Cardiovascular Disease Prevention in the Clinical Setting: The Role of Pharmacists
Modifiable risk factors for cardiovascular disease (CVD) include diabetes, smoking, obesity, hypertension, hyperlipidemia, and lack of physical activity.1 Appropriate use of medications for the management of many of these risk factors has significantly reduced the incidence of cardiovascular events. However, CVD is still the number one killer of both men and women in the United States.2 With the current landscape of healthcare changing, and the continued emphasis on improving outcomes while reducing overall healthcare costs, integrating clinical pharmacists onto the front lines of patient care and enhancing their scope of practice can have a substantial impact on reducing cardiovascular risk.
Many studies have been conducted that have demonstrated positive outcomes when pharmacists have been involved in direct patient care of patients with CVD. The impact of these studies has demonstrated improvements in blood pressure control, cholesterol treatment, smoking cessation, diabetes control, and medication adherence. Studies showing benefit of clinical pharmacy services dates back to as far at 1973.3
In the first study by McKenney et al., 50 patients who were non-adherent and had uncontrolled essential hypertension were enrolled.3 Twenty-five patients received evaluation and follow-up by a pharmacist and 25 patients served as a control group. In the pharmacist managed group, patients underwent an initial evaluation during which a medical and medication history was obtained. With each subsequent visit, response to antihypertensive therapy was evaluated, appropriate diet was reinforced, drug related adverse effects or issues were identified, and recommended medication changes were provided to the patients' primary physician when indicated. Following the 150-day study period, patients managed by a pharmacist showed significant improvements in disease state knowledge (average score on disease questionnaire 62% for usual care compared to 90% in study group, p <0.001), medication adherence 17% in the usual care group versus 79% in study group (p <0.001), and blood pressure control (average blood pressure 168/103 mmHg for usual care compared to 146/90 mmHg for study group (p <0.001).3
Many other studies in hypertensive patients have been conducted subsequently and have further evaluated the role of pharmacists and have shown similar results.4-7 In a larger study, Hunt et al. conducted a randomized trial to evaluate the effectiveness of hypertension management in 463 patients (n=233 control, n=230 intervention) by pharmacists in community based clinics.8 Patients in the intervention group had an initial pharmacist visit that reviewed medications and lifestyle modifications. Screening for adverse drug reactions, assessment of vitals, and optimization of anti-hypertensive regimens also occurred at this initial visit. On follow-up visits, the pharmacist, under a collaborative practice agreement (CPA), would adjust doses of existing anti-hypertensives, add an additional medication, or switch medications as needed. Results at the end of the 12-month study period demonstrated that patients who were in the intervention group had significantly lower systolic blood pressure (143 mmHg for the usual care compared to 137 mmHg for the study group, [p=0.007]) and diastolic blood pressure (78 mmHg for usual care compared to 75mmHg for study group [p=0.002]). Additionally, 62% of patients in the intervention group achieved their target blood pressure compared to only 44% in the control group (p=0.003).
The management of dyslipidemia by pharmacists has also resulted in positive outcomes. Bogden and colleagues evaluated the impact of pharmacists working with a physician on achieving lipid goals.9 This study was a single-blind randomized study evaluating 94 patients (n=47 usual care; n=47 intervention) who had uncontrolled dyslipidemia, total cholesterol (TC) ≥240 mg/dL, while treated with lipid lower therapy. The pharmacist would make recommendations on doses of lipid lowering agents, monitored for adverse effects, and selection of new lipid lower medications as appropriate. The results showed that patients in the intervention arm had twice the rate of success at achieving their lipid goal compared to the control arm (43% versus 21%; p <0.05). Additionally, total cholesterol levels decreased by a mean of 44 mg/gL compared to 13 mg/dL in the control arm (p <0.01). Interestingly, 19% of the recommendations made by the pharmacists were declined by the physicians. The patients in the intervention group in whom recommendations were declined by the physicians fared worse than those in whom the pharmacists' recommendations were accepted. Among patients in whom interventions were declined, only 17% met their lipid lower goal compared to 51% in whom the recommendation was accepted (p=0.047). Findings in more recent studies have shown not only significant reductions in total cholesterol, but also significant reductions in low density lipoprotein cholesterol (LDL-C).10-13 This is impactful as studies have shown that a 1% reduction in LDL-C reduces CVD risk by 1%.14
Pharmacists can improve quit rates among smokers. In an open-label, randomized trial conducted in a community based VA clinic, 100 smokers were randomized to receive three face-to-face group sessions run by a pharmacist team, or a single 5 to 10-minute session conducted by a pharmacist via telephone. Patients were followed for 6 months. Abstinence rates were significantly higher (28%) in the face-to-face group compared to the telephone group (11.8%; p <0.041). Another study randomized 102 smokers to either a minimal intervention arm (written materials and advice on smoking cessation), community based pharmacy program (weekly consultation with a pharmacist and nicotine patches supplied), or a hospital based program (consultative services by a pharmacist, nicotine patches provided, and discharge follow-up). Patients who underwent either the community based program or hospital based program had a significantly higher quit rate versus the minimal intervention treated patients, 38%, 24%, and 4.6% quit rates respectively (p=0.031).15
Pharmacists also have a proven role in managing patients with diabetes. One study evaluated patients with type 2 diabetes with hemoglobinA1C (HbA1C) >9% managed either by clinical pharmacists (n=222) or usual care in a clinic with limited to no clinical pharmacy services available (n=262).16 Patients were followed for up to 2 years. The results showed an average reduction in A1c of 2.7% in patients who received care from a pharmacist compared to 1.1% for those receiving usual care (p <0.001). Additionally, 19% of patients achieved an A1c of <7% in the pharmacist intervention group compared to only 6% in the usual care group (p <0.001). For pharmacist intervention group 53% achieved an A1c <8% compared to nearly 20% in the usual care group (p <0.001). These results are important as a 10-year follow up study of intensive glucose control in Type 2 diabetic patients demonstrated that a 1% reduction in A1c reduced the risk of myocardial infarction by 15%, microvascular complications by 24%, and a 17% reduction diabetes-related death over a 10-year period.17
Depending upon parameters that have been set up in a given practice setting, pharmacists have the ability to have a significant impact on prevention of CVD. Additionally, the scope of practice of pharmacists is evolving, allowing even more opportunity to have an impact on patient care. Some states, such as California and Colorado, recognize pharmacists as providers, allowing much more flexibility in the care they can provide. Additionally, many institutions as well as clinics have incorporated CPAs and Medication Therapy Management (MTM) into their practice models. An MTM is a distinct service that incorporates five core elements: review of medications, medication related action plan, personal medication record, an intervention and/or referral, and documentation and follow-up.18 A CPA is a formal agreement in which a licensed provider makes a diagnosis, supervises patient care, and refers patients to a pharmacist under a protocol that allows the pharmacist to perform specific patient care functions.19,20 The scope of what is allowed will often vary based on individual expertise and the practice site itself.
In addition to the above mentioned interventions, pharmacists in the community and clinic setting can also provide services such as point of care testing, blood pressure screening/monitoring, smoking cessation counseling, lifestyle modification counseling, guidance on over-the-counter product selection, help with medication assistance programs, and recommend cost effective therapies given a patient's need. Pharmacists who practice in the clinical setting in a hospital can provide education, evaluate for drug interactions, monitor response to drug therapy, and order necessary laboratory testing (e.g., cholesterol, HbA1c) to optimize care.
Overall, pharmacists have the capability to play a large role in reducing cardiovascular risk by collaborating to provide patient care that can result in significant improvements in CVD risk factors. Additionally, physician-pharmacist collaboration has also been shown to be cost effective.21,22 Many pharmacists are highly trained as experts on medication use, making them uniquely qualified to be an integral part of the healthcare team. Furthermore, pharmacists are the most accessible of all healthcare practitioners. By utilizing their expertise, the overall infrastructure of healthcare delivery will be enhanced.
- Fleg JL, Forman DE, Berra K, et al. Secondary prevention of atherosclerotic cardiovascular disease in older adults: a scientific statement from the American Heart Association. Circulation 2013;128:2422-46.
- Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics--2016 update: a report from the American Heart Association. Circulation 2016;133:e38-360.
- McKenney JM, Slining JM, Henderson HR, Devins D, Barr M. The effect of clinical pharmacy services on patients with essential hypertension. Circulation 1973;48:1104-11.
- Green BB, Cook AJ, Ralston JD, et al. Effectiveness of home blood pressure monitoring, web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA 2008;299:2857-67.
- Bogden PE, Abbott RD, Williamson P, Onopa JK, Koontz LM. Comparing standard care with physician and pharmacist team approach for uncontrolled hypertension. J Gen Intern Med 1998;13:740-5.
- Borenstein JE, Graber G, Saltiel E, et al. Physician-pharmacist comanagement of hypertension: a randomized, comparative trial. Pharmacotherapy 2003;23:209-16.
- Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med 2009;169:1996-2002.
- Hunt JS, Siemienczuk J, Pape G, et al. A randomized controlled trial of team-based care: impact of physician-pharmacist collaboration on uncontrolled hypertension. J Gen Intern Med 2008;23:1966-72.
- Bogden PE, Koontz LM, Williamson P, Abbott RD. The physician and pharmacist team: an effective approach to cholesterol reduction. J Gen Intern Med 1997;12:158-64.
- Ellis SL, Carter BL, Malone DC, et al. Clinical and economic impact of ambulatory care clinical pharmacists in management of dyslipidemia in older adults: the IMPROVE study: Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers. Pharmacotherapy 2000;20:1508-16.
- Faulkner MA, Wadibia EC, Lucas BD, Hilleman DE. Impact of pharmacy counseling on compliance and effectiveness of combination lipid-lowering therapy in patients undergoing coronary artery revascularization: a randomized, controlled trial. Pharmacotherapy 2000;20:410-6.
- Villa LA, Von Chrismar AM, Ozarzun C, Eujenin P, Fernandez ME, Quezada M. Pharmaceutical care Program for dyslipidemic patients at three primary health care centers. Impacts and outcomes. Latin AM J Pharm 2009;28:415-20.
- Lee VW, Fan CS, Li AW, Chau AC. Clinical impact of a pharmacist-physician co-managed programme on hyperlipidaemia management in Hong Kong. J Clin Pharm Ther 2009;34:407-14.
- Grundy SC, Cleeman JI, Merz NB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol 2004;44:720-32.
- Dent LA, Harris KJ, Noonan CW. Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation. Ann Pharmacother 2009;43:194-201.
- Johnson KA, Chen S, Cheng IN, et al. The impact of clinical pharmacy services integrated with medical homes on diabetes-related clinical outcomes. Ann Pharmacother 2010;44:1877-86.
- Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 Diabetes. N Engl J Med 2008;359:1577-89.
- American Pharmacists Association, National Association of Chain Drug Stores Foundation. Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Associ 2008;48:341-53.
- Hammond RW, Schwartz AH, Campbell MJ, et al. Collaborative drug therapy management by pharmacists--2003. Pharmacotherapy 2003;23:1210-15.
- Centers for Disease Control and Prevention. Collaborative Practice Agreements and Pharmacists' Patient Care Services: A Resource For Pharmacists. Available at: http://www.cdc.gov/dhdsp/pubs/docs/Translational_Tools_Pharmacists.pdf. Accessed August 22nd, 2016.
- Polgreen LA, Han J, Carter BL, et al. Cost-effectiveness of a physician-pharmacist collaboration intervention to improve blood pressure control. Hypertension 2015;66:1145-51.
- Simpson SH, Lier DA, Majumdar SR, et al. Cost-effectiveness analysis of adding pharmacists to primary care team to reduce cardiovascular risk in patients with Type 2 diabetes: results from a randomized controlled trial. Diabet Med 2015;32:899-906.
Keywords: Antihypertensive Agents, Blood Pressure, Cardiovascular Diseases, Cholesterol, LDL, Diabetes Mellitus, Type 2, Drug Interactions, Drug-Related Side Effects and Adverse Reactions, Dyslipidemias, Glucose, Hyperlipidemias, Hypertension, Medication Adherence, Medication Therapy Management, Myocardial Infarction, Nicotine, Patient Care, Patient Care Team, Pharmacists, Pharmacy Service, Hospital, Point-of-Care Systems, Risk Factors, Smoking, Smoking Cessation, Primary Prevention
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