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 worldwidemore
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
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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