Third Community Pharmacy Agreement Research & Development Grants Program
Pharmacy Cardiovascular Health Care Model
Final Report to the Pharmacy Guild of Australia
This research is funded by the Australian Government Department of Health and Ageing through the Third Community Pharmacy Agreement Research and Development Program
“Community pharmacists are well placed to help patients who have cardiovascular disease or who are at risk of this.” Petty D. Drugs and professional interactions: the modern day pharmacist. Heart 2003; 89 (Suppl 2): 31-2
Chief Researcher: Professor Gregory Peterson Lead investigators: Jeff Hughes Dr Kay Stewart Professor Roger Nation Professor Shane Scott Assoc Prof Karen Farris
Pharmacy Cardiovascular Health Care Model
Co-investigators: Dr Shane Jackson Kim Fitzmaurice Peter Gee Luke Bereznicki Project Manager: Michael Ryan
Contact person for correspondence Professor Gregory Peterson Unit for Medication Outcomes Research and Education School of Pharmacy University of Tasmania Locked Bag 83 Hobart Tas 7001 Phone: 61-3-62262197 Fax: 61-3-62267627
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Table of Contents Table of Contents .................................................................................................................................................. 3 Index to Figures..................................................................................................................................................... 6 Index to Tables ...................................................................................................................................................... 9 Abstract................................................................................................................................................................ 16 Executive Summary ............................................................................................................................................ 16 Acknowledgements.............................................................................................................................................. 30 1.Introduction ...................................................................................................................................................... 31 1.1
Overview of possible roles for community pharmacy .......................................................................... 33
2. Methodology and results................................................................................................................................. 36 2.1 Systematic literature review ................................................................................................................ 36 2.1.1 MEDLINE search terms and criteria ............................................................................................... 38 2.1.2 International Pharmaceutical Abstracts (IPA) search terms and criteria ......................................... 38 2.1.3 Cochrane search terms and criteria ................................................................................................. 39 2.1.4 EMBASE search terms and criteria................................................................................................. 39 2.1.5 INFORMIT search terms and criteria ............................................................................................. 40 2.1.6 Kinetica search terms and criteria ................................................................................................... 40 2.1.7 Community Pharmacy Research Database (CPRD) search terms and criteria ................................ 41 2.1.8 Summary of database searching ...................................................................................................... 42 2.2 Evaluating quality of research papers ................................................................................................. 45 2.2.1 Overall assessment of evidence....................................................................................................... 50 2.2.2 Results of the Systematic Review ................................................................................................... 51 2.3 Public survey ....................................................................................................................................... 54 2.3.1 Public Survey Methods ................................................................................................................... 54 2.3.2 Results of the public survey ............................................................................................................ 55 2.3.3 Summary of the results of the public survey ................................................................................... 78 2.4 Survey of peak representative organisations ....................................................................................... 80 2.4.1 National Heart Foundation .............................................................................................................. 82 2.4.2 National Stroke Foundation ............................................................................................................ 85 2.5 Canvassing of Australian community pharmacists and pharmacy organisations to report on their own CVD activities ................................................................................................................................................... 87 2.5.1 General Public (education, posters etc) ........................................................................................... 88 2.5.2 High-risk groups (screening/ referral) ............................................................................................. 89 2.5.3 Management of existing CVD......................................................................................................... 89 2.5.4 Summary of self-reported CVD activities: ...................................................................................... 93 3. Developing the Pharmacy Cardiovascular Health Care Model .................................................................. 94 3.1
Draft National Chronic Disease Strategy .......................................................................................... 104
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3.2
Draft National Service Improvement Framework for Heart, Stroke and Vascular Disease.............. 107
3.3
Potential roles for community pharmacists for the ‘General Community’ group ............................. 124
3.4
Potential roles for community pharmacists for the ‘At-Risk’ group .................................................. 125
3.5
Potential roles for community pharmacists for the ‘confirmed CVD’ group .................................... 126
3.6 Additional overarching guidelines .................................................................................................... 128 3.6.1 Education of Pharmacists ............................................................................................................. 128 3.6.2 Relevant Professional Practice Standards ................................................................................. 128 3.6.2 Blood Handling Procedures ...................................................................................................... 130 3.6.3 Ethics and Privacy Guidelines...................................................................................................... 137 Health Information and the Privacy Act 1988 ................................................................................................ 139 A short guide for the private health sector - December 2001 ......................................................................... 139 4.The Tentative Model ...................................................................................................................................... 145 5. Elements of the Pharmacy Cardiovascular Health Care Model: Public/preventive health promotion 147 5.1 ................................................................................................................................................................... 147 Guiding principles and existing framework .................................................................................................... 147 5.2 Health promotion to prevent development and progression of CVD ................................................. 148 5.2.1 The SNAP Framework.............................................................................................................. 153 5.3
Improving community awareness of their risk factors ....................................................................... 169
5.4 Promote awareness of the early symptoms of acute cardiovascular events ...................................... 171 5.4.1 Chest pain ................................................................................................................................. 171 5.4.2 Stroke ........................................................................................................................................ 181 6.Elements of the Pharmacy Cardiovascular Health Care Model: Continuum of care.............................. 183 6.1
Guiding principles and existing framework....................................................................................... 183
6.2
Transfer of medication related information and follow-up of patients post-discharge ..................... 184
7. Elements of the Pharmacy Cardiovascular Health Care Model: High-risk patients .............................. 192 7.1
Guiding principles and existing framework....................................................................................... 192
7.2
Pharmacy-based risk factor screening and referral for assessment .................................................. 193
8. Elements of the Pharmacy Cardiovascular Health Care Model: Compliance with therapy .................. 212 8.1
Guiding principles and existing framework....................................................................................... 212
8.2 Promoting patient compliance with drugs, diet and exercise ............................................................ 212 8.2.1 Hyperlipidaemia ............................................................................................................................ 216 8.2.2 Hypertension ................................................................................................................................. 225 8.3
Practical strategies to promote compliance in cardiovascular disease ............................................ 226
9.Elements of the Pharmacy Cardiovascular Health Care Model: Medication management and reviews233 9.1
Guiding principles and existing framework....................................................................................... 233
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9.2 Promoting evidence-based pharmacotherapy of CVD ...................................................................... 234 9.2.1 Heart failure .................................................................................................................................. 245 9.2.2 Atrial fibrillation ........................................................................................................................... 249 9.2.3 Hypertension ................................................................................................................................. 250 9.2.4 Hyperlipidaemia ............................................................................................................................ 252 9.3 Monitoring and educating patients .................................................................................................... 257 9.3.1 Patient education, including participation in cardiac rehabilitation programs .......................... 258 9.3.2 High-risk drugs requiring ongoing monitoring ......................................................................... 261 9.4
Use of information and communications technology solutions to promote QUM in CVD ................ 284
10.Assessment of Opinion on the Model.......................................................................................................... 291 10.1 Input from stakeholders using a modified Delphi Process ................................................................ 291 10.1.1 National Heart Foundation........................................................................................................ 294 10.1.2 The Royal Australian College of General Practitioners ............................................................ 298 10.1.3 National Stroke Foundation ..................................................................................................... 298 10.1.4 Heart Support ........................................................................................................................... 303 11. Conclusions .................................................................................................................................................. 307 12. Recommendations ....................................................................................................................................... 298 13. References .................................................................................................................................................... 315
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Index of Figures Figure 1
Framework for the potential roles of community pharmacists in alleviating the societal burden of cardiovascular disease ....................................................................................... 34
Figure 2
“ABC” format to summarise the key principles of an evidence-based approach to the prevention of CVD. ........................................................................................................... 35
Figure 3
Approach to the conduct of the systematic literature review of pharmacy programs in cardiovascular disease........................................................................................................ 37
Figure 4
Example screen shot of the comprehensive electronic database of relevant literature ...... 44
Figure 5
Approach to the development of the National Pharmacy Cardiovascular Health Model .. 94
Figure 6
Stages of CVD risk ............................................................................................................ 95
Figure 7
Continuum of chronic disease prevention and care ........................................................... 98
Figure 8
Continuum of chronic disease prevention and care ........................................................ 101
Figure 9
From Pharmacy News, 13 May 2004 .............................................................................. 113
Figure 10
From Pharmacy News, 21 July 2005 ............................................................................... 113
Figure 11
From Pharmacy News, 27 May 2004 .......................................................................... 114
Figure 12
Staged approach to developing the pharmacist-physician collaborative working relationship ................................................................................................................... 120
Figure 13
Stages of CVD (normal health, elevated risk for CVD, and diagnosed CVD) .............. 122
Figure 14
Possible roles for community pharmacists within the stages of CVD............................ 123
Figure 15
Lifestyle interventions and drug treatments shown to reduce the risk of cardiovascular morbidity and/or mortality ............................................................................................... 150
Figure 16
Lifestyle guidelines for preventing cardiovascular events .............................................. 151
Figure 17
Risk factor assessment, targets and monitoring intervals for the prevention of vascular disease41 ........................................................................................................................... 152
Figure 18
Five step model (5As) for detection, assessment and management of risk factors within the SNAP Framework................................................................................................... 154
Figure 19
The National Heart Foundation of Australia’s Heartmoves program. ............................ 159
Figure 20
Excerpt from the patient decision aid “Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke”, developed by the Ottawa Health Research Institute (http://decisionaid.ohri.ca/decaids.html). ......................................................................... 160
Figure 21
Example of materials for consumers available from the National Heart Foundation of Australia’s website........................................................................................................... 162
Figure 22
Information leaflets for patients with CVD available from the National Heart Foundation of Australia’s website. ..................................................................................................... 163
Figure 23
Example of general material on prevention of CVD for consumers available from the National Heart Foundation of Australia’s website........................................................... 164
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Figure 24
Educational material available for order through the National Heart Foundation of Australia’s Heartline ........................................................................................................ 166
Figure 25
Pharmacy Self Care card on exercise and CVD .............................................................. 167
Figure 26
Pharmacy Self Care card on hypertension....................................................................... 168
Figure 27
Example of educational material on prompt presentation for chest ................................ 179
Figure 28
Excerpt from ‘Heart Attack, available in 10 languages from the National Heart Foundation of Australia’s website. ..................................................................................................... 180
Figure 29
Excerpt from ‘Transient Ischaemic Attack’, available from the Stroke Foundation’s website. ............................................................................................................................ 181
Figure 30
Example of an educational poster suitable for display in community pharmacy (from the Stroke Foundation’s website). ......................................................................................... 182
Figure 31
Deficits in the delivery of care at the hospital-community interface............................... 184
Figure 32
Pharmacy-based Heart Assessment and Referral Methodology: a program to tackle coronary heart disease in the Australian community (Pharmacy Guild of Australia/Government, Third Community Pharmacy Agreement Research and Development Grants Program. Project ............................................................................ 195
Figure 33
Predictors of poor patient compliance ............................................................................. 216
Figure 34
Discontinuation rates with lipid-lowering drug therapy (from Simons et al.226). Dispensing data six to seven months after initial supply. Values are numbers (percentages) ............ 218
Figure 35
Treatment persistence with antihypertensive medications. Data from Jones et al.256 ..... 226
Figure 36
General strategies to improve compliance with medication ............................................ 227
Figure 37
General approach to enhancing patient compliance with lipid-lowering drug therapy ... 228
Figure 38
Multiple strategies that can improve medication compliance in CVD ............................ 231
Figure 39
Clinical aid outlining appropriate therapy for patients in different CVD risk categories 235
Figure 40
Therapeutic guidelines for preventing cardiovascular events in patients with CVD ...... 237
Figure 41
National Prescribing Service guidelines on drug use in CVD......................................... 239
Figure 42
Example of media coverage of a published study of management of CHF by members of the Project Team .............................................................................................................. 247
Figure 43
Underuse of beta-blockers and the pharmacist ................................................................ 256
Figure 44
Suggest content of cardiac rehabilitation programs ........................................................ 260
Figure 45
Pharmacist checklist for patient counselling on warfarin ................................................ 264
Figure 46
One page guide to warfarin treatment ............................................................................. 265
Figure 47
New anticoagulants or better use of existing therapy? .................................................... 267
Figure 48
Need for close monitoring of amiodarone therapy .......................................................... 283
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Figure 49
Decision support box to promote the appropriate use of low-dose aspirin (from PROMISe2). The pharmacy dispense screen has links to print-friendly secondary windows providing further information for the pharmacist and an information leaflet for the patient......................................................................................................................... 285
Figure 50
Screen shot of automated intervention alert for Low-dose aspirin (from PROMISe2) ... 286
Figure 51
Patient handout for aspirin automatic intervention prompt ............................................. 287
Figure 52
Pharmacist information sheet for aspirin automatic intervention prompt ....................... 288
Figure 53
Example of an intervention from the PROMISe2 study relating to the aspirin alert within the dispensing software.................................................................................................... 289
Figure 54
Effect of aspirin intervention prompt on the overall intervention rate in different phases of the PROMISe2 study ....................................................................................................... 289
Figure 55
The response from the National Heart Foundation, providing feedback on the draft Model ......................................................................................................................................... 298
Figure 56
The response from the National Stroke Foundation, providing feedback on the draft Model ......................................................................................................................................... 302
Figure 57
The response from Heart Support, providing feedback on the draft Model .................... 306
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Index of Tables Table 1
INFORMIT search terms and criteria................................................................................ 40
Table 2
CPRD search terms and criteria ........................................................................................ 41
Table 3
Source of papers for literature review ............................................................................... 42
Table 4
Information extracted from clinical papers ....................................................................... 45
Table 5
NHMRC levels of evidence classification ........................................................................ 46
Table 6
Checklist for appraising the quality of studies of interventions ........................................ 47
Table 7
Quality of Non-randomised controlled trials (NHMRC) .................................................. 48
Table 8
Definitions of types of outcomes (NHMRC) .................................................................... 49
Table 9
Body of evidence assessment matrix (NHMRC) .............................................................. 50
Table 10
Summary of papers examined, by CVD focus and evidence grade .................................. 52
Table 11
Location of residents completing survey ........................................................................... 56
Table 12
Categories of patients based on future risk of a cardiovascular event .............................. 96
Table 13
Common obstacles to inter-professional collaboration ................................................... 118
Table 14
Collaboration Between Community Pharmacists and Family Physicians: Lessons Learned from the Seniors Medication Assessment Research Trial ............................................... 119
Table 15
Strategies to Achieve Stage 1: Increasing Pharmacists’ Recognition among Doctors .... 121
Table 16
Strategies to Achieve Stage 2: Relationship Exploration and Trial ................................ 121
Table 17
Strategies to Achieve Stage 3: Expanding the Professional Relationship ....................... 121
Table 18
Common causes of chest pain ......................................................................................... 175
Table 19
Differentiating features with the major causes of chest pain........................................... 176
Table 20
Counselling Plan for High-Risk Patients ......................................................................... 178
Table 21
Summary of subject details from Pharmacy-based Heart Assessment and Referral Methodology: a program to tackle coronary heart disease in the Australian community 196
Table 22
Main unit costs for pharmacy-based cardiovascular risk profiling ................................. 198
Table 23
Summary table of benefits, costs and cost-effectiveness of a ......................................... 200
Table 24
Individuals at increased risk of CVD .............................................................................. 205
Table 25
Some roles for the pharmacist in the care of the patient with dyslipidaemia (modified from Luxford) ........................................................................................................................... 224
Table 26
Examples of conditions which may be under-diagnosed and/or under-treated in the elderly ......................................................................................................................................... 243
Table 27
Some roles of the pharmacist in patients with dyslipidaemia (modified from Luxford). 253
Table 28
Patient partnership in medicine taking ............................................................................ 258
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Table 29
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Specific aims of cardiac rehabilitation programs ............................................................ 259
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Abstract Cardiovascular health is a National Health Priority Area. Cardiovascular disease is the largest cause of premature death and death overall in Australia, and its health and economic burden exceeds that of any other disease. Australia has one of the highest incidences of cardiovascular disease in the Asia-Pacific region. Cardiovascular disease accounts for approximately 40% of deaths among Australians. These issues are expected to become more acute over the next decades with the growing number of elderly Australians, among whom cardiovascular disease is most common. Cardiovascular disease will affect one in four Australians by 2051. Total financial costs of cardiovascular disease are more than $14 billion per annum (1.7% of GDP). Direct health system costs of cardiovascular disease were estimated at $7.6 billion in 2004 (11% of total health spending). The proximal causes of the cardiovascular disease epidemics are well known. The major risk factors - inappropriate diet and physical inactivity (as expressed through unfavourable lipid concentrations, high body mass index, and raised blood pressure), together with tobacco use - explain at least 75% of new cases of cardiovascular disease. In the absence of these risk factors, cardiovascular disease is a rare cause of death. The optimum levels of cardiovascular disease risk factors are known; unfortunately, only about 5% of the adult population of developed countries is at low risk with optimum risk factor levels. It is essential that pharmacists join other health professionals in national programs to tackle the leading cause of morbidity and mortality in Australia. It would seem that pharmacists, being the most readily accessible health professional in the community setting, could fulfil a useful role in the prevention, detection, and management of cardiovascular disease. Considerable information on the status of cardiovascular disease in Australia (e.g. statistics, health care delivery programs, government and professional group policies) was collected. The Project Team then performed a systematic review of published studies describing community pharmacy-based cardiovascular disease programs. This included an assessment of the quality of the published randomised controlled studies. The systematic review was developed within the following three major sub-areas. x
Health promotion to prevent development and progression of cardiovascular disease in the general population.
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x
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Screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate (high-risk individuals).
x
Improving therapeutic outcomes in cardiovascular disease – e.g. promoting evidencebased guidelines in the pharmacotherapy of cardiovascular disease, monitoring and promoting compliance with prescribed drug therapy (patients with existing cardiovascular disease).
Information was also collected on community pharmacy cardiovascular disease programs that have operated or are currently operating in Australia and abroad, to identify opportunities for them to be adopted or expanded in Australia. A national public survey was performed to assist in developing the Pharmacy Cardiovascular Health Care Model. The intention was to assess the public’s perceptions of pharmacists’ involvement and role in cardiovascular disease prevention and management. Peak national organisations were also canvassed for views on pharmacy’s role in cardiovascular disease. The results of the systematic review and public survey, along with the collective learnings from previous studies in Australia and overseas by the Project Team members, were subsequently used in the development of a Pharmacy Cardiovascular Health Care Model. This model builds on existing health service and health promotion priorities, and promotes partnership and collaboration across the health care system. As far as possible, the model has been developed to be consistent with the goals of the ‘National Strategy for Heart, Stroke and Vascular Health in Australia’, and the draft versions of the ‘National Chronic Disease Strategy’ and the ‘National Service Improvement Framework for Heart, Stroke and Vascular Disease’. Feedback was provided by the Expert Advisory Group and key stakeholder organisations. The Pharmacy Cardiovascular Health Care Model is based on the following priority areas.
x Public/preventive health promotion including: -
health promotion to prevent development and progression of cardiovascular disease;
-
improving awareness of risk factors;
-
improving awareness of symptoms and early warning signs of acute episodes.
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x Continuum of care including: -
transfer of medication-related information between hospital and community;
-
follow-up of patients post-discharge to identify and remedy any drug-related problems.
x High-risk patients including: -
referral for screening and risk-assessment (must be based on absolute risk assessment);
-
pharmacy-based risk factor screening and referral (may be a role).
x Compliance with therapy including: x
promoting patient compliance with drugs, diet, exercise.
Medication management and reviews including: -
promoting evidence-based drug therapy of cardiovascular disease and preventing drug-related problems;
-
monitoring and educating patients e.g. through Home Medicines Review scheme.
The model supports the role of the pharmacy profession in promoting the dissemination and uptake of best preventive and treatment practices for heart, stroke and vascular diseases; enhances the role of consumers in maintaining and managing their own health; and improves the management of heart, stroke and vascular diseases across the continuum of care. The model will require improved clinical performance by pharmacists, greater collaboration with other health professionals, and improved use of information and communications technology. In related projects, the research team has demonstrated that electronic communication of medication histories between hospital and community improves the pharmaceutical care of elderly patients with cardiovascular disease, while in a randomised controlled trial it has been demonstrated that a computer-based educational alert and reminder, related to the use of low-dose aspirin in high-risk diabetic patients, within pharmacy dispensing software significantly increases intervention rates by pharmacists. The Project Team has also made the following recommendations. 1. The Pharmacy Guild of Australia and other relevant organisations (e.g. Pharmaceutical Society of Australia) progress the proposed framework, as detailed in this Project, prior to a wider implementation.
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2. The Pharmacy Guild of Australia and the Pharmaceutical Society of Australia form closer links with the key national organisations related to cardiovascular disease, especially the National Heart Foundation of Australia and the National Stroke Foundation, as well as the National Prescribing Service. 3. There be an ongoing improvement in communication between community pharmacists and general practitioners and their respective organisations, and reinforcement of the fact that the Pharmacy Cardiovascular Health Care Model and related programs are intended to assist in improving the health of Australians and not as a threat to the medical profession. 4. Comprehensive training packages for pharmacists and pharmacy assistants on cardiovascular disease prevention and management be developed and disseminated. 5. There be increased promotion of the Home Medicines Review scheme in patients with cardiovascular disease, particularly in collaboration with the National Heart Foundation of Australia and the National Prescribing Service, as a key component of the Pharmacy Cardiovascular Health Care Model. 6. Pharmacy-based cardiovascular disease screening programs be specifically targeted at those individuals likely to be at elevated risk of cardiovascular disease and incorporate absolute risk assessment and close liaison with general practitioners. Further, only pharmacists with appropriate training and demonstrated competence should perform cardiovascular disease risk factor assessments. More research needs to be conducted on the clinical and economic outcomes of community pharmacy cardiovascular disease screening programs before they are widely implemented. 7. There be further development of information technology-based strategies (e.g. prompts within dispensing software) to encourage pharmacists to intervene and investigate possible instances of under-use of important cardiovascular agents, such as aspirin and E-blockers. The vast pool of electronic data at community pharmacists’ fingertips must be utilised to greater effect. 8. The role of accredited pharmacists in improving the management of therapy with warfarin be further developed and evaluated, given the promising results to date. This includes the need for further research to be conducted on the impact of pharmacistconducted INR monitoring on patient care and outcomes. Subsequently, the profession should develop training courses and an accreditation process for consultant
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pharmacists to perform monitoring of warfarin therapy, in collaboration with general practitioners.
The Pharmacy Cardiovascular Health Care Model has the potential to encourage the adoption and maintenance of healthy lifestyle behaviours, improve the detection and management of cardiovascular disease and make a significant impact on current health care practices and expenditure in Australia. The model will also improve the quality use of medicines by consumers and enhance the practice of community pharmacy in Australia.
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Executive Summary Cardiovascular diseases (predominantly ischemic heart disease and stroke) are the leading causes of death worldwide, accounting for about one-third or 17 million of global deaths annually. That figure is expected to increase to 25 million by 2025, unless major prevention efforts can halt the rise. Cardiovascular disease (CVD) places a heavy burden on Australians and cardiovascular health is recognised as a National Health Priority Area. It is essential that pharmacists join other health professionals in national programs to tackle the leading cause of morbidity and mortality in Australia. For instance, it would seem that pharmacists, being the most readily accessible health professional in the community setting, could fulfil a useful role in the detection, counselling, and referral of members of the public at risk of CVD.
1. Framework development Firstly, a framework for the potential roles of community pharmacists in alleviating the societal burden of CVD was constructed and this is shown below. Key possible activities include the following. x Health promotion to prevent development and progression of CVD (general population). x Screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate (high-risk individuals). x Improving therapeutic outcomes in CVD – e.g. promoting evidence-based guidelines in the pharmacotherapy of CVD, monitoring and promoting compliance with prescribed drug therapy (patients with existing CVD).
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Health promotion to help prevent development of cardiovascular disease
Screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate
Promoting evidence-based guidelines in the pharmacotherapy of cardiovascular disease
Monitoring and promoting adherence to prescribed drug therapy
Health promotion to slow progression of cardiovascular disease
Monitoring response to pharmacotherapy of cardiovascular disease (e.g. clinical control, adverse drug reactions) Framework for the potential roles of community pharmacists in alleviating the societal burden of cardiovascular disease
Considerable information on the status of CVD in Australia (e.g. statistics, health care delivery programs, government and professional group policies) was collected by the Project Team.
2. Systematic literature review The Project Team then performed a systematic review of published studies describing community pharmacy-based CVD programs. This included an assessment of the quality of the
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published randomised controlled studies. The systematic review was developed within the following three major sub-areas. x
health promotion to prevent development and progression of CVD;
x
screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate; and
x
improving therapeutic outcomes in CVD – e.g. promoting evidence-based guidelines in the pharmacotherapy of CVD, monitoring and promoting compliance with prescribed drug therapy. Literature searching across each of these areas within multiple databases (including
MEDLINE, International Pharmaceutical Abstracts, EMBASE and the Cochrane Library) was performed simultaneously and independently by two researchers, each of whom had been trained in systematic review and meta-analysis methodology by the Australasian Cochrane Centre. The quality of the studies was assessed - noting for example, randomisation and adequate allocation concealment or blinding. The figure below sets out the approach to the conduct of the systematic literature review of pharmacy programs in CVD. The final product was an electronic, searchable database of relevant articles, including an assessment of the quality of publications. A copy of the database has been submitted with this report. A relatively small proportion of the sourced literature was suitable for systematic review. A total of 132 papers were deemed relevant and eligible for systematic review. In general, the quality of these studies was poor, with only a small amount of high quality randomised controlled trials evaluating the effect of community pharmacy’s involvement in CVD prevention and management. The most evidence for community pharmacist involvement in the management of CVD was related to hypertension and hyperlipidaemia. However, a number of these studies were of poor methodological quality or were conducted in hospital outpatient clinic or managed care settings, making the results difficult to extrapolate to community pharmacy practice in Australia.
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Areas of focus x x x
Health promotion to prevent development and progression of CVD Screening for cardiovascular risk factors and recommending referral Improving therapeutic outcomes in CVD
Electronic and manual literature review of each major area independently by 2 researchers
x x x
Review and collate articles of potential interest Database entry Systematic review
x x x
Review and collate articles of potential interest Database entry Systematic review
Reconciliation of database entries Other information via Web resources and direct consultation with AIHW, NHF etc.
Overall review of published studies, and meta-analyses where appropriate
Preparation of report
Approach to the conduct of the systematic literature review of pharmacy programs in cardiovascular disease Information was also collected on community pharmacy CVD programs that have operated or are currently operating in Australia. This information was sought from State Branches of the Pharmacy Guild of Australia and Pharmaceutical Society of Australia, Schools of Pharmacy and Divisions of General Practice. There was very little information forthcoming on community pharmacy involvement in CVD programs. Most details came from outpatient cardiac rehabilitation programs, and these pharmacist services were generally
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funded by the pharmacist’s usual employee i.e. hospital pharmacy, or contracted by the outpatient clinic concerned. Two postings to AusPharmList were used to canvass experiences of Australian community pharmacists, although the feedback from this source was also minimal. While there is good evidence that community pharmacists are well placed to help patients who have, or who are at risk, of CVD, there is very little information available on these types of activities. Unfortunately, as has been noted many times previously, the pharmacy profession as a whole does not generally document or publish its actual activities to enable the public, other health professionals and governments to appreciate the extent of pharmacy practice in Australia. At present, the role of community pharmacists in the prevention and management of CVD in this country and overseas can be essentially described in the same manner as the results of the 2000 Cochrane Database Systematic Review of pharmacists’ role expansion there are relatively few studies, with doubtful generalisability as they have poorly defined interventions, cost assessments and patient outcome data. More rigorous research is needed. The pharmacy profession in Australia needs to urgently produce high quality studies of community pharmacists’ expanded role in CVD.
3. Public survey A national survey was performed to assist in developing the Pharmacy Cardiovascular Health Care Model. The intention was to assess the public’s perceptions of pharmacists’ involvement and role in CVD prevention and management. A computer-assisted telephone interview (CATI) survey of 505 households was conducted across Australia. The survey was administered to metropolitan, rural and remote residents (Australian consumers over the age of 29 years) via a 15-minute telephone interview. People aged over 29 years were targeted as they represent a higher rate of community
pharmacy
use
and
are
more
likely
to
benefit
from
CVD
detection/prevention/treatment programs. The sample was screened to include only those who had visited a pharmacy in the previous month, and a quota of 50% with CVD.
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Respondents’ ages ranged from 30 to 90 years (mean 57 years of age); 58% of respondents were female and 42% male. Fifty percent of respondents were in full time or part time work, with 30% pensioners and 10% in home duties. The targeted equal sample split of CVD:non CVD was achieved (251:254). It was found that there was little difference between the responses from each state. Regional (n = 189) and metropolitan (n = 316) respondents were picked up in the random sampling. The data came from a good cross-section of the adult population (i.e. metropolitan and country, female and male, incidence of hypertension and diabetes). There was a high level of satisfaction with the quality of service provided by regularly visited pharmacies, although there appeared to be a lack of awareness amongst consumers as to the skills and capabilities of pharmacists and of services available through pharmacies. Consumers indicated that providing advice on how to take medicines properly was the major activity in which pharmacists were most capable. The majority of respondents also agreed or strongly agreed that pharmacists are capable of providing screening or testing for hypertension and diabetes, and providing advice on lifestyle changes (weight loss, smoking, alcohol intake etc.) and information about cardiovascular diseases and their management. The majority of respondents agreed or strongly agreed that pharmacists are capable of: x
providing screening or testing for raised blood pressure.
x
providing screening or testing for diabetes
x
providing advice on lifestyle changes (weight loss, smoking, alcohol intake etc).
x
supplying medicines for cardiovascular diseases
x
providing advice on over-the-counter and herbal medicines to be avoided by patients with a cardiovascular disease.
x
providing information about cardiovascular diseases and their management.
x
providing advice on how to take medicines properly. This is the activity that most respondents see as the one in which pharmacists are most capable.
A minority of respondents agreed or strongly agreed that pharmacists are capable of: x
providing screening or testing for raised cholesterol
x
diagnosing cardiovascular diseases
x
prescribing drug treatment for cardiovascular diseases.
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In regard to pharmacists’ capability in checking or monitoring the outcomes of drug treatment, respondents were evenly divided with 40% either agreeing or strongly agreeing and 41% either disagreeing or strongly disagreeing and the balance neither agreeing nor disagreeing. Although doctors were seen as the most likely provider of diagnostic and screening services, respondents said that they would be likely or very likely to use a pharmacist (after doctors) for services such as to: x
prescribe medicines
x
obtain prescription medicines,
x
seek advice on over-the-counter and herbal medicines to be avoided by patients with cardiovascular diseases from a doctor,
x
seek information on cardiovascular diseases and their management
x
seek advice on how to take medicines properly
x
monitor the outcome of their drug treatment
In summary, there appeared to be a gap in the perception of what consumers believe pharmacists can do and are capable of doing, and what the pharmacy profession believes it can do and currently does. Clearly the profession as a whole needs to undertake a program of self-promotion to educate consumers of the potential role that pharmacists can have in their lives.
4. Survey of peak representative organisations Peak national organisations (National Heart Foundation of Australia and National Stroke Foundation) were canvassed to determine their views on pharmacy involvement in CVD and health promotion activities, relevant to their particular organisation’s constituency. The intention was to use the outcomes to guide the development of an overarching model that depicts the three stages of CVD where community pharmacists could intervene. The website of each body was also used to find information on the perceived role of the pharmacy profession. The National Heart Foundation of Australia replied that it would take into account pharmacy involvement in cardiovascular areas with the evidence provided by the present project. The Foundation believed all activities that could be provided by pharmacies, such as
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23
heath advice, screening and monitoring with consequent referral, should be evidence-based and occur within an appropriate accredited environment by trained practitioners. It also suggested these activities should be supported by government policy and also should include links to others in health care practice, such as general practitioners. The Heart Foundation considered the core role of the pharmacist as one of medication advice in the areas of side effects, drug interactions and compliance. It suggested pharmacy health promotion advice should be given using other organisations’ resources and also links to national programmes. The Heart Foundation’s web site has health professional resources (for doctors), such as lipid and hypertension management guidelines.
General resources do not mention the
pharmacy as a source of information or having any role in cardiac disease management in health promotion or screening. The National Stroke Foundation considers pharmacies as outlets for information, education for public health campaigns while working in partnerships to keep people safe. It also sees the pharmacy profession working on the development of best evidence guidelines for medication use in stroke prevention. The organisation had no opinion on the role of pharmacy in anticoagulation but does see a role in hypertension and smoking cessation. The role in hypertension is one of screening to increase the identification of those with hypertension and consequent referral. Pharmacies are seen as information sources using the ‘Strokesafe’ resources developed by the foundation and actively encouraging individuals in lifestyle change to reduce the risk of stroke. Generally, the pharmacy profession is not seen to have a role outside the pharmacy itself except working on the evidence guides on medication. There is a large unmet need in Australia to perform scientifically rigorous trials of the management of CVD by community pharmacists in collaboration with general practitioners. As noted by the National Heart Foundation of Australia, the potential role of the pharmacy profession is considerable but needs to be evidence-based, and one that liaises with other health professionals involved in patient care. There is also a clear need for the professional pharmacy organisations to work collaboratively with the key stakeholder organisations associated with CVD.
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5. Developing the Pharmacy Cardiovascular Health Care Model The systematic literature review, public survey and canvassing of pharmacists and key organisations were all conducted to inform the development of a Pharmacy Cardiovascular Health Care Model. This Model was to build on existing health service and health promotion plans in CVD, and promote partnership and collaboration across the health care system. It was to be consistent with the goals of pre-existing national strategies, rather than re-defining what the national priorities should be.
Approach to the development of the National Pharmacy Cardiovascular Health Model
A guiding principle was that any model should be built around existing health service and health promotion plans in CVD, and encourages partnership and collaboration across the health care system. The model should be consistent with the goals of pre-existing national strategies. The National Strategy for Heart, Stroke and Vascular Health in Australia presented
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a useful starting point, depicting what are essentially the major three stages of CVD (normal health, elevated risk for CVD, and diagnosed CVD).
Stages of CVD (normal health, elevated risk for CVD, and diagnosed CVD) The results of the systematic literature review and public survey, along with the advice from peak organisations and the collective learnings from previous studies in Australia and overseas by the Project Team members, were subsequently used in the development of a Pharmacy Cardiovascular Health Care Model. The sources of guidance (systematic literature review, environmental scan and public survey, along with input from the Expert Advisory Group and key stakeholder groups) were reasonably consistent in that the focus should be on high-risk patients, particularly with regard to improving the quality use of medicines (QUM). The expanded involvement of pharmacists in improving compliance with medication, alone, would have major implications for the prevention of cardiovascular events and health resources savings nationally. The Model lists potential priority areas in CVD where community pharmacy could play a useful role.
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Public/preventive health promotion ¾ Health promotion to prevent development and progression of cardiovascular disease ¾ Improving community awareness of risk factors ¾ Improving awareness of symptoms and early warning signs of acute episodes
Continuum of care ¾ Transfer of medication-related information between hospital and community ¾ Follow-up of patients post-discharge to identify and remedy any drug-related problems
High-risk patients ¾ Referral for screening and risk-assessment ¾ Pharmacy-based risk factor screening and referral
Compliance with therapy ¾ Promoting patient compliance with drugs, diet and exercise
Medication management and reviews ¾ Promoting evidence based drug therapy of cardiovascular disease and preventing drug-related problems
¾ Monitoring and educating patients e.g. through the Home Medicines Review scheme Each of these proposed elements is discussed in the report. This discussion includes the following. x
The relevant National Chronic Disease Strategy key points.
x
National Service Improvement Framework for Heart Stroke and Vascular Disease critical intervention points.
x
Evidence for the proposed element.
x
Strategy for improvement.
x
Examples of supporting resources.
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Opinions were subsequently canvassed on the draft Model. Although the feedback obtained was relatively limited, it was supportive of the Model. The Model will require improved clinical performance by pharmacists, greater collaboration with other health professionals and improved use of information and communications technology. Pharmacists need to practise their skills and acquire additional training to be able to perform these expanded roles effectively. Only those with the requisite skills will be able to achieve the desired outcomes including having a positive influence on the quality of medication use in CVD. Greater cooperation between pharmacy organisations and the peak bodies associated with CVD would facilitate the acceptance and implementation of pharmacy-based services targeting CVD. Again, as noted by the National Heart Foundation of Australia, “Clearly the relationship between pharmacy and the National Heart Foundation of Australia is a key one that can support a potential change in pharmacy practice, a change endorsed by the peak body representing this health priority”. One example of where support would be of assistance would be in the greater promotion of the Home Medicines Review scheme, which represents a unique opportunity in Australia to optimise drug use in CVD and improved medication safety following hospitalisation of patients with CVD. The National Heart Foundation of Australia’s endorsement of this scheme and its promotion to the medical profession and the public would help achieve this goal. A Home Medicines Review for all patients discharged from hospital with an acute cardiovascular event would be an ideal mechanism, in the right environment, to provide education in regard to medicines and more general aspects of the secondary prevention of CVD. Similarly, greater collaboration between the pharmacy organisations and the National Prescribing Service is critical for the profession and for society in improving QUM generally. One area where pharmacists are likely to have a major positive influence is in the screening and /or monitoring of patients with CVD when directed at improving the outcome of drug therapy (e.g. blood pressure monitoring; INR monitoring with warfarin). Given the increasing usage of warfarin for chronic atrial fibrillation, coupled with the availability of accurate, portable and relatively inexpensive monitoring devices, there is an opportunity to improving the management of therapy with warfarin by developing the role of the pharmacists in the area. The Project’s research has clearly shown that education and INR monitoring of
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patients by appropriately trained pharmacists improves clinical outcomes and, when implemented in a collaborative model, is welcomed by patients and general practitioners. This should be a role developed by accredited pharmacists who have completed advanced training in anticoagulation management. The Project Team has made the following recommendations. 1. The Pharmacy Guild of Australia and other relevant organisations (e.g. Pharmaceutical Society of Australia) progress the proposed framework, as detailed in this Project, prior to a wider implementation. 2. The Pharmacy Guild of Australia and the Pharmaceutical Society of Australia form closer links with the key national organisations related to CVD, especially the National Heart Foundation of Australia and the National Stroke Foundation, as well as the National Prescribing Service. 3. There be an ongoing improvement in communication between community pharmacists and general practitioners and their respective organisations, and reinforcement of the fact that the Pharmacy Cardiovascular Health Care Model and related programs are intended to assist in improving the health of Australians and not as a threat to the medical profession. 4. Comprehensive training packages for pharmacists and pharmacy assistants on CVD prevention and management be developed and disseminated. 5. There be increased promotion of the Home Medicines Review scheme in patients with CVD, particularly in collaboration with the National Heart Foundation of Australia and the National Prescribing Service, as a key component of the Pharmacy Cardiovascular Health Care Model. 6. Pharmacy-based CVD screening programs be specifically targeted at those individuals likely to be at elevated risk of CVD and incorporate absolute risk assessment and close liaison with general practitioners. Further, only pharmacists with appropriate training and demonstrated competence should perform CVD risk factor assessments. More research needs to be conducted on the clinical and economic outcomes of community pharmacy CVD screening programs before they are widely implemented. 7. There be further development of information technology-based strategies (e.g. prompts within dispensing software) to encourage pharmacists to intervene and investigate possible instances of under-use of important cardiovascular agents, such as
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aspirin and E-blockers. The vast pool of electronic data at community pharmacists’ fingertips must be utilised to greater effect. 8. The role of accredited pharmacists in improving the management of therapy with warfarin be further developed and evaluated, given the promising results to date. This includes the need for further research to be conducted on the impact of pharmacistconducted INR monitoring on patient care and outcomes. Subsequently, the profession should develop training courses and an accreditation process for consultant pharmacists to perform monitoring of warfarin therapy, in collaboration with general practitioners.
The Pharmacy Cardiovascular Health Care Model has the potential to encourage the adoption and maintenance of healthy lifestyle behaviours, improve the detection and management of CVD and make a significant impact on current health care practices and expenditure in Australia. The model will also improve the quality use of medicines by consumers and enhance the practice of community pharmacy in Australia.
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Acknowledgements The Project Team thanks the following for valuable assistance with various aspects of the project: x
The funding body (Australian Government Department of Health and Ageing, through the Third Community Pharmacy Agreement Research and Development Program) and the Pharmacy Guild of Australia;
x
Dr Simone Jones and the members of the Expert Advisory Group;
x
All stakeholders who provided input;
x
Mr Ian DeBoos, DeBoos Associates;
x
Mr James Reeve, Mr Peter Tenni and Dr Omar Hasan; and
x
Mr Rod Unmack, Mr Keith Gordjin and Mr Brett O’Halloran, PCA/NU Systems.
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1. Introduction Cardiovascular diseases (predominantly ischemic heart disease and stroke) are the leading causes of death worldwide, accounting for about one-third or 17 million of global deaths annually. That figure is expected to increase to 25 million by 2025, unless major prevention efforts can halt the rise.1 Cardiovascular disease (CVD) places a heavy burden on Australians.2-5 It remains the major public health problem in Australia and the leading cause of mortality and disability. x Every 10 minutes one Australian dies from CVD, accounting for 38% of all deaths. x CVD causes 22% of the burden of disease in Australia. x Compared to other diseases, CVD is the largest health cost item. x Total financial costs of CVD are more than $14 billion per annum – 1.7% of GDP. x Direct health system costs of CVD are estimated at $7.6 billion in 2004 (11% of total health spending). x Cardiovascular disease will affect one in four Australians by 2051.2
The proximal causes of the CVD epidemics are well known. The major risk factors inappropriate diet and physical inactivity (as expressed through unfavourable lipid concentrations, high body mass index, and raised blood pressure), together with tobacco use explain at least 75% of new cases of CVD.3 In the absence of these risk factors, CVD is a rare cause of death. The optimum levels of CVD risk factors are known; unfortunately, only about 5% of the adult population of developed countries are at low risk with optimum risk factor levels.3 The prevention of CVD in Australia, as in many other countries, is far from optimal. For instance, based on findings in the AusDiab study in 1999-2000,4 only 14% of patients with hypertension are treated and adequately controlled, and 33% are treated but not controlled. Similar figures have been reported in Canada and the United States.5, 6
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National Heart Foundation of Australia. The shifting burden of cardiovascular disease. Report prepared by Access Economics, 2005.2
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33
OVERVIEW OF POSSIBLE ROLES FOR COMMUNITY PHARMACY
A framework for the potential roles of community pharmacists in alleviating the societal burden of CVD is shown in Figure 1. Key possible activities include the following. x Health promotion to prevent development and progression of cardiovascular disease (general population). x Screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate (high-risk individuals). x Improving therapeutic outcomes in cardiovascular disease – e.g. promoting evidencebased guidelines in the pharmacotherapy of cardiovascular disease, monitoring and promoting compliance with prescribed drug therapy (patients with existing CVD).
It is essential that pharmacists join other health professionals in national programs to tackle the leading cause of morbidity and mortality in Australia. For instance, it would seem that pharmacists, being the most readily accessible health professional in the community setting, could fulfil a useful role in the detection, counselling, and referral of members of the public at risk of cardiovascular disease.
Community pharmacists are well placed to help patients who have cardiovascular disease or who are at risk of this. They have an opportunity to identify at-risk patients, based on their knowledge of the families, what drug treatments are being taken, and information provided by patients. They can identify under treated patients at the point of dispensing and feed relevant information back to the surgery. Public health is another important aspect of the community pharmacist’s work and involves provision of education and advice on lifestyle and diet. Pharmacists are also involved in smoking cessation services, and are able to support patients by providing structured advice and smoking cessation products. Some pharmacies participate in screening services for example, measuring cholesterol and blood pressure. This can be useful provided that screening is undertaken in the context of global risk assessment and that services are discussed with local GPs to secure agreement on such matters as when patients should be referred for medical advice.7
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Health promotion to help prevent development of cardiovascular disease
Screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate
Promoting evidence-based guidelines in the pharmacotherapy of cardiovascular disease
Monitoring and promoting adherence to prescribed drug therapy
Health promotion to slow progression of cardiovascular disease
Monitoring response to pharmacotherapy of cardiovascular disease (e.g. clinical control, adverse drug reactions) Figure 1
Framework for the potential roles of community pharmacists in alleviating the societal burden of cardiovascular disease
Acknowledging that there is a significant treatment gap in the secondary prevention of CVD in practice, Gluckman et al.8 have recently developed an “ABC” format to summarise the key principles of an evidence-based approach to the secondary prevention of CVD (Figure 2). This format is useful not only in the development of hospital clinical pathways, but also in the community-based management of individuals with vascular disease and/or type 2 diabetes mellitus. It also has application in identifying potential roles of community pharmacy in the management of CVD.
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Figure 2
35
“ABC” format to summarise the key principles of an evidence-based approach to the prevention of CVD.8
These frameworks provide a useful indication of some of the key current issues in CVD where community pharmacists could make a significant contribution.
x High levels of lifestyle-related cardiovascular risk factors in society (e.g. cigarette smoking, obesity and inactivity). x Under-detection of hypertension, hyperlipidaemia and diabetes mellitus. x Under-use of agents according to evidence-based guidelines: including antiplatelet agents; warfarin (in non-valvular atrial fibrillation); angiotensinconverting enzyme inhibitors, spironolactone and E-blockers (in heart failure). x Under-dosing of agents according to evidence-based guidelines (e.g. angiotensin-converting enzyme inhibitors in heart failure). x Poor therapeutic outcomes: blood pressure and lipid control, anticoagulation.
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2. Methodology and results 2.1
SYSTEMATIC LITERATURE REVIEW
The Project Team undertook a systematic review of published studies describing community pharmacy-based cardiovascular disease programs. As proposed, a systematic review was chosen as the preferred method of literature review. It is superior to a conventional literature review, as it includes an assessment of the quality of the published studies and the performance of statistical meta-analyses where appropriate. The systematic review was developed within the following three major sub-areas. x
health promotion to prevent development and progression of cardiovascular disease;
x
screening for cardiovascular risk factors and recommending referral for medical assessment and management when appropriate; and
x
improving therapeutic outcomes in cardiovascular disease – e.g. promoting evidencebased guidelines in the pharmacotherapy of cardiovascular disease, monitoring and promoting compliance with prescribed drug therapy. Literature searching across each of these areas was performed simultaneously and
independently by two researchers, each of whom had been trained in systematic review and meta-analysis methodology by the Australasian Cochrane Centre. The quality of the studies was assessed - noting for example, randomisation and adequate allocation concealment or blinding. Figure 3 sets out the approach to the conduct of the systematic literature review of pharmacy programs in cardiovascular disease.
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Areas of focus x x x
Health promotion to prevent development and progression of CVD Screening for cardiovascular risk factors and recommending referral Improving therapeutic outcomes in CVD
Electronic and manual literature review of each major area independently by 2 researchers
x x x
Review and collate articles of potential interest Database entry Systematic review
x x x
Review and collate articles of potential interest Database entry Systematic review
Reconciliation of database entries Other information via Web resources and direct consultation with AIHW, NHF etc.
Overall review of published studies, and meta-analyses where appropriate
Preparation of report
Figure 3
Approach to the conduct of the systematic literature review of pharmacy programs in cardiovascular disease
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The team members used the following databases and search terms:
2.1.1 MEDLINE search terms and criteria
((Pharmacy[MH] OR Pharmaceutical Services[MH] OR Pharmacists[MH] OR Pharmacies[MH]) AND (Monitoring, Physiologic[MH] OR Primary Prevention[MH] OR Mass Screening[MH] OR Disease Management[MH] OR Health Promotion[MH] OR "health education"[mh]) AND (Cardiovascular System[MH] OR Coronary Arteriosclerosis[MH] OR hypertension[MH] OR Heart Failure, Congestive[MH] OR Hyperlipidaemia[MH] OR lipids[MH] OR Cholesterol[MH] OR Drug therapy[MH] OR Patient Compliance[MH] OR smoking cessation[MH] OR Diabetes Mellitus[MH] OR Drug Therapy[MH] OR Exercise[MH] OR Body weight[MH] OR diet[MH])) AND English [Lang] AND "adult"[MeSH Terms] AND "humans"[MeSH Terms]
Limiting to English language and years 1990 – 2005 resulted in 191 papers.
2.1.2 International Pharmaceutical Abstracts (IPA) search terms and criteria Criteria 1:
(pharmacy or pharmaceutical services or pharmacists or pharmacies).mp. [mp=title,
subject heading word, registry word, abstract, trade name/generic name] which resulted in 64,215 papers;
Criteria 2:
(monitoring physiologic or primary prevention or mass screening or disease
management or health promotion or health education).mp. [mp=title, subject heading word, registry word, abstract, trade name/generic name] which resulted in 3,213 papers;
Criteria 3:
(cardiovascular system or coronary atherosclerosis or hypertension or heart failure,
congestive or hyperlipidaemia or lipids or cholesterol or drug therapy or patient compliance or smoking cessation or diabetes mellitus or exercise or body weight or diet).mp. [mp=title, subject heading word, registry word, abstract, trade name/generic name] which resulted in 30,483 papers;
Criteria 4:
The combination of criteria 1, 2 and 3 resulted in 410 papers;
Limiting Criteria 4 to English language and human and years 1990 – 2005, resulted in 130 papers.
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2.1.3 Cochrane search terms and criteria
Search ID 1:
cardiovascular system or coronary atherosclerosis or hypertension or heart failure,
congestive or hyperlipidaemia or lipids or cholesterol or drug therapy or patient compliance or smoking cessation or diabetes mellitus or exercise or body weight or diet in Keywords in all products produced 165,769 hits;
Search ID 2:
monitoring physiologic or primary prevention or mass screening or disease
management or health promotion or health education in Keywords in all products produced 8917 hits;
Search ID 3:
pharmacy or pharmaceutical services or pharmacists or pharmacies in Keywords in all
products produced 617 hits;
Search ID 4:
combining search IDs 1 and 2 and 3 from 1990 to 2005 produced 49 hits.
2.1.4 EMBASE search terms and criteria Search ID 1:
pharmacy or pharmaceutical services or pharmacists or pharmacies).ab,ot,sh,hw,ti.
produced 25,905 citations;
Search ID 2:
monitoring physiologic or primary prevention or mass screening or disease
management or health promotion or health education).ab,ot,sh,hw,ti. produced 49,425 citations;
Search ID 3:
(cardiovascular system or coronary atherosclerosis or hypertension or heart failure,
congestive or hyperlipidaemia or lipids or cholesterol or drug therapy or patient compliance or smoking cessation or diabetes mellitus or exercise or body weight or diet).ab,ot,sh,hw,ti. produced 626,136 citations;
Search ID 4:
combining search criteria 1 and 2 and 3 produced 245 citations;
Search ID 5:
limiting search criteria 4 to – human and English and year 1990 to 2005 produced 219
citations.
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2.1.5 INFORMIT search terms and criteria Informit incorporates and searches the following databases; AMI, APAFT, APAIS, APAISHEALTH, DRUG, MEDITEXT, ATSIhealth, H&S Health and Society database, RURAL – Rural and Remote Health Database.
Table 1
INFORMIT search terms and criteria
Set
Search terms
Records
#4
#1 AND #2 AND #3
131
#3
hypertension or coronary arteriosclerosis or cardiovascular system or lipids or heart failure or hyperlipidemia or patient compliance or drug therapy or cholesterol or exercise or body weight or smoking cessation or diet or
53202
#2
monitoring physiologic or primary prevention or mass screening or disease management or health promotion or health education
22716
#1
pharmacy or pharmacist or pharmacies or pharmaceutical services
15831
Total number of papers found 131 Number of papers deemed relevant 34 Excluding duplicates left 22 relevant papers
2.1.6 Kinetica search terms and criteria Command search using the same search terms as above (Informit). Search terms were used as subject headings and subject keywords. No relevant papers were found on this site.
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2.1.7 Community Pharmacy Research Database (CPRD) search terms and criteria The
recently
established
Community
(http://www.communitypharmacyresearch.org)
Pharmacy
Research
was also reviewed.
Database
This database was
searched by relevant disease state/condition. Paper titles were assessed for relevance; 19 were relevant but already recorded in our database.
Table 2
CPRD search terms and criteria
Search term
Number of papers
Number of relevant papers
Coronary artery disease
8
3
Cardiovascular disease
3
1
Coronary heart disease
4
0
Dyslipidaemia
13
2
Heart arrhythmia
1
0
Heart disease
1
0
Heart failure
8
2
Hypertension
17
10
Obesity
2
1
Tobacco/nicotine addiction
5
0
TOTALS
62
19
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2.1.8 Summary of database searching
Table 3 Database
Source of papers for literature review Total papers
Deemed not relevant (*)
Rele vant
New
Duplicated
Excluded
Added for quality review
MEDLINE
191
140
51
51
0
0
51
IPA – Ovid
130
80
50
48
2
0
48
Cochrane
49
31
18
4
13
1 not in English
3
EMBASE
219
185
34
29
5
3 not in English
26
Journals@Ovid
20
12
8
8
4
4
4
Total
132
(*) The search terms used for the bibliographic databases were thoroughly researched and refined over a period of time, and tailored to each specific database wherever possible. The terms were kept generally broad to reduce the possibility of missing papers. The downside of this process is that it is inevitable that extraneous articles would be identified. To eliminate theses extraneous articles, the title and abstract of every identified paper was printed out for review by two independent researchers. Papers were excluded according to the following criteria. o
A diabetes focus. If the paper primarily described a diabetes monitoring program it was excluded. This does not mean that all papers that referred to blood sugar monitoring or screening were excluded, as any screening program that incorporated BP, TC, HDL, and BSL monitoring etc. were still included.
o
Hospital or outpatient clinic setting.
o
Activities clearly not transferable to the community setting were cause for exclusion.
o
Anonymous articles that were clearly ‘news-clippings’ and referred to a published study. In this case, the published article was identified and located during manual searching.
Any papers that were not unanimously supported by both reviewers were discussed at length to reach consensus.
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Appendices 2 and 3 sets out the citation details of the 132 articles referred to the ‘quality review processes. Each of the two researchers performing the systematic review abstracted pertinent data from every article and entered this into a Microsoft Access database according to a predefined format. The resulting databases were then compared in the presence of a third researcher, and any significant discrepancies resolved. The final product is an electronic, searchable database of relevant articles, including an assessment of the quality of publications. A copy of the database has been submitted with this report. An example screenshot of the database is shown below (Figure 4).
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Figure 4
44
Example screen shot of the comprehensive electronic database of relevant literature
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The following information was extracted from each of the published papers and entered into the database.
Table 4
Information extracted from clinical papers Publication details Country and evidence grading Time frame Setting and participants Study design Intervention Outcome measures Key findings Limitations
2.2
EVALUATING QUALITY OF RESEARCH PAPERS
The two reviewers had attended Cochrane courses and had read publications by the NHMRC on reviewing the evidence in practice9-11. The reviewers classified each study according to the following NHMRC levels of evidence classification (Table 5)9, 11. The definitions for each of these types of trials are defined by the NHMRC.
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46
NHMRC levels of evidence classification
Level
Intervention
I
A systematic review of level II studies
II
A randomised controlled trial
II-1
A pseudo randomised controlled trial (i.e. alternate allocation or some other method)
III-2
A comparative study with concurrent controls:
III-3
IV
x
Non-randomised, experimental trial
x
Cohort study
x
Case-control study
x
Interrupted time series with a control group
A comparative study without concurrent controls: x
Historical control study
x
Two or more single arm study
x
Interrupted time series without a parallel control group
Case series with either post-test or pre-test/post-test outcomes
For randomised controlled trials the following NHMRC criteria (Table 6) were used by the reviewers. All randomised controlled trials were given a quality mark according to each of the criteria for each of the four categories. Discrepancies were resolved through consensus of the two reviewers and if this could not be clarified a third reviewer resolved the outcome.
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47
Checklist for appraising the quality of studies of interventions
Method of treatment assignment a. Correct, blinded randomisation method described OR randomised, double-blind method stated AND group similarity documented b. Blinding and randomisation stated but method not described OR suspect technique (eg allocation by drawing from an envelope) c. Randomisation claimed but not described and investigator not blinded d. Randomisation not mentioned
Control of selection bias after treatment assignment a.
Intention to treat analysis AND full follow-up
b.
Intention to treat analysis AND 1ml)
o
Parenteral exposure to laboratory specimens containing high titre of virus.
Hepatitis: Hepatitis A, B and C are all viruses that attack the liver with each form of the virus having different levels of seriousness to health, Hepatitis B being a common cause of liver cancer and cirrhosis of the liver.
HIV/AIDS: Refers to the Human Immunodeficiency Virus (HIV) which gradually impairs the immune system of an infected person and eventually weakens a person's defences against disease. HIV is the putative causative agent for Acquired Immune-Deficiency Syndrome (AIDS).
Mucous Membrane: The lining of the mouth, nose and respiratory tract, the conjunctival membrane covering the eye, the gastrointestinal tract and the urinogenital tract.
Source Individual: The person whose blood or body fluid was inoculated or splashed onto the affected person. The source individual may sometimes not be identifiable, for example, when an affected person has been injured by a needle/instrument and it is not know on whom it was used.
RESPONSIBILITIES Accountable Persons: Accountable Persons need to ensure that employees in their control who are at risk of exposure to blood and body fluids are appropriately trained in correct handling procedures, are aware of the associated risks, are supplied with all protective equipment and are provided with any vaccinations required. In the event of an occupational exposure, ensure that procedures outlined in this document are followed and that in the case of an infected person confidentiality is maintained.
Employees: Whilst undertaking any activity associated with blood and body fluids, employees are required to do so in a manner which does not adversely affect their own health and safety, or that of others, by following this Policy and Procedure. Employees must report all incidents arising from exposure to blood and body fluids and adopt work practices to minimise such incidents. In particular, employees who know they have HIV/AIDS or Hepatitis, are required to exercise their duty of care towards others to minimise the risk of transmitting infection.
GENERAL PREVENTATIVE MEASURES for minimising risk of infection from exposure to blood and body fluids are: o
ҏensuring that people considered to be at risk eg. employees directly involved in patient care,
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employees handling blood and body fluids are immunized o
ҏensuring that hands are washed after contact with blood and body fluids, especially before eating or drinking.
o
ensuring that gloves are worn when handling blood or body fluids, which substantially reduces the risk of hands being contaminated. However, gloves contaminated with blood or body fluids should be discarded between treating persons, as the wearing of gloves does not prevent cross-infection. Hands should be thoroughly washed after discarding gloves.
o
ensuring that waterproof aprons/gowns are worn when clothing is likely to be soiled with blood or body fluid
o
ҏensuring that masks and/or protective eye wear is worn in situations where ocular and/or mucous membrane exposure to splashed or sprayed blood or body fluid is likely, eg. cleaning soiled equipment.
o
ensuring that employees with cuts or abrasions on exposed parts of the body cover these with waterproof dressings.
o
ensuring that needles and disposable sharp instruments used on any treated person are discarded directly into a container for the disposal of sharps which complies with Australian Standards.
PROCEDURE FOR DEALING WITH EXPOSURES Affected Person o
ҏIf skin is penetrated, wash the area well with soap and water (alcohol based hand rinses or foams, 60-90 per cent alcohol by weight should be used when water is not available).
o
ҏIf blood gets on the skin, irrespective of whether there are cuts or abrasions, wash well with soap and water.
o
ҏIf the eyes are contaminated, rinse the area gently but thoroughly with water or normal saline, while the eyes are open; and
o
If blood or body fluid gets in the mouth, spit it out and then rinse the mouth with water several times.
o
ҏEnsure the safe disposal of the needle or sharp (if applicable).
Then report IMMEDIATELY to your Accountable Person. Complete an Accident/Incident Report form which must include: o
ҏdate and time of exposure;
o
ҏhow the incident occurred; and
o
ҏname of the source individual (if known).
Regardless of the status of the source individual, the affected person should immediately be evaluated and the risk assessed, preferably by a physician or trained health care worker with experience in the management of these situations. Prophylaxis should be offered on the basis of the risk of infection associated with the injury/exposure. Accountable Persons If an employee has suffered a possible parenteral, definite parenteral or massive exposure it is important that you make sure that immediate steps are taken to reduce the risk to the employee of contracting a serious illness.
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o
Ensure that the employee has thoroughly washed the exposed area and the needle or sharp has been disposed of safely (if applicable).
o
ҏArrange for blood to be taken from the employee as soon as possible by referring the person to a General Practitioner or the Accident/Emergency (Casualty) Department of the nearest Public Hospital.
o
ҏFind out whether a known source individual is involved in the incident and if so, organise for blood to be taken from the source individual which needs to be tested for: o
ҏHIV antibody;
o
Hepatitis B surface antigen (HbsAg); and
o
Hepatitis C antibody (Anti-HCV).
o
The source blood should be collected and processed immediately after the incident. (Remember, informed consent with appropriate counselling is required).
o
When the source individual is known to be positive for either HIV antibody, HbsAG or antiHCV, ensure that a physician with experience in the management of these infections has been contacted.
o
ҏEnsure that an Accident/Incident Report Form has been completed and includes:
o
The date and time of the incident;
o
ҏHow the incident happened; and
o
ҏNature of exposure, eg. Whether the affected person had been stabbed by a syringe or other sharp, or been splashed in the eye, or other mucosal contact has occurred.
o
ҏSource information if known
o
ҏReassure the employee that only a small proportion of accidental exposure to blood or body fluid results in infection.
o
Provide support and advise the employee that counselling can be arranged.
o
ҏInvestigate the circumstances of the accident and take measures to prevent recurrence. This may include changes to work practices, changes to equipment, and/or training.
Note: It is most important that confidentiality of employee and source individuals be maintained.
MEDICAL MANAGEMENT INFORMATION Affected Person The affected person should be examined IMMEDIATELY to confirm the nature of exposure and counselled about the possibility of transmission of blood borne disease. If the accident involved non-parenteral or doubtful parenteral exposure then no further testing or examinations are required apart from the possibility of further counselling. This should be determined according to the individual circumstances. If the accident involved massive, definite or possible parenteral exposure then the following should occur: o
ҏimmediate steps to identify status of the source individual;
o
blood should be taken from the affected person (the types of tests undertaken will depend
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upon the status of the sources); and o
ҏarrangements should be made for follow-up assessments of the affected person when the status of the source individual is confirmed.
Source individual In the case of massive, definite or possible parenteral exposure then the source individual should be investigated. If the status of the source individual is unknown at the time of the accident, then tests should be undertaken to ascertain the source’s infection status for HIV, HBV and HCV. Blood samples may already be in the laboratory and available for immediate testing. The following tests should be undertaken on the source: o
ҏHIV antibody
o
ҏHBsAg; and
o
ҏAnti-HCV
Blood tests for HIV and HBV should be undertaken urgently so that prophylactic treatments can be given to achieve best outcomes. The source individual (if accessible) should be appropriately counselled and informed consent should be obtained prior to undertaking the tests. SHARPS DISPOSAL GUIDELINES – modified from the University of Tasmania “Sharps Disposal Policy and Procedures”
Sharps: Sharps are defined in the "National Guidelines for the Management of Clinical and Related Wastes" published by the National Health and Medical Research Council as "objects or devices having acute rigid corners, edges, points or protuberances capable of cutting or penetrating the skin". Hypodermic needles, pasteur pipettes, scalpel blades and broken glass all fit this definition.
PROCEDURE: DISPOSAL OF SHARPS All sharps have the potential to cause injury through cuts or puncture wounds. In addition, many sharps are contaminated with blood or body fluids, microbiological materials, toxic chemicals or radioactive substances, posing a risk of infection or illness if they penetrate the skin. It is therefore essential to follow safe procedures when using and disposing of sharps in order to protect staff and students from sharps injuries. The following sharps disposal procedures shall be adhered to: 1. Pharmacies which use sharps must have a designated container suitable for the safe storage of used sharps. Suitable containers are rigid and impervious, with a tightly fitting lid and they must be clearly labelled as sharps containers. They must be discarded when full. 2. All sharps are to be placed in the sharps container immediately after use. If the container is full then users must not try to force further sharps inside as this may lead to an injury. 3. To avoid needlestick injuries, used needles must not be recapped, bent or otherwise manipulated unless an approved needle containment device is being used. 4. Containers of used sharps contaminated with biological, infectious or radioactive material must be
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labelled accordingly 5. When a sharps container is full the lid must be securely closed and the container disposed of properly. Sharps containers must not be placed into the general rubbish stream, but disposed of in an approved manner. Local Councils are generally the best point of contact to establish what the approved manner of disposal of sharps containers is in your local area.
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Ethics and Privacy Guidelines
Prior to undertaking clinical research involving human subjects, ethics approval must be obtained from the relevant committee. In general, these bodies assess ethics applications for the following reasons. o Ensure the information that is dispersed to the participants contains all the risks, benefits and actual tests and tasks that they will have to undergo if they participate within the research, indicated clearly and in everyday language that the ordinary person can understand. o Ensure that specific features of the various participant groups are protected against prejudice and have been considered appropriately. o Ensure that there is adequate indemnity for the patients o Ensure that there are adequate mechanisms for reporting of serious adverse events that occur to patients These same principles should be considered before undertaking clinical screening in the community pharmacy setting. Ethics approval as such is not required, but the issues should be considered and addressed to ensure informed consent is supplied by the patient. All pharmacists are covered by a professional code of conduct written by the Pharmaceutical Society of Australia.42 The relevant principle is shown below.
Principle THREE A pharmacist must respect the confidentiality of information acquired in the course of professional practice relating to clients and their families. Such information shall not be disclosed to anyone without the consent of the client. Exceptions may arise where the health of the client or others is at risk, where information is sought by an officer of a statutory authority empowered under legislation, where a court order requires the release of confidential information, or the information is released to those assuming responsibility for the patient (e.g. next of kin, parent, relative, guardian or anyone with powers of attorney).
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Obligations 3.1 The pharmacist must exercise discretion and restrict access to information relating to clients and their families to those who, in the pharmacist's judgment, need the information to discharge their responsibilities to the client or, in extraordinary circumstances, the public. 3.2 The pharmacist must ensure that anyone who has access to information relating to client and their families a. is aware of the need to respect its confidential nature, and b. does not disclose such information but refers the matter to the pharmacist. 3.3 Where exceptional circumstances necessitate disclosure of information relating to clients and/or their families the content should be limited to the minimum necessary for the purpose of the disclosure.
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HEALTH INFORMATION AND THE PRIVACY ACT 1988
A SHORT GUIDE FOR THE PRIVATE HEALTH SECTOR - DECEMBER 2001
This Guide provides a brief introduction to the Commonwealth privacy law covering the private health sector. For private sector health service providers, the amended Privacy Act 1988 takes effect from 21 December 2001. This Guide does not describe the law in detail.
PRIVACY AND HEALTH CARE Access to quality health care is an important priority for all Australians. It is also important that individuals' privacy is respected during the provision of health care and treatment services. Being reassured about privacy gives consumers the confidence to access the health services they need. People have different views about their privacy, including when and why it is important. Their views may depend on the sensitivity of the information or their circumstances and beliefs. At times, health service providers need to share information with each other to ensure that a person receives good quality health care. The Privacy Amendment (Private Sector) Act 2000, which amends the Privacy Act 1988, allows the sharing of information with others, where necessary, while outlining the privacy issues and safeguards to consider in these circumstances. Importantly, the legislation gives a person choice about how their health information is handled. Open communication between health service providers and health consumers regarding the handling of health information is central to properly addressing privacy issues. PROTECTING HEALTH INFORMATION In today's health environment, the privacy protection of health information is important for both electronic health records and paper-based records. When deciding how best to protect a person's health information, health service providers may need to consider: x x x x
Who should be allowed to see hospital medical records, records kept in a pharmacy, or computerised records in a medical practice? When and how is it appropriate for one health service to transfer information to another? What safeguards must apply when information is used for health research? Is the person's consent needed for handling health information in each situation?
This is where the privacy legislation can help.
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> THE PRIVACY AMENDMENT (PRIVATE SECTOR) ACT 2000 The Privacy Amendment (Private Sector) Act 2000 amends the Commonwealth Privacy Act 1988 ('the Privacy Act') to establish minimum privacy standards for the Australian private sector, including for all private sector organisations that both provide health services and hold health information. The legislation applies from 21 December 2001. The Privacy Act creates a single, nationally consistent framework for protecting privacy. It complements existing codes of practice and ethics in the health sector. The Commonwealth legislation prevails over State or Territory privacy legislation, to the extent that these laws are inconsistent. WHAT IS A 'HEALTH SERVICE'? The Privacy Act stipulates providing a 'health service' includes any activity that involves: x x x
assessing, recording, maintaining or improving a person's health; or diagnosing or treating a person's illness or disability; or dispensing a prescription drug or medicinal preparation by a pharmacist.
The Privacy Act applies to all private sector organisations that deliver these types of services, including all small health services that hold health information. The types of health services covered include traditional health service providers such as private hospitals and day surgeries, medical practitioners, pharmacists, and allied health professionals, as well as complementary therapists, gyms, weight loss clinics and many others. > WHAT TYPE OF INFORMATION IS PROTECTED? The Privacy Act protects 'personal information' about individuals - that is, any information recorded about a person where their identity is known or could reasonably be worked out. Personal information includes a person's name, address, Medicare number and any health information (including opinion) about the person. Sometimes, details about a person's medical history or other contextual information can identify them, even if no name is attached to the record. This is still 'personal information'. The Privacy Act does not cover de-identified statistical data, where individuals cannot reasonably be re-identified. 'Health information' is a particular kind of 'personal information' and attracts additional privacy protection because of its greater sensitivity. 'Health information' includes information about a person's health, disability, use of health services, or other personal information collected from someone when delivering a health service.
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THE NATIONAL PRIVACY PRINCIPLES (NPPS) Ten NPPs form the core of the private sector provisions of the Privacy Act. These principles set the minimum standards for privacy that organisations must meet. The principles cover the whole information handling lifecycle - from the collection of health information, to its storage and maintenance, as well as its use and disclosure. The principles, as they might apply in the health sector, are summarised below. For more details see the Privacy Commissioner's Guidelines on Privacy in the Private Health Sector. NPP 1 - Collection and NPP 10 - Sensitive Information These principles apply to the collection of health information. In general, they require a health service provider to: x x x
collect only the information necessary to deliver the health service; collect lawfully, fairly and not intrusively; and obtain a person's consent to collect health information about them.
Providers also need to ensure that consumers are informed about why their health information is being collected, who is collecting it, how it will be used, to whom it may be given and that they can access it if they wish. > NPP 2 - Use and Disclosure This principle sets out how providers can use and disclose health information. 'Use' refers to the handling of information within an organisation. 'Disclosure' is the transfer of information to a third party outside the organisation. A health service provider may use or disclose health information: x x x x
for the main reason it was collected (the primary purpose); or for directly-related secondary purposes, if the consumer would reasonably expect these; or if the consumer gives consent to the proposed use or disclosure; or if one of the other provisions under this principle applies.
The key is to make sure that there is alignment between the expectations of the health service provider and those of the consumer about what will be done with the health information. > NPP 3 - Data Quality Health service providers are required to take reasonable steps to keep health information up to-date, accurate and complete.
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> NPP 4 - Data Security This principle requires that health service providers take reasonable steps to protect and secure health information from loss, misuse and unauthorised access. Information that is no longer needed should be destroyed. As health information may be needed for future care of the individual or for public health reasons, the priority should be to secure the data properly. > NPP 5 - Openness Health service providers need to be open about how they handle health information. A provider must develop a document for consumers which clearly explains how their organisation handles health information. The document must be made available to anyone who asks for it. > NPP 6 - Access & Correction Consumers have a general right of access to their own health records. Access can only be denied in certain circumstances - for instance where access can pose a serious risk to a person's life or health. Also, consumers can ask for information about them to be corrected, if it is inaccurate, incomplete or out-of-date. The provider will need to take reasonable steps to correct the information. > NPP 7 - Identifiers There are restrictions on how Commonwealth government identifiers, such as the Medicare number or the Veterans Affairs number, can be adopted, used or disclosed. At present, a health service provider is not permitted to adopt these identifiers for their own record keeping systems. These identifiers may only be used or disclosed for the reasons they were issued or if other provisions under this principle apply. NPP 8 - Anonymity Where lawful and practicable, consumers must be given the option to use health services without identifying themselves.
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NPP 9 - Transborder data flows If health information needs to be transferred out of Australia, this may occur if laws (or a scheme) with similar privacy protection to these principles bind the recipient. Otherwise, health information should only be transferred with the consumer's consent, or if other provisions under this principle apply. COMPLAINTS Complaints about alleged breaches of privacy can be made to the Privacy Commissioner. The Commissioner can investigate, conciliate and, if necessary, make determinations about complaints. However, the Commissioner will not investigate, unless the complainant has first complained formally to the health service provider concerned. GUIDELINES ON PRIVACY IN THE PRIVATE HEALTH SECTOR For more assistance on how the privacy legislation applies to health service providers, see the Privacy Commissioner's Guidelines on Privacy in the Private Health Sector and Information Sheets (especially Information Sheet 9 2001 Handling Health Information for Research and Management). These Guidelines and the Privacy Act 1988 are available on the Office's web site at www.privacy.gov.au. Health service providers are also encouraged to contact their professional body or association for further information on privacy in their profession. FOR FURTHER INFORMATION CONTACT: Office of the Privacy Commissioner x x x
1300 363 992 (Hotline)
[email protected] www.privacy.gov.au
SOME PRIVACY ISSUES FOR PHARMACISTS Collecting health information, dispensing medication and discussing symptoms in a public space
When a pharmacist collects health information from a patient in a place where they may be overheard, this should be done in a manner sensitive to the surroundings - as some individuals may be particularly concerned about discussing health issues in an open area. In some circumstances, the pharmacist may wish to take additional steps to protect privacy, such as taking the patient to one side. Change of business circumstances and pharmacies
When a pharmacy's business circumstances change, some privacy-related steps may be needed. If the new arrangements lead to delivering services in the same way as before, but under new ownership, patients should be advised of the change, perhaps via a notice in the pharmacy or in a local newspaper.
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If the new arrangements change the way services are delivered, including the way health records are used and disclosed, then the consent of patients will usually be needed. This might occur, for instance, if a pharmacy becomes newly co-located with other clinical services and shared record handling is introduced, or where a large corporation buys a pharmacy, and the corporation wants to transfer health information within the organisation. Access to health records
From 21 December, patients have a general right of access to their own health records and can ask for a copy. Patients also have a right to seek the correction of information held about them, if this is shown to be inaccurate, incomplete or not up-to-date. Children's privacy
The Privacy Act does not set an age limit at which a child or young person can exercise their own privacy rights - this occurs when the individual becomes competent to make such decisions. Where a child or young person is competent they should make their own decisions; if they are not competent to do so, a pharmacist may discuss their health record with a parent. If a parent seeks information about their child, but the child explicitly asks that certain health information not be disclosed to that parent, the pharmacist may consider it appropriate to keep such information confidential. Providing personal information to others - the collection of medication by friends, neighbours or relatives
A patient's consent to the disclosure of their personal information can be expressed or implied. In many instances, implied consent may reasonably be inferred from the actions of the patient. Depending on the circumstances, it may be inferred that a patient has consented to someone else collecting medication on their behalf (and thereby receiving some of their personal information), if they have given a friend or relative their prescription for that reason. Complaints
Complaints about alleged breaches of privacy can be made to the Federal Privacy Commissioner. The Commissioner can investigate, conciliate and, if necessary, make determinations about complaints. Need more information...?
Other resources include: x x x
a privacy booklet 'Guidelines on Privacy in the Private Health Sector', and a range of Information Sheets.
