May 2014 by McMahon Group

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The Pharmacist’s News Source

pharmacypracticenews.com

Volume 41 • Number 5 • May 2014

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UP FRONT

Clopidogrel increases bleeding after robotic CABG.

CLINICAL

4 8

ISMP’s six best practices for hospital drug safety.

$3.7 million grant spurs pharmacistcoordinated pharmacogenomics research.

Pharmacists can provide invaluable clinical care for HF patients.

POLICY

Reimbursement Matters: understanding the revenue cycle.

OPERATIONS & MGMT

24 28

Leadership in Action: Trust, the oil of highly performing teams. Specialty pharmacy: why and how to get in.

PRACTICE PEARL Vanderbilt pharmacists offer strategies to improve post-acute care transitions. See pharmacypracticenews.com

NOW AVAILABLE! Our brand new iPad app!

As Nitro Shortage Eases, Lessons Learned for Future

Revolutionizing Pharmacy Ed With Simulation Centers

y mid-April, the nitroglycerin shortage that had gripped hospitals for months showed some signs of abating, with Baxter, one of three major manufacturers of the drug, announcing that it had returned its customers to a 100% allocation following months of severe restrictions. As a result, at least one facility— Tampa General Hospital—said it was able to ease limits on the use of the critical cardiac medication. But no such relief was in sight at Carilion Roanoke Memorial Hospital, in Virginia, which reported that its shipments of nitroglycerin had just been cut. Indeed, “I’d like to know where [Tampa General] is getting their nitro!” said Lisa L. Deal, PharmD, an emergency medicine pharmacy specialist in the hospital’s Department of Pharmacy. Given the changeable nature of nitroglycerin supplies, drug shortage experts say it may not yet be time to ease up on strategies for stretching

tep inside and you may find yourself flying through a heart, navigating a pituitary tumor or watching fluoroquinolone bind to a receptor in bacterial DNA. Faculty and students at the University of Toledo (UT), in Ohio, call it “the cave.” The 8μ8-foot virtual reality room is just one component of a $36 million state-of-the-art simulation center that opened at the university on April 22, and only the latest evolution in the use of simulation as a teaching aid in medicine and pharmacy. From holographic patients and high-fidelity mannequins to virtual cleanrooms and interactive online simulations, schools and universities across the United States have come a long way from relying solely on classrooms and textbooks to train the next generation of health care professionals.

see NITRO SHORTAGE, page 10

see SIMULATION, page 34

•

Do CSTDs Need More Attention In Health Systems? New Orleans—Closed system transfer devices (CSTDs) may become a more high-profile technology for pharmacy directors tasked with ensuring worker and patient safety, given the pace of new developments surrounding the sterile compounding systems. Just last month, the devices were mentioned in the much-awaited United States Pharmacopeia (USP) Chapter <800> updated guidelines on safe handling. Moreover, a new study by

•

see CSTDs, page 16

Courtesy of BHDP Architects. Architects

in this issue

A view i into i t the th simulated i l t d operating ti room att the th newly l launched l h d University U i it off Toledo T l d Interprofessional Immersive Simulation Center.

•

Growth of Ambulatory Pharmacy Spurs Consensus Recommendations Dallas—New consensus recommendations issued by the American Society of HealthSystem Pharmacists (ASHP) could provide the cohesion a rapidly expanding body of ambulatory care pharmacists needs to meet an increasing number of clinical care opportunities. The preliminary recommendations were presented at the inaugural ASHP Ambulatory Care Conference and Summit, where experts and practitioners hotly debated and revised them. “The ambulatory care segment of pharmacy is growing rapidly, as providers and payors seek to improve care and reduce

costs by keeping patients out of the hospital,” said ASHP President Gerald Meyer, PharmD, FASHP, the director of experiential education at Jefferson School of Pharmacy, in Philadelphia, during the summit. “We’re here to broadly define elements of a practice model that ambulatory care pharmacists can look to for guidance.” In this four-part series, Pharmacy Practice News presents the consensus recommendations, which are split into four domains: defining ambulatory care pharmacy practice,

•

see CONSENSUS, page 30

New Product Naloxone (Evzio, Kaléo) auto-injector approved for opioid overdose. See page 19

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Up Front 3

Pharmacy Practice News • May 2014

Cardiovascular Disease

Clopidogrel Increases Bleeding After Robotic CABG P

atients should not take the antiplatelet drug clopidogrel for five days before undergoing robotic coronary artery bypass graft (CABG) procedures, according to researchers at the University of Arizona. In 2011, the American Heart Association issued a recommendation to hold clopidogrel for five days before traditional CABG, but the organization had not made a similar statement for the robotic procedure. “This study provides food for thought,” said Sophia Vainrub, PharmD, a clinical pharmaacist at the University of Arizona, in TucT son, “to justify applying the practicce of holding clopidogrel for five days before CABG to robotic CABG procedurees as well.” Dr. Vainrub presented the ressults of this study at the 2013 Ameriican College of Clinical Pharmacy meetting (abstract 91). “I think the result is interestingg, but I don’t think it is surprising,”” said Long To, PharmD, a clinicall pharmacist at Henry Ford Hospital,, in Detroit, who was not involved w with this research. It will provide a good reference for clinicians, who might have questions about the increasingly popular robotic procedure, Dr. To said. In a retrospective study of 136 patients who underwent robotic CABG, 29% received clopidogrel five days before surgery. Bleeding occurred

in a significantly higher percentagee of patients who received clopidogreel than patients who did not (26% vss. 8%, respectively; P=0.011). Likewisee, patients in the clopidogrel group had a higher median chest tube output durring the 24-hour period after surgeryy than did patients who did not receivee the drug (900 vs. 735 mL, respectivelyy; P=0.002). Although it does not involvee a sternotomy, robotic CABG still is associated with bleeding, Dr. To said d,

Robotic CABG with Clopidogrel molecule (inset).

‘This study provides food for thought, to justify applying the practice of holding clopidogrel for five days before CABG to robotic CABG procedures as well.’ — Sophia Vainrub, PharmD

particu ularly at the targeted vessel and incisio on sites. “Theese data serve as a good starting point o of investigation into the clinical ramificcations of higher intraoperative blood lloss and higher chest tube output in the first 24 hours following robotic CAB BG,” Dr. Vainrub told Pharmacy Practicce News. “Sincce those parameters were statisstically significantly different in our small patient sample, when o applied to a larger patient population, it is possible that they u mayy prove clinically significant,” she said. “H However, a larger study would be needed d to evaluate this appropriately.” The choice to hold clopidogrel should be taillored to an individual patient’s needs, Dr. To said. It’s standard practice to o hold clopidogrel before traditional CABG, but if a patient has a historyy of myocardial infarction and is at high h risk for reinfarction, clinicians “don’t want to [incur] any risk [they] don’t have to” and they may want the patient to continue to take clopidogrel. The higher odds of bleeding may be preferable compared with increased chances of reinfarction. —Ben Guarino Drs. To and Vainrub reported no relevant ﬁnancial conﬂicts of interest.

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Volume 41 • Number 5 • May 2014 • pharmacypracticenews.com

ANESTHESIOLOGY/PAIN Julie A. Golembiewski, PharmD, Chicago, IL Melvin E. Liter, MS, PharmD, FASHP, Lexington, KY

INTERNAL MEDICINE

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BIOTECHNOLOGY

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CARDIOLOGY

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CNS/PSYCHIATRY

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Charles F. Caley, PharmD, Storrs, CT Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, Texas Larry Ereshefsky, PharmD, San Antonio, T Texas

Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Contributing Editors James Prudden, Group Editorial Director

Ali McBride, PharmD, MS, BCPS, St. Louis, MO Sara S. Kim, PharmD, BCOP, New York, NY

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4 Clinical

Pharmacy Practice News • May 2014

Medication Safety

ISMP’s Six Best Practices for Hospital Drug Safety T

he Institute for Safe Medication Practices (ISMP) has issued six easyto-implement drug safety recommendations to reduce the frequency of several serious adverse events (AEs). The “20142015 Targeted Medication Safety Best Practices for Hospitals” addresses errors associated with vincristine, methotrexate and glacial acetic acid use, as well as confusion with measurement units and routes of administration. “If you can implement these six best practices, you’ll make a significant impact on the incidence of drug-related errors,” said Darryl Rich, PharmD, MBA, a medication safety specialist at the ISMP. Dr. Rich said all of the AEs addressed by the recommendations have resulted in serious harm or death, and, despite being reported and discussed in multiple issues of the ISMP’s Medication Safety Alert! over the past 20 years, continue to occur. “We also chose ones that can be prevented with one or two interventions that have already been effectively implemented in multiple hospitals,” Dr. Rich added. “And our best practices do not duplicate other association initiatives.” Kyle Hultgren, PharmD, the director of the Center for Medication Safety Advancement at Purdue University College of Pharmacy in West Lafayette, Ind., said the errors addressed by the best practices recommendations are significant, “in both scope and magnitude. Any one of these commonplace practices can precipitate a catastrophic error if not addressed in the recommended manner,” added Dr. Hultgren, who was not involved in the creation of the best practices. Asked if the short list of six best practices is complete, Dr. Hultgren said that “while many organizations could lobby for any number of items they think should be present on such a list, every day we spend debating lists is another day we avoid taking action on what we know can save lives. This is an extraordinary place to take action.”

Best Practice 1 The Problem: When injected intrathecally, vinca alkaloids—including vinblastine, vinorelbine, vincristine and liposomal vincristine—can result in fatal neurologic destruction. The ISMP, as well as other national and international drug safety agencies, have warned repeatedly of the potential for accidental intrathecal injection of these agents, but Dr. Rich said errors continue to occur. To date, 120 cases have occurred worldwide, with 44 deaths due to this type of error reported in the United States and Canada alone (ISMP Medication Safety Alert! Sept. 5, 2013). The ISMP has found that vincristine is the vinca alkaloid most frequently impli-

‘To our knowledge, there hasn’t been a single incident of vincristine or another vinca alkaloid being prepared in a minibag and administered intrathecally.’ —Darryl Rich, PharmD, MBA cated in accidental intrathecal injection. “In most of the published cases, the root causes of inadvertent intrathecal administration have not been fully described, but mistaking intravenous vincristine for an intrathecal medication such as methotrexate, cytarabine, or hydrocortisone, seems to be a common cause,” the ISMP wrote in a Sept. 5, 2013 Medication Safety Alert!. The Recommendation: Dispense vincristine and other vinca alkaloids in a minibag of a compatible solution and not in a syringe. The rationale behind this recommendation is that the volume of vincristine prepared in a minibag is too large for intrathecal administration, thus ensuring the drug is administered intravenously only, Dr. Rich said. “It also looks different from other medications that may appropriately be given intrathecally but are in a syringe,” he added. “To our knowledge, there hasn’t been a single incident of vincristine or another vinca alkaloid being prepared in a minibag and administered intrathecally. The score is 120 cases with a syringe and zero when in a minibag.” When vincristine is diluted in a minibag in dextrose 5% in water, lactated Ringer’s solution and 0.9% sodium chloride, it remains stable for between 24 hours and 21 days if it is stored in light at 4 C or in the dark at 25 C, Dr. Rich noted, citing Trissel’s Handbook of Injectable Drugs ((17th edition. Bethesda, MD: ASHP; 2012:1104-1105).

Best Practice 2 The Problem: Deaths have occurred due to the accidental administration of daily oral methotrexate for non-oncologic indications that are intended for weekly or biweekly administration (ISMP Medication Safety Alert! Sept. 19, 2013). The ISMP has traced such errors to any one of several steps in the prescribing and use process. For example, Dr. Rich said, physicians committing the error might be accustomed to prescribing methotrexate on a daily basis, which is the frequency of use in cancer treatment. Similarly, pharmacy technicians or pharmacists may inadvertently select or approve daily use instead of weekly for the same reason. Additionally, a patient might not be properly educated regarding correct methotrexate use, Dr. Rich noted. The Recommendation: Use a weekly

dosage-regimen default for oral methotrexate. If it is overridden to daily, require a hard-stop verification of an appropriate oncologic indication. And provide patient education by a pharmacist for all weekly oral methotrexate discharge orders. The ISMP also recommends that hospitals establish a protocol to ensure that patients receiving weekly methotrexate are appropriately educated. “Explain the weekly dosing schedule, explain that taking extra doses is dangerous and have the patient repeat back the instructions,” Dr. Rich said. He also noted that the ISMP offers a free consumer leaflet on oral methotrexate that is available online at www.ismp.org/AHRQ.

Best Practice 3 The Problem: The ISMP has received multiple reports of care providers weighing patients in pounds but then recording their weight in kilograms (ISMP Medication Safety Alert! Aug. 26, 2010). Dr. Rich said this can lead to a greater than twofold increase in weightbased drug dosing and a variety of significant drug-specific AEs. The Recommendation: Ensure that scales used for weighing patients are set to metric and then weigh patients and express their weights only in metric units. Dr. Rich urged hospitals to replace scales that only measure weight in pounds with scales that only measure in grams or kilograms. If hospital scales use both measures, he said to lock out the ability to measure weight in pounds. “Also ensure that information systems, printouts, preprinted order forms and medication device screens, such as infusion pumps, list or prompt for weight only in metrics,” he said.

Best Practice 4 The Problem: Patients have been administered liquid medications intravenously when they were intended for oral use, with fatal consequences (ISMP Medication Safety Alert! Aug. 23, 2012). According to Dr. Rich, in most of these cases, oral liquids had been prepared extemporaneously or dispensed in parenteral syringes that can be connected to vascular access lines. He said it is “particularly fatal ... when nimodipine is withdrawn from liquid capsules for administration through a nasogastric [NG] tube or other gastric tube but then accidentally [is] given intravenously.”

D Despite it clear l warnings i on labels, l b l intrathecally administered vinblastine has been implicated in 44 deaths in the United States and Canada alone.

There have been more than 50 reports of oral liquid drug measurement errors due to confusion between metric and non-metric container labeling. Newer syringe systems with more consistent calibrations are designed to reduce such confusion.

A number of cases occurred when a patient with subarachnoid hemorrhage and an NG tube was ordered oral nimodipine, he said. “In one of these cases, the pharmacy was unaware that the patient had an NG tube and dispensed oral gelatin capsules without instructions. Then the nurse softened the capsules under hot water and withdrew the medication liquid using a needle and parenteral syringe and accidentally administered this via the IV line,” he said. “Although the nurse immediately noticed her mistake and tried to withdraw the contents from the IV line, the patient rapidly decompensated and died.” The Recommendation: Ensure that all oral liquids that are not commercially available as unit doses are dispensed by the pharmacy in an oral syringe. Nimodipine is available commercially as an oral liquid, or it can be compounded by the pharmacy, prepared in an oral syringe and dispensed. “Oral syringes are designed to be incompatible with vascular lines, so they cannot be inadvertently attached,” Dr. Rich said. Other measures include only using oral syringes clearly marked with “Oral Use Only,” as well as ensuring that oral syringes cannot be connected to any type of parenteral tubing.

Best Practice 5 The Problem: There have been more than 50 reports of oral liquid drug measurement errors due to confusion between metric and non-metric container labeling, with some leading to injuries

•

see BEST PRACTICES, page 6

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6 Clinical

Pharmacy Practice News • May 2014

Medication Safety

Pharmacists Resolve Oral Chemo Errors at Admission A

Cleveland Clinic hospital has devised an interesting twist to pharmacist-conducted medication reconciliation: By assigning outpatient oncology pharmacists to review selected inpatient oral cancer drug orders, the hospital has improved the accuracy and safety of the chemotherapy regimens. During the program’s first year, the pharmacists found that nearly twothirds of oral chemotherapy orders at the time of hospital admission included errors. The errors were due, in part, to the fact that many of the orders were written by clinicians who did not typically prescribe oncology medications, according to Nicholas Link, PharmD, BCOP, a clinical pharmacy specialist at Hillcrest Hospital, a Cleveland Clinic Hospital in Mayfield Heights, Ohio, who developed the program. “Admitting physicians prescribing chemotherapy home medications upon admission are often not trained in oncology,” she said, “and it has become challenging for non-oncology pharmacists to keep up with the growing number of oral chemotherapeutics.” Because Hillcrest Hospital does not have inpatient oncology pharmacists to conduct cancer medication reconciliations, in 2012, the outpatient oncology pharmacists were called upon to carry out the process. Dr. Link explained that rerouting orders to the outpatient pharmacy has required a slightly revised workflow: The hospital’s computerized physician order entry system was modified so that inpatient pharmacists are notified when oral chemotherapy drug orders are placed at the time of admission. They then relay the order information to their outpatient oncology pharmacist colleagues, who subsequently reconcile the medications by interviewing patients and reviewing their medical records. According to Dr. Link, outpatient oncology pharmacists conducted 132

BEST PRACTICES continued from page 4

and hospitalization (ISMP Medication Safety Alert! Dec. 1, 2011). “These include mix-ups between milliliter and household measures, such as drops and teaspoonfuls,” Dr. Rich said. In one case reported to the ISMP, a child prescribed 1 mL midazolam syrup for sedation before a procedure was inadvertently administered 1 teaspoonful of the drug by a nurse who was using an oral syringe that included both measures, Dr. Rich said. Dosing cups and droppers are two other devices that commonly include

Table. Oral Chemotherapy Prescribing Errors At Admission Orders Erroneous With Multiple Orders Errors

Provider

Total Orders

Error Rate, %

Multiple Error Rate, %

Internal medicine

107 (81%)

Non–internal medicine

25 (19%)

Total

132

reconciliations between May 2012 and March 2013, and found that 63% of orders included at least one error and 18% had multiple errors (Table). The pharmacists corrected all of the errors during medication reconciliation, Dr. Link noted. The most commonly prescribed medication was methotrexate (56%), and the most common type of error was missing frequency of administration (40%; Figure).

“A common mistake was ordering once-weekly methotrexate but not specifying the day of [the] week on which the drug was to be administered,” he said, adding that this kind of error potentially is less severe than frequency omissions for more complex drug regimens. One example of a potentially more serious error was an order for capecitabine indicating that the drug was to be adminis-

Missing frequency 44 (40%) Contraindication 38 (35%)a Missing dose 23 (21%) Other 5 (4%)b

N=110

10%

20%

30%

Contraindications consist of medication/cancer-related (21) and admit medical condition–related (17).

This category includes wrong dosage form (2), patient yet to initiate therapy (2) and patient no longer taking medication (1).

40%

Figure. Types and proportions of prescribing errors.

both metric and non-metric measures, the ISMP has noted. The Recommendation: Purchase oral liquid dosing devices that only display the metric scale. If patients are taking an oral liquid medication after discharge, supply them with (or provide a prescription for) oral syringes to enable them to measure oral liquid volumes in milliliters. Dr. Rich said there are a variety of products that can help hospitals comply with these best practice recommendations. Health Care Logistics supplies Narrow Graduated Medication Cups marked only in milliliters, and Baxter manufactures the Exacta-Med Plastic Oral Dispenser with Tip Cap. Additionally, NeoMed oral

syringes will now display measures in the metric system only, he said, adding that “there are likely other similar products that ISMP is not aware of.”

Best Practice 6 The Problem: Four ISMP Medication Safety Alert! issues have noted accidental topical application of “glacial” acetic acid, which has a 99.5% concentration or higher (ISMP Medication Safety Alert! Jan. 24, 2013). The mistake has resulted in severe pain, serious tissue damage, third-degree burns and one bilateral leg amputation. “In most of these cases, glacial acetic acid was either accidentally purchased or used in place of a much more diluted form of

tered on days 1 through 14 of a 21-day cycle but failing to specify which day of the cycle the patient was at on admission, Dr. Link noted. Other serious errors included oral oncology drugs that were contraindicated because of a patient’s condition at the time of admission still being ordered. “Regardless of the perceived severity of the prevented error, any process that prevents errors is a great improvement,” Dr. Link stressed. The intricacies involved in oncology drug prescribing make Hillcrest Hospital’s program a valuable one, commented Jane Rogers, PharmD, BCOP, a clinical pharmacy specialist at the University of Texas MD Anderson Cancer Center, in Houston, who was not involved in the research. “When a patient is admitted to the hospital, these agents need to undergo the same thorough review that’s performed for injectable chemotherapies,” Dr. Rogers said. Such steps need to be taken, she added, “not only to ensure accuracy in medication ordering but also to decide whether or not to continue them in the inpatient setting. A medication reconciliation should take into consideration variables [such as] organ function status changes, patient performance status changes, chemotherapy cycle, the day of the patient’s cycle, the reason for admission, any drug–drug interaction changes, and whether adverse effects need management.” Dr. Link said that in addition to verifying medication orders, such “assessments of patient-specific variables are a critical component of the oral chemotherapy reconciliation process at Hillcrest Hospital.” —David Wild Drs. Link and Rogers reported no financial conflicts of interest. The Cleveland Clinic initiative was first presented at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting.

acetic acid, such as vinegar, or a commercially available 0.25% acetic acid solution,” Dr. Rich said. The Recommendation: Remove glacial acetic acid from all areas of the hospital and replace it with 5% vinegar solution, or commercially available, diluted acetic acid 0.25% for irrigation or 2% for “otic” use. “The pharmacy should never order, stock or distribute glacial acetic acid,” Dr. Rich stressed. —David Wild Drs. Rich and Hultgren reported no relevant conﬂicts of interest. Dr. Rich presented the ISMP drug safety recommendations at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting.

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8 Clinical

Pharmacy Practice News • May 2014

Cardiology

Team Approach to Heart Failure Effective but Underused

recent study is the latest addition to a growing body of research indicating that pharmacists working under collaborative drug therapy management (CDTM) arrangements can provide invaluable clinical care for patients with heart failure (HF). The findings showed that pharmacist services provided under a CDTM arrangement, including interventions such as initiation, discontinuation and

titration of HF drugs, was associated with 30-day readmission rates as low as 3.4% compared with the national average of 24% to 30%. “The heart failure management programs that seem to be the most successful are those that involve pharmacists as integral members of a multidisciplinary health care team,” said Brent Reed, PharmD, an assistant professor of pharmacy practice and

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science at the University of Maryland School of Pharmacy, in Baltimore, who specializes in cardiology and was not involved in the study. “Collaborative care agreements such as the one in this study allow pharmacists to practice to the full extent of their expertise and scope.” Indeed, prior studies have shown that patients receiving collaborative pharmacist–physician care can have significantly improved cardiovascular outcomes, including blood pressure control, compared with similar patients receiving cardiologist care alone ((Pharm Pract [Granada] 2012; 10:173-179). Angela Cheng-Lai, PharmD, and Lendita Prlesi, PharmD, both of whom are clinical pharmacy managers at Montefiore Medical Center, in New York City, set out to study the effects of HF collaborative care on 30-day readmission rates. The metric has become increasingly important since the Centers for Medicare & Medicaid Services imposed a 2% reimbursement penalty, which will increase to 3% in 2015, if an institution’s 30-day readmission rates are excessively high for patients with HF, as well as myocardial infarction and pneumonia. Since 2012, Montefiore pharmacists have been practicing under a CDTM protocol at the medical center’s outpatient cardiology clinic. The agreement allows pharmacists to adjust the dosing of HF drugs for clinic patients who have been diagnosed with HF or those with left ventricular ejection fraction less than 40%. “Our main goal at the clinic is to optimize use of ACE [angiotensin-converting enzyme] inhibitors and β-blockers, especially in patients with systolic heart failure,” Dr. Cheng-Lai said. “If patients are not receiving one of these agents and do not have contraindications for use, we initiate treatment. If they come in on a low dose and we feel they can handle a higher dose, we’ll titrate them up and get them as close to the target dose as soon as possible.” Between March 2012 and June 2013, Drs. Cheng-Lai and Prlesi conducted hour-long consultations with 59 HF patients, including 57 who had been discharged from Montefiore hospital. The median time between discharge and pharmacy consult was three weeks for the 57 patients. The pharmacists conducted a range of interventions, both general and specific to HF medication management. Their most common interventions were addressing adherence issues, which 49.2% of patients required, and titrating β-blockers, which 35.6% of patients needed (Table).

Clinical 9

Pharmacy Practice News • May 2014

Cardiology Table. Pharmacist Interventions in Heart Failure Patients General Interventions, %

Heart Failure Medication Interventions, %

Adherence issues addressed: 49.2

β-blockers up-titrated: 35.6

Unnecessary medications discontinued: 23.7

ACEI/ARB initiated: 16.9

Switched to appropriate therapy: 22

ACEI/ARB up-titrated: 11.9

Duplicate medications reconciled: 8.5

Diuretics initiated: 5.1

Improper medication use corrected: 6.8

Diuretics up-titrated: 3.4

demic medical centers and other large integrated health systems,” he added. “So, many providers outside these settings may be unaware of the services pharmacists can provide and the impact they can have on outcomes, in heart failure treatment and beyond.” —David Wild

Aldosterone antagonists initiated: 3.4 None of the participants reported relevant financial conflicts of interest. The Montefiore Medical Center study was presented at the American Society of Health-Systems Pharmacists 2013 Midyear Clinical Meeting.

Isosorbide dinitrate/hydralazine initiated: 1.7 ACEI, C ,a angiotensin-converting g ote s co ve t g enzyme e y e inhibitor; b to ; ARB,, angiotensin a g ote s II receptor ecepto blocker b oc e

The researchers reviewed patients’ post-visit data and found that 3.4% (2 of 59) were readmitted to the hospital within 30 days of discharge. Dr. ChengLai said that this readmission rate contrasts considerably with the 24% to 30% national average 30-day readmission rate for patients with HF (Circulation 2012;126:501-506). “I think our findings are very promising,” Dr. Cheng-Lai said. “Our evaluation of the impact of direct pharmacist care on heart failure patients is ongoing and we hope to verify these positive findings in a larger population of patients.”

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Study Limitations Toni Fera, PharmD, an independent hospital and pharmacy consultant located in Pittsburgh, who was not involved in this research, said that the study was conducted in a single practice and included a small number of patients, features that limit the strength of the results. However, she echoed Dr. Cheng-Lai’s sentiment, saying, “hopefully, these promising results will stimulate further research. “There are new roles evolving for ambulatory care pharmacists as hospitals now face incentives to increase patient satisfaction and reduce unplanned readmissions, and findings like these help to build the business case that supports pharmacy services across the continuum of care,” she added. (See story, page 1.) Dr. Reed suggested that the small size of the study population could partly be a reflection of the challenge pharmacists face in recruiting patients and conveying the message that direct clinical care provided by pharmacists is effective. “Although pharmacists are seen as one of the nation’s most trusted and accessible health care professionals, few patients are aware that we can enter into collaborative care agreements with physicians and other health care providers,” he said. “And while physicians who have worked alongside pharmacists as part of multidisciplinary health care teams are some of the profession’s greatest advocates, until recently, most of this collaboration has taken place within aca-

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10 Clinical

Pharmacy Practice News • May 2014

Cardiology

NITRO SHORTAGE

‘[Nitroglycerin] is something we’re really concerned about because if additional supplies don’t come in soon, you can only do conservation so long before things run out.’

continued from page 1

supplies of the vasodilator. The coping methods, such as advocating alternative agents and sharpening patient selection criteria for the drug, may well prove indispensable if nitroglycerin once again experiences supply chain hiccups. The rationing measures were needed because of the high demand for nitroglycerin, which is widely regarded as the optimal “stat” drug for treating the millions of people who experience myocardial infarctions or worsening heart failure in the United States each year. “With its short half-life and ability to be easily titrated for maximum effect, IV nitroglycerin really is the drug of first choice for these patients, especially in emergency room [ER] settings,” said Nicole M. Acquisto, PharmD, BCPS, an emergency medicine clinical pharmacy specialist at the University of Rochester Medical Center, in N.Y. The drug is also widely used, said C. Michael White, PharmD, the director of the University of Connecticut/Hartford Hospital Evidence-based Practice Center, in Storrs. Patients in cardiac crisis who are fortunate enough to make it to the hospital alive, Dr. White noted, “typically get IV nitroglycerin. If we can’t give them that ideal first option, then the potential to negatively impact a large number of people is certainly there.”

Conservation Has Its Limits For hospitals that rely on pharmacies’ just-in-time ordering to keep inventories lean and drug costs as low as possible, the prolonged squeeze on nitroglycerin stocks has triggered deep concerns about running short and being unable to treat their most critical patients. The situation is especially serious for smaller and rural hospitals, where a single individual with an acute coronary event could wipe out an entire stock in a single visit. The nitroglycerin crisis first surfaced in 2012 when Hospira, followed later by American Regent/Luitpold, halted production because of manufacturing issues. It has deepened in recent months after Baxter—prompted by rising demand— limited the drug to 40% and then 20% of normal shipments. It was just the latest, but one of the most serious of the more than 300 drug shortages that Erin Fox, PharmD, FASHP, is following as the director of the Drug Information Service at the University of Utah Hospitals and Clinics, in Salt Lake City. Dr. Fox said nitroglycerin “is something we’re really concerned about because if additional supplies don’t come in soon, you can only do conservation so long before things run out.” She said that Utah Hospitals and Clinics has instituted measures to preserve supplies, including “trying to limit the time

—Erin Fox, PharmD, FASHP

patients spend on nitroglycerin drips.” In the procedure areas that may need only small amounts, she said, the pharmacy department is drawing up doses “to make sure we have it for all of our patients.” Asked to comment on Baxter’s announcement of a return to 100% allocations, Dr. Fox replied, “I am encouraged, but I will believe it when I see it. Baxter says they are now going to allocate 100% of [a hospital’s] past usage, but they have a complicated rolling allocation ordering period and specific times when you can order. They refuse to provide the details in writing for our buyers.” Baxter spokesperson John O’Malley told Pharmacy Practice News that “the increased allocation details are being communicated both verbally and via a letter sent directly to customers.” Mr. O’Malley added that the company’s “primary goal is—and always has been— to ensure that patients’ needs are met, and we have taken a number of actions to enable continued access to products needed for critical patient therapies.” Those actions, he noted, date back to January 2014, when Baxter first began putting supplies of nitroglycerin products “through a temporary allocation and fulfillment process ... to expedite product for urgent need. Effective April 15, however, we returned customers to 100% allocation.”

Down to a Week’s Supply Katelyn R. Dervay, PharmD, BCPS, a pharmacotherapy specialist in emergency medicine at Tampa General Hospital, said she spoke with Baxter in mid-April and was told that her facility “is now up to a 120% allocation of the IV bottles for infusion. So we have removed our own restrictions on the product.” Dr. Dervay added, however, that “the nitro vials are still not available.” Restrictions on IV nitroglycerin at Tampa General began in March, when it became evident that “using the drug the way we used to, we had about a week’s supply,” she explained. As a level 1 trauma center licensed for more than 1,000 beds, Tampa General had to apportion its diminishing supply among several key departments and procedure areas where IV nitroglycerin is routinely used,

includiing the emergency department ((ED), cardiac catheterization lab, caardiac operating rooms and coronary care units, Dr. Dervay noted. “W We worked with our providers to iidentify the most appropriate patients for this medication,” Dr. Dervay said, including those with heart failure accompanied by pulmonary edema and those undergoing cardiac catheterizations. “ED patients who presented with angina were given an alternative form of nitroglycerin to relieve their symptoms,” such as sublingual tablets, spray or paste.

A Different Story Carilion Clinic, a seven-hospital health care system in southwest Virginia, has been on even more of a roller coaster when it comes its nitroglycerin supplies. When first contacted by Pharmacy Practice News in early April, the system had enough IV nitroglycerin on hand to supply its flagship Roanoke Memorial Hospital for one to two months, according to Dr. Deal. As a result, Carilion had not yet had to impose restrictions, she said, but would if supplies dropped below one month’s use. “We get allocated five boxes of 12 drips a month from Baxter,” she said at the time. “As of right now, we’re OK.” But by mid-April, Dr. Deal got a different story from her staff. “I just called my inventory technician and he said our allocation had been reduced—so I don’t see any signs [of improvement].” If it turns out that nitroglycerin supplies continue to be pressured and restrictions on the drug’s use are needed, Dr. Deal said, “we would save those multidose vials and use them in the [catheterization] lab because nitroglycerin can be used intra-arterially during cath procedures to vasodilate cardiac vessels.”

Down Six Cases At Maimonides Medical Center, in New York City, Victor Cohen, PharmD, BCPS, a clinical pharmacy manager and specialist in emergency medicine, said that the 711-bed facility has been reduced to four cases a month of injectable nitroglycerin, down from its usual 10 cases. To conserve the drug for patients who need it most, he said, “we alerted everyone” to use alternative agents whenever possible, including sublingual and topical formulations of nitroglycerin. For hypertensive patients, he said, “you can use other vasodilators, especially if an afterload reduction is needed.” Dr. Cohen mentioned that IV nicardipine had been recommended,

and added that “you can also use Cleviprex” (clevidipine injectable emulsion; The Medicines Company), a relatively new drug that has “been shown to be very helpful in acute hypertension.” He cited two studies supporting the use of clevidipine in this setting. In the VELOCITY (Evaluation of the Effect of Ultra-Short-Acting Clevidipine in the Treatment of Patients with Severe Hypertension) trial, 94% of 127 patients with severe hypertension (systolic blood pressure [SBP)]>180 mm Hg) who received IV clevidipine achieved target SBPs within 30 minutes (Congest Heart Faill 2010;16:55-59). In the PRONTO (Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure) trial, 104 severely hypertensive patients (mean SBP: 186.5 mm Hg) were randomized to receive IV clevidipine (51) or standard hypertensive care (53). More patients in the clevidipine group (71%) achieved the prespecified target blood pressure range than those receiving standard care, and time to target was more rapid for clevidipine-treated patients ((Am Heart J 2014;167:529-536).

Uncharted Territory The lack of IV nitroglycerin also has had an effect on other types of cardiac patients. Dr. White said he received a message from a colleague at a nearby community hospital that had to switch from papaverine to IV nitroglycerin plus verapamil for its patients undergoing bypass surgery after the papaverine supply dried up. “Now they can’t get the nitroglycerin,” he said. “So what are we supposed to do?” the colleague asked. “And the answer was, ‘I don’t know,’” Dr. White said, “because there is nothing else that has really been studied.” Baxter said it is taking steps to limit such instances where clinicians run out of supply—and options. “As the only manufacturer supplying the U.S. market with nitroglycerin in an intravenous or injectable form, Baxter is deploying product through the company’s primary distribution centers in order to enable and support expedited shipping,” the company noted in an email. “We also have worked to increase material supply and have redirected manufacturing operations in order to increase production.” —Bruce and Joan Buckley None of the sources reported any relevant ﬁnancial conﬂicts of interest.

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12 Clinical

Pharmacy Practice News • May 2014

Personalized Medicine $3.7 million grant spurs pharmacist-coordinated research

Pharmacogenomics Gains More Tracti A

t the University of Florida’s (UF) Shands Hospital, patients scheduled for percutaneous coronary intervention are routinely screened for genetic variations that could render the anti-clotting drug clopidogrel ineffective. A blood test is processed within 24 hours and results are added to patients’ electronic medical record (EMR). If patients have a variation that could predispose them to heart attack, stent thrombosis or other issues, the EMR alerts the cardiologist. When a prescription is written for a patient with such a genetic variation, the EMR recommends alternate drugs. This is just one example of how the burgeoning field of pharmacogenomics, the study of how genes affect an individual’s responses to drugs, is moving into patient care. Although some institutions have been researching this for years, “it’s relatively new that it’s become so widespread,” said Howard McLeod, PharmD, the medical director of the DeBartolo Family Personalized Medicine Institute at Moffitt Cancer Center, in Tampa, Fla. “For a long time, it was either a research tool or something a few places did because they were zealous believers. Now pretty much every pharmacy school is teaching it.” With a $3.7 million grant from the National Human Genome Research Institute, UF researchers will expand their work to investigate genetic variations affecting responses to additional medications, starting with azathioprine and 6-mercaptopurine, according to Julie Johnson, PharmD, the dean of UF’s College of Pharmacy and the director of UF Health’s Personalized Medicine Program. They also will work with hospitals in Orlando and Tallahassee to adopt pharmacogenetic testing. Other hospitals also have adopted pharmacogenomics into practice. At St. Jude Children’s Research Hospital, in Memphis, Tenn., patients are routinely screened for four genes—cytochrome (CYP) P450 2C19 (CYP2C19), 9 CYP 2D6 (CYP2D6), 6 SLCO1B1 and thiopurine methyltransferase (TPMT)—that T could yield metabolic variations that negatively interact with 12 drugs. Test results are added to the patient’s EMR; if a clinician orders one of those 12 drugs for a patient with a high-risk genotype, the EMR will fire an alert suggesting alternate medications or doses. To date, some 55 clinical decision support rules have been added to the hospital’s EMR system. Additionally, the hospital is analyzing patient blood samples for 226 additional gene variations that may become important for drug use. The information will be stored in the research laboratory until sci-

entific evidence suggests it could be used to aid prescribing decisions, according to Mary Relling, PharmD, the chair of the hospital’s pharmaceutical department. The system doesn’t preclude a physician from ordering additional genetic tests, Dr. Relling said, “but we’re hoping over time that we’ll have enough penetration of this preemptive approach for the vast majority of patients that you’ll no longer have to have a clinician think, ‘I’m going to order drug X so I’d better also order gene test Y.’ Gene test Y will have already been done and the results will be available to them in the EMR.”

Screening for Safer Clopidogrel Like UF Shands, the University of North Carolina at Chapel Hill, also screens patients undergoing cardiac catheterization for the CYP2C19 gene that can affect clopidogrel metabolism, noted Dr. McLeod, who directed the university’s Institute for Pharmacogenomics and Individualized Therapy until last September. Gastroenterologists and rheumatologists there also routinely use the TPMT T test in deciding whether to use azathioprine for inflammatory bowel disease or autoimmune disease. Such testing is needed, Dr. McLeod noted, because patients with the TPMT T mutation cannot properly metabolize the drug; as a result, they are at high risk for the buildup of toxic blood levels of the medication that can lead to neutropenia. “A normal dose of azathioprine for everyone else is functionally an overdose for a patient with a TPMT T mutation,” he explained.

In the works are plans to rou-tinely test patients for the CYP3A55 genotype to guide dosing of tacrolimus or sirolimus to prevent rejection of transplanted d kidneys. “CYP3A5 breaks down n these drugs, so we can use the in nformation to estimate the correct dru ug dose about twice as fast,” Dr. McLeo od said, “which may mean patients don’t have to be readmitted to the hospital.” And at Moffitt, Dr. McLeod is starting a committee to look at molecular aspects of clinical care and help decide what gene variants should be acted on and how. He’s also looking to implement a similar approach for patients with a predisposition to extreme toxicity. “If you’re a busy oncologist, you might know about KRAS or some other gene variants, and know what to do,” he said. “As you start sequencing more broadly, there are lots of different genes you’ve never even heard of before, and you don’t have time to go look them up.” In many cases, genetic testing can make an important clinical difference. Among more than 1,000 cardiology patients who had their CYP2C19 genotype tested at UF, 28% had a variation leading to a suggested alternative to clopidogrel. At St. Jude, EMR alerts for prescribers fired 1,552 times between May 2011 and November 2012 for patients with TPMT and CYP2D6 variations, and an analysis revealed that they appropriately guided prescribing 95% of the time. “There will be many drugs where genetics is completely useless, and there will be others where genetics will make a

‘There will be many drugs where genetics is completely useless, and there will be others where genetics will make a huge difference in terms of dose selection and toxicity management.’ —Howard McLeod, PharmD

Molecular model of thiopurine methyltransferase (TPMT), an enzyme that can interfere with drug metabolism in patients with certain genetic polymorphisms.

huge difference in terms of dose selection and toxicity management,” Dr. McLeod said. “Right now I would be surprised if there’s any clinical center in the U.S. that hasn’t at least evaluated whether pharmacogenomics is going to be useful.”

Focus on 60 ‘Actionable’ Drugs Dr. Relling co-leads the Clinical Pharmacogenetics Implementation Consortium (CPIC), an international collaboration between PharmGKB and the National Institutes of Health’s Pharmacogenomics Research Network that writes guidelines for prescribing specific drugs based on genetic test results. CPIC has estimated there will be 15 relevant genes with variations that could lead to adverse effects from about 60 drugs. “There’s probably about 1,000 approved chemical entities in the U.S., so a maximum of 10% of all medications will have what we think are actionable pharmacogenetic associations, and we don’t think that number is really going to change much over the next five to 10 years. “We’re only going to improve therapy for a minority of drugs,” Dr. Relling added, “but some are very commonly used and some are extremely dangerous, and there will be situations where you can prevent life-threatening adverse reactions to drugs.” There’s still work to be done. Some of the most commonly prescribed drugs have been evaluated, but others have yet to be studied, Dr. McLeod pointed out. Genetic testing for drug reactions could, in the next several years, become as common as [a magnetic resonance imaging] scan, he said. Meanwhile, “we’re out of the ‘hype’ stage,” Dr. McLeod stressed, adding that the field provides a great opportunity for pharmacists to serve as leaders in providing clinical guidance. For CPIC’s guidelines, see http://bit. ly/1h70GK5. —Karen Blum

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14 Clinical

Pharmacy Practice News • May 2014

Metabolic Medicine

Pharmacists Can Play Key Role in Bariatrics P

harmacists in many practice settings can play a key role in managing chronically obese patients who undergo bariatric surgery, according to three pharmacists who have helped bolster their facilities’ ability to manage the clinical needs of these complex patients. “Obesity is one of those chronic conditions [on which] pharmacists in both inpatient and outpatient settings can have a big impact,” said Katie S. McClendon, PharmD, BCPS, a clinical pharmacist at the University of Mississippi Medical Center’s West Jackson Family Medicine Center, in Jackson. “I’m an outpatient ambulatory care pharmacist, but hospital pharmacists may be involved before surgery in selecting appropriate antibiotics, in venous thromboembolism prophylaxis and in adjusting diabetes control.” She said that pharmacists in both settings also can help control the chronic conditions and risk factors that increase a surgical patient’s chances of an adverse event—not just type 2 diabetes but also high blood pressure, elevated cholesterol level and smoking. There is also a role for pharmacists in helping patients achieve their weight loss goals before electing surgery. Such efforts may include dietary and lifestyle modifications, but they also may be focused on pharmacologic therapy, including the two newest medications, lorcaserin (Belviq, Eisai) and phentermine/topiramate (Qsymia, Vivus). Although these drugs have proven effective in inducing significant weight loss in some overweight and obese patients, both carry warnings about increased risks for cardiovascular-related and other adverse events. Qsymia, in fact, comes with a Risk Evaluation and Mitigation Strategies (REMS) requirement relating to the known teratogenic potential of one of its two components, topiramate. It can be dispensed only by certified pharmacies. Lorcaserin has a Pregnancy X warning. “These medications do have safety concerns,” Dr. McClendon said. “We want to be thoughtful of that but not to the extent that we don’t remember that they may be appropriate for some of our patients who need additional tools to help them be successful in their weight loss.”

Reducing the Risk Pharmacists can help to reduce the risks of these drugs, according to Kathryn Hurren, PharmD, BCACP, a clinical pharmacy specialist in the Department of Ambulatory Care, VA Ann Arbor Healthcare System, in Michigan. Dr. Hurren told Pharmacy Practice News that “pharmacists can screen patients

for potential contraindications to these medications before dispen nsing. Pharmacists with access tto laboratory information can ensuree that no drug-related laboratory abnormalities are occurring, especially with Qsymia. Avoiding significant drug interactions is very important with these medications. For example, lorcaserin is serotonergic and should not be used with other serotoner-gic medications, such as [selectivve serotonin reuptake inhibitors].” Despite the potential of these newer weight loss treatments and other older ones, bariatric surgery may be the only answer for obese patients who fail to lose weight and face the prospect of multiple comorbidities and premature death. According to the Centers for Disease Control and Prevention, the prevalence of obesity has increased steadily over the past decade, from 30.3% of adults aged 20 years or older in 19992000 to 35.9% by 2010 (http://1.usa. gov/1d5bLbw). w Despite this magnitude, only a small percentage of obese patients choose to undergo bariatric surgery. The American Society for Metabolic and Bariatric Surgery estimates that only about 160,000 bariatric procedures were performed in the United States in 2010 (http://bit.ly/1hFTENQ). Q

Area of Growth for Pharmacists At the University of Washington Medical Center’s Level 1 Bariatric Surgery Center, approximately 175 to 200 procedures are performed each year, according to Lingtak-Neander Chan, PharmD, an associate professor at the University of Washington School of Pharmacy and specialist for the University of Washington Medical Center bariatric surgical department, both in Seattle. Dr. Chan said because of his faculty duties, his role on the surgical team is mostly on a consulting basis. “I know that most bariatric surgery centers don’t have a full-time or even part-time pharmacist,” he told Pharmacy Practice News. “Certainly, that is one area where we hope to see more pharmacists.” Dr. Chan said there was a lot that pharmacists can do “before and especially after bariatric surgery” to help ensure optimal outcomes. For example, he said, “Our research [and other research has] shown that the absorption pattern of medications changes; so the same drug given as a liquid may get absorbed very quickly and achieve a very high blood level. And we have patients who clearly experience adverse reactions, and we have to modify their regimen.” In addition, he said, patients taking extended-release tablets may find

th h at at

medications get stuck, and they have to be converted to immediate-release doses that need to be given several times per day. “And some patients will have the doses readjusted to maximize the treatment benefits,” he said. “Ideally, we want to convert some of these medications or dosage forms at least a couple of weeks prior to surgery,” he said, “so a patient doesn’t have to have everything new from scratch; and of course in some cases, there will also be insurance coverage issues, so you want them all resolved prior to surgery.” Dr. Hurren addressed additional factors that can affect patient outcomes following surgery. “Depending on the procedure,” she noted, “bariatric surgery patients may have decreased surface area, increased gastric pH, decreased gastric emptying, bypassed active drug transporters and altered first-pass metabolism and enterohepatic recycling.” Additionally, she said, “There are limited data regarding the pharmacokinetic changes for specific medications. Instead, anticipating potential changes requires an understanding [of ] how the pharmacokinetic properties of the medication and the anatomical changes of the procedure will interact. Pharmacists can assist in therapeutic drug monitoring and determining optimal dosage forms.” After surgery, patients require “a chronic regimen of vitamins and minerals to avoid deficiencies and related complications, such as anemia and osteoporosis,” according to Dr. Hurren. Patients also may need changes in their regimens for chronic obesity-related diseases, such as type 2 diabetes mellitus, hypertension and dyslipidemia after surgery, she said. “Pharmacists are the optimal providers to anticipate, monitor for and manage potential pharmacokinetic changes of oral medications resulting from the changed anatomy.”

An Ongoing Challenge Part of the medication therapy education that bariatric surgery patients require can be done by hospital pharmacists at discharge, but monitoring a patient’s progress is a permanent requirement. “You have received a surgery that has changed your anatomy forever,” Dr. Chan said, “so you are basically going to have a lifelong lifestyle change. Along the line of some of the comorbidities, the surgery would drastically change their insulin requirement, blood sugar control, serum lipids and blood pressure. So, shortly after surgery, these medications need to be readjusted. If they are followed closely by the primary care provider, that’s great,” he said, “but if a patient lives in a more remote area, that’s another area where pharmacists can play a role.” He noted that patients can have some of their signs and symptoms monitored at a pharmacy, “and the results can be referred back to their primary care provider for dose adjustment.” For example, he said, “we have patients who live 150 miles from the university medical center, so they don’t fill their medication prescriptions here; they go back to their local pharmacies.” Dr. Chan stressed that it is important to coordinate with the remote pharmacy to ensure that, for example, they stock the “special dosage forms” bariatric surgery patients may require. —Bruce and Joan Buckley Drs. Chan and Hurren reported no relevant ﬁnancial conﬂicts of interest. Dr. McClendon reported a research grant from Allergan for a project focusing on patients who undergo bariatric surgery. All three presented some of their experiences treating bariatric patients during a session at the American Society of Health-System Pharmacists 2013 Midyear Clinical Meeting.

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16 Clinical

Pharmacy Practice News • May 2014

Safe Handling

CSTDs continued from page 1

federal health officials, slated for release in the next few months, contains testing methodologies—albeit not outright results—that hospitals can use to compare the efficacy of currently available CSTDs as an aid in vendor selection. Couple those developments with a growing body of data suggesting that the relatively high cost of CSTDs can be more than offset by savings due to reduced drug waste and other efficiencies, and it becomes clear that “this technology really deserves to get more widespread consideration by health systems today,” according to James Jorgenson, RPh, MS, FASHP, the president of Hospitals & Health Systems, at the health care consultancy Visante Inc., in St. Paul, Minn.

A Look at the Data Any consideration of CSTDs should begin with a review of data on hazardous drug handling, Mr. Jorgenson noted during a session on the devices at the recent annual meeting of the Hematology/Oncology Pharmacy Association. He said two key questions need to be explored: does the preparation of chemotherapy drugs result in leakage and environmental contamination, and does that contamination pose a significant health risk to exposed workers and patients? “On both counts, the data are pretty clear,” Mr. Jorgenson said. “Numerous studies have shown, via environmental ‘wipe’ sampling and other techniques, that hazardous drugs are indeed present in the workplace, and I don’t mean inside the vials, syringes or IV bags where they belong.” Specifically, he noted, drug traces have been detected on pharmacy and nursing area work surfaces, the outside of drug vials and even general work surfaces and in air samples, according to one review of the literature ((J Oncol Pharm Practt 2011;7:9-13). Multiple studies, he added, have shown that these chemotherapy traces are showing up in the urine of health care workers, including nurses, pharmacists and technicians. Mr. Jorgenson has found in his own research that a CSTD can reduce such surface contamination. In the study, all 17 wipe samples collected before CSTD implementation had detectable levels of cyclophosphamide, versus only seven of 21 samples taken six months after implementation ((Am J Health Syst Pharm 2003;60:2314-2320). The question, of course, is whether there is a direct correlation between such exposures and adverse health outcomes. According to Mr. Jorgenson, although it is very difficult to show a causal relationship, the many studies showing significantly elevated rates of miscarriages in nurses handling cytotoxic agents ((J

‘Numerous studies have shown, via environmental “wipe” sampling and other techniques, that hazardous drugs are indeed present in the workplace, and I don’t mean inside the vials, syringes or IV bags where they belong.’ —James Jorgenson, RPh, MS, FASHP Womens Health 2010;19:1851-1862) “tells us that we need to be improving our efforts at protecting these individuals.”

Cost Remains a Concern Unfortunately, health system pharmacy leaders who see these data as compelling often meet resistance when trying to convince the C-suite to invest in a CSTD system. “These devices can cost hundreds of thousands of dollars,” Mr. Jorgenson said, “and that can be a tough sell in the current fiscal climate, where cost pressures are still the norm.” Indeed, recent industry figures suggest that only 41% of hospitals currently have implemented CSTDs, and of the hospitals that balk, nearly 80% cited cost as a main barrier, he noted. However, simply looking at acquisition cost can be a misleading method for assessing the financial impact of CSTDs, he stressed. “I can show that for every $1 spent on CSTDs, a hospital has the potential to save $5,” Mr. Jorgenson noted. “So I like to say that with CSTDs, you get safety and d savings.” Facilities can achieve those savings, he explained, via several efficiencies gained. But perhaps the most striking, he noted, is a process known as drug vial optimization (DVO), in which CSTDs are used by pharmacies to extend the period of time in which the stable drug contents of a partially used vial can be used for sterile compounding and dispensing to patients. Researchers have shown that extended sterility, sometimes referred to as beyond-use dating (BUD), is indeed an achievable goal when CSTDs are used, Mr. Jorgenson noted. For example, in a growth medium simulation using a CSTD, Carey et al determined that at 168 hours, none of the more than 300 drug vials they studied had any visual or microbiological evidence of bacterial growth ((Hosp Pharm Europe 2010;49:1718). Coupled with real-world studies showing similar outcomes, “these data clearly show that CSTDs are capable of maintaining long-term sterility,” he said. When used in such a fashion, several health systems have found that CSTDs can be highly cost-effective, Mr. Jorgenson reiterated. The University of Texas MD Anderson Cancer Center, in Houston, for example, completed an independent study with three other hospitals which showed that they were able to maintain

product sterility for up to seven days using a CSTD, versus the six hours achieved using methods that did not employ the closed system technology ((Pharmacy Practice News, March 2014, page 16). As a result of that extended sterility, drug waste from discarded, partially used vials was reduced significantly and hundreds of thousands of dollars saved annually.

The Regulatory Arena There also are increasing regulatory pressures to adopt optimal safe handling strategies (some including CSTDs) to protect workers and patients, Mr. Jorgenson noted. Washington state, for example, was the first to pass such legislation (SB 5994), using National Institute for Occupational Safety and Health (NIOSH) guidelines as its basis. The law, he noted, acknowledges that exposure to hazardous drugs in the workplace is associated with acute and short-term, as well as long-term, adverse health effects. And the law also points to the fact that reproductive studies on health care workers have shown an increase in fetal abnormalities, fetal loss and fertility impairment resulting from occupational exposure to cytotoxic agents. “In January [2014], California passed safe handling laws as well, and other states are in the process of drafting similar legislation,” he said. In another encouraging development, USP recently released its draft Chapter <800> guidelines on the handling of hazardous drugs in the workplace. “First off, it states that there is no acceptable level of personnel exposure to hazardous drugs,” Mr. Jorgenson said. “That is an extremely important message to emphasize, because it lowers the bar for seeing a need to implement CSTD-type interventions.” As for specific mentions of CSTDs, the language regarding the devices in USP Chapter <800> is a bit stronger than that found in Chapter <797>. Although the older guidelines state that use of the devices “is ‘preferred’ because of their inherent closed system process,” the proposed new guidelines state that “[CSTDs] ‘should’ be used when compounding hazardous drugs.” But then it gets a bit murky: In another section, the draft states that “[CSTDs] ‘shall’ be used when administering hazardous drugs.” In both cases, the following caveat is added: “when the dosage form allows.”

Ernie Anderson, MS, RPh, a health care consultant based in Brockton, Mass., who implemented CSTDs when he was the director of pharmacy at two large health systems in the Northeast, said that USP Chapter <800> “is long overdue,” and he agreed that the statement claiming there is no tolerable level of personnel exposure to hazardous drugs “is spot on.” However, he was less enthused with the potentially confusing use of the terms “should” and “shall” when it comes to the USP’s recommendations on CSTDs. “Either you clearly state that this is something we should all be doing, or clearly state that it is just a suggestion,” Mr. Anderson said. “I can’t really tell from that wording where they stand.” Acknowledging that these are just draft guidelines—the comment period ends July 31, 2014—Mr. Anderson made his own position clear on the USP wording. “I’m not a fan of mandates,” he said. “They often cause more problems than they solve, with the Joint Commission and other agencies perhaps getting involved.” Such a scenario, he said, “may force a rapid pace of CSTD adoption that not all health systems are ready for.”

Are All CSTDs Created Equal? Assuming that all of these arguments in favor of CSTDs resonate—clinical, financial and regulatory—and a health system decides to purchase a CSTD, the next challenge is to determine which system to choose. “This can be an involved process—there are six systems currently available,” Mr. Jorgenson said. Help may be at hand from a new study that points to qualitative differences between CSTDs. Conducted by NIOSH, the study compared all CSTDs and CSTDtype devices on the market. “My understanding is that the study looked primarily at whether the devices succeeded in maintaining a closed system and preventing leaks of cytotoxic agents into the environment, and found some differences between the devices tested,” Mr. Jorgenson said. Although NIOSH has indicated that it won’t release the device-specific results of the test, he noted, “there are indications that they will release the study methodology in the next few months.” When those testing methods are made available, hospitals can take them to an independent lab “and for a reasonable cost ask the lab to use the methods to compare the CSTD devices in consideration,” Mr. Jorgenson pointed out. It then would be reasonable “to include those results in your decision making.” Mr. Jorgenson cited a recent study by DeAusen et al, which also suggested that there may be some variability in the degree to which different commercially available CSTDs prevent leakage. The authors acknowledged that there were “several major limitations” to the

Clinical 17

Pharmacy Practice News • May 2014

Safe Handling research, which may be why their conclusion was not so much to endorse one device over another, as much as it was to emphasize that the data “supports the use of CSTDs” in general “to help protect health care workers” ((Am J Health Syst Pharm 2013;70:619-623).

Important Questions Philip Johnson, MS, RPh, FASHP, the oncology director at Premier Inc., agreed that the case for CSTDs is strong enough for health systems to explore their potential safety benefits for all staff involved with compounding or administering hazardous substances. For hospitals exploring CSTDs, several key questions need to be addressed, Mr. Johnson stressed. He first echoed the point that if there are data suggesting qualitative differences between CSTDs, “those need to be carefully reviewed.” Based on his own determinations, he noted, “the currently available devices are very different, each with its own unique selling points.” Further, he added, “you must understand the importance of staff training, the actual risk when all variables are considered, and the [financial] impact both in terms of added supply costs and the potential to decrease drug waste.” Mr. Johnson added another important consideration. “We know [CSTDs] may reduce worker exposure to cytotoxic agents, but is it necessary to use a CSTD for every chemotherapy drug or only those that are truly classified as hazardous?” Mr. Anderson said “there may be some logic” to the idea of reserving CSTDs for only the more cytotoxic medications. But such an approach, he pointed out, would have several practical drawbacks. “Asking technicians to keep track of— and document—chemotherapy admixtures that require a CSTD versus those that don’t could really be problematic in terms of workload and compliance,” he noted. “But more importantly, I’d be worried about the mixed message such a policy would be sending to our staff. To me, either we’re serious about preventing exposures or we’re not.” Mr. Johnson raised a final key point in devising a CSTD strategy: should the design of a hospital’s sterile compounding facility be a factor? “If a USP Chapter <797>–compliant room is in use, properly maintained and certified, and staff properly trained,” he posited, “does such a facility really need to add CSTDs as an added layer of protection for every chemotherapy formulation?” Mr. Anderson said that at first glance, such a setup would seem to provide adequate protection against leaks and worker contamination. “But as studies have shown, you can get aerosolization of these compounds no matter how good your technique is—even when

you’re using these various technologies and safeguards.” That’s not to say, Mr. Anderson stressed, that one can skimp on environmental controls. “They certainly reduce the degree of exposure to cytotoxic contaminants,” he said, “but they don’t eliminate it.” Adding a CSTD, he said, “may well be the best way to create a truly closed system.”

An Issue of Ethics? Mr. Anderson added that in his discussions regarding CSTDs, “by far” the most common concerns regarding the devices

involve the issue of cost. “These systems are expensive, make no mistake,” he said. “But I agree with Mr. Jorgenson’s take that the data on worker exposure to cytotoxic agents shows a clear-cut safety risk. So although I don’t discount the need for us to be fiscally responsible, in this case, the safety data should be the most compelling factor. To me, it argues strongly in favor of more widespread CSTD adoption.” Mr. Anderson added that “this is also a question of leadership and ethics: to protect the safety and well-being of your workers is one of the most important

duties you have as a pharmacy director.” Given that prism, he noted, “[implementing CSTDs] is something you just have to do.” —David Bronstein Mr. Jorgenson disclosed that he is a speaker for Becton Dickinson and has obtained research funding from Carmel Pharma. Mr. Anderson and Mr. Johnson reported no relevant ﬁnancial conﬂicts of interest.

Next Issue: More devices and technologies for bolstering safe handling.

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Volume 41 • Number 3 • March 2014

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in this issue UP FRONT

Student’s Corner: the ‘Five Ps’ of pharmacy assessment.

CLINICAL

4 6 16

Practice Pearl: a collaborative plan for enhancing the quality and safety of insulin therapy. Hep C rates slashed in liver transplant patients; results “practice-changing.” Hospitals at the tipping point for more widespread CSTD adoption.

WEB EXCLUSIVE

Part 1 of a 2-Part Series

ASP Building Tips: Going Slow Yields Big Success Orlando, Fla.—“Learn to crawl before you walk and run,” was the first piece of advice Ed Eiland, PharmD, MBA, BCPS (AQ-ID), FASHP, dispensed to a room full of attendees at the 2013 American Society of HealthSystem Pharmacists Midyear Clinical Meeting eager to implement or strengthen their own antimicrobial stewardship program (ASP). Based on the $1.34 million in savings Dr. Eiland achieved with his own revamped ASP, not to mention a 25% drop in 30-day hospital readmissions and a nearly 50% drop in Clostridium difficile infections (CDIs), the go-slow strategy can yield major dividends.

Phase 1 (2005-2007) His team’s first step in building the ASP was to assemble an antimicrobial management team (AMT), including pharmacists, infectious

•

Radiofrequency Identification (RFID) reduces errors, speeds process of refilling drug trays. See Technology section, pharmacypracticenews.com

EDUCATIONAL REVIEW

Cardiovascular Medications With Food and Grapefruit Juice See page 22.

see ASP BUILDING TIPS, page 8

Nearly $1 M in cost avoidance

Pharm Technicians Praised for Spot-on Med Reconciliation

New sterile compounding legislation:

Does Bill Have the Muscle To Stop Another NECC? B

y the end of 2013, a sigh of relief cou uld be heard in some patient safety circles afterr newly passed legislation gave state and federall officials broadened oversight powers to regu ulate sterile compounders. With the new insp pection muscle bestowed on those officials, the chances of another New England Co ompounding Center (NECC)-type outbreeak killing or injuring hundreds of patien nts seemed significantly diminished. The latest details on the results off those inspections, however, suggest that safety gaps still remain. Of the 20 sterile compounding facilities that have registered with the FDA under the bill’s new “outsourcing facility” category, less than half had been inspected by the FDA as of late Febru-ary. That may not be surprising, given the early days of the legislation’s rollou ut. The more striking finding is that only tw wo of the inspected facilities have been given a clean bill of health. Sites failed insp pection for

•

see COMP POUNDING, page 26

A Push for Practice Change Yields Big Payoff at U Kansas

Orlando, Fla.—Emergency department (ED) pharmacy technicians (PTs) at several hospitals received praise at the 2013 American Society of Health-System Pharmacists Midyear Clinical Meeting for conducting medication reconciliations with up to 96% accuracy. The studies found that PTs were able to detect a substantial number of errors included

Chicago—Millions of dollars in new revenue. A 30 percentage-point gain in patient satisfaction score. A fourfold increase in the capture rate for pharmacist-completed admission histories and discharges. Any of those achievements would be impressive on its own. But scoring all three in less than a year’s time is a testament to the power of taking an entrepreneurial approach to practice change, according to Rick Couldry, MS, FASHP, the director of pharmacy at the University of Kansas Hospital in Kansas City, Kan. At the American Society of Health-System Pharmacists’ (ASHP) annual leadership conference, Mr. Couldry described some of the key components of his strategy for revamping pharmacy operations. One effective strategy, he noted, is to tell compelling patient stories that communicate viscerally why a proposed practice model change is needed, and be prepared to answer the question of “So what?” by delivering measurable evidence of a program’s

see ED TECHNICIANS, page 10

see BIG PAYOFF, F page 30

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New Product Codonics, RIVA V team up for safer labeling. See Technology section, pharmacypracticenews.com

18 Clinical

Pharmacy Practice News • May 2014

Organ Transplantation Focus on electronic-based technology

Medication Adherence in Solid Organ Transplant Recipients Seth Heldenbrand, PharmD Clinical Pharmacy Specialist, Solid Organ Transplant Associate Professor College of Pharmacy Department of Pharmacy Practice University of Arkansas for Medical Sciences Little Rock, Arkansas

he International Society for Pharmacoeconomics and Outcomes Research defines medication adherence as the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen. Depending on how it is calculated, nonadherence to medications can account for nearly 70% of medication-related hospital admissions and approximately $100 billion to $300 billion in health care costs annually. Medication nonadherence following solid organ transplantation can lead to acute rejection, graft loss, infections, additional morbidity and even death. The gravity of this issue has not been lost on transplant pharmacists, who, in controlled trials, have been shown to improve both medication adherence and certain transplant-related outcomes.1

Causes of Nonadherence Medication nonadherence can be broadly categorized as intentional or unintentional. Intentional nonadherence involves the patient making a conscious choice not to take a medication as prescribed. Patients demonstrate intentional nonadherence for a variety of reasons including their financial situation, social pressures, adverse effects of the drugs and a lack of perceived benefits of therapy. Conversely, unintentional nonadherence occurs when a patient plans to take a medicine as instructed but fails to do so for some reason (eg, carelessness, forgetfulness, poor planning, etc). Although this view is somewhat simplistic, it highlights the need for tools and strategies to help the patient struggling with medication adherence. Monitoring medication adherence is an important component of patient care after a solid organ transplant. Several methods, such as patient self-reporting, manual pill counts, prescription refill records, electronic pill bottle adherence technologies, laboratory monitoring, and emerging biologic dose administration recording devices, can help clinicians monitor adherence. Newer technologies under development rely on microtransmitters to confirm pill ingestion and adherence by sending

data wirelessly to a remote monitor. However, each method of monitoring adherence has limitations. For example, the accuracy of patient self-reporting hinges on the patient’s memory and honesty. Patients forgetting their pill bottles or “pill dumping” before the evaluation can compromise manual pill counts. Invasive blood monitoring guarantees ingestion but not adherence. Because all methods to monitor medication adherence have their drawbacks, most experts recommend using more than one tool simultaneously to achieve best results.

Traditional Tools To Improve Adherence Most methods to improve medication adherence focus on changing the patient’s medication-taking behavior. Changing behavior typically requires modifying a patient’s beliefs about the medication regimen. For example, a patient is much less likely to be adherent if he or she believes that the regimen is too complex, too expensive, or has too many adverse effects. Adherence interventions or the removal of barriers to adherence can be classified as behavioral, educational, or organizational. Transplant pharmacists have numerous tools that can be employed alone or in combination to improve patient adherence through behavior modification. Methods that have been studied in the transplant setting include counseling, reinforcement, and education. Other methods include dosage reminders, financial mitigation, and simplification of dosages. This can be accomplished by the organ transplant pharmacist working alone or it can be done in concert with a physician. Traditional medication reminders such as simple alarms, calendar reminders, and daily or weekly pillboxes are commonly used to help transplant patients stay on their drug regimens and are most effective in mitigating unintentional nonadherence, particularly with less complex regimens. However, in most patients, as the complexity of the regimen increases, the effectiveness of these interventions wanes. Behavioral interventions and medication counseling generally are regarded as reliable methods that have been frequently evaluated and provide the most benefit to patients struggling with nonadherence. In patients taking more than six medications, pharmacist counseling is considered the best method for improving adherence.2 The medication burden for the average transplant recipient is substantial; such a patient typically is discharged

from the hospital taking anywhere from 11 to 14 drugs. Therefore, the Centers for Medicare & Medicaid Services (CMS) mandates the involvement of transplant pharmacists in patient education and care. Common patient education strategies that transplant pharmacists use include traditional education, medication counseling, medication-taking aids such as pillboxes, and detailed regimen instructions. Other methods include the use of motivational interviewing and emotional intelligence. These techniques focus on identifying with patients and facilitating their intrinsic motivation to help them modify their behaviors. Again, it is best to use these methods in combination to produce a meaningful improvement in medication adherence.

Smartphone Apps And Adherence Emerging technologies such as smartphone applications that promote medication adherence and that are tailored to a patient’s specific needs have the potential to significantly improve adherence and outcomes. The prevalence of smartphones has been growing among all demographic groups over the past five years. Applications aimed at medication adherence have shown promise in several small studies, but large-scale trials assessing their true ability to improve adherence are lacking. Smartphone apps may represent a useful tool for patients demonstrating unintentional nonadherence. In a recent article, Lindsey Dayer, PharmD, BCOP, a clinical pharmacist in palliative care and an assistant professor at the University of Arkansas for Medical Sciences, in Little Rock, and her colleagues wrote: “Adherence apps can be downloaded for little to no cost, and their benefits may be realized by anyone taking prescription medications.

However, these apps may prove most beneficial for patients with complex medication regimens or for caregivers ... or family members. The growing prevalence of smartphones in the United States and their constant, easy accessibility make adherence apps appealing to many because they cost little and can provide user-specific information.”3 The number of adherence apps available from the various online marketplaces is overwhelming. Dr. Dayer and her colleagues reviewed 160 apps downloadable from iTunes, Android Marketplace and Blackberry App World.3 Functionality varied widely among the available apps, so the authors identified the most desirable features and then scored and ranked the apps by which ones had the highest number of valuable features. Important app features evaluated by the researchers included the ability to enter medication data online; complex instruction capability; cloud storage of data; HIPAA compliance; tracking of taken and missed doses; and the ability to sync or export data to health care professionals. The ability of a provider to enter the regimen using drop-down boxes and send it to the patient’s device through online data entry can reduce patient input errors and can decrease stress on patients who are not tech savvy. Moreover, the capability to export robust medication administration data is a useful function for providers monitoring adherence rates and helps identify problem areas for patients who are missing doses. Although some apps handle only simple instructions such as taking a medication once or twice per day, others can facilitate medication tapers, nondaily dosing, and monthly pill holidays that generate accurate reminders and eliminate unnecessary ones. Of the apps that were reviewed and tested by Dayer et al, the one with

Clinical 19

Pharmacy Practice News • May 2014

Organ Transplantation the highest performance was MyMedSchedule (iTunes and Android). MyMedSchedule has a companion website (www.medactionplan.com) that can be used by patients and health care providers. “MedActionPlan … allows providers to quickly create personalized treatment plans for patients that are easy to understand and follow,” Tim Peters, owner of MedActionPlan, LLC, said in an interview with Pharmacy Practice News. “Providers can send this information directly into the patients’ MyMedSchedule, a patient version of MedActionPlan. Getting patients proactive in their health care is an important step in addressing nonadherence.” Pharmacists have been using MedActionPlan and MyMedSchedule in transplant patients since its introduction in 2004. “MedActionPlan is … the best tool on the market for closing the gap between medication education for transplant recipients and medication reconciliation for transplant health care professionals,” said Pam Maxwell, PharmD, BCPS, a transplant specialist and residency director at University Health-System, in San Antonio. “Its ease of comprehension for extremely complex medication regimens promotes adherence within a diverse patient population, while its user-friendly automation promotes efficiency for providers and engagement in self-care for patients.” However, these apps have one major limitation, according to Sarah Hutton, PharmD, a transplant pharmacist at Sanford Hospital, in Sioux Falls, South Dakota. The technology “does not com-

municate with our electronic medical record [EMR],” Dr. Hutton said. “Hence, a provider is still required to do medication reconciliation in the EMR. This results in a lot of duplicate work and introduces risk for transcription errors.” Other apps that Dayer et al ranked highly were MyMeds ((www.mymeds. com) and MedSimple ((www.medsimpleapp.com). Notably, none of the apps communicated with EMR systems at the time the authors reviewed them—a lack of functionality that persists. Both are available in the iTunes and Android marketplaces. Other innovative features that are being integrated into newer apps include escalating reminder systems that enlist the help of caregivers using patient-specified social networking to improve adherence. Escalating reminders become more aggressive if the patient neglects to confirm or deny the indicated dose. If all reminders are ignored and the patient has specified a caregiver to contact, the app can alert the caregiver that the patient has missed doses and should be reminded to take the medication. Medication adherence is a complex problem, especially for transplant recipients who often have a high medication burden and are more likely to suffer immediate as well as long-term consequences of nonadherence. A variety of tried and emerging tools exist for pharmacists and other clinicians to help ensure adherence. Medication adherence apps are exciting technologies aimed at addressing these prob-

Series Editor: Eric M. Tichy, PharmD, BCPS, FCCP Senior Clinical Pharmacy Specialist, Solid Organ Transplantation Director, PGY-2 Residency-Transplant Department of Pharmacy Yale-New Haven Hospital New Haven, CT

dherence to the post-transplantation medication regimen remains the greatest area in which pharmacy providers and patients can have a defined effect on transplant outcomes. As with other problems in society, there is significant potential for technology to provide a solution to the conundrum of medication nonadherence. The transplant pharmacy community has long been an early adopter of Web- and smartphone-based programs that are designed to provide medication use education and tools to improve patient adherence to the medication regimen. Although there are more than 160 smartphone applications designed to improve patient adherence to the medication regimen, an informal poll of the American College of Clinical Pharmacy Immunology/Transplantation Practice and Research Network recently showed that only one app was pervasively used (MyMedSchedule), with other transplant centers continuing to rely mostly on paper-based systems. A major limitation of these Web- and smartphone-based programs is the lack of automated coordination with the “official” EMR medication list. Furthermore, these programs do not even coordinate with the outpatient dispensing pharmacy. The lack of electronic coordination between these 3 entities (dispensing pharmacy, provider medical record, and patient) leaves a fragmented process with numerous opportunities for miscommunication and errors that are detrimental to medication use adherence. The challenge for the producers of smartphone technology is to provide a patientfriendly interface that also serves as a platform that coordinates between the provider medical record and dispensing pharmacy. When those aims are achieved, our patients will have received an indispensable service.

lems. Clinical evidence on how to best use these technologies to improve medication regimen adherence should be available in the near future.

References 1. Alloway RR, Dupuis R, Gabardi S, et al. Evolution of the role of the transplant pharmacist on the multidisciplinary transplant team.

Am J Transplant. 2011;11(8):1576-1583. 2. Conn VS, Hafdahl AR, Cooper PS, et al. Interventions to improve medication adherence among older adults: meta-analysis of adherence outcomes among randomized controlled trials. Gerontologist. 2009;49(4):447-462. 3. Dayer L, Heldenbrand SM, Anderson P, et al. Smartphone medication adherence apps: potential benefits to patients and providers. J Am Pharm Assoc. 2013;53:172-181.

NEW PRODUCT

FDA Approves Naloxone Auto-Injector for Opioid Overdose

he FDA approved the first prescription treatment specifically designed for use by family members or lay caregivers to treat a known or suspected opioid overdose. Evzio (naloxone hydrochloride injection, Kaléo) rapidly delivers a single dose of naloxone via a handheld auto-injector. The drug has been the standard treatment for opioid overdose, but until the Evzio approval, only trained medical personnel could administer it. Several medical groups, including the American Medical Association, a longtime advocate of increasing the availability of naloxone to help reduce overdose deaths, have supported the newly approved treatment. Drug overdose deaths, largely driven by prescription drug overdoses, are now the leading cause of injury death in the United States. The most recent data from the Centers for Disease Control and Prevention show that more than 16,000 lives are lost each year due to opioid-related overdoses. This novel treatment will help save some of these lives because it will be available to the public and can be carried in a person’s pocket, said Lynn Webster, MD, the immediate past president of the American Academy of Pain Medicine. “Part of the problem in the past was a lack of options besides calling 911 to help a person having an opioid overdose,” Dr. Webster said. “In cases involving illicit drug use, there was often a fear to contact the authorities. ... when a family member did call for help, sometimes the ambulance just didn’t arrive in time. Having something that is measured and controllable will save lives by enabling the earlier use of the drug in such emergencies.” Evzio is intended for injection into the muscle or under the skin. Similar to

automated defibrillators, once turned on, the device provides verbal instruction describing how to deliver the medication. Because naloxone may not work as long as opioids, repeat doses may be needed, according to the FDA. It is not, however, a substitute for further, immediate medical care, the agency stressed. The use of Evzio in patients who are opioid-dependent may result in severe withdrawal. In one pharmacokinetic study of 30 patients, a single Evzio injection provided the equivalent amount of naloxone compared with a single dose using a standard syringe. Evzio was reviewed under the FDA’s priority review program, and the drug was granted a fast-track designation, a process designed to facilitate the development and expedite the review of drugs used to treat serious conditions when no satisfactory alternative therapy exists. “This can be a very useful way to help some people who have overdosed but it’s not the solution,” Dr. Webster said. “We need to find opioid replacements for the treatment of chronic pain, and the best way for that to happen is for the industry to develop safer medications that don’t have any rewarding properties and don’t jeopardize respiratory function.” For more information, call (888) INFO-FDA, or visit www.evzio.com for full prescribing information.

—Paul Bufano

20 Clinical

Pharmacy Practice News • May 2014

Case Report Emergency department toxicology:

Diphenhydramine Overdose in a Male Adult Michael Dark, PharmD, BCPS Emergency Department Pharmacist Metroplex Health System Killeen, Texas

iphenhydramine is a first-generation histamine receptor-1 antagonist. Pharmacologically, it suppress-

es the histamine response and, thus, inflammation, itching, and swelling. It has an onset of action of 15 to 30 minutes, with a peak plasma concentration at approximately 2 hours. Diphenhydramine often is used recreationally1 and as a method of suicide.2 In intentional overdoses, patients report visual and auditory hallucinations as well as

delirium. The anticholinergic potential of diphenhydramine is very large. Common anticholinergic adverse drug reactions include mydriasis, confusion, tachycardia, and urinary retention. Physostigmine is an acetylcholinesterase inhibitor used for anticholinergic toxicity reversal. By inhibiting acetylcholinesterase, physostigmine potenti-

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer. Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery. This activity is jointly sponsored by Global Education Group and Applied Clinical Education. Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade. Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois

Challenge Questions 1. What would you do next? 2. What potential postoperative risks does this patient face?

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ates the action of acetylcholine (opening and depolarizing sodium ion channels), countering anticholinergic activity. The onset of action of physostigmine typically is 5 to 10 minutes. The dose for reversal of anticholinergic toxicity is 0.5 to 2 mg given intravenously,3 although there is an older report suggesting that 0.3 mg given intravenously is effective.4 This case is a 23-year-old white man weighing 70 kg. This patient was brought by ambulance to the emergency department (ED) 45 minutes after an intentional overdose (850 mg) of diphenhydramine in a suicide attempt. The patient was sedated and had altered mental status. He could not give a history or answer any questions. He was experiencing myoclonic muscle contractions and his vitals were blood pressure, 158/98 mm Hg; heart rate, 124 beats per minute; respiratory rate, 21 breaths per minute; oxygen saturation, 100%; and temperature, 99.1oF (Figure). Skin, mucous membranes, and pupils were normal. Thirty minutes after the patient arrived in the ED (75 minutes postingestion), gastrointestinal (GI) decontamination was initiated with 50 g of activated charcoal. The patient was hooked up to telemetry and given an IV access site. Thirty minutes after GI decontamination, the patient had no improvement in mental status, myoclonus, or heart rate, although blood pressure decreased to within normal limits. At this point, the patient was given 0.3 mg of IV physostigmine. Lactated Ringer’s solution also was added for IV hydration. After 15 minutes with very little effect (some reduction in heart rate), the patient was given another 0.3 mg of physostigmine IV, after which his mental status and vitals returned to baseline. The myoclonus resolved

SEND US YOUR CASE REPORTS If you have an interesting case report that you would like to share with our readers, please submit it. All submissions will be considered for publication.

Write to Editorial Director David Bronstein at davidb@mcmahonmed.com

Clinical 21

Pharmacy Practice News • May 2014

Case Report 180 160 140

45 minutes

120 105 minutes

100 80

120 minutes

60 145 minutes

40 20 0 Systolic blood pressure, mm Hg

Diastolic blood pressure, mm Hg

Heart rate, beats per minute

Respirations per minute

Temperature

Figure. Patient’s vitals from 45 minutes after ingestion to 145 minutes after ingestion.

treatment. http://toxnet.nlm.nih.gov/cgi-bin/ sis/search/f?./temp/~pdeUev:1. Accessed March 6, 2014. 4. Lee JH, Turndorf H, Poppers PJ. Physostigmine reversal of antihistamine-induced excitement and depression. Anesthesiology. 1975;43(6):683-684. 5. Chyka PA, Seger D, Krenzelok EP, et al. Position paper: single-dose activated charcoal. American Academy of Clinical Toxicology; European Association of Poisons Centres and Clinical Toxicologists. Clin Toxicol (Phila). 2005;43(2):61-87.

Dr. Dark reported no relevant ﬁnancial conﬂicts of interest.

30 minutes after the second IV dose of physostigmine.

Discussion The Hazardous Substances Data Bank indicates that 25 mg/kg or 1,000 mg of diphenhydramine in adults is toxic.3 This patient ingested 850 mg. He received one dose of activated charcoal with no effect. He also received 2 doses of physostigmine 15 minutes apart. The first dose of physostigmine had little effect and the second dose stabilized the patient. The dose of activated charcoal (50 g by mouth) was appropriate,5 but there is no evidence supporting the use of charcoal for GI decontamination beyond 1-hour post-ingestion.5 Two physostigmine doses of 0.3 mg were given 15 minutes apart. The first dose elicited a response in the form of decreased heart rate but did not resolve the patient’s altered mental status or myoclonus. The second dose resolved the altered mental status and myoclonus. This result supports the findings by Lee et al also showing a patient who required 2 doses of 0.3 mg of IV physostigmine for complete reversal.4

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Conclusion Physostigmine has been proven to be an effective agent for reversal of anticholinergic toxicity. However, physostigmine 0.3 mg IV was not sufficient to induce complete reversal in this patient or the case written by Lee et al. These 2 cases demonstrate that an additional physostigmine dose of 0.3 mg IV (total of 0.6 mg IV) may be needed for the drug to be effective. Notably, neither patient in these 2 cases showed adverse effects caused by physostigmine. Thus, 0.6 mg was a safe and effective dose of physostigmine when used for reversal of anticholinergic toxicity.

References

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1. Thomas A, Nallur DG, Jones N, et al. Diphenhydramine abuse and detoxification: a brief review and case report. J Psychopharmacol. 2009;23(1):101-105.

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22 Policy

Pharmacy Practice News • May 2014

Reimbursement Matters

End-to-End Audits for Pharmacy R

evenue cycle. End-to-end audits. We often hear these terms bandied about as being important, but do you really understand what they mean and why they’re important to you in the pharmacy? And even more importantly, how your procedures, actions (or lack of them) can have a profound effect on reimbursement? Regardless of whether you’re a clinician or a pharmacy manager or the information technology (IT) guru of the pharmacy system, understanding the revenue cycle and being able to conduct an end-to-end audit and then fix any identified problems is essential. This is an important goal to reach not just for ensuring a revenue stream this year, but also for years to come as each updated year’s payments are built on accumulated previous data. The alternative— doing it incorrectly—will continue to haunt you and your peers. A typical end-to-end audit covers the amount that was charged and the amount that was received and tries to determine causes of discrepancies. But it’s a much more complicated scenario when expensive drugs are involved because many factors along the path may have contributed to issues. Working through the revenue cycle diagram (Figure) will help identify trigger points that become action steps. As with all aspects of health care, pharmacy is not in this alone and does not operate within a silo. You’ll need to put your best negotiating and teambuilding skills to work to solve these issues that require cooperation with physicians, nursing, IT and the financial group, to name a few. Here are some additional considerations and action steps needed to ensure success, based on the key points in the revenue cycle. Patient in outpatient area. This first step is critical. Any patient not admitted as an inpatient is considered an outpatient, regardless of where in the hospital the patient may be treated or seen. This includes clinics, the emergency room, the operating room, observation units, and diagnostic or treatment areas that may be shared with inpatients or located in inpatient areas. Action: 1. Ensure that your pharmacy systems distinguish between an inpatient and an outpatient when you receive a drug order or when a drug is dispensed from an automated dispensing cabinet. 2. Ensure that you receive the payor information along with other admitting data. Physician chooses drug. If the drug is expensive, have you determined whether a patient navigator or financial

Figure. The revenue cycle. LCD, local coverage determination; MAC, Medicare administrative contractor; NCD, national coverage determination

advisor has worked with the patient and the physician to determine payment requirements? Does your pharmacy staff, including your clinicians, know what these requirements are? Does the drug fall into the specialty pharmaceutical or specialty pharmacy arena? Physicians, nursing and pharmacy departments determine prior authorizations and coverage determination status and confirm documentation. Both private payors as well as Medicare and Medicaid require documentation of rationale for use in a very specific manner before agreeing to pay for the product. Action: Use pharmacy drug master (PDM) or computerized prescriber order entry systems to tag drugs with prior authorization and local or national coverage determination (LCD/NCD) requirements so these are not missed. Remember that Medicare puts you on the honor system, trusting that you will have met requirements but not paying if you haven’t. Remember, once the drug has already been given, fixes to documentation after the fact are not permitted. Physician writes drug order. Is this step out of sequence? Does the physician order come before any of the authorization and financial discussion steps? If so, is it possible that the order is processed before all the information is available and required steps taken? Again, it is worth repeating and stressing that data

cannot be added to the chart after-thefact to justify actions. Pharmacy that acquires, prepares and dispenses drug generates charge. There are so many moving pieces here and so many systems involved that constant vigilance is essential, remembering at all times that a slight change to one system can cause a ripple effect through the whole chain of events. Action: Look into the following key issues that could affect coverage: 1. Is the actual drug purchased and dispensed in sync with what is listed in the PDM, including the NDC number? 2. Have you created a PDM and charge description master (CDM) entry for zero-priced drugs, such as whitebagged medications and complementary products? Remember, drug administration fees cannot be billed unless the zero-priced drug is also billed at zero charge. 3. Is the Healthcare Common Procedure Coding System (HCPCS) code included in the PDM? Does it match the HCPCS code in the CDM? Are they current? 4. Are all miscellaneous HCPCS codes removed as soon as either a temporary or permanent HCPCS code is assigned? 5. Are you vigilant with brand-specific HCPCS codes? 6.Are the CMS-assigned billing units correct and is the crosswalk to con-

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bkirschen@aol.com with suggestions on reimbursement issues that you would like to see covered.

Bonnie Kirschenbaum, MS, FASHP

vert actual dose given to billing units functional? 7. Do you have a Medicare waste billing program and is it functional? 8. Have you remembered to bill for all packaged or bundled drugs or those that are not separately payable? Drug administration fees cannot be billed unless these drugs also are billed; they will be included in reimbursement of the bundle or package. Nursing administers drug with documentation and generates drug administration fee. Drug administration fees are divided into two main categories: those for complicated products including chemotherapy, immunotherapy and biologics, and those for simpler products. Both of these categories require documentation of both the time the product was hung and the time infusion finished. Action: 1. Work with nursing and the revenue cycle group to create a list of products that fall into the complicated category. This is critical; lack of pharmacy involvement in this scenario has led to multiple “creative” fixes, usually resulting in significant underpayment. 2. Use the electronic medication administration record to make it simple for nursing to document times. Charges sent to Medicare administrative contractor or other payor; payment received or denied. Are there multiple systems that information passes through before the charge finally is submitted? Check each of these thoroughly and regularly to ensure that data are consistent and in sync from one to the other. Determine the reasons for denial and follow through to correct flaws in your systems. Internal accounting transfers money, credits pharmacy with drug and portion of drug administration fee. This last step is crucial, and especially so as the fee-for-service payment model transitions to a bundled or packaged model. Pharmacy is responsible for acquiring the product and needs to work with the finance team internally to determine a method for transferring payment dollars from the bundle back to their cost center. However, you need to know what went into the bundle and ensure that it’s complete to be able to do this. Good luck with this most crucial part of keeping your pharmacy finances on track! As always, we welcome comments and questions. After all, these columns are meant to prompt discussion. ■

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24 Operations & Management

Pharmacy Practice News • May 2014

Leadership in Action

Trust: The Oil of Highly Performing Teams

n the previous five articles based, in part, on Henry Cloud’s “Boundaries for Leaders” (HarperCollins, 2013), we looked at the relationship between our thinking—that is, our actual brain function—and the effect that it has on our creativity, productivity and leadership. We looked at the importance of paying attention and focusing on the relevant, inhibiting the distractions and using our working memory of relevant infor-

mation to make decisions. We looked at the importance of cultivating a positive emotional climate in ourselves and at how that can help us to make strong, productive connections with others. We explored the importance of concentrating on the factors that, as leaders, we can control to get the necessary results from our staffs. And we looked at high-performance teams. In this article, we focus on trust as the factor

that enables teams to perform.

Trust Allows Teams To Perform As leaders in pharmacy, we often feel overwhelmed by all the items on our plates. We know that our teams need to be high-performing to get things accomplished and move our departments forward. Yet sometimes we are frustrated with the snail’s pace at which progress is being made. You have several

in Your Inbox ... to receive the monthly e-newsletter from

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“Leadership in Action” is authored by Ernest R. Anderson Jr., MS, RPh, of Brockton, Mass. Mr. Anderson welcomes your input on leadership issues, at ernestanderson1130 @gmail.com

Ernest R. Anderson Jr., MS, RPh

people on your management team, each working on their own projects that will, ultimately, accomplish the goals of your department. I submit to you that the oil that lubricates your team to be effective and collaborative is trust. Well, of course, you say. We all know that; but, if you look at the members of your leadership team, are they truly demonstrating collaboration, or are they working on their own projects and not seeing that they are part of the whole? Are they only concerned with the vertical aspects of their projects at the expense of the horizontal, the other members of your management team who have their own projects as well? In previous articles, I described the importance of team members understanding the broad vision for the department in the context of the health system and where the team member’s individual projects fit in to that overall vision. Each member must recognize this to accomplish the overall goals. Every project, process and initiative requires the commitment of the entire management team working together. So what do you do if you are not getting the results you are looking for? How do you build in your team the trust that will lubricate the processes to form a highly effective, results-oriented interdependent team? Let’s answer this question.

Defining Trust Within Your Team

Get the latest news delivered directly to your computer and PDA. The new interactive format has embedded Web site links that give you instant access to additional information as well as unique searching features and printing capabilities. Each installment contains brief summaries of the most important articles from the current month’s issue, and breaking news ahead of print.

As a starting point, defining and agreeing to the critical components of trust sets the framework. Here are some components, as recorded in Stephen M.R. Covey’s “The Speed of Trust” (Free Press, 2008). • Connection through understanding • Motivation and intent • Character • Capacity and ability • Track record Trust grows when we feel understood. Trust grows, not when we understand other people, but when they know we understand them. There is a big difference. This validates the other person. They know “we get it.” Often, this requires clarifying questions and can be confirmed when you tell the other person what you understand. They need to feel it. This usually reduces defensiveness and allows validation. For this to work, it is imperative that those involved tell the truth. People need to trust each other to feel safe to tell the truth. As a leader, you need to

Pharmacy Practice News • May 2014

Operations & Management 25

Leadership in Action demonstrate listening skills and receptivity to feedback. You may want to have a frank discussion with your team about the safety of being honest. Do all members feel safe giving feedback? Sometimes feedback is tough to hear, but can be life-changing. Some members may find it harder to give feedback than to receive it. They don’t want to “hurt” anyone. Only when your team plays honestly on the field of your conference room can you build trust. Getting all the information out on the table allows for faster decisions, fewer meetings and consistent progress. Trust grows when we know someone intends to help us. As the team leader, are you only looking out for yourself or does your team understand that your intent is to help them in any way you can? When your staff is successful, you are successful. Do your managers know you have their best interest at heart? This is servant leadership. Are all the members of your management team “for one another”? Do they have one another’s backs? This breeds trust and teamwork. Is your team about the “whole” looking out for one another and not just their own functions? You as the leader must demonstrate your intent, so others can internalize and own it as they relate to others. Trust grows when we demonstrate character. Character is integral and inseparable in the trust discussion. Character encompasses many attributes including morality, ethics, traits, attitudes and ways of behaving. The key question is how does each member function within the team? Are there characteristics that should be brought to light that adversely affect the functioning of the team? These could include blind spots, an inability to connect, putting one’s own interests over those of the team, an inability to deal with criticism or negative realities, risk aversion, a lack of discipline, being a “yes” person and others. Conversely, we trust people who exhibit characteristics such as a willingness to listen, honesty, perseverance, selflessness, a willingness to take calculated risks, a willingness to serve others, discipline, kindness and wisdom. In summary, being credible instills trust. Trust grows when we believe in someone’s ability and capability. People can have the greatest of intentions but simply lack skills in a particular area. Trust builds when we know an individual has the ability to accomplish the task at hand. If that is not the case, then the solution is building a team that has complementary skills, so together great work can be accomplished through the knowledge of those best equipped for each task. Trust grows when someone has a good track record. The evidence of a good track record breeds trust with fellow

team members. When your team knows they can count on you, you have their backs; they trust you implicitly because you have proven yourself in the past. A team also can have a track record with other teams in the system.

Making Investments We all make choices about how we will invest our lives. People are willing to give their hearts, souls and minds to something or someone they can trust. Are you that trustworthy leader? I hope so. ■

26 Operations & Management

Pharmacy Practice News • May 2014

Pharmacy Leadership

Effective C-Suite Reports Mix Panache and Substance Orlando, Fla.—Hospital and healthsystem C-suites are faced with a seemingly endless flood of data, charts and reports, but executives only have a finite amount of time and attention. The challenge for pharmacy leadership, therefore, is to create analytics that show the most important outcomes in the most effective way. For Erin Taylor, PharmD, the assistant director of Inpatient Pharmacy Services at Baystate Medical Center, in Springfield, Mass., fighting for the attention of her bosses was certainly a challenge. But an additional hurdle her department faced in communicating their outcomes to the hospital’s executives was what she believes is a lack of understanding regarding pharmacy’s functions and contributions.

“The C-suite basically wants one metric that captures the pharmacy’s impact, but there’s no single metric that defines either our operations or our clinical benefit to the organization,” explained Dr. Taylor, who presented her department’s strategy in a poster at the American Society of Health-System Pharmacists (ASHP) 2013 Midyear Clinical Meeting (poster 5-006). Dr. Taylor said her team has chosen to use pharmacy department metrics that tie in with specific strategic hospital goals, and to present them by combining a visual dashboard and a business report (Table). On the metrics side, Dr. Taylor’s team linked the hospital’s quality leadership goal with rates of dispensing errors and breakdowns of the types of dispensing

errors that occurred. Similarly, they tied the hospital’s financial stewardship goal with pharmacy productivity measures, like drug and labor expenses and antibiotic costs. “These metrics provide a far better picture of what our workflow and impact on the organization is, rather than presenting just one metric like the number of doses dispensed—that doesn’t show anything meaningful,” Dr. Taylor said. She and her pharmacy leadership colleagues have asked their staff to document interventions using the hospital’s electronic health record system and have been drawing on those data to create dashboards and business reports. The data are collated on a monthly or quarterly basis and presented to hospital executives using a mix of graphs,

‘The C-suite basically wants one metric that captures the pharmacy’s impact, but there’s no single metric that defines either our operations or our clinical benefit to the organization.’

—Erin Taylor, PharmD

Table. Pharmacy Metrics and Organizational Goals at Baystate Medical Center Organizational Goal

Corresponding Pharmacy Metric

Quality leadership

• Dispensing events per 1,000 patient-days • Dispensing event classification

Growth and financial stewardship

• Drug expenses: -Pharmacy drug expense totals by cost center -Drug expense/PIS (weighted–adjusted per patient-day) -Annual top 15 drug expenditures -Cumulative cost-savings Initiatives • Labor expenses: -Pharmacy wage and non-wage expenses compared with budget -Labor expense/PIS (weighted–adjusted per patient-day) -Hours worked/PIS (weighted–adjusted discharge) • Inpatient medication order verification volume (includes average orders per pharmacist-hour worked per day) • Inpatient medication doses dispensed (includes doses dispensed per technician-hour worked per day) • Automated dispensing machine activity and labor • Pyxis growth/technician FTEs • Pharmacy technician activity overview • Antimicrobial stewardship program initiatives (ROI): -Targeted antibiotic DOT/1,000 patient-days -Antibiotic cost per discharge

Academic innovation

• Investigational drug services overview (number of active studies, number of patients enrolled) • Cumulative count of departmental research publications, regional and national presentations and poster presentations • Experiential education summary (count of IPPE/APPE students, PGY1 residents, PGY2 residents)

Care innovation and integration

• Pharmacy clinical activity metrics: -Overall patient care interventions: frequency and volume -Overall patient care interventions: cost avoidance -Direct patient care activities (e.g., medication histories, patient education): cost avoidance

Organizational engagement

• Gallup employee engagement scores: department roll-up

bullet points and brief sentences, Dr. Taylor said. “The graphs allow them to get a quick idea of the pharmacy’s performance, and the sentences can be inserted directly into their quarterly reports,” she explained. Despite the C-suite membership’s initial preference for a single pharmacy metric, she said executives have responded well to the combination of dashboard and business report. “We’ve given them the data that they can use on a more senior level.”

Getting Institutional Buy-In Jannet Carmichael, PharmD, who is the Veterans Affairs Sierra Pacific Network (VISN) 21 pharmacy executive and postgraduate year-2 residency director at the VISN in Reno, Nev., said aligning pharmacy and organizational strategic goals is a good approach to designing a dashboard and business report. “It’s a great way to get institutional buy-in,” said Dr. Carmichael, who helped design the VISN 21 pharmacy clinical dashboard and was not involved with Dr. Taylor’s project. “I also like the idea of creating dashboards for the C-suite because it provides a very digestible way to deliver information in a brief time to busy people.” Dr. Carmichael recommended adding an interactive component to ramp up the “oomph” factor of a clinical dashboard. “See if you can drill for more information, for example,” she suggested. Scott Knoer, MS, PharmD, who is the chief pharmacy officer at the Cleveland Clinic, in Ohio, said pharmacy leaders should keep in mind the evolving accountable care l an ds cape, w i th i ts emphasis on outcomes related to patient safety and quality of care. He said measures like Hospital Consumer Assessment of Healthcare Providers and Systems survey scores and 30-day readmission rates are becoming more important as these types of outcomes are increasingly tied to reimbursement. “It’s still important to show cost metrics, savings summaries, pharmacy retail capture rates and specialty pharmacy sales, for example,” Dr. Knoer said. “But the kinds of things that keep CEOs up at night are improving quality and safety.” —David Wild

DOT, days of therapy; FTE, full-time equivalent; IPPE/APPE, Intro Pharm Practice Experience/Advanced Pharm Practice Experience; PGY, postgraduate year; PIS, pharmacy intensity score; ROI, return on investment

None of the participants reported any relevant ﬁnancial conﬂicts of interest.

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28 Operations & Management

Pharmacy Practice News • May 2014

Finances Right strategy can yield huge revenue boost, better care coordination

Specialty Pharmacy: Why and How To Get In Orlando, Fla.—If you’re a hospital or health system with an oncology, hematology or neurology practice of any size, and you aren’t already investigating your options for establishing your own specialty pharmacy, you’re way behind the game. That was one key take-away message from “Strategies for Building a Specialty Pharmacy,” a midday symposium sponsored by AmerisourceBergen that was held during the 2013 Midyear Clinical Meeting of the American Society of Health-System Pharmacists. Featuring Jim Smeeding, RPh, MBA, the executive director of the National Association of Specialty Pharmacy, and Sylvia Bartel, RPh, MPH, the director of pharmacy and clinical support at Boston’s Dana-Farber Cancer Institute, the session explored the size of the specialty market; how hospitals and health systems can break in; and what the stakes are if they don’t. “NME [new molecular entity] approvals have reached levels not seen in the past decade, but most are specialist-

driven therapies,” Mr. Smeeding said, adding that 30 specialist-driven medications were approved in 2012 versus nine primary care–driven drugs. “The major challenge to everyone in the room today is not if you want to participate in specialty pharmacy; the challenge is if you will be allowed to participate!” Hospitals and health systems that do not have their own specialty pharmacies are losing out on a tremendous source of revenue. Mr. Smeeding suggested that a moderately sized health system with $2 billion to $3 billion in annual revenue stands to gain $20 million to $30 million annually by adding its own specialty pharmacy. “If you don’t, you’re getting back products that have already been dispensed and reimbursed to a specialty pharmacy, and all you’re going to get is the fee for administration,” he said. “You have all of the risk and need to administer, but none of the revenues associated with the product.” What’s more, fragmentation of care

‘There’s a lot of anecdotal evidence that keeping [specialty] care inside the [health] system is better for our patients, but we need a higher level of analytics and data mining to prove it.’ —Kyle Skiermont, PharmD

Specialty Patients

Does hospita al have relevantt clinical progrram?

Leak

Does hospita al have specialtty pharmacy capabilities?

Dana-Farber’s Experience Leak

Does hospita al have necessary pa ayor contracts?

Leak

Does hospita al have access to spe ecialty drugs?

Revenue captured by for-profit specialty pharmacy companies

Dispense specialty prescription

Figure. Areas for profit leak in hospitals without specialty pharmacy services and contracts. Source: ExceleraRx, LLC.

resulting from dealing with a separate specialty pharmacy affects both cost and quality. Little wonder, Mr. Smeeding noted, that UHC (an alliance of leading nonprofit academic medical centers) will soon be unveiling its own specialty pharmacy program. There are some key considerations before a hospital or health system pursues a specialty pharmacy strategy, Mr. Smeeding said. “To understand if you can be successful with a specialty pharmacy plan, you must understand acquisition cost; contract availability and reimbursement levels; and your targeted disease states.” He suggested a few other questions to consider: • Can you acquire the drugs competitively—at a wholesale acquisition cost (WAC) of –3% or better? • Does your institution drive enough small molecule products so you can get a respectable discount? • Does your system have a sizable infusion business that you can use to build your case mix of generics to help drive lower acquisition cost? • Is there a group of physicians who can drive scripts and support—such as a major transplant or oncology program, HIV clinic or hepatitis C practice? A hospital or health system does not have to build its own specialty pharmacy from the ground up, Mr. Smeeding added. It can partner with an existing specialty pharmacy, in either an onsite or central model. It also can pursue a joint venture with other complementary hospitals or health systems. “Start small,” he advised. “Focus on a few disease states. Once you’re established, utilize the expertise and leverage of your hospital or health system to expand.”

When Dana-Farber opened its specialty pharmacy in 2010, it had a few advantages. As the leading oncology player in the Boston marketplace, DanaFarber joined with Tufts to respond to a request for proposal from Blue Cross and Blue Shield to provide specialty pharmacy services. Today, according to Ms. Bartel, Dana-Farber’s specialty pharmacy dispenses about 22 different drugs, with a 99% patient compliance rate and infrequent interruptions in treatment (Table). “We have the advantage of no medication errors, drug loss or drug unavailability from an outside specialty pharmacy,” she said. But there have been some challenges, primarily involving data management

Table. 2010 Outcomes/ Accomplishments of Dana Farber Cancer Institute’s Specialty Pharmacy Program • ~700 dispenses per year • ~22 different drugs • ~700 compliance calls • Infrequent interruptions in treatment • No medication errors, drug loss, drug unavailability • 50% refill rate • Patient compliance rate, 99% (doses held, generic to brand switch) • Enhanced medication access for patients • Enhanced medication monitoring for patients • Enhanced profitability • Retaining medications administered in infusion

and the development of the tools needed to handle the level of clinical data requested, Ms. Bartel noted. “You also have to understand that hospital-based specialty pharmacy is unique,” she said. “Patient education is done by physicians, registered nurses and registered pharmacists. There’s no need for ‘stat’ orders, and call center operations are minimal. It’s really a business within a business.”

A Challenging Build-Out At a separate Midyear session on considerations for constructing a specialty pharmacy business plan, Kyle Skiermont, PharmD, the director of specialty and infusion operations for Fairview Pharmacy Services—the prescient system that saw hospital-based specialty pharmacy coming years before almost anyone else—noted that the health system had an advantage because it was able to grow into specialty organically. “When we started, in the late 1990s, there weren’t a lot of payor lockouts or limited-distribution drugs. If you could do the services needed and take care of the patient, you could get paid for and get access to the medication,” Dr. Skiermont said. “One of the big hurdles now is that specialty pharmacy has gotten so sophisticated that there is a lot of infrastructure and services that need to be

Operations & Management 29

Pharmacy Practice News • May 2014

Finances offered on day 1. That’s the challenge: Find the expertise and get the dollars needed to get up and running in a short period of time.” But even with the head start that Fairview had, Dr. Skiermont noted that it still faces challenges. “We’re really trying to prove our value, getting better measurements of what outcomes we’re seeing with our patients. There’s a lot of anecdotal evidence that keeping care inside the system is better for our patients, but we need a higher level of analytics and data mining to prove it,” he said. “Because our other big hurdle is how we continue to maintain access to payor and pharma contracts. More and more new medications are coming out as limited distribution, and while we’ve had some good luck getting access to them, we haven’t gotten as many as we would like—so we still have to have external relationships with other specialty pharmacies.” The challenges of breaking into the specialty pharmacy market extend beyond gaining access to those limited-distribution contracts, Dr. Skiermont noted. They also include the fact that so few hospitals and health systems have shown a successful track record of meeting the needs of specialty pharmacy drug manufacturers. “That’s not to say we haven’t already done it—there are definite early adopters who can show we have this capability,” he stressed. “There’s just not a huge pool of success to point to, at least so far.” He added that most health systems have a laundry list of competing strategic goals that may deservedly be much higher on their priority lists than developing specialty pharmacy expertise. And the overall lack of experience with specialty pharmacy provision is another major roadblock that needs to be overcome. Still, the effort is worthwhile, Dr. Skiermont stressed, not only because of the improvements in patient care that could be achieved as a result of less fragmented care, but also the potential for enhanced revenue. That latter point was illustrated by a realistic case study that he presented, which showed a health system adding millions of dollars in revenue as a result of developing a specialty pharmacy capability. “It may have been a case study, but I can point to several health systems that have in fact achieved this level of enhanced revenue,” he said. “So the ROI [return on investment] is definitely there.”

Convincing the C-Suite Despite such potential financial gains, it still can be hard to convince the C-suite to understand the danger of not participating in the specialty pharmacy opportunity, Mr. Smeeding said. “Hospital administrators look at pharmacies as cost centers,” he said. “Getting them to support a new enterprise that needs to be funded to generate positive

‘Hospital administrators look at pharmacies as cost centers. Getting them to support a new enterprise that needs to be funded to generate positive revenue can be a challenge.’ —Jim Smeeding, RPh, MBA revenue can be a challenge. The pharmacy needs to make a positive argument about investing and developing this service, and the opportunity cost if you don’t. Not everybody is going to be

allowed to play, and the longer you wait on the sidelines, the harder it’ll be.” Dr. Skiermont agreed that there is wisdom in getting the C-suite in your health system to understand the oppor-

tunity cost of not developing a specialty pharmacy expertise. In fact, during his presentation, he offered a visual that illustrated the multiple ways in which profits can bleed out of a health system that is losing patients to specialty pharmacy providers. “There’s lots of strategies you can use to get this message across,” Dr. Skiermont said. “But whatever you use, it’s time to do it now; the time for waiting to see how other hospitals are faring with this is probably over.” —Gina Shaw

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INDICATION FOR GLASSIA GLASSIA is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). GLASSIA increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including GLASSIA, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available. GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

DETAILED IMPORTANT RISK INFORMATION FOR GLASSIA HYPERSENSITIVITY • GLASSIA is contraindicated in immunoglobulin A (IgA) deficient patients with antibodies against IgA or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products. • Hypersensitivity reactions have been reported in patients following administration. Patients should be closely followed and vital signs monitored continuously. Discontinue the infusion if hypersensitivity symptoms occur and administer appropriate emergency treatment. TRANSMISSION OF INFECTIOUS AGENTS • GLASSIA is derived from pooled human plasma and may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Despite manufacturing steps designed to minimize the risk of viral transmission, such products may still potentially transmit human pathogenic agents. USE DURING PREGNANCY • GLASSIA should not be given to pregnant women unless clearly needed, as reproduction studies have not been done in animals or humans. ADVERSE REACTIONS • The serious adverse reaction observed during clinical trials was exacerbation of chronic obstructive pulmonary disease (COPD). The most common adverse reactions occurring in >0.5% of infusions in clinical trials were headache and upper respiratory infection Please see GLASSIA Brief Summary of Full Prescribing Information on the adjacent page. References: 1. GLASSIA [Alpha1-Proteinase Inhibitor (Human)] Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation. 2. ASHP guidelines on preventing medication errors in hospitals. American Society of Health System Pharmacists website. http://www.ashp.org/s_ashp/docs/files/MedMis_Gdl_Hosp.pdf. Accessed June 18, 2013. Baxter is a registered trademark of Baxter International Inc. Glassia is a registered trademark of Kamada Ltd. March 2014 USBS/341/14-0009

30 Operations & Management

Pharmacy Practice News â&#x20AC;˘ May 2014

Ambulatory Care

CONSENSUS

â&#x20AC;&#x2DC;Credentialing of pharmacists who provide direct patient care ... will help ensure high-quality care and an expanded scope of practice.â&#x20AC;&#x2122;

continued from page 1

delivering and integrating patient care services, developing sustainable business models and evaluating outcomes. Each series installment will be accompanied by insights from those who helped create the recommendations, as well as experts not directly involved in developing them. In this first installment, Samuel Johnson, PharmD, a clinical pharmacy specialist in applied pharmacogenom-

â&#x20AC;&#x201D;Samuel Johnson, PharmD ics at Kaiser Permanente Colorado, in Denver, and clinical assistant professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceu-

Adverse Reactions1 Occurring in > 5% of Subjects During the First 12 Weeks of Treatment

GLASSIA [Alpha1-Proteinase Inhibitor (Human)] Injection Solution - For Intravenous Use Only Brief Summary of Prescribing Information. Please see package insert for full prescribing information.

GLASSIA No. of subjects: 33

Prolastin No. of subjects: 17

No. of subjects with adverse reactions1 (AR) (percentage of all subjects)

Cough

3 (9%)

4 (24%)

Upper respiratory tract infection

3 (9%)

0 (0%)

Headache

3 (9%)

3 (18%)

Sinusitis

2 (6%)

1 (6%)

Chest discomfort

2 (6%)

0 (0%)

Dizziness

2 (6%)

0 (0%)

Hepatic enzyme increased

2 (6%)

0 (0%)

Adverse Event (AE)

INDICATIONS AND USAGE GLASSIA is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically eWident emphysema due to seWere congenital demciency of Alpha1-PI (alpha1-antitrypsin demciency) GLASSIA increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining nuid levels of Alpha1-PI â&#x20AC;˘ The effect of augmentation therapy with any Alpha1-PI product, including GLASSIA, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI demciency has not been conclusively demonstrated in randomi[ed, controlled clinical trials â&#x20AC;˘ Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available â&#x20AC;˘ GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI demciency has not been conclusively established

DOSAGE AND ADMINISTRATION

tical Sciences, in Aurora, shares his thoughts on the importance of defining and advancing the profession of ambulatory care pharmacy.

For Intravenous Use Only. 6se aseptic techniRue for all preparation and administration steps %ose mg Lg body weight intravenously once weeLly Administer at a rate not to exceed mL Lg body weight per minute, depending on patient response and comfort â&#x20AC;˘ %ose ranging studies using efmcacy endpoints have not been performed

Postmarketing Experience The following adverse reactions have been identimed during post-approval use of GLASSIA Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their freRuency or establish a causal relationship to drug exposure â&#x20AC;˘ 3espiratory, Thoracic and .ediastinal Disorders: Dyspnea â&#x20AC;˘ Gastrointestinal Disorders: Nausea â&#x20AC;˘ General Disorders and Administration Site Conditions: 'atigue

CONTRAINDICATIONS

USE IN SPECIFIC POPULATIONS

GLASSIA is contraindicated in immunoglobulin A (IgA) demcient patients with antibodies against IgA or in individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products

Pregnancy Pregnancy Category C

â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘

WARNINGS AND PRECAUTIONS Hypersensitivity Reactions GLASSIA may contain trace amounts of IgA Patients with selective or severe IgA demciency and with Lnown antibodies to IgA, have a greater risL of developing severe hypersensitivity and anaphylactic reactions .onitor vital signs continuously and observe the patient carefully throughout the infusion Discontinue the infusion if hypersensitivity symptoms occur and administer appropriate emergency treatment Have epinephrine and other appropriate supportive therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction

Animal reproduction studies have not been conducted with GLASSIA It is also not known whether GLASSIA can cause fetal harm when administered to pregnant women or can affect reproductive capacity GLASSIA should be given to a pregnant woman only if clearly needed Nursing Mothers It is not known whether Alpha1-PI is excreted in human milk Because many drugs are excreted in human milk, caution should be exercised when GLASSIA is administered to a nursing woman Pediatric Use Safety and effectiveness in pediatric patients have not been established

Transmissible Infectious Agents Geriatric Use Because this product is made from human plasma, it may carry a risk of Clinical trials of GLASSIA included 11 subKects of years of age or transmitting infectious agents, such as viruses, the variant Creutzfeldtolder This number of subKects was not sufmcient to determine whether they Jakob disease (vCJD), and theoretically, the Creutzfeldt-Jakob disease respond differently from younger subKects As for all patients, dosing for (CJD) agent This also applies to unknown or emerging viruses and other geriatric patients should be appropriate to their overall situation Safety and pathogens The risk of transmitting an infectious agent has been minimized effectiveness in patients over years of age have not been established by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by inactivating and PATIENT COUNSELING INFORMATION removing certain viruses during the manufacturing process (see Description â&#x20AC;˘ Inform patients of the early signs of hypersensitivity reactions, including <11> in full prescribing information for viral reduction measures) Despite these hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, measures, such products may still potentially transmit human pathogenic hypotension, and anaphylaxis Advise patients to discontinue use of the agents product and contact their physician and/or seek immediate emergency care, All infections thought by a physician possibly to have been transmitted by this depending on the severity of the reaction, if these symptoms occur product should be reported by the physician or other healthcare provider to â&#x20AC;˘ Inform patients that GLASSIA is made from human plasma and may contain ,amada Ltd at 1- -GLASSIA or 'DA at 1- -'DA-1 or www fda gov infectious agents that can cause disease (e g , viruses and, theoretically, medwatch the CJD agent) Explain that the risk of GLASSIA transmitting an infectious agent has been reduced by screening the plasma donors, by testing the No seroconversions for hepatitis B or C (HBV or HCV) or human donated plasma for certain virus infections, and by a process demonstrated immunodemciency virus (HIV) or any other known infectious agent were to inactivate and/or remove certain viruses during manufacturing (see reported with the use of GLASSIA during the clinical trials Warnings and Precautions) Symptoms of a possible virus infection include ADVERSE REACTIONS headache, fever, nausea, vomiting, weakness, malaise, diarrhea, or, in the case of hepatitis, Kaundice The serious adverse reaction1 observed during clinical trials with GLASSIA was exacerbation of chronic obstructive pulmonary disease (C0PD) â&#x20AC;˘ Inform patients that administration of GLASSIA has been demonstrated to raise the plasma level of Alpha1-PI, but that the effect of this augmentation on The most common adverse reactions ( of infusions) in clinical trials the frequency of pulmonary exacerbations and on the rate of progression of were headache ( of infusions or ) and upper respiratory infection emphysema has not been established by clinical trials ( of infusions or ) 1

An adverse reaction is any adverse event which met any of the following criteria: (a) an adverse event that began within hours following the end of product infusion, or (b) an adverse event considered by either the investigator or sponsor to be at least possibly related to product administration, or (c) an adverse event for which causality assessment was missing or indeterminate

Baxter is a registered trademark of Baxter International Inc Glassia is a registered trademark of ,amada Ltd Baxter Healthcare Corporation, 8estlake Village, CA 1 6SA Issued .arch 1 6SBS/ 1/1 -

Dr. Johnson co-authored a briefing document that informed the first domain of the consensus recommendations, along with Dennis Helling, PharmD, the executive director emeritus of Pharmacy Operations and Therapeutics at Kaiser Permanente Colorado, and a clinical professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. They noted that the manuscript will be published later this summer in the American Journal of Health-System Pharmacy. Todd Sorensen, PharmD, a professor and the associate head in the Department of Pharmaceutical Care and Health Systems, and the Peters Chair in Pharmacy Practice at the University of Minnesotaâ&#x20AC;&#x2122;s College of Pharmacy, in Minneapolis, also shared his thoughts on the guidelines, although he was not involved in developing the recommendations.

Domain 1: Defining Ambulatory Care Pharmacy Practice 1.1. To provide optimal patient-centered care, pharmacists who provide ambulatory care services must attain and maintain appropriate competencies and credentials. Competency â&#x20AC;Ś is attained through training and/or commensurate experience. Examples of credentials include BCACP, BCPS, BCOP, BCPP, and CGP but are at the discretion of the practice setting. Further, pharmacists in the ambulatory care setting should be included in organization-based credentialing and privileging processes. Dr. Johnson: With so many opportunities opening up for ambulatory care pharmacists to provide chronic disease management and clinical services, we need to ensure newly trained ambulatory care pharmacists attain and maintain core competencies and credentials. Credentialing of pharmacists who provide direct patient careâ&#x20AC;&#x201D;as an increasing number of pharmacists are doing in the ambulatory care environmentâ&#x20AC;&#x201D;will help ensure high-quality care and an expanded scope of practice. This is already happening in states such as California, where pharmacists who are designated as advanced practice pharmacists can perform patient assessments; order and interpret drug therapyâ&#x20AC;&#x201C;related tests in coordination with the patientâ&#x20AC;&#x2122;s prescriber; refer patients to other health care providers; initiate, adjust and discontinue drug therapy with an order from the patientâ&#x20AC;&#x2122;s prescriber; and evaluate and manage disease and health conditions in collaboration with other providers. Itâ&#x20AC;&#x2122;s important to note that, although weâ&#x20AC;&#x2122;re setting these aspirational goals, as a community of ambulatory care pharmacists we also acknowledge that many practicing pharmacists do not have, and

Operations & Management 31

Pharmacy Practice News • May 2014

Ambulatory Care

are unlikely to obtain, obtain specialty credentials. However, many have significant ambulatory care practice experience, which we believe is a reasonable alternative practice pathway. Dr. Sorensen: Something I like about this first recommendation is that it focuses on ambulatory care practice and patient care in a general sense and does not get into specifics on particular clinical settings. Patient care is the same whether it’s at a community pharmacy, in a clinic or anywhere else it is provided. I also am strongly in favor of the guidelines’ emphasis on competencies and credentials. Defining standards or credentials that make one eligible to deliver a service is the first step in establishing a complement of highquality care providers—be it a network of providers for a payor, or a team of providers within an organization—who will deliver this quality. It is worth noting, however, that while the profession can and should create recommendations that guide thinking on this issue, employers or payors will ultimately set and/or implement any standards or credentials they deem as requirements for pharmacists to be eligible to provide medication management services, or to be paid for these services in a feefor-service environment. In fact, some employer and payors may choose not to apply any standards or credentials, although I would expect that most will. And as we shift more to pay-for-performance or accountable care arrangements, the role of setting expectations on what credentials, if any, pharmacists may need will likely continue to shift to the employer because they are the ones who will be accountable for the quality of care provided by its staff. 1.2. As members of the interprofessional patient care team, pharmacists who provide ambulatory care services: perform patient assessments; have prescribing authority to manage disease through medication use and provide collaborative drug therapy management; order, interpret and monitor medication therapy-related tests; coordinate care and other health services for wellness and prevention of disease; provide education to patients and caregivers incorporating health literacy and cultural sensitivity; and document care processes in the medical record. Dr. Johnson: Any clinical patient care services we provide should be within an interprofessional, team-

based, collaborative context, and this recommendation underscores that point. In terms of prescribing authority, our contribution within a collaborative setting is through comprehensive medication management, and the effect of that has been well documented [[Ann Pharmacother 2013;47:124-131]. Another important element in this item is our call to have care services documentation be a part of the ambulatory care process. By implication, this would mean having access to electronic health records (EHRs). Currently, com-

munity pharmacies not closely affiliated with a health system, hospital or clinic often care for patients without having access to EHRs, which essentially leaves them flying blind. Not having access to EHRs also means you can’t consistently document your own interventions, which is essential not only for providing optimal care and ensuring other health care team members have up-to-date patient information but also for potential reimbursement. Dr. Sorensen: Both this recommendation and 1.5 are companion recom-

mendations, in that until we have a defined patient care process—which 1.5 addresses—outlining the range of activities that ambulatory care pharmacists engage in does not mean so much. This is because many of the activities identified in this recommendation are not unique to pharmacists and can be performed by physicians, nurses, nurse practitioners and physicians’ assistants. What will make them unique is if they fit into a pharmacyspecific patient care process, which we

•

see CONSENSUS, page 32

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32 Operations & Management

Pharmacy Practice News • May 2014

Ambulatory Care

CONSENSUS

‘The ambulatory care segment of pharmacy is growing rapidly, as providers and payors seek to improve care and reduce costs by keeping patients out of the hospital.’

continued from page 31

still need to identify and define. 1.3. Across the continuum of ambulatory care, patients in every setting should have access to and have an opportunity to be evaluated by pharmacists who provide ambulatory care services. Dr. Johnson: We have some ambassadorial work to do to ensure that patients, regardless of the ambulatory care setting, have access to a pharmacist. We need to emphasize the contri-

—Gerald E. Meyer, MBA, PharmD, FASHP bution of ambulatory care pharmacists within a collaborative, interprofessional health care team. As mentioned earlier, we can point

to a large volume of literature showing improved clinical and economic outcomes when ambulatory care pharmacists are included in the care pro-

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cess. Ambulatory care pharmacy services— ranging from patient counseling and education to adherence interventions and drug utilization reviews to chronic disease management—can significantly improve clinical outcomes, like controlling hemoglobin A1c, lowering blood pressure and cholesterol levels and raising quality of life [[Med Care 2010;48:923-933]. In light of these demonstrable benefits, we have a duty to inform patients as well as other providers that such services should be more widely available. Dr. Sorensen: This statement maintains that we need to be flexible in how we identify and ensure access for all patients who need or desire medication management evaluation from a pharmacist. It is stated in a way that accommodates the evolving focus on population management, which targets high-risk patients who are most likely to benefit from pharmacist medication management services, while not defining criteria or patient populations. This is important, because too narrow a definition might prevent us from identifying all patients who would benefit from medication management services. It also does not restrict service delivery to isolated settings. 1.4. There must be an increase in the number of ASHP-accredited residency positions offering training in ambulatory care and similar training experiences outside of residency in order to ensure there are enough appropriately trained pharmacists to meet the needs of patients, providers, health systems, and payers. Dr. Johnson: With the current number of pharmacy residencies, the vast majority of students graduating within the next five years will find themselves without a residency position, or they will have to wait a year before finding one. We need more residency offerings in ambulatory care settings that provide critical experience to help pharmacists develop, implement and maintain pharmacy practices that lead to improved patient care. Postgraduate residency positions should provide adequate exposure to ambulatory care pharmacy operations, clinical services and research. This should begin at a broad level in postgraduate year (PGY) 1 and advance to specialty and subspecialty care in the form of PGY3 subspecialty residencies and fellowships, for example. Advanced training should be specialty-specific as well as specific to a particular ambulatory pharmacy setting, whether it’s a community pharmacy, a hospital-based outpatient clinic, a retail pharmacy, an integrated health system, clinic or medical home. To increase the number of residency positions, health-system stakeholders must understand that residencies are an absolutely necessary part of ensur-

Operations & Management 33

Pharmacy Practice News • May 2014

Ambulatory Care ing optimal patient care. This is about training pharmacists to participate in interprofessional, team-based care efforts and to provide medication management for patients and to advance the workforce of pharmacists across the spectrum of ambulatory care. Dr. Sorensen: This recommendation touches on a topic that, I believe, could be addressed in an entire domain of its own. The big question is: what is the proper path and preparation for the ambulatory care practitioner? The recommendation calls for an increase in residency education opportunities, but that’s a fairly generic statement and it assumes our current model of residency education is the right one, which I do not think it is. The current residency training model emerged when the primary clinical practice setting for most graduates was the hospital. At the time, ambulatory care pharmacy was seen as a specialist practice. But if you consider that most pharmacists will be practicing in the ambulatory care setting in the coming years, it becomes clear that we need to articulate a PGY1 path to ambulatory care practice. So, just as we have done for hospital pharmacy, we need to define the difference between a generalist and specialist in ambulatory care pharmacy. PGY1 training provides generalist hospital practice preparation, and PGY2 prepares hospital pharmacy residents for specialization in defined areas. The educational paths for generalist and specialist ambulatory care practitioners need a similar kind of definition. 1.5. Pharmacists who provide ambulatory care services should articulate and promote a standardized pharmacist patient care process. Dr. Johnson: Although we are not pointing to any particular standardized processes, we want to encourage pharmacists to find and follow a standardized, team-based patient care approach. The Joint Commission of Pharmacy Practitioners is in the process of developing such standardized clinical care processes, which would be taught in pharmacy school and reinforced in postgraduate residency training. Additionally, the American College of Clinical Pharmacy recently released a document that articulates expectations for clinical pharmacists in the United States ((www.accp.com/report/ index.aspx?iss=0314&art=1). The expectation would be that pharmacists providing clinical services in an ambulatory or inpatient setting would follow these practices to provide the best care possible. Dr. Sorensen: We need to define patient care processes, and this recommendation essentially says we need to figure that out. I think it’s OK that it lacks specificity—as long as we have a

pharmacists and the value we bring to the health care team. If we provide the same elements of care as other health care providers, then we aren’t making the case for why we need to be on the team. Payors, legislators and members of the health care team need to know what our unique contribution is.

‘If you consider that most pharmacists will be practicing in the ambulatory care setting in the coming years, it becomes clear that we need to articulate a PGY1 path to ambulatory care practice.’

whole new set of discussions to gain clarity on what the process of patient care in the ambulatory setting looks

—Todd Sorensen, PharmD

—David Wild

like. This resolution rightly suggests that we need a patient care process that describes the unique contribution of

Drs. Meyer, Johnson and Sorensen reported no relevant ﬁnancial conﬂicts of interest.

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34 Technology

Pharmacy Practice News • May 2014

Education & Training

SIMULATION

out pricking their hand. But Dr. Abel emphasized that it does allow for the chance to safely repeat and reinforce the process, without the high costs associated with replacing products.

continued from page 1

“What a better way to train than sitting in a lecture hall with 100 other people and a talking head,” said Steven Martin, PharmD, BCPS, a professor and the chairman of the Department of Pharmacy Practice at UT’s College of Pharmacy and Pharmaceutical Studies. Pharmacy may be a relative latecomer to the use of simulation—health care itself started well behind the oil, gas, automobile and flight industries—but the field is now reaping the benefits. “Eventually, the patients are the beneficiaries,” Dr. Martin said. Perhaps the greatest improvements in education afforded by simulation are not technological at all. The learning often is done in teams, which more closely resembles the naturally collaborative work of a pharmacist. In addition to the first five-sided, LED immersive environment in the world, the new University of Toledo Interprofessional Immersive Simulation Center (IISC) houses individual hospital rooms, an ICU, operating suites, labor and delivery and pediatric care, among other settings. From a central control tower with one-way glass, instructors drive the simulations. Everything is within “easy reach” for all health care professionals, said Pamela Boyers, PhD, the senior advisor for the Advancement of Interprofessional Education, the executive director of the IISC and an assistant professor of surgery at UT. Students from all UT colleges will have opportunities to be involved. For example, using the three-dimensional (3D) and virtual immersive worlds, theater students can take advantage of opportunities to act as patients or distraught family members in simulations, providing even more authentic experiences for health care teams. “The whole goal of simulation is to provide a place where students can learn to work together early in their education. Traditionally, people don’t really learn how to work together until after they graduate and go into their first job,” Dr. Boyers said. “If you never practice together, how can you play well as a team?” added Dr. Martin, naming a lineup of participants including physicians, nurses, therapists, administrators and social workers. There are particular situations, such as a patient’s discharge or transfer to the ICU, when this practiced communication and coordination are particularly critical, he noted. Celeste Sejnowski, PharmD, a second-year critical care resident at UT, said she feels more confident in her skills since training in the simulator. “You can read about it in books,” she said. “But to really be able to put it all

A Million-Dollar Investment That Should Pay Off

The University Th U i it off Toledo T l d Interprofessional I t f i l Immersive I i Simulation Si l ti Center. C t Rendering courtesy of BHDP Architects.

together—alongside other medical professionals—it’s really different. I feel more confident making dosing recommendations after going to the simulation lab throughout the year.”

A Proven Teaching Method Studies back up what faculty and students say they already know. Simulatorbased training has been shown to raise scores on a wide range of patient care measures, including tests of communication and teamwork ((Pharm Pract [Granada] 2003;11:61-65), acute care pharmacotherapy ((Simul Healthc 2012;7:162-165), and clinical decision making ((Am J Pharm Educ 2011;75:189). The training technique also has been shown to increase accuracy in blood pressure assessments ((Am J Pharm Educ 2007;71:48) and reduce medication administration errors ((Intensive Care Med 2010;36:1526-1531). In the latter study, after a simulation-based educational intervention was performed in an adult coronary critical care unit, medication administration error rates dropped from 30.8% to 4.0% ((P<0.001). For more than a decade, Amy Seybert, PharmD, the chair of the Pharmacy and Therapeutics Department in the University of Pittsburgh’s School of Pharmacy and co-author of four of the five cited publications, has run one of the nation’s pioneering simulation teaching programs. Although the school does not yet have 3D tools, Dr. Seybert noted that pharmacy students and residents train throughout their education with highfidelity mannequins that can do everything from talking, sweating, bleeding and urinating, to producing bowel, lung and heart sounds. “We make it as realistic as possible,” she said. In one of her cardiology courses, students observe the potentially positive and negative effects of a drug. They might see a patient with hypertension, prescribe medication and watch it lower the patient’s blood pressure. “But then we have a scenario where the patient starts to cough and can’t breathe due to one of the drugs,” Dr. Seybert said. “They learn that angioedema is a severe side effect.” Through another new simulation,

students learn when to recommend stopping heparin. The lesson can be a messy one: The mannequin will bleed— in urine, from IV sites—when a student does not make the correct recommendation. “It’s stage blood, diluted a little bit,” Dr. Seybert said. “Sometimes it can be tough to clean up.”

Virtual Cleanroom Meanwhile, faculty and students at Purdue University, in West Lafayette, Ind., use 3D technology in a virtual, four-paneled, fully immersible cleanroom. They, too, call it “the cave.” Linda Huang, a PharmD candidate in her last rotation at Purdue, praised the technology, which has helped train pharmacy students there for seven years. “A lot of us in the program don’t have an opportunity to pursue an internship in hospitals and get real cleanroom experience,” she said. “The virtual cleanroom helps us see what one really looks like and allows us to learn how to manipulate products.” In the room, the first of its kind in pharmacy education, students donning 3D glasses and a wireless controller learn to navigate equipment and products—including detailed labels— and practice safe preparation of IV and other treatments for virtual orders. Steven Abel, PharmD, FASHP, the associate vice president for engagement and a professor of pharmacy practice at Purdue, said that more than 90% of students at the pharmacy school have reported feeling that this virtual experience prepared them well for the real cleanroom setting. The students’ mean scores on tests of compliance with United States Pharmacopeia (USP) Chapter <797> requirements for sterile IV preparations significantly improved as well, according to a report co-authored by Dr. Abel in the American Journal of Pharmaceutical Education (2011;75:7). A virtual cleanroom can never fully replace the real thing, of course, the educators stressed. Students are not able to physically touch a syringe or a product bag, let alone learn how to insert the needle into the port with-

The price tag of the virtual cleanroom was $1 million. Although that is a hefty up-front investment, Dr. Abel suggested that the university should save money in the long run. For one, rather than being forced to remodel in response to any updates in USP Chapter <797> compounding regulations (a draft of USP Chapter <800> has been released for public comment), changes can simply be programmed into the virtual world. Partnerships with pharmaceutical companies could provide additional financial benefits, Dr. Abel said. “If we populate the room with compounding systems specific to a particular company, we can achieve a level of detail that enables individuals to learn how to program the systems, to facilitate their work,” he explained. “The goal is to essentially teach people how to use the equipment in our controlled setting versus a real one.” This can be done, he noted, to help train company employees, as well as to also train pharmacists and technicians. Similar revenue support is expected from industry collaborators at UT. Additionally, Dr. Abel noted that the focus this past year has been on advancing an online, computer-based version with a variety of educational modules. From their laptops, he said, students can cap and uncap syringes, extract diluent from a vial and inject the product as if they were doing real product preparation. “We wanted to give the students a controlled environment where they can practice, practice, and practice again,” he said. Pharmacists around the country are now sharing notes, and identifying simulation tools that they can borrow or build on from one another. Purdue, for example, could program a virtual hospital room or community pharmacy into their “cave.” UT, meanwhile, has hopes of one day housing a virtual cleanroom in its one-of-a-kind facility. “There’s no given prescription for exactly what to do in simulation centers for health care education, but the UT IISC offers faculty and students opportunities to create innovative and experiential learning opportunities,” Dr. Boyers said. “Ultimately, we aim to improve patient safety and reduce costs, including the overall cost of health care.” —Lynne Peeples None of the sources reported any relevant ﬁnancial conﬂicts of interest.

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