implementation of non-vitamin k antagonist oral …...review open access implementation of...

Heidbuchel et al. Thrombosis Journal (2015) 13:22 DOI 10.1186/s12959-015-0046-0

REVIEW Open Access

Implementation of non-vitamin K antagonistoral anticoagulants in daily practice: the needfor comprehensive education for professionalsand patients
Hein Heidbuchel1*, Dana Berti2, Manuel Campos3, Lien Desteghe1, Ana Parente Freixo4, António Robalo Nunes5,Vanessa Roldán6, Vincenzo Toschi7 and Riitta Lassila8
Abstract

Non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly used for the prevention and treatment ofvenous thromboembolism and for stroke prevention in patients with atrial fibrillation. NOACs do not require routinecoagulation monitoring, creating a challenge to established systems for patient follow-up based on regular bloodtests. Healthcare professionals (HCPs) are required to cope with a mixture of patients receiving either a vitamin Kantagonist or a NOAC for the same indications, and both professionals and patients require education about thenewer drugs. A European working group convened to consider the challenges facing HCPs and healthcare systemsin different countries and the educational gaps that hinder optimal patient management. Group members emphasisedthe need for regular follow-up and noted national, regional and local variations in set-up and resources for follow-up.Practical incorporation of NOACs into healthcare systems must adapt to these differences, and practical follow-up thatworks in some systems may not be able to be implemented in others. The initial prescriber of a NOAC shouldpreferably be a true anticoagulation specialist, who can provide initial patient education and coordinate thefollow-up. The long-term follow-up care of patients can be managed through specialist coagulation nurses, in adedicated anticoagulation clinic or by general practitioners trained in NOAC use. The initial prescriber should beinvolved in educating those who perform the follow-up. Specialist nurses require access to tools, potentially includingspecific software, to guide systematic patient assessment and workflow. Problem cases should be referred forspecialist advice, whereas in cases for which minimal specialist attention is required, the general practitioner couldtake responsibility for patient follow-up. Hospital departments and anticoagulation clinics should proactively engagewith all downstream HCPs (including pharmacists) to ensure their participation in patient management andreinforcement of patient education at every opportunity. Ideally, (transmural) protocols for emergency situationsshould be developed. Last but not least, patients should be well-informed about their condition, the treatment,possible risk scenarios, including the consequences of non-adherence to prescribed therapy, and the organisationof follow-up care.

Keywords: Anticoagulation clinic, Educational pathways, Non-vitamin K antagonist oral anticoagulant, Patient education

* Correspondence: [email protected] University and Heart Center, Jessa Hospital, Stadsomvaart 11, Hasselt3500, BelgiumFull list of author information is available at the end of the article

© 2015 Heidbuchel et al. This is an Open Access article distributed under the terms of the Creative Commons AttributionLicense (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in anymedium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Heidbuchel et al. Thrombosis Journal (2015) 13:22 of 14

Background: non-vitamin K antagonist oralanticoagulants and the need for educationThe well-documented limitations of vitamin K antagonists(VKAs) have led to the development of non-VKA oral an-ticoagulants (NOACs) that have more predictable pharma-cological properties, do not require routine coagulationmonitoring, depend less on patient and lifestyle factors,and have fewer restrictions in terms of diet andco-medications [1]. NOACs are changing clinical practiceand are increasingly used for the prevention and treatmentof venous thromboembolism (VTE) and stroke preventionin patients with non-valvular atrial fibrillation (AF).Unlike VKAs, NOACs are not subject to regular dose

adjustments [2]; however, their use requires changes toestablished systems for patient follow-up based on regularblood tests. The lack of a need for regular coagulationmonitoring should not preclude regular contact withhealthcare professionals (HCPs) to oversee the safe andeffective management of NOAC therapy. Important checksinclude monitoring of renal and hepatic function, exclusionof thrombocytopenia or anaemia (especially in elderlypatients), assessment of nuisance bleeding or other adverseevents, confirmation of adherence to the prescribed medi-cation and evaluation of other aspects of overall treatmentand health, including optimal management of hypertension[2]. Because some patients are well managed on VKAs orhave conditions for which NOACs are contraindicated (e.g.prosthetic heart valves), HCPs and healthcare systems areincreasingly required to cope with patients receiving eithera VKA or a NOAC for the same or different indications.Anecdotal evidence suggests that many HCPs lack

education on NOACs and are concerned about pre-scribing them. Additionally, specific management andfollow-up protocols (e.g. for serious bleeding compli-cations) are still in development. Although somepatients receiving NOACs may not require frequentcontact with an HCP, others, such as those withco-morbid conditions, renal impairment or a high riskof bleeding complications, should be seen more often.HCPs and patients must understand relevant aspectsof the prescribed anticoagulant and the importantdifferences between NOACs and VKAs. In many (butnot all) countries, monitoring of patients receivingVKAs is usually performed at a dedicated outpatientclinic [3], and staff at these clinics serve well as focaldisseminators of education on NOACs to HCPs andpatients.This document has been created to consider best

practice for dissemination of education and the evolv-ing role of the coagulation clinic in the NOAC era.

Development of this documentA workshop was held in September 2013 involvingEuropean HCPs with expertise in anticoagulation from

a range of specialties, including cardiologists, haematol-ogists and specialist nurses from Belgium, Finland, Italy,Portugal, Slovenia, Spain and the United Kingdom. Thisworking group was asked to consider the challengesfacing HCPs and healthcare systems in their countrieswith respect to the introduction of NOACs, and thegaps in educational structures and settings that hinderor endanger the optimal management of patients receiv-ing these drugs. The outputs of the discussions weretaken forward to create this manuscript. Bayer Health-Care provided logistical support for the meeting.

Current models of anticoagulant prescription andmonitoringTo understand the flow of educational informationwithin an anticoagulation management paradigm, it isfirst necessary to consider commonly used patient man-agement models. These models are built primarily forpatients receiving long-term VKA therapy and fall intotwo main categories: anticoagulation clinic coordinationand coordination by general practitioners (GPs). In somesystems, a hybrid model exists, in which unstable orcomplicated patients are seen in a hospital clinic andstable patients are managed by their GP. In all cases, thenetworking between these functions is criticallyimportant.

Anticoagulation clinic modelPatients regularly attend a specialist outpatient clinic forinternational normalised ratio (INR) monitoring. Follow-ing prespecified algorithms, a nurse may take responsi-bility for INR interpretation and subsequent VKA doseadjustment, or may refer to the supervising consultantcardiologist or haematologist for atypical patients orscenarios. The nurse or consultant (or both) may takeresponsibility for educating the patient on their conditionand treatment. Official anticoagulation clinics exist inseveral European countries, including Belgium, Italy,the Netherlands, Portugal, Spain, Slovenia, Sweden andthe United Kingdom, but in many countries this service isdecentralised.

General practitioner modelIn the absence of a dedicated outpatient clinic, responsi-bility for ongoing monitoring of patients receivingchronic anticoagulant therapy generally falls to GPs. GPstend to be familiar with VKAs and have a detailed know-ledge of their patients’ health and lifestyle. Practicenurses may take responsibility for routine INR monitor-ing in some cases. The GP model is used in Germanyand to a variable extent in other countries. The risk ofnon-uniform management strategies and the lack of


quality control may be a drawback of these services. Aptrecent study in the United States reported that thenumber of patients tested per GP practice was posi-tively associated with INR time in therapeutic range(TTR) [4].

Possible new models for long-term non-vitamin Kantagonist oral anticoagulant careCurrent systems face the need to integrate patients tak-ing NOACs with those taking VKAs. Consultant cardi-ologists and haematologists have a strong knowledgebase to support this integration but may not be at thefront line of day-to-day patient interaction. Therefore, itis important that their knowledge is disseminated tonurses, GPs and other relevant HCPs. The models pre-sented here draw on previous work by members of thisconsensus group [5]. Each model has advantages anddrawbacks (Table 1) and would require adaptation to ac-count for specific differences in country, regional andlocal healthcare systems.

Table 1 Advantages, disadvantages and requirements of propoK antagonist oral anticoagulants or vitamin K antagonists

Model Initialprescriber

HCPresponsiblefor routinefollow-up

Advantages

Nurse-coordinatedanticoagulationclinic

Hospitalspecialist

Nurse specialist • Nurses well placed to coorcontact with patients, theprescriber and other HCPs

• Nurses can take a holistic v(co-morbidities), make a fuassessment and educate thpatient

• Less intensive for the specallowing them to focus fulthe treatment plan

Nurse-assistedanticoagulationclinic

Hospitalspecialist

Cardiologist/haematologist,assisted bynurse

• Nurse does not require extanticoagulation expertise bstill organise patient visitsprovide basic checks andeducation

GP coordinated,withoutanticoagulationclinic

Hospitalspecialist orspecialist GP

GP • Reduces pressure on hospiresources

• GPs generally know their pwell

• Can perform home visits

GP, general practitioner; HCP, healthcare professional; NOAC, non-vitamin K antago

Anticoagulation clinic modelsNurse coordinatedSpecialist anticoagulation nurses are well placed todrive the integration of NOACs into existing anticoa-gulation clinic structures [5]. In the nurse-coordinatedmodel, a nurse coordinator, working according tostandard operating procedures, takes responsibility forroutine patient management in the anticoagulationclinic. The clinic is largely autonomous but remainsunder the supervision of consultant physicians, whosee patients at predefined intervals and/or on referralfrom the nurse. The nurse keeps in contact with thepatient, determines the frequency of clinic visits andmay provide education to GPs, pharmacists and patientsand their families about the medical condition and itstreatment (Figure 1). Sufficient resources for training ex-pert nurses and mechanisms for benchmarking and qual-ity control are required. Pressure on resources could beeased by identifying easy-to-manage, low-risk patients re-ceiving NOACs, with whom contact could be maintainedprimarily through the GP, with the nurse coordinator

sed models for monitoring of patients taking non-vitamin

Disadvantages Requirements for NOACintegration

dinateinitial

• Requires well-educated expertnurses and resourcesfor an anticoagulationclinic

• Determination of individual patientvisit schedules

iewlle • Medico-legal liability

issues

• Easy-to-manage patients couldhave primary contact throughthe GP; clinic could function as acoordinator and remote evaluatorof care

ialist,ly on

• Non-medical as well as medicalaspects and patient preference tobe taken into account whenconsidering whether to switch fromVKA to NOAC

ensiveut canand

• Resource- and time-heavy for specialist

• As above

tal • Increased pressure onGP resources

• GPs to maintain contact withpatients at a frequency based onpatient risks and preferences

atients • GPs must be welltrained inanticoagulation (NOACsas well as VKAs)

• Specialist department to beavailable to evaluate the patient atthe GP’s request

• Good relationship/network neededbetween hospitaldepartments and localcommunity physicians

• GP may rely on the specialist forhis/her own education – onlywell-educated GPs should beprescribers of NOACs

nist oral anticoagulant; VKA, vitamin K antagonist.

Figure 1 Patient flow and educational pathways in a model of long-term management of patients receiving NOACs. AF, atrial fibrillation; GP,general practitioner; HCP, healthcare professional; NOAC, non-vitamin K antagonist oral anticoagulant; VTE, venous thromboembolism.


keeping in touch with the patient and controlling follow-up (e.g. by telephone with the patient or GP). In this case,the clinic functions as a structured coordinator of care,even when it is delivered by others.

Nurse assistedThe cardiologist/haematologist at the anticoagulationclinic may be the primary care coordinator [5] whomanages the workflow and be the point of contact forthe patient (Figure 1). This system requires a lower levelof nurse expertise, although nurses can still assumemuch of the daily organisation and patient education.On the other hand, this model is time- and resource-heavy for the responsible physicians. Anticoagulationclinics in Italy, and some in Spain, use this system.

General practitioner modelIn systems lacking dedicated anticoagulation clinics, theGP is responsible for routine follow-up of patients takingNOACs (Figure 1). The GP can refer to the hospital con-sultant in the event of problems that require specialistintervention, such as a thromboembolic event or majorbleeding episode. GP-based follow-up can ease thedemands on hospital resources, and the GP may evenperform home visits for elderly patients or others forwhom office visits are difficult. Many GPs are currentlyundereducated about NOAC therapy and may considerthat the lack of routine coagulation monitoring means

that no follow-up is needed, or may be unwilling to allo-cate time and resources to educate and evaluate patientsreceiving NOACs. A good relationship and networkingopportunities between cardiology/haematology depart-ments and GPs is, therefore, vital.GPs should maintain contact with their patients at a

frequency advised by the initial prescriber based on thepatient’s risk profile and preferences. The GP may relyon the hospital cardiology/haematology department fortheir own education on NOAC therapy. In some coun-tries (such as Belgium, Finland, Germany, Portugal andSpain), GPs are allowed to initiate anticoagulant treat-ment. This may not be ideal unless they have specialistknowledge of NOACs, but even so, the mechanisms forquality control remain uncertain.

Important considerations for incorporation of non-vitamin K antagonist oral anticoagulants into all modelsPatients receiving NOACs may not need to interact withan HCP as often as those taking VKAs, but nevertheless,contact frequency should be based on individual medicalneeds. Extensive contact may not be required for themajority of patients who are in generally good health,have a limited potential for relevant drug interactionsand have a low or moderate risk of bleeding, providedthat they receive appropriate education and are expectedor known to have good treatment adherence. In patientswith a high risk of bleeding, anaemia, thrombocytopenia


or declining renal or hepatic function, or likely orsuspected suboptimal adherence, the responsible HCPshould see the patient directly on a regular basis [6]. Tokeep track of relevant information and remind patientsof important aspects of their therapy, the EuropeanHeart Rhythm Association (EHRA) has proposed auniversal NOAC patient anticoagulation card (Figure 2;printable version in supplementary material) [2], andcompanies have produced drug-specific versions(example in Figure 3). Information on the patient’s base-line (non-anticoagulated) readings for relevant generic

Figure 2 Adapted European Heart Rhythm Association (EHRA) proposal foantagonist oral anticoagulants. Pharmacy has been included in the list of vanticoagulation) generic coagulation assays and the date of the test have bprintable version of this card is available as a supplementary file. Adapted fpractitioner; CrCl, creatinine clearance; NOAC, non-vitamin K antagonist ora

or specific coagulation assays (e.g. activated partialthromboplastin time or dilute thrombin time [Hemoclot®]for dabigatran, and prothrombin time or anti-Factor Xaassays for direct Factor Xa inhibitors), and the date onwhich these tests were performed, could also be added tothe card or the electronic laboratory file of the patient.This is important if these tests are used to check for thepresence or absence of a NOAC effect in an emergency.For stable patients with AF receiving VKAs, the

European Society of Cardiology (ESC) considers a TTR of70% to constitute good management [7]. However, in real

r a universal anticoagulation card for patients receiving non-vitamin Kisit sites (page 2), and the results of baseline (prior to initiatingeen added to the emergency information (page 4), as indicated. Arom Heidbuchel et al. Europace 2013;15:625–51 [2]. GP, generall anticoagulant.

Figure 3 Example of a drug-specific patient anticoagulation card for rivaroxaban. Copyright Bayer HealthCare, reproduced with permission.


life, an INR range of 2.0–3.0 is often not attained [8,9],and in some randomised clinical studies in which theINR was monitored rigorously, the mean TTR was only55–65% [10-13]. HCPs should consider whether theirpatient really is well managed on a VKA; considering thebroad indications for NOAC therapy, it is likely that mostpatients are candidates for switching to NOACs, providedthey do not have contraindications. For a patient withpoor adherence, the HCP responsible may feel more com-fortable with regular monitoring, but constant dose ad-justments due to irregular INRs may actually contributeto the problem, and switching to a fixed-dose NOAC maysimplify treatment and improve adherence. The possiblepsychological impact on patients caused by the loss ofmonitoring visits (e.g. social contact for elderly patientsand reassurance that their medication is working) may beovercome by regular visits for other necessary tests or anoverall health check. However, the decision to switch ornot should be taken by the HCP and the patient in tan-dem, based on both being informed about the treatmentchoices available.To harmonise procedures, a centralised database of all

NOAC- and VKA-anticoagulated patients should be

created and made available to all relevant HCPs withinthe local system. This database should provide informa-tion on diagnosis, drug and dose regimen and anticipatedduration of treatment, alongside agreed standard manage-ment protocols. Data on INR measurements and TTRwould also be useful to inform decisions about switching.The information within such a system could be controlledby the relevant overseeing specialist department.

Opinion statements

� Where the healthcare structure allows, long-termmanagement of patients receiving anticoagulationcan be efficiently handled by a centralised(anticoagulation) clinic. As an alternative, GPs orspecialist nurses with appropriate training andexperience can take responsibility, with specialistsupport and supervision

� Initiation of NOAC treatment should be restrictedto GPs who receive specialist training and shouldotherwise be avoided

� Practical incorporation of NOACs into healthcaresystems must take into account national, regional


and local variations in practice as well as availableresources; anticoagulation clinics may be best suitedto handle routine medical and educational tasks andnetworking between specialties

� Problem cases and scenarios need to be referred toan expert facility run by coagulation specialists

Flow of education to support non-vitamin K antagonistoral anticoagulant implementation: needs, responsibilitiesand support materialsPatients receiving anticoagulants have contact with dif-ferent HCPs (including, but not limited to, those speci-fied in this document) at different time points duringtheir treatment. Each of these HCPs has a responsibilityto educate and/or reinforce patient education. HCPsmust have the appropriate level of knowledge and beable to communicate it effectively in terms that thepatient can understand. This requires that informationmigrates from clinical consultants (usually the initialprescribers) through the layers of the healthcare networkto reach the patient. This can occur through regularHCP education meetings in the anticoagulation clinic,adoption of national guidelines, support from patientanticoagulation associations and provision of publicinformation.

The initial prescriberThe clinical diagnosis of a thromboembolic conditionand the initial decision to prescribe anticoagulant treat-ment is best done by a specialist (e.g. a cardiologist,neurologist, geriatrician or haematologist) rather than bya GP or other physician without training or experienceof anticoagulant treatment. Firstly, specialists have ac-cess to the latest clinical data and insights and, therefore,have the expertise to make the initial prescribing deci-sion (and plan the length of treatment); secondly, theycan provide patient education and disseminate relevantinformation to other HCPs involved in downstream care(Table 2, Figure 1); and thirdly, they also gather centra-lised data on complications and their management,which are useful for the wider healthcare community.Ideally, education should be based on national guidelineswritten by representatives of those disciplines that aremost likely to encounter emergency situations involvingNOACs.After discharge, the initial prescriber often ceases to

have primary responsibility for patient follow-up butshould remain available to consult in the case of difficul-ties. The responsible HCP should be aware of the sce-narios, such as trauma and acute inflammatory andgastrointestinal diseases (poor absorption or vomiting),that should trigger a specialist consultation. In countriessuch as Italy, the initial prescriber, in most cases thehaematologist working in the anticoagulation clinic, is

also responsible for follow-up of patients receivingNOACs.Many cases of VTE or AF are diagnosed in the emer-

gency room. Patients entering the system via this routemay never actually be admitted to an inpatient depart-ment, but instead may be discharged with a prescriptionfor an oral anticoagulant. It would be preferable forthese patients to transition first via an anticoagulationclinic.

Opinion statements

� The initial prescriber should preferably be anexperienced specialist

� The initial prescriber is also responsible for initialpatient education and for educating other HCPsabout thrombotic conditions, anticoagulanttreatment and duration, and risk scenarios

� The initial prescriber may or may not have primaryresponsibility for further follow-up, but should beavailable for consultation and to gather informationon complications

Anticoagulation clinic nurseIt is the opinion of this writing group that the follow-upand continuing education of all patients receiving long-term NOAC or VKA anticoagulation in the communityis best performed by a specialist anticoagulation clinic,headed either by a specialist nurse(s) (nurse coordinated)or by a cardiologist/haematologist supported by nurses(nurse assisted). In the NOAC era, in patients treatedfor VTE, an ideal time for a first follow-up visit may beat the point that patients transition from parenteral todabigatran therapy or from the more intensive doses ofapixaban (after 7 days of treatment) or rivaroxaban (after21 days). During follow-up, the role of the anticoagula-tion nurse becomes wider than basic INR monitoringand includes other tests, such as calculating creatinineclearance, taking a holistic view of patient care and pro-viding education to patients and other HCPs (Table 2,Figure 1). This education includes knowledge about un-stable situations, such as acute illness, starting or stop-ping co-medications, trauma and management of majorand even minor (e.g. tooth extraction) surgery. A singleclinic is likely to be responsible for patients receivingNOACs and those receiving VKAs and must address thedifferent requirements of all patients.Evidence suggests that patients with AF have a poor

level of education about their disease, its severity and itstreatment [14], and that improving their knowledge iscrucial to the success of anticoagulant therapy [15,16].The University of Maastricht in the Netherlands has pio-neered a software-based approach to nurse-led coordin-ation of care. Patient data are entered into the software

Table 2 Educational needs and responsibilities for healthcare professionals responsible for patients receiving non-vitamin K antagonist oral anticoagulant therapy

The initial prescriber The anticoagulation clinic nurse The general practitioner The pharmacist The patient

Needs Needs Educational needs Educational needs Educational needs

• Access to the latest data and expertopinion via colleagues, academicliterature, and internal and externalmeetings and congresses

• To receive regular updates oncurrent best practice from thecardiology/haematologydepartment (as detailed above);nurse coordinators also needaccess to academic literature andthe chance to attend nationalcoagulation nursing meetings

• Ongoing updates (6-monthly in thefirst 1.5 years and annual thereafter)from specialists on evolvingtreatment options for VTE/AF; thesecould be provided online or byemail, or via an in-hospital trainingday, and tied to professionaldevelopment

• Ongoing (annual or ad hoc)updates from anticoagulation clinicnurses and/or GPs regarding theloco-regional organisation ofstructured anticoagulant care(who is responsible for what, whichlines of communication are available,etc.) and questions to ask the patientwhen filling a prescription(adherence – check blister pack)

• Basic knowledge of theircondition, treatment and theimportance of adherence

• Simple flowcharts outliningrecommended indications,dose adjustment andfollow-up

• Clear and concise guides on howto perform follow-up actions(SOPs), including clear instructionson how and when to contact theirsupervising physician, GPs, otherHCPs and patients themselvesthroughout follow-up

– GPs are likely to be familiar withVKAs but less so with NOACs,and they will need to receiveeducation on the differencesbetween NOACs and otheragents, and important aspectsof ongoing care of patientsreceiving NOACs, includingpatient education

Educational responsibilities

• Awareness of what to do if anadverse event occurs, andability to differentiate betweenminor and major events

Responsibilities

• Software to assist in these tasks

– What to do in different scenarios;what constitutes an emergency/which issues should be referredvia a routine appointment to thecoagulation clinic/specialistdepartment

• To patients:

• Regular contact with an HCPresponsible for follow-up at afrequency dependent onindividual risk assessment

• Provide education to other hospitaldepartments and community GPson treatment options for VTE/AF(regular updates)

• To the patient (at each visit)

– Support with posters/checklists/desk note reminder cards,references to online sources ofinformation

– Ensure that appropriatequestions are asked of thepatient when they collect theirmedication, based on theindication for use and the typeof patient (elderly, with renalimpairment, etc.) andmedication (NOAC, VKA, etc.)

• Materials and tools to assistwith ongoing education andtherapeutic adherence– Hospital meetings, including

specific training days for GPs ifpracticable (could link toprofessional development) Responsibilities

– Provide patient leaflets andchecklists to GP offices

– Ensure that patients are notprescribed contraindicatedco-medications


– Support with posters, checklists,desk note reminder cards thatHCPs can take away and use;provide links to online sourcesof information

– Continual reinforcement of keyeducational messages about theanticoagulant they are taking(NOAC or VKA) at each visit(frequency of visits different foreach patient based on healthand risk factors for thrombosis/bleeding as discussed above)


– Add follow-up information tothe patient’s NOAC card

• To take a proactive role in theirown treatment

• Provide education and training toanticoagulation clinic nurses (at least6-monthly updates)

– Informal assessment of patientunderstanding (e.g. can theyname their condition and explainwhy they have to take ananticoagulant, what the dose is,what signs of bleeding theyshould be looking out for, etc.?)

• To the patient

• Notify the coagulation clinic and/orGP of any concerns about thepatient

– This could take the format of asession co-chaired by a seniornurse from the clinic or a GPexperienced in NOAC use plusthe specialist to give two differentperspectives (practical andscientific)

– Support with printed leafletsand checklists, educationalposters in the office, etc.

– In the absence of ananticoagulation clinic: follow-upwith patients receivinganticoagulants (NOACs or other)at regular intervals (frequencydependent on risk) to remindthem of the important aspects oftheir medication and what to doif they are concerned about anaspect of their health relating totheir treatment

– Topics

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Table 2 Educational needs and responsibilities for healthcare professionals responsible for patients receiving non-vitamin K antagonist oral anticoagulant therapy(Continued)

• To GPs – As an adjunct to ananticoagulation clinic: take theopportunity at any patient visitfor any reason other thananticoagulation to remind themof the important pointsregarding their anticoagulanttreatment (adherence – checkblister pack to make sure alldoses taken)

• Which patients are suitable forNOACs (e.g. stable condition,good renal function,knowledgeable about treatment,having a carer in charge ofmedication) vs which are not(or less) suitable (e.g. confused,elderly, likely to be non-compliant, with contraindications)– support with case studies

– Periodical (3- to 6-monthly?)contact to check on individualpatients

• To pharmacists (ad hoccommunication):

• Fundamental aspects of eachNOAC vs heparin/VKAs (e.g.predictable pharmacology,drug interactions, etc.)

• Those requiring only infrequentvisits to the anticoagulationclinic

– Pass on educational informationon questions to ask the patientbefore issuing a repeatprescription (this interactioncould be mediated by thepatient NOAC card)

• Practical guides (e.g. based onEHRA advice) on topics such astaking a full bleeding history,calculating risk score(CHA2DS2-VASc, HAS-BLED,etc.),switching, appropriatelaboratory tests and how tointerpret them

• Follow-up on patients whohave missed scheduled clinicvisits

– Remind about importantaspects of pharmacology, druginteractions, etc.

• ‘What to do if…’ guidance,including identification ofpotential emergency scenarios(serious bleeding event, e.g.head injury, major surgeryrequired) vs minor problems(e.g. nose bleed, minorsurgical procedure) andwhom to contact in each case

• Receive information onchanges of patient status thatmay lead to an intensificationof follow-up (e.g. anaemia,thrombocytopenia, new con-comitant medication that mayincrease the risk of bleeding,exclusion of hypertension)

– Send posters/checklists;encourage pharmacist to get incontact if they have concerns

• Latest information on patientadherence and how it can beimproved; which practicaltools they can use and offerto patients

– Reminders about key aspects ofanticoagulants (NOAC and VKA),e.g. pharmacology, druginteractions, etc., and warningsigns to look out for in patientsreceiving them (e.g. bleeding,vomiting, bruising)

– Smartphone/tablet apps andother online tools could beused in case physical meetingscannot be held


• Education of the patient abouttheir condition and how it will bemanaged

• To the pharmacist

– First discussion at point of initialprescription

– Periodical (annual?) contact toremind pharmacists aboutquestions they should ask thepatient when filling a repeatprescription for anyanticoagulant (e.g. ask thepatient to present his/her NOACcard; the pharmacist could alsocomplete a line on the follow-uppage of the NOAC card,indicating how many drug doseshave been delivered or any otherimportant information), and,specifically for NOAC vs LMWH/VKA, whom to contact in case ofconcerns

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Table 2 Educational needs and responsibilities for healthcare professionals responsible for patients receiving non-vitamin K antagonist oral anticoagulant therapy(Continued)

• Emphasise patientunderstanding of theircondition and the drug theyare taking (NOAC or VKA), andthe importance of correctadherence to the prescribedregimen – use language thatthe patient can understand

– Key information onpharmacology and druginteractions

• Support with printed leafletsand checklists that the patientcan take home – these caninclude QR codes/online links,but should be physical copiesso that patients can keepthem in a convenient placeand have constant accessto them


– Second discussion to reinforcemessages before discharge

• Warning signs to look out for(e.g. anaemia,thrombocytopenia,hypertension, bleeding,vomiting, bruising)

• Importance of keepingfollow-up appointments withcoagulation clinic/GP

• Why adherence is important

– Support with printed leaflets andchecklists as above

– Provision of NOAC card to thepatient

AF, atrial fibrillation; EHRA, European Heart Rhythm Association; GP, general practitioner; LMWH, low molecular weight heparin; NOAC, non-vitamin K antagonist oral anticoagulant; QR, quick response; SOP, standardoperating procedure; VKA, vitamin K antagonist; VTE, venous thromboembolism.

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Figure 4 Basic educational checklist for healthcare professionals when managing patients starting non-vitamin K antagonist oral anticoagulanttherapy. NOAC, non-vitamin K antagonist oral anticoagulant; VKA, vitamin K antagonist.


program to generate a risk score and an advised courseof therapy, based on guidelines. The nurse-led approach,overseen by a supervising cardiologist, was shown to re-duce cardiovascular hospitalisations and deaths [17], andto correlate with an improvement in patients’ AF-relatedknowledge over time [18], compared with standardcardiologist-led care. Centres could consider developingtheir own software or adapting existing programs to fittheir protocols. A sample checklist for patient educationis shown in Figure 4. Materials such as booklets, vali-dated websites, smartphone apps and short videos thatprovide important information to patients in an access-ible manner are extremely useful.

Opinion statements

� A specialist coagulation nurse is well placed totake overall responsibility for patient educationand to coordinate follow-up with other HCPs

� Coagulation nurses require specialist education,examples of best practice, and access to simpleand effective tools to assist with patienteducation

� Specific software tools that help the nurse withsystematic assessment of the patient andworkflow guidance should be developed andshared


The general practitionerA GP is often involved in the initial diagnosis of a thrombo-embolic disorder but should be encouraged to swiftly referall suspected cases to the specialist hospital department.This is especially important in patients with suspected pul-monary embolism and those with renal or hepatic impair-ment. It is possible that GPs consider they have aresponsibility to prescribe anticoagulation therapy. How-ever, if an established care network with rapid back-up froma specialist centre is available, they may be more willing torefer the prescribing decision to a specialist, which will im-prove overall patient care.The GP may be the most frequent point of contact for a

patient receiving a NOAC after discharge and can take re-sponsibility for follow-up of patients deemed at low risk.In the absence of an anticoagulation clinic, the role of GPsin patient education assumes greater importance and theywill have the main responsibility for long-term patientfollow-up (Table 2, Figure 1). Hospital departments andanticoagulation clinics should proactively engage with GPsand provide them with education and training on themanagement of patients taking NOACs.A GP education programme for NOACs should have a

practical focus and include obligatory training sessionswith real-life problems/clinical cases that the GPs cansubmit for discussion, as well as simple guidance and algo-rithms. GPs should know whom to contact in the specialistcentre in case of questions or concerns about specificpatients.

Opinion statements

� In the absence of an anticoagulation clinic, GPsare likely to take responsibility for themanagement and ongoing education of patientsreceiving NOACs

� Even when a clinic exists, patients considered at lowrisk of bleeding may not be required to attendregularly; in this case, the GP may take responsibilityfor follow-up

� GPs should reinforce educational messagesregarding anticoagulation with patients at everyopportunity, even if the patient is visiting foranother reason

� Hospital departments or anticoagulation clinicsshould proactively engage with GPs and providethem with education on NOACs

The pharmacistPharmacists have an important (and so far underestimatedand underused) role in the monitoring of patient adher-ence to NOAC treatment. In particular, they can check

that patients understand the dose and regimen, as wellas reinforcing general educational messages (Table 2,Figure 1). Hospital departments or anticoagulation clinicsshould proactively engage with pharmacists to ensure theycan effectively participate in the management of patientsreceiving anticoagulants. Some countries have nationaldatabases that support the pharmacist in evaluatingpatient adherence. Further research into the developmentof such systems is warranted.

Opinion statements

� Pharmacists are important in checking patientadherence

� Hospital departments or anticoagulation clinicsshould proactively engage with pharmacists andprovide them with education on NOACs, includingdrug interactions

The patientIn the NOAC era, with less regimented HCP contact,patients must increasingly take responsibility for theirown understanding of their condition and treatment.Primarily, they need to have a basic knowledge of whythey are being treated, how their treatment works, theimportance of adherence and what to do if an adverseevent occurs. Differentiation between a minor eventthat can be self-managed (e.g. a nose bleed) and one thatshould prompt them to contact an HCP or go to theemergency department is required. Even if a patient isnot regularly attending a GP or anticoagulation clinic,the responsible HCP should keep in regular contact, e.g.with a brief telephone call. Patients should be able to askquestions, and family members should be included if ap-propriate, such as in the case of patients with diminishedself-responsibility. Materials can be provided to remindpatients of important information, and these should betailored to the individual patient. For example, a calen-dar can help to remind patients to take their treatment,but some patients may find a pill box with days of theweek, or a reminder on their mobile telephone, to bemore effective. Several organisations also offer onlinepatient support websites, including the EHRA (http://www.afibmatters.org/), the AF Association in the UK(http://www.atrialfibrillation.org.uk/) and Anticoagula-tion Europe (http://www.anticoagulationeurope.org/).Ideally, some of this content could be translated intolocal languages. Patients must be aware of the import-ance of their patient card (Figure 2).

Opinion statements

� Therapy is likely to be enhanced by proactivelyinvolving the patient in the management of their


condition; this requires that the appropriate level ofinformation is given using appropriate language, andconfirmation that the provided information has beenunderstood by the patient

� Educational messages should be reinforced with allpatients by all HCPs at every opportunity

ConclusionsIncorporation of NOACs into healthcare systems musttake account of national, regional and local variations,and it is recognised that some systems may not be ableto incorporate all the suggestions in this document. Theinitial prescriber of a NOAC should preferably be a spe-cialist, who may handle problem and emergency cases aswell as proactively engage with all downstream HCPs toensure that they participate effectively in patient man-agement and reinforce patient education. The initial pre-scriber has to consider involvement in the educationof other HCPs and coordination of patient follow-up.The long-term care of patients may be managed throughan anticoagulation clinic and/or specialist nurses, underguidance and supervision. Coordination by GPs whoare trained in NOAC use is an alternative. GPs andpharmacists should be involved in the follow-up path-ways that are coordinated by anticoagulation clinics orspecialists. Last but not least, the patient should be wellinformed about their condition, treatment, possible risksituations and the organisation of follow-up care. Only apatient with insight into their condition will be fullyadherent to therapy and follow-up and have a successfuloutcome.

Competing interestsWe declare the following conflicts of interest: Hein Heidbuchel wasCoordinating Clinical Investigator for the Biotronik-sponsored EuroEcostudy on health economics of remote device monitoring; has been a memberof the scientific advisory boards and/or lecturer for Siemens Medical Solutions,Boehringer Ingelheim, Bayer, Bristol-Myers Squibb, Pfizer, Daiichi Sankyo,Cardiome and Sanofi-Aventis; received unconditional research grants throughthe University of Leuven from St Jude Medical, Medtronic, Biotronik and BostonScientific Inc.; and received contract research funding through the University ofLeuven from Siemens Medical Solutions. Vanessa Roldán has receivedconsultancy and lecture fees from Bayer, Bristol-Myers Squibb/Pfizer, BoehringerIngelheim and Daiichi Sankyo. Riitta Lassila has received consultancy fees fromAstraZeneca, Boehringer Ingelheim and Bayer. Manuel Campos has receivedconsultancy fees from Bayer and Bristol-Myers Squibb/Pfizer. Dana Berti, LienDesteghe, António Robalo Nunes, Ana Parente Freixo and Vincenzo Toschi haveno other conflicts of interest to declare. All authors participated in meetingsrelated to the preparation of this manuscript, organised by Bayer HealthCarePharmaceuticals.

Authors’ contributionsThe outputs of the initial working group meeting were used to create thefirst draft of the manuscript, under the responsibility of the lead author.Comments and revisions were subsequently provided by the members ofthe working group listed as co-authors. All authors read and approved thefinal manuscript.

AcknowledgementsThe authors wish to acknowledge Sue Rhodes (VTE Specialist Nurse andJoint Anti-Coagulant Lead, Great Western Hospital, Swindon, UK) for her

assistance with the development of this manuscript. Medical writingassistance from Stephen Purver was provided with funding from BayerHealthCare Pharmaceuticals.

Author details1Hasselt University and Heart Center, Jessa Hospital, Stadsomvaart 11, Hasselt3500, Belgium. 2Department of Cardiovascular Medicine, University HospitalGasthuisberg, University of Leuven, Leuven, Belgium. 3Department ofHaematology, Thrombosis and Haemostasis, Unit- Centro Hospitalar do Porto,Porto, Portugal. 4Centre of Thrombosis and Haemostasis, Department ofTransfusion Medicine, São João University Hospital, Porto, Portugal.5Immunohaemotherapy Service, Centro Hospitalar Lisboa Norte and Hospitaldo SAMS-SBSI, Lisbon, Portugal. 6Haematology and Medical Oncology Unit,Hospital Universitario Morales Meseguer, University of Murcia, Murcia, Spain.7Department of Haematology and Blood Transfusion, Thrombosis Centre,San Carlo Borromeo Hospital, Milan, Italy. 8Department of Haematology,Division of Coagulation Disorders, Cancer Centre, Helsinki University CentralHospital, Helsinki, Finland.

Received: 13 January 2015 Accepted: 10 March 2015

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