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Authors and Disclosures

J Daniel Robinson, PharmD Professor of Pharmacy and Medicine, Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL Richard Segal, PhD Professor and Chair of Pharmacy, Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida Larry M Lopez, PharmD FCCP BCPS Professor and Associate Chair of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida Randell E Doty, PharmD Clinical Associate Professor, Associate Dean for Experiential Education, College of Pharmacy, University of Florida Reprints Dr. Robinson, Department of Pharmacy Practice, College of Pharmacy, University of Florida, PO Box 100486, Gainesville, FL 32610, fax 352/273-6242, robinson@cop.ufl.edu

From The Annals of Pharmacotherapy

Impact of a Pharmaceutical Care Intervention on Blood Pressure Control in a Chain Pharmacy Practice
J Daniel Robinson; Richard Segal; Larry M Lopez; Randell E Doty Posted: 01/15/2010; The Annals of Pharmacotherapy. 2009;44(1):88-96. 2009

Abstract and Introduction

Abstract Background: Hypertension affects over 50 million Americans, with only 50% of patients being adequately controlled. Several pharmacist counseling and pharmacist-physician comanagement studies have documented that community pharmacist interventions improve blood pressure (BP) management. Objective: To determine whether community pharmacists can improve clinical endpoints including hypertension control, drug therapy dosing, adherence to prescribed regimens, adverse drug reaction incidence, patient understanding, response to therapy, and quality-of-life. Methods: The program included the education and training of a group of 18 chain community pharmacists in hypertension therapies, monitoring, and management. Protocols and documentation tools were based on nationally accepted clinical practice guidelines for hypertension in place at the time of the study. Pharmaceutical care (PC) was then compared with usual care (UC) over a 12-month period.

Results: The study initially enrolled 180 PC and 196 UC patients, with 44% (PC) and 32% (UC) of the patients reporting a final BP measurement. A larger proportion (50%) of PC patients who had poorly controlled hypertension at baseline (>140/90 mm Hg) were controlled compared with UC patients (22%). The average reduction in systolic BP was 9.9 mm Hg in PC patients compared with 2.8 mm Hg in UC patients (p < 0.05). Changes in diastolic BP were similar in the PC and UC groups. Based on patient self-report, PC patients were more likely to say that they take their medicines as prescribed compared with UC patients (p < 0.05). The 1- to 6-month antihypertensive adherence rate was higher in PC patients (0.91 0.15) compared to UC patients (0.78 0.30) (p = 0.02); there was no significant difference in adherence rate during the 7- to 12-month period. Conclusions: Community pharmacists can positively affect patient medication adherence during the 6-month period following counseling by a pharmacist along with an improvement in patient BP. However, there is much room for improvement in PC programs and in the number of patients who properly adhere to their medications. Introduction Over 100 million people in the US have one or more chronic diseases such as hypertension, diabetes, or conditions related to hyperlipidemia.[1] Hypertension affects over 60 million Americans and an estimated 1 billion people worldwide. The proportion of patients with hypertension being adequately controlled falls far below even the conservative goal of Healthy People 2010 of 50%, and has changed minimally since 1988. [2] Despite the well-documented benefit shown from controlling hypertension in reducing cardiovascular morbidity and mortality, only 25% of Americans and 13% of Canadians meet the current therapeutic guidelines. Poor medication adherence and quality of care with regard to current therapeutic guidelines contribute to inadequate control of this condition.[3] At least 5 well-cited studies as early as 1973 with pharmacist counseling[4] and as late as 2008 with pharmacist-physician comanagement have documented the positive impact that chain community pharmacists[5] and clinic pharmacists[68] have in improving blood pressure (BP) management. The focus of this investigation was to determine whether community pharmacists could improve the drug use process in patients with hypertension. The program used tools previously developed [9] and included the education and training of a group of 18 chain community pharmacists in hypertension therapies, monitoring, and management (Appendix I). The pharmacists were trained in patient communication, drug therapy monitoring, and disease management skills that included interacting with and referring patients to their primary care providers or other healthcare providers. Specific objectives included improved drug therapy dosing and adherence to prescribed regimens, increased patient understanding of their disease and its treatment, enhanced patient response to therapy, and the avoidance of adverse drug reactions. While the pharmacist selected patients initially based on whether they suffered from poorly controlled hypertension, the program focused on the total health care and wellness of the patient. The program sought to make patients active participants in the healthcare process through a collaborative approach between the pharmacist, patient, and physician. Patients were taught how to take better care of their health and become a partner in their care. The objectives of this project were to evaluate the impact of pharmaceutical care (PC) provided at a group of community chain pharmacies on several drug therapy objectives associated with the management of hypertension. The specific objectives included: 1. To evaluate whether patient participation in a PC program is associated with a reduction in BP compared with reduction in those who do not participate. 2. To evaluate whether participation in a PC program is associated with improved quality-of-life (QOL). 3. To evaluate whether patient participation in a PC program is associated with better medication-taking practices (eg, medication adherence) compared with practices in those who do not participate.

Methods
Hypertension PC protocols and documentation tools were developed by the design team at the College of Pharmacy, University of Florida, for the purpose of identifying, preventing, and resolving pharmaceutical problems for the subjects. Protocols were based on nationally accepted clinical practice guidelines for hypertension in place at the time of the study.[10] The program evaluation was based on a prospective, controlled design in which patients in both groups were invited to be part of the study to compare the PC group with patients receiving usual care (UC) during a 12month period. This research was approved by the University of Florida's Institutional Review Board/Human Subjects Research Committee. Pharmacy and Pharmacist Selection The PC program took place in 9 chain community pharmacies located in the Tampa, FL, region. PC pharmacies were selected based on the number of hypertension prescriptions dispensed in the stores, store location, and input from the district managers. Once a site was selected for inclusion in the PC group, 18 of the 23 pharmacists in the PC sites completed a skills-based training program that we previously developed and passed a thorough evaluation by demonstrating to the training team their ability to measure BP, administer the interview protocols, demonstrate proper patient counseling techniques, and so forth.[7,11] Seven additional pharmacies from the same corporate chain in the same geographic region were selected by their district manager to serve as a concurrent UC control group. The UC group of 14 pharmacists was trained only on data collection and the screening process, not on the cardiovascular intervention. Special care was taken to ensure that the UC group pharmacists did not work in any of the pharmacies in the PC group to avoid cross contamination of the groups. Patient Selection To identify patients who may benefit from the PC program, each pharmacy's automated prescription database was queried to identify patients who appeared to have a diagnosis of hypertension based on having at least one antihypertensive medication dispensed in the previous 6-month period. Initial contact with each patient receiving care in a PC or UC pharmacy occurred either by a telephone call from his or her pharmacist or while the patient was present in the pharmacy. The patients were invited to come to the pharmacy for a BP measurement to determine whether the patient was eligible for participation in the program (at no cost to the patient). The pharmacist asked patients associated with PC and UC pharmacies several screening questions to determine whether the patient met the criteria for participation in the program. Patients who had a BP equal to or greater than 140/90 mm Hg were invited to participate. Exclusion criteria included patients who had an acute myocardial infarction or unstable angina within the past 3 months or stroke within the past 12 months; pregnant or nursing females; and patients with a history of alcoholism, drug abuse, or psychosis. Initial demographic information collected from each patient after entry into the study included, in addition to BP, date of birth, height, weight, past medical and medication history, and a description of lifestyle (ie, frequency and quantity of tobacco and ethanol use; frequency and intensity of exercise). Follow-up was arranged according to the discretion of the pharmacist, but no patient was seen less frequently than every month. During follow-up, each patient's weight and BP were determined and each patient was asked about lifestyle changes, adherence to medication regimens, and occurrence of adverse drug reactions. See Appendix I for details associated with these follow-up interviews.

Primary Care Provider Education and Notification of Patient Enrollment Pharmacists practicing in PC pharmacies were trained to notify the patient's primary care provider or other appropriate provider that the patient was part of a new PC program. Sources of Data and Data Collection Data about drug utilization were collected from automated databases maintained by the pharmacy or by patient self-report. Data concerning patients' QOL care were collected directly from the patient. The data were collected beginning February 1999 and ending March 2000. Blood Pressure Data on systolic and diastolic BPs were collected based on readings from the Vita Stat[12] BP machines located in the community pharmacies and readings were observed by a pharmacist. Patients were instructed, using a standardized procedure, as to how to use the BP machine. Each BP machine was calibrated before and during the program evaluation to ensure the reliability and validity of the readings. Clinical indicators included BP at the beginning and end of the study and the percentage of subjects whose BP was less than 140/90 mm Hg at the end of the study. Quality-of-life QOL was measured using a global measure and a disease-specific assessment of QOL. The Short Form (SF)-36 health survey was used (permission obtained from The Health Institute, New England Medical Center) as a generalized multidimensional health-related QOL questionnaire.[1315] The SF-36 can be self-administered; it includes the measurement of physical functioning, role limitations, bodily pain, general health, vitality, social functioning, and role limitations due to emotional problems and mental health. The scale used for each domain is measured from 0 (lowest possible QOL) to 100 (highest possible QOL). Medication Adherence Adherence was evaluated based on an analysis of medication profiles. For this analysis, adherence was assessed during 3 periods: during the 6-month period prior to study enrollment, the first 6 months following study enrollment (1-6 mo), and then 7-12 months. A conservative measure for adherence rate for antihypertensives was calculated based on the prescription refill records from the pharmacy medication profile: number of days in which the patient had access to any antihypertensive medication/number of days during the assessment period. To assess the effect of the PC intervention on the outcome measures, the change from baseline to final data collection was determined and then the distribution of change scores was compared across groups by Student's t-test for continuous data or by nonparametric tests for categorical data. The study was powered to detect a 5mm Hg difference in the change scores in systolic and diastolic BP, assuming a type I error of 0.05 and a statistical power of 80%. The power analysis suggested that at least 40 patients should be enrolled in each of the PC and UC study groups.

Results
The program initially enrolled 180 PC patients and 196 UC patients. No significant differences were detected between patients in the PC or UC groups in terms of age, comorbidities, or the types of prescribed medications (p > 0.05). We omitted data from the analyses for subjects who received prescription services during the 12month study related to their hypertension from a pharmacy other than the PC or UC pharmacy where they were enrolled. We also omitted data from subjects who did not complete a final visit at the end of the study since a

BP measurement was needed to assess BP control and the survey was needed to assess QOL. The percentage of enrolled patients who reported a final BP measurement was 44% for PC subjects and 32% for UC subjects. The number of visits with a pharmacist for PC patients varied based on the pharmacists' assessment of each patient's needs. All PC patients had at least 3 face-to-face encounters with their pharmacist during the 12-month period and 64% had at least 5 encounters over the 12-month period. Blood Pressure No significant differences for the BP measurements between the 2 study groups were detected at baseline (Table 1). The BP in a larger proportion of PC patients (50%) who had poorly controlled hypertension at baseline (>140/90 mm Hg) dropped below 140/90 mm Hg by the end of the study compared with the BP in UC patients (22%). The average reduction in systolic BP (SBP) was 9.9 mm Hg in PC patients compared with 2.8 mm Hg in UC patients (p < 0.05). Changes in diastolic BP were similar in the PC and UC groups, with decreases of 2.9 mm Hg and 1.0 mm Hg, respectively (p = 0.16). Table 1. Blood Pressure Measures a Control (n = 62) BP (mm Hg) Baseline Systolic Diastolic 87.4 9.9 Change PC (n = 78) Baselineb Change 2.9 1.3

151.5 14.9 2.8 2.3 151.5 14.0 9.9 2.0 1.0 1.5 82.4 13.2

BP = blood pressure; PC = pharmaceutical care. a Mean SD. b PC patients experienced the greatest reduction in systolic BP compared with usual care patients (p < 0.05). Quality-of-life The SF-36 survey findings were examined to compare QOL between the PC and UC patients for the 8 major domains listed in Table 2. Compared with the "normal" person in the US, study patients reported lower QOL at baseline in all of the domains, with the exception of mental health and social functioning. [14,15] The study findings revealed that PC patients demonstrated larger improvements in QOL in physical and social function (p < 0.05) compared with UC patients, although PC patients at baseline reported lower levels of QOL for these dimensions compared with UC patients. Table 2. Change in Quality-of-Life from Baseline to End of Study a Average Values Population[13] 84.2 23.3 80.9 34.0 81.3 33.0 71.9 20.3 74.7 18.1 for General US Control Baseline Change PC Baseline Change

Quality-of-Life Physical functioning

b

70.1 26.0 3.3 2.5 60.3 26.5 3.6 2.3 63.0 37.7 5.5 5.1 58.9 41.2 3.2 4.6 66.2 40.2 5.2 6.2 65.6 41.1 0.7 5.6 60.0 18.4 0.2 1.9 58.3 20.4 0.4 1.7 72.0 12.9 0.3 1.6 72.0 14.8 0.6 1.4

Role-physical Role-emotional General health Mental health

Vitality Bodily pain

60.9 20.9 75.2 23.7

53.6 17.3 0.4 1.8 51.8 16.5 0.1 1.6 89.2 20.0 3.0 2.4 84.2 21.0 4.1 2.1 70.6 32.7 3.2 5.9 62.9 34.6 7.2 5.7

Social functioning b 83.3 22.7

PC = pharmaceutical care; QOL = quality-of-life. a Mean SD. b PC patients had larger improvements in QOL domain compared with control patients (p < 0.05). Medication Adherence Medication profiles for 67 patients (41 PC, 26 UC) were used to reveal differences between refill patterns for PC and UC patients. Medication profiles were either unavailable (13 pts.) or incomplete (60 pts.) for the remainder of the subjects. Findings from this analysis revealed no significant pretest differences between study groups for antihypertensives (p = 0.28). The 1- to 6-month antihypertensive adherence rate was higher in PC patients (0.91 0.15; mean SD) compared with UC patients (0.78 0.30) (p = 0.02). However, no statistically significant differences were detected during the 7- to 12-month period, with 0.91 0.15 adherence in the PC group compared with 0.83 0.28 in the UC group (p = 0.09).

Discussion
It is encouraging that a group of chain community pharmacists had a positive impact on management of patients with poorly controlled hypertension. Our finding that, by the end of the study, BP in half of the patients exposed to the intervention fell below 140/90 mm Hg compared to only 22% of the UC group is encouraging. However, there is certainly much room for improvement. One might wonder what happened to the other 50% of the patients and why they did not reach their goal. The average reduction in systolic SBP decreased by 9.9 mm Hg in PC patients compared to 2.8 mm Hg in the UC patients (p < 0.05). This finding might also encourage pharmacists to participate in programs such as this and look for ways to improve patient BP management. On the other hand, we were disappointed to discover that changes in diastolic BP (DBP) were similar in the PC and UC groups, with decreases of 2.9 mm Hg and 1.0 mm Hg, respectively, thus, suggesting that there is a lot of room for improvement. The other possibility, of course, is occurrence of type II statistical error and that a larger sample size would have exposed the difference. However, if one compares the results of similar programs conducted over the past 10 years in English-speaking countries, the chain community pharmacists performed fairly well. Erickson et al.[16] reported in 1997 on training pharmacist fellows and students to work closely over a 5-month period with physicians in a University of Michigan internal medical clinic performing similar interventions to personnel we trained in our program. Their study revealed a significant reduction in SBP by 12.0 mm Hg and in DBP by 4.7 mm Hg. They reported that 45% of patients were controlled in the PC group versus 30% controlled (<140/90 mm Hg) in the UC group (p = 0.17). Carter et al.[17] also reported in the same year significant decreases in SBP by 11.0 mm Hg and DBP by 3.0 mm Hg over a 6-month period achieved by rural Iowa medical clinic pharmacists. They reported that 68% of patients were controlled (<150/90 mm Hg) in the PC group versus 58% in the UC group with use of similar tasks. Chabot et al.[18] reported in 2003, from Quebec, Canada, on a 9-month study involving 9 community pharmacists. Their findings indicated a decrease in SBP of 7.8 mm Hg (statistically significant) and DBP of 6.4 mm Hg (not statistically significant) in high-income patients who received PC, whereas in UC patients, SBP increased by 0.5 mm Hg and DBP decreased by 4.0 mm Hg, but no significant changes in low-income patients. They reported BP control as less than 140/90 mm Hg in patients younger than 60 years of age and less than 160/90 mm Hg if 60 years of age or older. Their PC group was 69% controlled versus 42% in the UC group (p = 0.07), again using tasks similar to those our pharmacists performed.

In a feasibility study with no control group, 6 community pharmacists in London, UK, were trained to provide PC and monitor BP.[19] The initial BP was 186/97 mm Hg; at 2-3 months, 151/94 mm Hg; and at 12 months, 139/86 mm Hg (p < 0.001). However, they reported that only 45% patients were under control (<160/95 mm Hg), and this range is certainly controversial. This study was quite different from ours in design. In a study reported in 2005 involving 12 Iowa community pharmacists without a control group, those providing highintensity monitoring similar to ours observed significant SBP decreases of 13.4 mm Hg and DBP decreases of 8.8 mm Hg and reported 42% as controlled (<140/90 mm Hg).[20] The last similar study, which was reported in 2006, involved 376 patients with coronary artery disease and hypertension. Over a 7-month period, a pharmacist-managed blood pressure program was initiated and evaluated at the Kaiser Permanente health maintenance organization in the Denver and Boulder, CO, area.[21] The average SBP decreased 16.1 mm Hg and DBP decreased 5.9 mm Hg in all patients; SBP and DBP decreased by 18.4 and 6.2 mm Hg, respectively, in patients with concomitant diabetes. Within the entire group, 47.6% achieved control (<140/90 mm Hg), with 43.9% of those with concomitant diabetes achieving control (<130/80 mm Hg). Obviously, many hurdles are being encountered by pharmacists in bringing patients under control. Therefore, of the 6 cited pharmacist-managed hypertension pharmaceutical care programs over the past 10 years, 5 are quite similar to ours, the exception being the one in London with no control group. The decrease in SBP and DBP has ranged from 7.8 to 16.1 mm Hg and from 3.0 to 8.8 mm Hg, respectively. The patients brought under hypertensive control ranged from 42% to 69%, with the length of the studies ranging from 3 to 7 months. Considering that our study ran for a full 12 months in a chain community pharmacy, which is less structured than some of the above environments, the decreased DBP is slightly below the range, at 2.8 mm Hg; however, the decreased SBP of 9.9 mm Hg is well within the range. The percentage of patients controlled held well within the range of 24-69%, at 50%. Therefore, even though 50% is far less than ideal, it appears that the problem with hypertension control is widespread and that the pharmacists in our study demonstrated a 2.27-fold improvement over a similar patient population in the area (when compared to our UC group of only 22% within proper BP range). Findings from this analysis revealed no pretest significant differences between study groups for antihypertensive medication adherence, while the 1- to 6-month antihypertensive 91% adherence rate was higher in PC patients compared to the 78% rate for the UC patients. During the 7- to 12-month period, adherence in the PC group remained at 91% while the UC group increased slightly to 83%; however, this difference was not statistically significant. Comparison with the above studies is complicated, because only 3 of the studies reported medication adherence data and 2 of them are patient self-reported adherence data. Chabot et al.[18] reported a self-reported adherence improvement from 61% at baseline to 92% after the study period in a high-income group. Zillich et al.[20] stated that their PC patients reported improvements from a baseline of 61.3% to 87.7% upon study completion. McConnell et al.[21] reported in their study that generic medication refill rates remained at 96% from baseline to the completion of the study. To answer the question of why only 50% of the patients had their blood pressure controlled, despite intensive efforts on the part of pharmacists, certainly part of the answer may lie in the lack of full medication adherence. Other answers may lie in lack of patient adherence to other recommendations by their primary care provider, such as salt restriction, proper exercise, and weight loss. However, Carter and Zillich, who have performed some of the work in this area for many years, wrote an excellent review about this topic in The Annals.[22] They cited several studies showing that, although medication is a contributing factor, the major factor leading to poorly controlled BP is the lack of aggressive medication therapy and physicians who were satisfied with poorly controlled hypertension.[2,23,24] They went on to cite 2 other studies that demonstrated a role for pharmacists who directly identify suboptimal or lack of needed medication and establish an intervention program.[25,26] Care from a pharmacist and nurse team was evaluated in a 2008 randomized controlled trial in 14 community pharmacies in Edmonton, Canada. Of 227 diabetic patients with BPs greater than 130/80 mm Hg, SBP in the group that received management care was decreased at 6 months only by 5.6 mm Hg over controls (p < 0.01). The study did not track patient adherence.[8]

A limitation of our program is that the pharmacists who were practicing had minimal experience at making therapeutic recommendations to the PCPs. Contact with the PCPs was usually limited to letting them know that their patients were either nonadherent to their medications and/or their BP was not being controlled. It was left up to the discretion of the physician as to how aggressively to manage the patient's medication therapy. Training of community pharmacists to conduct these types of clinical activities probably should be expanded to include time spent in an established ambulatory care clinic devoted to these and other similar activities to better familiarize them with clinical hypertension decision-making. Similar to other practice-based research projects involving community pharmacists, conclusions of this study must be tempered by consideration of a number of other limitations as well. First, with the selection of PC versus UC pharmacists by the chain district managers, there is inherent bias in the populations being served by the pharmacies. Although the pharmacies are within the same geographic area, it is possible that they serve people with varying socioeconomic backgrounds. These possible differences in socioeconomics may have also played a role in regard to medication adherence, including losses to follow-up. Third, we were able to prevent cross-contamination of staff pharmacists by ensuring that those who worked in UC pharmacies did not work for PC pharmacies. We were unable, however, to prevent such cross contamination of patients. In community practice, it is not uncommon for patients to fill their prescriptions at several locations within the same chain due to convenience. It may be possible that patients enrolled in the study may have visited both pharmacy groups without realizing it. Fourth, we were disappointed that fewer than half of the patients in the PC and UC groups could be included in the analysis. Rather than using an intent-to-treat analysis, we decided to include only patients for whom we had clinical endpoints in the analysis, suggesting that our findings may not be expanded to patients with hypertension who are not regularly monitored and counseled by their pharmacist. The reasons for loss to follow-up included instances where patients had at least one prescription filled in a pharmacy other than the one where they were enrolled, and potential changes in the commitment level of some pharmacists due to loss of administrative support for these activities. This perceived change in level of commitment was not actually measured, but it appeared to be a factor since pharmacists were not rewarded for their participation in the project. Fifth, the small change in diastolic BP for patients in the PC group was probably a result of the baseline DBP being 87 mm Hg for the UC group and 82 mm Hg for the PC patients. Hence the PC group's average DBP was already well controlled and to lower it below 80 mm Hg was not a goal for these patients. Finally, our findings about the impact of PC on QOL are difficult to interpret. Although patients exposed to PC had larger changes in both physical and social functioning compared to UC patients, PC patients at baseline reported lower levels of functioning for both domains compared to UC patients. Thus, our findings about QOL should be interpreted with caution. Based on these observations, we conclude that a group of community pharmacists can positively affect patient medication adherence as well as improve patients' SBP and QOL. These preliminary observations further suggest that a larger trial is possible and that this larger trial could evaluate impact of community pharmacists on outcomes of hypertension such as overall utilization of healthcare resources, frequency of hospitalization for hypertension or other cardiovascular-related disorders, and frequency and impact of adverse drug reactions.

Appendix
Appendix 1. Pharmaceutical Care Practice Plan Patients With Hypertension The pharmacist will provide the following services to patients in the treatment group with hypertension: 1. Interview the patient to obtain pertinent demographic diagnostic, dietary, OTC and prescription drug history information. 2. Evaluate the patient's prescription refill history to obtain estimated rate of adherence.

3. Determine blood pressure during the initial visit as well as each subsequent visit and document the need and rationale for additional intervention(s). 4. Implement a therapeutic care plan for each patient that will include the following: a. Education to be given in written and oral format Disease: Definition and significance of blood pressure control Definition and significance of "hypertension" Signs and symptoms of hypertension When to seek help Therapy/Medications: Name (generic and trade) and pharmacologic class Appropriate use, rationale, and expected effects When to seek help What to do about "missed dose(s)" Other medications to avoid Foods to avoid Therapy/Lifestyle Modifications Dietary (Na restriction) Ethanol Tobacco Exercise Weight loss Adherence improvement strategies (Optional) Appropriate use of home blood pressure monitoring devices b. Monitoring Therapy Blood pressure: Measurement technique(s) Interpretation of value(s) Adverse Effects of drugs: Detection Management Drug Interactions 5. Refer the patient back to his/her primary care physician for reassessment and therapy adjustments as needed. 6. Contact the primary care physician on behalf of the patient to discuss problems and to recommend therapy changes when appropriate. 7. Document all data in the patient's record and provide these data for subsequent evaluation. The pharmacist will provide the following services* to patients with hypertension in the control group. 1. Screen prescription(s) for prescribing error(s); intervene as required. 2. Fill prescription order(s). 3. Limited patient education (eg, regimen, potential adverse effects). 4. Respond to patient-volunteered adverse drug reactions. 5. Routine care

OTC = over-the-counter.

*This represents the pharmacists' usual level of care without advanced training in cardiovascular pharmaceutical care. References 1. Scolaro KL, Stamm PL, Lloyd KB. Devices for ambulatory and home monitoring of blood pressure, lipids, coagulation, and weight management, part 1. Am J Health Syst Pharm 2005;62:180212. DOI 10.2146/ajhp040346.p1 2. Berlowitz DR, Ash AS, Hickey EC, et al. Inadequate management of blood pressure in a hypertensive population. N Engl J Med 1998;339:195763. DOI 10.1056/NEJM199812313392701 3. McKenney JM, Slining JM, Henderson HR, Devins D, Barr M. Hypertensive patients who received pharmacist counseling were more compliant with their treatment, and achieved better blood pressure control, than a control group. Circulation 1973;48:110411. 4. Park JJ, Kelly P, Carter BL, Burgess PP. Comprehensive pharmaceutical care in the chain setting. J Am Pharm Assoc (Wash) 1996;NS36:44351. 5. Okamoto MP, Nakahiro RK. Pharmacoeconomic evaluation of a pharmacist-managed hypertension clinic. Pharmacotherapy 2001;21:133744. DOI 10.1592/phco.21.17.1337.34424 6. Borenstein JE, Graber G, Saltiel E, et al. Physician-pharmacist co-management of hypertension: a randomized comparative trial. Pharmacotherapy 2003;23:20916. 7. Grainger-Rousseau TJ, Miracles MA, Hepler CD, Segal R, Doty RE, Ben-Joseph R. Therapeutic outcomes monitoring: application of pharmaceutical care guidelines to community pharmacy. J Am Pharm Assoc 1997;NS37:64761. 8. McLean DL, McAlister FA, Johnson JA, et al. Randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention pharmacists-hypertension (SCRIP-HTN). Arch Intern Med. 2008;168:235561. DOI 10.1001/archinte.168.21.2355 9. Nau DP, Grainger-Rousseau TJ, Doty RE, Hepler CD, Ried LD, Segal R. Preparing pharmacists for pharmaceutical care. J Am Pharm Assoc 1998;38:6445. 10. Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 Report. JAMA 2003;289:256072. DOI 10.1001/jama.289.19.2560 11. Mallion JM, Baguet JP, Siche JP, Tremil F, De Gaudemaris R. Clinical value of ambulatory blood pressure monitoring. J Hypertens 1999;17:58595. http://dx.doi.org/10.1097/01.hjh.0000249720.05006.d5 12. Rosner BA, Appel LJ, Raczynski JM, et al. A comparison of two automated monitors in the measurement of blood pressure reactivity. Trials of Hypertension Prevention Collaborative Research Group. Ann Epidemiol 1990;1:5769. 13. Martinelli V, Fusar-Poli P, Emanuele E, et al. Getting old with a new heart: impact of age on depression and quality of life in long-term heart transplant recipients. J Heart Lung Transplant 2007;26:5448. http://dx.doi.org/10.1016/j.healun.2007.01.023 14. Gourley GA, Portner TS, Gourley DR, et al. Humanistic outcomes in the hypertension and COPD arms of a multi-center outcomes study. J Am Pharm Assoc (Wash) 1998;38:58697. 15. Ware JE. The SF-36 Health Survey. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia: Lippincott-Raven Publishers, 1990:33745. 16. Erickson SR, Slaughter R, Halapy H. Pharmacists' ability to influence outcomes of hypertension therapy. Pharmacotherapy 1997;17:1407. 17. Carter BL, Barnette DJ, Chrischilles E, Mazzotti GJ, Asali ZJ. Evaluation of hypertensive patients after care provided by community pharmacists in a rural setting. Pharmacotherapy 1997;17:127485. 18. Chabot I, Moisan J, Gregoire JP, Milot A. Pharmacist intervention program for control of hypertension. Ann Pharmacother 2003;37:118693. DOI 10.1345/aph.1C267

19. Earle KA, Taylor P, Wyatt S, Burnett S, Ray J. A physician-pharmacist model for the surveillance blood pressure in the community: a feasibility study. J Hum Hypertens 2001;15:52933. DOI 10.1038/sj.jhh.1001220 20. Zillich AJ, Sutherland JM, Kumbera PA, Carter BL. Hypertension Outcomes Through Blood Pressure Monitoring and Evaluation by Pharmacists (HOME Study). J Gen Internal Med 2005;20:10916. DOI 10.1111/j.1525-1497.2005.0226.x 21. McConnell KJ, Zadvorny EB, Hardy AM, Delate T, Rasmussen JR, Merenich JA. Coronary artery disease and hypertension: outcomes of a pharmacist-managed blood pressure program. Pharmacotherapy 2006;26:133341. DOI 10.1592/phco.26.9.1333 22. Carter BL, Zillich AJ. Pharmaceutical care services for patients with hypertension. Ann Pharmacother 2003;37:13357. DOI 10.1345/aph.1D094 23. Hyman DJ, Pavlik VN. Characteristics of patients with uncontrolled hypertension in the United States. N Engl J Med 2001;345:47986. DOI 10.1056/NEJMoa010273 24. Malone DC, Carter BL, Billups SJ, et al. An economic analysis of a randomized, controlled, multicenter study of clinical pharmacist interventions for high-risk veterans: the IMPROVE study. Impact of Managed Pharmaceutical Care Resource Utilization and Outcomes in Veterans Affairs Medical Centers. Pharmacotherapy 2000;20:114958. DOI 10.1592/phco.20.15.1149.34590 25. Oliveria SA, Lapeurta P, McCarthy BD, L'Italien GJ, Berlowitz DR, Asch SM. Physician-related barriers to the effective management of uncontrolled hypertension. Arch Intern Med 2002;162:41320. DOI 10.1001/archinte.162.4.413 26. Carter BL, Chrischilles EA, Scholz D, Hayase N, Bell N. Extent of services provided by pharmacists in the Iowa Medicaid Pharmaceutical Case Management program. J Am Pharm Assoc 2003;43:2433. DOI 10.1331/10865800360467015 Abbreviation BP = blood pressure; ERT = estrogen replacement therapy; HDL-C = high-density lipoprotein cholesterol; HTN = hypertension; Hx = history; LDL-L = low-density lipoprotein cholesterol; MI = myocardial infarction. Financial disclosure Pfizer Inc. provided an unrestricted grant for this study. We acknowledge the assistance of Richard Farris PhD for project coordination and data analysis; Feng Wang and Amparo de la Pena in data analysis; George Vuturo for program design assistance; Kathryn Wesling, Walt Slijepcevich, George Kitchens, David Medvedeff, and participating pharmacists from the Eckerd Corporation. The Annals of Pharmacotherapy. 2009;44(1):88-96. 2009