The Pharmacist’s Role in Medication Optimization for Patients With Chronic Heart Failure (FULL)

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The Pharmacist’s Role in Medication Optimization for Patients With Chronic Heart Failure
A pharmacy medication titration clinic helped patients with chronic heart failure successfully reach target doses.

In the U.S., about 5.1 million people have clinically manifested heart failure (HF).1 The absolute mortality rate for HF is about 50% within 5 years of diagnosis, and 1 in 9 death certificates in the U.S. list HF as a cause of death.2 Heart failure is the primary diagnosis in more than 1 million hospitalizations annually.1 Patients with HF who are at risk for all-cause rehospitalization have a 1-month readmission rate of 25%, and their median survival time decreases with each hospitalization.3,4 Heart failure is the top reason for discharge of veterans treated within the VA health care system.5

Some medications decrease morbidity and mortality in patients with systolic dysfunction.6 These medications include angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and β-blockers (BBs). Studies have demonstrated effectiveness of these medications in patients with reduced ejection fraction (EF) of less or equal to 40%. Other medications with proven success include aldosterone antagonists, hydralazine in combination with a nitrate, and digoxin. The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines provide medication recommendations based on the ACCF/AHA stages of HF and the New York Heart Association (NYHA) functional classifications, designated as guideline-directed medical therapy (GDMT).6,7 Therapeutic interventions are aimed at reducing morbidity and mortality for ACCF/AHA stage C HF. The ACCF/AHA guidelines also recommend establishing multidisciplinary HF disease management programs for patients at high risk for hospital readmission to facilitate implementation of GDMT, address different barriers to behavior change, and reduce the risk of subsequent rehospitalization for HF.6

In October 2010, the Jesse Brown VAMC (JBVAMC) in Chicago, Illinois, opened its Heart Failure Disease Management Program (HFDMP) to prevent readmissions by targeting patients discharged after HF exacerbations and arranging follow-up in the HFDMP clinic. Enrollment in the clinic is initiated when an inpatient physician places a consultation. A cardiology nurse practitioner (NP) receives the consultation and schedules an in-clinic appointment for the patient within 1 week of discharge. The patient goes to the clinic on average every 2 weeks until he or she is on a stable, optimal medication regimen and is competent in self-management. After 3 months, the patient transitions to the general cardiology clinic. This process allows the HFDMP to see new patients in need of intense care and education for HF. The multidisciplinary HFDMP began with a NP and a cardiologist and 6 months later in April 2011 added a pharmacist.

After enrolling in HFDMP, the patient can be referred to the pharmacist for independent optimization of medication therapy in the Pharmacy Medication Titration Clinic (PMTC). The PMTC at JBVAMC is different from other HF clinics in that the pharmacist has prescribing authority and can interact face-to-face with patients to titrate medications. Once a patient is on an optimal medication regimen, he or she is referred to the NP and cardiologist. The PMTC is open 4 hours twice per month and offers 30-minute time slots. The authors conducted a study of the effectiveness of face-to-face PMTC appointments within the HFDMP.

Methods

This study, approved by the institutional review board at the University of Illinois at Chicago and the research and development service at JBVAMC, was a retrospective electronic chart review of patients enrolled in the HFDMP. Study patients were aged ≥ 18 years and were enrolled in the HFDMP between April 15, 2011 and April 15, 2013. Exclusion criteria included EF higher than 40%, 1 or no appointment attended, and enrollment before April 15, 2011. There were 2 study groups: HFDMP patients enrolled in PMTC (PMTC group) and HFDMP patients not enrolled in PMTC (no-PMTC group). For 1:1 comparison, the number of patients who met the criteria for the PMTC group was used to determine the number of patients to include in the no-PMTC group. Baseline date was the date of enrollment into either HFDMP or PMTC.

Data collected at baseline included demographics, NYHA class of HF, blood pressure (BP), heart rate, ejection fraction (EF), date of HF diagnosis, number of hospitalizations for HF within previous 6 months, serum creatinine level, height, weight, comorbidities, and HF medications. Data collected at the end date included NYHA class of HF; BP; heart rate; EF; HF medications; reason for not achieving target dose of medication or GDMT; ACEI, ARB, or BB adherence, defined as 80% of medication refills 6 months after date of discharge from group; readmission for HF within 30 days and 90 days; length of stay (LOS), including bed type if readmitted; emergency department (ED) visits for HF within 6 months of date of discharge from group; and death within 6 months of date of discharge from group. Clinical GDMT was defined as reaching the maximum tolerable or target dose of each HF medication for each patient depending on clinical presentation, as recommended by the ACCF/AHA guidelines for HF.6 It incorporated NYHA class of HF, contraindications, hypotension, bradycardia, dizziness, and hyperkalemia as well as the prescribing of aldosterone antagonists, hydralazine and isosorbide dinitrate, and digoxin.

 

 

Study Outcomes

There were 2 primary endpoints: difference in percentage of patients who achieved target ACEI or ARB doses and difference in percentage of patients who achieved target BB doses. Secondary endpoints were difference between PMTC and no-PMTC groups in percentage of patient achievement in clinical GDMT; percentage medication adherence; percentage of patients with change in NYHA class of HF; percentage of patients with change in EF, including mean change; percentage of patients with 30-day and 90-day readmissions for HF; mean LOS if readmitted within 30 days and 90 days; percentage of patients with ED visits for HF within 6 months after baseline; and percentage mortality within 6 months after baseline.

Statistical Analysis

A 2-tailed Fisher exact test was used for nominal data, and a Student t test for continuous data. Statistical significance was set at P < .05.

 

Results

Of the 228 HFDMP enrollees, 29 were seen in the PMTC during the study period, and 199 were not seen in the PMTC. Of the 29 patients seen in the PMTC, 24 met the criteria for the PMTC study group. Charts of 106 of the 199 patients not seen in the PMTC were randomly reviewed until 24 patients who met the study criteria were selected for the no-PMTC study group. Thus, the PMTC group and the no-PMTC group each had 24 patients for 1:1 comparison. Eighty-seven patients were excluded from the study: 22 with EF > 40%, 50 with 1 or no appointment attended, and 15 who were enrolled in HFDMP before April 15, 2011.

Mean age was 66 years. All patients were male, and most were African American. The baseline characteristics of the PMTC and no-PMTC groups were similar, except a higher percentage of patients in the PMTC group had NYHA class II or III of HF (Table 1).

The ACEI or ARB target dose was achieved by a higher percentage of patients in the PMTC group, 79.2% (n = 19) vs 50% (n = 12), but the difference was not significant (P = .07) (Figure 1). However, BB target dose was achieved by a significantly higher (P = .01) percentage of patients in the PMTC group, 87.5% (n = 21) vs 20.8% (n = 5)(Figure 2). Furthermore, a significantly higher (P = .02) percentage of patients in the PMTC group, 62.5% (n = 15) vs 25% (n = 6), achieved composite clinical GDMT (Table 2). Last, there was not a statistically significant difference in 80% adherence with ACEI or ARB dosing or with BB dosing between the PMTC group (70.8%; n = 17) and the no-PMTC group (75%; n = 18).

For a higher percentage of patients in the PMTC group, 50% (n = 12) vs 29.2% (n = 7), NYHA class of HF improved, but the difference was not significant (P = .24). In addition, EF improved in a higher percentage of patients in the PMTC group, 71.4% (n = 10) vs 41.7% (n = 5), and mean (SD) improvement in EF was higher in the PMTC group, 12.5% (12%) vs 5.4% (13%), but neither difference was significant (P = .23 and P = .16, respectively).

A higher percentage of patients in the no-PMTC group were readmitted for HF within 30 days, 8.3% (n = 2) vs 0%, but the difference was not significant. Likewise, a higher percentage of patients in the no-PMTC group were readmitted for HF within 90 days, 20.8% (n = 5) vs 4.2% (n = 1; P = .19). Mean LOS for these readmissions was longer in the PMTC group, 8 days (n = 1) vs 6.5 days (n = 8). There was a higher percentage of ED visits for HF in the no-PMTC group, 37.5% (n = 9) vs 20.8% (n = 5), but did not reach statistical significance (P = .34). Last, the no-PMTC group had a higher percentage of deaths within 6 months after baseline, 37.5% (n = 9) vs 20.8% (n = 9), which also was not significant.

Discussion

This study demonstrated that, within HFDMPs, there is a role for a pharmacist who has prescribing authority and interacts face-to-face with patients in the clinic. Significantly more patients in the PMTC group achieved target BB doses by the end of the study. Target doses of BBs have been found to decrease morbidity and mortality.8-10

The present study also found a positive trend toward achieving target ACEI or ARB doses. Reasons for not achieving target doses included contraindication to the medication, medication discontinuation during hospital admission, hypotension, hyperkalemia, and titration not complete by end of study period. Two of the many reasons for titration not being complete were clinic enrollment timing and nonadherence. Although achievement of target ACEI or ARB doses did not reach statistical significance, statistically significantly more patients achieved composite clinical GDMT.

As defined in the study, clinical GDMT captured the prescribing of hydralazine and isosorbide dinitrate in patients intolerant to ACEIs and ARBs. This study, the first known to evaluate achievement in GDMT, demonstrated a pharmacist’s ability to titrate more than just ACEI, ARB, and BB doses. This finding is clinically important in that appropriate pharmacologic therapy can reduce the number of hospitalizations for HF and improve survival, even though the study found that its PMTC group showed only trends toward fewer 30-day and 90-day readmissions for HF, fewer ED visits for HF, and less mortality.6 This finding may be attributable to the small number of readmissions for HF and deaths among the study groups.

One endpoint that did not show an expected difference with pharmacist intervention was medication adherence. However, medication nonadherence likely was a reason for patient referral to the PMTC. Baseline medication adherence was not determined, so improvement in adherence could not be assessed. Findings might have been different, too, if medication adherence had been evaluated with patient interviews and refill history, not just refill history.

In the PMTC group, LOS for readmissions for HF did not improve. However, the group had only 1 readmission, which may have skewed the result. No studies have linked outpatient pharmacist intervention to decreased LOS for readmission for HF. The endpoint was evaluated to assess whether medication stability leads to reduced LOS and to complete a limited cost analysis. Analysis of mean cost based on number of readmissions, bed type, and LOS revealed a cost savings of $167,556.82 for the PMTC group (Table 3). Other potential cost savings that are difficult to quantify and that were not accounted for include extended time between ED visits or readmissions for HF and increased quality of life and daily functioning.

This is the first study known to evaluate a pharmacist who had prescribing authority and interacted face-to-face with patients. Other studies have evaluated the role of the pharmacist in the multidisciplinary management of patients with HF. In 1999, the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study reported the effect of direct HF-related patient care by a pharmacist who performed medication evaluations, provided patient education, and made medication recommendations to a physician.11

After a medication dosing change, the pharmacist provided telephone follow-up to assess for problems with the drug therapy and then, if any were identified, referred patients to the physician. Pharmacist intervention demonstrated a decrease in all-cause mortality and HF events and an increase in ACEI doses. Unlike the pharmacist in the present study, the pharmacist had to get recommendations approved and prescribed by a physician. The present PMTC allows for pharmacist intervention, including medication therapy changes and follow-up appointments without consultation with a physician. If needed, the HF cardiologist is available in the HFDMP clinic or by telephone.

Jain and colleagues evaluated a protocol-driven medication titration clinic staffed by nurse and pharmacist specialists.12 Although their study was limited by its descriptive nature, the authors concluded that the clinic increased the number of patients who achieved target ACEI/ARB or target BB doses. In the present study, the percentage of PMTC patients who achieved target doses increased during the study period, from 50% to 79.2% (ACEI/ARB) and from 20.8% to 87.5% (BB). Unlike other clinic pharmacists, however, the PMTC pharmacist titrates medications independently and does not follow a set clinic protocol.

Similar to the PHARM study, the Heart Failure Optimal Outcomes From Pharmacy Study (HOOPS) evaluated pharmacists who worked collaboratively with physicians to optimize HF therapy.13 As in the PMTC, patients and pharmacists had 30-minute appointments together. In HOOPS, however, physician agreement was needed before pharmacist recommendations were implemented. That study found that more patients with pharmacist intervention started an ACEI or ARB, had the medication titrated, and received recommended doses. More patients also either started a BB or increased its dose, but this did not increase the number of patients who received recommended BB doses. In addition, pharmacist intervention did not affect clinical outcomes. The authors acknowledged this finding might be attributable to the pharmacists’ lack of proper HF management training. Patients in the study were also more stable, whereas PMTC patients arrived after HF discharge and were followed until medication therapy was optimized. The HOOPS followed patients for only 3 or 4 visits, regardless of target dose achievement status.

In a study conducted within the VA health care system, Martinez and colleagues evaluated the use of pharmacists who had prescribing authority and were permitted to order laboratory tests under a scope of practice similar to that in the present study.14 However, their coordination agreement allowed them only to initiate and adjust doses of certain HF medications according to defined protocols. The pharmacist conducted monthly education classes and had medication titration appointments with individual patients by telephone over 2-week intervals. Face-to-face appointments were limited to medication reconciliations, whereas all appointments in the present study were face-to-face. In addition, Martinez and colleagues found that a higher percentage of patients who attended pharmacist appointments achieved target ACEI, ARB, and BB doses, whereas the present study found a higher percentage only of achieved target BB doses, not ACEI or ARB. However, the present study also found increased composite clinical GDMT achievement, which Martinez and colleagues did not evaluate. As mentioned, GDMT achievement may be a broader evaluation of optimal HF medical therapy, as it incorporates ACEI or ARB intolerance.

Martinez and colleagues acknowledged several study limitations different from those of the present study.14 Most members of their study population were white men, unlike this study’s population. Combining these 2 studies’ results may support use of pharmacist intervention for both white and African American men. In addition, the authors noted that patients often forgot their medications or were confused about doses, and concluded that forgetfulness and confusion may stem from having only telephone interviews and lacking written instructions for the interval between clinic appointments. By contrast, all PMTC patients were seen face-to-face, and handouts detailing any changes helped minimized confusion. Even with face-to-face appointments, however, patient nonadherence persisted, making it difficult to optimize HF therapy. Patients did not always follow instructions to bring HF medications (or medication lists) and daily weight measurements to clinic visits, which complicated medication reconciliations, interventions, and educational efforts regarding dose changes. Furthermore, patients sometimes missed face-to-face appointments, often because of transportation difficulties. In these situations, telephone appointments may be beneficial. The obstacle of transportation is removed, and, during the at-home telephone call, the patient has easy access to medications and measurements.

 

 

Limitations

This study had several limitations. It was retrospective, and its sample size was too small for conclusions regarding morbidity and mortality. As the population was predominantly African American males, results may not be applicable to other races and females. Furthermore, not evaluating HF causes at baseline could have confounded results, as disease progression, response to medications, and prognosis can vary, depending on etiology. Moreover, as patients are referred from the HFDMP to the PMTC, there may have been a bias in patient selection for the PMTC group. Patients in the PMTC group may have been more clinically stable yet had a larger knowledge deficit, an adherence issue, or a need for difficult, frequent titrations. Patients also may have been less likely to be seen during the first 30 days after discharge. In addition, it could have been beneficial to match patients on NYHA class of HF at baseline to ensure HF severity was balanced between groups. Last, the adherence analysis may not be accurate, as it relied on refill history, which may not reflect how medications were taken at home.

It would be beneficial to expand this initial study with a larger sample. Presumed HF causes and medication adherence should be captured at baseline. Additional endpoints, including quality of life and patient cognition, could enhance results. Furthermore, comparing the HFDMP with the general cardiology clinic may reveal other benefits of a focused HFDMP and its PMTC. Last, evaluating patients who are recently discharged from HF admission yet not enrolled in the HFDMP may provide more information regarding the utility of both the HFDMP and the PMTC.

 

Conclusion

For the PMTC group in this study, achievement of target BB doses and achievement in composite clinical GDMT were significant, but achievement of target ACEI/ARB doses were not.

 

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References

1. Go AS, Mozaffarian D, Roger VL, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127(1):e6-e245.

2. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004;292(3):344-350.

3. Krumholz HM, Merrill AR, Schone EM, et al. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009;2(5):407-413.

4. Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007;154(2):260-266.

5. U.S. Department of Veterans Affairs, VA Office of Research and Development, Executive Committee, Chronic Heart Failure Quality Enhancement Research Initiative (CHF-QUERI), Health Services Research and Development Service. Chronic heart failure [QUERI fact sheet]. https://www.queri.research.va.gov/about/factsheets/chf_factsheet.pdf. Published July 2014. Accessed October 9, 2017.

6. Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.

7. New York Heart Association Criteria Committee. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, MA: Little Brown; 1994.

8. Parker M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996;334(21):1349-1355.

9. CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999;353(9146):9-13.

10. MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353(9169):2001-2007.

11. Gattis WA, Hasselblad V, Whellan DJ, O’Connor CM. Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management team: results of the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study. Arch Intern Med. 1999;159(16):1939-1945.

12. Jain A, Mills P, Nunn LM, et al. Success of a multidisciplinary heart failure clinic for initiation and up-titration of key therapeutic agents. Eur J Heart Fail. 2005;7(3):405-410.

13. Lowrie R, Mair FS, Greenlaw N, et al; Heart Failure Optimal Outcomes From Pharmacy Study (HOOPS) Investigators. Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Eur Heart J. 2012;33(3):314-324.

14. Martinez AS, Saef J, Paszczuk A, Bhatt-Chugani H. Implementation of a pharmacist-managed heart failure medication titration clinic. Am J Health Syst Pharm. 2013;70(12):1070-1076.

Author and Disclosure Information

Dr. Noschese is associate chief of pharmacy operations at Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois. Dr. Bergman is a clinical pharmacy specialist, Dr. Brar is an acute care nurse practitioner in the cardiac device clinic, and Dr. Kansal is a cardiologist and director of the heart failure clinic and the critical care unit, all at Jesse Brown VAMC in Chicago.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of
Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Dr. Noschese is associate chief of pharmacy operations at Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois. Dr. Bergman is a clinical pharmacy specialist, Dr. Brar is an acute care nurse practitioner in the cardiac device clinic, and Dr. Kansal is a cardiologist and director of the heart failure clinic and the critical care unit, all at Jesse Brown VAMC in Chicago.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of
Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Dr. Noschese is associate chief of pharmacy operations at Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois. Dr. Bergman is a clinical pharmacy specialist, Dr. Brar is an acute care nurse practitioner in the cardiac device clinic, and Dr. Kansal is a cardiologist and director of the heart failure clinic and the critical care unit, all at Jesse Brown VAMC in Chicago.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of
Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

A pharmacy medication titration clinic helped patients with chronic heart failure successfully reach target doses.
A pharmacy medication titration clinic helped patients with chronic heart failure successfully reach target doses.

In the U.S., about 5.1 million people have clinically manifested heart failure (HF).1 The absolute mortality rate for HF is about 50% within 5 years of diagnosis, and 1 in 9 death certificates in the U.S. list HF as a cause of death.2 Heart failure is the primary diagnosis in more than 1 million hospitalizations annually.1 Patients with HF who are at risk for all-cause rehospitalization have a 1-month readmission rate of 25%, and their median survival time decreases with each hospitalization.3,4 Heart failure is the top reason for discharge of veterans treated within the VA health care system.5

Some medications decrease morbidity and mortality in patients with systolic dysfunction.6 These medications include angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and β-blockers (BBs). Studies have demonstrated effectiveness of these medications in patients with reduced ejection fraction (EF) of less or equal to 40%. Other medications with proven success include aldosterone antagonists, hydralazine in combination with a nitrate, and digoxin. The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines provide medication recommendations based on the ACCF/AHA stages of HF and the New York Heart Association (NYHA) functional classifications, designated as guideline-directed medical therapy (GDMT).6,7 Therapeutic interventions are aimed at reducing morbidity and mortality for ACCF/AHA stage C HF. The ACCF/AHA guidelines also recommend establishing multidisciplinary HF disease management programs for patients at high risk for hospital readmission to facilitate implementation of GDMT, address different barriers to behavior change, and reduce the risk of subsequent rehospitalization for HF.6

In October 2010, the Jesse Brown VAMC (JBVAMC) in Chicago, Illinois, opened its Heart Failure Disease Management Program (HFDMP) to prevent readmissions by targeting patients discharged after HF exacerbations and arranging follow-up in the HFDMP clinic. Enrollment in the clinic is initiated when an inpatient physician places a consultation. A cardiology nurse practitioner (NP) receives the consultation and schedules an in-clinic appointment for the patient within 1 week of discharge. The patient goes to the clinic on average every 2 weeks until he or she is on a stable, optimal medication regimen and is competent in self-management. After 3 months, the patient transitions to the general cardiology clinic. This process allows the HFDMP to see new patients in need of intense care and education for HF. The multidisciplinary HFDMP began with a NP and a cardiologist and 6 months later in April 2011 added a pharmacist.

After enrolling in HFDMP, the patient can be referred to the pharmacist for independent optimization of medication therapy in the Pharmacy Medication Titration Clinic (PMTC). The PMTC at JBVAMC is different from other HF clinics in that the pharmacist has prescribing authority and can interact face-to-face with patients to titrate medications. Once a patient is on an optimal medication regimen, he or she is referred to the NP and cardiologist. The PMTC is open 4 hours twice per month and offers 30-minute time slots. The authors conducted a study of the effectiveness of face-to-face PMTC appointments within the HFDMP.

Methods

This study, approved by the institutional review board at the University of Illinois at Chicago and the research and development service at JBVAMC, was a retrospective electronic chart review of patients enrolled in the HFDMP. Study patients were aged ≥ 18 years and were enrolled in the HFDMP between April 15, 2011 and April 15, 2013. Exclusion criteria included EF higher than 40%, 1 or no appointment attended, and enrollment before April 15, 2011. There were 2 study groups: HFDMP patients enrolled in PMTC (PMTC group) and HFDMP patients not enrolled in PMTC (no-PMTC group). For 1:1 comparison, the number of patients who met the criteria for the PMTC group was used to determine the number of patients to include in the no-PMTC group. Baseline date was the date of enrollment into either HFDMP or PMTC.

Data collected at baseline included demographics, NYHA class of HF, blood pressure (BP), heart rate, ejection fraction (EF), date of HF diagnosis, number of hospitalizations for HF within previous 6 months, serum creatinine level, height, weight, comorbidities, and HF medications. Data collected at the end date included NYHA class of HF; BP; heart rate; EF; HF medications; reason for not achieving target dose of medication or GDMT; ACEI, ARB, or BB adherence, defined as 80% of medication refills 6 months after date of discharge from group; readmission for HF within 30 days and 90 days; length of stay (LOS), including bed type if readmitted; emergency department (ED) visits for HF within 6 months of date of discharge from group; and death within 6 months of date of discharge from group. Clinical GDMT was defined as reaching the maximum tolerable or target dose of each HF medication for each patient depending on clinical presentation, as recommended by the ACCF/AHA guidelines for HF.6 It incorporated NYHA class of HF, contraindications, hypotension, bradycardia, dizziness, and hyperkalemia as well as the prescribing of aldosterone antagonists, hydralazine and isosorbide dinitrate, and digoxin.

 

 

Study Outcomes

There were 2 primary endpoints: difference in percentage of patients who achieved target ACEI or ARB doses and difference in percentage of patients who achieved target BB doses. Secondary endpoints were difference between PMTC and no-PMTC groups in percentage of patient achievement in clinical GDMT; percentage medication adherence; percentage of patients with change in NYHA class of HF; percentage of patients with change in EF, including mean change; percentage of patients with 30-day and 90-day readmissions for HF; mean LOS if readmitted within 30 days and 90 days; percentage of patients with ED visits for HF within 6 months after baseline; and percentage mortality within 6 months after baseline.

Statistical Analysis

A 2-tailed Fisher exact test was used for nominal data, and a Student t test for continuous data. Statistical significance was set at P < .05.

 

Results

Of the 228 HFDMP enrollees, 29 were seen in the PMTC during the study period, and 199 were not seen in the PMTC. Of the 29 patients seen in the PMTC, 24 met the criteria for the PMTC study group. Charts of 106 of the 199 patients not seen in the PMTC were randomly reviewed until 24 patients who met the study criteria were selected for the no-PMTC study group. Thus, the PMTC group and the no-PMTC group each had 24 patients for 1:1 comparison. Eighty-seven patients were excluded from the study: 22 with EF > 40%, 50 with 1 or no appointment attended, and 15 who were enrolled in HFDMP before April 15, 2011.

Mean age was 66 years. All patients were male, and most were African American. The baseline characteristics of the PMTC and no-PMTC groups were similar, except a higher percentage of patients in the PMTC group had NYHA class II or III of HF (Table 1).

The ACEI or ARB target dose was achieved by a higher percentage of patients in the PMTC group, 79.2% (n = 19) vs 50% (n = 12), but the difference was not significant (P = .07) (Figure 1). However, BB target dose was achieved by a significantly higher (P = .01) percentage of patients in the PMTC group, 87.5% (n = 21) vs 20.8% (n = 5)(Figure 2). Furthermore, a significantly higher (P = .02) percentage of patients in the PMTC group, 62.5% (n = 15) vs 25% (n = 6), achieved composite clinical GDMT (Table 2). Last, there was not a statistically significant difference in 80% adherence with ACEI or ARB dosing or with BB dosing between the PMTC group (70.8%; n = 17) and the no-PMTC group (75%; n = 18).

For a higher percentage of patients in the PMTC group, 50% (n = 12) vs 29.2% (n = 7), NYHA class of HF improved, but the difference was not significant (P = .24). In addition, EF improved in a higher percentage of patients in the PMTC group, 71.4% (n = 10) vs 41.7% (n = 5), and mean (SD) improvement in EF was higher in the PMTC group, 12.5% (12%) vs 5.4% (13%), but neither difference was significant (P = .23 and P = .16, respectively).

A higher percentage of patients in the no-PMTC group were readmitted for HF within 30 days, 8.3% (n = 2) vs 0%, but the difference was not significant. Likewise, a higher percentage of patients in the no-PMTC group were readmitted for HF within 90 days, 20.8% (n = 5) vs 4.2% (n = 1; P = .19). Mean LOS for these readmissions was longer in the PMTC group, 8 days (n = 1) vs 6.5 days (n = 8). There was a higher percentage of ED visits for HF in the no-PMTC group, 37.5% (n = 9) vs 20.8% (n = 5), but did not reach statistical significance (P = .34). Last, the no-PMTC group had a higher percentage of deaths within 6 months after baseline, 37.5% (n = 9) vs 20.8% (n = 9), which also was not significant.

Discussion

This study demonstrated that, within HFDMPs, there is a role for a pharmacist who has prescribing authority and interacts face-to-face with patients in the clinic. Significantly more patients in the PMTC group achieved target BB doses by the end of the study. Target doses of BBs have been found to decrease morbidity and mortality.8-10

The present study also found a positive trend toward achieving target ACEI or ARB doses. Reasons for not achieving target doses included contraindication to the medication, medication discontinuation during hospital admission, hypotension, hyperkalemia, and titration not complete by end of study period. Two of the many reasons for titration not being complete were clinic enrollment timing and nonadherence. Although achievement of target ACEI or ARB doses did not reach statistical significance, statistically significantly more patients achieved composite clinical GDMT.

As defined in the study, clinical GDMT captured the prescribing of hydralazine and isosorbide dinitrate in patients intolerant to ACEIs and ARBs. This study, the first known to evaluate achievement in GDMT, demonstrated a pharmacist’s ability to titrate more than just ACEI, ARB, and BB doses. This finding is clinically important in that appropriate pharmacologic therapy can reduce the number of hospitalizations for HF and improve survival, even though the study found that its PMTC group showed only trends toward fewer 30-day and 90-day readmissions for HF, fewer ED visits for HF, and less mortality.6 This finding may be attributable to the small number of readmissions for HF and deaths among the study groups.

One endpoint that did not show an expected difference with pharmacist intervention was medication adherence. However, medication nonadherence likely was a reason for patient referral to the PMTC. Baseline medication adherence was not determined, so improvement in adherence could not be assessed. Findings might have been different, too, if medication adherence had been evaluated with patient interviews and refill history, not just refill history.

In the PMTC group, LOS for readmissions for HF did not improve. However, the group had only 1 readmission, which may have skewed the result. No studies have linked outpatient pharmacist intervention to decreased LOS for readmission for HF. The endpoint was evaluated to assess whether medication stability leads to reduced LOS and to complete a limited cost analysis. Analysis of mean cost based on number of readmissions, bed type, and LOS revealed a cost savings of $167,556.82 for the PMTC group (Table 3). Other potential cost savings that are difficult to quantify and that were not accounted for include extended time between ED visits or readmissions for HF and increased quality of life and daily functioning.

This is the first study known to evaluate a pharmacist who had prescribing authority and interacted face-to-face with patients. Other studies have evaluated the role of the pharmacist in the multidisciplinary management of patients with HF. In 1999, the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study reported the effect of direct HF-related patient care by a pharmacist who performed medication evaluations, provided patient education, and made medication recommendations to a physician.11

After a medication dosing change, the pharmacist provided telephone follow-up to assess for problems with the drug therapy and then, if any were identified, referred patients to the physician. Pharmacist intervention demonstrated a decrease in all-cause mortality and HF events and an increase in ACEI doses. Unlike the pharmacist in the present study, the pharmacist had to get recommendations approved and prescribed by a physician. The present PMTC allows for pharmacist intervention, including medication therapy changes and follow-up appointments without consultation with a physician. If needed, the HF cardiologist is available in the HFDMP clinic or by telephone.

Jain and colleagues evaluated a protocol-driven medication titration clinic staffed by nurse and pharmacist specialists.12 Although their study was limited by its descriptive nature, the authors concluded that the clinic increased the number of patients who achieved target ACEI/ARB or target BB doses. In the present study, the percentage of PMTC patients who achieved target doses increased during the study period, from 50% to 79.2% (ACEI/ARB) and from 20.8% to 87.5% (BB). Unlike other clinic pharmacists, however, the PMTC pharmacist titrates medications independently and does not follow a set clinic protocol.

Similar to the PHARM study, the Heart Failure Optimal Outcomes From Pharmacy Study (HOOPS) evaluated pharmacists who worked collaboratively with physicians to optimize HF therapy.13 As in the PMTC, patients and pharmacists had 30-minute appointments together. In HOOPS, however, physician agreement was needed before pharmacist recommendations were implemented. That study found that more patients with pharmacist intervention started an ACEI or ARB, had the medication titrated, and received recommended doses. More patients also either started a BB or increased its dose, but this did not increase the number of patients who received recommended BB doses. In addition, pharmacist intervention did not affect clinical outcomes. The authors acknowledged this finding might be attributable to the pharmacists’ lack of proper HF management training. Patients in the study were also more stable, whereas PMTC patients arrived after HF discharge and were followed until medication therapy was optimized. The HOOPS followed patients for only 3 or 4 visits, regardless of target dose achievement status.

In a study conducted within the VA health care system, Martinez and colleagues evaluated the use of pharmacists who had prescribing authority and were permitted to order laboratory tests under a scope of practice similar to that in the present study.14 However, their coordination agreement allowed them only to initiate and adjust doses of certain HF medications according to defined protocols. The pharmacist conducted monthly education classes and had medication titration appointments with individual patients by telephone over 2-week intervals. Face-to-face appointments were limited to medication reconciliations, whereas all appointments in the present study were face-to-face. In addition, Martinez and colleagues found that a higher percentage of patients who attended pharmacist appointments achieved target ACEI, ARB, and BB doses, whereas the present study found a higher percentage only of achieved target BB doses, not ACEI or ARB. However, the present study also found increased composite clinical GDMT achievement, which Martinez and colleagues did not evaluate. As mentioned, GDMT achievement may be a broader evaluation of optimal HF medical therapy, as it incorporates ACEI or ARB intolerance.

Martinez and colleagues acknowledged several study limitations different from those of the present study.14 Most members of their study population were white men, unlike this study’s population. Combining these 2 studies’ results may support use of pharmacist intervention for both white and African American men. In addition, the authors noted that patients often forgot their medications or were confused about doses, and concluded that forgetfulness and confusion may stem from having only telephone interviews and lacking written instructions for the interval between clinic appointments. By contrast, all PMTC patients were seen face-to-face, and handouts detailing any changes helped minimized confusion. Even with face-to-face appointments, however, patient nonadherence persisted, making it difficult to optimize HF therapy. Patients did not always follow instructions to bring HF medications (or medication lists) and daily weight measurements to clinic visits, which complicated medication reconciliations, interventions, and educational efforts regarding dose changes. Furthermore, patients sometimes missed face-to-face appointments, often because of transportation difficulties. In these situations, telephone appointments may be beneficial. The obstacle of transportation is removed, and, during the at-home telephone call, the patient has easy access to medications and measurements.

 

 

Limitations

This study had several limitations. It was retrospective, and its sample size was too small for conclusions regarding morbidity and mortality. As the population was predominantly African American males, results may not be applicable to other races and females. Furthermore, not evaluating HF causes at baseline could have confounded results, as disease progression, response to medications, and prognosis can vary, depending on etiology. Moreover, as patients are referred from the HFDMP to the PMTC, there may have been a bias in patient selection for the PMTC group. Patients in the PMTC group may have been more clinically stable yet had a larger knowledge deficit, an adherence issue, or a need for difficult, frequent titrations. Patients also may have been less likely to be seen during the first 30 days after discharge. In addition, it could have been beneficial to match patients on NYHA class of HF at baseline to ensure HF severity was balanced between groups. Last, the adherence analysis may not be accurate, as it relied on refill history, which may not reflect how medications were taken at home.

It would be beneficial to expand this initial study with a larger sample. Presumed HF causes and medication adherence should be captured at baseline. Additional endpoints, including quality of life and patient cognition, could enhance results. Furthermore, comparing the HFDMP with the general cardiology clinic may reveal other benefits of a focused HFDMP and its PMTC. Last, evaluating patients who are recently discharged from HF admission yet not enrolled in the HFDMP may provide more information regarding the utility of both the HFDMP and the PMTC.

 

Conclusion

For the PMTC group in this study, achievement of target BB doses and achievement in composite clinical GDMT were significant, but achievement of target ACEI/ARB doses were not.

 

Click here to read the digital edition.

In the U.S., about 5.1 million people have clinically manifested heart failure (HF).1 The absolute mortality rate for HF is about 50% within 5 years of diagnosis, and 1 in 9 death certificates in the U.S. list HF as a cause of death.2 Heart failure is the primary diagnosis in more than 1 million hospitalizations annually.1 Patients with HF who are at risk for all-cause rehospitalization have a 1-month readmission rate of 25%, and their median survival time decreases with each hospitalization.3,4 Heart failure is the top reason for discharge of veterans treated within the VA health care system.5

Some medications decrease morbidity and mortality in patients with systolic dysfunction.6 These medications include angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and β-blockers (BBs). Studies have demonstrated effectiveness of these medications in patients with reduced ejection fraction (EF) of less or equal to 40%. Other medications with proven success include aldosterone antagonists, hydralazine in combination with a nitrate, and digoxin. The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines provide medication recommendations based on the ACCF/AHA stages of HF and the New York Heart Association (NYHA) functional classifications, designated as guideline-directed medical therapy (GDMT).6,7 Therapeutic interventions are aimed at reducing morbidity and mortality for ACCF/AHA stage C HF. The ACCF/AHA guidelines also recommend establishing multidisciplinary HF disease management programs for patients at high risk for hospital readmission to facilitate implementation of GDMT, address different barriers to behavior change, and reduce the risk of subsequent rehospitalization for HF.6

In October 2010, the Jesse Brown VAMC (JBVAMC) in Chicago, Illinois, opened its Heart Failure Disease Management Program (HFDMP) to prevent readmissions by targeting patients discharged after HF exacerbations and arranging follow-up in the HFDMP clinic. Enrollment in the clinic is initiated when an inpatient physician places a consultation. A cardiology nurse practitioner (NP) receives the consultation and schedules an in-clinic appointment for the patient within 1 week of discharge. The patient goes to the clinic on average every 2 weeks until he or she is on a stable, optimal medication regimen and is competent in self-management. After 3 months, the patient transitions to the general cardiology clinic. This process allows the HFDMP to see new patients in need of intense care and education for HF. The multidisciplinary HFDMP began with a NP and a cardiologist and 6 months later in April 2011 added a pharmacist.

After enrolling in HFDMP, the patient can be referred to the pharmacist for independent optimization of medication therapy in the Pharmacy Medication Titration Clinic (PMTC). The PMTC at JBVAMC is different from other HF clinics in that the pharmacist has prescribing authority and can interact face-to-face with patients to titrate medications. Once a patient is on an optimal medication regimen, he or she is referred to the NP and cardiologist. The PMTC is open 4 hours twice per month and offers 30-minute time slots. The authors conducted a study of the effectiveness of face-to-face PMTC appointments within the HFDMP.

Methods

This study, approved by the institutional review board at the University of Illinois at Chicago and the research and development service at JBVAMC, was a retrospective electronic chart review of patients enrolled in the HFDMP. Study patients were aged ≥ 18 years and were enrolled in the HFDMP between April 15, 2011 and April 15, 2013. Exclusion criteria included EF higher than 40%, 1 or no appointment attended, and enrollment before April 15, 2011. There were 2 study groups: HFDMP patients enrolled in PMTC (PMTC group) and HFDMP patients not enrolled in PMTC (no-PMTC group). For 1:1 comparison, the number of patients who met the criteria for the PMTC group was used to determine the number of patients to include in the no-PMTC group. Baseline date was the date of enrollment into either HFDMP or PMTC.

Data collected at baseline included demographics, NYHA class of HF, blood pressure (BP), heart rate, ejection fraction (EF), date of HF diagnosis, number of hospitalizations for HF within previous 6 months, serum creatinine level, height, weight, comorbidities, and HF medications. Data collected at the end date included NYHA class of HF; BP; heart rate; EF; HF medications; reason for not achieving target dose of medication or GDMT; ACEI, ARB, or BB adherence, defined as 80% of medication refills 6 months after date of discharge from group; readmission for HF within 30 days and 90 days; length of stay (LOS), including bed type if readmitted; emergency department (ED) visits for HF within 6 months of date of discharge from group; and death within 6 months of date of discharge from group. Clinical GDMT was defined as reaching the maximum tolerable or target dose of each HF medication for each patient depending on clinical presentation, as recommended by the ACCF/AHA guidelines for HF.6 It incorporated NYHA class of HF, contraindications, hypotension, bradycardia, dizziness, and hyperkalemia as well as the prescribing of aldosterone antagonists, hydralazine and isosorbide dinitrate, and digoxin.

 

 

Study Outcomes

There were 2 primary endpoints: difference in percentage of patients who achieved target ACEI or ARB doses and difference in percentage of patients who achieved target BB doses. Secondary endpoints were difference between PMTC and no-PMTC groups in percentage of patient achievement in clinical GDMT; percentage medication adherence; percentage of patients with change in NYHA class of HF; percentage of patients with change in EF, including mean change; percentage of patients with 30-day and 90-day readmissions for HF; mean LOS if readmitted within 30 days and 90 days; percentage of patients with ED visits for HF within 6 months after baseline; and percentage mortality within 6 months after baseline.

Statistical Analysis

A 2-tailed Fisher exact test was used for nominal data, and a Student t test for continuous data. Statistical significance was set at P < .05.

 

Results

Of the 228 HFDMP enrollees, 29 were seen in the PMTC during the study period, and 199 were not seen in the PMTC. Of the 29 patients seen in the PMTC, 24 met the criteria for the PMTC study group. Charts of 106 of the 199 patients not seen in the PMTC were randomly reviewed until 24 patients who met the study criteria were selected for the no-PMTC study group. Thus, the PMTC group and the no-PMTC group each had 24 patients for 1:1 comparison. Eighty-seven patients were excluded from the study: 22 with EF > 40%, 50 with 1 or no appointment attended, and 15 who were enrolled in HFDMP before April 15, 2011.

Mean age was 66 years. All patients were male, and most were African American. The baseline characteristics of the PMTC and no-PMTC groups were similar, except a higher percentage of patients in the PMTC group had NYHA class II or III of HF (Table 1).

The ACEI or ARB target dose was achieved by a higher percentage of patients in the PMTC group, 79.2% (n = 19) vs 50% (n = 12), but the difference was not significant (P = .07) (Figure 1). However, BB target dose was achieved by a significantly higher (P = .01) percentage of patients in the PMTC group, 87.5% (n = 21) vs 20.8% (n = 5)(Figure 2). Furthermore, a significantly higher (P = .02) percentage of patients in the PMTC group, 62.5% (n = 15) vs 25% (n = 6), achieved composite clinical GDMT (Table 2). Last, there was not a statistically significant difference in 80% adherence with ACEI or ARB dosing or with BB dosing between the PMTC group (70.8%; n = 17) and the no-PMTC group (75%; n = 18).

For a higher percentage of patients in the PMTC group, 50% (n = 12) vs 29.2% (n = 7), NYHA class of HF improved, but the difference was not significant (P = .24). In addition, EF improved in a higher percentage of patients in the PMTC group, 71.4% (n = 10) vs 41.7% (n = 5), and mean (SD) improvement in EF was higher in the PMTC group, 12.5% (12%) vs 5.4% (13%), but neither difference was significant (P = .23 and P = .16, respectively).

A higher percentage of patients in the no-PMTC group were readmitted for HF within 30 days, 8.3% (n = 2) vs 0%, but the difference was not significant. Likewise, a higher percentage of patients in the no-PMTC group were readmitted for HF within 90 days, 20.8% (n = 5) vs 4.2% (n = 1; P = .19). Mean LOS for these readmissions was longer in the PMTC group, 8 days (n = 1) vs 6.5 days (n = 8). There was a higher percentage of ED visits for HF in the no-PMTC group, 37.5% (n = 9) vs 20.8% (n = 5), but did not reach statistical significance (P = .34). Last, the no-PMTC group had a higher percentage of deaths within 6 months after baseline, 37.5% (n = 9) vs 20.8% (n = 9), which also was not significant.

Discussion

This study demonstrated that, within HFDMPs, there is a role for a pharmacist who has prescribing authority and interacts face-to-face with patients in the clinic. Significantly more patients in the PMTC group achieved target BB doses by the end of the study. Target doses of BBs have been found to decrease morbidity and mortality.8-10

The present study also found a positive trend toward achieving target ACEI or ARB doses. Reasons for not achieving target doses included contraindication to the medication, medication discontinuation during hospital admission, hypotension, hyperkalemia, and titration not complete by end of study period. Two of the many reasons for titration not being complete were clinic enrollment timing and nonadherence. Although achievement of target ACEI or ARB doses did not reach statistical significance, statistically significantly more patients achieved composite clinical GDMT.

As defined in the study, clinical GDMT captured the prescribing of hydralazine and isosorbide dinitrate in patients intolerant to ACEIs and ARBs. This study, the first known to evaluate achievement in GDMT, demonstrated a pharmacist’s ability to titrate more than just ACEI, ARB, and BB doses. This finding is clinically important in that appropriate pharmacologic therapy can reduce the number of hospitalizations for HF and improve survival, even though the study found that its PMTC group showed only trends toward fewer 30-day and 90-day readmissions for HF, fewer ED visits for HF, and less mortality.6 This finding may be attributable to the small number of readmissions for HF and deaths among the study groups.

One endpoint that did not show an expected difference with pharmacist intervention was medication adherence. However, medication nonadherence likely was a reason for patient referral to the PMTC. Baseline medication adherence was not determined, so improvement in adherence could not be assessed. Findings might have been different, too, if medication adherence had been evaluated with patient interviews and refill history, not just refill history.

In the PMTC group, LOS for readmissions for HF did not improve. However, the group had only 1 readmission, which may have skewed the result. No studies have linked outpatient pharmacist intervention to decreased LOS for readmission for HF. The endpoint was evaluated to assess whether medication stability leads to reduced LOS and to complete a limited cost analysis. Analysis of mean cost based on number of readmissions, bed type, and LOS revealed a cost savings of $167,556.82 for the PMTC group (Table 3). Other potential cost savings that are difficult to quantify and that were not accounted for include extended time between ED visits or readmissions for HF and increased quality of life and daily functioning.

This is the first study known to evaluate a pharmacist who had prescribing authority and interacted face-to-face with patients. Other studies have evaluated the role of the pharmacist in the multidisciplinary management of patients with HF. In 1999, the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study reported the effect of direct HF-related patient care by a pharmacist who performed medication evaluations, provided patient education, and made medication recommendations to a physician.11

After a medication dosing change, the pharmacist provided telephone follow-up to assess for problems with the drug therapy and then, if any were identified, referred patients to the physician. Pharmacist intervention demonstrated a decrease in all-cause mortality and HF events and an increase in ACEI doses. Unlike the pharmacist in the present study, the pharmacist had to get recommendations approved and prescribed by a physician. The present PMTC allows for pharmacist intervention, including medication therapy changes and follow-up appointments without consultation with a physician. If needed, the HF cardiologist is available in the HFDMP clinic or by telephone.

Jain and colleagues evaluated a protocol-driven medication titration clinic staffed by nurse and pharmacist specialists.12 Although their study was limited by its descriptive nature, the authors concluded that the clinic increased the number of patients who achieved target ACEI/ARB or target BB doses. In the present study, the percentage of PMTC patients who achieved target doses increased during the study period, from 50% to 79.2% (ACEI/ARB) and from 20.8% to 87.5% (BB). Unlike other clinic pharmacists, however, the PMTC pharmacist titrates medications independently and does not follow a set clinic protocol.

Similar to the PHARM study, the Heart Failure Optimal Outcomes From Pharmacy Study (HOOPS) evaluated pharmacists who worked collaboratively with physicians to optimize HF therapy.13 As in the PMTC, patients and pharmacists had 30-minute appointments together. In HOOPS, however, physician agreement was needed before pharmacist recommendations were implemented. That study found that more patients with pharmacist intervention started an ACEI or ARB, had the medication titrated, and received recommended doses. More patients also either started a BB or increased its dose, but this did not increase the number of patients who received recommended BB doses. In addition, pharmacist intervention did not affect clinical outcomes. The authors acknowledged this finding might be attributable to the pharmacists’ lack of proper HF management training. Patients in the study were also more stable, whereas PMTC patients arrived after HF discharge and were followed until medication therapy was optimized. The HOOPS followed patients for only 3 or 4 visits, regardless of target dose achievement status.

In a study conducted within the VA health care system, Martinez and colleagues evaluated the use of pharmacists who had prescribing authority and were permitted to order laboratory tests under a scope of practice similar to that in the present study.14 However, their coordination agreement allowed them only to initiate and adjust doses of certain HF medications according to defined protocols. The pharmacist conducted monthly education classes and had medication titration appointments with individual patients by telephone over 2-week intervals. Face-to-face appointments were limited to medication reconciliations, whereas all appointments in the present study were face-to-face. In addition, Martinez and colleagues found that a higher percentage of patients who attended pharmacist appointments achieved target ACEI, ARB, and BB doses, whereas the present study found a higher percentage only of achieved target BB doses, not ACEI or ARB. However, the present study also found increased composite clinical GDMT achievement, which Martinez and colleagues did not evaluate. As mentioned, GDMT achievement may be a broader evaluation of optimal HF medical therapy, as it incorporates ACEI or ARB intolerance.

Martinez and colleagues acknowledged several study limitations different from those of the present study.14 Most members of their study population were white men, unlike this study’s population. Combining these 2 studies’ results may support use of pharmacist intervention for both white and African American men. In addition, the authors noted that patients often forgot their medications or were confused about doses, and concluded that forgetfulness and confusion may stem from having only telephone interviews and lacking written instructions for the interval between clinic appointments. By contrast, all PMTC patients were seen face-to-face, and handouts detailing any changes helped minimized confusion. Even with face-to-face appointments, however, patient nonadherence persisted, making it difficult to optimize HF therapy. Patients did not always follow instructions to bring HF medications (or medication lists) and daily weight measurements to clinic visits, which complicated medication reconciliations, interventions, and educational efforts regarding dose changes. Furthermore, patients sometimes missed face-to-face appointments, often because of transportation difficulties. In these situations, telephone appointments may be beneficial. The obstacle of transportation is removed, and, during the at-home telephone call, the patient has easy access to medications and measurements.

 

 

Limitations

This study had several limitations. It was retrospective, and its sample size was too small for conclusions regarding morbidity and mortality. As the population was predominantly African American males, results may not be applicable to other races and females. Furthermore, not evaluating HF causes at baseline could have confounded results, as disease progression, response to medications, and prognosis can vary, depending on etiology. Moreover, as patients are referred from the HFDMP to the PMTC, there may have been a bias in patient selection for the PMTC group. Patients in the PMTC group may have been more clinically stable yet had a larger knowledge deficit, an adherence issue, or a need for difficult, frequent titrations. Patients also may have been less likely to be seen during the first 30 days after discharge. In addition, it could have been beneficial to match patients on NYHA class of HF at baseline to ensure HF severity was balanced between groups. Last, the adherence analysis may not be accurate, as it relied on refill history, which may not reflect how medications were taken at home.

It would be beneficial to expand this initial study with a larger sample. Presumed HF causes and medication adherence should be captured at baseline. Additional endpoints, including quality of life and patient cognition, could enhance results. Furthermore, comparing the HFDMP with the general cardiology clinic may reveal other benefits of a focused HFDMP and its PMTC. Last, evaluating patients who are recently discharged from HF admission yet not enrolled in the HFDMP may provide more information regarding the utility of both the HFDMP and the PMTC.

 

Conclusion

For the PMTC group in this study, achievement of target BB doses and achievement in composite clinical GDMT were significant, but achievement of target ACEI/ARB doses were not.

 

Click here to read the digital edition.

References

1. Go AS, Mozaffarian D, Roger VL, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127(1):e6-e245.

2. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004;292(3):344-350.

3. Krumholz HM, Merrill AR, Schone EM, et al. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009;2(5):407-413.

4. Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007;154(2):260-266.

5. U.S. Department of Veterans Affairs, VA Office of Research and Development, Executive Committee, Chronic Heart Failure Quality Enhancement Research Initiative (CHF-QUERI), Health Services Research and Development Service. Chronic heart failure [QUERI fact sheet]. https://www.queri.research.va.gov/about/factsheets/chf_factsheet.pdf. Published July 2014. Accessed October 9, 2017.

6. Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.

7. New York Heart Association Criteria Committee. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, MA: Little Brown; 1994.

8. Parker M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996;334(21):1349-1355.

9. CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999;353(9146):9-13.

10. MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353(9169):2001-2007.

11. Gattis WA, Hasselblad V, Whellan DJ, O’Connor CM. Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management team: results of the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study. Arch Intern Med. 1999;159(16):1939-1945.

12. Jain A, Mills P, Nunn LM, et al. Success of a multidisciplinary heart failure clinic for initiation and up-titration of key therapeutic agents. Eur J Heart Fail. 2005;7(3):405-410.

13. Lowrie R, Mair FS, Greenlaw N, et al; Heart Failure Optimal Outcomes From Pharmacy Study (HOOPS) Investigators. Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Eur Heart J. 2012;33(3):314-324.

14. Martinez AS, Saef J, Paszczuk A, Bhatt-Chugani H. Implementation of a pharmacist-managed heart failure medication titration clinic. Am J Health Syst Pharm. 2013;70(12):1070-1076.

References

1. Go AS, Mozaffarian D, Roger VL, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127(1):e6-e245.

2. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004;292(3):344-350.

3. Krumholz HM, Merrill AR, Schone EM, et al. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009;2(5):407-413.

4. Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007;154(2):260-266.

5. U.S. Department of Veterans Affairs, VA Office of Research and Development, Executive Committee, Chronic Heart Failure Quality Enhancement Research Initiative (CHF-QUERI), Health Services Research and Development Service. Chronic heart failure [QUERI fact sheet]. https://www.queri.research.va.gov/about/factsheets/chf_factsheet.pdf. Published July 2014. Accessed October 9, 2017.

6. Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239.

7. New York Heart Association Criteria Committee. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, MA: Little Brown; 1994.

8. Parker M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996;334(21):1349-1355.

9. CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999;353(9146):9-13.

10. MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353(9169):2001-2007.

11. Gattis WA, Hasselblad V, Whellan DJ, O’Connor CM. Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management team: results of the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study. Arch Intern Med. 1999;159(16):1939-1945.

12. Jain A, Mills P, Nunn LM, et al. Success of a multidisciplinary heart failure clinic for initiation and up-titration of key therapeutic agents. Eur J Heart Fail. 2005;7(3):405-410.

13. Lowrie R, Mair FS, Greenlaw N, et al; Heart Failure Optimal Outcomes From Pharmacy Study (HOOPS) Investigators. Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Eur Heart J. 2012;33(3):314-324.

14. Martinez AS, Saef J, Paszczuk A, Bhatt-Chugani H. Implementation of a pharmacist-managed heart failure medication titration clinic. Am J Health Syst Pharm. 2013;70(12):1070-1076.

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