Acsma toolkit - mythbuster

Campaign Toolkit
Myth Buster
Busting the myths around INR self-monitoring

At ACSMA we regularly hear stories about people on long-term warfarin being given incorrect
or misleading advice about the options for self-monitoring blood clotting levels (know as the
International Normalised Ratio or INR). In this document, we attempt to dispel some of the
myths and misconceptions
1) It isn’t safe for a person to self-monitor their own levels.

False: Patients on long-term warfarin who self-monitor their own INR levels can achieve a
higher level of time in therapeutic range, which means their INR levels are within the range as
specified by their doctor or nurse for more of the time. When the INR is in the specified range
the chances of having an adverse event, such as a stroke or a bleed, are reduced. It is
advisable that you speak with your doctor or nurse before changing any aspect of your care as
they wil be able to offer you advice. There are certain criteria that must be met in order for it to
be safe to self monitor your INR levels; please use the fol owing as a guide:
You must be on long-term warfarin Be manual y dexterous (be able to use your hands to hold smal er objects) Have sufficient eyesight for normal daily tasks Have a good mental capacity Be motivated to get involved with your own care Have consent from your doctor/Nurse
2) Self-monitoring does not provide patients with any additional health benefits or
improve their quality of life.

False: There are many published studies that demonstrate the significant benefits that self-
monitoring can bring. Self-monitoring reduces the risk of stroke by 50% and lowers mortality
rate by nearly 40%. Together these provide a robust case for self-monitoring to deliver a model
of care that is customised to the individual and is in line with the drive for self and supported
care. There is also evidence outlining improvements in patient-reported outcomes measures
(PROMs) and quality of life indicators through the freedom gained from not visiting hospital
clinics on a regular basis. By self-monitoring, patients can:
1) Improve time in therapeutic range and reduced risk of bleeding or clots
2) Enjoy greater independence and quality of life
3) Reduction in travel and associated costs and time savings
4) Have an improved feeling of wel being

3) Every patient who is on long-term warfarin is well aware that he or she has the
possibility to self-monitor their condition.

False: In a 2011 survey from AntiCoagulation Europe (ACE) and AF Association (AFA -
formerly the Atrial Fibril ation Association), it was revealed that:

• More than half of those taking warfarin did not know that self-monitoring existed, despite
the medical and quality of life benefits it offers. Campaign Toolkit
Myth Buster
Busting the myths around INR self-monitoring

• More than nine out of ten people wanted to be more involved and consulted in care
decisions. However, the majority of people were not aware of the current NHS actions to involve patients in care decisions. The National Institute for Health and Care Excel ence (NICE) estimates that 46% of patients
who are indicated for warfarin or newer oral anticoagulation drugs (NOACs) are not currently
taking any anticoagulation treatment1.
The reasons are multiple; variations in the quality of primary care, reluctance by GPs to
recommend warfarin, capacity issues within anticoagulation clinics and the reluctance of
patients to take warfarin due to concerns with the drug and the inconvenience it can bring.

4) Patients have no choice in how they manage their treatment of their long-term
condition.

False: Department of Health policy sets out the importance of having the patient at the heart of
care. Patients should be offered choices into their preferred therapy and model of care that
must include discussion of the relative benefits and risks. Patients should be able to have an
informative discussion with their health professional about their options for treatment and care.

5) Self-monitoring with INR devices is complicated and can only be done by a trained
clinician or anticoagulant nurse.
False: Self-monitoring is just as accurate as being tested with a GP or at an anticoagulation
clinic. Most people on long-term warfarin with reasonable eyesight and manual dexterity, or
their carer, may be suitable for self-monitoring. There is no age limit. Those who self-monitor
achieve a quality of anticoagulant control, which may be superior to that attained in routine
specialist anticoagulation clinics.
Some healthcare professionals can be initial y cautious; this might be because they are not
familiar with the concept of self-testing and so discourage their patients from self-testing. It is
important that patients talk to their Doctor or nurse about their wish to self-test. Patients wil
need their support for some initial training and wil need to arrange with them how to contact
them if an INR result is outside of the ideal target (therapeutic) range.
6) Self-testing does not provide results as accurate as clinically supervised testing.
False: Self-monitoring is just as accurate as being tested with a GP or at an anticoagulation
clinic. Studies have shown that the accuracy of Point of Care (POC) devices are comparable to
laboratory measures, with patients showing improvement in anticoagulant control and reduced
risk of thrombosis compared to clinic-based care2. In 2006, NICE recommended the use of self-
monitoring devices as an option for specific patients3. One such self-monitoring device that
1 Atrial fibril ation. The management of atrial fibril ation, NICE, June 2006, http://www.nice.org.uk/nicemedia/live/10982/30054/30054.pdf
accessed 29th May 2013
2 Point-of-care INR coagulometers for self-management of oral anticoagulation: primary care diagnostic technology update, British Journal of
General Practice, October 2012, http://pubmedcentralcanada.ca/pmcc/articles/PMC3481522/ accessed 29th May 2013
3 Atrial fibril ation. The management of atrial fibril ation, NICE, June 2006, http://www.nice.org.uk/nicemedia/live/10982/30054/30054.pdf
accessed 29th May 2013
Campaign Toolkit
Myth Buster
Busting the myths around INR self-monitoring

could be used is the CoaguChek® XS, which has a number of inbuilt technologies to ensure
the accuracy of results. Built-in controls on both the meter and the test strip confirm the blood is
correctly applied and the test was successful. The CoaguChek® XS has been independently
evaluated and approved by the Centre for Evidence-based Purchasing. It has an International
Sensitivity Index (ISI) of 1.0 as recommended by the World Health Organisation (WHO) and the
British Society of Haematology, for results that closely correlate with clinic methods, and a
coefficient of variation (CV) of <4.5% making it both accurate and precise.
7) Self-monitoring isn’t necessary because GP and hospital clinics provide satisfactory
monitoring and testing services.

False: According to a recent survey, 70% of patients find regular visits to their GP or clinic
inconvenient, and find it restricts their quality of life. Self-monitoring enables people to not be
restricted by clinic appointments and helps them regain a sense of independence in their daily
and professional lives. People would be able to liaise with their Doctor/nurse from the comfort
of their own home, saving both the person and their healthcare professional valuable time.
8) The test strips for the INR testing machines are expensive and are not available on
NHS prescription.

False: Many patients are able to obtain their test strips on NHS prescription. However, it is
dependent on whether a GP supports their patient in self-monitoring. The GP has to issue the
prescription so this is where some patients are finding they are not al owed to obtain test strips.
NICE has approved in principle the issuing of test strips on prescription but has left it to
individual Clinical Commissioning Groups (CCGs) to give local direction. Some CCGs do not
al ow GPs to issue test strips on prescription because of the perceived cost, so there stil
remains variability within the NHS.

9) Only older people take warfarin.
False: There is a vast age range of people who are on warfarin and it is not solely for older
people. Many people who suffer from Atrial Fibril ation (AF) are general y older; however AF
can develop in the early 40s or 50s; therefore these people would be good candidates for self-
monitoring. Dr. Carl Heneghan commented that “while there wil obviously be many older
patients who are not suitable for self-monitoring such as those with dexterity or memory
problems, most younger patients on warfarin would be good candidates, and they would
receive al the medical benefits we found, as wel as the enormous lifestyle benefits, such as
independence and freedom of travel. Many children and young people are on warfarin now for
life, having received artificial heart valves, and these would be the first obvious candidates”4.

10) INR self-monitoring devices machines aren’t validated to hospital standards.
False: Al INR devices wil have to carry a CE Mark of Conformity, which means the
manufacturer guarantees that the product meets al the appropriate provisions of the relevant
4 Comments made by Dr Carl Heneghan to heartwire, heartwire website, 2nd February 2006, http://www.theheart.org/article/640375.do accessed 30th May 2013. Campaign Toolkit
Myth Buster
Busting the myths around INR self-monitoring

Essential Requirements of the European Medical Devices Directive5. These provisions include
safety, quality control, and ensure the device is fit for intended purpose 6 . Conformity
assessment procedures become more demanding as the perceived level of risk associated
with the device increases. As anticoagulation self-monitoring devices come under Class IIa7
(medium risk8) due to their invasive use, there must be the involvement of independent third
party certification bodies cal ed Notified Bodies9 , which in the UK, is the Medicines and
Healthcare products Regulatory Agency (MHRA). The MHRA has certified al self-monitoring
anticoagulation in the UK with the CE marking, with POC devices for testing INR having been
available and used in a clinical setting since the late 1980s10 . Studies have shown that
anticoagulation devices, such as the widely used CoaguChek monitors, not only provide a safer
alternative to routine hospital testing11 but also are adequate for clinical use if used by patients
to determine their INR value by themselves12.
11) There are no cost benefits from patients self-monitoring to the NHS.

False: Studies show that if just 1 in 4 warfarin patients were able to self-monitor their INR
levels, the NHS could save up to £62 mil ion a year. Even the Prime Minister, the Rt. Hon.
David Cameron MP, said in December 2011 that self-monitoring technology is “effective,
convenient, and in the end, cheaper for the NHS”13.

12) No-one needs to take warfarin anymore now that newer oral anticoagulants (NOACs)
are available.

NOACs are anticoagulants (blood-thinning medicines) used to reduce the risk of blood clot
formation in patients with AF (an abnormal heart beat) and additional stroke risk factors.
However, not al warfarin users wil be suitable for these medicines.
5 Most medical devices now placed on the UK market have to comply with device specific legislation. There are three European Directives concerning medical devices. Active Implantable Medical Devices Directive (90/385/EEC), Medical Devices Directive (93/42/EEC), and In Vitro Diagnostic Medical Devices Directive (98/79/EC). Each Directive contains a wide-ranging and comprehensive list of Essential Requirements covering items such as electrical safety, chemical and mechanical safety, biocompatibility, and label ing requirements. 6 Frequently Asked Questions, MHRA website, http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/Otherdevicesregulatoryguidance/Frequentlyaskedquestions/ accessed online 30th May 2013 7 Devices covered by the Directive are grouped into four classes: Class I (low risk), Class IIa (medium risk), Class IIb (medium risk with added assessment checks), Class III (high risk) 8 The Classification Rules, MHRA bul etin No.10, June 2011, http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007495.pdf accessed 30th May 2013 9 A Notified Body is an independent certification body designated by a Competent Authority to conduct conformity assessment procedures specified in the various Directives. A manufacturer may choose any Notified Body provided it has been designated to perform the particular conformity assessment procedure it wishes to use. A complete list of Notified Bodies is available on the EU Commission's website. 10 Warfarin therapy: Tips and tools for better control, The Journal of Family Practice, February 2011, http://www.jfponline.com/Pages.asp?AID=9332 accessed 30th May 2013 11 Precision and accuracy of CoaguChek S and XS monitors: The need for external quality assessment, Leon Pol er, European Action on Anticoagulation, March 2009 http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&ved=0CDEQFjAA&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F19277400&ei=AoetUfmxGY3I0AXrnoHgDg&usg=AFQjCNHdy8L6PoM21joXwHGVb6ZSSJZbdQ&sig2=Sff1SlBxF6Kx9-j8M_FJYA accessed 30th May 2013 12 Accuracy of the point-of-care coagulometer CoaguChek XS in the hands of patients, Journal of Thrombosis and Haemostasis, January 2013, http://onlinelibrary.wiley.com/doi/10.1111/jth.12050/ful accessed 30th May 2013 13 PM speech on life sciences and opening up the NHS, FT Global Pharmaceutical and Biotechnology Conference, 6th December 2011 https://www.gov.uk/government/speeches/pm-speech-on-life-sciences-and-opening-up-the-nhs accessed 30th May 2013.

Source: http://www.acsma.org.uk/wp-content/uploads/2013/01/ACSMA-Toolkit-Mythbuster.pdf