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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).
7
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
9
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
10
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
11
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.
12
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
13
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
15
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
18
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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