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Reducing Sex Disparities in Statin Therapy Among Female Veterans With Type 2 Diabetes and/or Cardiovascular Disease
Reducing Sex Disparities in Statin Therapy Among Female Veterans With Type 2 Diabetes and/or Cardiovascular Disease
Cardiovascular disease (CVD) is the leading cause of death among women in the United States.1 Most CVD is due to the buildup of plaque (ie, cholesterol, proteins, calcium, and inflammatory cells) in artery walls.2 The plaque may lead to atherosclerotic cardiovascular disease (ASCVD), which includes coronary heart disease, cerebrovascular disease, peripheral artery disease, and aortic atherosclerotic disease.2,3 Control and reduction of ASCVD risk factors, including high cholesterol levels, elevated blood pressure, insulin resistance, smoking, and a sedentary lifestyle, can contribute to a reduction in ASCVD morbidity and mortality.2 People with type 2 diabetes mellitus (T2DM) have an increased prevalence of lipid abnormalities, contributing to their high risk of ASCVD.4,5
The prescribing of statins (3-hydroxy-3-methyl-glutaryl-coenzmye A reductase inhibitors) is the cornerstone of lipid-lowering therapy and cardiovascular risk reduction for primary and secondary prevention of ASCVD.6 The American Diabetes Association (ADA) and American College of Cardiology/American Heart Association (ACC/AHA) recommend moderate- to high-intensity statins for primary prevention in patients with T2DM and high-intensity statins for secondary prevention in those with or without diabetes when not contraindicated.4,5,7 Despite eligibility according to guideline recommendations, research predominantly shows that women are less likely to receive statin therapy; however, this trend is improving. [6,8-11] To explain the sex differences in statin use, Nanna et al found that there is a combination of women being offered statin therapy less frequently, declining therapy more frequently, and discontinuing treatment more frequently.11 One possibility for discontinuing treatment could be statin-associated muscle symptoms (SAMS), which occur in about 10% of patients.12 The incidence of adverse effects (AEs) may be related to the way statins are metabolized.
Pharmacogenomic testing is free for veterans through the US Department of Veterans Affairs (VA) PHASER program, which offers information and recommendations for a panel of 11 gene variants. The panel includes genes related to common medication classes such as anticoagulants, antiplatelets, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, opioids, antidepressants, and statins. The VA PHASER panel includes the solute carrier organic anion transporter family member 1B1 (SLCO1B1) gene, which is predominantly expressed in the liver and facilitates the hepatic uptake of most statins.13,14 A reduced function of SLCO1B1 can lead to higher statin levels, resulting in increased concentrations that may potentially cause SAMS.13,14 Some alleles associated with reduced function include SLCO1B1*5, *15, *23, *31, and *46 to *49, whereas others are associated with increased function, such as SLCO1B1 *14 and *20 (Appendix).15 Supporting evidence shows the SLCO1B1*5 nucleotide polymorphism increases plasma levels of simvastatin and atorvastatin, affecting effectiveness or toxicity. 13 Females tend to have a lower body weight and higher percentage of body fat compared with males, which might lead to higher concentrations of lipophilic drugs, including atorvastatin and simvastatin, which may be exacerbated by decreased function of SLCO1B1*5.15 With pharmacogenomic testing, therapeutic recommendations can be made to improve the overall safety and efficacy of statins, thus improving adherence using a patient-specific approach.14,15
Methods
Carl Vinson VA Medical Center (CVVAMC) serves about 42,000 veterans in Central and South Georgia, of which about 15% are female. Of the female veterans enrolled in care, 63% identify as Black, 27% White, and 1.5% as Asian, American Indian/Alaska Native, or Native Hawaiian/Other Pacific Islander. The 2020 Veterans Chartbook report showed that female veterans and minority racial and ethnic groups had worse access to health care and higher mortality rates than their male and non-Hispanic White counterparts.16
The Primary Care Equity Dashboard (PCED) was developed to engage the VA health care workforce in the process of identifying and addressing inequities in local patient populations.17 Using electronic quality measure data, the PCED provides Veterans Integrated Service Network-level and facility-level performance on several metrics.18 The PCED had not been previously used at the CVVAMC, and few publications or quality improvement projects regarding its use have been reported by the VA Office of Health Equity. PCED helped identify disparities when comparing female to male patients in the prescribing of statin therapy for patients with CVD and statin therapy for patients with T2DM.
VA PHASER pharmacogenomic analyses provided an opportunity to expand this quality improvement project. Sanford Health and the VA collaborated on the PHASER program to offer free genetic testing for veterans. The program launched in 2019 and expanded to various VA sites, including CVVAMC in March 2023. This program has been extended to December 31, 2025.
The primary objective of this quality improvement project was to increase statin prescribing among female veterans with T2DM and/or CVD to reduce cardiovascular risk. Secondary outcomes included increased pharmacogenomic testing and the assessment of pharmacogenomic results related to statin therapy. This project was approved by the CVVAMC Pharmacy and Therapeutics Committee. The PCED was used to identify female veterans with T2DM and/or CVD without an active prescription for a statin between July and October 2023. A review of Computerized Patient Record System patient charts was completed to screen for prespecified inclusion and exclusion criteria. Veterans were included if they were assigned female at birth, were enrolled in care at CVVAMC, and had a diagnosis of T2DM or CVD (history of myocardial infarction, coronary bypass graft, percutaneous coronary intervention, or other revascularization in any setting).
Veterans were excluded if they were currently pregnant, trying to conceive, breastfeeding, had a T1DM diagnosis, had previously documented hypersensitivity to a statin, active liver failure or decompensated cirrhosis, previously documented statin-associated rhabdomyolysis or autoimmune myopathy, an active prescription for a proprotein convertase subtilisin/kexin type 9 inhibitor, or previously documented statin intolerance (defined as the inability to tolerate ≥ 3 statins, with ≥ 1 prescribed at low intensity or alternate-day dosing). The female veterans were compared to 2 comparators: the facility's male veterans and the VA national average, identified via the PCED.
Once a veteran was screened, they were telephoned between October 2023 and February 2024 and provided education on statin use and pharmacogenomic testing using a standardized note template. An order was placed for participants who provided verbal consent for pharmacogenomic testing. Those who agreed to statin initiation were referred to a clinical pharmacist practitioner (CPP) who contacted them at a later date to prescribe a statin following the recommendations of the 2019 ACC/AHA and 2023 ADA guidelines and pharmacogenomic testing, if applicable.4,5,7 Appropriate monitoring and follow-up occurred at the discretion of each CPP. Data collection included: age, race, diagnoses (T2DM, CVD, or both), baseline lipid panel (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), hepatic function, name and dose of statin, reasons for declining statin therapy, and pharmacogenomic testing results related to SLCO1B1.
Results
At baseline in July 2023, 77.8% of female veterans with T2DM were prescribed a statin, which exceeded the national VA average (77.0%), but was below the rate for male veterans (78.7%) in the facility comparator group.17 Additionally, 82.2% of females with CVD were prescribed a statin, which was below the national VA average of 86.0% and the 84.9% of male veterans in the facility comparator group.17 The PCED identified 189 female veterans from July 2023 to October 2023 who may benefit from statin therapy. Thirty-three females met the exclusion criteria. Of the 156 included veterans, 129 (82.7%) were successfully contacted and 27 (17.3%) could not be reached by telephone after 3 attempts (Figure 1). The 129 female veterans contacted had a mean age of 59 years and the majority were Black (82.9%) (Table 1).
Abbreviations: CVD, cardiovascular disease; PCSK9, proprotein convertase subtilisin/
kexin type 9; T2DM, type 2 diabetes mellitus; VAMC, Veterans Affairs medical center.
Primary Outcomes
Of the 129 contacted veterans, 31 (24.0%) had a non-VA statin prescription, 13 (10.1%) had an active VA statin prescription, and 85 (65.9%) did not have a statin prescription, despite being eligible. Statin adherence was confirmed with participants, and the medication list was updated accordingly.
Of the 85 veterans with no active statin therapy, 37 (43.5%) accepted a new statin prescription and 48 (56.5%) declined. There were various reasons provided for declining statin therapy: 17 participants (35.4%) declined due to concern for AEs (Table 2).
From July 2023 to March 2024, the percentage of female veterans with active statin therapy with T2DM increased from 77.8% to 79.0%. For those with active statin therapy with CVD, usage increased from 82.2% to 90.2%, which exceeded the national VA average and facility male comparator group (Figures 2 and 3).17
Secondary Outcomes
Seventy-one of 129 veterans (55.0%) gave verbal consent, and 47 (66.2%) completed the pharmacogenomic testing; 58 (45.0%) declined. Five veterans (10.6%) had a known SLCO1B1 allele variant present. One veteran required a change in statin therapy based on the results (eAppendix).
Discussion
This project aimed to increase statin prescribing among female veterans with T2DM and/or CVD to reduce cardiovascular risk and increase pharmacogenomic testing using the PCED and care managed by CPPs. The results of this quality improvement project illustrated that both metrics have improved at CVVAMC as a result of the intervention. The results in both metrics now exceed the PCED national VA average, and the CVD metric also exceeds that of the facility male comparator group. While there was only a 1.2% increase from July 2023 to March 2024 for patients with T2DM, there was an 8.0% increase for patients with CVD. Despite standardized education on statin use, more veterans declined therapy than accepted it, mostly due to concern for AEs. Recording the reasons for declining statin therapy offered valuable insight that can be used in additional discussions with veterans and clinicians.
Pharmacogenomics gives clinicians the unique opportunity to take a proactive approach to better predict drug responses, potentially allowing for less trial and error with medications, fewer AEs, greater trust in the clinician, and improved medication adherence. The CPPs incorporated pharmacogenomic testing into their practice, which led to identifying 5 SLCO1B1 gene abnormalities. The PCED served as a powerful tool for advancing equity-focused quality improvement initiatives on a local level and was crucial in prioritizing the detection of veterans potentially receiving suboptimal care.
Limitations
The nature of “cold calls” made it challenging to establish contact for inclusion in this study. An alternative to increase engagement could have been scheduled phone or face-to-face visits. While the use of the PCED was crucial, data did not account for statins listed in the non-VA medication list. All 31 patients with statins prescribed outside the VA had a start date added to provide the most accurate representation of the data moving forward.
Another limitation in this project was its small sample size and population. CVVAMC serves about 6200 female veterans, with roughly 63% identifying as Black. The preponderance of Black individuals (83%) in this project is typical for the female patient population at CVVAMC but may not reflect the demographics of other populations. Other limitations to this project consisted of scheduling conflicts. Appointments for laboratory draws at community-based outpatient clinics were subject to availability, which resulted in some delay in completion of pharmacogenomic testing.
Conclusions
CPPs can help reduce inequity in health care delivery. Increased incorporation of the PCED into regular practice within the VA is recommended to continue addressing sex disparities in statin use, diabetes control, blood pressure management, cancer screenings, and vaccination needs. CVVAMC plans to expand its use through another quality improvement project focused on reducing sex disparities in blood pressure management. Improving educational resources made available to veterans on the importance of statin therapy and potential to mitigate AEs through use of the VA PHASER program also would be helpful. This project successfully improved CVVAMC metrics for female veterans appropriately prescribed statin therapy and increased access to pharmacogenomic testing. Most importantly, it helped close the sex-based gap in CVD risk reduction care.
- Heron M. Deaths: leading causes for 2018. Nat Vital Stat Rep. 2021;70:1-114.
- US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guideline for the management of dyslipidemia for cardiovascular risk reduction. Published June 2020. Accessed August 25, 2025. https://www.healthquality.va.gov/guidelines/CD/lipids/VADODDyslipidemiaCPG5087212020.pdf
- Atherosclerotic Cardiovascular Disease (ASCVD). American Heart Association. Accessed August 26, 2025. https:// www.heart.org/en/professional/quality-improvement/ascvd
- American Diabetes Association Professional Practice Committee. 10. Cardiovascular disease and risk management: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S144-S174. doi:10.2337/dc22-S010
- American Diabetes Association. Standards of Care in Diabetes— 2023 abridged for primary care providers. Clinical Diabetes. 2022;41(1):4-31. doi:10.2337/cd23-as01
- Virani SS, Woodard LD, Ramsey DJ, et al. Gender disparities in evidence-based statin therapy in patients with cardiovascular disease. Am J Cardiol. 2015;115:21-26. doi:10.1016/j.amjcard.2014.09.041
- Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/ AHA Guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678
- Buchanan CH, Brown EA, Bishu KG, et al. The magnitude and potential causes of gender disparities in statin therapy in veterans with type 2 diabetes: a 10-year nationwide longitudinal cohort study. Womens Health Issues. 2022;32:274-283. doi:10.1016/j.whi.2021.10.003
- Ahmed F, Lin J, Ahmed T, et al. Health disparities: statin prescribing patterns among patients with diabetes in a family medicine clinic. Health Equity. 2022;6:291-297. doi:10.1089/heq.2021.0144
- Metser G, Bradley C, Moise N, Liyanage-Don N, Kronish I, Ye S. Gaps and disparities in primary prevention statin prescription during outpatient care. Am J Cardiol. 2021;161:36-41. doi:10.1016/j.amjcard.2021.08.070
- Nanna MG, Wang TY, Xiang Q, et al. Sex differences in the use of statins in community practice. Circ Cardiovasc Qual Outcomes. 2019;12(8):e005562. doi:10.1161/CIRCOUTCOMES.118.005562
- Kitzmiller JP, Mikulik EB, Dauki AM, Murkherjee C, Luzum JA. Pharmacogenomics of statins: understanding susceptibility to adverse effects. Pharmgenomics Pers Med. 2016;9:97-106. doi:10.2147/PGPM.S86013
- Türkmen D, Masoli JAH, Kuo CL, Bowden J, Melzer D, Pilling LC. Statin treatment effectiveness and the SLCO1B1*5 reduced function genotype: long-term outcomes in women and men. Br J Clin Pharmacol. 2022;88:3230-3240. doi:10.1111/bcp.15245
- Cooper-DeHoff RM, Niemi M, Ramsey LB, et al. The Clinical Pharmacogenetics Implementation Consortium guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and statin-associated musculoskeletal symptoms. Clin Pharmacol Ther. 2022;111:1007-1021. doi:10.1002/cpt.2557
- Ramsey LB, Gong L, Lee SB, et al. PharmVar GeneFocus: SLCO1B1. Clin Pharmacol Ther. 2023;113:782-793. doi:10.1002/cpt.2705
- National Healthcare Quality and Disparities Report: Chartbook on Healthcare for Veterans. Rockville (MD): Agency for Healthcare Research and Quality (US); November 2020.
- Procario G. Primary Care Equity Dashboard [database online]. Power Bi. 2023. Accessed August 26, 2025. https://app.powerbigov.us
- Hausmann LRM, Lamorte C, Estock JL. Understanding the context for incorporating equity into quality improvement throughout a national health care system. Health Equity. 2023;7(1):312-320. doi:10.1089/heq.2023.0009
Cardiovascular disease (CVD) is the leading cause of death among women in the United States.1 Most CVD is due to the buildup of plaque (ie, cholesterol, proteins, calcium, and inflammatory cells) in artery walls.2 The plaque may lead to atherosclerotic cardiovascular disease (ASCVD), which includes coronary heart disease, cerebrovascular disease, peripheral artery disease, and aortic atherosclerotic disease.2,3 Control and reduction of ASCVD risk factors, including high cholesterol levels, elevated blood pressure, insulin resistance, smoking, and a sedentary lifestyle, can contribute to a reduction in ASCVD morbidity and mortality.2 People with type 2 diabetes mellitus (T2DM) have an increased prevalence of lipid abnormalities, contributing to their high risk of ASCVD.4,5
The prescribing of statins (3-hydroxy-3-methyl-glutaryl-coenzmye A reductase inhibitors) is the cornerstone of lipid-lowering therapy and cardiovascular risk reduction for primary and secondary prevention of ASCVD.6 The American Diabetes Association (ADA) and American College of Cardiology/American Heart Association (ACC/AHA) recommend moderate- to high-intensity statins for primary prevention in patients with T2DM and high-intensity statins for secondary prevention in those with or without diabetes when not contraindicated.4,5,7 Despite eligibility according to guideline recommendations, research predominantly shows that women are less likely to receive statin therapy; however, this trend is improving. [6,8-11] To explain the sex differences in statin use, Nanna et al found that there is a combination of women being offered statin therapy less frequently, declining therapy more frequently, and discontinuing treatment more frequently.11 One possibility for discontinuing treatment could be statin-associated muscle symptoms (SAMS), which occur in about 10% of patients.12 The incidence of adverse effects (AEs) may be related to the way statins are metabolized.
Pharmacogenomic testing is free for veterans through the US Department of Veterans Affairs (VA) PHASER program, which offers information and recommendations for a panel of 11 gene variants. The panel includes genes related to common medication classes such as anticoagulants, antiplatelets, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, opioids, antidepressants, and statins. The VA PHASER panel includes the solute carrier organic anion transporter family member 1B1 (SLCO1B1) gene, which is predominantly expressed in the liver and facilitates the hepatic uptake of most statins.13,14 A reduced function of SLCO1B1 can lead to higher statin levels, resulting in increased concentrations that may potentially cause SAMS.13,14 Some alleles associated with reduced function include SLCO1B1*5, *15, *23, *31, and *46 to *49, whereas others are associated with increased function, such as SLCO1B1 *14 and *20 (Appendix).15 Supporting evidence shows the SLCO1B1*5 nucleotide polymorphism increases plasma levels of simvastatin and atorvastatin, affecting effectiveness or toxicity. 13 Females tend to have a lower body weight and higher percentage of body fat compared with males, which might lead to higher concentrations of lipophilic drugs, including atorvastatin and simvastatin, which may be exacerbated by decreased function of SLCO1B1*5.15 With pharmacogenomic testing, therapeutic recommendations can be made to improve the overall safety and efficacy of statins, thus improving adherence using a patient-specific approach.14,15
Methods
Carl Vinson VA Medical Center (CVVAMC) serves about 42,000 veterans in Central and South Georgia, of which about 15% are female. Of the female veterans enrolled in care, 63% identify as Black, 27% White, and 1.5% as Asian, American Indian/Alaska Native, or Native Hawaiian/Other Pacific Islander. The 2020 Veterans Chartbook report showed that female veterans and minority racial and ethnic groups had worse access to health care and higher mortality rates than their male and non-Hispanic White counterparts.16
The Primary Care Equity Dashboard (PCED) was developed to engage the VA health care workforce in the process of identifying and addressing inequities in local patient populations.17 Using electronic quality measure data, the PCED provides Veterans Integrated Service Network-level and facility-level performance on several metrics.18 The PCED had not been previously used at the CVVAMC, and few publications or quality improvement projects regarding its use have been reported by the VA Office of Health Equity. PCED helped identify disparities when comparing female to male patients in the prescribing of statin therapy for patients with CVD and statin therapy for patients with T2DM.
VA PHASER pharmacogenomic analyses provided an opportunity to expand this quality improvement project. Sanford Health and the VA collaborated on the PHASER program to offer free genetic testing for veterans. The program launched in 2019 and expanded to various VA sites, including CVVAMC in March 2023. This program has been extended to December 31, 2025.
The primary objective of this quality improvement project was to increase statin prescribing among female veterans with T2DM and/or CVD to reduce cardiovascular risk. Secondary outcomes included increased pharmacogenomic testing and the assessment of pharmacogenomic results related to statin therapy. This project was approved by the CVVAMC Pharmacy and Therapeutics Committee. The PCED was used to identify female veterans with T2DM and/or CVD without an active prescription for a statin between July and October 2023. A review of Computerized Patient Record System patient charts was completed to screen for prespecified inclusion and exclusion criteria. Veterans were included if they were assigned female at birth, were enrolled in care at CVVAMC, and had a diagnosis of T2DM or CVD (history of myocardial infarction, coronary bypass graft, percutaneous coronary intervention, or other revascularization in any setting).
Veterans were excluded if they were currently pregnant, trying to conceive, breastfeeding, had a T1DM diagnosis, had previously documented hypersensitivity to a statin, active liver failure or decompensated cirrhosis, previously documented statin-associated rhabdomyolysis or autoimmune myopathy, an active prescription for a proprotein convertase subtilisin/kexin type 9 inhibitor, or previously documented statin intolerance (defined as the inability to tolerate ≥ 3 statins, with ≥ 1 prescribed at low intensity or alternate-day dosing). The female veterans were compared to 2 comparators: the facility's male veterans and the VA national average, identified via the PCED.
Once a veteran was screened, they were telephoned between October 2023 and February 2024 and provided education on statin use and pharmacogenomic testing using a standardized note template. An order was placed for participants who provided verbal consent for pharmacogenomic testing. Those who agreed to statin initiation were referred to a clinical pharmacist practitioner (CPP) who contacted them at a later date to prescribe a statin following the recommendations of the 2019 ACC/AHA and 2023 ADA guidelines and pharmacogenomic testing, if applicable.4,5,7 Appropriate monitoring and follow-up occurred at the discretion of each CPP. Data collection included: age, race, diagnoses (T2DM, CVD, or both), baseline lipid panel (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), hepatic function, name and dose of statin, reasons for declining statin therapy, and pharmacogenomic testing results related to SLCO1B1.
Results
At baseline in July 2023, 77.8% of female veterans with T2DM were prescribed a statin, which exceeded the national VA average (77.0%), but was below the rate for male veterans (78.7%) in the facility comparator group.17 Additionally, 82.2% of females with CVD were prescribed a statin, which was below the national VA average of 86.0% and the 84.9% of male veterans in the facility comparator group.17 The PCED identified 189 female veterans from July 2023 to October 2023 who may benefit from statin therapy. Thirty-three females met the exclusion criteria. Of the 156 included veterans, 129 (82.7%) were successfully contacted and 27 (17.3%) could not be reached by telephone after 3 attempts (Figure 1). The 129 female veterans contacted had a mean age of 59 years and the majority were Black (82.9%) (Table 1).
Abbreviations: CVD, cardiovascular disease; PCSK9, proprotein convertase subtilisin/
kexin type 9; T2DM, type 2 diabetes mellitus; VAMC, Veterans Affairs medical center.
Primary Outcomes
Of the 129 contacted veterans, 31 (24.0%) had a non-VA statin prescription, 13 (10.1%) had an active VA statin prescription, and 85 (65.9%) did not have a statin prescription, despite being eligible. Statin adherence was confirmed with participants, and the medication list was updated accordingly.
Of the 85 veterans with no active statin therapy, 37 (43.5%) accepted a new statin prescription and 48 (56.5%) declined. There were various reasons provided for declining statin therapy: 17 participants (35.4%) declined due to concern for AEs (Table 2).
From July 2023 to March 2024, the percentage of female veterans with active statin therapy with T2DM increased from 77.8% to 79.0%. For those with active statin therapy with CVD, usage increased from 82.2% to 90.2%, which exceeded the national VA average and facility male comparator group (Figures 2 and 3).17
Secondary Outcomes
Seventy-one of 129 veterans (55.0%) gave verbal consent, and 47 (66.2%) completed the pharmacogenomic testing; 58 (45.0%) declined. Five veterans (10.6%) had a known SLCO1B1 allele variant present. One veteran required a change in statin therapy based on the results (eAppendix).
Discussion
This project aimed to increase statin prescribing among female veterans with T2DM and/or CVD to reduce cardiovascular risk and increase pharmacogenomic testing using the PCED and care managed by CPPs. The results of this quality improvement project illustrated that both metrics have improved at CVVAMC as a result of the intervention. The results in both metrics now exceed the PCED national VA average, and the CVD metric also exceeds that of the facility male comparator group. While there was only a 1.2% increase from July 2023 to March 2024 for patients with T2DM, there was an 8.0% increase for patients with CVD. Despite standardized education on statin use, more veterans declined therapy than accepted it, mostly due to concern for AEs. Recording the reasons for declining statin therapy offered valuable insight that can be used in additional discussions with veterans and clinicians.
Pharmacogenomics gives clinicians the unique opportunity to take a proactive approach to better predict drug responses, potentially allowing for less trial and error with medications, fewer AEs, greater trust in the clinician, and improved medication adherence. The CPPs incorporated pharmacogenomic testing into their practice, which led to identifying 5 SLCO1B1 gene abnormalities. The PCED served as a powerful tool for advancing equity-focused quality improvement initiatives on a local level and was crucial in prioritizing the detection of veterans potentially receiving suboptimal care.
Limitations
The nature of “cold calls” made it challenging to establish contact for inclusion in this study. An alternative to increase engagement could have been scheduled phone or face-to-face visits. While the use of the PCED was crucial, data did not account for statins listed in the non-VA medication list. All 31 patients with statins prescribed outside the VA had a start date added to provide the most accurate representation of the data moving forward.
Another limitation in this project was its small sample size and population. CVVAMC serves about 6200 female veterans, with roughly 63% identifying as Black. The preponderance of Black individuals (83%) in this project is typical for the female patient population at CVVAMC but may not reflect the demographics of other populations. Other limitations to this project consisted of scheduling conflicts. Appointments for laboratory draws at community-based outpatient clinics were subject to availability, which resulted in some delay in completion of pharmacogenomic testing.
Conclusions
CPPs can help reduce inequity in health care delivery. Increased incorporation of the PCED into regular practice within the VA is recommended to continue addressing sex disparities in statin use, diabetes control, blood pressure management, cancer screenings, and vaccination needs. CVVAMC plans to expand its use through another quality improvement project focused on reducing sex disparities in blood pressure management. Improving educational resources made available to veterans on the importance of statin therapy and potential to mitigate AEs through use of the VA PHASER program also would be helpful. This project successfully improved CVVAMC metrics for female veterans appropriately prescribed statin therapy and increased access to pharmacogenomic testing. Most importantly, it helped close the sex-based gap in CVD risk reduction care.
Cardiovascular disease (CVD) is the leading cause of death among women in the United States.1 Most CVD is due to the buildup of plaque (ie, cholesterol, proteins, calcium, and inflammatory cells) in artery walls.2 The plaque may lead to atherosclerotic cardiovascular disease (ASCVD), which includes coronary heart disease, cerebrovascular disease, peripheral artery disease, and aortic atherosclerotic disease.2,3 Control and reduction of ASCVD risk factors, including high cholesterol levels, elevated blood pressure, insulin resistance, smoking, and a sedentary lifestyle, can contribute to a reduction in ASCVD morbidity and mortality.2 People with type 2 diabetes mellitus (T2DM) have an increased prevalence of lipid abnormalities, contributing to their high risk of ASCVD.4,5
The prescribing of statins (3-hydroxy-3-methyl-glutaryl-coenzmye A reductase inhibitors) is the cornerstone of lipid-lowering therapy and cardiovascular risk reduction for primary and secondary prevention of ASCVD.6 The American Diabetes Association (ADA) and American College of Cardiology/American Heart Association (ACC/AHA) recommend moderate- to high-intensity statins for primary prevention in patients with T2DM and high-intensity statins for secondary prevention in those with or without diabetes when not contraindicated.4,5,7 Despite eligibility according to guideline recommendations, research predominantly shows that women are less likely to receive statin therapy; however, this trend is improving. [6,8-11] To explain the sex differences in statin use, Nanna et al found that there is a combination of women being offered statin therapy less frequently, declining therapy more frequently, and discontinuing treatment more frequently.11 One possibility for discontinuing treatment could be statin-associated muscle symptoms (SAMS), which occur in about 10% of patients.12 The incidence of adverse effects (AEs) may be related to the way statins are metabolized.
Pharmacogenomic testing is free for veterans through the US Department of Veterans Affairs (VA) PHASER program, which offers information and recommendations for a panel of 11 gene variants. The panel includes genes related to common medication classes such as anticoagulants, antiplatelets, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, opioids, antidepressants, and statins. The VA PHASER panel includes the solute carrier organic anion transporter family member 1B1 (SLCO1B1) gene, which is predominantly expressed in the liver and facilitates the hepatic uptake of most statins.13,14 A reduced function of SLCO1B1 can lead to higher statin levels, resulting in increased concentrations that may potentially cause SAMS.13,14 Some alleles associated with reduced function include SLCO1B1*5, *15, *23, *31, and *46 to *49, whereas others are associated with increased function, such as SLCO1B1 *14 and *20 (Appendix).15 Supporting evidence shows the SLCO1B1*5 nucleotide polymorphism increases plasma levels of simvastatin and atorvastatin, affecting effectiveness or toxicity. 13 Females tend to have a lower body weight and higher percentage of body fat compared with males, which might lead to higher concentrations of lipophilic drugs, including atorvastatin and simvastatin, which may be exacerbated by decreased function of SLCO1B1*5.15 With pharmacogenomic testing, therapeutic recommendations can be made to improve the overall safety and efficacy of statins, thus improving adherence using a patient-specific approach.14,15
Methods
Carl Vinson VA Medical Center (CVVAMC) serves about 42,000 veterans in Central and South Georgia, of which about 15% are female. Of the female veterans enrolled in care, 63% identify as Black, 27% White, and 1.5% as Asian, American Indian/Alaska Native, or Native Hawaiian/Other Pacific Islander. The 2020 Veterans Chartbook report showed that female veterans and minority racial and ethnic groups had worse access to health care and higher mortality rates than their male and non-Hispanic White counterparts.16
The Primary Care Equity Dashboard (PCED) was developed to engage the VA health care workforce in the process of identifying and addressing inequities in local patient populations.17 Using electronic quality measure data, the PCED provides Veterans Integrated Service Network-level and facility-level performance on several metrics.18 The PCED had not been previously used at the CVVAMC, and few publications or quality improvement projects regarding its use have been reported by the VA Office of Health Equity. PCED helped identify disparities when comparing female to male patients in the prescribing of statin therapy for patients with CVD and statin therapy for patients with T2DM.
VA PHASER pharmacogenomic analyses provided an opportunity to expand this quality improvement project. Sanford Health and the VA collaborated on the PHASER program to offer free genetic testing for veterans. The program launched in 2019 and expanded to various VA sites, including CVVAMC in March 2023. This program has been extended to December 31, 2025.
The primary objective of this quality improvement project was to increase statin prescribing among female veterans with T2DM and/or CVD to reduce cardiovascular risk. Secondary outcomes included increased pharmacogenomic testing and the assessment of pharmacogenomic results related to statin therapy. This project was approved by the CVVAMC Pharmacy and Therapeutics Committee. The PCED was used to identify female veterans with T2DM and/or CVD without an active prescription for a statin between July and October 2023. A review of Computerized Patient Record System patient charts was completed to screen for prespecified inclusion and exclusion criteria. Veterans were included if they were assigned female at birth, were enrolled in care at CVVAMC, and had a diagnosis of T2DM or CVD (history of myocardial infarction, coronary bypass graft, percutaneous coronary intervention, or other revascularization in any setting).
Veterans were excluded if they were currently pregnant, trying to conceive, breastfeeding, had a T1DM diagnosis, had previously documented hypersensitivity to a statin, active liver failure or decompensated cirrhosis, previously documented statin-associated rhabdomyolysis or autoimmune myopathy, an active prescription for a proprotein convertase subtilisin/kexin type 9 inhibitor, or previously documented statin intolerance (defined as the inability to tolerate ≥ 3 statins, with ≥ 1 prescribed at low intensity or alternate-day dosing). The female veterans were compared to 2 comparators: the facility's male veterans and the VA national average, identified via the PCED.
Once a veteran was screened, they were telephoned between October 2023 and February 2024 and provided education on statin use and pharmacogenomic testing using a standardized note template. An order was placed for participants who provided verbal consent for pharmacogenomic testing. Those who agreed to statin initiation were referred to a clinical pharmacist practitioner (CPP) who contacted them at a later date to prescribe a statin following the recommendations of the 2019 ACC/AHA and 2023 ADA guidelines and pharmacogenomic testing, if applicable.4,5,7 Appropriate monitoring and follow-up occurred at the discretion of each CPP. Data collection included: age, race, diagnoses (T2DM, CVD, or both), baseline lipid panel (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), hepatic function, name and dose of statin, reasons for declining statin therapy, and pharmacogenomic testing results related to SLCO1B1.
Results
At baseline in July 2023, 77.8% of female veterans with T2DM were prescribed a statin, which exceeded the national VA average (77.0%), but was below the rate for male veterans (78.7%) in the facility comparator group.17 Additionally, 82.2% of females with CVD were prescribed a statin, which was below the national VA average of 86.0% and the 84.9% of male veterans in the facility comparator group.17 The PCED identified 189 female veterans from July 2023 to October 2023 who may benefit from statin therapy. Thirty-three females met the exclusion criteria. Of the 156 included veterans, 129 (82.7%) were successfully contacted and 27 (17.3%) could not be reached by telephone after 3 attempts (Figure 1). The 129 female veterans contacted had a mean age of 59 years and the majority were Black (82.9%) (Table 1).
Abbreviations: CVD, cardiovascular disease; PCSK9, proprotein convertase subtilisin/
kexin type 9; T2DM, type 2 diabetes mellitus; VAMC, Veterans Affairs medical center.
Primary Outcomes
Of the 129 contacted veterans, 31 (24.0%) had a non-VA statin prescription, 13 (10.1%) had an active VA statin prescription, and 85 (65.9%) did not have a statin prescription, despite being eligible. Statin adherence was confirmed with participants, and the medication list was updated accordingly.
Of the 85 veterans with no active statin therapy, 37 (43.5%) accepted a new statin prescription and 48 (56.5%) declined. There were various reasons provided for declining statin therapy: 17 participants (35.4%) declined due to concern for AEs (Table 2).
From July 2023 to March 2024, the percentage of female veterans with active statin therapy with T2DM increased from 77.8% to 79.0%. For those with active statin therapy with CVD, usage increased from 82.2% to 90.2%, which exceeded the national VA average and facility male comparator group (Figures 2 and 3).17
Secondary Outcomes
Seventy-one of 129 veterans (55.0%) gave verbal consent, and 47 (66.2%) completed the pharmacogenomic testing; 58 (45.0%) declined. Five veterans (10.6%) had a known SLCO1B1 allele variant present. One veteran required a change in statin therapy based on the results (eAppendix).
Discussion
This project aimed to increase statin prescribing among female veterans with T2DM and/or CVD to reduce cardiovascular risk and increase pharmacogenomic testing using the PCED and care managed by CPPs. The results of this quality improvement project illustrated that both metrics have improved at CVVAMC as a result of the intervention. The results in both metrics now exceed the PCED national VA average, and the CVD metric also exceeds that of the facility male comparator group. While there was only a 1.2% increase from July 2023 to March 2024 for patients with T2DM, there was an 8.0% increase for patients with CVD. Despite standardized education on statin use, more veterans declined therapy than accepted it, mostly due to concern for AEs. Recording the reasons for declining statin therapy offered valuable insight that can be used in additional discussions with veterans and clinicians.
Pharmacogenomics gives clinicians the unique opportunity to take a proactive approach to better predict drug responses, potentially allowing for less trial and error with medications, fewer AEs, greater trust in the clinician, and improved medication adherence. The CPPs incorporated pharmacogenomic testing into their practice, which led to identifying 5 SLCO1B1 gene abnormalities. The PCED served as a powerful tool for advancing equity-focused quality improvement initiatives on a local level and was crucial in prioritizing the detection of veterans potentially receiving suboptimal care.
Limitations
The nature of “cold calls” made it challenging to establish contact for inclusion in this study. An alternative to increase engagement could have been scheduled phone or face-to-face visits. While the use of the PCED was crucial, data did not account for statins listed in the non-VA medication list. All 31 patients with statins prescribed outside the VA had a start date added to provide the most accurate representation of the data moving forward.
Another limitation in this project was its small sample size and population. CVVAMC serves about 6200 female veterans, with roughly 63% identifying as Black. The preponderance of Black individuals (83%) in this project is typical for the female patient population at CVVAMC but may not reflect the demographics of other populations. Other limitations to this project consisted of scheduling conflicts. Appointments for laboratory draws at community-based outpatient clinics were subject to availability, which resulted in some delay in completion of pharmacogenomic testing.
Conclusions
CPPs can help reduce inequity in health care delivery. Increased incorporation of the PCED into regular practice within the VA is recommended to continue addressing sex disparities in statin use, diabetes control, blood pressure management, cancer screenings, and vaccination needs. CVVAMC plans to expand its use through another quality improvement project focused on reducing sex disparities in blood pressure management. Improving educational resources made available to veterans on the importance of statin therapy and potential to mitigate AEs through use of the VA PHASER program also would be helpful. This project successfully improved CVVAMC metrics for female veterans appropriately prescribed statin therapy and increased access to pharmacogenomic testing. Most importantly, it helped close the sex-based gap in CVD risk reduction care.
- Heron M. Deaths: leading causes for 2018. Nat Vital Stat Rep. 2021;70:1-114.
- US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guideline for the management of dyslipidemia for cardiovascular risk reduction. Published June 2020. Accessed August 25, 2025. https://www.healthquality.va.gov/guidelines/CD/lipids/VADODDyslipidemiaCPG5087212020.pdf
- Atherosclerotic Cardiovascular Disease (ASCVD). American Heart Association. Accessed August 26, 2025. https:// www.heart.org/en/professional/quality-improvement/ascvd
- American Diabetes Association Professional Practice Committee. 10. Cardiovascular disease and risk management: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S144-S174. doi:10.2337/dc22-S010
- American Diabetes Association. Standards of Care in Diabetes— 2023 abridged for primary care providers. Clinical Diabetes. 2022;41(1):4-31. doi:10.2337/cd23-as01
- Virani SS, Woodard LD, Ramsey DJ, et al. Gender disparities in evidence-based statin therapy in patients with cardiovascular disease. Am J Cardiol. 2015;115:21-26. doi:10.1016/j.amjcard.2014.09.041
- Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/ AHA Guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678
- Buchanan CH, Brown EA, Bishu KG, et al. The magnitude and potential causes of gender disparities in statin therapy in veterans with type 2 diabetes: a 10-year nationwide longitudinal cohort study. Womens Health Issues. 2022;32:274-283. doi:10.1016/j.whi.2021.10.003
- Ahmed F, Lin J, Ahmed T, et al. Health disparities: statin prescribing patterns among patients with diabetes in a family medicine clinic. Health Equity. 2022;6:291-297. doi:10.1089/heq.2021.0144
- Metser G, Bradley C, Moise N, Liyanage-Don N, Kronish I, Ye S. Gaps and disparities in primary prevention statin prescription during outpatient care. Am J Cardiol. 2021;161:36-41. doi:10.1016/j.amjcard.2021.08.070
- Nanna MG, Wang TY, Xiang Q, et al. Sex differences in the use of statins in community practice. Circ Cardiovasc Qual Outcomes. 2019;12(8):e005562. doi:10.1161/CIRCOUTCOMES.118.005562
- Kitzmiller JP, Mikulik EB, Dauki AM, Murkherjee C, Luzum JA. Pharmacogenomics of statins: understanding susceptibility to adverse effects. Pharmgenomics Pers Med. 2016;9:97-106. doi:10.2147/PGPM.S86013
- Türkmen D, Masoli JAH, Kuo CL, Bowden J, Melzer D, Pilling LC. Statin treatment effectiveness and the SLCO1B1*5 reduced function genotype: long-term outcomes in women and men. Br J Clin Pharmacol. 2022;88:3230-3240. doi:10.1111/bcp.15245
- Cooper-DeHoff RM, Niemi M, Ramsey LB, et al. The Clinical Pharmacogenetics Implementation Consortium guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and statin-associated musculoskeletal symptoms. Clin Pharmacol Ther. 2022;111:1007-1021. doi:10.1002/cpt.2557
- Ramsey LB, Gong L, Lee SB, et al. PharmVar GeneFocus: SLCO1B1. Clin Pharmacol Ther. 2023;113:782-793. doi:10.1002/cpt.2705
- National Healthcare Quality and Disparities Report: Chartbook on Healthcare for Veterans. Rockville (MD): Agency for Healthcare Research and Quality (US); November 2020.
- Procario G. Primary Care Equity Dashboard [database online]. Power Bi. 2023. Accessed August 26, 2025. https://app.powerbigov.us
- Hausmann LRM, Lamorte C, Estock JL. Understanding the context for incorporating equity into quality improvement throughout a national health care system. Health Equity. 2023;7(1):312-320. doi:10.1089/heq.2023.0009
- Heron M. Deaths: leading causes for 2018. Nat Vital Stat Rep. 2021;70:1-114.
- US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical practice guideline for the management of dyslipidemia for cardiovascular risk reduction. Published June 2020. Accessed August 25, 2025. https://www.healthquality.va.gov/guidelines/CD/lipids/VADODDyslipidemiaCPG5087212020.pdf
- Atherosclerotic Cardiovascular Disease (ASCVD). American Heart Association. Accessed August 26, 2025. https:// www.heart.org/en/professional/quality-improvement/ascvd
- American Diabetes Association Professional Practice Committee. 10. Cardiovascular disease and risk management: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S144-S174. doi:10.2337/dc22-S010
- American Diabetes Association. Standards of Care in Diabetes— 2023 abridged for primary care providers. Clinical Diabetes. 2022;41(1):4-31. doi:10.2337/cd23-as01
- Virani SS, Woodard LD, Ramsey DJ, et al. Gender disparities in evidence-based statin therapy in patients with cardiovascular disease. Am J Cardiol. 2015;115:21-26. doi:10.1016/j.amjcard.2014.09.041
- Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/ AHA Guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678
- Buchanan CH, Brown EA, Bishu KG, et al. The magnitude and potential causes of gender disparities in statin therapy in veterans with type 2 diabetes: a 10-year nationwide longitudinal cohort study. Womens Health Issues. 2022;32:274-283. doi:10.1016/j.whi.2021.10.003
- Ahmed F, Lin J, Ahmed T, et al. Health disparities: statin prescribing patterns among patients with diabetes in a family medicine clinic. Health Equity. 2022;6:291-297. doi:10.1089/heq.2021.0144
- Metser G, Bradley C, Moise N, Liyanage-Don N, Kronish I, Ye S. Gaps and disparities in primary prevention statin prescription during outpatient care. Am J Cardiol. 2021;161:36-41. doi:10.1016/j.amjcard.2021.08.070
- Nanna MG, Wang TY, Xiang Q, et al. Sex differences in the use of statins in community practice. Circ Cardiovasc Qual Outcomes. 2019;12(8):e005562. doi:10.1161/CIRCOUTCOMES.118.005562
- Kitzmiller JP, Mikulik EB, Dauki AM, Murkherjee C, Luzum JA. Pharmacogenomics of statins: understanding susceptibility to adverse effects. Pharmgenomics Pers Med. 2016;9:97-106. doi:10.2147/PGPM.S86013
- Türkmen D, Masoli JAH, Kuo CL, Bowden J, Melzer D, Pilling LC. Statin treatment effectiveness and the SLCO1B1*5 reduced function genotype: long-term outcomes in women and men. Br J Clin Pharmacol. 2022;88:3230-3240. doi:10.1111/bcp.15245
- Cooper-DeHoff RM, Niemi M, Ramsey LB, et al. The Clinical Pharmacogenetics Implementation Consortium guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and statin-associated musculoskeletal symptoms. Clin Pharmacol Ther. 2022;111:1007-1021. doi:10.1002/cpt.2557
- Ramsey LB, Gong L, Lee SB, et al. PharmVar GeneFocus: SLCO1B1. Clin Pharmacol Ther. 2023;113:782-793. doi:10.1002/cpt.2705
- National Healthcare Quality and Disparities Report: Chartbook on Healthcare for Veterans. Rockville (MD): Agency for Healthcare Research and Quality (US); November 2020.
- Procario G. Primary Care Equity Dashboard [database online]. Power Bi. 2023. Accessed August 26, 2025. https://app.powerbigov.us
- Hausmann LRM, Lamorte C, Estock JL. Understanding the context for incorporating equity into quality improvement throughout a national health care system. Health Equity. 2023;7(1):312-320. doi:10.1089/heq.2023.0009
Reducing Sex Disparities in Statin Therapy Among Female Veterans With Type 2 Diabetes and/or Cardiovascular Disease
Reducing Sex Disparities in Statin Therapy Among Female Veterans With Type 2 Diabetes and/or Cardiovascular Disease
Implementation of a Pharmacist-Led Culture and Susceptibility Review System in Urgent Care and Outpatient Settings
Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.1 In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.2 By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.3 Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.
Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.4 Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.3 Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.5 A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.6 Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.
Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.
Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.
The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.
Quality Improvement Project
This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.7 This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1
Program Inclusion
Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.
Implementation
Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.
Observations
Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.
Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.
Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P
Discussion
This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.
Limitations
The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.
The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.
Future Directions
Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.
On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.
Conclusions
This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.
This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.
Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.
1. Centers for Disease Control and Prevention. Antibiotic use in outpatient settings, 2017: progress and opportunities. Accessed August 19, 2021. https://www.cdc.gov/antibiotic-use/stewardship-report/outpatient.html
2. Centers for Disease Control and Prevention. Antibiotic/antimicrobial resistance. Accessed August 19, 2021. https://www.cdc.gov/drugresistance/index.html
3. Jonas OB, Irwin A, Berthe FCJ, Le Gall FG, Marquez PV. Drug-resistant infections: a threat to our economic future. March 2017. Accessed August 19, 2021. https://documents.worldbank.org/en/publication/documents-reports/documentdetail/323311493396993758/final-report
4. Davis LC, Covey RB, Weston JS, Hu BBY, Laine GA. Pharmacist-driven antimicrobial optimization in the emergency department. Am J Health Syst Pharm. 2016;73(5)(suppl 1):S49-S56. doi:10.2146/sp150036
5. Baker SN, Acquisto NM, Ashley ED, Fairbanks RJ, Beamish SE, Haas CE. Pharmacist-managed antimicrobial stewardship program for patients discharged from the emergency department. J Pharm Pract. 2012;25(2):190-194. doi:10.1177/0897190011420160
6 Randolph TC, Parker A, Meyer L, Zeina R. Effect of a pharmacist-managed culture review process on antimicrobial therapy in an emergency department. Am J Health Syst Pharm. 2011;68(10):916-919. doi:10.2146/ajhp090552
7. Infectious Diseases Society of America. Infectious diseases society of America guidelines 2019. Accessed August 24, 2021. https://www.idsociety.org/practice-guideline/practice-guidelines/#/+/0/date_na_dt/desc
Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.1 In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.2 By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.3 Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.
Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.4 Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.3 Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.5 A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.6 Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.
Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.
Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.
The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.
Quality Improvement Project
This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.7 This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1
Program Inclusion
Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.
Implementation
Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.
Observations
Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.
Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.
Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P
Discussion
This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.
Limitations
The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.
The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.
Future Directions
Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.
On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.
Conclusions
This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.
This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.
Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.
Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.1 In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.2 By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.3 Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.
Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.4 Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.3 Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.5 A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.6 Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.
Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.
Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.
The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.
Quality Improvement Project
This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.7 This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1
Program Inclusion
Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.
Implementation
Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.
Observations
Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.
Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.
Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P
Discussion
This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.
Limitations
The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.
The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.
Future Directions
Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.
On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.
Conclusions
This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.
This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.
Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.
1. Centers for Disease Control and Prevention. Antibiotic use in outpatient settings, 2017: progress and opportunities. Accessed August 19, 2021. https://www.cdc.gov/antibiotic-use/stewardship-report/outpatient.html
2. Centers for Disease Control and Prevention. Antibiotic/antimicrobial resistance. Accessed August 19, 2021. https://www.cdc.gov/drugresistance/index.html
3. Jonas OB, Irwin A, Berthe FCJ, Le Gall FG, Marquez PV. Drug-resistant infections: a threat to our economic future. March 2017. Accessed August 19, 2021. https://documents.worldbank.org/en/publication/documents-reports/documentdetail/323311493396993758/final-report
4. Davis LC, Covey RB, Weston JS, Hu BBY, Laine GA. Pharmacist-driven antimicrobial optimization in the emergency department. Am J Health Syst Pharm. 2016;73(5)(suppl 1):S49-S56. doi:10.2146/sp150036
5. Baker SN, Acquisto NM, Ashley ED, Fairbanks RJ, Beamish SE, Haas CE. Pharmacist-managed antimicrobial stewardship program for patients discharged from the emergency department. J Pharm Pract. 2012;25(2):190-194. doi:10.1177/0897190011420160
6 Randolph TC, Parker A, Meyer L, Zeina R. Effect of a pharmacist-managed culture review process on antimicrobial therapy in an emergency department. Am J Health Syst Pharm. 2011;68(10):916-919. doi:10.2146/ajhp090552
7. Infectious Diseases Society of America. Infectious diseases society of America guidelines 2019. Accessed August 24, 2021. https://www.idsociety.org/practice-guideline/practice-guidelines/#/+/0/date_na_dt/desc
1. Centers for Disease Control and Prevention. Antibiotic use in outpatient settings, 2017: progress and opportunities. Accessed August 19, 2021. https://www.cdc.gov/antibiotic-use/stewardship-report/outpatient.html
2. Centers for Disease Control and Prevention. Antibiotic/antimicrobial resistance. Accessed August 19, 2021. https://www.cdc.gov/drugresistance/index.html
3. Jonas OB, Irwin A, Berthe FCJ, Le Gall FG, Marquez PV. Drug-resistant infections: a threat to our economic future. March 2017. Accessed August 19, 2021. https://documents.worldbank.org/en/publication/documents-reports/documentdetail/323311493396993758/final-report
4. Davis LC, Covey RB, Weston JS, Hu BBY, Laine GA. Pharmacist-driven antimicrobial optimization in the emergency department. Am J Health Syst Pharm. 2016;73(5)(suppl 1):S49-S56. doi:10.2146/sp150036
5. Baker SN, Acquisto NM, Ashley ED, Fairbanks RJ, Beamish SE, Haas CE. Pharmacist-managed antimicrobial stewardship program for patients discharged from the emergency department. J Pharm Pract. 2012;25(2):190-194. doi:10.1177/0897190011420160
6 Randolph TC, Parker A, Meyer L, Zeina R. Effect of a pharmacist-managed culture review process on antimicrobial therapy in an emergency department. Am J Health Syst Pharm. 2011;68(10):916-919. doi:10.2146/ajhp090552
7. Infectious Diseases Society of America. Infectious diseases society of America guidelines 2019. Accessed August 24, 2021. https://www.idsociety.org/practice-guideline/practice-guidelines/#/+/0/date_na_dt/desc