Journal of Clinical Pharmacy and Therapeutics (2005) 30, 345–353

ORIGINAL ARTICLE

Improving the outcomes of anticoagulation in rural

Australia: an evaluation of pharmacist-assisted
monitoring of warfarin therapy
S. L. Jackson* BPharm PhD Scholar , G. M. Peterson* MBA PhD FSHP FACPP FAIPM ,
L. R. Bereznicki* BPharm PhD Scholar , G. M. Misan
BPharm PhD , D. M. L. Jupe BM
BCh MRCP MRCPath FRCPA and J. H. Vial§ MD FRACP
*School of Pharmacy, University of Tasmania, Hobart, Tas.,
South Australian Centre for Rural and Remote
Health, Whyalla, SA, Department of Haematology, Royal Hobart Hospital, Hobart, Tas. and §School of
Medicine, University of Tasmania, Hobart, Tas., Australia

P < 0Æ0001). A total of 398 additional pharmacy-

SUMMARY
based tests were conducted in the pharmacy and
Objective: The aim of this project was to assess 8Æ5% of the additional tests resulted in a sub-
whether rural pharmacist involvement in the sequent dosage change. The monitoring was well
management of patients receiving warfarin has received by pharmacists, GPs and patients.
the potential to lead to safer and more effective Conclusions: The results of the trial were very
anticoagulation, and is valued and welcomed by positive. The CoaguChek S monitor in pharmacy-
patients and their general practitioners (GPs). based testing performed accurately compared
Methods: A convenience sample of rural pharma- with conventional laboratory testing. Further
cists was trained in the use of the CoaguChek S research needs to be conducted on the impact of
International Normalized Ratio (INR) monitor community pharmacy-conducted INR monitoring
and then conducted pharmacy-based testing for on patient care and outcomes.
approximately 3 months. Two types of testing
were performed in the pharmacy: (i) comparison Keywords: anticoagulation, International Nor-
testing was defined as pharmacy-based tests taken malized Ratio, monitoring, pharmacy, point-
within 4 h of conventional laboratory testing or of-care, rural, warfarin
(ii) additional testing, which was a pharmacy-
based test with no direct comparison laboratory
test taken. Pharmacists, GPs and patients com- INTRODUCTION
pleted anonymous satisfaction surveys after the
completion of the pharmacy-based testing. There is clear evidence of the poorer health status
Results: Pharmacists from 16 rural pharmacies of rural and remote Australians (1, 2). Overall,
were trained to use the CoaguChek S monitor. average death rates in rural and especially remote
During the trial period, 518 INR tests were per- areas are higher than in metropolitan areas (2). The
formed in the pharmacies on 137 different mortality rates in rural and remote areas are higher
patients. A total of 120 tests were evaluated against for many major conditions, including diabetes,
results from laboratory testing. The pharmacy- cardiovascular disease and asthma. Access diffi-
based INR values were significantly correlated culties due to distance, time, cost and transport
with the laboratory INR values (mean of availability in rural and remote regions are ampli-
2Æ32 ± 0Æ77 and 2Æ32 ± 0Æ59 respectively; r = 0Æ88, fied by the shortages and uneven distribution of
health facilities and health professionals (2).
Received 25 April 2004, Accepted 10 March 2005
A previous study by the authors has indicated
Correspondence: G.M. Peterson, School of Pharmacy, Faculty of
Health Science, University of Tasmania, Private Bag 26, Hobart,
that Australian doctors believe that the availability
Tas., Australia 7001. Tel.: 61 3 62262197; fax: 61 3 62262870; of portable International Normalized Ratio (INR)
e-mail: [email protected] monitors would assist with the management of

2005 Blackwell Publishing Ltd 345

346 S. L. Jackson et al.

anticoagulated patients (3). This is particularly (Australia), Castle Hill, NSW, Australia) INR
relevant in rural or remote settings because of the monitor and given educational material relating to
relative lack of access to pathology services. It is not warfarin (16). The training typically involved
uncommon for doctors from rural or remote approximately 2–3 h with the pharmacists dis-
regions in Australia to have to wait 2 days for cussing anticoagulation and the use of the INR
pathology results. monitor. Pharmacists were shown how to conduct
The key objective of point-of-care (POC) testing INR tests and were also observed conducting tests
is to generate a result quickly so that appropriate on consenting subjects or pharmacy staff. Problems
treatment can be implemented, leading to an or difficulties encountered by the researchers
improved clinical or economic outcome (4). POC [through previous research activities (17, 18) and
testing in pharmacies has two main functions. The personal experience] were raised with the phar-
first is in disease screening or risk assessment (e.g. macists and potential solutions to these difficulties
blood glucose or cholesterol determination). The were discussed. The pharmacists were provided
second is in the monitoring of chronic diseases and with a laminated colour brochure on the INR
the effects of medicines used to manage these dis- monitor, and ongoing assistance if needed. Phar-
eases, as with anticoagulant therapy. macists were provided with INR monitors, tests
The increasing number of patients on warfarin strips and other consumables free of charge for the
and concerns over the ability of conventional health duration of the trial.
services to cope is one of the reasons for the Local GPs were visited, informed of the availab-
expansion of POC testing and moves to find alter- ility of the CoaguChek S monitor in their region, and
native models of service provision within primary were invited to refer their patients to the pharmacy
care for anticoagulated patients. Many models of for POC testing. During the visits to the GPs, the
anticoagulant management have been proposed in accuracy of the CoaguChek S monitor (17, 18) and its
the literature: innovative models, such as commu- use in several overseas countries was discussed.
nity and general practice-based anticoagulant clin- Patients referred to the pharmacy or who were
ics run by nurses (5) and pharmacists (6–13), have identified as taking warfarin were given an infor-
been proposed as solutions to reducing the risks of mation sheet and gave written informed consent to
anticoagulant misadventure (14). Very few studies undergo fingerprick testing at the pharmacy.
have studied the effect of community pharmacists’ Patients could have two types of testing performed
involvement in anticoagulant management (15). in the pharmacy: comparison testing was defined
The aim of the project was to assess whether as a pharmacy-based test taken within 4 h of con-
rural pharmacist involvement in the management ventional laboratory testing, and additional testing
of targeted ‘high-risk’ patients (i.e. those receiving was a pharmacy-based test with no direct com-
warfarin therapy) has the potential to lead to safer parison laboratory test taken. All results were sent
and more effective anticoagulation, and is valued to the patient’s GP via a specially designed fax
and welcomed by patients and their general prac- form. The results of the testing, such as INR, time
titioners (GPs). taken, outcome of test (dosage changes) were
recorded. It was recommended to pharmacists that
all results were recorded for patients in the stand-
METHODS
ard warfarin educational booklet.
A convenience sample of rural pharmacists was Pharmacists and GPs were instructed that this
identified by the researchers through a composite type of testing was not to replace conventional
of previous research activities with the research pathology testing. The service was offered free of
team and via contact through an electronic mailing charge to patients for the duration of the trial.
list (AusPharmList). Pharmacies needed to have an Pharmacies were remunerated at a rate of $4 per
area where POC testing within the pharmacy could test for the duration of the trial.
be reasonably completed privately during normal The CoaguChek S INR monitor was left with
workflow. each participating pharmacy for approximately
The pharmacists were trained in the use 3 months. GPs and pharmacists were later sent
of the CoaguChek S (Roche Diagnostics Pty Ltd an anonymous questionnaire (using a visual

2005 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics, 30, 345–353
 Rural pharmacy monitoring of warfarin 347

analogue scale) to evaluate the pharmacy-based 6

INR monitoring. The extremes of the scale were

5
marked with (0) ‘strongly agree’ and (10) ‘strongly
disagree’. Median results with 10th and 90th per-

CoaguChek S INR
4
centiles were plotted to represent the responses
to the evaluation questionnaires. Participating 3
patients were given an anonymous satisfaction
survey from community pharmacists after the 2

completion of the INR monitoring trial.

The INR values from CoaguChek S and the 1

laboratory were compared using regression analy-

0
sis. A Bland–Altman plot (19) was utilized to assess 0 1 2 3 4 5 6
the magnitude of disagreement between the Laboratory INR
CoaguChek S and the laboratory.
Fig. 1. Relationship between CoaguChek S and laborat-
ory International Normalized Ratio (INR) values.
RESULTS

A total of 22 pharmacies were identified and invi- done’ and ‘lack of time (at present) to implement
ted to participate in the project. Sixteen pharmacies the service.’
agreed to participate and were visited by one of the Characteristics of the patients and the test results
authors (SLJ) and trained to use the CoaguChek S are shown in Table 1. A total of 518 tests were
monitor. Three pharmacies did not conduct any conducted in the pharmacies and 137 different
testing during the trial period. Reasons cited for patients were tested. Over three-quarters of the
testing not being performed included a ‘lack of pharmacy-based tests were taken in addition to
interest by patients in having additional testing conventional laboratory testing.
The majority of tests (67Æ0%) were in the expan-
Table 1. Characteristics of pharmacy-based Interna- ded therapeutic range of 2Æ0–3Æ5, with over one-
tional Normalized Ratio (INR) testing and patients quarter (27Æ8%) being £1Æ9 and the remainder
involved (5Æ2%) were ‡3Æ6. A total of 120 pharmacy-based
INR tests had comparison laboratory tests taken for
Testing characteristics Result which the results were made available to the
research team. The mean (SD) INR values for the
No. of tests conducted 518
Tests per pharmacy 24 (0–171)
No. of patients tested 137 1.5
Tests per patient 2 (1–30)
Age of patient (years) 72 (23–100)
CoaguChek S INR - Laboratory INR

1.0
Test duration (minutes) 5 (2–15)
Reason for use of warfarin (N = 122*) 0.5
Atrial fibrillation 63 (52)
Valve replacement 20 (16) 0.0

Venous thromboembolism 33 (27)

Others 6 (5) –0.5

No. of chronic medical conditions 3 (1–7)

No. of chronic medications 5 (1–15) –1.0

Type of testing
–1.5
Comparison with conventional 120 (23) 0 1 2 3 4 5 6
laboratory testing Mean of CoaguChek S INR and Laboratory INR
Additional testing in the pharmacy 398 (77)
Fig. 2. Bland–Altman style bias plot for CoaguChek S
Values are presented as median (range) or n (%). and laboratory International Normalized Ratio (INR)
*As reason for use not recorded in some cases. values.

2005 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics, 30, 345–353
348 S. L. Jackson et al.

Table 2. Comparison of International Normalized Ratio I found this to be a valuable service provided to my patient(s)
(INR) categories for CoaguChek S and laboratory results
(values given as percentage of laboratory readings)
Strongly Strongly
agree disagree
CoaguChek S INR
I would feel comfortable operating this service if it was ongoing

Laboratory £1Æ9 2Æ0–3Æ5 ‡3Æ6

INR (n = 36) (n = 76) (n = 8) Strongly Strongly
agree disagree
£1Æ9 (n = 33) 82 18 0 I received positive feedback from the general practitioners
2Æ0–3Æ5 (n = 82) 11 85 4
‡3Æ6 (n = 5) 0 0 100
Strongly Strongly
agree disagree

I believe that more patients would benefit from this type of service
Table 3. Outcomes of additional testing conducted in
the pharmacy
Strongly Strongly
INR Result (%) Dosage Result (%) agree disagree
range (n = 398) changes (n = 390*)
I believe that this service would increase the compliance of patients on warfarin

£1Æ9 27Æ1 Increase 5Æ9

2Æ0–3Æ5 68Æ1 No change 91Æ5 Strongly Strongly
‡3Æ6 4Æ8 Decrease 2Æ6 agree disagree

I believe that my patient(s) found this to be a worthwhile service

*As some outcomes were not recorded.

Strongly Strongly
I found this to be a valuable service provided to my patient(s) agree disagree

Fig. 4. Responses to the community pharmacist evalua-

Strongly Strongly
agree disagree tion questionnaire (medians, with range lines plotted at
I would feel more confident in initiating or managing newly initiated patients on warfarin if this was a the 10th and 90th percentiles).
regular service

matched laboratory and pharmacy-based tests were

Strongly
agree
Strongly
disagree
2Æ32 ± 0Æ59 and 2Æ32 ± 0Æ77 respectively. Seventy-six
I received adequate feedback from the pharmacist
per cent of CoaguChek S INR readings were within
10% of the laboratory readings, with 84Æ8% of
results within 0Æ5 INR units of the laboratory result.
Strongly Strongly
agree disagree The pharmacy-based INR values were significantly
I believe that more patients would benefit from this type of service correlated with the laboratory INR values (r = 0Æ88,
P < 0Æ0001; Fig. 1). The pharmacy-based tests
Strongly Strongly showed only slight variation compared with
agree disagree
laboratory testing for INR values <4Æ0, as displayed
I found the suggestions made by the pharmacist to be useful
in the Bland–Altman style plot shown in Fig. 2.
The categorization of comparison laboratory
Strongly Strongly
agree disagree and pharmacy-based INR values is displayed in
I believe that my patient(s) found this to be a worthwhile service Table 2. There was a significant relationship
between the two methods (v2 = 130, d.f. = 4,
Strongly Strongly P < 0Æ0001). Discrepant categorization of INR
agree disagree
values from the laboratory and CoaguChek S
Fig. 3. Responses to the GP evaluation questionnaire occurred in 15% of the samples. That is, 85%
(medians, with range lines plotted at the 10th and 90th (102/120) of CoaguChek S values were placed in
percentiles). the same nominal category as the laboratory INR.

2005 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics, 30, 345–353
 Rural pharmacy monitoring of warfarin 349

Table 4. Response to the patient satisfaction question- Table 4. Continued

naire pharmacy-based testing
Response to questions n (%)
Response to questions n (%)
If this were a regular service, would you be prepared
How satisfied are you with the monitoring to pay for it?
conducted by your pharmacist? Yes 32 (57)
Quite dissatisfied 6 (10) No 24 (43)
Indifferent of mildly dissatisfied 2 (4) If you answered yes to the previous question, how much
Mostly satisfied 13 (22) would you be prepared to pay per visit?
Very satisfied 37 (64) $1–5 20 (63)
Has the monitoring provided by the pharmacist $6–10 8 (25)
helped you to deal more effectively with your $11–15 4 (13)
medication warfarin? $16+ 0
Yes, they helped a great deal 33 (57)
Yes, they helped somewhat 17 (29) Some responses do not total 62, because some respond-
No, they really did not help 8 (14) ents did not answer all questions.
No, they seemed to make things worse 0 *Totals greater than 62 because respondents could
Which type of testing would you prefer? indicate more than one response.
Fingerprick testing at the pharmacy 40 (66)
Fingerprick testing at the general 6 (10)
practitioner’s surgery About 7Æ5% were falsely lowered with the
Conventional pathology testing 13 (21) CoaguChek S (corresponded to a higher labora-
Unsure 3 (5) tory reading) and the same amount was falsely
Is there any other information you need, or would elevated (corresponded to a lower laboratory
like, about warfarin but have not received? result).
Yes, there definitely is 13 (23) Table 3 displays INR ranges and outcomes of the
Yes, I think there is 10 (18)
398 additional pharmacy-based tests. About 8Æ5%
No, I do not think there is 30 (53)
of additional testing conducted in the pharmacy
No, there definitely is not 4 (7)
Overall, how would you rate the quality of the service
resulted in a subsequent dosage change.
that you received from the pharmacist? Figure 3 displays the response to the evaluation
Excellent 45 (76) questionnaire from the GPs. Responses were
Good 13 (22) obtained from 15 of 30 GPs who were caring for
Fair 0 patients who had pharmacy-based testing, giving a
Poor 1 (2) response rate of 50%. The median responses from
Did you find the regular warfarin (INR) monitoring* the GPs are positive in all but one question, with
Painful 5 (8) wide 10th and 90th percentiles reflecting some
Informative 13 (21) variable views on the pharmacy-based monitor-
Motivating 1 (2)
ing. However, the response to the evaluation
A waste of time 3 (5)
question ‘I found the suggestions made by the
Interesting 12 (19)
Annoying 3 (5)
pharmacist to be useful’ was slightly negative.
Convenient 27 (44) Figure 4 displays the response to the evaluation
Beneficial 28 (45) questionnaire from the community pharmacists.
Do you think this service would be best provided in Fifteen responses were obtained from 22 (68%)
your home or at your local pharmacy? community pharmacists who were users of the INR
Home 13 (22) monitor. The overall evaluation from the pharma-
Local pharmacy 38 (64) cists was positive. The response to one question ‘I
General practitioner’s surgery 8 (14) received positive feedback from the GPs’, however,
Do you think this service should be available to all was less positive than the others. Most comments
patients on warfarin?
reflected good patient feedback, the issue of train-
Yes 57 (98)
ing, time to conduct this type of service and the
No 1 (2)
issue of remuneration.

2005 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics, 30, 345–353
350 S. L. Jackson et al.

The responses from patients to the satisfaction many potential users. The performance of the
questionnaire are displayed in Table 4. Responses CoaguChek S in the community pharmacy setting
were received from 62 patients, giving a response was excellent, especially when considering that data
rate from patients tested of 45%. Most of the were collected from many sites and was compared
comments from patients reflected an appreciation with different laboratories. Previous studies have
of the convenience with using pharmacy-based found that the variation between portable INR
testing. They seemed to be very happy with POC monitors and laboratory was not larger than the
monitoring but perhaps found it a barrier to util- variation encountered between different laborator-
ization of the service that pharmacists were unable ies measuring a single sample (24). To our know-
to adjust warfarin dosages on the basis of these ledge, this is the first published study comparing the
results. Some patients expressed views that gov- accuracy of the CoaguChek S INR monitor in com-
ernments or other organizations should pay for this parison with laboratory testing in a sample of com-
type of monitoring. munity pharmacies.
In nearly 10% of cases the additional testing
conducted in the pharmacy resulted in a change in
DISCUSSION
warfarin dosage. Clinical decisions were made
This project was designed to test the feasibility of (generally followed by pathology testing in the next
community pharmacy-based INR monitoring in day or so) on the basis of INR tests in the phar-
rural Australia. We also wanted to gauge the macy. It is difficult to quantify the impact that the
acceptance of this type of service by community changes in therapy had on clinical outcomes. In
pharmacists, GPs and patients. We recruited a rel- most cases, pharmacists recorded only dosage
atively large number of pharmacies (16), with a changes and not clinical outcomes, although the
broad spread or rurality, for a study of this type study was not designed to assess the latter. How-
and the pharmacists involved conducted a large ever, it is likely that the availability of POC testing
number of tests (518) on 137 patients. in community pharmacies may have a large impact
Use of the CoaguChek S monitor in community on clinical outcomes if pharmacy-based testing is
pharmacies resulted in accurate performance com- utilized in rural areas. Further research needs to be
pared with conventional laboratory testing. Previ- conducted on the impact of community pharmacy-
ous studies by the research team have obtained conducted INR monitoring on patient care and
correlation coefficients (r) of 0Æ90 in an anticoagula- outcomes.
tion clinic (17) and r = 0Æ89 in general practices (18), The quality of the INR monitoring service was
compared with r = 0Æ88 in this study. Other studies rated as good or excellent by nearly all patients.
have shown that the CoaguChek (previous version Importantly, the majority of patients indicated that
of the INR monitor) and CoaguChek S devices pro- the pharmacy-based monitoring helped them deal
duce INR values that are highly correlated with more effectively with warfarin. This emphasizes
laboratory INR values (r = 0Æ91–0Æ97) (20–25). the ability of pharmacists to educate patients
Eighty-five per cent of all dual measurements regarding their anticoagulant therapy, and in fact,
were within 0Æ5 INR units in this study, which the effects of education delivered through phar-
compares well to the figure of 79% reported by macy-based INR monitoring may have larger
Douketis et al. (25), and 83% by the authors in an long-term impacts on compliance and anticoagu-
outpatient anticoagulant clinic (17). This study also lant-related misadventure (7). It is a limitation of
found that 76% of all comparison tests were within the study and room for further research that nearly
10% of the laboratory value. This compares one-third of patients indicated that there was more
exceptionally well with other studies conducted by information that they would like about warfarin.
the research team, which have shown results of Structured education programmes could be devel-
55% of results within 10% of the laboratory in oped through community pharmacies and could
general practices (18) and 44% in an anticoagula- complement pharmacy-based INR monitoring.
tion clinic (17). Nearly 50% of respondents indicated that they
This study was unique in evaluating the Coagu- found the testing convenient and beneficial.
Chek S in a number of diverse settings and with Patients receiving anticoagulation are often elderly,

2005 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics, 30, 345–353
 Rural pharmacy monitoring of warfarin 351

cannot endure long waiting times, and find trav- identified previously as a concern for implementa-
elling to hospitals or pathology laboratories diffi- tion of professional services (29). It is recognized that
cult (26). Pharmacies are usually located in a number of community pharmacies may have to
convenient and accessible locations, improving undergo structural modifications to cope with the
access for patients. A convenient approach could array of professional services that may be provided
be to provide long-term monitoring through in the future.
accredited community pharmacies. As noted by Studies have found that elderly rural patients
Moffat (27), the pharmacy profession has a great with chronic atrial fibrillation (AF) receive warfarin
opportunity to use diagnostic testing to monitor less frequently than urban patients, despite pos-
patients’ responses in assisting them to manage sessing a similar high-risk profile for stroke and
their chronic conditions and their prescribed fewer relative contraindications (30, 31). POC test-
medicines. Clearly, however, ongoing quality ing of rural and remote Australians taking warfarin
assurance schemes will need to be developed to has the potential to improve the prescribing rates of
ensure pharmacy-based INR monitoring systems warfarin in AF, thereby lessening the risk of debi-
are of a high standard. litating strokes. It also clearly has the potential to
The testing process was well received by the improve the safety of use of warfarin, and be par-
community pharmacists; they felt confident ticularly beneficial to the care of rural and remote
delivering this type of service and found it be a patients.
valuable service for patients. Pharmacists, how- The National Pharmaceutical Association in the
ever, will need to address issues such as the need UK has claimed that ‘community-based pharmacy
for separate counselling and consultation areas anticoagulation clinics could help the National
for testing, and occupational health and safety Health Service save 5000 lives and £24 million a
issues associated with handling bodily fluids. year’ (32). This figure was based on the under-
Responding pharmacists indicated that they utilization of anticoagulants for stroke prevention
thought that pharmacy-based INR monitoring in AF, suggesting a rise to 50% of patients being
would improve the compliance of patients on appropriately treated if community pharmacies
warfarin. In fact, pharmacist-managed anticoagu- were involved in anticoagulant monitoring. If
lation clinics have reported increased compliance similar data from the Australian community were
after instituting education programmes (7). Con- used, documenting the underuse of antithrombot-
sistent with other reports of POC testing by ics for AF (3, 33), and if pharmacy-based antico-
pharmacists (28), the pharmacists in this project agulation clinics were able to assist in the
indicated that testing should be part of a larger management of anticoagulated patients and there-
programme (28), such as comprehensive antico- fore increase the proportion of anticoagulated
agulant education. patients with AF by 10% (from 40 to 50%), this
The evaluation from the GPs was generally pos- would save approximately Aust$12 million dollars
itive, but variations in a number of the responses per annum due to reduced stroke incidence and
were evident. A negative response was observed to would likely reduce the incidence of bleeding
the question ‘I found the comments made by the complications.
pharmacist to be useful.’ This may reflect barriers
between general practice and pharmacists regarding
ACKNOWLEDGEMENTS
perceived encroachment of pharmacy services on
traditional general practice territory (29). More for- We thank the participating community pharma-
mal integration of pharmacists into health care and cists. The project was funded by the Common-
the development of partnerships with GPs are cru- wealth of Australia through the Rural and Remote
cial to the establishment of pharmacy-based INR Pharmacy Infrastructure Grants Program as a
monitoring. Professional barriers to the implemen- component of the Rural and Remote Pharmacy
tation of expanded services in pharmacy have been Workforce Development Program (administered
identified in the literature. These include the ‘shop- by the Pharmacy Guild of Australia). Shane
keeper image’ of community pharmacy (29). The Jackson is an Australian Commonwealth Depart-
design of many community pharmacies has been ment of Health and Aged Care, Quality Use of

2005 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics, 30, 345–353
352 S. L. Jackson et al.

Medicines Evaluation Program (QUMEP) PhD hospital. American Journal of Health-System Pharmacy,
scholar. Roche Diagnostics Pty Ltd (Australia) 53, 1151–1157.
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