Original Article

Patient Safety in Primary Care: Are GeneralPractice Nurses the Answer to ImprovingWarfarin Safety? An Australian Perspective

Judy Lowthian, MPH, BAppSc(SpPath), LMusA, Catherine Joyce, BA(Hons), MPsych, PhD, Basia Diug, BBiomed(Hons), Michael Dooley,BPharm, Grad.Dip(Hospital Pharmacy)

Primary health care plays a pivotal role in health sys-tems. The ageing population and mounting preva-

lence of chronic disease will place increasing demandson primary care. Currently, 30% of general practice pa-tients in Australia are aged 65 and over (Australian In-stitute of Health and Welfare 2009) and almost half ofgeneral practice consultations involve a chronic condition(Knox et al. 2008). Older patients with chronic condi-tions often have multiple co-morbidities and medications,requiring general practitioners (GPs) to coordinate andcase manage their care. Managing such complex patientsposes challenges for GPs who are often time poor (Jacob-sen et al. 2003), which results in an increasing relianceon shared care and patient self-management. This poten-tially increases the risk of patient safety incidents suchas medication-related adverse events. Patient safety, whichrefers to “the reduction of risk of unnecessary harm associ-ated with health care to an acceptable minimum,” (Runci-man et al, 2009, p. 19) is a fundamental principle of healthcare influenced by a number of interrelated factors, relatedto individual patients, health professionals, policies, guide-lines, and regulatory procedures. In this paper, we presentthe example of warfarin management to illustrate safetyand quality issues in the Australian primary care setting.

WARFARIN: A HIGH-RISK MEDICATION

Warfarin is a high-risk medication, and is one of the mostcommon causes of medication-related adverse events, such

Judy Lowthian, Research Fellow, Monash University, Melbourne, Australia; Catherine Joyce, Senior Research Fellow, Monash University, Melbourne, Australia; Basia Diug,Doctoral Scholar, Monash University, Melbourne, Australia; Michael Dooley, Professor of Clinical Pharmacy, Director of Pharmacy, Alfred Health and Professor of ClinicalPharmacy, Co-director, Centre for Medicine Use and Safety, Monash Institute of Pharmaceutical Sciences, Department of Pharmacy Practice, Faculty of Pharmacy andPharmaceutical Sciences, Monash University, Melbourne, Australia.

Worldviews on Evidence-Based Nursing, 2011; 25–29. ©2010 Sigma Theta Tau International

Address correspondence to Judy Lowthian, Monash University, Level 6, 99 Commercial Road, Melbourne 3004, Australia; Judy.Lowthan@med.monash.edu.au

Accepted 5 October 2010Copyright ©2010 Sigma Theta Tau Internationaldoi: 10.1111/j.1741-6787.2010.00211.x

as thromboembolism and serious bleeding (Runcimanet al. 2003). It is therefore the subject of medicationsafety alerts in several Australian states. Major haemor-rhage occurs in 10%–16% of patients with atrial fibrilla-tion (AF) annually (Wysowski et al. 2007) with minorbleeding occurring in up to 16% of patients (Connollyet al. 1991; Schulman 2003). Such events impact on a pa-tient’s morbidity, functional independence, and quality oflife.

Warfarin is primarily used to treat AF and is a majorcause of morbidity. AF affects 9% of patients aged over80 years (Ninio 2000; Go et al. 2001), and occurs at a rateof 1.3 per 100 encounters in general practice (AustralianInstitute of Health and Welfare 2009). Embolic stroke isthe foremost complication that is substantially reduced byanticoagulation (Hart et al. 2007).

Prescription of warfarin has been rising by 9% per an-num (Baker et al. 2004). With the ageing of the populationthis is likely to continue, given that 30% of patients com-mencing warfarin are aged over 70 years (Palareti et al.2000).

RISKS TO PATIENTS IN THE PRIMARYCARE SETTING

The majority of AF patients are managed in the primarycare setting. Throughout areas of the United Kingdom(UK), Canada, and Australia, care typically involves ashared model between specialists, GPs, and a pathology

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service; with clinical responsibility devolved largely to theGP (Rodgers et al. 1997; Ceresne & Upshur 2002; Murray& Greaves 2003; Lowthian et al. 2009). In this model, thespecialist often recommends prescription of warfarin tothe GP, who refers the patient to a pathology provider formonitoring and dose adjustment, with the patient return-ing to the GP for periodic review and prescription renewal.Other shared models include point-of-care (POC) testingby pharmacists or anticoagulant clinics based within out-patient clinics or general practices.

There are a number of identified issues arising from thisshared model that impact on patient safety. These includea lack of clarity regarding the division of responsibilityfor review of patient education; review of psychosocialfactors including cognition and mood, medication man-agement capabilities, and adherence; review of concomi-tant medications including prescription, over-the-counter,complementary, and alternative medicines; supervision ofpatient attendance for anticoagulation monitoring; andtimely communication and dosage adjustment (Makehamet al. 2008; Lowthian et al. 2009). Patient factors, suchas compliance, medication knowledge, cognitive function,and social support mechanisms, along with health care fac-tors play a major role in determining the safety of warfarin(Lowthian et al. 2009).

Although treatments delivered in primary care carryrisks to patient safety just as those in acute settings do, littleis known about the epidemiology of harm in primary care(Wilson & Sheikh 2002; Australian Commission on Safetyand Quality in HealthCare 2010). There are general prac-tice standards in Australia, which include medicine man-agement (Royal Australian College of General Practitioners2007), similar to the UK (General Medical Council 2006),but compliance is not mandatory. Australian general prac-tices must comply in order to be eligible for governmentincentive payments but only two thirds of general prac-tices are currently registered for these payments (PrimaryHealth Care Research and Information Service 2009a). Itis not known whether registered practices provide safercare than those not registered. The majority of reportederrors in primary care are administrative errors, involvingprescriptions, communication, appointments, and equip-ment (Rubin et al. 2003; Elder et al. 2004). The Threatsto Australian Patient Safety study, estimated an incidenceof two errors per 1,000 patients seen by GPs (Makehamet al. 2006). Approximately, 7% of these were warfarinerrors (Makeham et al. 2008).

The increasing complexity of patient care in the pri-mary care setting demands the identification of potentialstrategies to mitigate the risk associated with high-riskmedications such as warfarin.

THE ROLE OF GENERAL PRACTICENURSES

General Practice Nurses (GPNs) are now commonplace inAustralian general practice, and are developing an impor-tant role in chronic disease management including man-aging medicines. GPNs are registered or enrolled nursesemployed by general practices. There is now one GPN forevery 2.7 GPs in Australia (Primary Health Care Researchand Information Service 2009b). Their role includes ex-tending the range of services provided by a practice aswell as substituting for the GP in the provision of sometasks (Parker et al. 2009). Some specific tasks are sub-sidised (e.g., immunisation, wound care, pap smears, andhealth assessments) (Halcomb et al. 2008), and increas-ingly GPNs play an important role in the management ofchronic conditions such as AF. Blood tests such as In-ternational Normalised Ratio (INR) tests are now one ofmore common non-subsidised tasks undertaken (Joyce &Piterman 2010). More than one in 10 GPN-patient encoun-ters involve a cardiovascular condition, and GPNs performblood tests such as the INR in 38% of these (Joyce &Piterman 2010). Almost 70% of all blood tests performedby GPNs are for patients with cardiovascular conditions(Joyce & Piterman 2010).

The role of Australian GPNs is similar to their rolein the UK and New Zealand, although less flexible. Inthe UK, nurses have a broad, autonomous role, per-forming immunisations, health promotion, providing tele-phone advice, and managing patients with chronic disease(Sibbald et al. 2006; Redsell & Cheater 2008). In Australia,the current GPN role is more task oriented, strongly influ-enced by funding models, which subsidise particular tasks,as described above (Joyce & Piterman 2010).

GPNs’ involvement in warfarin management offers bothopportunities and challenges. Potential benefits includetask delegation by the GP (and hence improved efficiency);convenience and access for patients; and improved educa-tion about the patient’s underlying conditions and medica-tion management issues including adherence. These bene-fits are confirmed by a systematic review reporting modestinternational evidence that GPNs achieve similar healthoutcomes to GPs, with GPNs particularly effective in en-hancing patient knowledge and compliance (Keleher et al.2009). In addition, in the UK and Australia, it has beenshown that GPNs and community pharmacists can mon-itor patients INR levels with POC monitoring with mini-mal training (Fitzmaurice et al. 1998; 2000; Jackson et al.2005).

Generalised competency standards have been developedto provide a framework for GPNs (Australian Nursing

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TABLE 1Recommended changes to improve safety of warfarin management incorporating GPNs

Monitoring� Monitoring of patient attendance for routine INRs� Undertaking regular reviews of patient medications including over-the-counter medicines with the patient and pharmacist� Reviewing psychosocial status and medication management capabilities on a regular basis to minimise potential harm from

under/over compliance

Communication and record-keeping� Checking that laboratory or POC INRs are recorded in the patient record and in the patient’s personal diary� Alerting the GP of sub and supra therapeutic INRs� Communicating INR blood results and warfarin dosage changes to the patient in a timely manner� Establishing an “alert system” for the GP, to ensure any changes in health or medication status trigger review of anticoagulation status

Patient education� Conducting regular review of patient comprehension of warfarin-related issues

Key:INRs = International Normalised Ratio blood tests.(∗normal therapeutic range for patients with atrial fibrillation is 2.0–3.0 & patients with mechanical valve replacement 2.5–3.5).POC = Point of Care tests.GP = General Practitioner.

Federation 2005), however ongoing training will be re-quired to ensure GPNs are adequately equipped to em-brace the opportunities and challenges of working in gen-eral practice and primary health care settings (Redsell &Cheater 2008; Parker et al. 2010).

We believe GPNs have a role to play in the managementof patients on warfarin with: monitoring of adherence,medication changes, psychosocial status and medicationmanagement capabilities; and maintenance, review, andcommunication of these with the treating GP. Potentialroles for GPNs in warfarin management are highlighted inTable 1.

A SAFE AND EFFECTIVE PRIMARY CARESECTOR

The risks to warfarin patients that we have identified areindicative of risks to patients generally in the primary caresector. A number of changes and strategies may assist toimprove patient safety, including a more structured ap-proach to team-delivered care involving GPs, GPNs, andcommunity pharmacists (Ackermann et al. 2010). In ad-dition to direct provision of care to individual patients,other strategies could include routine data collection oferrors, patient outcomes and quality, and safety indica-tors (Makeham et al. 2008), patient and process-focussedteam meetings, clear role delineation, and development ofproactive communication protocols, with education andtraining for GPNs in medication management.

Patient safety is an evolving priority for Australia (Aus-tralian Commission on Safety and Quality in HealthCare2010). In the hospital setting, reporting of incidents andadverse events monitoring is mandated and linked to fund-

ing of Australian public hospitals (State Government ofVictoria 2010). Similar reporting measures are used inparts of Europe and the United States (dePouvourville1997; Centers for Medicare & Medicaid Services 2010).It is a challenge to develop a culture of patient safetyin primary care with progress likely to be slow and frag-mented unless supported by a systematic approach, suchas the UK Quality Outcomes Framework (Departmentof Health 2009). In the first instance, GPs and GPNscould partner in the recording and monitoring of errorsrelating to clinical care, prescriptions, communication,equipment, and appointments, as routinely occurs in theacute setting. GPNs already play a pivotal role in clinicalorganisation and practice management including monitor-ing of quality and safety (Pascoe et al. 2005; Pearce et al.2009). Implementation of a formal, systematic approachto team-delivered care for warfarin management would bea logical extension, as outlined in Table 1.

CONCLUSIONS

The challenges of managing warfarin patients provide im-portant lessons for improving management of chronicand complex conditions in the primary-care setting. Morestructured formal processes to ensure the safety, quality,and effectiveness of patient care are needed. GPNs can as-sist in providing best practice care to such patients andtheir role should be supported and enhanced.

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