Evidence submitted by Advanced Medical
Solutions (Def 34)
1. INTRODUCTION
1.1 Advanced Medical Solutions (AMS) is
a British company, specialising in the research, development,
manufacture and sale of wound care products for use in A&E
departments and operating theatres, instead of conventional sutures
and staples. We are developing on our successes in the branded
wound care sector by launching our own range of generic advanced
wound care products, ActivHeal®, for sale directly into the
NHS. Independent clinical evaluation has shown that ActivHeal®
significantly reduces the cost of treating wounds whilst still
maintaining the quality of wound care.
1.2 In this submission, we intend to offer
some observations based on the difficulties we have faced expanding
our business into the NHS, in the context of the NHS deficits,
as well as comment on some broader issues affecting the NHS procurement
process which would have an effect on NHS deficits.
1.3 In particular, AMS believes:
There is a disconnection between
clinical decision-makers and budget holders within the NHS.
There is a general lack of awareness
and recognition of costs, even in a restricted funding environment.
NHS staff need to become more
aware of, and responsible for, cost effectiveness so that they
prescribe cheaper versions of the same product, where this does
not affect patient care.
In the area of wound care alone,
it would be possible to save £25 million nationally. This
alone would not bring the NHS into the black but would go some
way to alleviating the current financial crisis.
2. THE REASONS
FOR THE
DEFICITS
2.1 AMS believes one reason for the deficits
is a disconnection between clinical decision-makers and budget
holders and a general lack of awareness and recognition of costs,
even in a restricted funding environment. There is a general lack
of good business practices, because not all clinical gatekeepers,
such as prescribing nurses, are accountable for their spending,
particularly in areas like wound care.
2.2 In the case of wound care, independent
clinical evaluation found that ActivHeal® reduces the cost
of treating wounds whilst still maintaining the quality of wound
care. ActivHeal® therefore offers real and immediate savings
to the NHS. This is estimated to be the order of £25 million
per year across England and Scotland at a time of severe funding
pressures. This is based on a 40% saving on the annual wound care
budget for the NHS of £60 million and has been verified by
the NHS Purchasing and Supply Agency (PASA) for its portion of
the market.
2.3 Since AMS began direct sales to the
NHS in February 2004, AMS has converted ten NHS Trusts. On average,
each Trust has saved approximately £25,000 per annum. The
most recent conversion was the Oxford Radcliffe NHS Trust, which
consists of four hospitals. Further Trusts are pending, some of
which have the potential to save £50,000 or more.
2.4 ActivHeal® is also supported by
a modern and effective training package consisting of Trust-specific
educational materials. Advanced distance learning packages and
individual access to qualified Clinical Support Nurse practitioners
with specialist knowledge of Advanced wound care and Tissue Viability.
In addition, a proportion of the savings made by using ActivHeal®
could be set aside for the benefit of wound care nurses. At present,
these nurses are dependent on the patronage of larger wound care
companies for their professional development.
2.5 Independent assessment has shown that
AMS products are as good as the branded versions, yet cheaper.
However, despite the advantages of the products, AMS has been
facing on-going difficulties in converting Trusts to using ActivHeal®.
2.6 The challenges faced by AMS include:
Piecemeal approach: AMS currently
has to approach each individual hospital, delaying projected cost
savings throughout the NHS.
Time efficiency: it has taken
an average of seven months to convert each Trust.
Patronage of clinicians by major
companies, who provide a great deal of professional training,
continues unchallenged and such training is rarely audited for
value or relevance.
2.7 These issues make it difficult for small
companies, like AMS, to compete with larger, more established
companies. AMS and other small companies are competing on an unlevel
playing field. This is not only detrimental to smaller players
but also to the NHS, as it is not able to benefit from the lower
prices that would result from more competition and business practices
that did not involve the patronage of clinicians.
2.8 As the Health Select Committee's inquiry
into the Influence of the Pharmaceutical Industry highlighted,
large, branded companies often provide inducements to clinicians
to try to persuade them to use their products.
2.9 In the area of wound care, such practices
are widespread. The selling model used by the major wound care
companies usually involves large teams of reps who deliver what
is effectively a consumer sell to individual nurses, the majority
of whom have no knowledge of, or interest in, the cost of the
products that they use.
2.10 In secondary care, effort is primarily
directed at Clinical Nurse Specialists such as Tissue Viability
Nurses (TVNs) or Vascular Nurses, who act as technical gatekeeper,
and final arbiter for the products used in their trust, and have
no financial responsibility.
2.11 In the lucrative primary care sector,
the decision-making is more devolved than in acute, and usually
individual Practice Nurses and District Nurses either self prescribe,
or make a dressing choice which the GP then signs. Despite often
being the budget holder, GPs very rarely make prescribing decisions
relating to woundcare, incontinence or Stoma products. Although
there are TVNs in post in primary care, their formulary choices
can be overruled by individual nurses.
2.12 The selling process in primary care
is therefore more akin to the pharmaceutical selling process,
but involves selling to nurses with less experience in assessing
products than GPs, and with much fewer controls on patronage and
inducements that apply to medics.
2.13 Examples of such endorsements and inducements
include:
Funding for a general nurse
to attend a wound care conference is often provided through sponsorship
from a wound care company.
Clinical Nurse Specialists such
as TVNs are also sponsored to present to other nurses, thereby
endorsing the products.
A number of high profile TVNs
and consultant TVNs are paid to lecture at conferences, and to
publish clinical papers which are intended to influence the decision-making
of less experienced clinicians. Such publications frequently contain
product promotion. [3]
Social events and seminars are
regularly sponsored by branded companies. Although not explicitly
asking nurses to prescribe their dressings, it is hard for nurses
to maintain complete independence.
Training: the provision of education
in wound care is often cited as being part of the added value
inherent in the high purchase prices of the branded products.
This can vary, but consists largely of the local rep providing
lunch once a quarter and presenting the latest sales arguments
loosely structured as training. No company provides independent
non-product specific training and none of the training packages
has been accredited by, for example, the Royal College of Nursing,
although the mechanism to do so is available and relatively inexpensive.
Neither does anyone evaluate the value of such training to the
participant.
2.14 The Surgical Dressing Manufacturers
Association (SDMA) imposes a Code of Practice on all of its members
and arbitrates on complaints, usually from other members, about
the activities of a member organisation. The code is prescriptive
on matters such as gifts, inducements, business courtesies and
the behaviour of reps, but the code does not include training
provision and resources provided by companies. We believe these
should be added to the list of disclosures and the code itself
should be made more effective in stopping all these practices.
2.15 AMS does not sponsor nursing posts
and we oppose such sponsorship. We would suggest that a clear
and accountable declaration of any training provision and resources
provided should be added to the list of disclosures required by
a Code of Practice.
2.16 Training and resources, provided by
companies, to educate clinical staff is often cited as justification
for elevated pricing. Whilst the industry should provide training
to ensure products are used safely and effectively, clinical training
should be an internal NHS or technical nursing issue. If product
offerings were to be stripped of their alleged "added value"
components, or if these were precisely defined, the Trusts could
take an informed view of the value of such components.
2.17 AMS suggests that savings made on unit
prices could be available to give Tissue Viability Nurses (TVNs)
financial control over nursing posts and their own training budgets.
These savings would be greater than the cost of the training currently
provided by companies and could be tailored to meet the needs
of the nurses and NHS, rather than the requirements of the companies
providing the training.
2.18 If such changes were implemented and
there was a greater connection between prescribing and cost, the
NHS would save significant sums of money. This would probably
require Government policy although it could be implemented at
the local level.
3. THE CONSEQUENCES
OF THE
DEFICITS
3.1 The consequences of the deficits are
clear in the numerous recent announcements of plans for NHS Trusts
to lay staff off, close wards and/or reduce services.
3.2 There seems to be an apparent preference
for laying off operational staff and closing wards, rather than
looking at ways to cut costs and resolving on-going operational
deficiencies. AMS would suggest that it would be possible to save
significant sums of money by preventing the problems outlined
above.
3.3 AMS believes the only way to ensure
early adoption and savings for the NHS for wound care and related
products, such as stoma, is through a more central decision-making
process along the lines of the generic pharmaceuticals model,
which has delivered substantial savings.
4. RECOMMENDATIONS
4.1 Companies selling to the NHS should
be prevented from offering gifts, inducements, training provision
and other resources provided.
4.2 Before laying off staff and closing
wards, there should be an assessment of ways for the NHS to save
money, through greater cost effectiveness, such as with procurement.
AMS believes such moves would save significant sums of money,
without affecting the level of patient care.
4.3 More responsibility for spending should
lie with the prescriber. This could be achieved by checking all
prescribing is relatively cost effective.
4.4 Procurement for wound care and associated
products should be through a more central decision-making process,
along the lines of the generic pharmaceuticals model, which has
delivered substantial savings. This would make the process more
efficient, enable the NHS to maximise savings and assist smaller
companies to compete with the larger businesses. This approach
would not mandate from above that clinicians should prescribe
one particular product but should emphasise that there are usually
several equivalent products to choose from, and where this is
the case, decisions can be based on cost without affecting patient
care.
Advanced Medical Solutions
6 June 2006
3 Eg articles by K and P Vowden (TVN & Vascular
Surgeon, Bradford), Elizabeth Scanlon (TVN Leeds) and Claire Williams
(TVN North Wales), in "Moist Wound Healing; Achieving a balance"-a
sponsored supplement to the "Wounds-UK" journal. Back
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