Research

Update and Precision Dosing Survey Opportunity

1. NCAP is interested in the ongoing Comprehensive Medication Management (CMM) project being led by investigators at UNC and funded by ACCP. For the March 2017 quarterly update, go to: https://www.accp. com/report/index.aspx?iss=0317&art=1

2. The UNC Eshelman School of Pharmacy is undertaking a Precision Dosing Initiative. One of the first steps is to determine what, if any, information is available concerning integration of precision dosing software into the electronic medical record and how that is being used by providers. We have prepared a brief survey on this topic. The survey should take no more than 10 minutes to complete. The survey has been reviewed by the UNC Biomedical IRB, and it was determined that the survey did not constitute Human Subjects Research.

Here is the link to the survey:

https://unc.az1.qualtrics.com SE/?SID=SV_9tMm4AphJGglsKp

Prescribing Patterns of Statin Therapy Compared to American Diabetes Association Standards of Care at an Academic Internal Medicine Center

Adam Corey, Jennifer J. Kim

Abstract

Objective: This study aims to describe the adherence to guidelines published by the American Diabetes Association with regard to statin therapy in lipid-lowering treatment. Per 2016 recommendations, all patients with diabetes mellitus between the ages of 40 and 75 should be on statin therapy, if tolerated. This guideline includes patients with atherosclerotic cardiovascular comorbidities and at least one risk factor who are candidates for therapy with a high-intensity statin. Methods: This retrospective, descriptive study analyzed all patients age 40-75 years and diagnosed with diabetes mellitus with a documented clinic encounter between January 1, 2015 through August 15, 2016. Patients were excluded if they did not have a documented primary care physician at the time of data collection. Data collected included current medications, medical conditions, height, weight, LDL, and history of statin use.

Results: Six hundred twenty-nine patients were included in the study. The majority of patients (450, 71.5%) were currently on statin therapy. Of the 179 patients (28.5%) not receiving a statin, only 12 (5.2%) had a non-statin lipid-lowering agent on profile. In addition, 65 patients (36.3%) had no stated history of statin use, 28 patients (15.6%) reported intolerance to statin, and 72 patients (40.2%) lost statin therapy after prior use.

Conclusion: Based on the available data, guidelinedirected treatment is being followed in the setting of medical resident training with multiple opportunities for pharmacist-led interventions to improve statin prescribing for diabetes patients.

Introduction

Heart disease remains the leading cause of death in the United States.1 For atherosclerotic cardiovascular disease (ASCVD) risk reduction, the American Diabetes Association (ADA) standards of care recommends that, with lifestyle changes, diabetes patients between the ages 40 and 75 years should be considered for statin therapy of at least moderate-intensity. High-intensity statin therapy is recommended for those with a history of prior ASCVD events (coronary artery disease, cerebrovascular accident, or peripheral artery disease) or the presence of one of more risk factors including an LDL-cholesterol ≥ 100 mg/dL, hypertension, smoking, body-mass index (BMI) ≥ 25, or family history of premature ASCVD.2 Disease-state guidelines assist clinical practitioners in determining treatment, generally based on available clinical evidence. Adherence to ADA guidelines is expected to improve clinical outcomes for diabetes patients by managing the disease and reducing morbidity and mortality.

The reduction of ASCVD events and mortality favors the use of statin therapy in diabetes patients, improving patient outcomes and reducing costs. Initiation of statins depends on the prescriber to educate the patient and recommend use. The patient’s use of statins depends

on understanding the purpose and potential side effects of the drugs. Patients decline a prescription for a statin because they may not know that diabetes increases the risk of ASCVD or may express concerns regarding the associated myalgia with statin use. Patient nonadherence may also relate to the cost of agents or to statin discontinuation in the transitions of care process.

The importance of statin therapy for diabetes patients provides an opportunity for pharmacists and other providers to identify appropriate interventions to improve care. Electronic medical records (EMRs) can be used to quickly identify patients who would benefit from pharmacotherapy interventions to reduce ASCVD. This study reports on a sample of diabetes patients to identify the rate of current statin therapy and to identify the reasons for statin agents not being prescribed.

Cone Health Internal Medicine Center (IMC) is a hospital-based, patient-centered medical home caring for adult patients regardless of financial status. As part of Cone Health Medical Group, the clinic serves as a teaching site for the Cone Health Internal Medicine Residency located within Moses H. Cone Memorial Hospital in Greensboro, NC. Medical staff includes 12 attending physicians, 22 resident physicians and 1 clinical pharmacist. Of 2,000 total patients, the payer mix consists of approximately 45% Medicare, 17% Medicaid, 19% commercial, and 19% uninsured. About 20% of the population receives charity care. Patients with documented diabetes make up approximately 31% of patients seen in the clinic.

A generalist clinical pharmacist is available Monday through Friday to collaborate with the interdisciplinary team to resolve medication-related problems, optimize treatment and prevention for a variety of disease states, provide patient education, participate in quality improvement initiatives, and serve as educator for Greensboro Area Health Education Center, University of North Carolina Eshelman School of Pharmacy, and Cone Health Internal Medicine Physician and Pharmacy Residency programs.

Methods

This study was an IRB-approved cross-sectional analysis of diabetes patients within the internal medicine clinic. All patients between 40 and 75 years old encountered in clinic between January 1, 2015, through August 15, 2016, with a documented diabetes diagnosis were included in the analysis. Patients without an identified primary care physician at the time of data collection were excluded. Descriptive statistics were used to analyze information collected from patient profiles. Patient information collected included current medical conditions, medications, height, weight, lipid panels, and history of statin use.

Theprimary outcome was percentage of patients on statin therapy in accordance with ADA guidelines. The secondary objectives were to determine the reasons patients lack appropriate statin therapy and to describe population ASCVD risk factors.

Results

An electronic database search identified 629 patients who met inclusion criteria and found that 450 patients (71.5%) were currently on statin therapy (Table 1). However, 179 (28.5%) patients were not prescribed a statin medication at the time of data collection. Within one month following data collection, 9 patients (5%) had a statin added to their patient profile.

Of the 179 patients not on statin therapy, 65 (36.3%) had no history of a statin being prescribed nor any discussion of statin use in the medical chart (Table 2). Seventy-two patients (40.2%) had documentation of previous statin therapy, but the medication was removed from their profile. Only 28 (15.6%) patients without a statin had a documented intolerance.Several patients lacked any records of having a lipid panel collected despite age and diabetes status.

Of the patients not on statin therapy, 40 (22.4%) had experienced a documented ASCVD event including 11 cases of coronary artery disease, 16 strokes or transient ischemic attacks, and 13 with peripheral artery disease (Table 3). Hypertension was most prevalent in our group without statin therapy (90.5%), followed by overweight/obesity (84.4%), LDL-cholesterol ≥ 100 mg/dL (59.2%), and then smoking (25.1%). Overall, 10% of patients possessed all 4 risk factors, while 48% had 3 of the 4 risk factors. Only 2 patients not on a statin lacked ASCVD and risk factors.

Discussion

A thorough review of 629 clinic patients diagnosed with diabetes between the ages of 40 and 75 years found that 71.5% were currently prescribed statin therapy. This number reflects those patients with a statin on the medication profile at the time of data collection regardless of dose-intensity. Of the patients on statin therapy, 91.9% were prescribed either a moderate- or high-intensity statin. Atorvastatin 40 mg was the most prescribed agent at 20% followed by pravastatin 40 mg at

19.3%. The ADA guidelines recommend a high-intensity statin for nearly all patients within the collected data set, unless they have no ASCVD risk factors or were unable to tolerate a higher intensity dose.2 An escalation of therapy may represent an avenue of targeted intervention for pharmacists, particularly in the 8.9% of patients taking a low-intensity statin.

Out of 629 patients, 28.5% were lacking any statin therapy at the time of data collection and represent an opportunity for pharmacist-directed intervention to decrease ASCVD risk. Subsequently, 5% of the patients were started or restarted on a statin between data collection and subsequent EMR review one month later. Sixty-five patients (36.3%) had no history of any statin use within the EMR records. For many patients, no discussion of statin therapy had been mentioned in the patient notes. Several patients had no recorded lipid panel, limiting the possibility of identifying a major risk factor for ASCVD. One patient note specifically stated that she was not a candidate for statin therapy despite the presence of diabetes and three additional risk factors for ASCVD.

Many patients (40.2%) without current statin therapy had previously been prescribed a statin, but the agent no longer appeared on the medication profile. In many cases, no reason was given for the discontinuation. The medication simply disappeared. In a few instances, the patient reported “not taking” during medication reconciliation when hospitalized, leading to discontinuation at discharge with no note indicating the reason. It could not be determined if the patient stopped due to adverse events, cost or another reason. Adverse events and statin intolerance was noted in 15.6% of patients. The statin was discontinued due to elevated liver function tests or, most commonly, muscle aches. Some patients reported intolerance to multiple statins, but most stopped lipid-lowering therapy after one agent. These patients may benefit from a trial of an alternative statin or the initiation of a non-statin therapy such as ezetimibe.

Every patient included in the study had indications for statin therapy due to the presence of diabetes and age. Patients with a history of ASCVD represent one of the statin benefit groups and should receive high-intensity treatment.2 A history of ASCVD was found in 22.4% of patients without a statin. Many of these were patients previously receiving treatment, but the agent was lost for undocumented reasons. The ADA also recommends high-intensity therapy in patients with one or more ASCVD risk factors.2 Only 2 patients without current statin use met the criteria for moderate-intensity doses because they had no history of ASCVD nor had any risk factors. Hypertension was the most common risk factor, found in 90.5% of patients. Overweight patients made up 84.4% of the patient population. These numbers are consistent with the anticipated comorbidities of obesity, diabetes and hypertension. Only 59.2% of patients had a recent LDL-cholesterol greater than 100 mg/dL. This result could be due to several reasons. Seven patients lacked any history of lipid panels and the LDL could not be determined. Additionally, 20 patients had previously been on statin therapy before, therefore an LDL-cholesterol <100 would be due to efficacy of treatment as opposed to identification of patient baseline risk factors.

Few published studies have assessed statin prescribing practices. One study reviewed primary care patients aged 40-75 years and found that 1,448 (32%) of 4,536 patients were not on statin therapy when indicated.3 Another study evaluated a national registry and found that 32.4% of 1,129,205 statin-eligible patients were not on statin therapy.4 Our study found 28.5% without statin therapy out of 629 patients, similar to the other studies cited above, identifying a potential area for pharmacists to impact care.

The pharmacist’s potential role in improving statin prescribing was recently described in one randomized trial of dyslipidemia patients in Canada. Pharmacists met with patients at an initial clinic visit followed by subsequent visits or telephone calls as necessary, occurring at 6, 12, 18, and 24 weeks post-randomization. Pharmacists ordered medications and labs and managed adverse effects as indicated. This study achieved an improvement in the proportion of patients achieving LDL-cholesterol targets by 25% (p = 0.007). Odds of achieving target LDL-cholesterol were 3.3 times higher for intervention patients (p = 0.031). The adjusted mean difference between groups of LDL-cholesterol reduction was 0.546 mmol/L, or 21 mg/dL (p < 0.001). These results indicate that pharmacists can impact care for patients requiring lipid-lowering therapy and can serve as a model for clinical pharmacist service implementation.5

The current study focused on the identification of eligible diabetes patients between the ages of 40 and 75 years. We selected diabetes patients in order to implement a targeted approach for quality improvement in our practice setting. According to the ADA, statins are recommended in all patients in our study. For patients who fall outside of this population, statins are recommended for those under 40 years with ASCVD or risk factors, and those over the age of 75 should be considered for at least moderate-intensity therapy. The ADA guidelines were chosen for practicality in our practice

setting because indications for statin therapy utilize characteristics that are readily retrievable by our EMR. Other guidelines determine the need for therapy based on risk calculators that may require more information and more time. However, risk calculators may be used in a variety of patient populations and can help to guide other cardiovascular risk reduction therapy recommendations such as aspirin initiation. Clinicians may have access to lipid panel results that include patient risk scores, and EMR platforms may evolve for feasibility of these calculations. Strategies utilized for statin prescribing will vary for each practice setting depending on resources and personnel available.

Future goals of our study include implementing a pharmacist-led service for statin prescribing, increasing inter-professional education around statin prescribing, reviewing for appropriate statin intensity, improving documentation of reasons for no statin when otherwise indicated, utilizing strategies for statin intolerance such as a trial of other statins or reduced dosing, expanding to other statin benefit groups, facilitating appropriate use of non-statin agents, and supporting adherence and persistence to lipid-lowering therapy.

Conclusions

In an internal medicine teaching clinic, 71.5% of diabetes patients were on statin therapy. This cross-sectional analysis identified initial opportunities for improving statin prescribing for patients who may benefit from ASCVD risk reduction through targeted pharmacist interventions in the 28.5% of patients not receiving statin therapy.

References

1. Centers for Disease Control and Prevention.

Leading causes of death. National Center for Healthcare Statistics. http://www.cdc.gov/nchs/ fastats/leading-causes-of-death.html. Accessed

October 24, 2016. 2. American Diabetes Association. Cardiovascular disease and risk management. Diabetes Care. 2016;39(Suppl. 1):S60-S71. 3. Schoen MW, Salas J, Scherrer JF, Buckhold FR.

Cholesterol treatment and changes in guidelines in an academic medical practice. Am J Med. 2015;128:403-409. 4. Maddox TM, Borden WB, Tang F, et al. Implications of the 2013 ACC/AHA cholesterol guidelines for adults in contemporary cardiovascular practice: insights from the NCDR PINNACLE registry. J Am Coll Cardiol. 2014 Dec 2;64(21):2183-

92. 5. Tsuyuki, RT, Rosenthal M, Pearson GJ. A randomized trial of a community-based approach to dyslipidemia management: Pharmacist prescribing to achieve cholesterol targets (RxACT Study).

Can Pharm J (Ott). 2016;149:283-292.

Adam Corey1, PharmD Candidate Corresponding author: Jennifer J Kim2,3, PharmD, BCPS, BCACP, CPP 1UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, 2Department of Pharmacy, Moses H. Cone Memorial Hospital, Greensboro, NC 27401, 3Greensboro Area Health Education Center, Greensboro, NC 27401.

Disclosure: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

This research was first presented in poster format at the NCAP Annual Convention, November 2016.

Abbreviations: ADA = American Diabetes Association, ASCVD = atherosclerotic cardiovascular disease, BMI = body-mass index, EMR = electronic medical record, IMC = Internal Medicine Center, IRB = institutional review board.

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Number Percent ON Statin Therapy 450 71.5% NOT on Statin Therapy 179 28.5%

Total Patients Included 629 100%

IMC = Internal Medicine Center Table 2. Reasons Patients Lack Statin Therapy

Statin Lost from Profile No History of Statin Use Documented Intolerance Number (n=179) Percent of NOT on Statin 72 40.2%

65 36.3%

28 15.6%

Subsequently Added 9 5.0% Patient Refused Therapy 5 2.8%

Table 3. ASCVD or Risk Factors of Patients Lacking Statin Therapy Number (n=179) Percent of NOT on Statin Clinical ASCVD 40 22.4%

ASCVD Risk Factors

Hypertension 162 90.5% LDL ≥ 100 106 59.2% Overweight/Obese 151 84.4% Current Smoker 45 25.1%

Multiple Risk Factors

Three Risk Factors 86 48.0% Four Risk Factors 18 10.1% ASCVD = atherosclerotic cardiovascular disease