integrated Health
*3 The use of CAM and conventional treatments among primary care consulters with chronic musculoskeletal pain
(BMC Family Practice 2007)
3. Background
The benefits of unconventional therapies (aka CAM
therapies) on chronic pain,
their cost effectiveness
the need for CAM regulation and
the need for ongoing CAM research
have been recognised by health authorities in Scotland
and the rest of the UK since, at least, 1994
(‘Management of Patients with Chronic Pain’) all the way
to the SIGN guideline on chronic pain management
published in 2013.
This issue has been discussed for over 20 years
4. Background - Key documents recommending CAM
1994: The Management of Patients with Chronic Pain (Scottish
Government)
2000: The economic burden of back pain in the UK (‘Maniadakis Paper’)
2000: Services for patients with pain - Report of the Clinical Standards
Advisory Group Committee
2004: Chronic Pain Services in Scotland (‘McEwen Report’)
2006: Management of Chronic Pain in Adults (QIS)
2007: GRIPS report (Getting Relevant Information on Pain Services)
2008: Department of Health Steering Group (‘Pitillo Report’)
2009: NICE guideline (Early management of persistent non-specific low
back pain)
2013: SIGN Guideline on Management of Chronic Pain(#136)
5. Background - GUIDELINES
1999
NICE - ‘Early management of persistent non-specific
low back pain’:
5.1.4 Offer one of the following treatment options - taking into
account patient preference - an exercise programme, a course
of manual therapy or a course of acupuncture.
(Manual therapies in these guidelines are spinal manipulation,
spinal mobilisation and massage) The guideline also
recommends ‘Alexander Technique’
Evidence included “high quality systematic review with a very
low risk of bias” and other “well conducted RCT with a low risk
of bias”
6. Background - GUIDELINES
2013
SIGN ‘Management of Chronic Pain’ (#136):
7.1.1 Manual therapy should be considered for short term
relief of pain for patients with chronic low back pain
7.1.2 Manual therapy, in combination with exercise, should
be considered for the treatment of patients with chronic neck
pain. (grade 1++ evidence with a 'B' classification).
8.1 Acupuncture should be considered for short term relief of
pain in patients with chronic low back pain or osteoarthritis.
‘A' classification
‘Guidelines’ are developed making use of the best evidence
available and GPs are encouraged to follow them.
7. Current status of CAM referrals
Referrals to CAM therapist is supported by the
Government: “A GP or hospital clinician may refer a patient
for alternative treatment” [circular HDL(2005) 37]
BMA: “The BMA is supportive of those forms of
complementary therapy for which evidence of claims of
efficacy can be demonstrated”
GPs may delegate treatment to complementary therapists
who are not registered with a statutory regulatory body.
Dr Blair Smith (Scottish Lead Clinician for Chronic Pain):
“We also need to develop and review non-pharmacological
treatments, including psychological approaches, exercise
and activity, and complementary techniques such as
acupuncture.” (The Scotsman – 28th
March 2014)
8. Current status of CAM referrals
Government [circular HDL(2005) 37]
The GP or hospital clinician would require to
1. be satisfied of the value of the treatment and
2. the competence of the practitioner
3. and would remain responsible for the patient's
medical care
But support for CAM comes with certain conditions
In effect, GPs need to:
determine the evidence for the use of different forms of CAM for
different conditions as well as determine qualifications, insurance
status and safety/ethics of a therapist.
9. Current status of CAM referrals
GMC
you must be satisfied that systems are in place to assure
the safety and quality of care provided – for example, the
services have been commissioned through an NHS
commissioning process or the practitioner is on a
register accredited by the Professional Standards
Authority.
BMA
GPs may delegate treatment to complementary therapists who
are not registered with a statutory regulatory body. In doing so,
they remain responsible for the treatment given and would
bear some liability should the patient come to any harm.
But support has certain conditions
10. Current status of CAM referrals
“In terms of referral pathways, a GP referring to a CAM
would be considered as a TERTIARY REFERRAL under
the extra-contractual referral process (ECR)”
[NHS Lanarkshire]
A form is completed (for each patient) outlining
• the basic clinical details,
•the treatment (or sometimes investigation) proposed,
•the duration and an estimate of cost
Such referrals are considered by the Divisional Medical Director
The new Scottish service model for chronic pain (launched in 2013)
promotes the use of non-pharmacological treatments firstly within primary
care then, for more complex cases, secondary care. Never tertiary.
11. Inequality of access
The Government say that it’s up
to Health Boards to decide
whether to provide
unconventional therapies or not
Health Boards/GPs need regulation in order to comply with
conditions for non-statutory referrals.
Regulation is determined by the Government
NHS BOARDS
Can provide but
not regulate
GOVERNMENT
Can regulate
but not provide
Currently, access to CAM therapies recommended by
guidelines is dictated by how affluent patients are.
Equality can only exist if therapies are provided by the NHS.
12. INEQUALITY OF ACCESS – POSSIBLE SOLUTION
REGULATION
GPs could refer their patients to therapists registered with a
recognised national regulatory organisation, ideally
accredited by the ‘Professional Standards Authority’
CNHC (Complementary and Natural Health Care)
Originally funded by the Dept of Health in Whitehall
Created to regulate CAM in the whole of the UK
(much like the GMC regulate GPs)
Accredited by the Professional Standards Authority
Endorsed by the General Medical Council (GMC)*
13. INEQUALITY OF ACCESS – POSSIBLE SOLUTION
REFERRAL PATHWAY
Creation of a direct REFERRAL PATHWAY similar to other
existing mainstream services such as physiotherapy
WIDER DISSEMINATION OF INFORMATION
Making GPs, practice managers and other health
professionals (as well as patients) more aware of existing
chronic pain resources such as guidelines, chronic pain
website and the revised (2013) Scottish chronic pain service
model
ANY MORE?
e.g.
• dedicated ‘drug-free’ chronic pain clinics?
• dedicated Government funding?
14. Needed discussions
Matters related to the delivery of unconventional therapies through
the NHS need to be discussed - such as:
• central regulation of unconventional therapies (rather than
therapy-specific regulation)
• referral pathway
• delivery model
• cost effectiveness
• risk/benefit analysis
• possible integration within the MSK service
• use of unconventional therapies in the context of the GRIPS
and McEwen reports
• use of unconventional therapies in the context of human
rights and the ‘Patient Rights (Scotland) Bill’
• the desirability of continuous evidence assessment through
trials and audits (before research)
15. RESOURCES
CAM in the NHS: www.bit.ly/CAMintheNHS
Revised chronic pain model: Chronic Pain Services in Scotland
SIGN guideline #136: http://bit.ly/CPGuideline
NICE guideline CG88: www.nice.org.uk/guidance/CG88
Chronic pain support website: www.chronicpainscotland.org
Service Improvement Groups (SIGs): http://bit.ly/SIGsScotland
For further information or enquiries
paulo@intlifepain.org
Editor's Notes
*1 Integrated Healthcare: A Way forward for the Next Five years? Published by the Foundation for Integrated Health
*2 A Healthy Partnership – Integrating Complementary Healthcare into Primary Care; 2005 (published by the Prince of Wales Foundation for Integrated Health
*3 The use of CAM and conventional treatments among primary care consulters with chronic musculoskeletal pain (BMC Family Practice 2007 - Face-to-face interview-based survey )
1994:The Management of Patients with Chronic Pain (Scottish Government)
2000: The economic burden of back pain in the UK (‘Maniadakis Paper’)
2000: Services for patients with pain - Report of the Clinical Standards Advisory Group Committee
2004: Chronic Pain Services in Scotland (‘McEwen Report’)
2006: Management of Chronic Pain in Adults (QIS)
2007: GRIPS report (Getting Relevant Information on Pain Services)
2008: Department of Health Steering Group (‘Pitillo Report’)
2009: NICE guideline (Early management of persistent non-specific low back pain)
2013: SIGN Guideline on Management of Chronic Pain(#136)
McEwen Report – Recommendation 14
With regard to outcome evaluation the contribution of complementary therapy, long-term outcomes, patient functioning and rehabilitation could usefully be included and linked to international research.
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The Joint Commission *1 in the USA have just published "Revisions to pain management standard effective January 1, 2015" which makes non-pharmacological strategies (including Complementary and Alternative Medicine) a required integral part of chronic pain management standard. Their 'Standard PC.01.02.07 includes "Both pharmacologic and nonpharmacologic strategies have a role in the management of pain . . . Nonpharmacologic strategies: physical modalities (for example acupuncture therapy, chiropractic therapy, massage therapy . . .)"
*1 The Joint Commission (TJC) is a United States-based organization that accredits more than 20,000 health care organizations and programs in the United States. A majority of state governments recognize Joint Commission accreditation as a condition of licensure and the receipt of Medicaid reimbursement.
“No opioids or tricyclic antidepressants and only some NSAIDs have a UK marketing authorisation for treating low back pain.
If a drug without a marketing authorisation for this indication is prescribed, informed consent should be obtained and documented”
The SIGN guideline #136 shows that the evidence for manual therapies have
the same grading as some of the standard chronic pain drugs (eg gabapentin, Pregabalin and many others) - ie the grading is 1++
and are given a 'B' classification (the same as NSAIDs and strong opioids for low back pain, Lidocaine plaster, Carbamazepine, and better than CBT).
(1++ means High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias" - the highest level of evidence)
Re short term effect: Duloxetine 60 mg daily is effective in treating painful diabetic peripheral neuropathy in the short term to 12 weeks but is still prescribed in the NHS
Re efficacy of drugs: An often prescribed drug such as Tramadol, has only "a modest benefit compared to placebo" on lower back pain and "of unclear clinical benefit" and "one good quality review found no significant reduction in pain compared to baseline" and when opioids were compared to placebo or active controls there was limited evidence of efficacy".
SCOTTISH EXECUTIVE - Health Department - Public Health Division
NHS Circular: HDL(2005) 37
If an NHS Board sees a need for the provision of a particular type of CAM in its area it is open to that Board to provide that therapy, at the Board's discretion.
Recently the Executive made available to NHS Boards copies of a booklet produced by the Prince of Wales' Foundation for Integrated Health, Complementary Healthcare - A Guide for Patients.
Complementary and Alternative Medicine is an area in which there is increasing public interest. Chief Executives are asked to take this into account in the planning of services.
BMA
Whether GPs are prepared to delegate treatment in these circumstances would therefore depend principally upon their knowledge of, and belief in the efficacy of, the therapy and their personal knowledge of the competence of the individual therapist.
- they (GPs) need to be satisfied that the individual (therapist) is suitably qualified and experienced to undertake the role.
- GPs should also be aware that, in such circumstances, they may be held liable for any harm arising to their patients
- ensure that tasks are delegated only to those who are competent to fulfil them satisfy themselves that the treatment seems appropriate to the patient’s needs and is likely to benefit the patient. As above, this presupposes some knowledge of, and belief in the efficacy of, the therapy.
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General Medical Council (GMC) 2015
7. Usually you will refer to another doctor or healthcare professional registered with a statutory regulatory body.
8. Where this is not the case, you must be satisfied that systems are in place to assure the safety and quality of care provided – for example, the services have been commissioned through an NHS commissioning process or the practitioner is on a register accredited by the Professional Standards Authority.
A form is completed outlining
the basic clinical details,
the treatment (or sometimes investigation) proposed,
the duration and an estimate of cost.
Such referrals are considered by the Divisional Medical Director
In a ‘real life’ situation, one of my local GPs in South Lanarkshire was asked if she would refer one of her patients for massage therapy for his low back pain as he had heard that it was recommended in the chronic pain guideline.
When she told him that she would have to write to the Health Board who, in turn, would consider her request at their next meeting some time in the future and would then decide whether they would approve the request or not (and under what conditions) and write back to the GP, the patient decide that he couldn’t wait that long and withdrew his request.
There was a significant positive association between CAM use and non-manual social class and gross income over £15 600 (Results from the National Omnibus survey 2004)
“We often talk in the Parliament about joined-up talking and thinking. Surely pain management is an excellent example of a service that could span the NHS and the independent sector as well as complementary medicines” Mary Scanlon MSP [Scottish Parliament Official Report, 27 February 2002, Col 9753]
“With NHS Lanarkshire budget constraints our concern would be that referrals would essentially be blocked for CAM therapy and not receive board approval”
(local GP practice)
The use of unconventional therapies both in acute and chronic pain management as a first-line approach choice at primary care level together with conventional approaches would have the benefit of freeing valuable specialist resources for more complex cases. [Services for Patients with Pain - 1 84182 157 8] This view is also supported by the Clinical Standards Advisory Group statement that “It is important to recognise that only a minority of patients with pain will need treatment by specialist pain services”.
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Drugs are often not effective and can have extreme negative side-effects:
There are around 65,000 gastrointestinal haemorrhage emergencies a year in the UK as adverse effects from NSAIDs (Ibuprofen, aspirin, etc) (NSAIDs and adverse effects: Bandolier); Vioxx killed at least 60,000 people before it was withdrawn;
in September 2011 it was discovered that Diclofenac and other common pain killers/anti-inflammatories increase the risk of stroke and serious heart problems by 40% (just 5% below the risk associated with Vioxx);
In the USA, the FDA have ordered lower doses of Acetaminophen in prescription painkillers (used for headaches, aching muscles and sore throats) as it has been the leading cause of liver failure in the USA being estimated to be directly responsible for some 120 deaths a year;
GPs could refer their patients to therapists registered with a recognised national regulatory organisation, ideally accredited by the ‘Professional Standards Authority’
This organisation would have a central database of ‘safe’ therapists who were pre-screened and have all the requisites to practice
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“Physical treatments such as massage [should be] made available on the NHS and much quicker access (possibly in partnership with funding existing providers)”. Dr Marilyn McNeill (Pain Concern) [What I want to achieve: Cross Party Group on Chronic Pain Comments (2007)]
Complementary therapies make an enormous contribution and should be developed. Patients are at risk if they do no understand that Chronic Pain is a condition in it’s own right. Patients in most circumstances have to pay for therapy and shouldn’t do this. (Liz McLeod – Chair of Physiotherapy at Pain Association and advisor to Pain Concern - CPG meeting June 2002)
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HUMAN RIGHTS: In ‘‘Getting it right? Human rights in Scotland’ , the Scottish Human Rights Commission state that “Health facilities, goods and services have to be accessible to everyone without discrimination”.
And that this has four dimensions:
non-discrimination (in law and fact),
physical accessibility
economic accessibility and
information accessibility.
The same document by the SHRC also states that
“Participation in decision-making and legal capacity is pivotal to the realisation of an individual’s dignity and rights”.
“The freedom to accept or refuse specific medical treatment, or to select an alternative form of treatment, is vital to the principles of self-determination and personal autonomy”
Matters related to the delivery of unconventional therapies through the NHS need to be discussed - such as:
central regulation of unconventional therapies (rather than therapy-specific regulation)
referral pathway
delivery model
cost effectiveness
risk/benefit analysis
possible integration within the MSK service
use of unconventional therapies in the context of the GRIPS and McEwen reports
use of unconventional therapies in the context of human rights and the ‘Patient Rights (Scotland) Bill’
the desirability of continuous evidence assessment through trials and audits (before research)
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In 1998, Congress established The National Center for Complementary and Alternative Medicine (NCCAM) as a branch of the National Institute for Health’s (NIH) Office of Alternative and Complementary Medicine.
The NCCAM was created to
fund research to study the effects of CAM on various illnesses;
explore CAM practices within a rigorous, scientific context;
train CAM researchers;
and to disseminate authoritative information.
The budget of the NCCAM is $100 million, funding several large clinical trials and supporting fifteen specialized research centres.