Select Committee on Health Written Evidence


Memorandum by Baxter Healthcare (PS 60)

PATIENT SAFETY

1.  INTRODUCTION

  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.  BACKGROUND ON BAXTER HEALTHCARE

  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 DIVISION AND PATIENT SAFETY

  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.[361] Data from the UK Renal Registry suggests that patients on haemodialysis may contribute 8-10% of all cases of MRSA bacteraemia in the UK.[362]

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 home.

  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 IN RENAL REPLACEMENT THERAPY—INFECTIOUS COMPLICATIONS OF TREATMENT

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 HD—this 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.  PERITONITIS IN PD

  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 patient-years.

  5.1.6  Home based therapy with PD carries a risk of peritonitis but there is a low risk of septicaemia and death.

6.  INFECTIOUS COMPLICATIONS OF HD

  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.

    —  USA—the 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 MRSA—there 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 PD peritonitis.

7.  CONCLUSION

  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 PD capacity.

  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 acquired infections.

  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 increased demand.

    "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 2008-2009)"

  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.

REFERENCES

  1.  Verger C et al—Kidney International 2006; 70: S12-S20.

  2. Perez-Fontan M et al—Peritoneal Dialysis International 2003; 25: 274-284.

  3. Guo A and Mujais S—Kidney International 2003; 64 (supp. 88): S3-S12.

  4. Pisoni RL et al—Kidney International 2002; 61: 305-316.

  5. Fluck R et al—Nephrology Dialysis Transplantation 2007; 22 (supp. 7): 51-57.

  6. Polkinghorne KR et al—American Journal of Kidney Disease 2004; 43 (4): 696-704.

  7. Ponce P et al—Nephron Clinical Practice 2007; 107: c133-c138.

  8. USRDS annual report 2007.

  9. Ramanathan V et al—Infection Control and Hospital Epidemiology 2007; 28: 606-609.

September 2008








361   Akpolat T, Dilek M, Yavuz M, et al. Low seroconversion rates in CAPD patients compared to hemodialysis patients: potential advantages for transplant candidates. Perit Dial Int. 2002;22:520-523. Back

362   Renal Registry Eighth Annual Report. Back


 
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Prepared 30 October 2008