CASE STUDIES
Clinical pharmacy
ar Layar
Expansion of clinical pharmacy through increased use of outpatient pharmacists for anticoagulation services Achsah Philip, Monica Green, Therese Hoffman, Stefani Gautreaux, David Wallace, Ryan Roux, and Kevin W. Garey
T
he ASHP Pharmacy Practice Model Initiative (PPMI) endorses increased clinical pharmacy services1; however, this can be difficult in an era of healthcare cost containment.2 For example, retrospective studies have demonstrated that pharmacist involvement improves diabetes care in a medical home setting3 and through a centralized pharmacy specialist–managed program.4 Each of these programs required increased personnel and time. In our experience, clinical pharmacy services must be expanded within a cost-neutral or cost-containment setting. Anticoagulation services are one of the best documented clinical pharmacy services in the ambulatory care setting.5 A study conducted at Kaiser Permanente Colorado Region incorporated a telephone service provided by a clinical pharmacy anticoagulation service specifically targeting a stable patient population for telephone follow-up.6 The
Purpose. The expansion of clinical pharmacy services through increased use of outpatient pharmacists for anticoagulation services is described. Summary. Due to the high demand for clinical pharmacist services by patients and medical staff at Harris Health System in Houston, Texas, and the strict budgetary restrictions to improve the quality of care through cost-neutral services, a new telephone anticoagulation monitoring service, provided by clinical pharmacists, was established at four of the busiest anticoagulation ambulatory care centers within the system. One clinical staff pharmacist was trained in each of the four clinics by a clinical pharmacy specialist. Each pharmacist received roughly two weeks of training to provide this service. Implementation of the new anticoagulation monitoring service occurred on April 1, 2013. Data collected between October 2011 and April 2014 revealed significantly more visits per month
intervention increased the likelihood of achieving the target International
Achsah Philip, Pharm.D., M.S., BCPS, is Clinical Informatics Pharmacist, Medication Use Policy and Informatics, Department of Pharmacy Services, Medical University of South Carolina, Charleston; at the time of writing she was Health-System Pharmacy Administration Resident, Harris Health System, Houston, TX. Monica Green, Pharm.D., BCPS, BCACP, is Ambulatory Clinical Manager; and Therese Hoffman, Pharm.D., M.B.A., is Director of Ambulatory Care Service, Harris Health System. Stefani Gautreaux, Pharm.D., M.B.A., is Pharmacy Operations Manager, M. D. Anderson Cancer Center, Houston. David Wallace, Pharm.D., is Clinical Associate Professor, University of Houston College of Pharmacy, Houston. Ryan Roux, Pharm.D., M.S., is Director of Pharmacy Operations, M. D. Anderson Cancer Center. Kevin W. Garey, Pharm.D., M.S., is Professor and Chair, University of Houston College of Pharmacy.
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Am J Health-Syst Pharm—Vol 72 Apr 1, 2015
for the clinical pharmacy service after the implementation of the telephone anticoagulation monitoring service (p = 0.011). Redistribution of workflow resulted in a 16% increase in clinical pharmacy patient volume at the ambulatory care clinics (p = 0.011). The percentage of International Normalized Ratio values in the therapeutic range, the proportion of hospitalizations due to thromboembolic or bleeding events, work hours per prescription volume, project completion rates, and the number of students precepted did not significantly differ between groups. Conclusion. The implementation of a clinical pharmacy telephone service for patients receiving anticoagulation at an outpatient center resulted in increased patient clinic visits without adversely affecting patient outcomes or increasing personnel or costs. Am J Health-Syst Pharm. 2015; 72:568-72
Normalized Ratio (INR) range compared with the control group and
Address correspondence to Dr. Garey ([email protected]). The authors acknowledge the following clinical pharmacists who were involved in this study and cared for patients in the ambulatory care clinics: Linda Onunka, Pharm.D., BCACP, CGP; Sylvester Agbahiwe, Pharm.D., BCACP; Tara Canteri, Pharm.D., M.B.A., CDE; Angela Appling, Pharm.D.; Justin Galindo, Pharm.D.; Rominy Luke, Pharm.D.; Yen Hoang-Nguyen, Pharm.D.; Lori Leal, Pharm.D.; and Sara Ruppelt, Pharm.D. The authors have declared no potential conflicts of interest. Copyright © 2015, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/15/0401-0568. DOI 10.2146/ajhp140404
CASE STUDIES
reduced the risk of major bleeding. A study of anticoagulation clinics in Veterans Affairs healthcare clinics also demonstrated the effectiveness of telephone monitoring services by clinical pharmacists.7 Background Harris Health System (HHS), a fully integrated healthcare system in Harris County, Texas, includes 16 community health centers and three tertiary care hospitals. The majority of patients seen in the health system are uninsured. In 2013, HHS provided more than $1.25 billion in medical care for the uninsured. The pharmacy department at HHS comprises clinical staff pharmacists and clinical pharmacy specialists in the inpatient and outpatient settings. Historically, clinical staff pharmacists (generally new graduates or nonresidency-trained pharmacists) were responsible for verifying and dispensing prescriptions and other technical pharmacy work. Problem At HHS outpatient centers, clinical pharmacy specialists provide chronic disease management services via face-to-face patient encounters
for anticoagulation, diabetes, hypertension, hyperlipidemia, and other diseases. Due to the high demand for clinical pharmacist services by patients and medical staff and the strict budgetary restrictions to improve the quality of care through cost-neutral services, many patients could not be seen by a pharmacist or had a delayed time to their initial and follow-up visits. To this end, a new telephone anticoagulation monitoring service, provided by clinical pharmacists, was established at four of the busiest anticoagulation ambulatory care centers within the system. Analysis and resolution Program description and evaluation. Sponsoring-physician agreements per Texas State Board Rule 295.13 and Texas Medical Examiners Rule 193.7 were signed to allow the clinical staff pharmacists to provide this new anticoagulation telephone management. The program was developed by the HHS pharmacy department and critiqued, revised, and approved for implementation by the HHS medical director, and administrators. To be eligible for the telephone anticoagulation service, patients had
Clinical pharmacy
to have had at least three consecutive INR readings within the target therapeutic range. During their face-to-face visit, patients were asked by the clinical pharmacy specialist if they would like to be followed using the newly developed telephone service. If the patients agreed, they were provided with a time during which the clinical staff pharmacist would call them. Before this telephone call, patients were required to visit a local laboratory to have their INR measured. Each telephone call with the clinical pharmacist was approximately 15 minutes. Patients were ineligible for the service if they had been discharged from the hospital within the previous 12 months or were younger than 18 years. Patients were removed from the telephone service if they missed three or more telephone appointments, missed two or more laboratory appointments, or did not respond to a mailed letter for patients unable to be contacted by telephone. Patients were also sent back to the clinic to be seen by a clinical pharmacy specialist if their INR was outside of the target range (Figure 1). Pharmacist training. One clinical staff pharmacist was trained in each
Figure 1. Algorithm for patient removal from telephone service to return to face-to-face ambulatory care visits. INR = International Normalized Ratio, CPS = clinical pharmacy specialist.
INR not in range?
Second time?
First time?
INR < 3.5
INR ≥ 3.5 < 6
Contact CPS for consultation
INR ≥ 6
Return to CPS
Return to CPS
Am J Health-Syst Pharm—Vol 72 Apr 1, 2015
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CASE STUDIES
Clinical pharmacy
of the four clinics by a clinical pharmacy specialist. Each pharmacist spent roughly one week with the clinical pharmacy specialist to shadow his or her activities and review management of the patient. In addition, instructional videos were created and provided to staff pharmacists to illustrate how the telephone service should be documented in the patient’s chart. Printed material that reviewed the INR protocol, proper note documentation, and anticoagulation therapy management was also provided to each clinical staff pharmacist. A note template was created to assist the pharmacist when reviewing anticoagulation therapy with the patient. The duration of training
for the clinical staff pharmacists was roughly two weeks. Study design and analysis. A study to determine the effectiveness of this clinical pharmacy service was approved by the institutional review board of the University of Houston. A waiver of informed consent was granted to the retrospective evaluation of this service. Using a quasiexperimental study design, the total number of clinical pharmacy visits and the time to the third available appointment for the clinic (process measure used by HHS) were compared before and after implementation of the telephone service. Efficacy measures included the percentage of INR values in the target therapeutic
Table 1.
Characteristics of Patients in the Preintervention and Postintervention Groupsa
Characteristic
No. (%) Patients Preintervention Postintervention Group (n = 301) Group (n = 201)
Male 147 (49) Ethnicity White 51 (17) Black 107 (36) Hispanic 124 (41) Other 19 (6) Comorbidities Hypertension 211 (70) Hyperlipidemia 142 (47) Diabetes 99 (33) Heart failure 71 (27) Obesity 43 (14) Cancer 10 (3) Indications for warfarin Atrial fibrillation 96 (32) MMVR or MAVR 58 (19) DVTb 50 (17) Pulmonary embolism 14 (5) Lupus 10 (3) Protein S deficiency 5 (2) INR goal 2.0–3.0 239 (79) 2.5–3.5 62 (21)
110 (55) 35 (17) 67 (33) 89 (45) 10 (5) 141 (70) 91 (45) 61 (30) 54 (29) 22 (11) 10 (5) 75 (37) 42 (21) 21 (10) 3 (2) 4 (2) 5 (3) 158 (79) 43 (21)
a The median age of patients was 59 years in the preintervention group and 61 years in the postintervention group. Unless otherwise noted, differences were not significant between groups. MMVR = mechanical mitral valve replacement, MAVR = mitral and aortic valve replacement, DVT = deep vein thrombosis, INR = International Normalized Ratio. b p = 0.03.
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range and hospitalizations due to thromboembolic events. Process measurements included work hours to prescriptions dispensed, total students precepted, and projects completed during the two time periods. Randomly selected patients from each of the four participating ambulatory care clinics were evaluated using a random-number generator. HHS’s computerized electronic health record (EPIC, Verona, WI) and pharmacy databases were used to gather data on patient demographics, total clinical pharmacy and anticoagulation visits, times to third available appointment, and productivity measures. Electronic chart reviews were conducted on sampled patients to assess times in therapeutic range and readmissions due to thromboembolic or bleeding event. Pharmacy reporting databases were used to assess the number of completed monthly projects tracked by the clinical pharmacy manager. Statistical analysis. Power calculations were based on a 20% increase in clinical pharmacy visits, with 17 months of data in the preintervention group and 12 months for the postintervention group. Data were downloaded into an Excel spreadsheet (Microsoft Corp., Redmond, WA) and analyzed using Student’s t test for continuous variables and Pearson’s chi-square test for categorical data. Statistical analysis was performed using SAS version 9.3 (SAS, Cary, NC). The a priori level of significance was 0.05. Results. Implementation of the new anticoagulation monitoring service occurred on April 1, 2013. Data were collected from October 2011 to April 2014 and analyzed. The demographics of patients seen in these clinical pharmacy clinics did not differ between the two study periods (Table 1). The mean ± S.D. number of visits per month for the clinical pharmacy service significantly differed between the preintervention group and the postinterven-
CASE STUDIES
Discussion The incorporation of clinical staff pharmacists into clinical pharmacy roles at HHS increased the number of patient visits at the clinical phar-
macy sites and did not adversely affect care at these sites or affect operational or project metrics of jobrelated duties. Although one patient in the telephone service died before the end of the study, this death could not be attributed to anticoagulation management. A similar framework could be adopted in health systems that currently use a two-tier pharmacist system. The redistribution of workflow resulted in a 20% increase in clinical pharmacy patient volume at the ambulatory care clinics and a 22.9% improved time for scheduled third appointments. These results expand and complement those of other published studies utilizing services (i.e., telephone, self-management) to monitor anticoagulation patients.6,8,9 The telephone anticoagulation service implemented at HHS repurposed clinical staff pharmacists with primary distributive functions to serve a clinical role. This transition from distributive to clinical functions is important if our profession is to meet the objectives of the PPMI summit.1 Due to their targeted clinical training, clinical staff pharmacists generally required a minimal time commitment to qualify for the telephone service (roughly one to two weeks). With proper training, the use of these pharmacists for clinical duties did not adversely affect the safety or process measures evaluated.
A survey of 110 pharmacy-led anticoagulation clinics revealed that only 23% of clinics offered formal anticoagulation training for pharmacists.10 Another study reviewed the efficacy of the Indian Health System’s anticoagulation training program using a survey questionnaire. Roughly 45% of survey respondents who received anticoagulation management training were staff pharmacists. Interestingly, only 20.5% of pharmacists remained in a distributive setting.11 This study had several limitations. The study was conducted at four ambulatory care practice sites that care for the underserved population of Harris County, Texas, which may limit the generalizability of the results to other practice sites. Further, process measures applicable to the preintervention and postintervention groups were not described, so exact areas of synergy could not be studied in detail. Future studies should evaluate expanding anticoagulation service to more sites to assess if the quality of care can be maintained with a larger volume of patients. Conclusion The implementation of a clinical pharmacy telephone service for patients receiving anticoagulation at an outpatient center resulted in increased patient clinic visits without
Figure 2. Number of patients seen by clinical pharmacists before and after implementation of a telephone anticoagulation monitoring service.
Mean No. Monthly Visits
tion group (270 ± 254 versus 313 ± 98, respectively; p = 0.011) (Figure 2). Anticoagulation visits accounted for 50% of all clinical pharmacy visits in the preintervention group and 46% of all visits in the postintervention group (p > 0.70). The mean ± S.D. elapsed time to the third available clinic appointment was greater in the preintervention group, but this difference was not significant (13.2 ± 8.0 days versus 10.8 ± 5.3 days in the postintervention group, p = 0.07). The number of clinical pharmacy visits for anticoagulation did not significantly differ between groups (134 ± 36 visits in the preintervention group versus 143 ± 32 visits in the postintervention group, p = 0.13). During the study, 43 patients enrolled in the telephone anticoagulation service, 26 of whom were later removed due to missed laboratory appointments (n = 2), INR values outside of the therapeutic range (n = 11), patient preference for faceto-face clinic visits (n = 3), patient discharge from the health system (n = 4), death (n = 1), hospitalization (n = 2), or other reasons (n = 3). The percentage of INR values in the therapeutic range (45.6% in the preintervention group versus 44.2% in the postintervention group) and the proportion of hospitalizations due to thromboembolic or bleeding events (10.6% versus 7.0% in the preintervention and postintervention groups, respectively) did not differ between groups. Work hours per prescription volume also did not differ between groups (0.21 ± 0.02 hour versus 0.22 ± 0.03 hour in the preintervention and postintervention groups, respectively. Likewise, project completion rates and the number of students precepted did not meaningfully change between groups.
Clinical pharmacy
350 300
Before intervention After intervention
250 200 150 100 50 0
Total Visits
Anticoagulation Visits
Am J Health-Syst Pharm—Vol 72 Apr 1, 2015
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CASE STUDIES
Clinical pharmacy
adversely affecting patient outcomes or increasing personnel or costs. References 1. Pharmacy Practice Model Initiative: executive summary. Am J Health-Syst Pharm. 2011; 68:1079-85. 2. Brennan C, Donnelly K, Somani S. Needs and opportunities for achieving optimal outcomes from the use of medicines in hospitals and health systems. Am J Health-Syst Pharm. 2011; 68:1086-96. 3. Reta A, Dashtaei A, Lim S et al. Opportunities to improve clinical outcomes and challenges to implementing clinical pharmacists into health care teams. Prim Care. 2012; 39:615-26. 4. Olson K, Rasmussen J, Sandhoff B et al. Lipid management in patients with coronary artery disease by a clinical pharmacy service in a group model health maintenance organization. Arch Intern Med. 2005; 165:49-54 5. Wan Y, Heneghan C, Perera R et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes. 2008; 1:84-91. 6. Witt DM, Sadler MA, Shanahan RL et al. Effect of a centralized clinical pharmacy anticoagulation service on the outcomes of anticoagulation therapy. Chest. 2005; 127:1515-22. 7. Rose AJ, Petrakis BA, Callahan P et al. Organizational characteristics of high- and low-performing anticoagulation clinics in the Veterans Health Administration. Health Serv Res. 2012; 47:1541-60. 8. Wittkowsky AK, Nutescu EA, Blackburn J et al. Outcomes of oral anticoagulant therapy managed by telephone versus inoffice visits in an anticoagulation clinic setting. Chest. 2006; 130:1385-9. 9. Verret L, Couturier J, Rozon A et al. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial. Pharmacotherapy. 2012; 32:871-9. 10. Mehlberg J, Wittkowsky AK, Possidente C. National survey of training and credentialing methods in pharmacistmanaged anticoagulation clinics. Am J Health-Syst Pharm. 1998; 55:1033-6. 11. Schupbach RR, Sparrow ND, Miller MJ et al. Participant perspectives from the Indian Health Service anticoagulation training program. Int J Clin Pharm. 2013; 35:1091-8.
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Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Clinical pharmacy
ar Layar
Expansion of clinical pharmacy through increased use of outpatient pharmacists for anticoagulation services Achsah Philip, Monica Green, Therese Hoffman, Stefani Gautreaux, David Wallace, Ryan Roux, and Kevin W. Garey
T
he ASHP Pharmacy Practice Model Initiative (PPMI) endorses increased clinical pharmacy services1; however, this can be difficult in an era of healthcare cost containment.2 For example, retrospective studies have demonstrated that pharmacist involvement improves diabetes care in a medical home setting3 and through a centralized pharmacy specialist–managed program.4 Each of these programs required increased personnel and time. In our experience, clinical pharmacy services must be expanded within a cost-neutral or cost-containment setting. Anticoagulation services are one of the best documented clinical pharmacy services in the ambulatory care setting.5 A study conducted at Kaiser Permanente Colorado Region incorporated a telephone service provided by a clinical pharmacy anticoagulation service specifically targeting a stable patient population for telephone follow-up.6 The
Purpose. The expansion of clinical pharmacy services through increased use of outpatient pharmacists for anticoagulation services is described. Summary. Due to the high demand for clinical pharmacist services by patients and medical staff at Harris Health System in Houston, Texas, and the strict budgetary restrictions to improve the quality of care through cost-neutral services, a new telephone anticoagulation monitoring service, provided by clinical pharmacists, was established at four of the busiest anticoagulation ambulatory care centers within the system. One clinical staff pharmacist was trained in each of the four clinics by a clinical pharmacy specialist. Each pharmacist received roughly two weeks of training to provide this service. Implementation of the new anticoagulation monitoring service occurred on April 1, 2013. Data collected between October 2011 and April 2014 revealed significantly more visits per month
intervention increased the likelihood of achieving the target International
Achsah Philip, Pharm.D., M.S., BCPS, is Clinical Informatics Pharmacist, Medication Use Policy and Informatics, Department of Pharmacy Services, Medical University of South Carolina, Charleston; at the time of writing she was Health-System Pharmacy Administration Resident, Harris Health System, Houston, TX. Monica Green, Pharm.D., BCPS, BCACP, is Ambulatory Clinical Manager; and Therese Hoffman, Pharm.D., M.B.A., is Director of Ambulatory Care Service, Harris Health System. Stefani Gautreaux, Pharm.D., M.B.A., is Pharmacy Operations Manager, M. D. Anderson Cancer Center, Houston. David Wallace, Pharm.D., is Clinical Associate Professor, University of Houston College of Pharmacy, Houston. Ryan Roux, Pharm.D., M.S., is Director of Pharmacy Operations, M. D. Anderson Cancer Center. Kevin W. Garey, Pharm.D., M.S., is Professor and Chair, University of Houston College of Pharmacy.
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for the clinical pharmacy service after the implementation of the telephone anticoagulation monitoring service (p = 0.011). Redistribution of workflow resulted in a 16% increase in clinical pharmacy patient volume at the ambulatory care clinics (p = 0.011). The percentage of International Normalized Ratio values in the therapeutic range, the proportion of hospitalizations due to thromboembolic or bleeding events, work hours per prescription volume, project completion rates, and the number of students precepted did not significantly differ between groups. Conclusion. The implementation of a clinical pharmacy telephone service for patients receiving anticoagulation at an outpatient center resulted in increased patient clinic visits without adversely affecting patient outcomes or increasing personnel or costs. Am J Health-Syst Pharm. 2015; 72:568-72
Normalized Ratio (INR) range compared with the control group and
Address correspondence to Dr. Garey ([email protected]). The authors acknowledge the following clinical pharmacists who were involved in this study and cared for patients in the ambulatory care clinics: Linda Onunka, Pharm.D., BCACP, CGP; Sylvester Agbahiwe, Pharm.D., BCACP; Tara Canteri, Pharm.D., M.B.A., CDE; Angela Appling, Pharm.D.; Justin Galindo, Pharm.D.; Rominy Luke, Pharm.D.; Yen Hoang-Nguyen, Pharm.D.; Lori Leal, Pharm.D.; and Sara Ruppelt, Pharm.D. The authors have declared no potential conflicts of interest. Copyright © 2015, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/15/0401-0568. DOI 10.2146/ajhp140404
CASE STUDIES
reduced the risk of major bleeding. A study of anticoagulation clinics in Veterans Affairs healthcare clinics also demonstrated the effectiveness of telephone monitoring services by clinical pharmacists.7 Background Harris Health System (HHS), a fully integrated healthcare system in Harris County, Texas, includes 16 community health centers and three tertiary care hospitals. The majority of patients seen in the health system are uninsured. In 2013, HHS provided more than $1.25 billion in medical care for the uninsured. The pharmacy department at HHS comprises clinical staff pharmacists and clinical pharmacy specialists in the inpatient and outpatient settings. Historically, clinical staff pharmacists (generally new graduates or nonresidency-trained pharmacists) were responsible for verifying and dispensing prescriptions and other technical pharmacy work. Problem At HHS outpatient centers, clinical pharmacy specialists provide chronic disease management services via face-to-face patient encounters
for anticoagulation, diabetes, hypertension, hyperlipidemia, and other diseases. Due to the high demand for clinical pharmacist services by patients and medical staff and the strict budgetary restrictions to improve the quality of care through cost-neutral services, many patients could not be seen by a pharmacist or had a delayed time to their initial and follow-up visits. To this end, a new telephone anticoagulation monitoring service, provided by clinical pharmacists, was established at four of the busiest anticoagulation ambulatory care centers within the system. Analysis and resolution Program description and evaluation. Sponsoring-physician agreements per Texas State Board Rule 295.13 and Texas Medical Examiners Rule 193.7 were signed to allow the clinical staff pharmacists to provide this new anticoagulation telephone management. The program was developed by the HHS pharmacy department and critiqued, revised, and approved for implementation by the HHS medical director, and administrators. To be eligible for the telephone anticoagulation service, patients had
Clinical pharmacy
to have had at least three consecutive INR readings within the target therapeutic range. During their face-to-face visit, patients were asked by the clinical pharmacy specialist if they would like to be followed using the newly developed telephone service. If the patients agreed, they were provided with a time during which the clinical staff pharmacist would call them. Before this telephone call, patients were required to visit a local laboratory to have their INR measured. Each telephone call with the clinical pharmacist was approximately 15 minutes. Patients were ineligible for the service if they had been discharged from the hospital within the previous 12 months or were younger than 18 years. Patients were removed from the telephone service if they missed three or more telephone appointments, missed two or more laboratory appointments, or did not respond to a mailed letter for patients unable to be contacted by telephone. Patients were also sent back to the clinic to be seen by a clinical pharmacy specialist if their INR was outside of the target range (Figure 1). Pharmacist training. One clinical staff pharmacist was trained in each
Figure 1. Algorithm for patient removal from telephone service to return to face-to-face ambulatory care visits. INR = International Normalized Ratio, CPS = clinical pharmacy specialist.
INR not in range?
Second time?
First time?
INR < 3.5
INR ≥ 3.5 < 6
Contact CPS for consultation
INR ≥ 6
Return to CPS
Return to CPS
Am J Health-Syst Pharm—Vol 72 Apr 1, 2015
569
CASE STUDIES
Clinical pharmacy
of the four clinics by a clinical pharmacy specialist. Each pharmacist spent roughly one week with the clinical pharmacy specialist to shadow his or her activities and review management of the patient. In addition, instructional videos were created and provided to staff pharmacists to illustrate how the telephone service should be documented in the patient’s chart. Printed material that reviewed the INR protocol, proper note documentation, and anticoagulation therapy management was also provided to each clinical staff pharmacist. A note template was created to assist the pharmacist when reviewing anticoagulation therapy with the patient. The duration of training
for the clinical staff pharmacists was roughly two weeks. Study design and analysis. A study to determine the effectiveness of this clinical pharmacy service was approved by the institutional review board of the University of Houston. A waiver of informed consent was granted to the retrospective evaluation of this service. Using a quasiexperimental study design, the total number of clinical pharmacy visits and the time to the third available appointment for the clinic (process measure used by HHS) were compared before and after implementation of the telephone service. Efficacy measures included the percentage of INR values in the target therapeutic
Table 1.
Characteristics of Patients in the Preintervention and Postintervention Groupsa
Characteristic
No. (%) Patients Preintervention Postintervention Group (n = 301) Group (n = 201)
Male 147 (49) Ethnicity White 51 (17) Black 107 (36) Hispanic 124 (41) Other 19 (6) Comorbidities Hypertension 211 (70) Hyperlipidemia 142 (47) Diabetes 99 (33) Heart failure 71 (27) Obesity 43 (14) Cancer 10 (3) Indications for warfarin Atrial fibrillation 96 (32) MMVR or MAVR 58 (19) DVTb 50 (17) Pulmonary embolism 14 (5) Lupus 10 (3) Protein S deficiency 5 (2) INR goal 2.0–3.0 239 (79) 2.5–3.5 62 (21)
110 (55) 35 (17) 67 (33) 89 (45) 10 (5) 141 (70) 91 (45) 61 (30) 54 (29) 22 (11) 10 (5) 75 (37) 42 (21) 21 (10) 3 (2) 4 (2) 5 (3) 158 (79) 43 (21)
a The median age of patients was 59 years in the preintervention group and 61 years in the postintervention group. Unless otherwise noted, differences were not significant between groups. MMVR = mechanical mitral valve replacement, MAVR = mitral and aortic valve replacement, DVT = deep vein thrombosis, INR = International Normalized Ratio. b p = 0.03.
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Am J Health-Syst Pharm—Vol 72 Apr 1, 2015
range and hospitalizations due to thromboembolic events. Process measurements included work hours to prescriptions dispensed, total students precepted, and projects completed during the two time periods. Randomly selected patients from each of the four participating ambulatory care clinics were evaluated using a random-number generator. HHS’s computerized electronic health record (EPIC, Verona, WI) and pharmacy databases were used to gather data on patient demographics, total clinical pharmacy and anticoagulation visits, times to third available appointment, and productivity measures. Electronic chart reviews were conducted on sampled patients to assess times in therapeutic range and readmissions due to thromboembolic or bleeding event. Pharmacy reporting databases were used to assess the number of completed monthly projects tracked by the clinical pharmacy manager. Statistical analysis. Power calculations were based on a 20% increase in clinical pharmacy visits, with 17 months of data in the preintervention group and 12 months for the postintervention group. Data were downloaded into an Excel spreadsheet (Microsoft Corp., Redmond, WA) and analyzed using Student’s t test for continuous variables and Pearson’s chi-square test for categorical data. Statistical analysis was performed using SAS version 9.3 (SAS, Cary, NC). The a priori level of significance was 0.05. Results. Implementation of the new anticoagulation monitoring service occurred on April 1, 2013. Data were collected from October 2011 to April 2014 and analyzed. The demographics of patients seen in these clinical pharmacy clinics did not differ between the two study periods (Table 1). The mean ± S.D. number of visits per month for the clinical pharmacy service significantly differed between the preintervention group and the postinterven-
CASE STUDIES
Discussion The incorporation of clinical staff pharmacists into clinical pharmacy roles at HHS increased the number of patient visits at the clinical phar-
macy sites and did not adversely affect care at these sites or affect operational or project metrics of jobrelated duties. Although one patient in the telephone service died before the end of the study, this death could not be attributed to anticoagulation management. A similar framework could be adopted in health systems that currently use a two-tier pharmacist system. The redistribution of workflow resulted in a 20% increase in clinical pharmacy patient volume at the ambulatory care clinics and a 22.9% improved time for scheduled third appointments. These results expand and complement those of other published studies utilizing services (i.e., telephone, self-management) to monitor anticoagulation patients.6,8,9 The telephone anticoagulation service implemented at HHS repurposed clinical staff pharmacists with primary distributive functions to serve a clinical role. This transition from distributive to clinical functions is important if our profession is to meet the objectives of the PPMI summit.1 Due to their targeted clinical training, clinical staff pharmacists generally required a minimal time commitment to qualify for the telephone service (roughly one to two weeks). With proper training, the use of these pharmacists for clinical duties did not adversely affect the safety or process measures evaluated.
A survey of 110 pharmacy-led anticoagulation clinics revealed that only 23% of clinics offered formal anticoagulation training for pharmacists.10 Another study reviewed the efficacy of the Indian Health System’s anticoagulation training program using a survey questionnaire. Roughly 45% of survey respondents who received anticoagulation management training were staff pharmacists. Interestingly, only 20.5% of pharmacists remained in a distributive setting.11 This study had several limitations. The study was conducted at four ambulatory care practice sites that care for the underserved population of Harris County, Texas, which may limit the generalizability of the results to other practice sites. Further, process measures applicable to the preintervention and postintervention groups were not described, so exact areas of synergy could not be studied in detail. Future studies should evaluate expanding anticoagulation service to more sites to assess if the quality of care can be maintained with a larger volume of patients. Conclusion The implementation of a clinical pharmacy telephone service for patients receiving anticoagulation at an outpatient center resulted in increased patient clinic visits without
Figure 2. Number of patients seen by clinical pharmacists before and after implementation of a telephone anticoagulation monitoring service.
Mean No. Monthly Visits
tion group (270 ± 254 versus 313 ± 98, respectively; p = 0.011) (Figure 2). Anticoagulation visits accounted for 50% of all clinical pharmacy visits in the preintervention group and 46% of all visits in the postintervention group (p > 0.70). The mean ± S.D. elapsed time to the third available clinic appointment was greater in the preintervention group, but this difference was not significant (13.2 ± 8.0 days versus 10.8 ± 5.3 days in the postintervention group, p = 0.07). The number of clinical pharmacy visits for anticoagulation did not significantly differ between groups (134 ± 36 visits in the preintervention group versus 143 ± 32 visits in the postintervention group, p = 0.13). During the study, 43 patients enrolled in the telephone anticoagulation service, 26 of whom were later removed due to missed laboratory appointments (n = 2), INR values outside of the therapeutic range (n = 11), patient preference for faceto-face clinic visits (n = 3), patient discharge from the health system (n = 4), death (n = 1), hospitalization (n = 2), or other reasons (n = 3). The percentage of INR values in the therapeutic range (45.6% in the preintervention group versus 44.2% in the postintervention group) and the proportion of hospitalizations due to thromboembolic or bleeding events (10.6% versus 7.0% in the preintervention and postintervention groups, respectively) did not differ between groups. Work hours per prescription volume also did not differ between groups (0.21 ± 0.02 hour versus 0.22 ± 0.03 hour in the preintervention and postintervention groups, respectively. Likewise, project completion rates and the number of students precepted did not meaningfully change between groups.
Clinical pharmacy
350 300
Before intervention After intervention
250 200 150 100 50 0
Total Visits
Anticoagulation Visits
Am J Health-Syst Pharm—Vol 72 Apr 1, 2015
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CASE STUDIES
Clinical pharmacy
adversely affecting patient outcomes or increasing personnel or costs. References 1. Pharmacy Practice Model Initiative: executive summary. Am J Health-Syst Pharm. 2011; 68:1079-85. 2. Brennan C, Donnelly K, Somani S. Needs and opportunities for achieving optimal outcomes from the use of medicines in hospitals and health systems. Am J Health-Syst Pharm. 2011; 68:1086-96. 3. Reta A, Dashtaei A, Lim S et al. Opportunities to improve clinical outcomes and challenges to implementing clinical pharmacists into health care teams. Prim Care. 2012; 39:615-26. 4. Olson K, Rasmussen J, Sandhoff B et al. Lipid management in patients with coronary artery disease by a clinical pharmacy service in a group model health maintenance organization. Arch Intern Med. 2005; 165:49-54 5. Wan Y, Heneghan C, Perera R et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes. 2008; 1:84-91. 6. Witt DM, Sadler MA, Shanahan RL et al. Effect of a centralized clinical pharmacy anticoagulation service on the outcomes of anticoagulation therapy. Chest. 2005; 127:1515-22. 7. Rose AJ, Petrakis BA, Callahan P et al. Organizational characteristics of high- and low-performing anticoagulation clinics in the Veterans Health Administration. Health Serv Res. 2012; 47:1541-60. 8. Wittkowsky AK, Nutescu EA, Blackburn J et al. Outcomes of oral anticoagulant therapy managed by telephone versus inoffice visits in an anticoagulation clinic setting. Chest. 2006; 130:1385-9. 9. Verret L, Couturier J, Rozon A et al. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial. Pharmacotherapy. 2012; 32:871-9. 10. Mehlberg J, Wittkowsky AK, Possidente C. National survey of training and credentialing methods in pharmacistmanaged anticoagulation clinics. Am J Health-Syst Pharm. 1998; 55:1033-6. 11. Schupbach RR, Sparrow ND, Miller MJ et al. Participant perspectives from the Indian Health Service anticoagulation training program. Int J Clin Pharm. 2013; 35:1091-8.
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