Clinical Topics & News

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.