1

An Integrated Service,

initiated by Community

Pharmacists, for the

Prevention of

Osteoporosis.

Final Report, November 2004

Researchers: Dr Susan J Taylor, Dr Judith A. Crockett

& Lynette J. McLeod

This projected has been funded be the Australian Government Department of Health and Ageing

through the Third Community Pharmacy Agreement Research and Development Program.

2

EXECUTIVE SUMMARY

Aim This project had two principal aims:

To develop, implement and evaluate an integrated service for the prevention of

osteoporosis, to be delivered by community pharmacists;

To determine whether measurement of bone mineral density (BMD) in the

pharmacy increases the effectiveness of the risk assessment/referral service in

terms of adherence to advice and uptake of referral compared with the same

service offered without BMD.

Method Six rural towns and six Sydney suburbs were identified as satisfying the inclusion

criteria defined. Advertising to recruit pharmacist participants was conducted through

newspapers. Of those pharmacists willing to participate that could offer suitable

premises and staffing levels, one pharmacist in each area was randomly chosen to be

involved in the study (12 pharmacists in total). The pharmacists were then randomised

into one of the two groups: either to offer a BMD test, or to not offer the test. Of the

six pharmacists in each group, three were from rural NSW and three were from

metropolitan Sydney. An education and training programme for participating

pharmacists was developed in collaboration with Osteoporosis NSW.

Twenty participants were to be recruited per pharmacist, comprising the study

population. Participants were recruited by poster advertising displayed in participating

pharmacies and local papers. The inclusion criteria for participants were:

Women over the age of 40, or men over the age of 50;

No BMD test in the last two years;

No previous treatment for osteoporosis.

A single radiographer was employed to carry out all the BMD tests within each BMD

group pharmacy. The tests were carried out over the period of one week in the urban

pharmacies, and then over another week in the rural pharmacies. The BMD test used

in this study was an X-ray of the forearm using a mobile DEXA machine.

3

The participants in the BMD group (Group 1) received an osteoporosis risk

assessment conducted by the pharmacist, a peripheral BMD check in the pharmacy,

and were provided with information and help by the pharmacist to make a decision

about treatment based on the risk assessment and BMD result. The pharmacist would

refer the participant to the appropriate health care practitioner if necessary. The

participants in the non-BMD group (Group 2) received the same service as those in

Group 1, but without the BMD measurement in the pharmacy.

Measurements were made at intervals that were appropriate to the timing of the

intervention. Pharmacists initially completed a risk assessment questionnaire for each

participant (Appendix 2). Participants were then followed up by their pharmacist,

either in person or by telephone, at three and six months regarding their understanding

and adherence to treatment advice. Participants were also followed up by the project

officer by phone at three months regarding adherence to treatment advice and

willingness to pay for the service provided. High risk participants and those referred

to other healthcare professionals were contacted at six months. An evaluation survey

was sent to participating pharmacists to provide feedback on the training provided and

the service programme. Cost-effectiveness and cost-benefit analyses were also

attempted.

Summary of Results

Twelve pharmacists were recruited to the study who, between them, recruited

217 participants.

Of these, 193 completed the study (113 BMD group and 80 Non BMD group).

Pharmacists categorised 11/193 (5.7%) participants as being at high risk of

osteoporosis, 3 in the BMD group and 8 in the Non BMD group (p=0.001) and

all these people were referred to their GP for follow up.

The most commonly encountered and most easily rectified risk factor found

was low intake of calcium.

o Pharmacists in the BMD group advised 45% of participants to increase

their calcium intake and, of these, 82% were doing so at the 3 month

follow up.

4

o In the Non BMD group pharmacists advised 53% of participants to

increase their calcium intake and of these 76% were doing so at the 3

month follow up. This difference was not statistically significant.

There was no difference in adherence to any other treatment decisions

between those given BMD with risk assessment and those who were not.

Participants were asked to place a monetary value on the service they received

by expressing their Maximum Willingness to Pay for it.

o In the BMD group the median maximum WTP was $30 compared with

$20 (p=0.001) expressed by the Non BMD group. This indicated that

those who experienced the BMD + Risk Assessment valued the service

significantly more highly than those who experienced the Risk

Assessment only.

It was clear from the comments of both pharmacists and participants that

participants expected a BMD test to be part of the service, even though the

scope of each service was clearly outlined in the relevant advertising. This

expectation was most likely due to the fact that such tests are already being

routinely offered in many community pharmacies.

BMD inclusion made it easier for pharmacists to recruit participants and also

made it easier for the pharmacists to deliver the service because all tests were

done on the same day. If the pharmacist organised extra staff for the day

he/she could then focus on the one activity.

Conclusions and Recommendations

This study compared the adherence to advice or referral given by pharmacists

about the prevention of osteoporosis following screening with either a BMD

test plus risk assessment questionnaire or a risk assessment questionnaire only.

No significant between group differences in adherence to advice or referral, as

reported by the people screened, were found.

However participants valued the BMD service significantly more highly than

the Non BMD service as measured by satisfaction scores and Willingness To

Pay Values expressed.

Only those people considered to be at most risk were referred to the GP and

this could be seen as a more efficient use of resources.

5

The results of this study and the current practice indicated that consumers are

very interested in receiving information about osteoporosis and their own risk

of it but especially interested in BMD testing in the pharmacy. However, their

uptake of referral was poor. It is not clear why this was so and warrants further

investigation.

The uptake of advice and referral is not known in relation to the current

situation where radiographers have operated relatively independently within

pharmacies but in that process the opportunity for follow up by pharmacists

has been minimised. However, a massive education program for both

pharmacists and the public would need to be undertaken to reverse the public

perception of the value of the service.

A more constructive approach might be to build on the current practice and try

to improve it. For example, an approach by pharmacists targeted towards

those more likely to be at risk eg those over 60 might be more effective,

manageable and sustainable given the many other demands on pharmacists’

time. Such consumers could be interviewed by the pharmacist using a risk

assessment questionnaire and then referred for BMD test if necessary, either in

the pharmacy (still open to debate) or via the GP with a follow up central

BMD test being done if necessary.

6

ACKNOWLEDGEMENTS The Department of Health and Aged Care – For funding this project through the Research and Development Grants Program – Investigator Initiated Projects The Pharmacists involved in the project – without whom the project would not have been possible:- Sonya Elias, Emile Garas, Kim Hua, Alan Hurdle, Paul Kevin, Terry Mourched, Debbie Nash, Ken Ooi, Martin Phillips, Gina Rickard, Amal Sekla & Sue Wild

Others involved in the project at various stages –Sylvia Shepherd (Osteoporosis NSW), Inta Marsden (Radiographer), Luke Kelly(Community Pharmacist), Judith Crockett & Lynette McLeod (Project Officers) Steering Committee Members – Janet Watters (Co-ordinator of the Dubbo Osteoporosis Epidemiology Study), Dr Michael Hooper (Endocrinologist, Concord Hospital).

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TABLE OF CONTENTS

Page No.

Executive Summary 2

Acknowledgements 6

1.Background 11

2.Methodology 22

2.1 Consultation and program development 22

2.2 Recruitment of pharmacists 22

2.3 Professional development of pharmacists 24

2.4 Recruitment of participants 24

2.5 Service delivery 25

2.6 Evaluation of program by pharmacists 26

2.7 Cost effectiveness analysis 27

2.8 Cost benefit analysis 27

2.9 Statistical analysis 28

3.Results 29

3.1 Recruitment of pharmacists 29

3.2 Recruitment of participants 29

3.3 Demographic characteristics of participants 31

3.4 Service Delivery 32

3.5 Evaluation of Service - pharmacists 41

3.6 Evaluation of Service – participants 43

3.7 Economic Evaluation 46

3.7.1 Cost effectiveness analysis 46

3.7.2 Cost Benefit Analysis 48

4.Discussion 52

5.Conclusion and Recommendations 57

6.References 59

7.Appendices A1-A99

8

LIST OF FIGURES AND TABLES

Page No.

Table 1.1a: Medication underlying secondary osteoporosis 12

Table 1.1b: Diseases/ conditions underlying secondary osteoporosis 12

Table 1.2: Risk factors of osteoporosis supported by medical evidence 14

Table 1.3: World Health Organisation criteria for the diagnosis of

osteoporosis

15

Table 1.4: Conditions for Medicare benefit for bone densitometry 17

Table 3.1: Location and type of service delivered by recruited

pharmacies

29

Table 3.2: Recruited participants (expected recruitment) for all

pharmacies

30

Table 3.3: Recruited participants (expected recruitment) with one non

BMD pharmacy removed

30

Table 3.4: Demographic characteristics of participants in the project 31

Table 3.5: Age grouping of participants 31

Table 3.6: Risk Factors 33

Table 3.7: Participants’ results from the BMD testing 33

Table 3.8: Pharmacy assessments for each experimental group 34

Table 3.9: Treatment decision decided on by the pharmacist and

participant

35

Table 3.10: Participants’ adherence to treatment decision after 3

months, grouped in BMD vs Non BMD

36

Table 3.11: Reasons given by participants for non-adherence to advice 36

Table 3.12: Participants referred to GP after risk assessment 37

Figure 3.1: Participants from BMD group referred to their GP, the

uptake of these referrals and their outcome

38

Figure 3.2: Participants from non BMD group referred to their GP, the

uptake of these referrals and their outcome

39

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LIST OF FIGURES AND TABLES (cont)

Page No.

Table 3.13: Adherence to advice at six months by participants who

were classified at high risk and/or who were referred to their GP

40

Table 3.14: Recruitment of participants at pharmacies that responded to

evaluation survey, grouped between urban and rural locations

42

Table 3.15: Estimated time it took to deliver the service per participant 43

Table 3.16: Participant satisfaction with general health screening and

promotional services in pharmacy divided by BMD group

44

Table 3.17: Participant satisfaction with health information offered by

pharmacy divided by BMD group

44

Table 3.18: Responses (as % responding) to each of the questions on

the provision of health promotion and screening services in pharmacies

45

Table 3.19: Cost of delivering the service 46

Table 3.20: Possible measures of effectiveness 47

Table 3.21: Number and proportion of participants willing to pay for

osteoporosis risk assessment

49

Table 3.22: Willingness to pay amounts for osteoporosis risk

assessment

50

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LIST OF APPENDICES

Appendix

No.

Pharmacy Selection Protocol 1

Risk Assessment Questionnaire 2

Decision Making Tool for Risk Categorisation 3

Information Pamphlets 4

Pharmacist Data Record Sheet 5

Referral Forms 6

Workshop Material 7

Newsletter 8

Advertisements 9

Consent Form 10

BMD Test Result 11

Three Month Follow Up Telephone Survey 12

Six Month Follow Up Telephone Survey 13

Pharmacist Feedback Survey 14

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1. BACKGROUND

Osteoporosis in Australia

Osteoporosis is a disorder characterised by a loss of bone mineral resulting in a

decrease in bone mass and a subsequent increase in bone fragility. It currently affects

one in ten Australians (75% of whom are over the age of 55 and 75% of whom are

female), and these figures are predicted to increase as the population ages (Access

Economics 2001). The deterioration of bone tissue that occurs in osteoporosis leads to

an increase in the susceptibility to fractures particularly of the spine, hip, pelvis, wrist

and upper arm. The Garvan Institute (2001) estimates that for Australians over the age

of 60, 1 in 2 women and 1 in 3 men will sustain an osteoporotic fracture. In the

absence of intervention the number of hospitalisations that occur for this type of

fracture will increase from one every 8.1 minutes to one every 3.7 minutes over the

next twenty years (Access Economics 2001).

Although osteoporosis is only associated with a small number of direct deaths (ABS

2004), the main morbidity are the fractures that occur. The most serious of these are

hip fractures, which can lead to lengthy hospitalisation, long-term nursing care,

disability and, complications resulting in death. Studies have shown that 20% of

people who suffer hip fracture die within six months, 50% of patients who survive are

discharged to nursing homes and 25% remain institutionalised one year later (Access

Economics 2001). Another major problem is what is termed the ‘cascade effect’,

where the occurrence of one fracture is associated with the increased risk of further

fractures (Access Economics 2001).

Relative to other conditions, osteoporosis is an expensive disease. The direct health

system costs of osteoporosis have been estimated at $(Aus)1.9 billion per annum, with

a further $(Aus)5.6 billion in indirect costs over the 2000/01 financial year. The

burden of the disease, expressed in terms of premature mortality and disability

together represented over 25000 healthy years of life lost to Australians in the same

period (Access Economics 2001). This represents 1% of the total burden of disease

and injury in Australia. Over half of the disease burden (53%) is due to premature

mortality.

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Types of Osteoporosis

There are four main types of osteoporosis (NIH, 2001):

1. Post-menopausal resulting from the increase in bone mineral loss due to the

decline in ovarian function and oestrogen production.

2. Age-associated (senile) resulting from the extended period of bone mineral loss

as people age.

3. Idiopathic which mainly affects men under 65, and has unknown causes.

4. Secondary which is caused by known pharmacological medication (Table 1.1a)

or disease (Table 1.1b).

Table 1.1a: Medication underlying secondary osteoporosis (from Access

Economics 2001).

Medications

Anticonvulsants Heparin (long-term)

Glucocorticoids Loop diuretics

GnRH analogs Thyroxine

Table 1.1b: Diseases/ conditions underlying secondary osteoporosis (from Access

Economics 2001).

Disease or Condition

Ankylosing spondylitis Hypercalcinuria

Bone metastases Neoplastic disease,

Cystic fibrosis Osteogenesis imperfecta

Early oophorectomy (in women) Pulmonary disease

Hemiplegia (stroke) Rhematoid arthritis

Homocystinuria Subtotal gasterectomy

Hypogonadism (in men) Systemic mastcytosis

Hyperthryroidism

Chronic diseases of kidneys, lungs, stomach, intestines or altered hormone

levels

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Risk Factors for Osteoporosis

Some people have a higher risk of developing osteoporosis than others. The main risk

factors of osteoporosis are associated with low bone mineral density, and can be

influenced by genetic, age-related, hormonal, medical, dietary and/or lifestyle factors

(see Table 1.2). While some of these factors cannot be modified (i.e. age, sex, family

history, racial origin), many are open to intervention thereby making osteoporosis

largely a preventable disease.

An increased risk of osteoporosis increases the risk of fracture. The results from many

studies indicate that this risk of fracture can also be influenced by factors that relate to

the risk of fall (NIH 2001). Fracture risk has been consistently associated with history

of falls, low physical function (such as gait speed, muscle strength, vision, cognition),

advanced age, and presence of environmental hazards (NIH 2001, Sambrook et al.

2002, Gillespie et al. 2004b). As for osteoporosis risk factors, many of these fall risk

factors cannot be modified but others are open to intervention.

Modifiable Risk Factors

Calcium is the most important factor in bone production and Vitamin D is required for

optimal calcium absorption. Inadequate dietary intake of either of these nutrients

places a person at increased risk of osteoporosis (NIH 2001, Gillespie et al. 2004a

Shea et al. 2004). Other lifestyle factors that have been shown to increase the risk of

osteoporosis are low weight and body mass index, smoking, and minimal weight-

bearing exercise (Bonaiuti et al. 2004, NIH 2001). Excess intake of alcohol and

caffeine consumption has also been suggested to have a negative effect on bone

health. Both these substances can reduce calcium absorption as well as increase

calcium loss via the urine by increasing urine output (Massey & Whiting 1993, NIH

2001). However there is inconsistent medical evidence supporting this association

with decreased bone mass (e.g. Kiel et al. 1990, Cooper et al. 1992, Barrett-Connor et

al. 1994, NIH 2001).

Other risk factors include those medical conditions and medications that cause

secondary osteoporosis. These need to be recognised and treated appropriately. The

menopause and other hormonal dysfunctions (e.g. amenorrhoea, low testosterone in

14

men) also need to be managed appropriately to reduce their impact on bone mineral

loss as do medication issues.

Improving strength and balance (exercise), using walking aids, improving the home

environment (e.g. rails on stairs, no loose rugs), addressing medication issues and

treating sight problems are important factors that can be addressed especially in the

over 50 age group to reduce fracture risk (NIH 2001, Sambrook et al. 2002, Gillespie

et al. 2004).

Table 1.2: Risk factors of osteoporosis supported by medical evidence (NIH

2001).

Non Modifiable Risk Factors

Age

Racial origin

Family history of osteoporosis

History of low trauma fractures

Height

Suboptimal bone growth in childhood / adolescence

Modifiable Risk Factors

Nutrition: low Calcium intake

low Vitamin D intake

body weight

Lifestyle: minimum weight bearing exercise

smoking

excessive alcohol consumption (although inconsistent evidence)

excessive caffeine consumption (although inconsistent evidence)

Hormonal: cessation of periods before menopause

menopause

low endogenous oestrogen levels

Medical condition / diseases increasing risk of osteoporosis (see Table 1.1b)

Medication increasing risk of osteoporosis (see Table 1.1a)

Falls: Physical function e.g. impaired vision, physical strength

Environmental / home aspects e.g. stairs, throw rugs

Medication e.g. blood pressure, dizziness

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Diagnosis of Osteoporosis

The main indicator of osteoporosis is bone mineral density (BMD). BMD

measurements have a high correlation with bone strength and load bearing capacity

and an inverse relationship with the risk of fracture; as BMD decreases the risk of

fracture increases exponentially (Marshall et al. 1996). BMD is measured by bone

densitometry, and is expressed in terms of a ‘T-score’, representing the number of

standard deviations (SD) from a normal young adult mean. According to the World

Health Organisation (WHO) definition, osteoporosis is present when the T-score is –

2.5 SD and below (see Table 1.3).

Table 1.3: World Health Organisation criteria for the diagnosis of osteoporosis

(Kanis 1994).

Category Criteria

Normal BMD 1 SD below average peak young adult

Osteopenia BMD >1 SD but < 2.5 SD below average peak young adult

Osteoporosis BMD 2.5 SD below average peak young adult

BMD = bone mineral density, SD = standard deviation

Treatment is strongly recommended when a T-Score of –2.5 SD is measured, to

prevent further bone loss and fracture. When a T-Score between -1 and –2.5 SD is

found treatment should be considered particularly if there are other risk factors

present. Patients recording a T-Score of greater than -1 SD require no treatment and

re-measurement would not be repeated for at least two to five years (Commonwealth

Department of Health and Family Services 1997).

Some BMD measurements also give a Z-score, which compares the measured bone

density with the average of people in the same age group and gender. A Z-score of 0

means that the patient’s bones are average density for their age group. Below 0 means

the patient’s bones are below average density and above 0 means they are above

average for their age group. Although not as relevant as a T-score, a Z-score below –2

means the patient is losing bone more rapidly than their peers and can serve as a

16

warning that further evaluation is needed or careful monitoring of treatment is

required (Rosenthal 2000).

Devices for measuring BMD use either X-ray or ultrasound technology, and can be

categorised based on the body site measured; central or peripheral. Dual-energy X-ray

absorptiometry (DEXA), is the most widely used technology. Measurement with this

device on the hip or spine areas (central) is considered the ‘gold standard’ method

(Rosenthal 2000, Sambrook et al. 2002). Quantitative ultrasound (QUS) has the

benefit of being a radiation free technique, and although it can reliably predict fracture

risk, it is not considered as precise as DEXA (NOF 1998).

Measurements of BMD at central sites such as the spine, femoral neck and hip, are

considered to be more ideal than at peripheral sites (Rosenthal 2000). However the

introduction of peripheral devices has allowed for BMD testing outside of specialist

centres because of the greater portability and lower costs. Peripheral DEXA (P-

DEXA) devices use the same X-ray based methodology as central DEXA but are

limited to measuring BMD at the forearm, wrist, hand or heel. However many studies

(e.g. Ryan et al. 1994, Nordin et al. 1997, Trivatayaratana & Trivatayaratana 2001,

Picard et al. 2004) have found that peripheral sites, particularly forearm

measurements, can provide adequate accuracy in BMD measurements. There is still

some debate about whether the peripheral DEXA scans on their own can be relied

upon for the diagnosis of osteoporosis (Blake and Fogelman, 2001).

Although BMD measurement is a good way to identify risk of fracture it has its

limitations and a diagnosis of osteoporosis should not be based solely on its results

(Rosenthal 2000). An individual’s medical history, clinical chemistry and risk profile

are also important factors for consideration. This individual evaluation is one of the

arguments against mass population screening using BMD tests (Rosenthal 2000, NIH

2001). Other arguments against using mass screening include the issues of detection

rates vs cost, expected low attendance, uptake and compliance, as well as the accuracy

of the different measurement techniques and measurement sites and the varying

reference ranges between people of different ethnic origin (Commonwealth

Department of Health and Family Services 1997, NIH 2001, Nelson et al. 2002,

Sambrook et al. 2002).

17

Instead BMD measurement is recommended to be part of patient care, reserved for

diagnosing osteoporosis in patients who are in high risk situations and monitoring

their responses to interventions and treatment (Commonwealth Department of Health

and Family Services 1997, Sambrook et al. 2002). At present Medicare rebate support

of BMD measurement is limited to patients in certain high risk categories (Table 1.4)

using DEXA or Quantitative computerised tomography (QCT) at specialist centres

(Australian Government Department of Health and Ageing 2004). A rebate is not

available for BMD testing conducted for screening purposes.

Table 1.4: Conditions for Medicare benefit for bone densitometry performed by

a specialist or consultant physician, using DEXA or QCT (From: Australian

Government Department of Health and Ageing 2004).

Condition specified

The conformation of a presumptive diagnosis of low BMD made on the basis of

1 or more fractures occurring after minimal trauma.

The monitoring of low BMD proven by bone densitometry at least 12 months

previously

Diagnosis and monitoring of bone loss associated with 1 or more of the

following conditions: prolonged glucocorticoid therapy, conditions associated

with excess glucocorticoid secretion, male hypogonadism, female hypogonadism

lasting more than 6 months before the age of 45 and / or where the BMD will

contribute to the management of a patient with any of the above conditions.

Diagnosis and monitoring of bone loss associated with 1 or more of the

following conditions: primary hyperparathyroidism, chronic liver disease,

chronic renal disease, proven malabsorptive disorders, rheumatoid arthritis or

conditions associated with thyroxine excess and or where the BMD will

contribute to the management of a patient with any of the above conditions.

For the measurement of BMD 12 months following a significant change in

therapy for: established low BMD or the confirmation of a presumptive

diagnosis of low BMD made on the basis of 1 or more fractures occurring after

minimal trauma.

BMD = bone mineral density

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Management of Osteoporosis

The key objective in managing osteoporosis is to restore and maintain bone strength

to prevent fractures. Treatment for osteoporosis can involve drug therapy and / or

lifestyle and diet modifications, and is largely dependent on the type of osteoporosis

(e.g. secondary, postmenopausal), and the characteristics of the patient. The main

drug therapies available to treat osteoporosis are bisphosphonates, hormone

replacement therapy (HRT), selective estrogen receptor modulators (SERMs) and

calcitonin. Other management options include lifestyle modifications such as a

reduction in smoking and an increase in exercise, and the treatment of the causes of

secondary osteoporosis such as hypogonadism. Despite what treatment is selected, the

intake of adequate calcium and vitamin D is considered imperative for optimal

success (Commonwealth Department of Health and Family Services 1997, NIH 2001,

Wade 2001, Sambrook et al. 2002).

Other management options for the prevention of fracture include the prevention of

falls by improving strength and balance (exercise), using walking aids, improving the

home environment (e.g. rails on stairs, no loose rugs), addressing medication issues

and treating sight problems, especially in the over 50 age group.

Pharmacist’s Role

It is not the role of the pharmacist to diagnose osteoporosis. Clearly this is the domain

and responsibility of medical practitioners. The pharmacist’s role is to help identify

people at risk of fractures due to the disease and to work in collaboration with other

health care practitioners to reduce that risk (Rosenthal 2000). This may be done in a

number of ways for example, health promotion initiatives through the pharmacy

(Shirley & Scott 1999, Gray et al. 2002) and increasing awareness and use of the

National Osteoporosis Foundation questionnaire to assess risk.

Consumers’ interest in the negative impact of the disease has been heightened,

possibly because of its increased profile in the lay press. This, coupled with the

increased availability of screening tests for other chronic conditions such as

hypercholesterolaemia and diabetes, has led consumers to expect access to BMD

19

tests, even if at their own expense. Providers of such tests have responded to the

demand and have perhaps helped to create further demand by offering their services

in community pharmacies.

BMD testing is currently available in some community pharmacies in Australia.

However, this service is provided by external staff, who usually measure BMD at

peripheral sites using QUS or pDEXA technology. Pharmacists currently have little

involvement in the process other than to allow access to the space and take bookings.

The radiographers who deliver the service do the advertising and provide any

information issued. Everyone except children and pregnant women are targeted.

Unless a consumer is advised by the radiographer to take a calcium supplement for

example, the pharmacist may have no contact with them at all. Consumers pay for this

service (approximately $40), with no rebate available, and pharmacists receive a

commission, usually 10%. Apart from this commission, an additional benefit to the

pharmacist of offering the BMD test is that it may attract new customers into the

pharmacy.

While this service may be of benefit to consumers (Elliot et al. 2002), its value

remains unclear as a diagnostic tool because of the uncertainty about the accuracy of

the technology used and the bone site chosen. However, both QUS and DEXA appear

to predict fracture risk equally well (National Osteoporosis Foundation) and as a

preliminary screening tool, combined with a questionnaire and referral for follow up,

plus central BMD test if necessary, peripheral BMD testing in the pharmacy may have

some merit.

Community pharmacies have been shown to play an important role in providing

screening services for risk factors for a range of diseases (e.g. Blenkinsopp et al.

2003, Hourihan et al. 2003) and osteoporosis could be no exception (Elliot et al.

2002). A screening procedure would not necessarily need to include BMD

measurements in the pharmacy as questionnaires which identify conditions and

lifestyle factors that predispose to loss of bone and osteoporotic fractures can help

determine whether a BMD test is necessary (Weinstein et al. 1999). In addition, the

clinical aspects elicited through the questionnaire can be taken into account when

assessing the prevention and management options. Some argue that if the result of a

20

BMD test would not alter the management then it should not be conducted either for

screening or a diagnostic test. Thus, the questionnaire has a complementary and

screening role rather than a diagnostic role per se.

Pharmacists could provide a more comprehensive service than they do currently by

helping clients to assess their own risk through a questionnaire, arranging BMD tests

in pharmacy or referring to the GP for such a test, assisting in preventative strategy

decision making, referral of clients to appropriate health care professionals and

counselling of clients in the correct use of medication and supplements.

Given the lack of involvement by pharmacists in the osteoporosis screening process as

conducted currently, this study was mainly designed to increase the involvement of

pharmacists in the screening and prevention of osteoporosis (not diagnosis) and aimed

to develop, implement and evaluate an integrated service involving consumer,

pharmacist, radiographer and other health care practitioners, particularly General

Practitioners, as appropriate. It also investigated whether measurement of BMD in the

pharmacy increased the effectiveness of the service and pharmacist referral in terms

of adherence to advice and uptake of referral compared with the same service offered

without BMD.

The specific objectives were as follows:-

To develop a risk assessment questionnaire, advice and referral protocol.

To recruit and train 12 pharmacists (six rural and six urban) to deliver the

service (BMD + risk assessment [6] or risk assessment only [6])

For pharmacists to

o recruit 20 participants each

o deliver the randomly assigned service

o follow up the participants at 3 and 6 months with respect to

adherence to treatment advice

adherence to referral advice

any fractures which may have occurred

For the project officer to

o Follow up the participants at 3 and 6 months with respect to

21

adherence to treatment advice

adherence to referral advice

any fractures which may have occurred

To evaluate the training for the program

To evaluate the program itself from the participants’ perspective and from the

pharmacists’ perspective

To conduct a cost effectiveness and a cost benefit analysis of the services.

22

2. METHODOLOGY

2.1 CONSULTATION AND PROGRAM DEVELOPMENT

A protocol for the conduct of the project was developed and approved by the

University of Sydney’s Human Research Ethics Committee. A Steering Committee

was formed encompassing all facets of expertise from the field; the coordinator of the

Dubbo Osteoporosis Epidemiology Study, a leading endocrinologist from Concord

Hospital, an education officer from Osteoporosis NSW, a diagnostic radiographer, a

community pharmacist, the chief research investigator and the project officer. The

Steering Committee met initially on the 3rd June 2003, followed by regular informal

discussions, where all aspects of the project protocol development were reviewed and

discussed. At the initial meeting the pharmacy selection protocol was reviewed and

the process of initial contact with pharmacists confirmed (Appendix 1).

As a result of this consultation with the Steering Committee and other experts in the

field, and taking into account current best practice guidelines, an osteoporosis

information package and screening protocol was developed to be delivered by

community pharmacists and a radiographer in the pharmacy. This package comprised

a risk assessment questionnaire (Appendix 2), a decision making tool (Appendix 3),

various information pamphlets on osteoporosis to hand out to participants (Appendix

4), a pharmacist data record sheet (Appendix 5) and General Practitioner (GP) referral

forms (Appendix 6), so the pharmacist could determine appropriate treatment, follow-

up, or referral to GP or other health care practitioner.

The risk assessment questionnaire and risk assessment categories had been pilot tested

in 2001 on 28 peri-menopausal women (Lawrence & Taylor, 2002). The

questionnaire was developed after an extensive review of the literature and available

risk assessment tools, using the “One minute risk test” developed by the International

Osteoporosis Foundation as a starting point (www.osteofound.org/osteoporosis/risk).

Extra questions were added to elicit more of the participants’ medical and medication

history.

2.2 RECRUITMENT OF PHARMACISTS

The research locations were identified using the following rationale for selection:

23

Rationale for selection of rural locations

Towns / cities selected for the project had to:

1. be reasonably close to Orange and to Sydney to reduce travel costs

2. have their own local paper

3. be geographically distinct to avoid overlap in recruitment of participants

4. have at least one pharmacy

5. fall into one of three rural population categories as per the Rural, Remote and

Metropolitan Areas (RRMA) classification (DPIE & DHSH 1994):

- between 25,000 and 100,000 (large rural centres)

- between 10,000 and 25,000 (small rural centres)

- under 10,000 (other rural centres)

Rationale for selection of urban locations

Suburbs selected for the project had to:

1. be readily accessible, particularly in terms of reasonable proximity to main

access routes and to Orange

2. encompass a broad cross section of communities in Western Sydney in terms

of demographic and income data

3. be served by a paper owned by a single publisher, reducing the risk of overlap

of advertising

4. be geographically distinct, to avoid overlap in recruitment of participants

5. have a low incidence of BMD testing

Based on the above criteria the towns of Blayney, Parkes, Lithgow, Molong, Orange

and Bathurst were selected for the rural locations. The suburbs of Bankstown,

Burwood, Fairfield, St Mary’s, Wentworthville and Blaxland were selected for the

urban locations. Western Sydney was chosen because pharmacies were less likely to

be offering BMD testing already. All pharmacists in these six suburbs of western

Sydney (n=66) and in six rural communities (n=20) were invited to participate in the

program.

Of those willing to participate who could offer suitable premises and staffing levels,

one pharmacist in each area was randomly chosen to be involved in the study. These

pharmacists were then randomised into one of the two groups (Group 1 – offer BMD

24

test and Group 2 – not offer BMD test (Non BMD)) described below making six

pharmacies in each group, (three from rural NSW and three from metropolitan

Sydney). While this randomisation did not ensure that a full randomised controlled

study was conducted it helped to minimise some of the potential bias.

2.3 PROFESSIONAL DEVELOPMENT OF PHARMACISTS

A seven hour education and training program for participating pharmacists was

developed in collaboration with Osteoporosis NSW. This program was delivered to

the participating pharmacists in the form of a one-day workshop (Appendix 7). The

training team included an endocrinologist, a radiographer, an education officer from

Osteoporosis NSW, a community pharmacist and the chief research investigator.

Background information on the disease process itself was presented, along with

information on the various tests available including the one being used in this study

(X-ray of the forearm with a mobile DEXA machine), preventative measures for

osteoporosis, referral, monitoring, and treatment options as well as the protocols of

the study.

Two training sessions were held, one in the rural area (University of Sydney – Orange

campus) and one in the urban area (University of Sydney – Camperdown campus).

Several pharmacists were unable to attend these sessions and were trained on site in

their pharmacy. The one-day workshop was followed up by on site visits to all

participating pharmacies by the chief research officer and the project officer to check

protocol adherence, consistency of service delivery and to answer any queries that the

pharmacist might have. A newsletter was produced by the research team and

distributed during the project to keep the participating pharmacists up-to-date with

project developments, and to act as a place where they could share their successes and

any problems related to the project (Appendix 8).

2.4 RECRUITMENT OF PARTICIPANTS

Sample Size

The study aimed for 20 participants per pharmacy (120 per group) in order to detect a

20% between group difference in uptake of referral and adherence. This is based on a

power of 80% and statistical significance of 5%.

25

Inclusion Criteria

Because the project was looking at screening procedures and prevention treatment for

osteoporosis, all participants were required to fit the following criteria:

1. women over the age of 40, or men over the age of 50

2. no BMD test in the last 2 years

3. no previous treatment for osteoporosis

Posters inviting women over the age of 40 and men over the age of 50 to undergo risk

assessment for osteoporosis were displayed in the participating pharmacies and

advertisements were placed in local papers indicating the pharmacies participating in

the study (Appendix 9). Interested participant were given an information sheet and

consent form (Appendix 11).

2.5 SERVICE DELIVERY

Risk Assessment and Treatment Decision

A single radiographer was employed to carry out all of the BMD tests within each

BMD group pharmacy. An example of a BMD test result and information provided to

the pharmacist is given in Appendix 10. Pharmacists delivered the rest of the service.

Willing participants were asked to sign a consent form (Appendix 11) and to complete

the risk assessment questionnaire that also included questions on their demographic

characteristics (Appendix 2). The pharmacist then guided the participants through the

risk assessment, treatment decision pathway and referral if required, documenting the

process at the same time on the pharmacist data record sheet (Appendix 5).

One pharmacy in the BMD group was asked to conduct their risk assessment

separately from the BMD Test and record this result. This was to provide some

insight into how the BMD test result was used in risk categorisation.

Experimental Groups

Group 1 (BMD) – provide BMD measurement

The participants in this group received an osteoporosis risk assessment conducted by

the pharmacist, a peripheral BMD check in the pharmacy (using DEXA of the

forearm) conducted by the radiographer, and then were provided with information and

help by the pharmacist to make a decision about treatment based on the risk

26

assessment and BMD result. Also the pharmacist would refer the participant,

according to protocol, to the appropriate health care practitioner if necessary.

Group 2 (non BMD) – do not provide BMD measurement

The participants in this group received the same service as those in Group 1 but

without the BMD measurement in the pharmacy.

Follow-up by Pharmacist

After three months the participant’s understanding and adherence to the treatment

decision was assessed and reinforced by pharmacist either in person or via the

telephone. Results were documented on the pharmacist data record sheet (Appendix

6). After six months, adherence to treatment was further assessed and also

documented on the pharmacist data record sheet (Appendix 5). Any further BMD

result was recorded.

Follow-up by Project Officer

It was proposed that all participants would be surveyed after three months and again

after six months of the service delivery. In the 3 month survey the participant’s

adherence to treatment advice and willingness to pay (WTP) for the service provided

were recorded in a telephone survey (Appendix 12). The participants were asked to

rate their satisfaction with the general health promotion and screening services

provided and the health information they personally received from their pharmacy, as

well as to rate their level of agreement about the provision of health promotion and

screening service in pharmacies generally, using a five point differential scale.

During the three month survey it was found that not all participants were willing to

continue their participation or were unable to be contacted successfully. Taking this

into account, along with time and cost restraints, it was decided that only a small

selected sub group, that included all high risk participants and those referred to other

health care practitioners, would be contacted for the six month survey (Appendix 13).

2.6 EVALUATION OF PROGRAM BY PHARMACISTS

At the completion of the service delivery participating pharmacists were asked to fill

in an evaluation survey to provide feedback on the training provided and the service

27

program (Appendix 14). A separate questionnaire was sent to pharmacists in Group 1

(BMD) and Group 2 (Non BMD).

2.7 COST EFFECTIVENESS ANALYSIS

The cost of providing the service was measured in terms of pharmacist time spent

with the participant when delivering the service, the cost of telephone calls, if

relevant, and the cost of a bone mineral density test. Development of materials and

training of pharmacists were not included because the training materials were funded

by the grant and pharmacists normally would be expected to pay for training as

continuing education.

Effectiveness was measured as the proportion of participants adhering to the treatment

decision and GP referral uptake given to them by the pharmacist. The incremental

cost effectiveness ratio was calculated which gave a measure of the extra cost

required to achieve any extra effectiveness in Group 1 compared with Group 2.

2.8 COST BENEFIT ANALYSIS

Although participants in this study could not be charged for the service they received,

it is known that people currently receiving BMD measurement in a community

pharmacy are paying approximately $40 per test. This indicates the value that

consumers place on such a test and represents a revealed preference. The maximum

WTP for the service participants received during the study was assessed to give a

measure of benefit in monetary terms and represented a stated preference. This stated

preference was then compared with the revealed preference.

The cost of providing the service in the BMG group was subtracted from the benefit

(maximum WTP) obtained from receiving that service to determine if the service was

self-sustaining. Similarly, the cost of providing the service in Non BMD group was

subtracted from the benefit (maximum WTP) obtained from receiving that service.

28

2.9 STATISTICAL ANALYSIS

In all analyses the level of significance was set at 0.05.

Recruitment and characteristics of participants

The recruitment success between urban and rural pharmacies, and BMD and non

BMD groups was analysed using a Fisher’s Exact Test. The differences between

demographic characteristics and osteoporosis risk factors of the two experimental

groups were also analysed using a Fisher’s Exact Test.

Service Delivery

Participants’ osteoporosis risk factors were compared between experimental groups

using Fisher’s Exact Test. Risk assessment results between groups were compared

using Pearson’s Chi-squared Test. The results from the BMD tests, adherence to

treatment decision and referral uptake were compared using Fisher’s Exact Test.

Evaluation of Service

The recruitment of regular versus new customers between locations and experimental

groups was compared using Fisher’s Exact Test. The participants’ satisfaction with

the general health promotion and screening services provided in their pharmacy and

the health information they personally received from the pharmacy were compared

between experimental groups using a Fisher’s Exact Test.

29

3. RESULTS

3.1 RECRUITMENT OF PHARMACISTS

The 12 pharmacies recruited were randomised into BMD and Non BMD service

delivery as shown in Table 3.1. There was one rural location from each of the three

RRMA population categories in each experimental group. The urban locations were

geographically distinct to avoid overlap of recruitment and encompassed a broad

cross section of communities in Western Sydney and the Blue Mountains.

Table 3.1: Location and type of service delivered by recruited pharmacies.

BMD Non BMD

Rural Molong Blayney

Kelso Orange

Parkes Lithgow

Urban Fairfield St Mary’s

Wentworthville Blaxland

Bankstown Burwood

3.2 RECRUITMENT RESPONSE

Two hundred and seventeen participants were recruited by the twelve pharmacists,

119 in the BMD group (59 in the urban pharmacies and 60 in the rural pharmacies)

and 98 in the non BMD group (55 in the urban pharmacies and 43 in the rural

pharmacies) (Table 3.2). All pharmacists aimed to recruit 20 participants (240 in

total). There was a significant difference in recruitment success between urban and

rural pharmacies (2=4.63, DF=1, p=0.031). There was no difference in recruitment

success between BMD and non BMD groups in the urban pharmacies (2=3.79,

DF=1, p=0.051), however there was a significant difference in recruitment success

between BMD and non BMD groups in the rural pharmacies (2=19.81, DF=1, p<

0.005).

30

Table 3.2: Recruited participants (expected recruitment) for all pharmacies.

Pharmacy / Trial group BMD Non BMD

Rural 60 (60) 43 (60)

Urban 59 (60) 55 (60)

After an onsite visit to one of the rural non BMD pharmacies it was found that the

pharmacist was not following the project protocol. It was necessary to exclude from

the analysis all data collected from the thirteen recruited participants at this pharmacy

and, because the community from which the participants were recruited was small,

this site had to be dropped from the study. This left a total of 204 recruited

participants. With these participants removed (Table 3.3) there was no significant

difference in recruitment success between urban and rural pharmacies (2=1.33,

DF=1, p=0.249), but there was still a highly significant difference in the recruitment

success between BMD and non BMD groups in the rural pharmacies (2=16.67,

DF=1, p< 0.005), with the BMD pharmacies being more successful.

Table 3.3: Recruited participants (expected recruitment) – one rural non BMD pharmacy removed. Pharmacy / Trial group BMD Non BMD

Rural 60 (60) 30 (40)

Urban 59 (60) 55 (60)

From the 204 initially recruited participants (one pharmacy removed as explained

above), one participant passed away (from urban BMD), and another (from urban non

BMD) pulled out of the trial for personal reasons before the risk assessment was

completed. The records of four participants were lost when one of the urban BMD

pharmacies was vandalised during the early stages of the project. This resulted in data

from 198 participants being available for analysis (114 BMD, 84 non BMD).

31

3.3 DEMOGRAPHIC CHARACTERISTICS OF PARTICIPANTS

Demographic Characteristics

Participants in each group were well matched with respect to age, gender, country of

birth, education and employment characteristics (Table 3.4), with no statistically

differences between the participants in the BMD and Non BMD groups detected.

All participants except one, a 36-year old disabled MS sufferer who was recruited in

the rural BMD group, fulfilled the inclusion criteria. Although this individual was less

than the 40+ that was targeted, she fulfilled the other requirements that put her at high

risk. Table 3.5 gives a break down of the age groups recruited. Pharmacists

successfully recruited the majority of the participants in the lower age brackets. This

group was targeted as they would receive the most benefit from the screening

procedure and prevention strategies offered as opposed to the older age bracket who

might consist of a higher proportion already suffering from osteoporosis.

Table 3.4: Demographic characteristics of participants in the project. BMD

n=114

Non BMD

n=84

Age (mean) 57.2 57.9

Age (range) 36-78 40-84

Females 87% 83%

Born in Australia 64.5% 71.6%

Post secondary education 36% 34%

Employed 81% 82.5%

Table 3.5: Age grouping of participants. BMD Non BMD Age group

Male Female Male Female

<50 0 27 0 22

50-59 7 32 6 17

60-69 2 26 2 18

70-79 6 11 6 5

Over 80 0 0 0 4

32

3.4 SERVICE DELIVERY

Risk Assessments

Pharmacists sent in 193 completed risk assessments of participants (113 from BMD

group and 80 from non BMD group), with five risk assessments missing. Three of

these missing risk assessments were from an urban non BMD pharmacy where they

were initially filled in incorrectly and, since the participants were not regular

pharmacy customers, could not be corrected. One participant (from rural BMD group)

accidentally took his/her risk assessment home where it was subsequently misplaced,

and one risk assessment (from rural non BMD) was lost in the pharmacy.

Osteoporosis Risk Factors

Table 3.6 lists the participants’ risk factors to osteoporosis. The majority of

participants were of white or Asian background (84% BMD and 87% non BMD).

There was no difference between the experimental groups for this non-modifiable risk

factor along with the reporting of family history of the disease. However the number

of participants reporting a history of low trauma fractures was significantly higher in

the non BMD group than the BMD group (2=4.80, DF=1, p=0.028). There were no

significant differences between the modifiable osteoporosis risk factors of the

participants in each experimental group. In terms of modifiable risk factors the

majority of participants were consuming inadequate quantities of calcium (Ca) (68%

BMD and 71% non BMD) and over-consuming caffeine based products (66% BMD

and 65% non BMD).

Bone Mineral Density Test Results

The BMD tests were carried out at the urban pharmacies in the first week of October

2004, and the rural pharmacies in the first week in November. A total of 114 BMD

tests were conducted at the six pharmacies. Only one female participant was classified

as having osteoporosis (T-score of -2.8) and 29 participants (25%) were classified as

having osteopenia (T-score between -1 SD and –2.5 SD). There was no difference in

the occurrence of osteopenia between the genders or between urban and rural

pharmacies. Not surprisingly a significant difference was found between the age

group and diagnosis of osteopenia (Table 3.7), with participants over the age of 60

33

more likely to be diagnosed with osteopenia than those under 60 years of age

(2=13.2, DF=1, p<0.005).

Table 3.6: Risk Factors

Modifiable risk factors

BMD

n= 114 (%)

Non BMD

n=84 (%)

Low Calcium intake 78 (68) 60 (71)

Minimum exercise 31 (27) 23 (27)

Low Vitamin D intake 13 (11) 10 (12)

High alcohol consumption 2 (2) 0

Smoking 12 (11) 9 (11)

High caffeine consumption 75 (66) 55 (65)

Medical condition increasing risk of osteoporosis 35 (31) 27 (32)

Medication increasing risk of osteoporosis 30 (26) 22 (26)

Cessation of periods before menopause 45 (40) 32 (38)

Early menopause 25 (22) 21 (25)

Non Modifiable Risk Factors

White / Asian 96 (84) 73 (87)

Family history 32 (28) 18 (21)

History of low trauma fractures 12 (11) 18 (21)

Table 3.7: Participants’ results from the BMD Testing

Age group T-Score > -1 SD

low risk (%)

T-Score -1 to –2.5 SD

osteopenia (%) T-Score –2.5 SD

osteoporosis (%)

<50 25 (21.9) 2 (1.8) 0

50-59 32 (28.1) 7 (6.1) 0

60-69 16 (14.0) 11 (9.6) 1 (0.9)

70-79 9 (7.9) 8 (7.0) 0

missing1 2 (1.8) 1 (0.9) 0

1No age recorded

34

The category of risk for each group is listed in Table 3.8. There was a significant

difference between the groups (BMD vs Non BMD) and the category of risk

(2=14.9, DF=2, p=0.001) with non BMD pharmacies being more likely to identify

participants at high risk of osteoporosis (10.0% compared to 2.7% in BMD

pharmacies).

Table 3.8: Pharmacy risk assessments for each experimental group.

Category of risk

BMD

n=113 (%)

Non BMD

n=80 (%)

Low 78 (69) 34 (42.5)

Moderate 32 (28.3) 38 (47.5)

High 3 (2.7) 8 (10)

Effect of BMD Tests on Risk Assessments

One of the BMD group rural pharmacies recorded their initial risk assessment (from

the questionnaire only) before the BMD Test was conducted and then revised their

risk assessment taking into account the results obtained from the BMD Test. Initially

6 participants were classified as moderate risk and 14 high risk. The results from the

BMD Test had 12 participants in the low risk and 8 in the moderate risk (osteopenia)

category. The pharmacy reviewed their risk assessments accordingly with the revised

risk assessments being 13 low risk and 7 moderate risk and 0 at high risk.

BMD Tests and GP Referral

Referral was not only dependent on the BMD test result. All other risk factors,

detected through the risk assessment questionnaire, were taken into account by the

pharmacist. The one female participant who was classified as having osteoporosis

after the BMD test was referred to the GP. Of the 29 participants who were classified

as having osteopenia, six were referred to the GP, having pharmacy risk assessment

scores of medium to high and an average BMD test result of –1.81. The other 23

participants classified in the osteopenia category who were not referred had pharmacy

risk assessments scores ranging from low to medium and an average BMD test result

of –1.45.

35

Pharmacist Three Month Follow-up

Nine of the pharmacies attempted the follow up of their participants after three

months. Five were successful in contacting all their participants (2 urban and 3 rural),

but, despite repeated reminders, only three of these (2 urban and 1 rural) sent in their

record sheets to the project officer. Three of the remaining four pharmacies (1 urban

and 2 rural) contacted over 50% of their participants, with one urban pharmacy only

following up two of their 20 participants. Reasons given for not conducting or

completing the pharmacist follow up included lack of time, and difficulty in

contacting the participants who were not regular customers.

Project Officer Three Month Follow-up

Three months after the service was provided in the pharmacies, 172 of the 198

participants (BMD 100, Non BMD 72) were successfully contacted by the project

officer for the telephone survey (Appendix 13).

Treatment Decision

As part of the three month follow up, participants were asked by the project officer

about the treatment decisions they had discussed with the pharmacist and their

adherence to these treatment decisions (Table 3.9).

Table 3.9: Treatment decision decided on by the pharmacist and participant.

Treatment Decision BMD

n=100 (%)

Non BMD

n=72 (%)

Calcium increase recommended 45 (45) 38 (53)

Increase exercise recommended 35 (35) 26 (36)

Vitamin D increase recommended 21 (21) 7 (10)

Reduction in smoking recommended 9 (9) 4 (4)

Reduction in alcohol consumption recommended 3(3) 4 (6)

Adherence to Treatment Decision

Table 3.10 gives the number of participants who adhered to the treatment decision,

regarding certain risk factors, after three months (taken as the number of participants

who recalled having been given advice on the three month survey and who were still

36

following that advice after three months). Analysis by Fisher’s Exact test showed

there was no significant differences in the adherence for each of the treatment

decisions between groups (BMD and Non BMD), however the small numbers in some

groups may have impacted on this result.

Table 3.10: Participants’ adherence to treatment decision after 3 months, grouped in BMD vs Non BMD.

Treatment Decision

BMD

(% of advised)

Non BMD

(% of advised)

Increase calcium intake 37/45 (82) 29/38 (76)

Increase exercise 24/35 (69) 21/26 (81)

Increase Vitamin D intake 18/21 (86) 4/7 (57)

Decrease smoking 3/9 (33.3) 0/4

Decrease alcohol consumption 3/3 (100) 3/4 (75)

Reasons for Non-Adherence

The reasons given by participants for non-adherence to advice are given in Table

3.11. Not all participants gave reasons for their non-adherence. Other health issues

prevented many of the participants from following the exercise advice, as well as the

lack of time and commitment. Three participants claimed it was too hot to exercise

during the summer months but only one of these participants had begun exercising

when interviewed at the six month survey in the cooler months.

Table 3.11: Reasons given by participants for non-adherence to advice.

Reasons for not following advice

Increase calcium intake

Increase exercise regime

Increase vitamin D

intake

Reduce / quit

smoking

Reduce alcohol intake

Health complications 0 7 0 0 0 Lack of time 0 6 0 0 0 Not committed/too lazy 0 1 1 3 0 Peer/social pressure 0 0 0 1 1 Memory 2 0 0 0 0 Belief that not necessary 3 0 1 0 0 Too hot 0 3 0 0 0 Too stressful 1 0 0 0 0 Treatment cause constipation 2 0 0 0 0 Dislike recommended treatment 1 0 1 0 0 Waiting for test results 0 0 1 0 0 Referral to General Practitioners (GP)

37

Pharmacists referred a total of 29 participants to their GP following the risk

assessments (7 in the BMD group and 22 in the non BMD group). All high risk

participants were referred as per the protocol. A higher proportion of moderate risk

patients were referred from the Non BMD pharmacies than the BMD pharmacies. The

BMD pharmacies did not refer any low risk patients but the Non BMD pharmacies

referred two (Table 3.12).

Table 3.12: Participants referred to GP after risk assessment. Pharmacy risk

assessment

BMD

(% of referred)

Non BMD

(% of referred)

Low 0 2 (9)

Moderate 4 (57) 12 (55)

High 3 (43) 8 (36)

Referral Uptake

In the BMD group 7 participants were referred to the GP, of whom only two followed

through with a visit. In the Non BMD group 22 were referred and only 3 of these took

up the referral. A full breakdown of the numbers of participants referred to their GP,

the uptake of these referrals and their outcome is given in Figure 3.1 (BMD group)

and Figure 3.2 (non BMD group). There was no statistical difference between the two

groups in referral uptake (2=0.999, DF=1, p=0.558). The three participants whose

uptake was unknown were not included in this analysis. All of the high risk

participants from either group (BMD and Non BMD) who were referred and visited

their GP had some action taken by the GP. There were two cases of medication

prescription and a BMD test for one of the participants in the non BMD group. The

result of this BMD test classified the participant as having osteopenia (T-score

between -1 SD and –2.5 SD) and she was also prescribed medication.

Fracture Incidence

One participant suffered a fracture of the toes and fingers in the three months after the

risk assessment. This participant was a 43-year old female, who was in the non BMD

group. Her pharmacist risk assessment was high and she was referred to her GP, who

38

Figure 3.1: Participants from BMD group referred to their GP, the uptake of these referrals and their outcome.

Risk Assessment(113)

High(3)Low (78) Medium (32)

Not referred toGP (78)

Referred to GP(0)

Not referred toGP (28)

Referred to GP(4)

Not referred toGP (0)

Referred to GP(3)

GP visitunknown (1) GP visited (1)GP not visited

(2)GP not visited

(2) GP visited (1)

No GP action(0)

GP action(1 - medication)

No GP action(1)

GP action(0)

39

Figure 3.2: Participants from Non BMD group referred to their GP, the uptake of these referrals and their outcome.

Risk Assessment(80)

High(8)Low (34) Medium (38)

Not referred toGP (32)

Referred to GP(2)

Not referred toGP (26)

Referred to GP(12)

Not referred toGP (0)

Referred to GP(8)

GP visitunknown (2)GP visited (1)GP not visited

(11)GP not visited

(4) GP visited (2)

No GP action(0)

GP action(2*)

No GP action(1)

GP action(0)

GP not visited(2) GP visited (0)

40

advised her to take Caltrate and have a BMD Test. The results from this test classified

her at moderate risk (osteopenia). This participant was also advised to increase her

calcium intake and decrease her alcohol consumption.

Pharmacist Six Month Follow-up

The planned six month follow up by pharmacists was not done. Given the high

proportion of low risk participants and non regular customers involved in the study

pharmacists independently decided that this was not a worthwhile use of their time.

Project Officer Six Month Follow-up

Twenty high risk and/or GP referred participants were surveyed for advice and

referral adherence six months after the risk assessment.

Adherence to Advice after 6 Months

There was no difference in adherence after six months between BMD and Non BMD

groups although the numbers surveyed were small (as explained above). Every

participant who had been given advice on increasing Vitamin D, and had adhered to

the advice after 3 months, was still adhering to the advice after 6 months. The same

situation occurred with calcium advice in the BMD treatment group. However only 5

of the original 9 advised to take calcium in the non BMD group were continuing to

take it after six months. All participants adhered to the exercise advice in the non

BMD group after three months but one dropped out after six months. Two participants

did not adhere to their exercise advice after three months in the BMD group and one

dropped out after six months however two participants who had not adhered to their

exercise advice at 3 months had started exercising by six months (Table 3.13).

Table 3.13: Adherence to advice at six months by participants who were

classified at high risk and/or who were referred to their GP.

Increase calcium Increase exercise Increase Vitamin D BMD non BMD BMD non BMD BMD non BMD advised at risk assessment 4 9 5 5 3 1 followed advice after 3 months 4 7 3 5 3 1 following advice after 6 months 4 5 4 4 3 1

41

Referral

There were no new GP referral uptakes after six months. Participants who had been

referred to their GP and who had not visited them within the first three months after

the referral had still not made the visit by six months.

3.5 EVALUATION OF SERVICE - PHARMACISTS

Evaluation of professional development program

Ten pharmacists (six rural and four urban) responded to the training evaluation survey

(Appendix 14). One urban pharmacy from each group (BMD and Non BMD) did not

respond. All pharmacists were satisfied or very satisfied with the training that was

given. They all felt that the training day increased their knowledge of osteoporosis,

they felt equipped and confident to carry out and interpret the risk assessments and

felt able to facilitate the prevention and management education. Those pharmacies

that provided the BMD test were all satisfied at the level of their knowledge of BMD

testing and the interpretation of the results but knew that the radiographer would

provide this information to participants. Eight of the ten pharmacies were satisfied

with both their understanding of the project’s aims and referral protocols. The other

two pharmacists were neutral in their level of satisfaction with either the project’s

aims or referral protocols.

All participating pharmacists agreed there was a good balance in the training

presentations between general osteoporosis information and specific project

information. However two pharmacists indicated there should have been more time

spent on practicing project procedures and role-playing. The pharmacists all agreed

that the scope of the background, BMD testing and project information presented was

adequate, however while 80% of the pharmacists believed there was adequate

information presented on the use of risk assessment, one believed there was too much

information presented on this topic with another believing there was too little.

Evaluation of recruitment of participants

All the responding pharmacists who offered the BMD test as part of their service said

it was not difficult to recruit participants for the project, and that offering the BMD

test had made it easier for recruitment. Two of the five responding pharmacists (one

rural, one urban) who did not offer the BMD test as part of their service found it

42

difficult to recruit participants. Sixty percent of these pharmacists believed that

recruitment was made more difficult because the BMD test was not offered.

There was no difference in the recruitment of regular customers versus new customers

between BMD and Non BMD pharmacies (2=0.2, DF=1, p=0.74). However there

was a significant difference in the recruitment of regular versus new customers

between the urban and rural locations (2=24.3, DF=1, p<0.001), with the rural

pharmacies recruiting more regular customers (Table 3.14). All participants from

three of the rural pharmacies were regular customers. Of these new customers who

were recruited by the pharmacies (47 in total) only two, both attending a rural

pharmacy became regular customers after the assessments were completed.

Table 3.14: Recruitment of participants at pharmacies that responded to

evaluation survey grouped between urban and rural locations.

Urban pharmacies

n=80

Rural pharmacies

n=103

Regular customers 45 91

New customers 35 12

Only three of the participating pharmacies (all rural) had offered BMD test prior to

this project. Two of these pharmacies were in the BMD group and felt that offering

the free BMD test attracted participants who otherwise would not have paid for a

commercial BMD test. The one pharmacy that was in the non BMD group felt that not

offering a BMD test did not reduce the attraction of the service offered.

Service Delivery

The pharmacists were asked to estimate the time they spent delivering each section of

the service. Both BMD and Non BMD pharmacies spent similar times doing the risk

assessment and counselling of participants. The BMD group as a whole spent less

time following up the participants than the Non BMD group. The BMD Test added

approximately twenty minutes to the total time it took to deliver the service (Table

3.15).

43

Participating pharmacists were also asked if they would make any changes to the

service if they were to deliver it in the future. One pharmacist felt that the risk

assessment guidelines were not adequate and needed to be clearer. Another thought

that, although the guidelines were adequate, a better system was needed to quantify

the dietary intact of calcium and Vitamin D. Four of the pharmacists found that

interruptions had been a major problem when delivering the service, and either more

staff would be required or the service could be delivered out of business hours to

minimise the impact.

Table 3.15 : Estimated time it took to deliver the service per participant.

Service BMD

Range (average)

Non BMD

Range (average)

Risk assessment 15-30 mins (21) 10-40 mins (25)

BMD Test 15-30 mins (19) -

Counselling 10-15 mins (12) 10-20 mins (15)

Follow up 5-15 mins (8) 10-30 mins (20)

TOTAL 45-90 mins (60) 20-75 mins (46)

There were six leaflets supplied as part of the package for pharmacists to handout to

the participants (Appendix 4). All of the pharmacists, except one found all of these

leaflets helpful and informative. Although this one pharmacist found two of the

leaflets (“Preventing osteoporosis” and “Osteoporosis fact sheet”) helpful, they found

the leaflet “Osteoporosis and exercise” unhelpful and had no opinion on the others.

3.6 EVALUATION OF SERVICE - PARTICIPANTS

Participants’ satisfaction with service

In the three month survey, participants were asked to rate their satisfaction with the

general health promotion and screening services provided in their pharmacy and the

health information they personally received from the pharmacy. Twenty-eight of the

198 participants (14 from each group) could not be reached for the three month

telephone survey. The results were divided into two groups, those participants who

received a BMD Test and those who did not (Tables 3.16 and 3.17). There was a

44

significant difference between the participants’ satisfaction of health screening and

promotional services in the pharmacy between groups (2=26.176, DF=1, p< 0.005)

as well as between the health information offered by their pharmacy (2=19.356,

DF=1, p< 0.005), with the participants who received a BMD test more satisfied than

those who did not.

Table 3.16: Participant satisfaction with general health screening and promotional services in pharmacy divided by BMD group.

Participant answer BMD

n=100 (%) Non BMD n=70 (%)

Extremely dissatisfied 0 0

Dissatisfied 0 6 (9)

No opinion 10 (10) 17 (24)

Satisfied 38 (38) 36 (51)

Extremely satisfied 52 (52) 11(16)

Table 3.17: Participant satisfaction with health information offered by pharmacy divided by BMD group.

Participant answer BMD

n=100 (%) Non BMD n=70 (%)

Extremely dissatisfied 0 0

Dissatisfied 0 4 (6)

No opinion 5 (5) 10 (14)

Satisfied 47 (47) 44 (63)

Extremely satisfied 48 (48) 12 (17)

This difference between treatment groups (BMD vs Non BMD) was also highlighted

in the comments from participants given in the three month follow up survey.

Although there were positive comments from both groups about the service they

received, many of the non BMD group (30% of respondents) were disappointed they

did not receive a BMD test; “A very worthwhile service, disappointed no BMD test”.

Participants listed the advantages of offering this service at the pharmacy as: easy

45

access, convenient location and hours of business, cost saving, personalised service,

early detection and prevention and greater awareness. The main problems with the

service were the accuracy of results (BMD test) and privacy issues.

Participants’ attitude to health promotion in pharmacies

The responses to the three month survey where participants were asked to rate their

level of agreement about the provision of a health promotion and screening service in

the pharmacy are given in Table 3.18. There were 168 participants who responded to

these questions (Twenty-six missing three month telephone surveys and four

participants who did not complete this section of the survey). Participants believed

that pharmacists can have other roles in health care as well as dispensing

prescriptions, and one of these roles is the promotion of good health in the

community. Participants also agreed that it is appropriate for pharmacists to be a

source of general health information and they should have information leaflets and

brochures available. Participants also supported the idea that pharmacists can help in

the early detection of diseases by performing screening test such as bone mineral

density.

Table 3.18: Responses (as % responding) to each of the questions on the

provision of health promotion and screening services in pharmacies.

Question Agree No opinion Disagree

Is it appropriate for the pharmacist to have health information leaflets or

brochures available in the pharmacy 97 2 1

The pharmacist has a role in promoting good health in the community 95 4 1 It is good to make available tests such as bone mineral density 94 4 2 The pharmacist should be a source of general health information for the

public 94 4 2

A pharmacy is not the place to be performing tests such as bone mineral

density testing 9 8 83

The pharmacist can help in the early detection of diseases by performing

screening tests 80 12 8

As well as dispensing prescriptions, a pharmacist has other roles in

health care 93 4 3

Screening tests such as measurement of bone density can be performed

in a pharmacy 88 6 6

46

3.7 ECONOMIC EVALUATION

3.7.1 Cost Effectiveness Analysis

Costs

Pharmacist Time

The average time taken by pharmacists to deliver the Risk Assessment + BMD

service (including follow up) was 60 minutes whereas that for the Risk Assessment

only service was 46 minutes (Table 3.14).

These totals were multiplied by $40, the average award rate for an experienced

practicing community pharmacist (Pharmacy Guild of Australia) then divided by 60

to give the average time per hour spent providing the service per patient. This gave a

figure of $40 for the BMD service and $30.67 for the Non BMD service

Telephone calls

The cost of a local telephone call was 20c. The total number of calls estimated by

Pharmacists was 17, 7 in the BMD group and 10 in the Non BMD group. Thus the

total cost of phone calls was $1.40 for the BMD group and $2 for Non BMD group.

BMD Test

The amount of $40 was paid to the radiographer for conducting the BMD test as part

of this project. This is also the usual fee charged when the service is offered

commercially.

The total cost of delivering the BMD service per participant was $81.40 whereas that

for the Non BMD service was $32.67 (Table 3.19).

Table 3.19: Cost of delivering the service.

Service BMD

Average

Non BMD

Average

Pharmacist Time $40 $30.67

Phone calls $1.40 $2.00

BMD Test $40 -

TOTAL COST $81.40 $32.67

47

Possible measures of effectiveness

Usually in cost effectiveness studies it is desirable to use Life Years Gained as the

outcome measure for effectiveness. However, in this study an intermediate outcome

had to be chose. Increase in calcium or Vitamin D intake or exercise were considered

along with referral to the GP.

Forty five of 113 participants in the BMD group were advised to take extra calcium.

Of these 45, 37 (82%) were taking extra calcium at the three month follow up. For the

Non BMD group 38/80 were advised to increase their calcium intake and of these 29

(76%) were taking extra calcium at the three month follow up. Similarly a higher

proportion in the BMD group were adhering to the advice about increased Vitamin D

intake in the BMD group. However, a higher proportion in the Non BMD group were

adhering to the advice about increased exercise (Table 3.20).

Uptake of referral to the GP was also recorded and considered as a measure of

effectiveness for the cost effectiveness analysis however, of the 22 participants in the

Non BMD group referred to their GP, only 3 had been to see their GP at the three

month follow up and there was no increase after the six month follow up. Similarly,

of the 7 participants referred in the BMD group only 2 had been to their GP by the

three month follow up and there was no change after the six month follow up (Table

3.20).

Table 3.20: Possible measures of effectiveness.

Treatment Decision

BMD

(% of advised)

Non BMD

(% of advised)

Increased calcium intake 37/45 (82) 29/38 (76)

Increased exercise 24/35 (69) 21/26 (81)

Increased Vitamin D intake 18/21 (86) 4/7 (57)

Referred and went to GP 2/7 (29%) 3/22 (13.6%)

Given the small sample size, increase in calcium intake advice was used as the

measure of effectiveness because more participants were advised to do this.

48

Cost Effectiveness Analysis

Thus, based on the self report of the participants the probability of following advice

for BMD group vs Non BMD group was 0.8 vs 0.76

Cost

The cost of the BMD service was $81.40 while that of the Non BMD service was

$31.67

Incremental Cost Effectiveness Ratio

C1-C2 = 81.40 – 31.67 = 49.73 = $1243.25

E1-E2 0.8-0.76 0.04

for each extra person adhering to advice about calcium following a BMD test

compared with no BMD test. This figure is not particularly meaningful because it

cannot easily be compared with other programs.

3.7.2 Cost Benefit Analysis

Stated Preference Data

When asked the question “Would you be willing to pay for the service you received?”

100 of the 167 participants contacted gave a response. In the BMD group 64/99 (64%)

answered in the affirmative while 36/68 (53%) of the Non BMD group said yes. This

difference was not statistically significant (Table 3.21).

When asked whether they would be willing to pay for the alternative service (ie the

service they did not receive) a statistically significant difference was found in the

proportion willing to pay for BMD + risk assessment compared with risk assessment

only (72% vs 19%) (Table 3.21).

49

Table: 3.21: Number and proportion of participants willing to pay for

osteoporosis risk assessment.

BMD Non BMD

Willing To Pay for service received * 64/99 (64%) 36/68 (53%)

Willing To Pay for risk assessment and BMD - 21/29 (72%)**

Willing To Pay for risk assessment only 16/85 (19%) ** -

* Service received by BMD group was risk assessment plus BMD while service

received by Non BMD was risk assessment by questionnaire only.

**P< 0.001 chi squared

Although 64/99 participants who received the BMD service responded that they

would be willing to pay for it, only 51 were prepared to offer an amount of money.

The mean maximum willingness to pay was $36 and the median $30. Similarly only

30 of the 36 respondents in the Non BMD group were prepared to place a monetary

value on the service they received. In this case the mean maximum WTP was $22 and

the median $20. As the data were collected from a small number of respondents they

were not normally distributed and so the median values were used for comparison.

The difference of $30 (BMD) vs $20 (Non BMD) was statistically significant. (p =

0.001 Mann-Whitney U test) indicating that those who received the BMD service

valued it more highly than those who received the Non BMD service (Table 3.22).

Twenty two participants in the Non BMD group valued the BMD service more highly

($28 vs $22) than the service they actually received while 7 of the BMD group valued

the Non BMD service less than the service they received ($25 vs $30) (Table 3.22).

Thus both groups valued the BMD service more highly by approximately $5.

However the number of people answering this question was small, considerably less

than the number who said they would be prepared to pay for the service they received

or the alternative and no statistically significant differences were found.

50

Table 3.22: Willingness to pay amounts for osteoporosis risk assessment.

BMD Non BMD

WTP amount for service received *

N

Mean

Median

Range

51

$36

$30

($1-80)

30

$22

$20

($3-50)

WTP amount for risk assessment only

N

Mean

Median

Range

7

$24

$25

($1-50)

WTP amount for risk assessment and BMD

N

Mean

Median

Range

22

$40

$28

($3-150)

* Service received by BMD group was risk assessment plus BMD while service

received by Non BMD was risk assessment by questionnaire only

Cost Benefit Analysis based on Stated Preference Data

BMD service

This stated preference data indicated that the median maximum WTP value was $30

for the BMD + Risk Assessment Service and the cost of providing that service was

$81.40.

Cost of providing BMD + Risk assessment – WTP = $81.40 - $30 = $51.40

Non BMD service

This stated preference data indicate that the median maximum WTP value was $20

for the Non BMD Risk Assessment Service and the cost of providing that service was

$32.67.

Cost of providing Risk assessment – WTP = 32.67 - $20 = $12.67

51

In both cases the cost outweighs benefit measured as participants’ WTP and therefore,

according to economic theory, the service should not be supplied. In other words, if

patients were charged the true cost of the service they might not take it up. However,

we know from Revealed Preference data from the general population (not the

participants in this study) that consumers currently pay approximately $40 for a BMD

test in a community pharmacy. This includes a brief risk assessment survey currently

conducted by the radiographer, rental of the pharmacy space and the BMD test with

results.

Sensitivity Analysis

Some double payment may have been incorporated in the costing of the BMD service.

An alternative costing could include a reduction in the amount paid to the

radiographer and limit his/her involvement to conducting and interpreting the DEXA

scan only. The amount of $40 normally charged includes a risk assessment conducted

by the radiographer. However, if this role is taken over completely by the pharmacist

the cost of the BMD test could be reduced to $25 and the cost of the complete BMD

service reduced to $56.40. Even if this were done the cost is still greater than the

benefit of $30 placed on the service by participants.

52

4. DISCUSSON Summary of Results Twelve pharmacists were recruited who then, between them, recruited 217

participants. Of these, 193 completed the study (113 BMD group and 80 Non BMD

group). Pharmacists categorised 11/193 (5.7%) participants as being at high risk of

osteoporosis, 3 in the BMD group and 8 in the Non BMD group (p=0.001) and all

these people were referred to their GP for follow up.

The most commonly encountered and most easily rectified risk factor found was low

intake of calcium. Pharmacists in the BMD group advised 45% of participants to

increase their calcium intake and, of these, 82% were doing so at the 3 month follow

up. In the Non BMD group pharmacists advised 53% of participants to increase their

calcium intake and of these 76% were doing so at the 3 month follow up. This

difference was not statistically significant.

There was no difference in adherence to any other treatment decisions between those

given BMD with risk assessment and those who were not.

Participants were asked to place a monetary value on the service they received by

expressing their Maximum Willingness to Pay for it. In the BMD group the median

maximum WTP was $30 compared with $20 (p=0.001) expressed by the Non BMD

group. This indicated that those who experienced the BMD + Risk Assessment valued

the service significantly more highly than those who experienced the Risk Assessment

only.

Recruitment

It was clear from the comments of both pharmacists and participants that participants

expected a BMD test to be part of the service, even though the scope of each service

was clearly outlined in the relevant advertising. This expectation was most likely due

to the fact that such tests are already being routinely offered in many community

pharmacies. BMD inclusion made it easier for pharmacists to recruit participants and

also made it easier for the pharmacists to deliver the service because all tests were

done on the same day. If the pharmacist organised extra staff for the day he/she could

then focus on the one activity.

53

Pharmacy/cist characteristics also played an important role in levels of recruitment

and efficacy of service delivery. One pharmacist misunderstood the project protocol

and this resulted in the loss of data from one site. Another rural site lost a locum

during the course of the project, which limited his time available for both recruitment

and service delivery.

Risk categorisation

The proportion of participants categorised at high risk in this study was 5.7%. Of the

11 people referred to their GP only 3 visited the doctor, 1 of the BMD group and 2 of

the Non BMD group. In all cases action was taken, with either medication being

prescribed or medication plus a central BMD test. An additional 70/193 were

categorised as being at moderate risk of osteoporosis, 30 in the BMD group and 38 in

the Non BMD group. Of the four in this category in the BMD group referred to their

GP only one went and of the 12 in the Non BMD group referred only one visited the

GP. The reasons for this low uptake are not known.

This means that for every 100 patients whose risk was assessed in the study, 1.6 were

found to be at high risk and had drug treatment prescribed. The approximate total cost

of detecting these 1.6 people was $10,600. (The total cost of screening the 193 people

in this study was approximately $20,480 based on a cost of $80 each for 113 in the

BMD group and $30 each for 80 in the Non BMD group.) In other words a large

number of people need to be screened at considerable cost in order to detect those at

high risk. Furthermore, some of those identified in this study failed to act upon the

advice given by the pharmacist, particularly with respect to referral to the GP.

These results to some extent confirm objections to subsidisation of mass screening for

osteoporosis due to the high cost and poor uptake of screening and poor uptake of

advice/treatment (Rosenthal 2000, NIH 2001). However, this project mainly targeted

younger members of the public in whom the incidence and risk of osteoporosis is

expected to be lower than in the elderly. This target population was chosen to try to

make people more aware of their risk factors and the action they could take to prevent

the disease before it was too late.

54

There is little information in the literature about the numbers needed to be screened in

order to prevent fractures. In one recent study a modelling exercise was conducted

(Nelson et al, 2002) and it was estimated that if 10,000 women between the age of 65

and 69 underwent bone densitometry of the femoral neck, 1200 would be identified as

being at high risk of osteoporosis. The number of women in this age group needed to

be screened and then treated appropriately to prevent one hip fracture in 5 years

would be 731. These authors concluded that the number needed to be screened for

benefit is high and, because treatment has significant costs and adverse effects, the

balance of risk and benefit may be unfavourable. However, because osteoporosis

becomes more prevalent with age the numbers become more favourable if older

people are screened.

Impact of BMD Test

BMD pharmacists were less likely to classify participants as high risk and often down

graded the category of risk if the BMD T-Score was >-1.5 SD as per the project

protocol. When a T-Score between -1 and –2.5 SD is found the patient is classified as

osteopenic and treatment should be considered particularly if there are other risk

factors present (Commonwealth Department of Health and Family Services 1997,

Sambrook et al. 2002). In this study only 6 from 29 (21%) of those with a T-Score in

this category had other risk factors which made it necessary for them to be referred to

GP. Thus inclusion of the BMD test as part of the risk assessment in the pharmacy

could be seen as an efficient measure since only those most at risk were referred on to

the GP. Some experts in the field worry that patients who have a “normal” T-Score

but other possible risk factors eg low calcium intake will fail to take any necessary

action to correct or prevent those risk factors from becoming problematic. However,

in this study no difference was detected in adherence between BMD and Non BMD

groups.

Participants who received a BMD test in this study had a higher perception of

satisfaction with the service than those who did not, as expressed in both their

satisfaction score and their WTP valuation. Again this could be due to awareness of

the availability of the BMD test. However, participants expressed a desire for greater

privacy during the test.

55

Public Education

There is a need for improvement in community awareness of modifiable risk factors

that contribute to osteoporosis, particularly the need for increased calcium intake and

possibly decreased caffeine intake. Although a high proportion of participants were

found to have a high intake of caffeine in their diet, no advice was offered on this

matter as part of this study. As discussed in the literature review section of this report,

although there is evidence to suggest that caffeine decreases calcium absorption and

increases calcium excretion in the urine there is inconclusive evidence to say that

caffeine decreases bone mass.

Program and training evaluation

The feedback from pharmacists about the training for the project was that the

background information given was good and adequate to equip them for the project.

However they would have appreciated more practice at role playing the project

procedures. With respect to the actual service delivery and risk assessment protocol,

pharmacists were happy with the guidelines but would have appreciated an easier

reference for quantifying calcium and Vitamin D intake. In addition, they found

interruptions were a major problem when delivering the service and recognised a need

for more staff or an out of hours service delivery.

Limitations

One of the major limitations of this study was the telephone interview methodology

chosen for participant follow up. While this was the only method possible under the

circumstances of the study, the high proportion of non-regular customers and their

expectation of a “one off service” made it exceedingly difficult to track them all

down. Added to this the fact that the majority of participants were at low risk and,

only needed to keep up their calcium intake, made them less inclined to co-operate

with a further follow up at six months. Many indicated this during the three month

follow up call.

Another disappointing aspect of the project was the lack of follow up conducted by

the pharmacists themselves. Reasons given were lack of time and inability to track

down non-regular customers. Another possible reason was that the pharmacists were

expecting the project officer to do this job. While this was the case, it was not the role

56

of the project officer to encourage participants to adhere to the advice they had been

given but simply to document their response. Pharmacists may have misunderstood

the role of the project officer in this respect.

A further limitation was the fact that the difference between groups in adherence and

uptake of referral was not as large as anticipated and so the sample size achieved was

perhaps not sufficient to show a significant between group difference if such a

difference existed.

Cost Benefit Analysis

The cost benefit analysis indicated that participants were willing to pay for both the

BMD plus Risk Assessment service and the Risk Assessment Questionnaire only

service. However, those who received the BMD service valued the service they

received significantly more highly than those who received and valued the alternative

$30 vs $20.

The amount participants stated that they were willing to pay for each of the services

($30 & $20) was less than the cost of providing each service ($80 & $30) and was

also less than the amount commonly paid for a BMD test in a community pharmacy

(revealed preference). However, the areas chosen for this study were not wealthy

areas and not commonly served with BMD testing. Moreover, pharmacists who had

previously offered BMD tests commented that many people who would not have paid

for a test enrolled in the study. These factors may have reduced the WTP values

stated.

57

5. CONCLUSION AND RECOMMENDATIONS

This study compared the adherence to advice or referral given by pharmacists about

the prevention of osteoporosis following screening with either a BMD test plus risk

assessment questionnaire or a risk assessment questionnaire only. No significant

between group differences in adherence to advice or referral, as reported by the

people screened, were found however participants valued the BMD service

significantly more highly than the Non BMD service as measured by satisfaction

scores and Willingness To Pay Values expressed. Only those people considered to be

at most risk were referred to the GP and this could be seen as a more efficient use of

resources.

Recommendations for Future Service

The results of this study and the current practice indicated that consumers are very

interested in receiving information about osteoporosis and their own risk of it but

especially interested in BMD testing in the pharmacy. However, the study has not

shown a difference in uptake of referral or advice following either questionnaire only

or questionnaire plus BMD. What is more disturbing is the low uptake of referral and

advice overall by those deemed to be at high risk and indicates that much more

education and encouragement to follow through is required, whether by pharmacists

or other health care practitioners.

It is not clear what the best approach should be to achieve this goal. The uptake of

advice and referral is not known in relation to the current situation where

radiographers have operated relatively independently within pharmacies but in this

process the opportunity for follow up by pharmacists has been minimised. However, a

massive education program for both pharmacists and the public would need to be

undertaken to reverse the public perception of the value of the service.

A more constructive approach might be to build on the current practice and try to

improve it. That was the intention of the current study but it fell short of our

expectations, possibly due to the size of the sample, given the low level of risk of the

majority of participants and the fact that many were not regular customers.

58

An approach by pharmacists targeted towards those more likely to be at risk eg those

over 60 might be more manageable and sustainable given the many other demands on

pharmacists’ time. Such consumers could be interviewed by the pharmacist using a

risk assessment questionnaire and then referred for BMD test if necessary, either in

the pharmacy or via the GP with a follow up central BMD test being done if

necessary. However, if a DEXA test is used in the pharmacy (still open to debate),

according to licensing regulations a radiographer must be involved to operate the

machinery and interpret the results. Payment would also be required. Pharmacists in

this study demonstrated that they could work closely with a radiographer but this not

usually the case in current practice and pharmacists would need to allow time for this

to happen.

Future Research

This study did not compare the adherence to advice and uptake of referral with that

following a service delivered in a community pharmacy by a radiographer alone

although there is little to suggest that uptake of advice or referral would be greater

than with pharmacist involvement. However, such a comparison would be a

worthwhile exercise. A more comprehensive study could compare the effectiveness of

risk assessment from questionnaire plus BMD in the pharmacy and a questionnaire in

the pharmacy plus a BMD test in a specialist centre, ideally in terms of incidence of

diagnosis and fracture. In this case the study would need to be conducted over many

years. Another approach could be to compare screening and referral services through

community pharmacies which lead to diagnosis with current non-pharmacy avenues

which lead to diagnosis. Further research is also necessary to determine why

consumers who are told they are at high risk of osteoporosis fail to visit their GPs for

further investigation and management.

59

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