Imagine being able to conduct a medication use evaluation (MUE) in an afternoon. Now envision, after completing the initial MUE, being able to monitor the end points continuously, checking the progress weekly, being able to adjust policy in real time, and proactively improving patient care. For most health-system pharmacists, this is far from the typical experience. Today’s hospital pharmacist, although supported by far better computerization than in the 20th century, is still well short of using technology optimized enough to make the above scenario a reality. However, evidence suggests that this is changing as more health systems turn their attention to electronic medical record (EMR) optimization and demonstrate the capacity for advanced technology.

For example, in a recent survey of national health-system pharmacy leaders, more than half (53%) thought that, by 2018, it would be somewhat likely that hospitals would be capable of continuously monitoring medication use and tracking patient-specific outcomes.

 This indicates growing confidence that health information technology investments will begin to meet expectations, delivering much-anticipated value. In just a few years, health care technology will empower health-system pharmacists to increase productivity to improve patient outcomes, largely due to advances in EMR.

The Electronic Medical Record Adoption Model

Health-system pharmacists have experienced a flurry of heavy EMR adoption, most notably within the past decade. This trend has been fueled by a combination of federal initiatives, such as the American Recovery and Reinvestment Act, the Health Information Technology for Economic and Clinical Health Act, and the Health Insurance Portability and Accountability Act. Amidst the rapid drive for EMR adoption, the Health Information Management Systems Society (HIMSS) Analytics, a nonprofit subsidiary, has provided the Electronic Medical Record Adoption Model (EMRAM) to monitor and recognize EMR adoption levels for acute and ambulatory health care facilities.

 This model is useful for benchmarking a site’s level of achievement and outlines the path toward ultimate EMR optimization.

The EMRAM comprises 8 stages (0-7) designed to allow health care organizations across the country to perform peer comparisons as they track their progress toward paperless EMRs. Starting with the acute-care version at level 0, a baseline with no ancillary department systems (ie, without lab, radiology, and pharmacy installation/integration), the model evaluates the comprehensive merging of technology use, information exchange, analytics, and patient engagement. The model ends with full paperless integration at stage 7.

Hospitals designated to be at stages 1 through 4 will have limited EMR capabilities, capped with computerized physician order entry (CPOE) and clinical decision support (CDS) protocols at stage 4. Stage 5 is achieved with the addition of closed loop medication administration, which requires an active medication order, an electronically identified provider (ie, a nurse), a bar-coded product, and a patient who is electronically identified. A stage 6, designation is awarded with implementation of physician documentation (templates), full CDS, and closed-loop medication administration. Stage 7 is awarded when the hospital no longer uses paper charts and has a variety of distinct data (photos, documentation) digitized within its EMR environment. At this stage, continuous data warehousing is mined in “real time” to analyze clinical data in order to improve patient care, all while clinical information is fluidly and appropriately shared electronically across the spectrum of care.

Based on statistics, most hospitals in the United States have already implemented key components of the EMRAM model. Eighty-eight percent of hospitals have initiated Barcode Medication Administration, with the majority of the remainder planning to install it in the near future. Eighty-two percent of hospitals have already implemented CPOE. Most hospitals in the United States already have bedrock established for advancing stages via EMRAM.

 The emerging focus of HIMSS and health care organizations is the achievement of stage 7 status.

Achieving stage 7 status can help an organization improve patient care, which can in turn improve patient outcomes and experience, leading to a return on investment. Because few health systems have received EMRAM recognition for stage 7, receiving the recognition can provide a “differential value” for organizations in competitive markets that share the same baseline EMR technology. For example, nearly 50% of Americans have an Epic medical record,

 with some regions reaching 75% to 90%. How an organization manages and uses its EMR technology can differentiate it from competitors.

Integrating EMRs into a specific disease-care process can change the way diseases are identified and then treated. Headquartered in Phoenix, Arizona, Banner Health is an example of how achieving stage 7 status can optimize patient care. Banner Health patients are monitored 24/7, and their EMRs are set to alert physicians and clinicians (ie, pharmacists) when a patient’s symptoms suggest sepsis. The EMR then presents the provider with an algorithm complete with clinical actions to follow. The suggestions are all rooted in evidence-based medicine shown to improve sepsis mortality. Because this system identifies symptoms early, the mortality rate due to sepsis in the Banner Health intensive care unit is has dropped to 15% to 17%, whereas the nationwide sepsis rate is 25% to 50%.

To achieve outcomes like this, pharmacists need to be involved in the design and implementation of EMRs. For example, if the sepsis early-warning detection system led to a prescription for an antibiotic, the pharmacist must play a role in ensuring timely verification and delivery. Other areas in which pharmacists can contribute significantly to stage 7 include the following:

â—       Improving barcode scanning rates

â—       Reducing transcription-related adverse drug events

â—       Reducing overall average cost of care

â—       Improving transitions of care

â—       Preparing immunization documentation and management

â—       Empowering rural hospitals and clinics

â—       Improving pharmacy generic dispensing rates

â—       Improving monitoring of drugs with narrow therapeutic indices (eg, heparin, warfarin, digoxin)

â—       Implementing an acetaminophen safety net

â—       Improving vaccination rates

Health-system pharmacists need to stay up-to-date with existing and emerging EMR capabilities. An initial step is to use himssanalytics.org/stage7 to identify your organization’s currently recognized EMRAM stage.

 If your site is not listed, your stage can be estimated using the stage descriptions. It is interesting to note that more than 50% of sites surveyed are at least stage 5. However, there is always room for improvement. If your organization is not at stage 7, consider how you can contribute to achieving it. If your organization has already demonstrated it is at stage 7, remember that this achievement only demonstrates that your organization has the ability to use your EMRs to drive higher quality and greater outcomes. It is up to you, your colleagues, and your leadership to realize the outcomes.

Most EMR vendors have user-group websites where individuals can create an account and connect with the user base across the country and around the world. Joining your EMRs’ user group is a great way to stay in tune with your EMRs’ community and up-to-date on its functionality, which you can compare with other EMR sites. Additionally, setting up subscriptions to topics relevant to your practice will bring fresh information to your inbox. EMR vendors usually coordinate user-group gatherings. Larger sites often send some attendees to participate. Attending one of these conferences, perhaps in lieu of another annual conference, can further your competency regarding EMRs and help ensure that pharmacy practice at your site is fully engaged in bringing advanced pharmacy-centric EMR capabilities to your site. Some programs at EMR conferences provide continuing education hours. If attending a conference is not feasible, signing up for webinars or conference calls may be an alternative.

Health-system pharmacists who work alongside other health care practitioners (eg, physicians, nurses) are in a strategic position to discuss opportunities for, and collaborate on, implementing new EMR capabilities. By following your organization’s process for submitting EMR requests, you can add traction to ideas discussed in your clinic or on your floor. Individuals interested in becoming more involved can offer to serve as “super users” or subject matter experts during EMR upgrades. Discussing with your supervisor the addition of EMR-oriented goals to your performance evaluations is a great way to add accountability to your EMR competency. Individuals who are interested in health care informatics can seek advanced training through residencies, master’s degree programs, and EMR certification programs, or can request additional pharmacy informatics responsibilities in their current role.

Author William Gibson once said, “The future is already here—it’s just not very evenly distributed.” This could be said about the advanced capabilities of EMRs, such as continuous MUEs. Today’s health-system pharmacist can help evenly distribute EMR technology by measuring EMR adoption using the HIMSS EMRAM, staying up-to-date on EMR functionalities, and optimizing EMR in his or her organization. With a bit of extra effort and participation, the future health-system pharmacy practice is just around the corner.

Adam S. Wolfe, PharmD, MS, BCPS, practices clinical and analytic management as the pharmacy services manager at CHESS, a health enablement company located in High Point, North Carolina. His professional interests include advancing pharmacy practice through the intersections of clinical, administrative, and data management.

Ryan M. Farrington, PharmD, BCPS, is a clinical pharmacist and member of the institutional review board at Saint Alphonsus Regional Medical Center in Boise, Idaho. His professional interests include pharmacy informatics and medication safety.

Pharmacy Forecast: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems 2014-2018

. Chapter 5. ASHP Foundation website. ashpfoundation.org/MainMenuCategories/CenterforPharmacyLeadership/Pharmacy-Forecast. Accessed November 9, 2015.

		HIMSS analytics. Health Information Management Systems Society website. himssanalytics.org/stage7. Accessed November 9, 2015.

. pppmag.com/article/pppv12n8s0/State_of_Pharmacy_Automation_2015. Accessed November 9, 2015.

		50 things to know about Epic, Cerner, MEDITECH, McKesson, athenahealth and other major EHR vendors. Becker's Healthcare website. beckershospitalreview.com/healthcare-information-technology/50-things-to-know-about-epic-cerner-meditech-mckesson-athenahealth-and-other-major-ehr-vendors.html. Accessed November 9, 2015.

		Banner Health. EMR and sepsis. Banner Health website. bannerhealth.com/About+Us/Innovations/Electronic+Medical+Record/EMR+and+Sepsis.htm. Accessed November 9, 2015.

Articles

Viewpoints

There is growing confidence that health information technology investments will begin to meet expectations.

Maximizing Electronic Medical Records: The Electronic Medical Record Adoption Model and the Health-System Pharmacist

Approximately 73.5 million adults in the United States have a high level of low-density lipoprotein cholesterol (LDL-C). LDL-C is known as “bad” cholesterol, and a high LDL-C level contributes to cardiovascular disease. The use of HMG-CoA reductase inhibitors (statins), diet, and exercise can help to lower cholesterol, but many patients require additional help.

Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors are a new class of medications used as add-on therapy to decrease the LDL-C level. The 2 currently approved PCSK9 inhibitors are alirocumab (Praluent by Sanofi) and evolocumab (Repatha by Amgen), approved in July and August 2015, respectively. Another PCSK9 inhibitor, bococizumab (Pfizer), will likely be presented to the FDA in 2016. In addition, Alnylam Pharmaceuticals/The Medicines Company and Eli Lilly have agents in phase 2 trials.

Therapeutic Use, Dosing, and Administration

Alirocumab and evolocumab are FDA-approved to lower LDL-C levels for heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia (evolocumab only), or clinical atherosclerotic cardiovascular disease in patients who require additional lowering of LDL-C. Although these agents effectively lower LDL-C levels, the impact on heart attacks, strokes, and mortality has not been established. These agents should be used in addition to diet and maximally tolerated statin therapy.

Alirocumab and evolocumab are administered by subcutaneous injection every 2 weeks; evolocumab may also be administered every 4 weeks. Most patients obtain sufficient LDL-C reduction using alirocumab 75 mg. However, if more LDL-C lowering is desired, the alirocumab dosage may be increased to 150 mg. Evolocumab may be dosed as either 140 mg every 2 weeks or 420 mg once monthly. Both agents should be stored in the refrigerator but warmed to room temperature before injection, although evolocumab may also be stored at room temperature in the original carton for 30 days. Because these agents are self-administered, patients should receive training on injection technique. Injection sites include the abdomen, thigh, or upper arm, and should be rotated each time.

Low-density lipoprotein receptors (LDLRs) on hepatocytes are responsible for clearing LDL from the body. PCSK9 is a protein that binds LDLRs to promote their degradation. Alirocumab and evolocumab are antibodies that inhibit PCSK9 and thus prevent LDLR degradation. This action will increase the number of LDLRs and subsequently increase the clearance of LDL, ultimately lowering LDL-C levels.

Alirocumab and evolocumab demonstrate similar pharmacokinetics. Both agents are moderately absorbed (72%-85%) and demonstrate long half-lives (11-20 days). Their volume of distribution is small: 0.04 to 0.05 L/kg for alirocumab, and 3.3 L/kg for evolocumab. Both agents are believed to undergo proteolytic degradation.

Head-to-head trials have not been conducted with alirocumab and evolocumab, but each has been compared with placebo. The ODYSSEY COMBO I study was a multicenter, randomized, double-blind trial that evaluated alirocumab as add-on therapy to treat patients on statins. Patients were at least 18 years of age (mean: 63 years), were receiving maximally tolerated statin (with or without other therapies), and had either an LDL-C level 

70 mg/dL and established cardiovascular disease or an LDL-C level 

100 mg/dL with coronary heart disease risk-equivalents. Patients received either alirocumab 75 mg subcutaneously every 2 weeks, followed by 150 mg every 2 weeks after 12 weeks if the LDL-C level was 

70 mg/mL (205 patients), or matching placebo (106 patients). The baseline mean LDL-C level was 100.3 mg/dL 

 32.3 mg/dL in the respective groups. The mean percentage change in LDL from baseline to week 24 (primary endpoint) was —48.2% (95% CI, –52.0% to –44.4%) in the alirocumab group and –2.3% (95% CI, –7.6% to 3.1%) in the placebo group (

Evolocumab was evaluated in a multicenter, 52-week, placebo-controlled trial with adults aged 18 to 75 years. During a 4- to 12-week run-in period, patients were assigned to a lipid-lowering regimen based on LDL-C level, previous statin use, and cardiovascular risk, as per the Adult Treatment Panel III of the National Cholesterol Education Program. Regimens included diet alone, diet with 10 mg atorvastatin daily, diet with 80 mg atorvastatin daily, or diet with 80 mg atorvastatin and 10 mg ezetimibe daily. For all 4 groups, patients with LDL levels at least 75 mg/dL and no greater than a fasting triglyceride level of 400 mg/dL were randomized to receive 420 mg evolucumab or placebo subcutaneously every 4 weeks for 48 weeks. The mean LDL-C level at baseline was 104.0 

 21.6 mg/dL for all patients receiving placebo versus 104.2 

 22.1 mg/dL for all patients receiving evolocumab. The least-squares mean percentage change in LDL from baseline in the evolocumab group (taking into account the change in placebo group) was 57.5 

 <.001). Evolocumab significantly reduced LDL-C levels in each run-in period group versus placebo (

 <.001 for all comparisons), with the mean reduction ranging from 48.5% to 61.6%.

Clinical outcomes, including cardiovascular morbidity and mortality, are not currently known. However, trials for these agents, including bococizumab, are underway, with the first expected to be completed in October 2017.

PCSK9 inhibitors are generally well tolerated, with adverse reactions occurring at rates similar to those for placebo. The most common adverse reactions related to alirocumab and evolocumab, respectively, include nasopharyngitis (11.3%, 10.5%), injection site reactions (7.2%, 5.7%), influenza (5.7%, 7.5%), and upper respiratory tract infection/sinusitis (3.0%, 9.3%). Discontinue use if hypersensitivity occurs.

Alirocumab and evolocumab have not been found to induce or inhibit any transporters or enzymes; therefore, drug interactions are not expected.

Evolocumab may be confused with elotuzumab.

PCSK9 inhibitors have shown efficacy in lowering LDL-C levels and may be a viable option for patients requiring LDL lowering in addition to statin therapy, diet, and exercise. Future trials may help to further elucidate the role of PCSK9 inhibitors on cardiovascular morbidity and mortality.

Jennifer L. Cruz, PharmD, BCPS, is an assistant professor of clinical education at UNC Eshelman School of Pharmacy.

	Katherine Summers is a PharmD candidate at UNC Eshelman School of Pharmacy.

		Cholesterol: high cholesterol facts. Centers for Disease Control and Prevention website. cdc.gov/cholesterol/facts.htm. Updated March 17, 2015. Accessed February 26, 2016.

		Facts & Comparisons eAnswers website. online.factsandcomparisons.com. Updated October 2015. Accessed February 2016.

		Clinical trials.gov website. clinicaltrials.gov. US National Library of Medicine. Accessed March 9, 2016.

		Praluent [package insert]. Bridgewater, NJ: Sanofi-Aventis; 2015.

		Repatha [package insert]. Thousand Oaks, CA: Amgen Inc; 2015.

		Kereiakes DJ, Robinson JG, Cannon CP, et al. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: the ODYSSEY COMBO I study. 

. 2015;169(6):906-915. doi: 10.1016/j.ahj.2015.03.004.

		Blom DJ, Hala T, Bolognese M, et al; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. 

. 2014;370(19):1809-1819. doi: 10.1056/NEJMoa1316222.

		Mathon J. PCSK9 race: Amgen, Sanofi, and Regeneron first out of the gate, but Pfizer poised to make up lost ground. Informa Business Intelligence website. citeline.com/pcsk9-race-amgen-sanofi-regeneron-first-gate-pfizer-poised-make-lost-ground. Published August 31, 2015. Accessed March 9, 2016.

Formulary Drug Review

Approximately 73.5 million adults in the United States have a high level of low-density lipoprotein cholesterol.

PCSK9 Inhibitors

It is estimated that 46 individuals die of prescription opioid overdoses every day in the United States. The Centers for Disease Control and Prevention reported that more than 16,000 individuals in the United States died of opioid overdoses in 2013.

 Results from the National Survey on Drug Use and Health demonstrate that almost 2 million Americans, 12 years or older, misused or abused opioid pain relievers in 2013.

 The rise in overdose deaths resulting from the misuse and abuse of prescription drugs has been linked to overprescribing, a 300% increase in prescription opioid sales since 1999, and improper medication disposal.

On March 10, 2016, the United States Senate passed a bill to combat the growing heroin and opioid epidemic throughout the nation. The Comprehensive Addiction and Recovery Act, a bipartisan bill, was passed with a vote of 94 to 1, demonstrating overwhelming support to reduce opioid addiction and related deaths. This bill will provide $725 million of federal grant money to local and state governments, and nonprofit organizations, to expand program resources, education, and monitoring programs. In addition, funds could be used to develop drug treatment programs.

“Today, Americans suffering with opioid addiction are closer than ever before to getting the help they need,” said Senator Richard Burr (R-NC). “There are thousands of North Carolina families currently grappling with this addiction, and I am encouraged that the Senate has produced bipartisan legislation that will help end the devastating crisis hurting families across the country. We can reverse this disturbing trend that has ravaged the United States over the past few decades.”

Pharmacists are equipped to play an important role in reducing opioid misuse and abuse, but are often an underused resource. Pharmacists have unique clinical knowledge, as well as an obligation to ensure that all efforts are made to prevent substance abuse in their communities by providing education, using prescription drug monitor programs, and providing patients and families with lifesaving resources.

Education is a crucial first step in tackling prescription abuse. Parents and teenagers should be targeted for education due to the many misconceptions about drug use. Illegal drugs are commonly discussed, but many individuals fail to understand the risks associated with prescription drugs, especially opioids. Many parents are also unaware that teens are abusing prescription drugs and, therefore, are unsuccessful in safeguarding access to those medications in the home. In the 2009 National Survey on Drug Use and Health, 70% of individuals who reported nonmedical use of pain relievers obtained them from relatives or friends, whereas only 5% of individuals reported getting them from a drug dealer or via the Internet.

 Because opioids are commonly prescribed and are readily available in most homes, it is important to educate families on the potential abuse that can result from easy access.

Pharmacists can reach out to their communities by participating in public substance abuse education and prevention programs, collaborating with other health care providers (HCPs), and working with local, state, and federal authorities to combat controlled substance abuse. Educating patients on proper storage and disposal of excessive, unused, and expired medications should become routine practice for pharmacists. Directing patients to local drop boxes, or other safe ways to dispose of medications, can further help to prevent medication diversion and abuse.

Statewide electronic databases, such as prescription drug monitoring programs (PDMPs), can be effective tools for pharmacists in identifying the appropriate use of controlled prescription medications. As of 2014, 49 US states have operational PDMPs in place to track the prescribing and dispensing of controlled prescription medications.

 This statewide electronic tool is used by prescribing physicians and pharmacists to provide data on prescribing and dispensing histories of controlled substance prescriptions, including opioid medications. Although this tool has proven to be useful in preventing drug diversion, it is only useful if HCPs use the system prior to prescribing and dispensing.

 Pharmacists must continue to regularly use their state PDMP  and inform other HCPs of the importance of its use. With added federal funding, additional local and state governments may be encouraged to establish effective PDMPs to monitor prescription drug use in their states.

Patient Resources and Assistance Programs 

Pharmacists can play a role in patient assistance by identifying individuals who have a substance abuse problem and referring them for evaluation and treatment. Pharmacists are equipped to identify individuals at greater risk for overdose or addiction, as well as recommend and provide lifesaving antidotes to family members in case of an opioid overdose. Family members should be counseled to look for signs of an opioid overdose (Table 1

). The typical signs of an opioid overdose should be communicated to family members of an opioid user. With opioid antagonists, such as naloxone nasal spray and Evzio auto-injection, lives can be saved by simply administering the medication to reverse the effects of opioids. Available naloxone products are listed in Table 2

. Community-based overdose prevention programs, such as Project Lazarus, focus on increasing access to naloxone for prescription opioid users. Physicians are encouraged to prescribe the antidote to patients at high risk for opioid overdose. Through this program, patients taking opioids, and their family members, are educated on how to use naloxone and are provided with a naloxone kit for home use.

Through new laws and increased funding, HCPs can expect to see an increase in the use of drug monitoring programs, drug treatment programs, and education and resources for families of individuals using opioids. To help prevent misuse or abuse of these drugs, pharmacists must be diligent in ensuring that opioid medications are dispensed to individuals who legitimately need them. Although pharmacists may not be able to eliminate all opioid misuse and abuse, a number of resources and strategies can be used to improve patient care and public safety, including adequately educating patients and the public about the dangers of prescription medications, ensuring that patients are aware of proper medication disposal practices, diligently using operational statewide PDMPs, and providing families of opioid users with opioid overdose kits. 

The authors thank Jordan Ballou, PharmD; Harkin Hayes Jr., PharmD; Laura Rhodes, PharmD; Chelsea Renfro, PharmD; and Alicia Watkins, PharmD, for their suggestions regarding the content of this article.

Desiree Gaines is a PGY1 community pharmacy resident with the University of North Carolina at Chapel Hill and Moose Pharmacy. Ashley Branham, PharmD, is the director of clinical services at Moose Pharmacy, in Concord, North Carolina. 

		National Vital Statistics System mortality data. CDC website. cdc.gov/nchs/deaths.htm. Accessed April 4, 2016.

		Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2013.

		Chang HY, Daubresse M, Kruszewski SP, Alexander GC. Prevalence and treatment of pain in EDs in the United States, 2000 to 2010. 

. 2014;32(5):421-431. doi: 10.1016/j.ajem.2014.01.015.

		Daubresse M, Chang HY, Yu Y, et al. Ambulatory diagnosis and treatment of nonmalignant pain in the United States, 2000-2010. 

. 2013;51(10):870-878. doi: 10.1097/MLR.0b013e3182a95d86.

		Results from the 2009 National Survey on Drug Use and Health (NSDUH): National Findings, SAMHSA (2010). Substance Abuse and Mental Health Services Administration website. oas.samhsa.gov/NSDUH/2k9NSDUH/2k9ResultsP.pdf. Accessed April 4, 2016.

		Status of state prescription drug monitoring programs (PDMPs). National Alliance for Model State Drug Laws website.  namsdl.org/library/1E4808C8-1372-636C-DD0293F829471A7E/. Accessed March 13, 2016.

		Simeone R, Holland L. An evaluation of prescription drug monitoring programs.  Simeone Associates, Inc, website. simeoneassociates.com/simeone3.pdf. Published September 1, 2006. Accessed April 4, 2016.

		Project Lazarus website. projectlazarus.org. Accessed March 13, 2016.

		Lank PM, Kusin S. Ethanol and opioid intoxication and withdrawal. In: Adams JG, ed. 

. 2nd ed. Philadelphia, PA: Elsevier Saunders; 2013:154.

		Lexi-Drugs. Lexi-Comp, Inc, website. online.lexi.com. Accessed March 10, 2016.

Chronic Care Focus

It is estimated that 46 individuals die of prescription opioid overdoses every day in the United States.

Opioid Addiction and Overdose: New Legislation and How Pharmacists Play a Critical Role in the Epidemic

WC is a 67-year-old man with hypertension, hyperlipidemia, and coronary artery disease, and had triple bypass surgery 17 years ago. His current home medications include amlodipine 10 mg once daily, atorvastatin 80 mg once daily, and aspirin 81 mg once daily. He presents to the clinic with shortness of breath (SOB), which occurs when performing simple tasks such as sweeping the floor. He reports sleeping in a recliner at night due to orthopnea. Physical examination reveals elevated jugular venous pressure and 1+ pitting lower extremity edema (LEE). An echocardiogram demonstrates systolic dysfunction, mild mitral regurgitation, a dilated left atrium, and an ejection fraction (EF) of 30%. Laboratory results show a pro-B-type natriuretic peptide level of 1302 pg/mL, a troponin level of <0.34, and an unremarkable basic metabolic panel (BMP). Measurement of vital signs shows blood pressure (BP) of 156/92 mm Hg, a heart rate of 80 beats/min, an Spo

 of 94%, a temperature of 36.5 °C, a pain level of 2 on a scale of 10, and a weight of 185 lb (84.1 kg). WC’s pharmacy coverage is Medicare Part D. The medical team would like assistance in optimizing the medication regimen for WC’s new diagnosis.

First, the patient’s heart failure needs to be classified to determine the appropriate treatment strategy. The patient’s EF is ≤40%; therefore, per the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) 2013 Guideline for the Management of Heart Failure, WC’s condition will be categorized as heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.

 The atrial dilation and systolic dysfunction seen on the echocardiogram are evidence of structural heart disease. The patient is also exhibiting symptoms that limit his daily activities. These 2 findings together categorize the patient’s condition as ACCF/AHA stage C.

 Further, the patient has SOB with normal activity, but is comfortable at rest, so his condition has a functional classification of II, according to the New York Heart Association (NYHA) .

The following are indicated for stage C HFrEF: an angiotensin-converting enzyme (ACE) inhibitor (or angiotensin receptor blocker if the patient cannot tolerate an ACE inhibitor) and beta blocker (specifically metoprolol succinate, bisoprolol, or carvedilol).

 In addition, for NYHA functional classes II through IV, an aldosterone antagonist is recommended if the estimated creatinine clearance is >30 mL/min and the potassium level is <5.0 mEq/dL.

 In clinical trials, these medication classes have demonstrated a decrease in mortality and morbidity when used in patients with HFrEF.

 Non-dihydropyridine channel blockers, such as verapamil and diltiazem, are not recommended due to their negative inotropic effects, which may cause harm in patients with HFrEF.

 Despite a lack of mortality benefit, loop or thiazide diuretics are recommended for symptomatic management of hypervolemia in patients with normal renal function.

 A diuretic is also recommended with initiation of a beta blocker in hypervolemic patients, due to increased fluid retention caused by beta blockers. It is important not to delay initiation of a beta blocker in these patients, due to the significant benefit demonstrated in clinical trials.

Because amlodipine is an antihypertensive that may contribute to LEE and has no proven functional or mortality benefit in HFrEF, it is reasonable to discontinue this medication in this patient. Hypertension is an important modifiable risk factor for all classifications of heart failure.

 Per the 2014 American Society of Hypertension and the International Society of Hypertension (ASH/ISH) guidelines for the management of hypertension, WC’s goal BP is <140/90 mm Hg.

 It would be acceptable to restart this medication at a later date if target doses of the ACE inhibitor, beta blocker, and aldosterone antagonist do not achieve the patient’s BP goal.

Based on guideline recommendations and evidence-based medicine, the following are reasonable recommendations for WC: discontinue amlodipine; initiate lisinopril 5 mg once daily, titrating it to the BP goal or a target dose of 40 mg, as tolerated; initiate furosemide 20 mg once daily, titrating it to the patient’s goal dry weight; initiate metoprolol succinate 25 mg once daily, titrating it, as tolerated, to a target dose of 200 mg once daily over 8 weeks; initiate spironolactone 25 mg once daily; return to the clinic in 3 to 7 days to reassess volume status, BP, and BMP to monitor renal function and electrolytes.

Heather Steelman Coleman, PharmD, is a PGY1 Ambulatory Care Pharmacy Resident at University of North Carolina (UNC) Health Care. She earned her doctor of pharmacy degree from UNC Eshelman School of Pharmacy.

		Writing Committee Members, Yancy CW, Jessup M, Bozkut B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. 

. 2013;128(16):e240-e327. doi: 10.1161/CIR.0b013e31829e8776.

		Garg R, Yusuf S. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure: Collaborative Group on ACE Inhibitor Trials. 

		Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). 

		Pitt B, Zannad F, Remme WJ, et al; Randomized Aldactone Evaluation Study Investigators. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. 

		Leto L, Aspromonte N, Feola M. Efficacy and safety of loop diuretic therapy in acute decompensated heart failure: a clinical review. 

. 2014;19(2):237-246. doi: 10.1007/s10741-012-9354-7.

		James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). 

. 2014;311(5):507-520. doi: 10.1001/jama.2013.284427.

		Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. 

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Pharmacist Rounds

The patient's heart failure needs to be classified to determine the appropriate treatment strategy.

Case Report: Congestive Heart Failure

Atrial fibrillation (AF), the most common cardiac arrhythmia, is strongly associated with increased morbidity and mortality and has become a major global public health challenge.

 It is estimated to affect approximately 3 million adults in the United States and 1% to 1.5% of the population throughout the developed world.

 The prevalence of AF increases significantly with age. Given the increasing elderly population in the United States, it has been predicted that over the next 50 years, the number of AF cases will exceed 5.5 million in the United States.

In addition, health care costs associated with AF, after hospitalization, have increased. In 2005, the total cost of care for nonvalvular AF was estimated to be more than $6 billion, with 75% of the cost related to inpatient care alone.

 conducted a retrospective matched cohort study to estimate the true cost burden of AF in the United States. This study showed that the total direct medical costs were approximately 73% higher in patients with AF compared with the matched control subjects, representing an additional annual cost of $8705 per patient with AF.

In the United States, between the years 2000 and 2010, there were more than 3 million hospitalizations for which AF was the primary diagnosis at discharge.

 conducted a study to assess the temporal trends of AF hospitalizations and their economic burden on the health care system. From 2000 to 2010, the number of hospitalizations significantly increased—from 1552 to 1812 per 1 million, respectively. Most of the admissions were for patients 65 years and older, and admissions increased more dramatically after 80 years of age. Although the length of hospital stay did not change over the 10-year period, the cost of care increased significantly after adjustment for inflation.

The increases in prevalence and cost highlight a need for systematic improvements. It is clear that one way to manage the increasing cost is to reduce the number of hospital admissions and readmissions for AF. Pharmacists play a fundamental role in tackling this public health challenge. Our medical center implemented an AF transitions-of-care (TOC) pathway for patients who present to the emergency department (ED) with a primary diagnosis of AF. The aim of this new treatment paradigm was to decrease hospital admissions and readmissions for AF, and ensure patients have adequate follow-up. The clinic appointments are primarily conducted by Clinical Pharmacist Practitioners (CPPs) with oversight by cardiologists and support from nurses, technicians, and administrative staff.

Prior to implementation, it is imperative to elicit support from physician providers. One must also reach out to healthsystem administration, administrative support staff, nursing, other CPPs, ED staff, and clinic providers (eg, cardiology, primary care). Everyone should be involved in designing the implementation plan and triage algorithm to ensure a smooth transition. An operational workflow is helpful to delineate the roles of all involved (Figure 1

The implementation phase consisted of deploying an ED protocol, which helped identify and select eligible patients, and a note template in the electronic medical record to document key points of the patient assessment. The ED provider risk stratifies each patient as low, moderate, or high risk based on the severity of AF symptoms, which is evaluated using the Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF) scale (Figure 2

), signs of fluid overload, vitals, occurrence of syncope, and presence of concomitant illness.

 Low-risk patients are routed to the AF TOC clinic; moderate-risk patients can receive treatment (eg, rate-controlling medication) and be observed in the ED, then routed to the AF TOC clinic or admitted to the hospital; and high-risk patients must be admitted to the hospital (Online Figure 3). To be classified as low risk, patients must have a heart rate (HR) ≤110 beats per minute (bpm); therefore, no rate control is required in the ED. Moderate-risk patients have a HR ≥110 bpm, and the ED provider is to initiate rate control to a resting HR <130 bpm. The ED provider also calculates the patient’s CHA

-VASc and HAS-BLED scores to evaluate the risk of stroke and bleeding. If a patient is routed to the AF TOC clinic, anticoagulation initiation may be deferred until followup, unless the patient has a mechanical heart valve, or based on physician discretion when the CHA

-VASc ≥2 and the HAS-BLED ≤3. An order set was developed to guide discharge orders for rate control and antithrombotic agents. If a patient is deemed appropriate for clinic follow-up, the ED health unit coordinator (HUC) requests an AF TOC clinic appointment to be scheduled within 72 hours (goal: 24-48 hr). The cardiology clinic schedulers then add the appointment to the CPP’s schedule in 40-minute blocks reserved for new patients with AF.

The focus of the AF TOC clinic appointment is to conduct a comprehensive review of the patient’s current illness and prior history, evaluate symptoms, assess possible inciting causes of AF, and provide education, as well as determine the need for anticoagulation and rate control therapy, further testing, and referral to a specialist or back to the primary care provider (PCP). The AF TOC clinic relies on a multidisciplinary team to successfully coordinate each patient visit. When a patient presents to the clinic, a nurse obtains the vitals and a technician obtains an electrocardiogram (ECG). After evaluating the ECG, the CPP conducts the patient visit, which takes up most of the appointment. Once the CPP has gathered all necessary information, the CPP discusses the patient and the recommendations with the supervising physician. The physician confirms ECG interpretation and provides input into the therapeutic plan. The physician may see the patient, depending on patient needs. The CPP requests necessary referrals and follow- up appointments, and orders additional diagnostic tests and medications as indicated.

To thoroughly understand the patient’s AF, the CPP obtains a detailed description of the current illness and medical history. The CPP evaluates for a history of AF, prior thrombotic or hemorrhagic events, prior cardiac workup, and AF-related symptoms, including palpitations, dyspnea, dizziness, syncope or presyncope, chest pain, weakness, and fatigue. Based on this information, a CCS-SAF score is calculated to classify the impact of AF on the patient’s quality of life. The CPP also uses targeted questioning and physical examination to identify factors, known or unknown to the patient, that are potentially contributing to the AF. These factors include hypertension, diabetes, obesity, hyperlipidemia, obstructive sleep apnea, tobacco, alcohol or caffeine use, hyperthyroidism, anxiety, heart failure, myocardial infarction, valvular disease, a history of cardiac surgery, and medication nonadherence. After thoroughly evaluating the patient’s comorbidities and symptoms, the CPP determines whether rate control is indicated and calculates CHA

-VASc and HASBLED scores to determine appropriate antithrombotic therapy. The CPP also initiates upstream management of any cardiovascular risk factors that are present.

Throughout the visit, the CPP incorporates detailed patient education regarding AF. This is the first AF episode for most patients; therefore, it is essential that they receive adequate information to make informed decisions regarding the management of their AF. Patient education includes information regarding what AF is, the different types of AF (eg, paroxysmal, persistent), risk factors for the development of AF, minimizing risk of stroke through antithrombotic therapies, managing AF through rate control or rhythm control, and other risk factor management. Lastly, patients are educated on self-management (to empower them to check their pulse at home), when to seek medical care for an AF episode, and instructions for therapeutic lifestyle changes (eg, exercise). This patient information is delivered verbally, and in a comprehensive handout with visual aids.

The final objective of the AF TOC clinic visit is to determine the appropriate next steps for managing the patient’s AF. Patients often warrant further diagnostic testing to rule out possible risk factors or further understand the AF burden (eg, echocardiogram, heart monitor). The clinic visit is designed to mitigate a hospital admission, but should not replace a thorough workup. Whenever possible, patients who already have a PCP or cardiologist are routed to follow up with them to maintain continuity with their current health care network. Alternatively, if the patient is not currently under the care of the appropriate providers, the CPP makes the necessary referrals. Sometimes, this means referring a patient to electrophysiology or providing information on how to set up care with a PCP; other times, this means scheduling a follow-up appointment with the CPP or supervising physician. Regardless of what follow-up is needed, each patient should be set up with a plan to ensure that the AF continues to be managed.

One barrier that routinely occurs in health care is access to providers. To avoid this problem, 1 CPP appointment slot is reserved specifically for AF TOC patients 4 days of the week. Although access is improved, lack of appointment use prevents the time from being used for other types of patient visits. Another downside is if more than 1 patient was referred within the same 72-hour window, double booking of appointments can occur. A potential resolution to this problem is to have the HUC in the ED directly schedule appointments at the time of decision making in the ED.

Health care systems and providers throughout the United States are looking for ways to reduce costs. Implementing an AF TOC clinic is an innovative way to enhance AF management by preventing hospitalizations, managing cardiac and metabolic risk factors earlier, and educating patients on self-care and when to seek medical care for AF episodes. The first step to piloting a similar program at your health care system is to speak with health-system administration and other health care providers to gauge interest and work through the logistics (eg, scheduling, clinic space). It is then imperative to educate other providers about your service and to have support from referring physicians to ultimately reduce the number of hospital admissions.

Rachel C. Lee, PharmD, BCPS, CPP, is a PGY2 resident in ambulatory care at University of North Carolina (UNC) Medical Center and Clinics, and a Clinical Pharmacist Practitioner at UNC Internal Medicine Clinic and UNC Hospitals Diabetes and Endocrinology Clinic in Chapel Hill, North Carolina.

Mary E. Roth, PharmD, BCPS, CPP, is a PGY2 resident in cardiology at UNC Medical Center and Clinics, and a Clinical Pharmacist Practitioner at UNC Hospitals Heart & Vascular Center at Meadowmont in Chapel Hill, North Carolina.

Zachariah M. Deyo, PharmD, BCPS, CPP, is a Clinical Pharmacist Practitioner and quality improvement lead at UNC Hospitals Heart & Vascular Center at Meadowmont, and adjunct assistant professor, PACE Division, at UNC Eshelman School of Pharmacy in Chapel Hill, North Carolina.

		Marmagkiolis K, Nikolaidis IG, Politis T, Goldstein L. Approach to and management of the acute stroke patient with atrial fibrillation: a literature review. 

 2008;3(4):326-332. doi: 10.1002/jhm.343.

		Patel N, Deshmukh A, Pant S, et al. Contemporary trends of hospitalization for atrial fibrillation in the United States, 2000 through 2010: implications for healthcare planning. 

 2014;129(23):2371-2379. doi: 10.1161/CIRCULATIONAHA.114.008201.

		Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. 

 2011;4(3):313-320. doi: 10.1161/CIRCOUTCOMES.110.958165.

		Dorian P, Cvitkovic SS, Kerr CR, et al. A novel, simple scale for assessing the symptom severity of atrial fibrillation at the bedside: the CCS-SAF scale. 

Clinical Care Focus

Atrial fibrillation, the most common cardiac arrhythmia, is strongly associated with increased morbidity and mortality and has become a major global public health challenge.

Transitions of Care for Patients with Atrial Fibrillation

I wonder if health-system pharmacists who read and hear about the growing opioid epidemic react as if this is someone else’s issue. Because many of us work in the acute care setting and this is primarily an ambulatory issue, it is easy to be a passive observer. I think there are many opportunities for health-system pharmacists to be actively involved in reducing opioid overuse.

A few important points stress the need for vigilance:

		Eighty percent of all opioid use in the world occurs in the United States. This is an incredible statistic when you consider that Americans make up only 5% of the world’s population.

		During the time leading up to his nomination as FDA Commissioner, Rob Califf, along with the FDA, has called for policies and processes to assist in reversing the epidemic.

 This has become a major issue for the FDA.

		In March, President Obama announced additional actions to help reduce opioid abuse.

 The White House is actively becoming involved in addressing it.

When recognizing the sheer size of the problem and the importance that governmental officials have placed on this epidemic, healthsystem pharmacists need to actively join the fight to limit inappropriate opioid use. Because we spend so much time ensuring appropriate medication use, this seems appropriate, and we are well trained to do it. Here are some things we can do:

Ensure that the approach to ordering controlled substances at your institution is sound.

 The number of individuals who have ordering privileges and power of attorney should be minimal, and there need to be appropriate checks and balances. If 1 individual manages the entire ordering and inventory process, the opportunity for diversion increases.

Have a process for checking waste in procedural areas.

 A large opportunity for diversion occurs during procedures because syringes are pre-drawn and then wasted if not used. Every provider needs to be aware that the pharmacy will regularly check waste that is returned for disposal for diversion reasons.

 Frequently generating reports to identify outliers among individuals who administer controlled substances is essential. Unfortunately, departments do not routinely do this. Although it is not exciting to consistently generate these reports, and never enjoyable to identify a diverter, having the discipline to do this regularly and robustly is essential to all pharmacy departments.

Use the state’s controlled substances reporting system (CSRS) for patients at risk for misuse during each medication history.

 Pharmacy departments are getting active in taking a medication history upon admission, and few even review the CSRS as part of this process. Although this is an important step in the medication reconciliation process, it is also an opportunity to identify an abuser who is getting frequent prescriptions. Actively reviewing the CSRS for these suspected patients can provide information to the medical team in order to address issues during admission.

Ensure the formulary has limited controlled substance availability and appropriate restrictions on prescribing.

 Although pain management is very important in the acute care setting, a designated individual needs to ensure that needless or inappropriate medications are not stocked and that only individuals who should prescribe some of these medications are the ones doing so.

 Educating physicians and monitoring prescriptions to minimize the total amount of doses allowed and the number of refills can help to limit the potential for addiction to start. Although we want to be certain that pain is controlled and patients are comfortable, we also want to make sure patient access is limited beyond this.

Employ a pain management pharmacist in the ambulatory care setting.

 Patients can be referred to a pain management pharmacist at discharge if pain does not resolve or is not managed appropriately. Pain management pharmacists can also advise their department on appropriate formulary medications and processes for limiting abuse.

We all have a role in making sure we do not contribute to the growing opioid epidemic. Health-system pharmacists are integral to the process. We need to join our ambulatory care colleagues to make sure all medicines are used appropriately.

I would appreciate any insights and experiences you might have regarding this perspective. Let me know what you think by e-mail at seckel@unc.edu or follow me on Twitter at @stepheneckel.

Stephen F. Eckel, PharmD, MHA, BCPS, FCCP, FASHP, FAPhA, is associate director of pharmacy, University of North Carolina Hospitals, and clinical associate professor at the University of North Carolina Eshelman School of Pharmacy.

		US: 5% of world population; 80% of opioid consumption. Allgov.com website. allgov.com/news/controversies/us-5-percent-of-world-population-80-percent-of-opioid-consumption-141215?news=855100. Published December 15, 2014. Accessed April 11, 2016.

I wonder if health-system pharmacists who read and hear about the growing opioid epidemic react as if this is someone else's issue.

May 2016

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