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A Clinical Pharmacist Patient-Safety Initiative to Reduce Against-Label Prescribing of Statins with Cyclosporine
436
Journal of Clinical Lipidology, Vol 9, No 3, June 2015
Study Funding: This study was supported by an inde-
Background/Synopsis: The risk of myopathy is
pendent educational grant from AstraZeneca. Background/Synopsis: Evidence-based guidelines were published in 2013 by the American College of Cardiology and American Heart Association (ACC/AHA) for treatment of dyslipidemia. The new guidelines have shifted from a ‘‘treat to target lipid goals’’ paradigm to focusing on reducing atherosclerotic cardiovascular disease (ASCVD) risk using an appropriate intensity of statin therapy. Physicians need expert guidance on incorporation of these guidelines into practice. Objective/Purpose: To determine if online educational interventions improve the evidence-based clinical decision making of primary care physicians (PCPs) and cardiologists in the U.S. related to the clinical application of new lipid management guidelines. Methods: An interactive, case-based, online CME activity was developed. The educational effects were assessed using a case-based linked pre-assessment/post-assessment study design that separated learners into three categories: improved (incorrect pre, correct post), reinforced (correct pre and post), and unaffected (incorrect pre and post). For all questions combined, the McNemar’s chi-squared test was used to assess whether the mean post-assessment score differed from the mean pre-assessment score. P values are shown as a measure of significance; P values ,.05 are statistically significant. Cramer’s V was used to calculate the effect size. Results: Improved clinical-decision making was seen among cardiologists (n 5 159; P ,.05; large effect size of 2.057) and PCPs (n 5 545; P ,.05; large effect size of 1.932). Correct responses on post-assessment questions were up to 309% and 288% higher after CME completion for cardiologists and PCPs, respectively. Learning concepts included understanding lipid management per the new guidelines, the percent reduction in LDL-C associated with high-intensity statin therapy, the frequency of 10year ASCVD risk score reassessment for primary prevention, and understanding lifestyle modifications to reduce LDL-C levels. Conclusions: This study demonstrates the success of a targeted, case-based, educational intervention on improving the clinical-decision making of US PCPs and cardiologists on the clinical application of updated lipid guidelines.
increased when HMG-CoA reductase inhibitors (statins) are combined with drugs that interfere with statin metabolism which can result in increased systemic exposure. Cyclosporine is of particular concern due to its ability to inhibit multiple metabolic pathways of statins. Over the past several years there have been changes to the prescribing label information for statins involving new contraindications and dose limitations with co-administration of interacting drugs, such as cyclosporine. Clinical practice guidelines also suggest exercising caution when prescribing statins to patients on agents that can interfere with statin metabolism. Despite these updates, previous publications have shown that persistent against-label prescribing of statins is common. Objective/Purpose: Evaluate the impact of a clinical pharmacist led patient-safety initiative to limit against-label prescribing of statins with cyclosporine Methods: Kaiser Permanente Colorado patients receiving both cyclosporine and against-label statin were identified in November 2013 through prescription claims data as part of a patient-safety initiative. An educational seminar was given to clinical pharmacists. Patient level data was provided for clinical pharmacists to review and convert to on-label statin as clinically appropriate in collaboration with physicians. Conversion rates to on-label statin (i.e. pravastatin #20 mg/day, rosuvastatin #5 mg/day,
133 A Clinical Pharmacist Patient-Safety Initiative to Reduce Against-Label Prescribing of Statins with Cyclosporine Donald G. Lamprecht, PharmD, Anne M. Denham, PharmD, Leslie K. Ruppe, PharmD, Sheila L. Stadler, PharmD, Brittany A. Todd, PharmD, (Aurora, CO)
Lead Author’s Financial Disclosures: None Study Funding: None
Abstracts
437 Craig Plauschinat, PharmD, MPH, Thomas Power, MD, (Wilmington, DE)
Lead Author’s Financial Disclosures: Dr. Huang is an employee of HealthCore Inc., under contract with Regeneron Pharmaceuticals Inc. Study Funding: This study was funded by Regeneron Pharmaceuticals Inc.
Background/Synopsis: The 2013 ACC/AHA guidelines on the treatment of blood cholesterol recommend high-intensity statins in adult patients between 21 and 75 years of age with ASCVD to reduce the risk of cardiovascular events. Little is known about the characteristics of these patients in a real-world setting.
Objective/Purpose: To compare the demographic and clinical characteristics among patients with clinical ASCVD (identified as the first of four Statin Benefit Groups in the guidelines) who newly initiated high-intensity, lower-intensity, or no statins in a real-world commercially insured population.
Methods: This observational, retrospective cohort study fluvastatin #40 mg/day) along with changes in LDL-C were assessed. Results: A total of 157 patients taking cyclosporine were identified, 48 of whom were also receiving statin therapy. Of these 48 patients, 33 (69%) were on an against-label statin regimen. The majority of patients (76%) were converted to on-label statin. Seventeen patients were switched to pravastatin 20 mg and eight patients to rosuvastatin 5 mg. In patients converted to pravastatin 20 mg, the mean LDL-C prior to conversion was 82.6 (629) mg/dL and after conversion was 96.1 (632.5) mg/dL (pvalue 5 0.066). In patients converted to rosuvastatin 5 mg, the mean LDL-C prior to conversion was 83.6 (622.3) mg/ dL and after conversion was 79.8 (627) mg/dL (p-value 5 0.73). In patients converted to on-label statin, mean LDL-C prior to conversion was 82.9 (626.4) mg/dL and mean LDL-C after conversion was 90.7 (631.2) mg/dL (p-value 5 0.21). Conclusions: Clinical pharmacists are well positioned to identify and address against-label prescribing. With a patient-safety centered approach, clinical pharmacists were able to substantially reduce the number of patients on against-label statin with cyclosporine.
134 Clinical Characteristics and Unmet Need Among RealWorld Atherosclerotic Cardiovascular Disease (ASCVD) Patients Stratified by Statin Use Qing Huang, PhD, MHS, Michael Grabner, PhD, Robert Sanchez, PhD, MS, Vincent Willey, PharmD, Mark Cziraky, PharmD, Swetha Palli, MS,
utilized medical, pharmacy and laboratory data from the HealthCore Integrated Research Database (HIRD) between Jan. 1, 2006 and and June 30, 2014. We identified patients who had at least 12-month pre- and three-month post-index continuous health plan enrollment. Patients must have had an ASCVD condition (acute coronary syndrome [ACS], coronary heart disease, ischemic stroke or peripheral arterial disease) to be included. Index dates were defined as the first statin fill date for high- and lower-intensity statin cohorts, and as the earliest eligibility date for clinical ASCVD for the non-statin cohort. Demographic and clinical characteristics of ASCVD patients were assessed on index date/baseline.
Results: We identified a total of 284,550 patients with 108,763 (38%) statin initiators and 175,787 (62%) nonstatin users with clinical ASCVD. Overall, only 9% of patients initiated high-intensity statins (atorvastatin 40/80mg, rosuvastatin 20/40mg, simvastatin 80mg). Among patients with available LDL-C results (16%), 90% had an LDL-C level above 70 mg/dL at baseline. Several differences in demographic and clinical characteristics were observed when comparing high-intensity initiators with lower-intensity or non-statin users (Table), including percentages of female (27% vs. 40% vs. 49%) and age 55+ patients (60% vs. 63% vs. 50%). A larger proportion of high-intensity initiators were initially under cardiologist care (47% vs. 32% vs. 14%). ASCVD characteristics varied significantly across the cohorts, with more ACS patients among high-intensity initiators (54% vs. 29% vs. 23%) and more ischemic stroke patients among non-statin users (11% vs. 20% vs. 28%). Comorbidities such as congestive heart failure, diabetes, dyslipidemia, and hypertension were more prevalent among statin initiators, compared to the nonstatin users.
Journal of Clinical Lipidology, Vol 9, No 3, June 2015
Study Funding: This study was supported by an inde-
Background/Synopsis: The risk of myopathy is
pendent educational grant from AstraZeneca. Background/Synopsis: Evidence-based guidelines were published in 2013 by the American College of Cardiology and American Heart Association (ACC/AHA) for treatment of dyslipidemia. The new guidelines have shifted from a ‘‘treat to target lipid goals’’ paradigm to focusing on reducing atherosclerotic cardiovascular disease (ASCVD) risk using an appropriate intensity of statin therapy. Physicians need expert guidance on incorporation of these guidelines into practice. Objective/Purpose: To determine if online educational interventions improve the evidence-based clinical decision making of primary care physicians (PCPs) and cardiologists in the U.S. related to the clinical application of new lipid management guidelines. Methods: An interactive, case-based, online CME activity was developed. The educational effects were assessed using a case-based linked pre-assessment/post-assessment study design that separated learners into three categories: improved (incorrect pre, correct post), reinforced (correct pre and post), and unaffected (incorrect pre and post). For all questions combined, the McNemar’s chi-squared test was used to assess whether the mean post-assessment score differed from the mean pre-assessment score. P values are shown as a measure of significance; P values ,.05 are statistically significant. Cramer’s V was used to calculate the effect size. Results: Improved clinical-decision making was seen among cardiologists (n 5 159; P ,.05; large effect size of 2.057) and PCPs (n 5 545; P ,.05; large effect size of 1.932). Correct responses on post-assessment questions were up to 309% and 288% higher after CME completion for cardiologists and PCPs, respectively. Learning concepts included understanding lipid management per the new guidelines, the percent reduction in LDL-C associated with high-intensity statin therapy, the frequency of 10year ASCVD risk score reassessment for primary prevention, and understanding lifestyle modifications to reduce LDL-C levels. Conclusions: This study demonstrates the success of a targeted, case-based, educational intervention on improving the clinical-decision making of US PCPs and cardiologists on the clinical application of updated lipid guidelines.
increased when HMG-CoA reductase inhibitors (statins) are combined with drugs that interfere with statin metabolism which can result in increased systemic exposure. Cyclosporine is of particular concern due to its ability to inhibit multiple metabolic pathways of statins. Over the past several years there have been changes to the prescribing label information for statins involving new contraindications and dose limitations with co-administration of interacting drugs, such as cyclosporine. Clinical practice guidelines also suggest exercising caution when prescribing statins to patients on agents that can interfere with statin metabolism. Despite these updates, previous publications have shown that persistent against-label prescribing of statins is common. Objective/Purpose: Evaluate the impact of a clinical pharmacist led patient-safety initiative to limit against-label prescribing of statins with cyclosporine Methods: Kaiser Permanente Colorado patients receiving both cyclosporine and against-label statin were identified in November 2013 through prescription claims data as part of a patient-safety initiative. An educational seminar was given to clinical pharmacists. Patient level data was provided for clinical pharmacists to review and convert to on-label statin as clinically appropriate in collaboration with physicians. Conversion rates to on-label statin (i.e. pravastatin #20 mg/day, rosuvastatin #5 mg/day,
133 A Clinical Pharmacist Patient-Safety Initiative to Reduce Against-Label Prescribing of Statins with Cyclosporine Donald G. Lamprecht, PharmD, Anne M. Denham, PharmD, Leslie K. Ruppe, PharmD, Sheila L. Stadler, PharmD, Brittany A. Todd, PharmD, (Aurora, CO)
Lead Author’s Financial Disclosures: None Study Funding: None
Abstracts
437 Craig Plauschinat, PharmD, MPH, Thomas Power, MD, (Wilmington, DE)
Lead Author’s Financial Disclosures: Dr. Huang is an employee of HealthCore Inc., under contract with Regeneron Pharmaceuticals Inc. Study Funding: This study was funded by Regeneron Pharmaceuticals Inc.
Background/Synopsis: The 2013 ACC/AHA guidelines on the treatment of blood cholesterol recommend high-intensity statins in adult patients between 21 and 75 years of age with ASCVD to reduce the risk of cardiovascular events. Little is known about the characteristics of these patients in a real-world setting.
Objective/Purpose: To compare the demographic and clinical characteristics among patients with clinical ASCVD (identified as the first of four Statin Benefit Groups in the guidelines) who newly initiated high-intensity, lower-intensity, or no statins in a real-world commercially insured population.
Methods: This observational, retrospective cohort study fluvastatin #40 mg/day) along with changes in LDL-C were assessed. Results: A total of 157 patients taking cyclosporine were identified, 48 of whom were also receiving statin therapy. Of these 48 patients, 33 (69%) were on an against-label statin regimen. The majority of patients (76%) were converted to on-label statin. Seventeen patients were switched to pravastatin 20 mg and eight patients to rosuvastatin 5 mg. In patients converted to pravastatin 20 mg, the mean LDL-C prior to conversion was 82.6 (629) mg/dL and after conversion was 96.1 (632.5) mg/dL (pvalue 5 0.066). In patients converted to rosuvastatin 5 mg, the mean LDL-C prior to conversion was 83.6 (622.3) mg/ dL and after conversion was 79.8 (627) mg/dL (p-value 5 0.73). In patients converted to on-label statin, mean LDL-C prior to conversion was 82.9 (626.4) mg/dL and mean LDL-C after conversion was 90.7 (631.2) mg/dL (p-value 5 0.21). Conclusions: Clinical pharmacists are well positioned to identify and address against-label prescribing. With a patient-safety centered approach, clinical pharmacists were able to substantially reduce the number of patients on against-label statin with cyclosporine.
134 Clinical Characteristics and Unmet Need Among RealWorld Atherosclerotic Cardiovascular Disease (ASCVD) Patients Stratified by Statin Use Qing Huang, PhD, MHS, Michael Grabner, PhD, Robert Sanchez, PhD, MS, Vincent Willey, PharmD, Mark Cziraky, PharmD, Swetha Palli, MS,
utilized medical, pharmacy and laboratory data from the HealthCore Integrated Research Database (HIRD) between Jan. 1, 2006 and and June 30, 2014. We identified patients who had at least 12-month pre- and three-month post-index continuous health plan enrollment. Patients must have had an ASCVD condition (acute coronary syndrome [ACS], coronary heart disease, ischemic stroke or peripheral arterial disease) to be included. Index dates were defined as the first statin fill date for high- and lower-intensity statin cohorts, and as the earliest eligibility date for clinical ASCVD for the non-statin cohort. Demographic and clinical characteristics of ASCVD patients were assessed on index date/baseline.
Results: We identified a total of 284,550 patients with 108,763 (38%) statin initiators and 175,787 (62%) nonstatin users with clinical ASCVD. Overall, only 9% of patients initiated high-intensity statins (atorvastatin 40/80mg, rosuvastatin 20/40mg, simvastatin 80mg). Among patients with available LDL-C results (16%), 90% had an LDL-C level above 70 mg/dL at baseline. Several differences in demographic and clinical characteristics were observed when comparing high-intensity initiators with lower-intensity or non-statin users (Table), including percentages of female (27% vs. 40% vs. 49%) and age 55+ patients (60% vs. 63% vs. 50%). A larger proportion of high-intensity initiators were initially under cardiologist care (47% vs. 32% vs. 14%). ASCVD characteristics varied significantly across the cohorts, with more ACS patients among high-intensity initiators (54% vs. 29% vs. 23%) and more ischemic stroke patients among non-statin users (11% vs. 20% vs. 28%). Comorbidities such as congestive heart failure, diabetes, dyslipidemia, and hypertension were more prevalent among statin initiators, compared to the nonstatin users.