Select Committee on Health Written Evidence


Memorandum by Bayer Schering Pharma (PS 18)

PATIENT SAFETY

INTRODUCTION

  1.  Bayer Schering Pharma is one of the ten largest specialty pharmaceutical companies in the world. We market our products in more than 100 countries, and generated worldwide sales of over ð€ñ10 billion in 2007. Over 37,000 employees currently work for Bayer Schering Pharma worldwide—more than 5,000 in research and development alone[132].

  2.  In the UK & Ireland, Bayer Schering Pharma employs almost 400 people and had total annual sales of £214 million in 2007[133].

  3.  With our products, we aim to improve people's quality of life. To achieve this, we concentrate on the research and development of innovative drugs and novel therapeutic approaches. At the same time, we are constantly improving established products. In this context, Bayer Schering Pharma uses experience gained in more than a century of business.

  4.  Bayer Schering Pharma's goal is a leading market position in each of its fields: Diagnostic Imaging, Haematology & Cardiology, Oncology, Primary Care, Specialised Therapeutics and Women's Healthcare.

  5.  This response focuses on venous thromboembolism (VTE) an area looked at by the committee in 2005[134].

  6.  VTE, encompassing deep vein thrombosis (DVT) and pulmonary embolism (PE), represents one of the most significant health threats to patients being treated in hospitals. VTE, known as the "silent killer", is commonly asymptomatic and difficult to diagnose, resulting in a lack of awareness of the condition. Prevention of VTE is emerging as a major international patient safety issue.

RISKS TO PATIENT SAFETY

  7.  In the UK, pulmonary embolisms following hospital acquired DVT, cause between 25,000 and 32,000 deaths each year3. This may be an underestimate since many deaths are not followed by a post-mortem[135].

  8.  This figure exceeds the combined total of deaths from breast cancer, AIDS and road traffic accidents[136]. It is twenty-five times greater than the annual deaths from MRSA and over five times greater than the number of deaths from hospital acquired infection[137].

  9.  Many of these deaths are preventable. VTE in hospitalised patients is largely preventable through effective risk-assessment and the use of thromboprophylaxis during the hospital stay of the patient and, in some cases, continuing after discharge[138]. Current treatment options include, low molecular weight heparins (LMWH), Factor Xa inhibitors, and vitamin K antagonists (warfarin).

  10.  Three quarters of fatal pulmonary embolisms occur in patients admitted for non-surgical reasons. Admission with acute medical illness increases patient risk eight times. This risk is often unrecognised by clinicians. Less than 1 in 10 fatal pulmonary emboli are diagnosed before death[139].

  11.  A recent UK survey suggested that 71% of patients assessed to be at medium or high risk of developing DVT did not receive any form of pharmacological or mechanical thromboprophylaxis[140]

  12.  VTE prophylaxis has been shown to be cost-effective[141].

  13.  The total cost (direct and indirect) to the UK of managing VTE is estimated at £640 million[142].

  14.  There are also significant costs associated with litigation, with £68 million being paid or owed for VTE claims over the last 10 years[143].

EFFECTIVENESS OF APPROACH TO ENSURING PATIENT SAFETY

  15.  NICE Guideline[144]

    a. Patients should be assessed to identify their risk factors for developing VTE

    b.  Healthcare professionals should give patients verbal and written information, before surgery, about the risks of VTE and the effectiveness of prophylaxis

    c. Inpatients having surgery should be offered thigh length graduated compression/ anti-embolism stockings from the time of admission to hospital and/or intermittent pneumatic compression or foot impulse devices

    d. Patients at increased risk of VTE and patients having orthopaedic surgery should be offered low molecular weight heparin (fondaparinux may be used as an alternative)

    i.     Low molecular weight heparin or fondaparinux should be continued for four weeks in hip replacement patients who have one or more risk factors for VTE

    e. Suitability of regional anaesthesia (which reduces the risk of VTE compared to general anaesthesia) should be considered

    f. Healthcare professionals should encourage patients to mobilise as soon as possible after surgery

  16.  The key recommendation not covered by the NICE guideline is that all medical patients should as part of a mandatory risk assessment, be considered for thromboprophylaxis measures. In particular, those patients likely to be in hospital longer than four days and with reduced mobility, with either severe heart failure, respiratory failure, acute infection, inflammatory illness or cancer.

  17.  Independent Expert Working Group recommendations[145]

    a. Systems, processes and knowledge base

    i.     Mandatory VTE risk assessment which should be embedded within the Clinical Negligence Scheme for Trusts

    ii.     The VTE risk assessment should be embedded within the Clinical Negligence Scheme for Trusts

    iii.     Improvement of public and professional understanding of VTE at a national level, through improved communication of information to patients and the public, accompanied by improved and co-ordinated programmes of professional education

    iv.     Establishment of VTE demonstration centres, highlighting best practice, developing a national risk assessment strategy and auditing local practice

    v.     Core standards to be established by the Department of Health for the NHS and independent sector to ensure 100% compliance with the requirement for risk assessment. These should be included in Standards for Better Health in the NHS and in Independent health care: national minimum standards.

    vi.     Compliance with such standards to be monitored by the Healthcare Commission

    vii.     Department of Health refers responsible healthcare institutions that have no protocols for mandatory assessment and documentation to the new local thrombosis demonstration centres for advice regarding best practice

    viii.     Evaluation of the impact on patients and the public of any future VTE strategy

    b. Thromboprophylaxis strategy

    i.     All medical patients should, as part of a mandatory risk assessment, be considered for thromboprophylaxis measures

  18.  A survey by the All Party Parliamentary Group on Thrombosis in 2007 showed that only 32% of Acute NHS Hospital Trusts undertook a documented mandatory risk assessment of every hospital patient on admission[146], as recommended in both the Chief Medical Officer's Independent Expert Working Group recommendations and NICE Guideline.

  19.  42% of Acute NHS Hospital Trusts do not have in place a multi-disciplinary thrombosis committee/ team responsible for the management of patients with VTE[147] as recommended by the Health Select Committee in 2005[148].

  20.  Similarly, 42% of Acute NHS Hospital Trusts do not offer patients information on VTE on admission or discharge[149].

  21.  33% of Acute NHS Hospital Trusts do not offer staff education regarding thromboprophylaxis[150].

WHAT THE NHS SHOULD DO

  22.  "VTE is a significant international patient safety issue and, since July 2004 when the Department of Health published Standards for Better Health, healthcare organisations have been charged with continuously and systematically reviewing all aspects of their activities that affect patient safety. Nevertheless, to date, the prevention of VTE has remained unaddressed in too many of our NHS hospitals"[151].

  23.  Bayer Schering Pharma believes that a systematic approach to identifying and treating those patients at risk from VTE in hospitals is key to addressing this issue.

  24.  Core to delivering such an approach is the successful implementation of mandatory risk assessment of patients on admission. At the moment evidence would suggest that this is not happening (ref. para 18).

  25.  The publication in 2009 of a new NICE Clinical Guideline, The prevention of Venous thromboembolism in all hospital patients will provide an important contribution to reducing the risk of VTE in all patients admitted to hospital.

  26.  What will success look like?[152]

    Patient admitted to hospital

    Professional workforce, aware of VTE risks, able to institute timely prophylaxis

    Individual patient risk of VTE assessed

    Appropriate preventative strategy implemented

    Evaluation of outcome

September 2008








132   Bayer HealthCare Corporate Brochure, Berlin, Germany Back

133   Bayer Schering Pharma press release, Newbury, 14 April 2008 Back

134   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

135   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

136   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

137   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

138   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

139   Developing a systems-based approach to VTE, A UK perspective, Dr Anita Thomas OBE, October 2007 Back

140   National Institute for Health and Clinical Excellence. Scope: The prevention of Venous thromboembolism in all hospital patients, September 2007 Back

141   Goldhaber SZ. Venous thromboembolism risk among hospitalised patients: Magnitude of the risk is staggering. Am.J.Hem. 2007; 82: 775-6 Back

142   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

143   All Party Parliamentary Group on Thrombosis, Awareness, Management and Prevention, 2007. Back

144   National Institute for Health and Clinical Excellence. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery. Clinical Guideline 46, April 2007 Back

145   Report of the independent expert working group on the prevention of venous thromboembolism in hospitalised patients. A report to Sir Liam Donaldson, Chief Medical Officer, Department of Health, April 2007. Back

146   All Party Parliamentary Group on Thrombosis, Awareness, Management and Prevention, 2007. Back

147   All Party Parliamentary Group on Thrombosis, Awareness, Management and Prevention, 2007. Back

148   8 March 2005, The prevention of Venous Thromboembolism in hospitalised patients, Health Select Committee, HC99 Back

149   All Party Parliamentary Group on Thrombosis, Awareness, Management and Prevention, 2007. Back

150   All Party Parliamentary Group on Thrombosis, Awareness, Management and Prevention, 2007. Back

151   Report of the independent expert working group on the prevention of venous thromboembolism in hospitalised patients. A report to Sir Liam Donaldson, Chief Medical Officer, Department of Health, April 2007. Back

152   Developing a systems-based approach to VTE, A UK perspective, Dr Anita Thomas OBE, October 2007 Back


 
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Prepared 30 October 2008