Dear Mr Singleton, Re: David_Wade_(Deceased)_ Regulation 28Report to_Prevent_Future Deaths Thank you for your letter of 8lh September 2016, together with your regulation 28 report, setting out the sad circumstances surrounding the death of Mr Wade. was very sony to read of the circumstances around his death, and would like to express my deep condolences to his family In your report you outline your primary concern as: "Patients who are provided with anti-coagulant therapy are at an increased risk of the development of haemorrhagic strokes: There appears to be no system in place to provide patients with literature setting out the symptoms of a bleed on the brain and the steps patients should take in response In light of your concerns would wish to bring to your attention Ihe standard anticoagulant booklet (more commonly known as the "yellow book' which is warfarin specific) given to patients as recommended by the former National Patient Safety Agency. A link to its content is below: btpxllunds npsa nhs uklresources/ZEntrvld45-61777 As you will see the yellow book does set out a list of symptoms which if any occur then urgent medical advice should be sought: This advice is also available to patients on NHS Choices The National Institute for Health and Clinical Excellence also supports the use of the yellow book as their clinical knowledge summary on wariarin makes reference to patients being given the yellow book: can confirm that the 'Yellow' Oral Anticoagulant Therapy (OAT) book is still in High quality care for all, now ad for future generations

print and widely available in the NHS. Shown in the table on page 2 of this letter; is the latest available data (2015) on distribution of the booklet across the NHS. In addition to distributing the booklet; note the second part of your concern regarding steps to be taken by the patient should experience symptoms of a bleed. Whilst this is an important issue it Is, fortunately, an uncommon one. In terms of absolute risk, the rate of spontaneous intracerebral haemorrhage (ICH) among 70-year-old subjects not on anticoagulants averages 0.15% per year; In those anticoagulated with warfarin to an "INR" (please see below) of 2.0 to 3.0 (the usual range), the risk of ICH is increased to 0.3 to 0.8% per International Normalised Ratio (INR) is the measure of the degree to which clotting is inhibited by the and for most clinical conditions requiring anticoagulation the aim is to double the time coagulation (akes when measured by the INR The risk of bleeding is probably slightly lower with the newer oral anticoagulants which are known a5 Direct Oral Anticoagulants ("DOAC"s) or Novel Oral Anticoagulants ("NOAC"s). fThis is a record book used (o record the patients use pf warfarin; It conlains critical information concerning Ihe patient his or her warfarin use and the associated INR; QAT Book
264.700 Ik is the palienls tracking record palient-held credit-sized card indicating thal thel holder is laking warfarin. IThis is to communicale the factof warfarin use tol OAT Card
104.700 plhers_potentially in an emergengy situalion fThe patient-held informalion supporling (he need for} monitoring INR wilh Warfarin: OAT Palient Info It provides general high-level informalion on warfarin) Book 29,250 pse but is nol exhaustive in this regard TThis is pack conlaining the OAT Book, lhe OATI pard , the OAT Palient information Book OAT Pack 184,750 and the QAT Sheet Ithis is an A4 sheet (hal can be used in a printer Ksuitably aligned for use) to record warfarin dose and OAT Sheet 6,300 JNRagainst lime_ When people do experience a bleed into their brain, whilst on anticoagulants, then lhe effect is usually obvious and profound. As consequence patients typically nearly always arrive promptly in hospital (from your regulation 28 report this would appear to have happened in Mr Wade's case): NHS England agrees that all patients starting on anticoagulants (both warfarin and DOACs) should be given all the relevant information, including that outlined above Anticoagulant clinics are where the majority of patients start their anticoagulants and usually have protocols for information provision Currently most patients being started on DOACs have their initial few months of treatment initiated by hospital clinicians who would also be expected to provide the relevant advice: High quality care for all, now and for future generations they year: drug

Overall, there is, of course, balance to be struck: It is important that patients are not deterred taking a treatment where the balance of benefit over risk is usually strongly in favour of benefit so information should be provided in considered way focussing on those benefits and not just the risks. Indeed the biggest in terms of population health is the failure to anti-coagulate people with atrial fibrillation. It is estimated that about 5000 people have unnecessary strokes each year in the UK because of fears about anticoagulation by patients and clinicians. Thank you for bringing this matter to my attention and hope this addresses your concerns.