Medication management and reviews

Transcription

1 Pharmacy Cardiovascular Health Care Model Elements of the Pharmacy Cardiovascular Health Care Model: Medication management and reviews promoting evidence-based pharmacotherapy, monitoring and educating patients 9.1 GUIDING PRINCIPLES AND EXISTING FRAMEWORK NATIONAL CHRONIC DISEASE STRATEGY: Key direction 31: Support appropriate use of medicines to maximise health outcomes and quality of life. Key direction 35: Develop education and training strategies for health care providers to gain knowledge and skills to support self-management, so that self-management becomes part of routine clinical practice. Key direction 36: Ensure that self-management is incorporated into clinical practice through its inclusion in multi-disciplinary care planning with the patient and their family and carers. NATIONAL SERVICE IMPROVEMENT FRAMEWORK FOR HEART, STROKE AND VASCULAR DISEASE Critical intervention point: Implement policies to encourage the safe and quality use of medicines. 21 An essential component of integrated care is the use of medicines. People with chronic disease often use multiple medicines, and improving their medication management between settings and over time is important for avoiding adverse drug events, improving health outcomes and achieving financial savings. The National Strategy for the Quality Use of Medicines and National Medicines Policy, while recognising that many people manage their health without using medicines, offer guidance for best practice in the role of medicines in maintaining health, preventing illness and treating disease. Collaboration between specialist and primary care, including pharmacists, is fundamental to the quality use of medicines. Health professionals also need to be skilled in behavioural interventions and other evidence-based approaches to encourage people to use medicines optimally. The quality use of medicines is an essential component of integrated care incorporating self-management. 19

2 Pharmacy Cardiovascular Health Care Model PROMOTING EVIDENCE-BASED PHARMACOTHERAPY OF CVD The major interventions in the prevention of CVD are considered to be lifestyle changes (including the cessation of smoking) and the treatment of hypertension and dyslipidaemia. 20 A multidisciplinary group of Australian physicians evaluated current best practice, based on a rigorous analysis of available published evidence to March 2004, and formulated a concise (single-page chart) and up-to-date guide for the prevention of CVD. 20 This consensus of opinions has been summarised as a clinical aid and is provided for use in clinical practice as a desktop reference (Figure 44). It could also be a useful aid for community pharmacists to promote the prevention of major cardiovascular events, within the Pharmacy Cardiovascular Health Care Model. Similarly, the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand recently published a consensus statement on strategies to prevent cardiovascular events in people with coronary heart disease (Figure 45).

3 Pharmacy Cardiovascular Health Care Model 235 Figure 39 Clinical aid outlining appropriate therapy for patients in different CVD risk categories 20

4 Pharmacy Cardiovascular Health Care Model 236 Figure 39 (continued): Clinical aid outlining appropriate therapy for patients in different CVD risk categories 20

5 Pharmacy Cardiovascular Health Care Model 237 Figure 40 Therapeutic guidelines for preventing cardiovascular events in patients with CVD 286

6 Pharmacy Cardiovascular Health Care Model 238 Figure 40 (continued): Therapeutic guidelines for preventing cardiovascular events in patients with CVD 286

7 Pharmacy Cardiovascular Health Care Model 239 The National Prescribing Service has recently published a short review on prescribing in CVD, which is a useful quick reference for pharmacists when collaborating with doctors to promote the quality use of medicines in CVD. 287 Figure 41 National Prescribing Service guidelines on drug use in CVD 287 Despite the widespread availability and promotion of these guidelines, secondary prevention of cardiovascular events in people who have begun to develop the disease is recognised as being a major gap in care in Australia and in the rest of the developed world. 19 Important gains might be made sooner through systematic application of proven treatments to patients with clinically evident CHD, especially those over the age of 65 years, for preventing cardiovascular events in patients with CVD.

8 Pharmacy Cardiovascular Health Care Model 240 The need for measures to improve the long-term secondary prevention in patients with cerebrovascular ischaemia was highlighted recently by Dutch researchers who, in a follow-up of nearly 2,500 patients who had enrolled in a trial of aspirin, determined that ten years after a minor ischemic stroke or transient ischaemic attack, 60% of patients were dead and 54% had had at least one more vascular event. 288 The risk for any vascular event was highest immediately after the ischaemic event, but then began a decline that reached its nadir about three years after the stroke. Then the risk began to rise again. It was speculated that the decline in event during the first three years after the enrolment event probably reflected the impact of treatment, in this case, aspirin, and the increase after three years might be explained by a drop-off in aspirin use and a return to previous unhealthy lifestyles. There is abundant evidence that older patients with coronary heart disease (CHD), or at high risk of CHD, are under-treated - possibly because of concerns regarding the increased likelihood of adverse events and drug interactions, or doubts regarding the cost-effectiveness of drug therapy in this population. 289 Given the high cost of therapy with statins (consuming almost one-fifth of the total Pharmaceutical Benefits Scheme budget) and the obvious limit to society s health care resources, it is critical that the outcomes of lipid-lowering drug therapy are maximised. 248 Elevated cholesterol levels remain a significant risk factor for CHD in the elderly. Although the relative risk of CHD tends to diminish with increasing age, this reduction is accompanied by an increase in absolute risk (i.e. the number of events) as the frequency of the illness increases markedly with age. 290 Whether this means that the elderly should be aggressively treated with lipid-lowering drug therapy or whether the elderly benefit as much as younger patients from pharmacological therapies directed at preventing coronary events has been long debated. The major problem has been the lack of research into reducing the risk of CHD in the elderly, so that therapeutic decisions must be typically made on a case-by-case basis. Some guidance can perhaps now be provided by results of the recently concluded Pravastatin in the Elderly at Risk (PROSPER) study, 291 which assessed the effects of pravastatin (40 mg/day) versus placebo in 2,804 men and 3,000 women, aged 70 to 82 years, who either had pre-existing vascular disease or were at significant risk for developing it because of smoking, hypertension, or diabetes. The average total cholesterol level at baseline was 5.4 mmol/l (men) and 6.0 mmol/l (women). The average follow-up period was 3.2

9 Pharmacy Cardiovascular Health Care Model 241 years. The primary endpoint was a composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke. Pravastatin reduced the incidence of the primary endpoint by 15% (95% confidence interval: 3-26%; p = 0.014). Coronary death and non-fatal myocardial infarction risk was also reduced by 19% and mortality from coronary disease fell by 24%. The risk for stroke, however, was unaffected, whereas the incidence of transient ischaemic attacks was reduced by 25% (p = 0.051). The investigators attributed the lack of an effect on strokes to the relatively short duration of the study. Recent publications suggest that stroke benefit from statins does not begin to appear until after 3 years of treatment. 292 Pravastatin had no effect on cognitive functions or incapacity, which may also reflect the short follow-up period of the study. Coronary heart disease death and myocardial infarction risk reduction in elderly patients by pravastatin in the PROSPER study was similar to the benefit of statins in middle-aged populations in other studies. An accompanying editorial concluded that: 293 PROSPER and the other large-scale trials have now collectively shown that cholesterol-lowering statin therapy rapidly reduces the risks of major vascular events not only in middle age but also in older age, and the benefits are substantial among patients who are at high risk because of pre-existing occlusive arterial disease, diabetes, or other factors (including age). These studies have also shown that such treatment is well tolerated and safe, even among older patients, with no good evidence of any increase in cancer or other nonvascular morbidity or mortality. Hence, long-term statin therapy should now be considered routinely for all such high-risk patients largely irrespective of either their presenting lipid concentrations or their age. The earlier Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, 294 conducted in Australia and New Zealand, showed that cholesterol-lowering therapy (again pravastatin 40 mg/day) prevented further cardiovascular events in 9014 patients with previous myocardial infarction or unstable angina and average baseline cholesterol levels (4.0 to 7.0 mmol/l). Major cardiovascular disease events were followed over 6 years. A subgroup analysis of 3514 patients aged 65 to 75 years of age showed that older patients were at greater risk than younger patients for death, myocardial infarction, unstable angina, and stroke (each p < 0.001). Pravastatin reduced the risk for all cardiovascular disease events, and similar relative effects were observed in older and younger patients. In patients 65 to 75 years of age,

10 Pharmacy Cardiovascular Health Care Model 242 pravastatin therapy reduced mortality by 21%, death from CHD by 24%, CHD death or nonfatal myocardial infarction by 22%, myocardial infarction by 26%, and stroke by 12%. For every 1000 older patients treated over 6 years, pravastatin prevented 45 deaths, 33 myocardial infarctions, 32 unstable angina events, 34 coronary revascularisation procedures, 13 strokes, or 133 major cardiovascular events, compared with 22 deaths and 107 major cardiovascular events per 1000 younger patients. The Heart Protection Study, with over 20,500 subjects aged years, was the largest 219, 295 trial of statin therapy ever conducted. It was a prospective double-blind randomised controlled trial investigating prolonged use (> 5 years) of simvastatin 40 mg daily and a cocktail of antioxidant vitamins (650 mg vitamin E, 250 mg vitamin C and 20 mg betacarotene daily) in patients with coronary disease, other occlusive arterial disease, or diabetes and a blood total cholesterol concentration of at least 3.5 mmol/l. Simvastatin treatment produced benefit across all patient groups regardless of age, gender or baseline cholesterol value. The statins are generally well-tolerated. Myopathy is the major adverse reaction of concern, although it is uncommon and generally resolves rapidly when treatment is stopped. 296 Increasing age per se does not appear to increase the risk of myopathy. However, the risk of myopathy with statin treatment increases with co-administration of drugs that inhibit statin metabolism. In fact, when muscle damage does occur with statins, it is commonly the result of drug-drug interactions rather than a specific adverse response to statin monotherapy. 297 Such interactions inevitably result in higher plasma concentrations of a statin and thereby an increased risk of myopathy. Multiple drug use, drug interactions and altered drug metabolism may put the elderly patient at increased risk of myopathy when statins are administered. 297 elderly patients. 296 Some caution is therefore advocated in the use of these drugs in In this regard, pravastatin and fluvastatin are least likely to provoke muscle cell damage, which, at least in part, relates to not being metabolised by the cytochrome P-450 3A4 pathway It is becoming increasingly recognised that under-treatment poses at least as much risk to elderly patients as polypharmacy Possible contributing factors include insufficient evidence of clinical benefit due to under-representation of older patients in clinical trials and doctors non-specific fear of polypharmacy. 306 Also, there is the need for systems of care that improve drug safety and enhance adherence in elderly persons on complex medication

11 Pharmacy Cardiovascular Health Care Model 243 regimens. 305 Many instances of under-use of appropriate drug therapy have been extensively documented. Specific examples of conditions which may be under-diagnosed and/or undertreated, especially in elderly or socially disadvantaged patients are listed in Table 26; a predominance of cardiovascular conditions is evident. As noted by Rochon and Gurwitz: 302 prescribing strategies that seek to limit the number of drugs prescribed to elderly patients in the name of improving quality of care may be seriously misdirected. A broader view of prescribing for seniors recognises that problems occur from both the over-prescribing and under-prescribing of drug therapies. The past few years have seen a number of studies illustrating the adverse consequences associated with under-prescribing of beneficial drug therapies. These studies point to a more complex model for assessing the quality of prescribing for seniors than simply counting the number of different medications that an elderly patient is receiving. Table 26 Examples of conditions which may be under-diagnosed 307, 308 and/or under-treated in the elderly Hypertension Hyperlipidaemia Congestive heart failure Asthma Depression Glaucoma Pain (partly attributable to the elderly tending to under-report their pain) Acute myocardial infarction (underuse of thrombolytic agents and -blockers) Atrial fibrillation (reluctance to use warfarin) Osteoporosis Prevention of venous thromboembolism postoperatively and in medical patients Vaccination (e.g. influenza and pneumococcal vaccines)

12 Pharmacy Cardiovascular Health Care Model 244 A recent study examining the national guidelines for cardiovascular prevention has found that guidelines should focus on older rather than younger patients. 309 Guidelines were obtained from Australia, New Zealand, Canada, UK and USA and it was found that the cost per cardiovascular event prevented is lowest in older patients and very high in those under 35 years of age. It was concluded that in order to justify their recommendations, guidelines should also quantify the resource implications in relation to the health benefits. 309 Pharmacists must double their efforts in ensuring the quality use of medicines in the elderly with CVD, including, when necessary, remedying under-treatment by promoting the use of medications according to evidence-based guidelines. Community pharmacists need to maintain or refresh their clinical skills and apply them continually in practice to tackle the issue of suboptimal medication use in the elderly, for the benefit of both elderly citizens and the future of the pharmacy profession. 142 The Competency Standards for Pharmacists in Australia specifically state that a pharmacist should be competent to promote and contribute to the quality use of medicines. 310 The need for enhanced collaboration between doctors and pharmacists is also critical. 305 Improving the safety of medicines management in primary care is likely to require the adoption of multiple strategies, including better support for prescribing decisions, more effective involvement of patients in these decisions, and better systems for monitoring the safety of medicines. Success is likely to be dependent on more effective use of computers (discussed later in this Report) and improving partnerships between general practice staff, patients, and pharmacists. 311 The primary focus of the pharmacist must be as a safety advocate for the patient, regularly reviewing their drug therapy and monitoring for potential adverse events. Better collaboration between doctors, patients, and pharmacists should be readily possible in Australia with, for instance, our unique schemes of Home Medicines Reviews and Residential Medication Management Reviews (or Comprehensive Medication Reviews). Community pharmacists need to fully commit and make the most of this opportunity to ensure that these medication review programs are sustained for the benefit of Australians, our health care system and the pharmacy profession. 138 Geber, J., D. Parra, et al. (2002). "Optimizing drug therapy in patients with cardiovascular disease: the impact of pharmacist-managed pharmacotherapy clinics in a primary care setting." Pharmacotherapy 22(6): We evaluated the effectiveness of pharmacist-managed pharmacotherapy clinics in implementing and maximizing therapy with agents known to reduce the morbidity and

13 Pharmacy Cardiovascular Health Care Model 245 mortality associated with cardiovascular disease. This was a retrospective chart review of 150 patients who were treated for coronary artery disease in primary care clinics. Appropriate treatment of hypercholesterolemia occurred in 96% of patients referred to a clinical pharmacy specialist, compared with 68% of those followed by primary care providers alone (p<0.0001). Eighty-five percent and 50%, respectively, achieved goal lowdensity lipoprotein (LDL) values below 105 mg/dl (p<0.0001). Appropriate therapy with aspirin or other antiplatelet or anticoagulant drugs was prescribed in 97% and 92%, respectively (p=0.146). As appropriate therapy with these agents was high in both groups, the ability to detect a difference between groups was limited. Among patients with an ejection fraction below 40%, appropriate therapy with an angiotensin-converting enzyme inhibitor or acceptable alternative was 89% and 69%, respectively (p<0.05). Twenty-seven cardiac events were documented in the clinical pharmacy group, versus 22 in the primary care group (p=0.475). Despite the relatively high percentage of patients reaching goal LDL in the primary care group, referral to clinical pharmacy specialists resulted in statistically significant increases in the number of patients appropriately treated for hypercholesterolemia and achieving goal LDL Heart failure Congestive heart failure (CHF) is the only cardiovascular disease with increasing incidence and prevalence. 313 Up to 20% of the population will develop CHF in their lifetime. 314 CHF has a high mortality rate (up to 60% within five years of diagnosis) and causes significant morbidity, with most patients requiring multiple hospitalisations approximately $ million per annum in health care costs in Australia. 315 CHF accounts for It is recognised that optimisation of drug therapy currently represents the most effective way of reducing healthcare costs associated with CHF. 318 Therapy previously used in patients with failing hearts (digoxin and other positive inotropes, and vasodilators) improved contractility, reversed haemodynamic abnormalities, and enhanced functional status, but they failed to improve mortality. 319 Now, however, there are many therapeutic options available (angiotensin converting enzyme inhibitors or ACEIs, angiotensin-ii receptor antagonists or AIIRAs, spironolactone and -blockers) that have been proven to benefit total mortality, heart failure mortality, hospitalisation rates, progression of left ventricular dysfunction, and symptom severity. Consequently, guidelines for the management of patients with chronic 286, 313, 315, 317, heart failure have undergone considerable change in recent years. However, there has been worldwide concern based on a number of studies, including two Australian ones by members of the Project Team, 324, 326 suggesting that the results of published CHF trials are not being applied in clinical practice as quickly or as fully as possible, especially in women and the elderly.

14 Pharmacy Cardiovascular Health Care Model 246 In the first study, an extensive range of clinical and demographic data were collected for 450 adult patients admitted to the medical wards of Tasmania s public hospitals with heart failure, either as a primary diagnosis or as a co-morbidity. 324 The patients (57% females) had a mean age of 77.8 ± 10.2 years, and were being treated with a median of 7 drugs on hospital admission. The study revealed evidence of underutilisation of drugs shown to improve outcome in CHF. For instance, contemporary guidelines suggest that ACE inhibitors improve prognosis in all grades of heart failure and should be used as initial therapy in virtually all patients, 286 yet only half the patients were receiving one of these agents on admission to hospital. The percentages of patients being treated with the major drugs of interest were: ACE inhibitors (50%), -blockers (22%), spironolactone (15%), digoxin (24%), loop diuretics (65%), and angiotensin-ii receptor antagonists (8%). Less than one-half the patients who were receiving an ACE inhibitor were taking a target dose for heart failure. Underuse of heart failure medications was most pronounced in women and elderly patients. It was concluded that current guidelines for the treatment of heart failure are still not being reflected in clinical practice. The relatively low use of drugs shown to improve survival in heart failure is of concern and warrants educational intervention. It has been established that users of non-steroidal anti-inflammatory drugs (NSAIDs) have a two-fold increase in risk of hospitalisation for CHF and that this effect is larger among patients with pre-existing cardiovascular diseases Consequently, most guidelines now recommend that NSAIDs should be avoided in CHF, 315, 317 yet more than 10% of the patients in this study were taking a NSAID on admission to hospital.

15 Pharmacy Cardiovascular Health Care Model 247 Figure 42 Example of media coverage of a published study of management of CHF by members of the Project Team 324 In the second study data were collected on 126 aged care residents with heart failure. 326 It found 56.3% (n = 71) were prescribed an ACEI for their heart failure, but of these 71, only 33.8% were receiving recommended target doses. Residents with renal dysfunction, diabetes mellitus and ischaemic heart disease were found to be more likely to be prescribed an ACEI. As were residents on NSAIDs and calcium antagonists, which may potentially worsen heart failure. This trend was not observed amongst residents receiving tricyclic antidepressants, aspirin and -blockers. This study again showed that ACEIs were under-prescribed and under-dosed amongst elderly patients with heart failure. In addition, residents were often prescribed medications that may potentially worsen heart failure, complicating the management of their disease. There are now comprehensive international data indicating that pharmacists, contributing as part of a multidisciplinary care team, can play an important role in optimising the drug therapy management of patients with CHF and is associated with improved outcomes, including higher rates of utilisation and dosing of beneficial drugs In the landmark Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) Study, patients with heart failure and left ventricular dysfunction (ejection fraction <45) undergoing evaluation in a clinic were randomised to an intervention or a

16 Pharmacy Cardiovascular Health Care Model 248 control group. Patients in the intervention group received a pharmacist evaluation, which included medication evaluation, therapeutic recommendations to the attending physician, patient education, and follow-up telemonitoring. The control group received usual care. The primary end point was combined all-cause mortality and heart failure clinical events. All clinical events were adjudicated by a blinded end point committee. The median follow-up was 6 months. All-cause mortality and heart failure events were significantly lower in the intervention group compared with the control group. In addition, patients in the intervention group received significantly higher ACEI doses. A recent study investigated the impact of a pharmacist-led pharmaceutical care program, involving optimisation of drug treatment and intensive education and self-monitoring of patients with CHF within the United Arab Emirates. 342 Intervention patients received a structured pharmaceutical care service while control patients received traditional services. A total of 104 patients in each group completed the trial. Over the study period (12 months), intervention patients showed significant improvements in a range of summary outcome measures including exercise tolerance, forced vital capacity, health-related quality of life, and self-reported compliance with medication. A major study of pharmaceutical care in patients with CHF is now underway in Indiana, USA. 343 In this 4-year, controlled trial, patients aged 50 years with a diagnosis of CHF are randomly assigned to pharmacist intervention or usual care. Intervention patients receive 9 months of pharmacist support and 3 months of post-intervention follow-up. The intervention involves a pharmacist providing verbal and written education, icon-based labelling of medication containers, and therapeutic monitoring. The pharmacist identifies patients barriers to appropriate drug use, coaches them on overcoming these barriers, and coordinates medication use issues with their primary care providers. Daily updates of relevant monitoring data are delivered via an electronic medical record system and stored in a personal computer system designed to support pharmacist monitoring and facilitate documentation of interventions. To measure medication compliance objectively, electronic monitoring lids are used on all CHF medications for patients in both study groups. Other assessments include self-reported medication adherence, results of echocardiography, brain natriuretic peptide concentrations, health services utilisation, and health-related quality of life.

17 Pharmacy Cardiovascular Health Care Model Atrial fibrillation The situation in the management of chronic or paroxysmal atrial fibrillation (AF) is similar. Despite evidence that antithrombotics are effective in reducing the risk of stroke in AF, they remain under-utilised. At present there is a well recognised under utilisation of warfarin in atrial fibrillation. 22 The presence of AF has been confirmed as an important risk factor for stroke and other thromboembolic events. 344, 345 The role of warfarin and aspirin for stroke prevention in nonrheumatic AF has been clearly established; meta-analyses 346 showed warfarin therapy in patients with non-rheumatic AF can reduce the risk of stroke by approximately 62%, with an acceptably low annual rate of major bleeding complications (1.3% compared to 1.0% in the control patients). Despite its proven cost-effectiveness 347 and the availability of risk stratification guidelines, 348, 349 numerous studies have indicated that antithrombotic therapy is still widely under-utilized in AF A number of barriers to warfarin prescribing have been proposed in the literature, yet the relative importance of these specific barriers remains unknown. Few surveys have directly questioned doctors regarding their perceived barriers to anticoagulation. A study by members of the Project Team 356 assessed the attitudes of Australian doctors towards the use of antithrombotic drug therapy for stroke prevention in patients with non-valvular AF, and particularly investigated the barriers to the prescribing of warfarin. It was concluded that there is considerable scope for improvement in doctors knowledge about the appropriate use of antithrombotic drug therapy in non-valvular AF and awareness of the results of recent clinical trials. Thus, Project Team members have recently concluded a successful educational intervention using the process of pharmacist-conducted academic detailing, 357 targeting identified barriers to the use of anticoagulation for stroke prevention in AF, and including the compilation and dissemination of clear guidelines for general practitioners. 358 In a controlled trial, outcomes were measured using evaluation feedback from the general practitioners, and drug utilisation data provided by (i) a series of patients presenting to hospital with an admission diagnosis of AF and (ii) dispensing of antithrombotic therapy under the Australian Pharmaceutical Benefits Scheme. Hospital admission data before and after the intervention revealed a significant increase in the use of warfarin in patients at high risk of stroke (33% to

18 Pharmacy Cardiovascular Health Care Model % of eligible patients; p < 0.05). Analysis of prescription data for warfarin also indicated that the increase in use of warfarin within the intervention region was significantly greater than for the control region (p < ). It was concluded that the pharmacist-conducted educational program lead to a significant increase in the prescribing of warfarin for stroke prevention in patients with AF. If the program were implemented across the spectrum of general practice, it could significantly reduce the incidence of stroke in patients with AF and its subsequent contribution to health-care expenditure. We conservatively estimated that this project has the potential to reduce the number of AF-related strokes by 10% per annum, decreasing the total number of strokes per annum by about 1.5% or 600 strokes if applied across Australia. The reduction in health-care costs associated with stroke would correspond to approximately Aus$14 million per annum Hypertension As previously mentioned, several studies have shown that pharmaceutical care in community pharmacies can improve adherence with therapy and the control of hypertension pharmacist is uniquely positioned in the health care system to assist with improving blood 279, 280 pressure control by utilising strategies to solve medication-related problems. Studies The within integrated health systems have demonstrated that when pharmacists are included as members of health care teams, control rates for hypertension increase. In addition, drug 279, 280 interactions, non-adherence, and costs can be reduced. In the US, community pharmacists have begun to assist physicians with monitoring of hypertensive patients through improving medication compliance, reducing adverse reactions, and improving blood pressure control. Many community pharmacists screen for new or inadequately controlled hypertension and refer patients to their doctors. It is becoming more common for some community pharmacists to develop collaborative relationships with specific physicians. These physicians often refer appropriate patients to a pharmacist for additional follow-up between physician office visits. The pharmacist may measure blood pressure, adjust dosages, and later the antihypertensive regimen via protocols approved by the physician. In these relationships, pharmacists maintain close communication with the doctor. 284

19 Pharmacy Cardiovascular Health Care Model 251 Chambers LW et al, Family physicians, pharmacies and public health authorities should work together to improve control of high blood pressure among Canadians. Building on existing community-based resources, they could help ensure the accuracy of readings and promote communication among health care providers about patients blood pressure. Physicians awareness of self-monitored blood pressure readings is key to improved management of hypertension. Optimal management, which includes self-monitoring in pharmacies, is currently limited by poor communication between physicians and pharmacists about clinical information generated in pharmacies. We recommend that pilot demonstration projects with peer health educator volunteers and linkage to family physicians be set up in pharmacies and evaluated. Such an innovative program could be established on a larger scale if outcomes are positive. A West Australian study recently examined the effect of the provision of pharmaceutical care by a clinical pharmacist on CVD risk factors, particularly blood pressure control, in patients with type 2 diabetes; 198 community-based patients were randomised to pharmaceutical care or usual care. 360 The pharmaceutical care patients had face-to-face goaldirected medication and lifestyle counselling at baseline and at 6 and 12 months plus 6- weekly telephone assessments and provision of other educational material. The nine steps of good pharmaceutical care practice were followed in each case, specifically, developing a pharmacist-patient relationship; collecting, analysing, and interpreting relevant information; listing and ranking drug-related problems; establishing pharmacotherapeutic outcomes with the patient; determining feasible pharmacotherapeutic alternatives; selecting the best pharmacotherapeutic solution; designing a therapeutic monitoring plan; implementing the individual regimen and monitoring plan; and follow-up. Patient-specific goals, current medication lists, and clinical and biochemical data were sent to the primary care physician and other involved health care professionals after each visit. Attention to diet (based on National Heart Foundation of Australia recommendations), exercise, and compliance with home blood glucose monitoring and treatment were encouraged initially by the pharmacist, who subsequently advised the patient to consult their doctor for consideration of intensification of pharmacotherapy if there had been insufficient progress at follow-up. In addition to scheduled contacts, all pharmaceutical care patients received a bimonthly newsletter on topics based on issues identified at interview. Other relevant educational pamphlets from the National Heart Foundation of Australia and Diabetes Australia were also provided.

20 Pharmacy Cardiovascular Health Care Model Hyperlipidaemia Our systematic literature review (Section 2.1) found a relatively large amount of overseas data on pharmacy involvement in the detection and management of cardiovascular disease, with the pivotal SCRIP (Study of Cardiovascular Risk Intervention by Pharmacists) 361 study having the best methodological design and outcomes. This was a randomised controlled trial conducted in 54 community pharmacies in Canada to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events. Patients randomised to pharmacist intervention received education and a brochure on risk factors, point-of-care cholesterol measurement, referral to their physician, and regular follow-up for 16 weeks. Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions. Usual care patients received the same brochure and general advice only, with minimal follow-up. The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication. The external monitoring committee recommended early study termination owing to benefit. The primary end point was reached in 57% of intervention patients vs. 31% in usual care (odds ratio, 3.0; 95% confidence interval, ; P<0.001). It was concluded that a community-based intervention program improved the process of cholesterol management in high-risk patients. The program demonstrated the value of community pharmacists working in collaboration with patients and physicians. This high-quality RCT provides significant evidence that community pharmacists can provide positive benefits to patients in the management of cardiovascular disease. This study provides an ideal model for transfer in to community pharmacy practice in Australia.

21 Pharmacy Cardiovascular Health Care Model 253 Table 27 Some roles of the pharmacist in patients with dyslipidaemia (modified from Luxford 260 ) Providing pharmaceutical advice - for instance, the timing of administration of lipid-lowering therapy, identification of drug interactions and adverse drug reactions Providing dietary advice Providing printed educational material Identifying other sources of information and advice e.g. the National Heart Foundation Simvastatin has been available since July 2004 for over-the-counter supply in the UK in a 10-mg formulation. 362 This change, if subsequently implemented in Australia, would make a significant difference to the role of community pharmacists in tackling CVD, and their training needs (and therefore have a major impact on any potential pharmacy-based models). This Report has not specifically addressed this issue at this time. Several recent papers in Clinical Pharmacology and Therapeutics have discussed the advantages and disadvantages of 363, 364 over-the-counter availability of statins, at least from a US perspective. Community pharmacists are well-placed to ask patients about the possible development of adverse reactions to CVD drug therapy for CVD and to remind patients that some drugs require regular monitoring for either clinical efficacy or safety reasons. For instance, once lipid-lowering therapy has been initiated, laboratory monitoring for safety of the therapy should occur at the same time as the follow-up fasting cholesterol profile (e.g. after six weeks of therapy). 196 Again, liver function tests (ALT and AST) and CK should be evaluated. In general, these laboratory tests should be repeated following any change in dosage or medication, and at least annually in stable patients. 196

22 Pharmacy Cardiovascular Health Care Model 254 Yamada, C., J. A. Johnson, et al. (2005). "Long-term impact of a community pharmacist intervention on cholesterol levels in patients at high risk for cardiovascular events: extended follow-up of the second study of cardiovascular risk intervention by pharmacists (SCRIPplus)." Pharmacotherapy 25(1): STUDY OBJECTIVE: To determine the effect of a community pharmacist intervention in patients at high risk for coronary heart disease on low-density lipoprotein cholesterol (LDL) levels 1 year after completion of the Second Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP- plus ). METHODS: Patients who completed the original study were invited to make a single return visit to their community pharmacy so that the pharmacist could measure their fasting LDL level using a point-of-care device. The primary outcome was change in LDL level from the 6-month (final) visit to the extended follow-up evaluation. RESULTS: Of the 359 patients who completed the original 6-month visit, data were collected for 162 (45%) patients. The mean +/- SD LDL level at completion of the original study was / mg/dl (2.79 +/ mmol/l) (an increase of 2.7 mg/dl [0.07 mmol/l], 95% confidence interval [ ]). Sixty-one (38%) patients were at the target LDL level (< 96.7 mg/dl [< 2.50 mmol/l]). CONCLUSION: The LDL reduction was maintained 1 year after completion of the extended follow-up. Since most patients were still not at the target LDL level, this finding suggests that continuing intervention is necessary to help patients reach this target. 361 Paulos, C. P., C. E. Nygren, et al. (2005). "Impact of a pharmaceutical care program in a community pharmacy on patients with dyslipidemia." Ann Pharmacother 39(5): BACKGROUND: Inappropriate use of medications is a significant problem in health care today. A possible solution to this problem may be achieved through better control of patients' drug therapy. OBJECTIVE: To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications, while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life. METHODS: Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks. Although both the intervention and control groups were surveyed, the randomly selected intervention group was interviewed more frequently and more comprehensively. Cholesterol, triglycerides, glucose, weight, risk factors, drug-related problems (DRPs), and quality of life were measured via a survey at the onset of the study and continually measured until the study's conclusion. RESULTS: In the intervention group, 26 DRPs were detected, of which 24 were resolved; in the control group, 26 DRPs were detected, of which 5 were resolved. When comparing initial and final blood cholesterol levels in the intervention group, the mean decrease was / mg/dl (p = ); in the control group, the average blood cholesterol level decreased by a mean of 1.4 +/ mg/dl (p = ). In the intervention group, the triglyceride level decreased an average of / mg/dl (p = ), while the control group experienced a mean triglyceride level increase of / mg/dl (p = ). As a result of the intervention, the quality of life in the intervention group was improved. CONCLUSIONS: Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values, cardiovascular disease risk factors, and patients' quality of life. 365 Studies worldwide have indicated some considerable under-use of -blockers in patients who had a prior myocardial infarction or with heart failure. Community pharmacists have a key role in identifying patients with CVD and helping to ensure that these patients receive the beneficial effects of -blockers and other proven preventive agents, if they are eligible. Utilising the Home Medicines Review (HMR) scheme is an ideal way to bridge the gap

23 Pharmacy Cardiovascular Health Care Model 255 between evidence in practice for the use of these agents and to reduce the societal burden of CVD in Australia (Figure 48). 366

24 Pharmacy Cardiovascular Health Care Model 256 Figure 43 Underuse of beta-blockers and the pharmacist 366

25 Pharmacy Cardiovascular Health Care Model MONITORING AND EDUCATING PATIENTS Community pharmacists have much to offer in terms of working with other health professionals and patients to improve therapeutic outcomes in CVD. As noted by Petty 7 in the United Kingdom, the pharmacy profession is moving from purely product supply to a clinical and information supply role. Proposed changes to the way the profession is funded should increase the speed of change. At present, pharmacists are not fully integrated into the primary health care team - this is in part the fault of the profession. Pharmacists skills could be better used to help patients with their long term medicines. Pharmacists can: 7 identify suboptimal treatment and monitoring identify problems patients have with medicine taking provide education on disease and the treatment explain reasons for changes that are being made to treatment. Pharmacists have extensive contact with patients with established CVD. In general, patients taking medications on an ongoing basis see their pharmacist much more frequently than their doctor. 205 Pharmacists have a unique opportunity to intervene and empower patients to become proactively involved in their own care, promote the evidence-based use of drugs in CVD, and monitor the therapeutic response and adverse reactions. Promoting evidence-based prescribing in CVD can also generate significant cost savings. In one US study, 40% of prescriptions written for hypertension did not conform to evidence-based guidelines. It was subsequently estimated that for elderly patients with hypertension in the United States in 2001, physician non-compliance with guidelines cost about US$1.2 billion. 367

26 Pharmacy Cardiovascular Health Care Model Patient education, including participation in cardiac rehabilitation programs Community pharmacists can be a source of education to patients about their treatments (Table 28). They can explain the risks and benefits of treatment, side effects, drug drug and drug food interactions, and can discuss the monitoring requirements and what action the patient should take if symptoms occur. 7 Table 28 Patient partnership in medicine taking 7 Education Risks and benefits of treatment Side effects Drug drug and drug food interactions Requirements for monitoring and what to do if symptomatic Ongoing support Re-emphasis of above factors Cardiac rehabilitation and other secondary prevention programs in people with coronary heart disease, stroke and vascular disease should begin at the moment of diagnosis and certainly at discharge from hospital. 16 It is known, however, that participation in cardiac rehabilitation programs is poor, especially among elderly female patients and people from lower socio-economic backgrounds. 16 The National Heart Foundation of Australia and the Australian Cardiac Rehabilitation Association have released guidelines for cardiac rehabilitation programs. Services should include physical activity, health education, counselling, behaviour modification strategies and support for self-management (Table 29 and Figure 39). Cardiac rehabilitation should be integrated into the routine management of all patients. 16 They should be tailored to meet the individual and cultural needs of the patient and their family. The provision of education on medications (e.g. indications, side effects, importance of compliance) is included as an element of outpatient cardiac rehabilitation.

27 Pharmacy Cardiovascular Health Care Model 259 Possible strategies that have been proposed for increasing the reach of cardiac rehabilitation services include: home follow-up programs, home self-help packages, and the use of specialised cardiac liaison nurses. 16 Another strategy would be increase the involvement of community pharmacists and perhaps more suitably, accredited consultant pharmacists. Rehabilitation services should be provided by any trained health professional caring for cardiac patients, since no sophisticated equipment or facilities are required. 16 A Home Medicines Review for all patients discharged from hospital with an acute cardiovascular event would present the ideal environment for the provision of education on both medications and more general aspects of the secondary prevention of CVD. Table 29 Specific aims of cardiac rehabilitation programs Facilitate and shorten the period of recovery after an acute cardiac event Promote strategies for achieving mutually agreed goals of ongoing prevention Develop and maintain skills for long-term behaviour change and self-management Promote appropriate use of health and community services, including concordance with prescribed medications and professional advice

28 Pharmacy Cardiovascular Health Care Model 260 Figure 44 Suggested content of cardiac rehabilitation programs 16

29 Pharmacy Cardiovascular Health Care Model High-risk drugs requiring ongoing monitoring While education of patients taking all cardiovascular drugs is important for pharmacists, it is particularly so with warfarin. The therapeutic benefits of warfarin are highly dependent on maintaining the INR within the therapeutic range. 368 Poor compliance, variable dietary intake, inadequate knowledge, and miscommunication between the patient and physician have all been cited in the literature as potential causes for fluctuations in the INR Warfarin use is increasing at about 10% per year, 373 and it is now commonly being initiated by general practitioners in the community setting for indications such as uncomplicated deep vein thrombosis and stroke prophylaxis in AF. Traditionally, warfarin counseling has been conducted by hospital pharmacists to inpatients, but community pharmacists are increasingly becoming responsible for initially educating patients regarding warfarin therapy. Point-of-care testing of the INR may also have future implications for patients and pharmacy practice in Australia if the general trends to increased community 144, 373, 374 management of warfarin observed in the United Kingdom are followed here. Warfarin dosing can be separated into two phases - initiation and maintenance. 375 previously common practice of administering a loading dose of warfarin is generally unnecessary; beginning with an average maintenance dose of 5mg daily will usually result in an INR > 2.0 after 4 to 5 days. 375 Low molecular weight heparins should be used if immediate anticoagulation is needed (deep venous thrombosis or pulmonary embolism) and is generally unnecessary for induction of anticoagulation for AF if maintenance doses of warfarin are used for initiation. It should be noted that the elderly, and those patients with heart failure or liver impairment, might require lower initiation doses of warfarin. 375 Concomitant drugs can interact with warfarin in a variety of ways. Inhibition of the metabolism of warfarin occurs with many drugs, including amiodarone, co-trimoxazole and metronidazole. Agents such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) increase the risk of warfarin-associated bleeding by inhibiting platelet function. 375 Broadspectrum antibiotics can increase the effect of anticoagulants by eliminating bacterial flora and depleting vitamin K stores. 375 paracetamol The An under-estimated cause of elevated INRs is Proposed mechanisms include competition for metabolism and the more probable reduction in synthesis of vitamin-k dependent clotting factors. 378 Patients receiving

30 Pharmacy Cardiovascular Health Care Model 262 warfarin should be counselled to have their INR monitored more frequently when starting paracetamol at dosages exceeding 2g/day. 378 A study by Hylek et al. 379 found that alcohol use was significantly associated with INR levels greater than 6.0. Patients taking warfarin should be advised to follow the National Health and Medical Research Council guidelines on the safe consumption of alcohol. 380 In terms of diet, it is important to cover the role of vitamin K and the importance of consistency of intake of vitamin K rich foods rather than the total avoidance of vitamin K rich foods. 381 Elderly patients typically exhibit declines in hepatic and renal function, causing changes in the clearance of warfarin and other medications. This has ramifications involving metabolic drug interactions with warfarin that can be more severe in elderly patients compared to their younger counterparts. 382 In general terms, the elderly are more likely to experience gastrointestinal bleeding if they have cardiovascular disease, take anticoagulants or NSAIDS, and are on multiple medications. 383 Studies have generally shown a relationship between patient knowledge and adverse outcomes of warfarin therapy. Good outcomes have been recorded where patients have had increased participation in their care and were encouraged to communicate more effectively with doctors and other health professionals about drug interactions and changes in lifestyle or diet. 19 Compliance with warfarin is essential to maintain good anticoagulant control and to prevent unnecessary dosage changes. Pharmacy-managed anticoagulation clinics have reported increased compliance after instituting education programs. 372 A recent report by Tang et al. 369 evaluated patients knowledge of warfarin and anticoagulant control. They concluded that patients warfarin knowledge was poor. Less than 50% of patients knew the strength of their warfarin tablets, the reason for taking warfarin and its effect on the body. They went on to report that: Their deficiencies in knowledge were even more obvious with respect to the possible consequences of under- or over-anticoagulation, drugs and medicated oils that might interact with warfarin and the management of a missed dose. 369 Patients who had read the anticoagulation booklet on warfarin had better knowledge than those who had not. Most importantly from this study was a positive correlation between patients warfarin knowledge and the number of INR values that were in the therapeutic range. 369 Roddie and Pollock 384 showed that 85% of patients with a good understanding of warfarin had a well controlled and stable INR, compared to only 63% in the poor-understanding group.

31 Pharmacy Cardiovascular Health Care Model 263 Generally, patients knowledge, drug compliance and anticoagulant control all improve after 372, patient education became part of a structured management program. The Anticoagulation Study Group 387 patients answered less than half of the questions correctly. Newcastle noted that knowledge was generally poor and 24% of Community pharmacists should take a key role in reinforcing knowledge regarding anticoagulation to reduce the risk of complications of anticoagulant therapy. Warfarin 369, 387, 388 education should be tailored to the level of education and age of the patient. Education of elderly and illiterate patients may require special consideration and include the use of visual aids. 369 Figure 45 displays a checklist for pharmacists that can be used for educating patients regarding anticoagulant therapy. Patients should be educated about the frequency of INR testing, which should be checked daily or second daily until the therapeutic range has been reached and sustained for 2 consecutive results. The INR can then be monitored twice weekly for 1-2 weeks and then less often according to stability. The testing interval should not exceed 4 weeks. Education regarding anticoagulation should begin after initiation and should be ongoing. Continuing education of patients is important since patients with chronic illnesses show a time-related decline in disease knowledge and medical advice. 389 Patients should be encouraged to play an active role in the management of their anticoagulant treatment. This is best initiated and sustained through active participation by the patient and family members in conjunction with the pharmacist and general practitioner. The risk for major bleeding during the first month of therapy is approximately 10 times the risk after the first year of therapy. 390, 391 It is essential that pharmacists communicate with patients the importance of regular monitoring and taking the correct dose (Figure 46). Patients should be educated to inform health carers that they are taking warfarin and to question if new drugs will change the effect of warfarin. The INR should be measured more frequently when any drug or complementary therapy is added. 375 As noted by Tang et al. 369 more attention should be given to the education of elderly and illiterate patients to maximise the health benefits of this effective but fluctuant medication. Increased education of patients by community pharmacists has the potential to decrease the adverse outcomes associated with warfarin therapy.

32 Pharmacy Cardiovascular Health Care Model 264 Checklist for patient counselling Mechanism of action Compliance (maintaining a diary of INRs, doses) Reason for treatment Explanation of INR, target range and regular testing Possible effects of poor control of anticoagulation Bleeding or severe bruising Recurrence of thromboembolism Appropriate action if excessive bleeding or bruising occurs Appropriate action if diarrhoea or vomiting occurs Starting a new treatment or changing a dose of current treatment Common OTC medication interactions, such as aspirin, NSAIDs, paracetamol, complementary therapies and laxatives. Role of vitamin K, and the importance of consistency in regards to vitamin K rich foods in the diet, rather than avoidance. Alcohol intake Minimise high risk activities associated with the risk of physical trauma Medic Alert bracelet/necklace and warfarin ID card Figure 45 Pharmacist checklist for patient counselling on warfarin 148

33 Pharmacy Cardiovascular Health Care Model Warfarin belongs to a class of drugs called anticoagulants ( blood thinners ) Warfarin keeps blood clots from forming or getting larger. 2 Many medications can change the way warfarin works. Ask your doctor or pharmacist about using any other medication, including over-the counter medications, vitamins and herbal products 3 Make sure your doctor or pharmacist know if you are taking aspirin or aspirin-like medications, such as medications for pain relief and the common cold 4 Avoid drinking large amounts of alcohol 5 Certain foods will change the way warfarin works. Do not change your diet while taking warfarin. Foods that contain vitamin K ( such as lettuce, spinach, brocolli, cabbage, cauliflower or liver) decrease the anti-clotting effect of warfarin. If you eat foods that have vitamin K, do not change the amount of these foods that you normally eat each day. 6 It is very important to have regular blood tests while taking warfarin. The test is called an INR, and it measures how thin your blood is compared to normal. 7 You should carry an identification card that shows you are taking warfarin. 8 Make sure your doctor or dentist knows you are taking warfarin before you have any surgery or dental work. 9 You should report the following to your doctor immediately Bleeding from the gums or nose Coughing up blood Red or black bowel motions Red or dark-brown coloured urine Unusually heavy menstrual bleeding Heavy bleeding from cuts or wounds that does not stop Easy bruising Severe headache 10 If you miss a dose: Take the missed dose as soon as possible. If you do not remember until the next day, skip the missed dose. Only take your usual dose for the day. You should not use two doses at the same time. Figure 46 One page guide to warfarin treatment 148

34 Pharmacy Cardiovascular Health Care Model 266 The National Service Improvement Framework for Heart, Stroke and Vascular Disease makes the point that there is under-utilisation of warfarin in the management of atrial fibrillation, especially in the elderly, and concludes that safer anticoagulant medication is required. We would argue that what is presently needed is better education of patients and health professionals, and systems to support the safe use of warfarin (e.g. point of care INR testing by GPs, pharmacists, and patients; Figure 47).

35 Pharmacy Cardiovascular Health Care Model 267 Figure 47 New anticoagulants or better use of existing therapy? 392

36 Pharmacy Cardiovascular Health Care Model 268 While being a very valuable drug, warfarin also is a recognised high-risk drug for adverse events (bleeds). Adverse events from warfarin use in Australia were estimated to cost over $100 million per annum in direct hospital costs alone, in Members of this Project Team have been involved in many community and hospital projects directed at improving the use and clinical outcomes of anticoagulation. internationally published projects have ranged from: These Studies of the quality of anticoagulant use (Corbett NE, Peterson GM. Review of the initiation of anticoagulant therapy. J Clin Pharm Ther 1995; 20: 221-4) Interventions to improve anticoagulant usage (Peterson GM, Drake CI, Jupe DML, Vial JH, Wilkinson S. Educational campaign to improve the prevention of postoperative venous thromboembolism. J Clin Pharm Ther 1999; 24: ) Clinical audits of the management of atrial fibrillation (Ang SY, Peterson GM, Friesen WT, Vial JH. Review of antithrombotic drug usage in atrial fibrillation. J Clin Pharm Ther 1998; 23: ; and Jackson SL, Peterson GM, Vial JH, Daud R, Ang SY. Outcomes in the management of atrial fibrillation: clinical trial results can apply in practice. Internal Med J 2001; 31: ) Laboratory-based research to investigate approaches to initiating warfarin therapy (Peterson GM, McLean S, Jupe DML, Griffith RL, Roberts JR. A model which predicts maintenance warfarin dosage requirements from the response to a single dose. Br J Clin Pharmacol 1985; 20: 177-8; and Jupe DML, Peterson GM, Coleman RL, McLean S. Warfarin dosage requirements: prospective clinical trial of a method for prediction from the response to a single dose. Br J Clin Pharmacol 1988; 25: ). Improving the prescribing of antithrombotics for stroke prevention in AF in the community setting through academic detailing and education of doctors (Jackson SL, Peterson GM, Vial JH. A community-based educational intervention to improve antithrombotic drug use in atrial fibrillation. Ann Pharmacother 2004; 38: ). The role and outcomes of an anticoagulation pharmacist position in the hospital setting (present project). Improving prophylaxis of venothromboembolism in medical patients (present project). The UMORE research group also has the most experience in Australia with portable International Normalised Ratio (INR) monitoring for patients receiving warfarin. These projects have been conducted with general practitioners and pharmacists, and we have demonstrated that, with training, these health professionals can accurately measure INR values in a variety of settings. Several projects recently completed are: An evaluation of the accuracy and reproducibility of the CoaguChek portable INR monitor (Jackson SL, Bereznicki LR, Peterson GM, Marsden KA, Jupe DM, Tegg E, et al. Accuracy, reproducibility and clinical utility of the CoaguChek S portable international normalized ratio monitor in an outpatient anticoagulation clinic. Clin Lab Haematol 2004; 26: 49-55) An evaluation of near-patient INR monitoring by rural general practitioners around Australia (Jackson SL, Bereznicki LR, Peterson GM, Marsden KA, Jupe ML, Vial JH, Rasiah RL, Misan G, Williams SM. Accuracy and clinical usefulness of the near-patient testing CoaguChek S INR monitor in rural medical practice. Aust J Rural Health 2004; 12: )

37 Pharmacy Cardiovascular Health Care Model 269 Improving the management of anticoagulation: A randomised controlled trial of point of care home followup of warfarin therapy after initiation in hospital (Jackson SL, Peterson GM, Vial JH, Jupe DML. Improving the outcomes of anticoagulation: an evaluation of home follow-up of warfarin initiation. J Intern Med 2004; 256: ; and Jackson SL, Peterson GM, Vial JH, Jupe DML. Suboptimal anticoagulant management in patients after hospital initiation of warfarin. Aust Fam Physician 2004; 33: 477-8) Improving the outcomes of anticoagulation in rural Australia: an evaluation of pharmacist-assisted monitoring of warfarin therapy (Jackson SL, Peterson GM, House M, Bartlett T. Point-of-care monitoring of anticoagulant therapy by rural community pharmacists: description of successful outcomes. Aust J Rural Health 2004; 12: ; and Jackson SL, Peterson GM, Bereznicki LR, Misan G, Vial JH, Jupe DML. Accuracy, clinical usefulness and perceptions of community pharmacy-based INR monitoring in rural Australia. J Clin Pharm Therapeutics 2005;30: ). Our research has shown that education and INR monitoring of patients by appropriately trained pharmacists improves clinical outcomes and is welcomed by patients and general practitioners Pharmacists have much to offer in becoming involved in the monitoring and education of patients on warfarin, especially those newly initiated, and particularly now with the availability of accurate near-patient testing devices.

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50 Pharmacy Cardiovascular Health Care Model 282 Amruso NA. Ability of clinical pharmacists in a community pharmacy setting to manage anticoagulation therapy. J Am Pharm Assoc 2004; 44: OBJECTIVES: To determine the ability of community pharmacists within an anticoagulation clinic to keep international normalized ratios (INRs) within therapeutic ranges and, secondarily, to determine the incidence of bleeding and thromboembolic events and patient satisfaction. DESIGN: Retrospective observational study. SETTING: Eckerd PatientCARE Network in Eckerd pharmacies in Tampa Bay area of Florida. PATIENTS: 50 patients taking warfarin and having INR determinations for 6 consecutive months. INTERVENTIONS: Clinical pharmacists monitored patients' anticoagulation status using point-of-care analyzers and making dosage changes as needed under a collaborative agreement. Extensive patient education was provided to patients regarding their anticoagulation. Data were collected from the initial visit through the 6 consecutive months. Patients were surveyed to assess their satisfaction with the clinic. MAIN OUTCOME MEASURES: Percentage of INRs within therapeutic range and, secondarily, incidence of bleeding and thromboembolic events and patient satisfaction with the clinic. RESULTS: During the 6 months of initial therapy with warfarin, 243 of 435 (56%) INRs were in desired therapeutic ranges. A total of 15 bleeding episodes were reported, of which 10 were minor and 5 were significant. No thromboembolic events were reported. There was a 22% response rate to the survey, in which all statements were rated as above average to excellent. CONCLUSION: Community pharmacists in an anticoagulation clinic effectively manage anticoagulation therapy, as the results of this clinic are similar to those of clinics managed by pharmacists in other settings. 397 Similarly, many other cardiovascular medications (e.g. statins, amiodarone, digoxin) require ongoing testing and monitoring (for efficacy or toxicity), and the community pharmacist s role should be to ensure this happens at the appropriate intervals. The need for frequent monitoring for toxicity with amiodarone was recently highlighted in the Australian Adverse Drug Reactions Bulletin (June 2005;

51 Pharmacy Cardiovascular Health Care Model 283 Figure 48 Need for close monitoring of amiodarone therapy

52 Pharmacy Cardiovascular Health Care Model USE OF INFORMATION AND COMMUNICATIONS TECHNOLOGY SOLUTIONS TO PROMOTE QUM IN CVD An approach to assist community pharmacists in identifying patients with CVD and helping to ensure that these patients receive the beneficial effects of -blockers and other proven preventive agents, if they are eligible, is through information and communications technology solutions - in particular, incorporating advanced decision support/automated intelligence modules into community pharmacy dispensing software systems. This approach could include relatively simple strategies such as electronic alerting mechanisms for checking repeat refill frequencies and checking for aspirin or ACEI use in patients receiving medication for Type 2 diabetes. 398 It is likely that clinical decision support in electronic prescribing and dispensing systems can improve the safety, quality, efficiency, and cost-effectiveness of drug therapy. However, at present, these potential benefits have not been realised in Australia. During the recently concluded PROMISe2 project ( Final Report submitted to the Pharmacy Guild of Australia; RFT , Evaluation of Clinical Interventions in Community Pharmacies), also conducted by UMORE, a group of pharmacies were randomly allocated to receive an electronic educational intervention prompt within their dispensing software (WiniFRED). The prompt was developed to test the hypothesis that a computer-based reminder could increase intervention rates associated with a particular type of intervention. The educational alert related to the use of low-dose aspirin (or other antiplatelet agent) for cardiovascular and cerebral vascular event prevention in high-risk diabetic patients. The alert was automatically triggered when any oral antidiabetic agent was selected for dispensing. Decision Support Box and Information Leaflet The aim is to assist pharmacists with interventions (and increase the intervention rate) by incorporating a decision support box (see Figure) on the dispensing screen. The box appears in the bottom right hand corner of the dispense screen only if the pharmacist selects one of the drugs in the Table. The box contains brief information to help the pharmacist decide whether an intervention is necessary for the patient taking one of these medications.

53 Pharmacy Cardiovascular Health Care Model 285 Table. Drugs indicating diabetes Type 2 Decision support box to appear for ALL strengths of the following generic drugs metformin glibenclamide gliclazide glimepiride glipizide acarbose pioglitazone rosiglitazone If the pharmacist decides that an intervention is necessary, and that they need to counsel the patient, they may click on a link to a secondary window to view/print further information to assist in counselling the patient. They may also print an information leaflet for the patient to take with them, or show their doctor. Pharmacists that have agreed to participate in the PROMISe project will be randomised into two groups; the box will appear for Group 1 (intervention group) but not Group 2 (control group). Twothirds of pharmacies will be in the intervention group and the remaining one-third will act as controls. An analysis of the interventions documented by the pharmacists using the DOCUMENT classification system will determine the effectiveness of the box. HTML secondary windows Patient information leaflet (Print Friendly Version) See over page for content Intervention Alert: Is this patient taking antiplatelet therapy (e.g. aspirin) to reduce cardiovascular disease (CVD) risk? Low-dose ( mg) aspirin per day is recommended for diabetics with no contraindications to aspirin who are: Information for Pharmacists See over page for content over 50 years of age. between 30 and 50 years with ONE or more CVD risk factor such as hypertension, smoking, obesity, hypercholesterolaemia or family history of CVD. Patient information leaflet Further information for pharmacists 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

54 Pharmacy Cardiovascular Health Care Model 286 Figure 50 Screen shot of automated intervention alert for Low-dose aspirin (from PROMISe2) Those pharmacies that were randomised to receive the aspirin intervention alert were provided with an Aspirin pack. This contained information suitable for the patient (see Figure 51) and also some supporting information for the pharmacist (see Figure 52).

55 Pharmacy Cardiovascular Health Care Model 287 Figure 51 Patient handout for aspirin automatic intervention prompt

56 Pharmacy Cardiovascular Health Care Model 288 Figure 52 Pharmacist information sheet for aspirin automatic intervention prompt

57 Pharmacy Cardiovascular Health Care Model 289 Figure 53 Example of an intervention from the PROMISe2 study relating to the aspirin alert within the dispensing software The presence of the educational intervention prompt was associated with a significantly higher rate of recorded clinical interventions related to recommending consideration be given to the use of low-dose aspirin in diabetic individuals, as well as all interventions overall (Figure 54). Figure 54 Effect of aspirin intervention prompt on the overall intervention rate in different phases of the PROMISe2 study Information and communications technology is also important for enabling continuing professional education in cardiovascular health and ongoing support for pharmacists via e- learning (e.g. web-based study guides and case material). The Pharmaceutical Society of