Memorandum by Baxter Healthcare (PS 60)
1.1 Baxter Healthcare welcomes the opportunity
to respond to the consultation on patient safety.
1.2 Patient safety is a theme that runs
through all of Baxter's businesses. We support the NHS in advancing
patient safety by continuously innovating in the development of
treatments and the delivery of care for people with critical conditions.
The company's innovations in medical devices, pharmaceuticals
and biotechnology all help reduce the risk of adverse incidents
occurring in the delivery of patient care. The company works in
partnership with healthcare providers and policy makers to develop
and support patient safety initiatives.
1.3 We recognize that the scope of the consultation
on patient safety is necessarily broad. Baxter's response to this
consultation has focused on the considerable knowledge and experience
that Baxter can bring to bear on patient safety in the specific
area of dialysis provision.
1.4 Baxter would be happy to be called to
give oral evidence in support of this submission.
2.1 Baxter is one of the top 10 healthcare
companies in the UK. We are a diversified company working in pharmaceuticals,
biotechnology and in public private partnerships with the NHS.
During our 45-year relationship with the NHS we have worked with
healthcare professionals and policy makers to innovate change;
and through our partnerships with patients and providers we develop
treatments and products that are based on the providing the highest
possible level of safety and quality to the patient in critical
areas of medicine such as cancer, renal therapy, intensive care,
surgery and haemophilia.
3. BAXTER RENAL
3.1 Baxter provides a portfolio of dialysis
products for the treatment of chronic and acute renal failure.
The company has been constantly innovating and developing new
products and services, working directly with patients, clinicians
and medical staff to enhance the therapies available by improving
safety and reducing operational risks.
3.1.1 As our population continues to age
and diseases affecting kidney function, such as diabetes increase,
then the number of patients requiring renal replacement therapy
continues to rise. Baxter are leaders in the field of PD and the
company continues to innovate with the development of assisted
automated peritoneal dialysis therapy (aAPD), enabling more people
with established renal failure to receive the renal replacement
therapy of their choice in their own home. When compared to hospital
haemodialysis (HD) home-based PD therapy limits exposure to certain
chronic viral infections such as hepatitis and HIV because there
is limited exposure to centre-based personnel or patients and
no direct exposure to blood processing instruments.
Data from the UK Renal Registry suggests that patients on haemodialysis
may contribute 8-10% of all cases of MRSA bacteraemia in the UK.
3.2 Education and Clinical Support
3.2.1 Patients and professionals have concerns
over safety in healthcare. Education, training and clinical support
can help address many of these concerns, because Baxter listens
to the concerns of patients and professionals the company has
invested heavily and is very proactive in these areas.
3.2.2 Baxter's renal education centre (BREC)
provides comprehensive training programmes for PD patients. Based
in a purpose built centre in Kew, London, BREC provides accommodation
for patients and carers for the duration of their training, whilst
they learn how to manage their condition safely and effectively.
This is the only facility of this type in the UK. Outside of London
a network of Baxter nurses train and support patients in their
3.2.3 Clinical support, advice and training
for healthcare professionals on all Baxter products and therapies
is provided by a team of clinical and training nurse specialists.
Regular study days are also organised for clinical professionals
involved in the care of dialysis patients.
4. PATIENT SAFETY
4.1 Executive Summary
4.1.1 Both currently available forms of
dialysis (peritoneal dialysis, PD; haemodialysis, HD) are effective
forms of renal replacement therapy, however there are infectious
complications associated with each. Indeed, infection is the second
most common cause of death in patients receiving long-term dialysis.
The overall infection rates are similar in the two types of therapy
but they are very different in terms of the severity of the problem
and the overall risks posed to the patient.
4.1.2 In HD the main infectious risk is
septicaemia associated with vascular access for dialysis; this
leads to increased mortality and increased NHS resource use in
this patient population.
4.1.3 In PD the main complication is peritonitis;
the risk of peritonitis is low, has declined over the recent past,
and the risk of death associated with peritonitis is low.
4.1.4 Analysis of the Hospital Episode Statistics
(HES) database for the period 2005-2008 shows that there is a
25-fold difference in the number of deaths associated with septicaemia
and dialysis between PD and HD. Many of the HD cases are associated
with the use of central venous catheters, a type of vascular access
which, according to current guidelines, should only be used in
a small number of patients. It is clear that in situations where
patients start dialysis without proper planning the use of central
venous catheters is high, with an obvious negative effect on outcomes.
The 2007-8 HES database demonstrates that in HD patients in England
there were over 1300 admissions with septicaemia, with an average
length of stay of over 16 days and more than 350 deaths. In over
60% of these patients, the bacteria causing the septicaemia was
a Staphylococcus; unfortunately the coding in HES does not record
whether this was a methicillin resistant organism (MRSA).
4.1.5 The most recent Renal Registry report
lists 43,900 patients in the UK receiving renal replacement therapy,
43% of whom are on HDthis implies that approximately 18,900
patients in total are exposed to increased risk of septicaemia
and death through the method of dialysis.
4.1.6 This inequality in risk associated
with therapy, in a patient group of this size, is striking and
requires urgent action to reduce this risk of health care associated
infection. Widespread adoption of a home-based therapy such as
PD would help to address this, but currently within the UK there
is a 10 fold variation in the use of home based therapy. This
inequality of provision is impossible to explain on clinical grounds
but is an important factor when considering infection risk.
5.1 PD is a home-based therapy, and has
the advantage of keeping patients in control of their own treatment.
NHS and DoH strategy highlights the need to deliver care as close
as possible to the patient's home, and to involve the patient
in their own treatment whenever possible. This type of therapy
achieves both these objectives.
5.1.1 In addition as PD involves treatment
in the home not a hospital setting and does not involve access
to the patient's circulation, the risk of septicaemia is very
low compared to HD. This is confirmed by 2007-8 HES data demonstrating
only 37 admissions with septicaemia, in line with the observations
in other countries eg the US Renal Data System 2007 report.
5.1.2 Peritonitis is the infectious complication
of PD and is an important factor leading to failure of the technique.
Key preventive measures include training and retraining of the
patient around appropriate technique while performing dialysis
exchanges, good care of the catheter exit site, and careful design
of dialysis fluid delivery systems.
5.1.3 With these measures the peritonitis
rate has significantly improved over the last 10 years as shown
in data from the French dialysis patient registry (Verger, 2006).
During the past decade, the rate of peritonitis amounted to one
episode every 29 months for patients on CAPD (continuous ambulatory
peritoneal dialysis) and to one episode every 35 months for those
on APD (automated peritoneal dialysis).
5.1.4 The European Best Practice Guidelines
for dialysis recommend a rate of no more than one episode of peritonitis
per 24 patient-months. When these figures are viewed alongside
the current length of time patients stay on PD it is apparent
that most patients will not experience an episode of peritonitis
while on PD.
5.1.5 In contrast to septicaemia the risk
of death associated with peritonitis in PD is low. Data from Spain
(Perez-Fontan 2005) show that for the period 1986-2004 the rate
of peritonitis in PD patients declined from approximately 0.8
episodes per patient per year to around half that figure. Over
the same period the associated mortality was <5 cases per 100
5.1.6 Home based therapy with PD carries
a risk of peritonitis but there is a low risk of septicaemia and
6.1 The vast majority of HD patients in
the UK receive dialysis three times a week in healthcare settings
whether in a hospital or more distant "satellite" centre.
A very small minority of patients receive HD within their homes.
6.1.1 HD requires access to the circulation
as part of the procedure; this can be with either a surgically
created join between an artery and vein (a fistula) or a plastic
central venous catheter (CVC). A fistula is the preferred form
of access and is permanent.
6.1.2 The UK has a vascular access problem
compared to other European countries (DOPPS, Pisoni RL et al,
2002). The majority of incident patients do not have permanent
access with a fistula and the majority in this study (75%) were
using a CVC. This has a significant impact on the risk of healthcare
associated infection in UK HD patients: this is now assessed as
the Vascular Access Survey reported in the UK Renal Registry report
which is presented to providers and commissioners.
6.1.3 The Vascular Access Survey performed by the
Renal Association (Fluck R et al, 2007) on behalf of the Renal
Registry in 2005 demonstrated that;
29% of all prevalent HD patients
were dialysed with a CVC,
69% of all incident HD patients were
dialysed with a CVC,
There were over 450 episodes of MRSA
septicaemia in these patients that year, that were estimated as
being 8-10% of all MRSA infections.
6.1.4 The risk to HD patients from healthcare
associated septicaemia has been recognised in studies from other
countries and this is typically associated with a high use of
CVCs for chronic dialysis;
Australia/NZ Registry (Polkinghorne
KR, 2004)demonstrated that the risk of death in HD patients
is increased 3 fold if they dialyse with a CVC.
A European study (Ponce P et al,
2007) demonstrated an overall hospitalisation rate of 3.5 per
100 patients months but also that in patients with a CVC the risk
of septicaemia was increased 5 fold and the risk of death 39 fold.
USAthe USRDS (2007 Report)
demonstrates the increased risk from CVCs.
6.2 Health Economic Impact
6.2.1 As well as the adverse clinical impact
of septicaemia in HD patients it is important to consider the
health economic impact of this problem. There are few studies
in this area despite the clear impact on the NHS but one US study
(Ramanathan V et al 2007) estimated that the treatment
of a septicaemia episode in an HD patient cost over $23000. If
this was caused by an MRSAthere was an incremental cost
of almost $6000 as well as increased mortality. This needs to
be placed in context with the previously mentioned HES data estimating
over 1300 admissions per year in England for septicaemia in HD
patients. Data do not exist to quantify the treatment costs of
7.1 Over a number of years, the procurement
of HD services requiring long term planning and capital investment
has taken nationwide focus away from the need to actively plan
7.1.1 As a treatment, PD is as effective
as HD, moreover, it provides the patient with a greater degree
of freedom within their treatment, is less expensive and as we
have shown improves patient safety by reducing exposure to hospital
7.1.2 The provision of care outside of the
traditional hospital setting is an important and recurring theme
within the NHS Next stage Review. The review clearly outlines
that planned care;
"could, and should, be provided closer to
people's homes, with greater use of technology and where outpatient
care not always meaning a trip to hospital."
7.1.3 The NHS Operating framework for 2008-2009
outlines that commissioners should pay particular attention to
areas where increases in demand may have an impact on services
and mentions home dialysis specifically as a way of dealing with
"demand for renal replacement therapy (dialysis
and transplantation) is projected to rise by around 5 per cent
per year until at least 2030. SCGs will wish to consider options
for expanding the provision of satellite dialysis centres and
offering more people the option of home dialysis, as well as expanding
traditional acute dialysis units. (p27 3.12 NHS Operating framework
7.1.4 Whilst the reduction of infection
rates was not explicitly stated as an aim of the moves towards
treatment in a non-hospital setting, we have clearly shown that
home renal therapies can help to address the problem of infections
in renal therapy.
7.1.5 A move towards ensuring a more balanced
portfolio of renal provision that combines both home and hospital
therapies would help to address the problem of renal infections.
This could be achieved if Strategic Health Authorities and Trusts
issued specific capacity planning documents for home therapies
Peritoneal Dialysis and Home Haemodialysis.
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3. Guo A and Mujais SKidney International
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4. Pisoni RL et alKidney International
2002; 61: 305-316.
5. Fluck R et alNephrology Dialysis
Transplantation 2007; 22 (supp. 7): 51-57.
6. Polkinghorne KR et alAmerican
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7. Ponce P et alNephron Clinical
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8. USRDS annual report 2007.
9. Ramanathan V et alInfection
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361 Akpolat T, Dilek M, Yavuz M, et al. Low
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