Community Pharmacy Clinical Interventions: How Pharmacists Can Improve the Cost Effectiveness and Quality of Healthcare Ted Williams Pharm. D. Candidate Oregon State University Introduction Healthcare practioners and administrators must collaborate to ration resources to provide maximal healthcare services to the highest risk patients. Significant effort over the past 15 years has been directed at treatment systems in which physicians, nurses, and pharmacists work collaboratively to improve outcomes. There have been several high profile projects conducted within large healthcare systems (Kaiser, Cigna) and large self-insured entities (Asheville Project). These projects have demonstrated that pharmacist-lead interventions provide significant cost savings and revenue increases. Pharmacy residents have been instrumental in demonstrating the applicability of these principles on a smaller scale and in retail community settings. These intervention programs have been slow to penetrate the community pharmacy culture. The focus of this paper is to provide the community pharmacy manager insight into how large scale project can be downsized to their practice. The business case for post primary care physician (PCP) interventions will be made. Then the case for pharmacist lead interventions will be presented, with an emphasis on how students and resident pharmacists can act as cost effective agents of change. Strategies for selecting a disease state to manage and keys to maintaining profitability will also be discussed. Why Interventions The introduction of a pharmacy intervention program should be approached as a business case. Both non-profit and for-profit organizations must be Page 1 of 12 Phar 727 Fall 2005 cognizant of finances. For-profit organizations have shareholders to answer to; non-profit organizations must be going concerns if they are to continue delivering services to the community. Any proposal for an intervention program should be built on the cornerstone of cost benefit analysis. An organization’s cash flow can be improved by either cost savings or revenue increases. A meta-analysis of the research literature from 1996 to 2000 showed cost benefit ratios of 2:1 to 17:1 with most being closer to 5:11. Most of these studies focused on increased revenue, rather than cost savings. Many studies also neglected to consider the cost of the intervention services provided. The studies surveyed nonetheless demonstrated that pharmacist interventions can produce cost benefits in the areas of 1) Drug Cost, 2) Morbidity and Mortality 3) Cost of hospital care. Cost savings from interventions depend upon the nature of the pharmacy and how they fit into the healthcare organization. Integrated health systems, insurance companies, self insured companies, or any entity interested in reducing healthcare costs across delivery channels will be interested in pharmacy interventions. Drug misadventures, either drug-drug interaction (DDI) or adverse effect of drugs, costs at least one dollar in damage control for every therapeutic dollar spent2. The disease states best suited for interventions will be discussed later in this paper. Chain and independent community pharmacies do not reap the benefits of reductions in overall healthcare costs. Community pharmacies must build their case on creating new revenue streams without incurring significant cost increases. Pharmacist provided intervention services for Medicare Part D are one of the most exciting opportunities for pharmacies to bill for and expand clinical service offerings. Medicare Part D mandates any provider of Medicare drug benefits programs to provide Medication Therapy Management (MTM) services to high risk patients.3 The reimbursement guidelines lack specificity, complicating cost benefit analysis. One study focused on designing a fee schedule for MTM Page 2 of 12 Phar 727 Fall 2005 services based on CMS guidelines for payments and expected pharmacy costs2. This study demonstrated a positive cost benefit ratio for moderate to severe interventions, but not for mild interventions. Only counseling sessions lasting over 15 minutes, provided direct economic benefit.2 Patients interested in these services were willing to pay the out of pocket fee in order to obtain the service when insurance plans did not cover the cost. A study conducted by Kaiser Permanente indicated that their pharmacists could conduct counseling services from 3 to 9 minutes while maintaining a positive cost benefit ratio.4 These studies indicate that patient counseling may have a positive revenue impact under certain circumstances. Another motivation for community pharmacies to provide intervention services is the level of professional satisfaction experienced by the pharmacist. One study reported the overwhelming majority (88.5%) of pharmacists involved in hyperlipidemia interventions reported being “very satisfied” with their professional role and additional 11.5% reported being “satisfied” with their professional role.5 In an era of pharmacist shortages, generating employee satisfaction may be enough motivation for community pharmacies to provide intervention services. Who Intervenes The choice of who conducts the intervention depends on several factors: cost, expertise, accessibility. Pharmacists are not the only healthcare professionals qualified to conduct intervention services. The salary difference between case management nurses ($50k/year)6 and pharmacists ($90k/year)7 makes nurses a less expensive alterative to pharmacists. Medicare Part D also leaves the door open for reimbursement of nurse-lead MTM services. Integrated healthcare systems must therefore weigh the costs and benefits of nurses acting under the supervision of a pharmacist vs. a pharmacist conducted system. Several models address cost issues by leveraging resident and intern pharmacists. There do not Page 3 of 12 Phar 727 Fall 2005 appear to be any studies directly comparing the efficacy and cost: benefit of nursing directed and pharmacist directed interventions. This may be an area of interest has Medicare Part D goes into effect. A study of nursing interventions for asthma patients proved effective in reducing indirect costs, direct cost as well as lost school and work time in asthma patients.8 These interventions included drug reviews and patient education on how, when, and why to use their medications. One soon-to-be published study found that nurses working in a collaborative team with physicians and pharmacists, nurses could also effectively reduce the HA1C levels of diabetes patients.9 These data strongly suggest that pharmacists may not be suited to all types of interventions. The accessibility of community pharmacist is a compelling factor when deciding who should deliver intervention services. The medication-centric clinical experience and training of pharmacists makes them uniquely qualified for interventions involving 1) complex medication management, 2) high risk of side effects, and 3) high risk of drug-drug interactions (DDI)10. The 30 day refill paradigm also increases the frequency of pharmacist patient interactions when compared to the monthly or semi-monthly interaction common in intervention programs. 8,10,11,12,13 The clinical pharmacist also has a strong influence on the prescribing patterns of physician.2 When the pharmacist works in the same clinic as physician, few, if any of the pharmacist’s recommendations are rejected. 2 At least one study suggested that pharmacists work as well, if not better than nurses when managing complex drug regimes.10 Another meta-analysis found that physician or pharmacist directed diabetes programs had the greatest effect on outcomes.14 When physician concordance is critical and clinician accessibility is limited, pharmacist interventions may be indicated. Pharmacy interns and residents are important agents of change for a variety of interventions. Resident’s often publish the results of the projects in the pharmacy journals like the JAPhA. But non-resident initiated projects also Page 4 of 12 Phar 727 Fall 2005 leverage the enthusiasm and cost savings of student pharmacists. One cardiovascular wellness program used residents to establish the treatment and administrative protocols.15 The resident’s lower salary kept the project’s cost: benefit ratio above one despite the start up costs. Ongoing interventions will be cost effective with either a resident pharmacist or a staff pharmacist.15 Pharmacy interns also are more inclined to reach under served communities and can provide significant cost savings for conducting basic screenings.16,17 One of these studies developed a mobile screening clinic/service which generated over $70,000 in revenue. 16 These studies demonstrate the cost and clinical effectiveness of student pharmacists in wellness and disease state management programs. Despite a general consensus among community pharmacists that there is a need and a benefit for interventions, only a small portion of pharmacists are interested in setting up intervention services in their pharmacies.18 The barriers cited to setting up intervention services were time (47%), staff (18%) and reimbursement (8%). One resident set about solving these problems by redesigning the workflow of a community to use existing staff and time to conduct interventions.19 The project was able to create a clinical pharmacist position without increasing personnel or time while generating a positive cash flow. This suggests that the perceived barriers to providing clinical services in a retail setting may be a function of perception rather than a function of resources. This fresh perspective on old problems is yet another benefit of student pharmacists. Most pharmacy colleges support, if not require, student involvement in wellness programs.20 Although the skills of first and second year pharmacy students are limited, they have been effective in screening and basic counseling activities, when supervised by pharmacists. 17 These early clinical experiences build the skills pharmacist will need to conduct interventions after graduation. Page 5 of 12 Phar 727 Fall 2005 Employing pharmacy interns provides financial benefits for pharmacies and invaluable experience for interns. When to Intervene Delivery of healthcare is not exempt from the basic economic principle of scarcity. Every patient chart cannot be meticulously reviewed for all possible lifestyle, pharmacological and complementary/alternative medicine (CAM) complications. Healthcare administrators must ration scarce resources to provide maximum benefit to the most vulnerable patients. The APhA recommends using the criteria in Figure 1 to determine which cases require MTM services. This analysis will only consider the three most severe disease states of cardiovascular disease, diabetes, and asthma. Three studies published in the last five years demonstrated the benefits and variations in interventions for cardiovascular disease. Project ImPACT produced impressive (90%) persistence and compliance in treatment of 397 patients.5 Pharmacists spent 30 to 60 Patient is referred for MTM services by a healthcare provider. Patient is receiving medications from multiple prescribers Patient is on four or more chronic medications. Patient has at least one chronic disease (e.g., o congestive heart failure, o diabetes, o hypertension, o hyperlipidemia, o asthma, o osteoporosis, o depression, o osteoarthritis, o chronic obstructive pulmonary disease Patient has laboratory values outside the normal range that could be improved with medication therapy. Patient has demonstrated non-adherence to the medication regimen for more than three months. Patient has issues of limited health literacy or cultural differences, and intensive communication is needed to maximize care. Total monthly cost of medication exceeds $200. Patient has been discharged from a hospital or skilled-nursing facility within 14 days and prescribed a new medication regimen. Figure 1. Considerations for MTM interventions from the APhA minutes with patient on their initial visit, and 10-30 minutes on follow up visits. The significant time investment was related to the severity of their condition. These time investments should make such services compatible Page 6 of 12 Phar 727 Fall 2005 with CMS guidelines for billing for MTM services as part of Medicare Part D. 2 A significant portion (62.5%) of Project ImPACT patients reached their target lipid levels. The SCRIP study demonstrated similar goal achievement rates (57%). 21 The SCRIP study also had significant patient-pharmacist interactions at weeks 2, 4, 8, 12, and 16. A follow up to the SCRIP study, the SCRIP-plus study, demonstrated important differences in counseling and outcomes. SCRIP-plus noted lower levels of adherence and lipid level achievement.21 Some of these variations may be due to the different durations of the studies. One important difference may be that the SCRIP-plus study conducted patient interviews at week two and six by telephone and in person during the third and sixth months. These differences suggest that the quality and quantity of the intervention is associated with successful interventions. This observation is consistent with the assertion that the availability of pharmacists for face-to-face contact makes them invaluable for interventions. These cardiovascular interventions have been replicated on a smaller scale in a community pharmacy intervention program coordinated by a resident.15 This project used two community pharmacists (one staff and one resident) to serve a single self-insured company of 107 employees with only 36 patients qualifying for interventions. The start-up costs during the first year of the program were offset by the reduced salary of the resident. Per patient savings for the self insured company for the second year of the project were projected at $1,265$2,905, depending on the compensation for the staff pharmacist which would replace the resident. The pharmacy benefited from the increased revenue generated by the intervention services. This study demonstrated a cost effective model for community pharmacies to provide intervention services to small self insured companies. The quintessential diabetes intervention project is the Asheville Project.22 This five year study demonstrated the ability of a pharmacy driven medication therapy management projects to reduce direct and indirect employer costs. Of Page 7 of 12 Phar 727 Fall 2005 interest to community pharmacists, total prescription costs increased between $1,500 and $2,200 dollar, per person, per year. This is a significant benefit for the pharmacy. A meta-analysis of diabetes intervention programs identified the most common patient perceptions as barriers to adherence to best practices:14 Diabetes not considered a serious disorder Aggressive treatment will not prevent problems The treatment/lifestyle protocol is too inflexible An additional barrier identified was the clinician’s view that the patient would not adhere to the presented guidelines. The study also found the physician or pharmacist lead programs showed the greatest effectiveness. Two studies of asthma treatments programs in different settings produced reductions in direct and indirect costs. 8,13 The PRICE clinic study in Sacramento, CA is the more interesting of the two for addressing the community pharmacy delivery model. The PRICE clinic has developed a model that will be easily adaptable to the requirements of Medicare Part D reimbursement. This clinic relied heavily on student pharmacists, but did not rely on charitable donations. The clinic reduced out-of-pocket costs for patients by increasing use of generics from 51% to 56% of total prescriptions. The PRICE clinic was able to stay profitable without MTM reimbursements serving Medicare patients. It therefore stands to reason that the additional revenue from consulting services would make asthma services viable in a for-profit community pharmacy as well. Where to Intervene The location of the pharmacist in relationship to both the patient and the PCP has a significant impact on the effectiveness of the intervention. Clinical pharmacy interventions in community settings have been present in HMOs like Kaiser Permanente for over ten years.23 The accessibility of pharmacists makes them ideal for face-to-face interventions. Recent literature has explored different mediums of communication between pharmacists and patients. This discussion Page 8 of 12 Phar 727 Fall 2005 will focus on innovations to the location and medium pharmacists and pharmacies use to conduct interventions. Telephone interventions by pharmacist have been used effective for a variety of disease states. Three telephone counseling sessions over 6 months for patients on antidepressant medications reduced discontinuation from 49% in the control group to 30% in the experimental group.11 Patients in this study demonstrated a better understanding of their medication’s mechanism of action and how the medication fit into their overall disease state management strategy. One study considered the preferred method of recruiting patients with a high risk of cardiovascular disease for intervention services.24 The study found that significantly more patients attended when invited by telephone (72.3%) vs. invited by mail (44.0%). These results make intuitive sense when compare to the results of telephone vs. in-person intervention success rates discussed above. There is an apparent relationship between the level of intimacy of the intervention and the success of the intervention. Wellness programs are often taken out of the clinic and into the community. These programs can be highly effective for revealing undiagnosed disease states and as sources of revenue.16 Such programs are particularly well received when the clinics provide services, such as bone density screenings, that are not commonly available.16 Community and senior centers are generally receptive to providing facilities for screening and brown bags. Pharmacy colleges often use their teaching facilities to provide these services.20 Wellness clinics provide cost effective, readily accessible services to the community. Intensive disease state management services requiring extensive medical history evaluations are best conducted in a clinic. 10,17 When a pharmacist can work in the same clinic as the PCP, there is greater physician and patient concordance with pharmacist recommendations.10 One study attributed their near complete physician deferral to the recommendations of the pharmacist to the trust developed between the physician and the pharmacist.10This assertion Page 9 of 12 Phar 727 Fall 2005 suggests that the key to an effective clinical pharmacy practices are building relationship between both the PCPs and the patients. One study went so far as to create a computer system to guide call center personnel to conduct interviews to predict adherent and non adherent patients.12 The system was able to correctly predict over 80% of adherence and discontinuation. Conclusions Possessing the requisite clinical skills does not guarantee pharmacists a role in patient care. Our profession must stay focused on delivering measurable economic and clinical results. As individuals we must aggressively pursue opportunities and leverage new and existing technology to deliver our services effectively to the broadest patient base at the lowest cost. Community pharmacists must follow the lead of healthcare pharmacists to forge relationship with primary care physicians so we can improve the quality of life of our patients. Pharmacies that challenge the notion that only large managed care organizations like Kaiser Permanente can deliver cost effective clinical services have reaped the professional and economic benefits of providing these services. Student pharmacists should be instilled with a sense of purpose; they are the agents of change. Resident and intern pharmacy student have fresh ideas and enthusiasm to guide the profession into a future focused on clinical care, not just distribution. References 1 Schumock, G.T., et al. Evidence of the Economic Benefit of Clinical Pharmacy Services: 1996– 2000. Pharmocotherapy 2003;23(1):113-132 2 The Lewin Group. Medication Therapy Management Services: A Critical Review. JAPhA 2005;45(5):580-587 3 American Pharmacists Association. Medication Therapy Management Community Pharmacy Practice: Core Elements of an MTM Service Version 1.0. April 29, 2005. Available at Page 10 of 12 Phar 727 Fall 2005 http://www.aphanet.org/AM/TemplateRedirect.cfm?template=/CM/ContentDisplay.cfm&Co ntentID=4231 4 Oh, Y., McCombs, J.S., Cheng, R.A., Johnson, K.A., Pharmacist Time Requirements for Counseling in an Outpatient Pharmacy. American Journal of Health System Pharmacists. 2002;59:2346-2355 5 Bluml, BM, McKenney, JM, Cziraky, MJ. Pharmaceutical Care Services and Results in Project ImPACT: Hyperlibidemia. Journal of the American Pharmaceutical Association 2000; 40(2):157165 6 2003 Case Management Salary Survey Results. Advance for Providers of Post-Acute Care. Downloaded on 11/27/2005 from http://post-acutecare.advanceweb.com/resources/pp_salary_survey.pdf 7 Mercer Human Resource Consulting. 2005 Pharmacy Compensation Survey - Spring Edition. Pharmacy Week Online. Downloaded on 11/27/2005 from http://www.pharmacyweek.com/job_seeker/salary/default.asp?article_id=5258 8 Castro, M. Zimmerman, N. A., Corcker, S., Bradley, J., Leven, C., Schechtman, K. B. Asthma Intervention Program Prevents Reaadmissions in High Healthcare Users. American Journal of Respiratory Critical Care Medicine. June 2003; 168:1095-1099 9Bray P, Thompson D, Wynn JD, Cummings DM, Whetstone L. Confronting disparities in diabetes care: the clinical effectiveness of redesigning care management for minority patients in rural primary care practices. 10 Choe HM, Mitrovich S, Dubay D, Hayward RA, Krein SL, Vijan S. Proactive Case Management of High Risk Patients with Type 2 Diabetes Mellitus by a Clinical Pharmacist: A Random Control Trial. American Journal of Managed Care 2005; 11(4):253-260 11 Rickles, N.M., Svarstad, B.L., State-Paynter, J.L., Taylor, L.V., Kobak, K.A. Pharmacist Telemonitoring of Antidepressant Use: Effects on Pharmacist-Patient Collaboration. Journal of the American Pharmacist Association. 2005; 45(3):344-353. 12 Berger, B.A., Liang, H., Hudmon, K.S. Evaluation of Software-Based Telephone Counseling to Enhance Medication Persistence Among Patients with Multiple Sclerosis. Journal of the American Pharmacist Association 2005;45(4):466-472 13 Suh, D., Shin, S., Okpara, I., Voytovich, R., Zimmerman, A. Impact on a Targeted Asthma Intervention Program on Treatment Costs in Patients with Asthma. American Journal of Managed Care 2001;7(9):897-906 Page 11 of 12 Phar 727 Fall 2005 14 Knight, et Al. A Systematic Review of Diabetes Disease Management Programs. The American Journal of Managed Care 2005; 11(4):242-250 15 Wilson, Ostenhaus, Farris, Doucette, Currie, Bullock, Kumber, Financial Analysis of Cardiovascular Wellness Program Provided to Self Insured Company from Pharmaceutical Care Provider’s Perspective. Journal of the American Pharmacist Association 2005; 45(5):588-592 16 Stratton TP, Williams RG, Meine KL. Developing a Mobile Pharmacist-Conducted Wellness Clinic. Journal of the American Pharmacist Association 2005; 45: 390-399 17 Stebbins, M.R., Kaufman, D.J., Lipton, H.L. The PRICE Clinic for Low-Income Elderly: A managed Care Model for Implementing Pharmacist-Directed Services. Journal of Managed Care Pharmacists 2005;11(2):333-341 18 Law, A.V., Okamoto, M.P., Chang, P.S. Prevalence and Types of Disease Management Programs in Community Pharmacies in California. Journal of Managed Care Pharmacists 2005; 11(6):505-512 19 Pai, A.K. Integration of a Clinical Community Pharmacist Position: Emphasis on Workflow Design. Journal of the American Pharmacist Association 2005; 45(3):400-403 20 Deshpande, A., Wade, W.E., Johnson, T., Franic, D.M. A Survey of Pharmacy Student Involvement in Wellness Programs. American Journal of Pharmaceutical Education 2004; 68(5):122 Available at http://www.ajpe.org/view.asp?art=aj6805122&pdf=yes 21 Tsuyuki, R.T, et al. A Randomized Trial of the Effect of Community Pharmacist Intervention on Cholesterol Risk Management: The Sutdy of Cardiovascular Risk Intervention by Pharmacists (SCRIP). Archive of Internal Medicine 2002;162:1149-1153 22 Young, Donna. Asheville Project improves patient outcomes, cuts medical costs. American Journal of Health-System Pharmacists. May 2003; 60:868-869 23 Johnson KA, Nye M, Hill-Besinque K, Cody M. Measuring of impact of patient counseling in the outpatient pharmacy setting: development and implementation of the counseling models for the Kaiser Permanente/USC Patient Consultation Study. Clinical Therapeutics 1995;17(5):9881002 24 Karwalaitys, T, Kaczorowski, J., Chambers, L.W., et al A random trial of Mail vs. Telephone Invitation to a Community-Based Cardiovascular Health Awareness Program for Older Family Practice Patients. BMC Family Practice 2005; 6:35. Available at http://www.biomedcentral.com/1471-2296/6/35 Page 12 of 12 Phar 727 Fall 2005