Pharmacy Practice News - February 2021 by McMahon Group



The Best-Read Pharmacist’s News Source

pharmacypracticenews.com

As COVID-19 cases soar …

CLINICAL

Stewardship efforts help reduce AEs during anticoagulation ...............

Muscle relaxants and pain a dangerous mix ...

OPERATIONS & MGMT

Drug diversion: yet another pandemic challenge ..........................

ISMP survey reveals gaps in compounding compliance ......................

TECHNOLOGY

Harnessing big data key to ADC-driven inventory control .......... Dashboards drive better medication management ..................

Pharmacist-led Initiatives Save Millions

ro m t he beginning of th e COVID-19 pandemic, there has been a scramble to meet the soaring demand for critical medications, as infection rates, hospitalizations and deaths surged in hot spots around the country. “There were so many moving parts,” said Meryl Biksacky, PharmD, a drug information specialist at Intermountain Healthcare, in Salt Lake City. “It took a constantly vigilant team approach, with a lot of heads in the mix and a lot of ingenuity.” Those early efforts at drug shortage team building and troubleshooting at Intermountain and other health systems helped ease the impact of drug supply disruptions, even as infections began to peak again in the fall and winter. Continued on page 8

FEATURED PRODUCT DYNALABS DVx from Infinity Labs. See page 3.

REVIEW ARTICLE

Medication Errors: The Year in Review See insert after page 14.



POLICY

Standardization spurs better system-wide compounding .................

Health Systems Stay Vigilant To Rx Shortages

Volume 48 • Number 2 • February 2021

TJC revisions aimed at boosting compliance

82% of Hospitals Miss the Mark On MM Standards

early 82% of hospitals surveyed by the Joint Commission in 2019 were noncompliant with at least one Medication Management (MM) chapter item. Still, experts say they are hopeful that recent revisions will help those hospitals meet the accreditor’s expectations. “We have some welcome new clarifications on medication orders, particularly those that have been relatively challenging for hospitals,”

aunching a diabetes stewardship program, removing IV acetaminophen from the formulary and negotiating more favorable self-insurance contracts were among the recent strategies pharmacists used to save their health systems millions of dollars, as reported at the ASHP 2020 Midyear Clinical Meeting and Exposition.

Diabetes Stewardship Drives $840K Savings A diabetes stewardship pharmacist program started by the University of Nebraska Medical Center (UNMC), in Omaha, led to significant improvements in glycemic control among inpatients and substantial cost savings. With specially trained pharmacists, including a dedicated pharmacist to monitor glycemic control and fluctuations in blood sugar in hospitalized patients, Nebraska Medicine experienced a roughly 65% reduction in hypoglycemia (–70 mg/dL) in critical care units and a nearly 50% reduction in such readings in non–critical care units from January 2015 through

Continued on page 12

Continued on page 22

An independent readership survey may be emailed to you soon. If you like how we cover the news, say you read 4 out of 4 issues!

 4 out of 4

Cost Saving Time Saving Waste Saving Life Saving

ADVANCED

Universal, Needle-Free Admixture System for Immediate Use IV Administration To learn more visit:

West and the diamond logo and By your side for a healthier world, are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. Vial2Bag AdvancedTM and Blue Vial Adapter are trademarks and registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc. Copyright ÂŠ 2020 West Pharmaceutical Services, Inc. #11438 â&#x20AC;˘ 1020

Up Front

Pharmacy Practice News • February 2021

Digital

COVID-19 on the Web

ning the week of Dec. 22, 2019, numbers were “c o n s i s t e n t l y elevated every single week in our facilities,” the investigators reported. Access: bit.ly/3qfyJds.

Here’s a sample of COVID-19 coverage on pharmacypracticenews.com. To access, see the URLs below or go to the COVID-19 pull-down menu in the Sections navigation tab on our home page. Toothpaste, Camel Urine Among Unfounded Methods People Tried to Treat COVID-19 Mouthwash, hot baths, mangoes and camel urine are among the various items people around the world have used to treat or prevent COVID-19, according to internet searches by a Massachusetts-based pharmacist. None had evidence to support their use. Access: bit.ly/35UqcoL

Poor Glycemic Control Heightens COVID-19 Risk Diabetic patients with insufficient glycemic control are more likely to experience poor outcomes, including death, if infected with COVID-19, according to a Chinese study. The report found that severe pulmonary infection and consequent acute respiratory

distress syndrome might be the primary cause of death in patients with insufficient glycemic control. Access: bit.ly/ 3o0fZNy.

Pandemic Takes Resources Away From In-Depth ICU Care The COVID-19 pandemic has stretched ICU resources in an unprecedented fashion, critical care pharmacists said during the ASHP 2 0 2 0 M i d ye a r Clinical Meeting and Exposition. COVID-19–related shortages of certain drugs and personal protective equipment can insert barriers to best practices in ICU patient care. Access: bit. ly/3byFNxK

Studies Try to Pinpoint COVID-19 Arrival in the U.S. The first case of COVID-19 in the United States was reported on Jan. 19. However, the novel coronavirus may have arrived and begun spreading domestically as early as late December, according to a new retrospective study in Los Angeles. Begin-

FEATURED PRODUCT

DYNALABS DVx for On-site Drug Verification

CRAB Cases On the Rise A rise in carbapenem-resistant Acinetobacter baumannii during a COVID-19 surge at a New Jersey hospital highlights the potential for multidrugresistant organisms to spread during times when standard infection prevention and control practices are disrupted. Access: bit.ly/2Kcgne5

COVID-19 Vaccine: Benefits Outweigh Anaphylaxis Risk After 21 cases of anaphylaxis following COVID-19 vaccination, the CDC adopted new safety recommendations for anyone who is giving the vaccine, includ-

EDITORIAL BOARD

he DYNALABS DVx is a multifunctional UV-Vis spectrometer coupled with advanced software that allows it to easily identify and quantify pharmaceuticals in seconds. This on-site drug verification device improves compounding quality, minimizes drug diversion and improves patient safety. Our DVx Service brings the power of an analytical laboratory and the expertise of our team into your facility! For more information, visit www.dynalabs.us or call toll-free at (888) DYNALAB.

ing making sure staff are trained in recognizing and managing the severe allergic reactions. Access: bit.ly/3sn32AR

ART/PRODUCTION STAFF Michele McMahon Velle, MAX Graphics/Creative Director

ADMINISTRATION Robert Adamson, PharmD, Livingston, NJ

Frank Tagarello, Senior Art Director/Managing Director MAX Graphics

James A. Jorgenson, MS, RPh, St. Paul, MN

Volume 48 • Number 2 • Febuary 2021 • pharmacypracticenews.com

Indu Lew, PharmD, Livingston, NJ

James O’Neill, Senior Systems Manager Marty Barbieri, Associate Director of Production

AMBULATORY CARE Meghan D. Swarthout, PharmD, MBA, BCPS, Sallston, MD ANESTHESIOLOGY/PAIN Julie A. Golembiewski, PharmD, Chicago, IL

NUTRITION Beverly Holcombe, PharmD, BCNSP, FASHP, FASPEN Chapel Hill, NC

EDITORIAL STAFF

Leona Smith, Production Associate

David Bronstein, Editorial Director davidb@mcmahonmed.com

Rob Sinclair, Circulation Manager

Marie Rosenthal, MS, Senior Editor mrosenthal@mcmahonmed.com

Van Velle, President, Partner

Vanessa Kumpf, PharmD, BCNSP, Nashville, TN

David S. Craig, PharmD, BCPS, Tampa, FL

ONCOLOGY Cindy O’Bryant, PharmD, Aurora, CO

Robert L. Barkin, MBA, PharmD, Chicago, IL CARDIOLOGY C. Michael White, PharmD, Storrs, CT

Lisa Holle, PharmD, Farmington, CT

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com

Ali McBride, PharmD, MS, BCPS, Phoenix, AZ

CNS/PSYCHIATRY Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, TX COMPLEMENTARY AND ALTERNATIVE MEDICINE Cathy Rosenbaum, PharmD, Cincinnati, OH CRITICAL CARE Judi Jacobi, PharmD, FCCM, Indianapolis, IN

Sara S. Kim, PharmD, BCOP, New York, NY

Kevin Horty, Don Pizzi, Adam Marcus, Contributing Editors

ORGAN TRANSPLANT PHARMACY Eric Tichy, PharmD, BCPS, New Haven, CT

James Prudden, Group Editorial Director

PEDIATRICS Gretchen Brummel, PharmD, BCPS, Hudson, OH

Elizabeth Zhong, Senior Copy Editor Kristin Jannacone, Copy Editor

McMAHON PUBLISHING Matthew McMahon, General Manager, Partner Lauren Smith, Michael McMahon, Michele McMahon Velle, Partners Ray and Rosanne McMahon, Co-founders

THE McMAHON GROUP, LLC McMAHON PUBLISHING, McMAHONMED.COM Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036 Telephone: (212) 957-5300 CT Office: 83 Peaceable Street, Redding, CT 06896

PHARMACOGENOMICS Henry “Mark” Dunnenberger, PharmD, Evanston, IL

SALES

REIMBURSEMENT Bonnie E. Kirschenbaum, MS, FASHP, Breckenridge, CO

David Kaplan, Group Publication Director dkaplan@mcmahonmed.com

SPECIALTY PHARMACY JoAnn Stubbings, BSPharm, MHCA, Chicago, IL

Sarah Rezvani, Account Manager srezvani@mcmahonmed.com

Elaine Strauss, PharmD, MS, Atlanta, GA

STERILE COMPOUNDING Kristina N. Bryowsky, PharmD, MBA, BCPS, Fenton, MO

Joe Malichio, Director, Medical Education jmalichio@mcmahonmed.com

NUCLEAR PHARMACY Jeffrey Norenberg, PharmD, Albuquerque, NM

TECHNOLOGY Thomas Van Hassel, RPh, Yuma, AZ

Craig Wilson, Sales Associate, Classified Advertising cwilson@mcmahonmed.com

We endeavor to obtain relevant financial disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication.

WANT TO SUBSCRIBE? CHANGE YOUR ADDRESS? HERE’S HOW All U.S. hospital pharmacists should receive Pharmacy Practice News free of charge. If you are a hospital pharmacist and do not receive the publication, you must add your professional address or make your address change directly with Pharmacy Practice News, Circulation

Dept., 545 West 45th St., 8th Floor, New York, NY 10036. You can also fax your request to (815) 366-8297, or send it via email, circulation@mcmahonmed.com. If you are not a hospital pharmacist but would like to receive Pharmacy Practice News, please send a check for $95.00 (U.S.) or $120.00 (outside U.S.) for a year’s subscription payable to Pharmacy Practice News to McMahon Publishing, 545 West 45th St., 8th Floor, New

York, NY 10036. Please allow 8 to 12 weeks for delivery of the first issue. Individual issues are $9.00 (U.S.) or $12.00 (outside U.S.). McMahon Publishing is a 48-year-old, family-owned medical publisher of clinical newspapers and specialty periodicals, and creates compelling medical education programs and custom publications. As the second largest publisher of medical newspapers, McMahon produces

Anesthesiology News, Gastroenterology & Endoscopy News, General Surgery News, Infectious Disease Special Edition, Pain Medicine News, Pharmacy Practice News and Specialty Pharmacy Continuum. Opinions and statements published in Pharmacy Practice News are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.

INFECTIOUS DISEASES Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH David P. Nicolau, PharmD, Hartford, CT Jason Pogue, PharmD, Detroit, MI LEADERSHIP Ernest R. Anderson Jr., MS, RPh, Boston, MA

A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and several annual or semiannual Special Editions.

Copyright © 2021 McMahon Publishing, New York, NY 10036. All rights reserved. Pharmacy Practice News (ISSN 0886-988x) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.

4 Clinical

Pharmacy Practice News • February 2021

Anticoagulation

Pharmacists on the Bleeding Edge of ADE Prevention D

espite the availability of newer agents, anticoagulants continue to be commonly associated with adverse events, speakers said during the ASHP 2020 Midyear Clinical Meeting and Exhibition. Pharmacists have ample opportunities to lead anticoagulation stewardship efforts at their home institutions, potentially improving patient safety and reducing health care costs. There is a growing need for anticoagulation stewardship, said Allison Burnett, PharmD, PhC, CACP, an antithrombosis stewardship pharmacist at the University of New Mexico Health Sciences Center and an associate adjunct clinical professor at the University of New Mexico College of Pharmacy, in Albuquerque.

Heightened Complexity of Care Since the introduction of direct oral anticoagulants (DOACs) a decade ago,

clinicians have been caring for more patients taking anticoagulation therapies, and anticoagulant prescribing overall has increased by about 40% (Am J Med 2015;128[12]:1300-1305.e2), said Burnett, who also is the president-elect of the Anticoagulation Forum, a peer organization of anticoagulant service providers in North America. In addition, she said, the prevalences of atrial fibrillation (Circulation 2006;114[2]:119125) and venous thromboembolism (Am J Hematol 2011;86[2]:217-220) are expected to at least double by 2050, and there are roughly twice as many anticoagulants and reversal agents than there were a decade ago, so patient care is becoming more complex. These agents have been associated with increasing rates of adverse drug events (ADEs) that exacerbate that complexity (see sidebar, “A Rising Problem”). “COVID-19 brought its own unique set of challenges to q g in regard g anticoagulant therapy, and really caused us to

A Rising Problem

dverse drug events (ADEs) related to o anticoagulants are particularly common in inpatients, said Nadine Shehab, PharmD, MPH, a pharmacist consultant with the Lantana Consulting Group and the CDC. She said they are the most common class involved in ADEs and iatrogenic deaths at acute care hospitals and the most common drug class associated with ADEs in long-term care hospitals, ls, according to 2018 and 2020 reports from the Department of Health and Human Services. These ADEs also are increasing. From 2011 to 2017, the proportion of estimated emergency department (ED) visits involving direct oral anticoagulants (DOACs) increased creased from approximately 2% to 38%, with warfarin, arin, rivaroxaban and apixaban most frequently y implicated in ED visits for ADEs (J Gen Intern Med 2020;35[1]:371-373). The proportion of estimated timated hospital admissions from DOACs increased ed from approximately 3% to 46% over that time frame. —Karen Blum

have to rely on largely anecdotal or low-quality evidence to manage a class of m medications known to be associated with adverse events,” Burnett said. Federal agencies have created programs to facilitate anticoagulation management. In 2014, the Depart2 ment of Health and me Human Services pubHum lished its National Action Plan for ADE Prevention to coordinated approaches identify coord to ADEs that were common, clinically significant, measurable measurab and preventable,

said Nadine Shehab, PharmD, MPH, a pharmacist consultant with the Lantana Consulting Group, in New York City, and the CDC. The plan called for exploring opportunities, including oversight efforts, to promote ADE prevention for anticoagulation. In response, she said, the Centers for Medicare & Medicaid Services (CMS) incorporated anticoagulation management into its Quality Payment Program. There are now three clinical performance improvement activities related to anticoagulation in CMS’s Merit-based Incentive Payment System, including for outpatient and perioperative anticoagulation management. Although these are not mandatory, “incorporation of these improvement activities by CMS truly represents a significant acknowledgment of see BLEEDING EDGE, page 6

Core Elements of Anticoagulation Stewardship

he Anticoagulation Forum has six core elements (bit.ly/2O71Uhl) for anticoagulation stewardship programs in addition to the Joint Commission’s core elements, according to Allison Burnett, PharmD, PhC, CACP, the president-elect of the Anticoagulation Forum, a peer organization of anticoagulant service providers in North America. These elements are: 1. Establish professional accountability and expertise. Identify a single program champion such as a physician, pharmacist or nurse who is well supported by clinicians and has advanced training and expertise in anticoagulation to help drive day-to-day initiatives. 2. Engage multidisciplinary support. Stewardship takes a village, Burnett said. Focus on building a highly functional multidisciplinary team to support stewardship efforts. Think about recruiting professionals who are proven catalysts for change and who can be good ambassadors for your program. Start small, and invite others as your successes grow. 3. Perform data collection, tracking and analysis. A good initial exercise is to conduct a baseline assessment

and identify a couple of areas that need work where you can achieve small successes. The companion checklist available on the Anticoagulation Forum website will help highlight any deficiencies in your organization (bit.ly/ 3bALPhb); complete it along with hospital leaders, if they are willing. Then, develop appropriate interventions and deploy them, using information from chart abstraction or patient safety events to track success in reducing thrombosis, bleeding events, etc. Employ residents and graduate students to help. 4. Implement systematic care. Stewardship efforts should encompass all anticoagulants used at your facility. This can be done through pathways or protocols, pharmacy-driven oversight programs, leveraging the electronic medical record through order sets and dashboards, or other means. Regardless of the modality, to be successful and sustainable, it should be evidence-based, aligned with your workflow and implemented at the system level. 5. Facilitate transitions of care. All care transitions represent high-risk junctures for patients. Because less

than half of hospitals have interoperability to readily exchange and share patient information, you may need alternative strategies, such as follow-up phone calls with other providers or verbal handoffs, to ensure the plan of care is very clear. 6. Advance education, comprehension and competency. The stewardship program needs to incorporate comprehensive education for patients and caregivers to ensure any deficiencies are remedied at the point of care, as well as for clinicians, who will need periodic refreshers on anticoagulant therapies, ongoing stewardship efforts and tasks that are expected of them. Experts on the stewardship team will benefit from protected time to attend meetings or professional courses and resources to help them maintain their expertise. The Anticoagulation Forum features myriad tools on its website to support anticoagulation management. For more information, visit acforum-excellence.org/ Resource-Center. —Karen Blum

Indicated for all persons suspected of exposure to rabies

THE FIRST AND ONLY HIGH-POTENCY HUMAN RABIES IMMUNE GLOBULIN (HRIG)

HyperRAB® (rabies immune globulin [human]) 300 IU/mL Over 45 years of safe and effective use in over 1 million patients.1-5

45+ YEARS OVER 1 MILLION

OF EXPERIENCE

PATIENTS

RELIABLE SUPPLY

REDEFINING HRIG ADMINISTRATION Please see Important Safety Information and brief summary of Prescribing Information for HyperRAB on adjacent pages, or visit www.HyperRAB.com for full Prescribing Information. HyperRAB® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. HyperRAB is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

#1 Prescribed HRIG in the US

References: 1. Cabasso VJ, Loofbourow JC, Roby RE, Anuskiewicz W. Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects. Bull World Health Organ. 1971;45(3):303-315. 2. Aoki FY, Rubin ME, Fast MV. Rabies neutralizing antibody in serum of children compared to adults following post-exposure prophylaxis. Biologicals. 1992;20(4):283-287. 3. Kuwert EK, Werner J, Marcus I, Cabasso VJ. Immunization against rabies with rabies immune globulin, human (RIGH) and a human diploid cell strain (HDCS) rabies vaccine. J Biol Stand. 1978;6(3):211-219. 4. Aoki FY, Rubin ME, Friesen AD, Bowman JM, Saunders JR. Intravenous human rabies immunoglobulin for post-exposure prophylaxis: serum rabies neutralizing antibody concentrations and side-effects. J Biol Stand. 1989;17(1):91-104. 5. Data on ﬁle, Grifols.

October 2020

US-HB3-2000068

6 Clinical

Pharmacy Practice News • February 2021

Anticoagulation

BLEEDING EDGE continued from page 4

anticoagulation management in improving patient care and monitoring health care costs,” Shehab said. In 2019, the Joint Commission added eight new performance elements to its National Patient Safety Goal for anticoagulant therapy (bit.ly/3i8m60Q). The goal was expanded to include DOACs. In addition, the FDA Safe Use Initiative funded the Anticoagulation Forum to develop core elements of anticoagulation

stewardship (see sidebar, “Core Elements of Anticoagulation Stewardship,” page 4). When implementing an anticoagulation stewardship program, the first step is securing a commitment from administrative leaders, Burnett said. When asking for resources for a stewardship program, understand what metrics are important to the organization. If any are associated with anticoagulation, take advantage of that. Share data from the literature or peer institutions highlighting the benefits of anticoagulation stewardship efforts and/or a compelling patient

case that could have benefited from the service. Don’t try to tackle everything at once; instead, look for a couple of areas where you can achieve early success. Remember, the goal is dedicated resources, not piling this work onto the responsibilities of existing staff. It may help to have a rough idea of budget, she added. Usually these efforts are led by a pharmacist in tandem with a physician. The outlay for that in compensation may run about $250,000 annually, Burnett said, citing estimates from salary.com. Comparing

the estimated costs of ADEs in the literature, which range from $15,000 for an acute venous thromboembolism (J Med Econ 2019;22[8]:751-759) to $49,000 for a stroke or systemic embolism (J Manag Care Spec Pharm 2015;21[10]:965-972), Burnett said, “you can see that you really only need to prevent a handful of events every year to justify the cost of your program.” —Karen Blum The sources reported no relevant financial disclosures.

Indication and Usage HYPERRAB® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. Important Safety Information For infiltration and intramuscular use only. Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available for treatment of acute allergic symptoms, should they occur. HYPERRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The most common adverse reactions in >5% of subjects during clinical trials were injection-site pain, headache, injection-site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain. Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine. Other antibodies in the HYPERRAB preparation may interfere with the response to live vaccines such as measles, mumps, polio, or rubella. Defer immunization with live vaccines for 4 months after HYPERRAB administration. Please see brief summary of Prescribing Information on adjacent page or visit HyperRAB.com for full Prescribing Information.

Clinical

Pharmacy Practice News • February 2021

Pain Medicine

Muscle Relaxants and Chronic Pain a Dangerous Mix

n what can be seen as a sign of a distressing trend considering current prescribing guidelines and the shortage of data on efficacy, the long-term use of skeletal muscle relaxants (SMRs) to treat pain appears to be on the rise. More concerning is that repeat prescriptions in older adults (over 65 years)— a patient population for whom guidelines advise against prescribing this class of drugs—nearly tripled in the last decade.

The findings emerged from a study of 300 million U.S. ambulatory care office visits. More than 30 million of those visits during 2005-2016 resulted in a prescription for an SMR for the first time or as part of ongoing therapy. Overall, the researchers wrote, “Office visits with a prescribed SMR nearly doubled, from 15.5 million in 2005 to 30.7 million in 2016” (JAMA Netw Open 2020;3[6]:e207664). Although initial prescriptions of an

SMR remained somewhat stable over that period, the team found that repeat prescriptions accounted for much of the increase, nearly tripling in all age groups (8.5 million in 2005; 24.7 million in 2016). “Given that there are minimal data on long-term safety and effectiveness, and these drugs are not indicated for use beyond a couple of weeks of therapy, it starts to raise [a] red flag,” said Charles Leonard, PharmD, an

HyperRAB

-----------DOSAGE FORMS AND STRENGTHS---------300 IU/mL solution for injection supplied in 1 mL, 3 mL and 5 mL single-dose vials.

HIGHLIGHTS OF PRESCRIBING INFORMATION

--------------------CONTRAINDICATIONS--------------------None.

Rabies Immune Globulin (Human) These highlights do not include all the information needed to use HYPERRAB® safely and effectively. See full prescribing information for HYPERRAB. HYPERRAB [rabies immune globulin (human)] solution for infiltration and intramuscular injection Initial U.S. Approval: 1974 ----------------INDICATIONS AND USAGE------------------HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons previously immunized with rabies vaccine that have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. --------------DOSAGE AND ADMINISTRATION------------For infiltration and intramuscular use only. Administer HYPERRAB within 7 days after the first dose of rabies vaccine. Postexposure HYPERRAB • Administer as soon prophylaxis, 20 IU/kg as possible after along with body weight exposure, preferably rabies OR at the time of the first vaccine, after 0.0665 mL/kg rabies vaccine dose. suspected body weight • Infiltrate the full exposure to dose of HYPERRAB Single dose rabies thoroughly in the area around and into the wound(s), if anatomically feasible. • Inject the remainder, if any, intramuscularly.

-------------WARNINGS AND PRECAUTIONS-------------• Severe hypersensitivity reactions, including anaphylaxis, may occur with HYPERRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. • HYPERRAB is made from human blood; it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. --------------------ADVERSE REACTIONS--------------------The most common adverse reactions in >5% of subjects in clinical trials were injection site pain, headache, injection site nodule, abdominal pain, diarrhea, ﬂatulence, nasal congestion, and oropharyngeal pain. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. --------------------DRUG INTERACTIONS------------------• Repeated dosing after administration of rabies vaccine may suppress the immune response to the vaccine. • Defer live vaccine (measles, mumps, rubella) administration for 4 months.

assistant professor of epidemiology at the University of Pennsylvania’s Perelman School of Medicine, in Philadelphia, and senior author of the paper. Possibly the most concerning aspect of this study is that adults 65 years and older account for nearly one-fourth (22.2%) of the office visits. The increase in SMR use occurred despite the fact that these drugs have known adverse effects in older patients and are never the recommended course of action to treat pain in this patient population. “Muscle relaxers can cause confusion at all ages, but [that effect is heightened] in the elderly,” said Kimberly Croley, PharmD, a clinical pharmacist at Laurel Senior Living Community, in London, Ky. However, her concern for her patients goes beyond increased risks for falls and fractures or motor vehicle accidents, pointing out that SMRs are not pain relievers at all, since they don’t treat a patient's pain or reduce inflammation. Instead, relief often comes from the sedative properties of these drugs. A sleeping patient, by definition, is a patient free from pain, she noted. A frequent source of pain in patients of this age group is procedures such as reconstructive hip or knee surgery, and proper recovery requires physical and occupational therapy to normalize a patient’s mobility levels. “But how do you rehab someone who sleeps all the time?” Croley asked. Her answer, simply, is “You don't.” As a result, “[patients] don’t get the benefit of the surgery. In some instances, the joint can almost become frozen.”

Digging Deeper Why is SMR use increasing? Leonard cited the fact that “treatment of persistent pain is incredibly challenging, and can be complicated by medical, psychological, social and environmental factors. As providers may hesitate to prescribe opioids, there are few pharmacologic treatment options available beyond acetaminophen or nonsteroidal anti-inflammatory drugs.” Croley said focusing on SMRs isn’t the answer. More than anything else, she feels that greater provider involvement, including a treatment plan, education of patient and caregivers, and messaging, are vital in addressing patients’ pain. “I’m a pharmacist. I should want people to take pills, but that’s not always the answer. Part of medical care should be not just chemistry, but a lifestyle,” she said. “When we have an acute illness, we will only treat the acute illness in the short term, as necessary, to get past it. Then we go back to focusing on wellness.” —W. Harry Fortuna

Grifols Therapeutics LLC Research Triangle Park, NC 27709 USA U.S. License No. 1871

3054805 Revised: 11/2019

The sources reported no relevant financial disclosures.

ctive mabtract cine.

8 Clinical

Pharmacy Practice News • February 2021

Supply Chain

Although most drug shortages result from increased demand or lack of active pharmaceutical ingredients, a shortage of the thyroid disease agent teprotumumab-trbw occurred after Operation Warp Speed officials ordered the drug’s contract manufacturer to halt production and begin bolstering supplies of COVID-19 vaccine. Photo credit: The International Society for Pharmaceutical Engineering.

COVID-19 Rx Shortages continued from page 1

Today, most health systems are in better shape to cope with COVID-19– related shortages than they were in early March. They got there because “as a community of health-system organizations, we had been working on different strategies to improve drug supply,” said Eric Tichy, PharmD, MBA, the vice chair of supply chain management for Mayo Clinic in Rochester, Minn. One example, he said, was the membership that many health systems shared in Civica Rx, the nonprofit generic drug manufacturer, which began distributing medications at the beginning of 2020, several months before the threat of a pandemic became evident to all but a handful of epidemiologists. Intermountain also benefited from Civica’s paid-access model, which supplies generic drugs to health-system members that contract to buy stipulated quantities on a yearly basis. “Dexamethasone is one product that we were able to obtain through Civica that helped ease the shortage impact,” Biksacky told Pharmacy Practice News. The corticosteroid is listed on the ASHP’s Current Drug Shortages database, which is maintained in partnership with the University of Utah Drug Information Service (bit.ly/3nzBCnJ). The shortage is being driven by increased demand for the treatment of hospitalized COVID-19 patients with severe inflammatory lung disease. Tichy also noted initiatives that Mayo Clinic’s group purchasing organization, Vizient, has implemented to improve critical drug supplies. (In December, Vizient launched an updated COVID-19 Surge Demand Calculator; bit.ly/3nA3nwq.)

5 Agents Under Close Watch Intermountain has five agents under close surveillance due to COVID-19, Biksacky said. They are the neuromuscular blocker cisatracurium, the proton

pump inhibitor pantoprazole (injection), the sedative-hypnotic agent propofol, the nutrition supplement Proteinex 15 (Llorens Pharmaceutical) and the thyroid eye disease agent teprotumumab-trbw (Tepezza, Horizon Therapeutics). Although propofol remains on the ASHP/University of Utah drug shortage list, Biksacky said that supplies of the sed-

only through the first quarter of this year. Teprotumumab-trbw has no therapeutic equivalent for treating the rare, progressive thyroid eye disease. An important goal for health systems has been to build safety stocks of critical medications facing depletion as COVID-19 patients needing mechanical ventilation for respiratory distress flooded critical care units. At Mayo Clinic, Tichy said shutting down elective procedures for several weeks not only helped conserve dwindling stocks

‘Near the start of the pandemic, the drug shortage team implemented daily brief shortage huddles, where we have key leaders call in every day and chat for 15 minutes at most, bringing up supply issues and trying to find solutions.’ —Meryl Biksacky, PharmD ative-hypnotic agent recently had eased when Intermountain was able to obtain larger vials from Pfizer. “Thankfully, the 100-mL vials have been adequately filling our needs recently,” she said. Biksacky added, however, that “if push comes to shove,” and propofol supplies begin to evaporate again, the drug shortages team has a last-resort mitigation strategy: a recipe for a 100-mL pooled bag that can be called into service. The recipe has been approved by the health system’s executive compounding committee, she said. Although most shortages result from increased demand, manufacturing interruptions or lack of active pharmaceutical ingredients, the teprotumumab-trbw shortage represents a different scenario. In December, manufacture of the insulinlike growth factor-1 receptor inhibitor was temporarily set aside, when the federal government’s Operation Warp Speed program, acting under the Defense Production Act of 1950, ordered Horizon’s contract manufacturer, Catalent, to halt production and begin bolstering supplies of COVID-19 vaccine. Horizon reported that the shortage was expected to last

of personal protective equipment, it also preserved critical medication supplies. Months of dealing with drug shortages have had a lasting impact. “We’ve learned we have to be very agile,” Tichy said. “From day to day, things are going to have to change quickly, and we have to be able to move our operations in an agile fashion. We also have to be able to communicate with federal agencies and manufacturers quickly.”

Stretching Pfizer Vaccine ‘A Christmas Miracle’ Rapid communication paid off when the first supplies of the Pfizer/ BioNTech vaccine arrived in December. As reported in Pharmacy Practice News in January (bit.ly/2XJcv7f ), “we found that we could get an extra dose or two out of every vial,” Tichy said. “That was a huge bonus. It meant the equivalent of an additional 20% of vaccine for every five-dose vaccine vial. That was very significant because for every 1,000 doses we were getting an extra 200. I was telling people that was like our Christmas miracle.” (For more

details on safe vaccine dilution practices, see pages 20-21.) Because health systems communicated the potential benefit among themselves, he said, “it got escalated up to the FDA. And within three days of the vaccine’s shipment,” he noted, the agency gave the go-ahead to use the extra doses.

Avoiding Waste Communication has continued to play a large part in helping health systems to mitigate shortages. “We raised awareness in the organization about the need to avoid product waste,” Tichy said. “And as a practice community, we quickly made sure we had the right evidence and didn’t rush into using things that were unnecessary. Hydroxychloroquine was a good example.” At Intermountain, communicating about drug shortages is part of the daily routine. “Near the start of the pandemic,” Biksacky said, “the shortage team implemented daily brief shortage huddles, where we have key leaders call in every day and chat for 15 minutes at most, bringing up supply issues and trying to find solutions.” The virtual chats not only involve the team leader, Conor Hanrahan, PharmD, the director of Medication, Policy, Outcomes and Stewardship, and her fellow drug information specialists— Renee Pitt, PharmD, Shannon Inglet, PharmD, and Sarah Yost, PharmD—but also critical pharmacy technicians and central purchasing stakeholders. The team also maintains a list of shortages updated in real time by the health system’s Drug Shortages Advisory Group. “It’s transparent to all and available on our intranet,” Biksacky said. “It provides a single source of truth to what our approaches are to given shortages. The list includes links to many conservation strategy documents that provide our staff and our caregivers with the most up-todate information.” —Bruce Buckley The sources reported no relevant financial disclosures.

Unit Dose Done Right Brightly Colored Labels Call Attention to Meds Requiring Special Handling

Unit Dos e Bar Cod , ing, Pharma c Nursing y & Supply Experts !

s Cold Seal s Tamper-Evident s Moisture Resistant s Ultraviolet Inhibitant s Reduces Cross Contamination s Ideal for Meds Covered by USP 800 s 6 and 12-month Beyond-Use Dating s 1-D and 2-D Bar Coding s Flexible Label and Report Formatting s Multiple Sizes and Shapes to Fit Your Meds & Storage Needs

Scan QR Code for more information and pricing.

Simple. Reliable.

800.523.8966

MediDose.com

10 Policy

Pharmacy Practice News • February 2021

Sterile Compounding

A Standardized Solution to Better Compounding B

y recruiting a team of champions and incorporating new compounding software, AdventHealth in Florida was able to more easily standardize its compounding operations across eight locations in the Orlando area and meet all requirements of USP <797>. The journey to standardization began in 2019, after Richard Montgomery, BSPharm, MBA, the health system’s corporate pharmacy contracts and operations manager, was looking across the enterprise trying to figure out the best way to do this, he explained during a recent webinar. Although the system includes 46 hospitals across nine states, the Orlando area had eight hospitals and some freestanding emergency rooms. With a radius of 25 miles between hospitals, it wasn’t uncommon for pharmacists or pharmacy technicians to travel among campuses, making this a perfect test site for a pilot, Montgomery said. In addition, the health system’s software vendor, Pharmacy Stars, mentioned its Compounding360 module could be used to help with training and formulas.

training oversight and following up on corrective actions, were already handled by each facility. But new requirements for overseeing changes to standard operating procedures (SOPs) and developing and reviewing quality assurance programs would need to be consistent. So, Wollitz reached out to the operations manager at each campus, who in large part were the pharmacy consultants of record. They were excited to take on this new role, she said. They formed a committee to help with items that would need to be standardized across the organization; the committee was made up of the DP from each site and the director of policy and quality and Christine Hong, the quality manager for the pharmacy department, to help offer guidance. The committee met monthly to discuss SOPs or any necessary operational changes. They also reviewed any new formulas to standardize them and used the Compounding360 software to review scorecards on how each site was following policies. They used meeting time to discuss any barriers or issues seen at the campuses,

‘When you have multiple sites, being able to standardize so that staff can float back and forth makes the process much easier for individuals who might be in an unfamiliar cleanroom or unfamiliar pharmacy.’ —Michael Ganio, PharmD Some areas that Montgomery was concerned about included sterile preparation and personal protective equipment, engineering controls, training and competency, and documentation, as well as having standard formulas for IV preparations. At the time, anticipated updates for USP Chapter <797> were looming, along with a requirement to define a designated person (DP) at each site to be accountable for compounding operations and personnel, said Amanda “Mandy” Wollitz, PharmD, the program director of pharmacy policy and quality at AdventHealth Orlando. “We were really excited about that accountability piece, but we also had concerns about how it could have complications for a health system trying to function as one unit and be greater as a whole,” she said. The health system already had several policies in place detailing its compounding requirements and expectations, but there was potential for misalignment across the system. “We really had our work cut out for us.” Reviewing the chapter in depth, Wollitz noted that some operational responsibilities of the DP, such as ensuring the quality of the environment,

implementing changes across the board if necessary. Members also had access to an internal messaging channel. Standardizing operations helped in several ways, Wollitz said. One is garbing. While the 360 platform posts instructions for sterile compounding, some pharmacy locations had unique layouts that needed individual instruction. The committee reworked instructions, ensuring each pharmacy’s layout, and updated the group document. The approach also helped with formulations. Typically, one person at each campus would create these, Wollitz said; now the work is distributed among multiple experts, with some designated second checks built into the process. It also helped ensure that facilities were using recommended or contracted supplies, and improved efficiency in creating a standard list for ordering. “We also now have a unified voice and expectations. There is no longer variation at our campuses,” she said. “We have floaters who go between campuses. They might previously have found different recipes or cleaning tasks at each pharmacy. Now, through the 360 platform, everything is streamlined.”

Sterile preparation and personal protective equipment, engineering controls, and formulas for IV preparations all can benefit from standardized operations.

One of the biggest improvements that Wollitz said she has seen is in staff attending to SOP and policy reviews. The organization does an annual review and has about 20 compounding policies. It’s difficult for one person to conduct a review and catch everything that may need to be tweaked, she said, “but with the committee, we now have many sets of eyes reviewing documents for accuracy. There have been a significant number of changes that we owe to the committee review.” The committee also developed a standard compounding and investigation action plan to research the root cause of any adverse events, and created a folder for all investigations to be centralized and easily accessed through the 360 platform. The committee also created a centralized environmental monitoring team to provide feedback to the DP and panel on any trends they note, and to share corrective action plans. Additionally, the compounding platform provided the team a just-in-time scorecard to review compliance on a daily basis, enabled central control of task and formula creations, and allowed for a library to share literature and standard education. Changes can be pushed out from a central account, Wollitz said. “Our quality program increases the transparency of our practices; we meet monthly and make decisions together, which allows us to pool experience across the organization to weigh in on any significant decisions,” Wollitz said. “Engaging experts at each site and sharing compliance data across the system, I can say we have exponentially improved quality and safety across our compounding sites.” The team is planning some additional upgrades to their system. They include filming the compounding areas and putting it into a virtual reality format so new employees can explore and interact with a virtual model of their own facility’s cleanroom environment before starting work. Furthermore, they are elevating the

training component by adding additional scenarios specific to their work sites and including polls on learning styles.

A Boon for Multiple Sites Although commercial software products to help with compounding and standardization aren’t free, they can be beneficial depending on the needs of a particular health system, commented Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP. “When you have multiple sites, being able to standardize so that staff can float back and forth makes the process much easier for individuals who might be in an unfamiliar cleanroom or unfamiliar pharmacy,” Ganio said. “At least they know the operations are the same.” Going with an outside vendor may make sense for multiple-site health systems such as AdventHealth, he said, whereas smaller facilities may find it easier to internally manage the process through centrally stored spreadsheets, training materials or other documents to track their tasks. Factors to consider include the individual needs of the health system, how complex the compounding operations are, and how many sites and staff members are part of the process. When selecting a vendor, Ganio advised, cost is always a primary concern, especially now during the pandemic, when hospital budgets are squeezed. In addition, he said: “I always recommend getting in touch with an institution that’s already using the software, to ask questions and find out how it is used in the real world. “The important take-home [message] is that health systems standardize in some way,” Ganio added. “It’s critical to have all of this information documented and accessible to the staff.” —Karen Blum The webinar was sponsored by Pharmacy Stars. The sources reported no relevant financial disclosures.

NOW AVAILABLE

Introducing the first product in our portfolio of +RFID smart labeled medications. ™

Smart Labels

NDC 65219-800-10

Diprivan (Propofol) Injectable Emulsion, USP 200 mg per 20 mL is now also available RFID-enabled.

Manufacturer embedded tag

+RFID products eliminate tedious manual tagging and data entry, which supports a more efﬁcient medication inventory process.

Ready-to-read

To learn more about our +RFID portfolio, please visit www.plusRFID.com.

Standards-driven

12 Operations & Management

Pharmacy Practice News • February 2021

Compliance

TJC Standards Gap continued from page 1

Jeannell Mansur, PharmD, a principal consultant in medication management and safety at Joint Commission Resources and Joint Commission International, said during a presentation at the ASHP 2020 Midyear Clinical Meeting and Exposition. Topping the list of noncompliance in 2019 was the medication administration standard (MM.06.01.01), which 49% of

hospitals failed to adhere to, Mansur noted. “Surveyors have been finding medications being administered for an indication when another medication was specified, or an ordered medication given for a different indication, and often this is done without a documented explanation,” she said. “Surveyors will also often see that administration of medication, particularly titration

medication, is performed differently than is directed by the order.” Mansur cited one common reason why orders are not carried out as written: Some nurses tend to administer medications based on patient preference. The Joint Commission has clarified that patient preference can indeed guide drug administration, provided that the patient-requested agent is less potent than the ordered medication, or is the same drug at a smaller dose or delivered via a less invasive route of administration. “For example, a patient prescribed

DRIVING INCREASED DRUG PREPARATION SAFETY 30% of hospitals have experienced a patient event involving a compounding error in the past 5 years1, yet only 33% of hospital facilities use IV workflow technology to help prevent dose preparation errors.2 A recent study found that hospitals using IV workflow technology detected 14 times more medication preparation errors than hospitals performing manual IV workflow.3

~2,800

~42%

OF ALL DOSES COMPOUNDED

COMPOUNDING ERRORS

INCORRECT DRUG ERROR

in 2019 by facilities using the DoseEdge System experienced an error intercepted by the system4

were intercepted by the the average hospital facility in 2019 using the DoseEdge System4

was the most common compounding error intercepted by the DoseEdge System in 20194

Help ensure doses in your pharmacy are prepared safely and accurately Call 888-229-0001 to ﬁnd your local Dose Management Specialist and choose the DoseEdge System today For the safe and proper use of the device, refer to the appropriate user’s guide. 1. Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations; 2016. www.ismp.org/guidelines/sterile-compounding 2. “IV Workflow.” Pharmacy Purchasing & Products, Mar. 2020, p. 12. https://www.pppmag.com/digitalmag/Main.php?MagNo=261&PageNo=1#page/1 3. Stephen F Eckel, Jordyn P Higgins, Elizabeth Hess, Thomas Cerbone, Jennifer B Civiello, Christian Conley, Nilofar Jafari, Shailly Shah, Stephen L Speth, Lynn Thornton, Multicenter study to evaluate the benefits of technology-assisted workflow on i.v. room efficiency, costs, and safety, American Journal of Health-System Pharmacy, Volume 76, Issue 12, 15 June 2019, Pages 895–901, https://doi.org/10.1093/ajhp/zxz067 4. Baxter Internal Data on File. DoseEdge System 2019 Safety Statistics

Baxter and DoseEdge are registered trademarks of Baxter International Inc., or its subsidiaries. USMP/MG84/20-0007 4/20

What’s in a Medication Order? The Joint Commission also has revised standard MM.04.01.01, element of performance (EP) 2, which now specifies that a complete medication order should, at a minimum, include the medication name, dose, route of administration and frequency. “The Joint Commission has for years required hospitals to have a policy stating what the required elements are for your basic garden-variety medication order, but they now felt that they needed to be more proscriptive to direct minimal requirements,” Mansur said. John Hertig, PharmD, an associate professor at Butler University College of Pharmacy and Health Sciences, in Indianapolis, who was not involved with the presentation, welcomed this revision. “Health systems now have clear guidance as to what should be minimally included on a medication order.” He added: “These elements form the foundation of a supporting policy regarding this medication management standard.”

PHARMACY WORKFLOW MANAGER

4.2%

a narcotic for severe pain and a nonnarcotic for moderate pain can choose to receive the nonnarcotic for severe pain, but institutions need a policy guiding this practice. and it needs to be documented in the medical record,” Mansur said.

Baxter Healthcare Corporation One Baxter Parkway Deerﬁeld, IL 60015 www.baxter.com

Titration Tweaks The Joint Commission also has issued clarifications to its titration order requirements, which Mansur said have been a “major challenge for hospitals to comply with. These are complex orders, and the Joint Commission requires [they contain] specific elements, which institutions sometimes omit,” she said. “We often find that medications are not administered in accordance with these complex orders.” The Joint Commission now allows titration orders to specify adjustments of several drugs meant to achieve the same physiologic end point, Mansur said. “This [allowance] gives nurses the option of using their clinical judgment to decide whether to adjust one or another drug, both prescribed for the same end point, as long as they stay within the defined parameters of the order itself.” However, Mansur noted that to take advantage of this allowance, hospitals need an organizational policy specifying which medications can be titrated in this way, as well as any other hospital requirements for the management of orders in this manner. The practice

Operations & Management

Pharmacy Practice News • February 2021

Compliance ‘Ambiguity is the enemy of safety, and these [medication management] clarifications will help not only ensure compliance but hopefully safer care as well.’ —John Hertig, PharmD medication and administration of more than one titration medication to the same end point were published in the June 2020 edition of The Joint Commission Perspectives (bit.ly/3q8qkIB). For health systems and hospitals

The Joint Commission has clarified that a medication may be paused and then restarted without requiring a new order, as long as the restarting dose for the given drug is specified in the order or in an institutional policy. Photo credit: Registerednursing.org.

also must be allowable by state law, and the nurse must demonstrate competency, Mansur said. “Competency requirements will be up to the hospital, but I’d encourage hospitals to develop competencies that confirm that nurses know how to make decisions for managing two titrated medications for the same indication.”

Clarifying Order Restarts The Joint Commission also has clarified that a medication may be paused and then restarted without requiring a new order, as long as the restarting dose for the given drug is specified in the order or in an institutional policy, Mansur added. The organization now permits that, in specific urgent or emergent situations where rapid and minute infusion rate changes might be necessary, block charting can be done in up to four-hour chunks. Again, hospitals need to have a policy in place defining these allowable urgent or emergent situations and specifying what documentation is required, which the Joint Commission also has described, Mansur noted. The Joint Commission specifies these orders should include the time of initiation and completion of the charting block; the name of the medications administered during the block; the starting, ending and maximum rates of medications given during the block; and the physiologic parameters evaluated to determine the administration of titratable medications during the block. “This allowance should help nurses manage very unstable patients, where it can be impractical to document every change in dosing as it is done,” Mansur said. The Joint Commission’s requirements for block charting, pausing of a

struggling to meet all Joint Commission requirements, Hertig offered some words of advice: “Ambiguity is the enemy of safety, and these clarifications will help not only ensure compliance but hopefully safer care as well.”

With these revisions, he added, institutions can optimize adherence to Joint Commission requirements by “writing a good policy and set of procedures, and making sure you actually follow them. Then, commit to reviewing policies and procedures at least yearly to ensure they are accurate, being followed and are up to date with contemporary best practices.” —David Wild The sources reported no relevant financial disclosures.

14 Operations & Management

Pharmacy Practice News • February 2021

Security

Amid COVID-19, Fight Against Rx Diversion Continues A

n updated set of ASHP Guidelines on Preventing Diversion of Controlled Substances, planned for 20212022, will help hospitals implement best practices using newer technologies. “Our new version will review and evaluate market improvements” targeting diversion from many angles, David Chen, MBA, BS Pharm, the assistant vice president for pharmacy leadership and planning at ASHP, told Pharmacy Practice News. Since 2017, when the first ASHP guidelines (bit.ly/35xqz8v) and 100-point hospital self-assessment test were issued, diverse technologies have reached the market, including: • analytical and artificial intelligence platforms that detect and track anomalous behaviors; • radiofrequency identification (RFID) labels from manufacturers that track medications from the source until administration to patients; and • waste tracking systems. The updated guidelines from ASHP

aim to address “1,000 points across a hospital where diversion could happen, from procurement to preparation and dispensing, to prescribing, administration and waste removal,” Chen said. “Every time you implement a process or tech-driven solution, someone figures out a potential way around it.” The stakes are high for solving or at least mitigating diversion, because the illegal activity poses risks to people who divert as well as the entire health care system, Chen noted. In response, health systems are deploying a wide range of anti-diversion tactics. “They have compliance and regulatory departments, and many are also establishing multidisciplinary controlled substance diversion prevention programs that involve senior leadership because they often require additional resources and policy changes,” he said. “Early adopters also invest in robust analytics and automation.” Massachusetts General Hospital (MGH), in Boston, and Children’s Mercy Hospital, in Kansas City, Mo., are two

A Sampler of Technologies That Curb Diversion Kit Check’s Bluesight for Controlled Substances added two features to its pharmacy module in summer 2020: single sign-on enabling pharmacy staff to access a full suite of solutions without another password, and system benchmarking to drive improvement and standardization of documentation practices across nursing floors and within ORs. BD HealthSight Diversion Management has a machine learning algorithm that looks beyond standard deviations to identify anomalous behaviors and help users correctly conclude investigations. “It does dynamic peer grouping. We compare like nurses caring for the same type patients with the same acuity level and opioid needs. It’s much cleaner to do it that way,” said Alan Frashier, RPh, CPh, MBA, the senior clinical sales consultant at BD. “This pulls it all together [rather than] connect dots that are very disparate in terms of what we ordered, what was pulled from the cabinet, what was actually charged to administer, and what may have been returned, canceled or wasted.” IntelliGuard Anesthesia Station is an RFID-automated medication management cart with end-to-end visibility of usable and end-of-life cycle medications. Users can customize tray pockets to accommodate ampules up to large IV bags; it has two-factor log-in and a biometric ID reader, emergency override access, a large touch screen monitor, and an automated Waste Witness module that issues audit reports, and it can integrate with electronic health records. Fresenius Kabi’s 20-mL vials of Diprivan (propofol). The product, launched in September 2020, ships with embedded RFID labels; prefilled syringes will follow by early 2021. The company said it plans to launch more than 20 other RFIDlabeled medications used in the OR. It claims it is the first pharmaceutical maker to embed medication identification data into the RFID tag following global GS1 standards, permitting full interoperability and compatibility. —A.H.

institutions on the leading edge of such anti-diversion efforts.

Mass General’s Approach At Massachusetts General, the added difficulties of caring for COVID-19 patients drove “higher diversion surveillance efforts overall,” said Christopher Fortier, PharmD, the chief pharmacy officer. Those efforts included an inventory audit following the hospital’s springtime surge “to ensure we accounted for the increased amounts of controlled substances we had to purchase” for the care of the sickest COVID-19 patients, he noted. The hospital’s annual mid-year audit focused on fentanyl, hydromorphone, lorazepam, methadone, midazolam, morphine and oxycodone. Although many factors may contribute to diversion, Fortier cited a few likely culprits. During the first COVID-19 surge last year, MGH had to make rapid adjustments to workflow and other key operations. For example, “we converted general care units to ICUs, and needed nurses and physicians who don’t normally work in the ICU to staff those areas,” he said. Such changes could contribute to breakdowns in the normal checks against diversion, he noted. Coupled with the added stress on health care practitioners, Fortier noted, these factors could explain why institutions have seen more discrepancies and overrides for controlled substances. The response at MGH, where 4,000 nurses administer more than 2 million controlled-substance doses annually, was to “purchase the next generation of [a] controlled substance surveillance system that uses machine learning algorithms. We’ll implement it probably in early 2021. Pharmacy will take the lead on managing it, working very closely with nursing and anesthesia,” Fortier said. “Technology like this is so new that the jury is still somewhat out—though I do know I want a machine learning system to help me identify a diverting worker in possibly a much shorter time frame, and I don’t want to weed through thousands of transactions each day. I want to see the exceptions pulled out of the system each day that show discrepancies and warrant further investigation. Machine learning brings in advanced algorithms to find those exceptions and saves an immense amount of time

looking for the needle in the haystack.” Fortier noted that soon after he came on board at the facility, he was tasked with “cleaning up” after the hospital paid the Drug Enforcement Administration a $2.3 million fine to resolve drug diversion allegations in September 2015. The health system agreed to implement a comprehensive corrective action plan lasting until September 2018. He noted that his institution’s multifaceted, evolving program is based on a culture he implemented “where people know this is serious, that we report appropriately, look out for peers, and put patients and care quality first so they’re never affected by diversion, as far as we know.” Hospital leadership’s interest in the program and in its multidisciplinary collaboration components “remains high,” Fortier added. “We’re always working to get better.” The anti-diversion program includes the following: • An interdisciplinary team of pharmacy, anesthesia and nursing leaders, police and security, human resources, compliance, legal, occupational health and employee assistance. “If someone is diverting and cooperates with the investigation, we want to help them,” Fortier said. • 1.5 FTEs who review drug surveillance data from technology and nursing leaders’ reports of anomalous behaviors (reported daily.) • There also are 170 automated dispensing cabinets (ADCs) with all drugs in individual pockets and blind counts, in which nurses don’t

Operations & Management

Pharmacy Practice News • February 2021

Security

Diversion Fight Defies Traditional Measures

ighting drug diversion can be a tough battle. Here are a few key challenges cited by anti-diversion experts: Results are hard to quantify. “How can you say how effective you are? You know what you did, but how do you really know what you prevented? It’s analogous to preventing medication errors,” said Christopher Fortier, PharmD, the chief pharmacy officer at Massachusetts General Hospital. Costs are difficult to capture. The economic effects of drug diversion on hospitals are hard to quantify “because it is multifaceted,” said David Chen, MBA, BS Pharm, the assistant vice president for pharmacy leadership and planning at ASHP. “If a health care worker has an event, it involves human resources; if theft, it impacts time and involves law enforcement; if investing in technology, there is that cost and the time to implement; and there is the actual product loss.” Scope is elusive. Diversion is widely underreported, and the illegal activity also extends beyond

know how many are in each pocket— all integrated with the pharmacy management and electronic health record systems. In addition, 90 anesthesia workstations document controlled substances waste within the pre-op, operative and post-op areas. • Drug testing of every newly hired employee is conducted.

Children’s Mercy Gets Proactive Brian C. O’Neal, PharmD, helped draft ASHP’s initial guidelines to curb drug diversion, and he brought many of those best practices to Children’s Mercy Hospital, in Kansas City, Mo., where he serves

controlled substances, pharmacistss and law enforcement sources have e told Pharmacy Practice News. Indeed, 70% of 235 health care professionals surveyed in late 2019 by Porter Research for the Invistics 2020 Healthcare Drug Diversion Study said they believe most diversion incidents in the United States go undetected (bit.ly/ y/ 3nKqXGX). Also, 86% of those surveyed veyed said they have met or known someone eone who has diverted drugs, and 43% thought their organization could be at risk for fines, bad publicity, lawsuits or overdoses due to past or potential drug diversion. Still, some trend data are available. Amid the COVID-19 crisis, Kit Check aggregated secondquarter data from 52 health systems using its Bluesight investigations feature. Data showed 12%, or 1.35 million, of 11.63 million controlled substances dispenses had an unexpected variance in administration and waste. Of these, 111,236 transactions were elevated for more scrutiny after managers could not reconcile them. Investigations averaged 25.7 days from opening to their conclusion (See Figure at right for more data breakdowns.)

as the senior director of pharmacy and biomedical engineering. Central elements of his program include: An interdisciplinary controlled substance oversight council. This group reviews details of any diversion incidents to improve the system. It also also establishes policies related to controlled substance handling and accountability. An internally developed controlled substance handling dashboard. This workflow software feature shows the numbers of discrepancies, overrides, transactions and events that might indicate poor practice and vulnerability. The software feature also confirms adherence to policies.

Fentanyl 23% of total

Oxycodone 7%

Midazolam 13%

Hydrocodoneacetaminophen 5%

Hydromorphone 12%

Propofol 3%

Morphine 11%

Ketamine 3%

Lorazepam 9%

Tramadol 2%

—A.H.

Overhead cameras. These are placed by all ADCs that hold controlled substances. The hospital system has 85 Cerner ADCs, which integrate with the Cerner pharmacy management system and Cerner electronic health records. “When you get an inventory discrepancy at an ADC, you don’t know for sure if the prior person caused it, or if the person who found it caused it,” O’Neal said. “Did one person access the return bin but not put anything in? Cameras put us at that location to help resolve discrepancies.” A satellite pharmacy within one of its two operating rooms. This setup tightens up waste procedures, so that “all controlled substances are returned to the OR pharmacy, where the anesthesia provider turns them in and watches with the pharmacist as they reconcile what was given out to them minus what came back,” O’Neal said. “We’re doing periodic sampling, but we’re working to transition to test everything that comes back after every OR procedure. Having a high-end refractometer or other analytic technology is also important.” He added that Children’s Mercy is evaluating the potential addition of ADCs outside of each group of three to four rooms within the pediatric ICU. “We currently have three medication rooms with ADCs in our PICU. We discovered, though, that the distance from bedside to medication rooms, coupled with the highly acute nature of some of our patients, can lead to some highly undesirable handling practices [such as person-to-person handoffs and failure to waste in a timely fashion]. Although there is certainly cost associated with adding ADCs, we’re looking at whether these [units] would offer our nurses an

Figure. Top 10 drugs that make up variances.a a

Total does not equal 100%; only top 10 listed.

Source: Kit Check data from 52 health systems using Bluesight investigative tool

additional tool to manage controlled substances in a compliant fashion, while being able to respond to the urgent needs of our patients.” Although O’Neal said he is implementing an advanced analytics diversion detection software system, he still feels “there’s not yet strong data behind AI to prove that these new software packages have cracked the code on diversion. These systems have a lot of data, but it will likely take an end user to come up with a road map they can present or allow the vendor to share with other users. We have the tools, but aren’t quite sure of what to do with all of these data just yet.”

Closing the Loop Michael Campbell, PharmD, MBA, the director of pharmacy services at Pomona Valley Hospital Medical Center (PVHMC), in California, underscored the link between the stressors of the pandemic and drug diversion. Pharmacy workflow modifications made during a pandemic, he noted, such as those aimed at reducing virus spread, conserving personal protective equipment and limiting employee exposure to infection, can increase the risk for diverting behavior. Campbell added that using softwareguided solutions makes sense. The technology, he noted, “requires users to complete steps to close controlled substances transactions.” The software also flags staff “who may need follow-up training in our controlled substance management processes.” —Al Heller The sources reported no relevant financial disclosures other than their stated employment.

16 Operations & Management

Pharmacy Practice News • February 2021

Sterile Compounding

ISMP survey reveals major compliance gaps

56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’

he USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems now employ technological tools to safeguard the sterile drug workflow process. But have health systems reached the optimal level of compliance? That’s what the Institute for Safe Medication

Practices (ISMP) wanted to know. So last July, ISMP launched a Pulse Check survey. More than 600 pharmacists, technicians and others allied with pharmacy responded. The answer, detailed in survey results described at a virtual Omnicell Illuminate meeting, was that although progress in achieving compounding

safety has been made, significant gaps remained.Three-fourths of respondents, for example, reported being aware of at least one pharmacy compounding error in the past 12 months, said Christina Michalek, RPh, the ISMP medication safety specialist who presented the findings. The errors ranged from incorrect dose or concentration to faulty labeling

to wrong drug used (Table). Some were found and corrected before dispensing, Michalek said, while others came to light only after leaving the pharmacy. Michalek noted that the well-documented risks of sterile compounding were not just confined to the pharmacy. “It begins with the products we decide to bring into an organization,” she said.

Table. Sterile Compounding Errors Error

TRUSTED SECURITY WHEN YOU NEED IT MOST PREP-LOCK™ TAMPER EVIDENT CAPS

In times of Pandemic, trust IMI to maintain the integrity of your medications, whether Therapeutics or Vaccines. Improve <797> compliance. Ensure the integrity of your compounds with Prep-Lock™ Tamper Evident Caps.

Percentage Of Mentions

Incorrect dose or concentration

Incorrect base solution

Incorrect base solution volume

Issue or error with 41 labeling of CSP (including omission) Incorrect reconstitution of drug (volume or diluent)

Incorrect drug

Wrong preparation technique (e.g., improper filtering, wrong tubing)

Expired drug, base solution or CSP

Wrong timing (e.g., preparing antineoplastic on wrong date)

Omission of a drug

CSP, compounded sterile preparation

Maintain Sterility. Evidence of access indicates the potential compromise of content

sterility. Standardize Security. Elevate your standard of care with one product to ensure drug integrity, maintain sterility, and mitigate diversion.

1.800.344.2554

MADE IN THE USA

The risks involve when and how medications are prescribed and the processes of verification and communication, she added; they also extend to the workplace environment, the lack of standardized practices, production pressures and the absence of technology. “These are all risks,” she said. An even more complete picture of compounding safety challenges emerged from an open-ended question that drew more than 600 responses. By far the biggest barrier, she said, “was the inability of pharmacists to accurately verify compounded sterile preparations using indirect processes like the syringe pull-back method.” Closely following was the difficulty in complying with USP General Chapter <797> and <800> standards. Rounding out the list were staff

Operations & Management

Pharmacy Practice News • February 2021

Sterile Compounding

training and competency issues, a lack of technology, not enough workspace and heavy workloads. Insufficient leadership support and work supervision also came under fire. The survey also addressed technology. A total of 361 respondents (57%) reported using at least some technological tools in sterile compounding. They included barcode verification with and without images, multiple ingredient compounding devices, gravimetric verification and robotic compounding.

she added. “This is a team sport. It’s not limited to the silo of the pharmacy.” Although COVID-19 appears to have

played little part in the survey results, Kienle said she is worried that the COVID-19 pandemic’s practice pressures might have caused people to become “even more lax on things like certification of their areas and maintaining and really upgrading the environmental pieces” that are fundamental to USP <797> and <800> standards. Michalek ended on an upbeat note. “Pharmacists and technicians have done some amazing work to continually improve the care and delivery of sterile injectable medication,” she said.

“As stewards of medication use, they are really in the best position to move forward with more improvements and more safety around compounded sterile preparations.” A print version of the ISMP Pulse Check survey report can be found at bit.ly/3qN37fF. —Bruce Buckley Michalek reported no relevant financial disclosures. Kienle is a member of the USP Compounding Expert Committee, but her comments are her own and not affiliated with or endorsed by USP.

! ßX(ׁّ‫ ׉‬ß !!Xy0 ! m( ²À ª J0 ² mÇÀX y²

Delving Into Best Practices Respondents were asked to rate the implementation level of nine ISMPdefined compounding best practices. The greatest extent of implementation (73%) related to cleanroom/sterile compounding area practices, including having enough workbenches to support only one staff member at a time per primary engineering control—laminar airflow workbench, biological safety cabinet, compounding aseptic isolator or compounding aseptic containment isolator. The survey also focused on standard operating procedures (SOPs). Were they defined and what was the level of compliance? More than half of respondents (56%) reported that SOPs were “defined and always followed.” About one-third (34%) said they were defined and “often followed,” while 10% said they were “never, rarely or sometimes” defined and followed.

‫ ׆׈ّژ‬0! ÇmÀª ّm à Iª00ð0ª mXy0

‘Alarming’ Results Patricia C. Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, found this result “pretty alarming.” “Only 56% said always? That’s crazy,” Kienle told Pharmacy Practice News. “It shows that some people still aren’t doing what they should have been doing for decades. People need to have procedures that match what they actually do and that are compliant with USP <797> and <800> standards, state regulations and best practices.” Kienle also said these procedures need to be in place in health-system areas “outside of the pharmacy where sterile compounds are mixed, like procedural areas, operating rooms, imaging and infusion centers—places that have been under the radar for years. “Pharmacy supports those areas, too,”

ׁّ‫ ׀‬0! À ّׄ‫ ׀‬0C w0(X! m Iª00ð0ª mXy0

ّ‫ ׀ׇ‬0! ÇmÀª ّ! m( ß !!Xy0 ²RX§§XyJ !Ç 0 mXy0

2 0! À ‫ ׈‬0C w0(X! m Iª00ð0ª mXy0

Xȁ ²ɈȌƧǲ

18 Operations & Management

Pharmacy Practice News • February 2021

Leadership in Action

Taking the Measure of a Leader ‘A leader is best when people barely know he exists, when his work is done, his aim fulfilled, they will say: we did it ourselves.’ —Lao Tzu

e all have experienced good leaders who we admire, as well as poor leaders who we don’t want to emulate. So, what are the desired characteristics that make a good leader, and the undesirable characteristics of poor leaders? What about me? Am I a good leader? How can I know? I’ve been asking myself that last question most of my adult life, because for most of that time, I have been an avid student of the leadership literature. In fact, I am still a learner and embrace that journey, because I believe we never fully “arrive”; there always are improvements to make in our leadership skills. The issue has been identifying the specific areas to improve. To that end, I’ve taken many assessment tools. The problem is they tend to measure personality inclinations and not true leadership skills. For leadership transformation to occur, I need to know where to focus. One off my more recent nt

discoveries in that search is LionsLead, a product development company (www. lionslead.com) that creates assessments to enhance productivity and growth in all areas of individual, team and organizational development. Let’s explore some of the key LionsLead concepts.

Personality and Behavior Your personality, your hard wiring, is fixed from an early age and reveals tendencies toward certain competencies but is not necessarily an indicator of— nor should it be used as an excuse for— behavior. That’s why LionsLead assessments measure and modify behavior, not personality. By revealing insights about choices, actions and reactions, individuals and teams can drive toward improvements by making small changes in behaviors that can significantly affect outcomes. The assumption underlying that assessment approach is as tthat the best leaders

learn how to perfect their actions— “what they do”—rather than being defined by their personality—“what they are.” They are built and become influential, admired and successful by their choices, actions and reactions. Their behaviors and beliefs drive the outcomes.

The Assessment Model LionsLead, like most personality and/or leadership assessment methods, uses its own jargon and definitions, but I will try and drill down to a few that convey the basic approach. The assessments enable rich and meaningful conversations about topics not often measured or discussed by other methods. To that end, they include 192 attributes that lead the person taking the assessment through what is known as a 5T process of transformation: 1. Translate – mapping competencies, to attributes, to behaviors 2. Truth-Telling – revealing accurate insights 3. Trust – honoring confidence in all aspects of communication and development 4. Testify – inspiring actions and achieving profound results 5. Timely – discovering now what years of observation may never provide

The Impact of Markers Of Excellence The LionsLead assessments drive progress toward the development of self, others, teams and, ultimately, the culture of companies and entire communities. They create: Purposeful behaviors. These are behaviors that are the measured best practices of results-oriented success. They’re also the behaviors that inspire right actions and choices. Principled leaders. These are leaders whose character matters most, and who embrace what the LionsLead developers have identified as seven character traits of top-tier leaders (more on that below). Authentic culture. Culture that is real and driven by guiding principles.

The Pathway to Exceptional Leadership

Figure. H.E.A.R.T. Model: a pathway to exceptional leadership. Source: LionsLead

Knowing what leadership is and how to acquire it can be elusive. Leading is a discipline and an art. Becoming a good leader is laudable. Being considered an extraordinary leader and a leader with strong coaching/mentoring skills creates a legacy. LionsLead uses the acronym H.E.A.R.T—a model that urges current and prospective leaders to consider a deeper and more rewarding way to lead

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

Ernest R. Anderson Jr., MS, RPh, FASHP, FMSHP

(Figure). If you see honoring the achievements of others and developing leaders who may never know you, then listen to and follow your heart and mind.

Steps of an Assessment Tool Most professionals and leaders wonder how they compare to the best leaders. The findings from a LionsLead assessment show how leaders compare to the benchmark of extraordinary leaders. These findings validate the strengths and weaknesses of assessed leaders. The interpretation of the findings should generate insightful and transformational conversations with a LionsLead advisor/coach. The tool is administered online and the results are reported online at the LionsLead administration website. There are a variety of LionsLead assessments that are geared toward different disciplines. My recommendation for pharmacy leaders is the LeadRight

3 Steps To Personal Transformation

Learning, through a LionsLead assessment, the behavioral changes needed to be a successful leader.

Building new neural pathways (neuroplasticity) necessary to sustain new effective behaviors.

Achieving an instinctive, effortless practice of new behaviors aligned with your heart, mind and soul. Note: To achieve the transformation, these changes often require a coach to assess, motivate, provide consistent feedback and encourage deep, profound self-reflection.

Pharmacy Practice News • February 2021

Operations & Management

Leadership in Action members to fulfill all of the key roles. In some cases, an individual could fulfill multiple roles in their areas of strength. If all members of a team take the LeadRight tool, not only can one look at the best roles for team members to play, but one can look at the strengths and weaknesses of the entire team across the entire set of competencies. Based on this overview, hopefully you’ll appreciate that Assessment Instrument, which consists of 315 statements to answer, generally multiple choice. Administration of the online assessment takes 90 to 120 minutes. The LionsLead advisor schedules a 90-minute confidential debrief with the leader to review the findings and develop a plan based on the results. A follow-up assessment is administered to measure progress, usually six months to one year later.

LeadRight Report Overview Results of the LeadRight assessment comprise specific, applicable competencies, represented by multiple attributes from the focused instrument and measured by associated behaviors. The report consists of seven competencies and 27 attributes. The seven LeadRight assessment competencies are: 1. Self Leadership 2. Leadership Essentials 3. Getting Things Done 4. Leading Others 5. Composure 6. Candidness 7. Personal Values Factor Another output of the assessment tool is the strengths that you would bring to a team. There are seven team roles that high-functioning teams must possess, as derived from the team role model of Meredith Belbin, PhD (bit.ly/ 39YSv6m). The team roles as defined by Belbin are: 1. Coordinator – creates the way team effort is applied. 2. Shaper – influences the way teams function. 3. Plant – advances new ideas and strategies. 4. Monitor – carefully evaluates ideas and suggestions. 5. Resource Investigator – explores and reports on ideas. 6. Team Worker – plays a supportive role filling gaps. 7. Complementor/Implementor – brings strong tactical focus and execution. The tool results identify a primary and secondary role and grades the participant’s ability in all roles as fair, good and strong. Ideally, your team will include enough well-matched

LionsLead can be a powerful leadership measurement tool. In fact, it’s validated by at least two statistical methods: the use of Cronbach scores, which measure an assessment's internal consistency, and item response theory, which determines the relevant strengths of each assessment statement and helps to ensure accuracy. Next month, we will explore specifics of the LeadRight tool and how you might be able to use it to assess the competencies and attributes of your team members. ■

20 Operations & Management

Pharmacy Practice News • February 2021

Supply Chain

Hospitals Hone COVID-19 Vaccine Cold Chain Strategies

ospitals are key participants in COVID-19 vaccine distribution. But the facilities still face many challenges, including storage of vaccines at compliant temperatures, unpredictable deliveries and, most recently, a shortage of specialized syringes needed to stretch doses of the Pfizer-BioNTech vaccine. Through it all, pharmacists are adjusting workflow to ensure the Pfizer and Moderna vaccines are administered as

efficiently as possible. Northwell Health, a network of 23 hospitals and nearly 800 outpatient facilities in New York, is a case in point. “We don’t know week to week what we’ll get,” said Onisis Stefas, PharmD, MBA, Northwell’s vice president and chief pharmacy officer. “It comes in dribs and drabs. Once the vaccine arrives, we send emails to invite prioritized employees [high-risk health care

workers so far] to be vaccinated at their hospital of choice. We do get emails less than 48 hours ahead of time from the New York State Department of Health, and they tend to be accurate, but that’s still not a lot of time to prepare.” Flexibility is key in such situations, Stefas noted. “We ramp up when we have vaccines, and ramp down when we don’t,” he said, adding that such adjustments have to be made rapidly

after deliveries fall short of expectations. In one recent example, New York state had been receiving 300,000 doses a week from the federal government to administer to 7 million eligible people. But in mid-January, it unexpectedly received only 250,000 doses, and health care providers had to abruptly cancel thousands of appointments. “It doesn’t matter how much vaccine you order because states allocate based on their own formulas,” Stefas said. Cold chain logistics is another moving target. “Hospitals that invested in ultracold freezers were more likely to get Pfizer vaccines first,” Stefas said. “So, we purchased ultracold freezers to add to a few we already had in research labs; our current total of 19 raises our storage capacity to 2 million doses across our health system.” As a result, “every Northwell hospital getting shipments of the Pfizer vaccine has an ultracold freezer to receive and store them.”

CDC Requirements

High-alert medication carries high risk. And for the patients who need essential Parenteral Nutrition treatment options, every one of our more than 1.7 million annual, custom-compounded PN solutions undergo critical double-checks by CAPS® pharmacists. As the nation’s largest network of outsourcing admixture pharmacies and the market leader in the compounding of Parenteral Nutrition, we understand that safety is your highest priority. Contact your local CAPS representative to learn more. Rx only. ©2021 CAPS® (Central Admixture Pharmacy Services, Inc.) All rights reserved. 1/21

The CDC requires every vaccine storage unit to have a temperature-monitoring device and a facility to document its daily minimum and maximum readings for regulatory compliance. To ensure compliance, Stefas said Northwell’s vaccination ramp-up included: • adding more sensors for its new ultracold freezers, which it integrated into an automated temperature monitoring system already in place; • adding electrical upgrades for the ultracold freezers; • collaborating with facilities, engineering and information technology to strategically position its vaccine storage units and ensure that monitoring and alert systems work well; and • establishing an inoculation reservations and scheduling system. But no amount of technology can make up for poor planning and prioritizing, Stefas stressed. To that end, Northwell’s pharmacy and other internal stakeholders created an algorithm that prioritized employees for inoculation, based on several factors, Stefas said: “Do the employees work in an ED or ICU? Where do they practice geographically and what is the COVID-19 prevalence there? How much patient interaction do they have? What is their age?” As vaccines came in, he added, “we were able to release invites to our highest-risk health care workers.” One key is to know how many people are scheduled to be vaccinated daily and where the vaccinations will take place in the hospital. Armed with that information, the night before, the Northwell pharmacy department places

Operations & Management

Pharmacy Practice News • February 2021

Supply Chain

Table. Safe Vaccine Temperatures

an appropriate number of vaccines in the refrigerator to thaw. In the early morning, pharmacy reconstitutes and labels the vaccines in compliance with Pfizer’s safe six-hour-use window (Moderna is good for up to 30 days in the refrigerator; see Table), and delivers them to the vaccine administration site leader. Pharmacy connects with the vaccination team throughout the day “to ensure they have enough product, and to ensure we didn’t prepare too much and waste any,” Stefas said. To ensure cold chain compliance, Northwell also trained staff to thermally protect, reconstitute and draw up the vaccines with online education and competency tests everyone had to pass.

Vaccine and Manufacturer

Storage and Handling Requirements

Pfizer/BioNTech

• Vaccine will arrive at between –80° and –60° C (–112° to –76° F) in a thermal shipping container with dry ice. • Use the thermal shipping container for temporary storage only; replenish dry ice pellets within 24 hours of delivery and every 5 days thereafter. • Store in an ultracold freezer within above temperatures; continuously record temperatures with a digital data logger and ultracold probe. • Document daily minimum and maximum temperatures. • Before mixing, thaw in refrigerator for up to 120 hours at 2° to 8° C (36° to 46° F). • 25 to 195 vials may take 2 to 3 days to thaw; fewer number of vials will take less time.

Moderna

• Store frozen in original cartons between –25° and –15° C (–13° to 5° F). • Check and record daily temperatures, including minimum and maximum. • Do not store on dry ice or below –40° C (–40° F). • Vials can be stored refrigerated between 2° and 8° C (36° to 46° F) for up to 30 days before first use. Unpunctured vials may be stored between 8° and 25° C (46° to 77° F) for up to 12 hours. • After first dose is withdrawn, hold vial between 2° and 25° C (36° to 77° F) for no longer than 6 hours. • Do not refreeze.

Johnson & Johnson (Ad26.COV2.S) (FDA EUA expected 2/2021)a

• Store for up to two years at –20° C (–4° F), up to three months at 2° to 8° C (36° to 46° F).

Oxford-AstraZeneca (AZD1222) (Not likely to receive FDA authorization until April 2021) a

• Store, transport and handle at normal refrigerated conditions of 2° to 8° C (36° to 46° F) for at least 6 months.

‘An Eye on the Clock’ Anna Legreid Dopp, PharmD, ASHP’s senior director of clinical guidelines and quality improvement, stressed that pharmacists have been a huge help in managing the storage-to-inoculation process, “thanks to a lot of deliberate planning.” In the case of the Pfizer vaccine, “hospitals are being strategic about timing once it is taken out of the freezer and thawed,” she said. “When thawed and ready, dedicated team members help with diluting the Pfizer vaccine, drawing it into syringes and prepping for administration. [This] is done with an eye on the clock and detailed labeling for the beyond use date/time.” (For more details on safe dilution of COVID-19 vaccines, see sidebar, “Beware Potential Errors.”) Legreid Dopp added that many ASHP members use a hub-and-spoke model for administering vaccines, in which a health system centrally receives bulk thermal shipments of vaccines (Pfizer, 975 vials; Moderna, 100 vials) it then has to thermally protect, break down and redistribute for use at multiple vaccination sites. “This is where manufacturers’ thermal shippers come in handy … to transport vaccine from locations with an ultracold freezer to those without,” she said. Pfizer noted that its shippers can serve as temporary storage units for up to 30 days, as long as they’re refilled with dry ice every five days. That can be a boon for smaller hospitals that may not have the resources to invest in ultracold freezers, noted Rafik Bishara, PhD, the chair of the Parenteral Drug Association’s Pharmaceutical Cold Chain Interest Group. Bishara also suggested that smaller and rural sites consolidate. “Mass vaccinations may be the best we can do in some areas if they don’t have equipment,” he said. “Maybe set up a local high school arena as a vaccination center with a mobile freezer. Or coordinate with a small hospital in the next city, if they have equipment to properly store vaccines at

EUA, emergency use authorization a

Projected market entry based on ASHP COVID-19 Vaccine Candidates Table (bit.ly/2Mak30G).

Sources: Pfizer/BioNTech: bit.ly/36ldCiu; Moderna: bit.ly/36epKBL; Johnson & Johnson: bit.ly/2Mak30G Oxford/AstraZeneca: bit.ly/3iMFG3j

Beware Potential Errors

hen it comes to safety, vaccines are no different from drugs: Potential adverse reactions need to be accounted for, according to Rafik Bishara, PhD, the chair of the Parenteral Drug Association’s Pharmaceutical Cold Chain Interest Group. To that end, hospitals should heed recently published examples of COVID-19 vaccination errors and develop action plans for avoiding such errors at their own facilities, Bishara noted. The Institute for Safe Medication Practices (ISMP), for example, published an article, “Learning from Errors with the New COVID-19 Vaccines,” on Jan. 14 that detailed several voluntarily reported mishaps, including four dilution errors involving the Pfizer COVID-19 vaccine (bit.ly/3t0VTX6). In one of the cases, an inadequate volume of diluent (approximately 1 mL) was added to the vaccine vial. Before the error was discovered, a 60-year-old patient received a nearly twofold overdose in his first vaccine dosing. The patient had no initial reaction to the overdose and was discharged after an hour, with follow-up calls planned for the next 48 hours. According to the ISMP report, clinic staff called a Pfizer representative to determine if the patient’s second vaccine dose should be altered, “but no immediate guidance was offered.” The ISMP report also noted that several hospitals are having difficulty obtaining the specialized syringes needed to handle the low volumes involved in diluting and/or extracting the Pfizer and Moderna COVID-19 vaccines. “We [have] learned that Operation Warp Speed, the federal COVID-19 vaccine response, has been shipping out a variety of syringe

the recommended temperature.” Whatever COVID-19 vaccination strategies are used, Bishara stressed the importance of having health-system pharmacists involved. “I fear patient compliance rates [will be adversely

types since vaccinations began, some of which are not low dead-volume syringes and, thus, not efficient enough to extract more than five doses from the Pfizer-BioNTech vaccine or more than 10 doses from the Moderna vaccine vials,” the report stated. The authors added some guidance on the type of syringe and technique needed to avoid problems: “While the number of doses withdrawn from a vial is influenced by the health care worker’s technique, using a syringe designed to limit the dead space between the syringe hub and needle reduces the amount of wasted vaccine and increases the ability to extract an extra dose(s) from COVID-19 vaccine vials.” Asked to comment on the syringe/dilution issue, Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP, noted that there is some room for flexibility. “More than one device or combination of syringes and needles have sufficient low dead space to extract the sixth or even seventh dose,” he said. “Some low-deadspace devices have needles already affixed to the syringe, but some combinations of individual syringes and needles may also result in low dead space. “In some cases, it may not be necessary to withdraw every dose using a low-dead-space syringe; using a combination of three low-dead-space syringes and three standard syringes can help optimize the use of low-dead-space syringes,” he said. Ganio added that “ASHP is working with industry and government stakeholders to develop resources to help guide pharmacists in optimizing the amount of vaccine doses.”

affected] if people feel good after the first injection and don’t come back for the second. So, hospital pharmacists have a major new role to educate themselves, nurses, doctors and technicians to reinforce the importance of taking

—David Bronstein, Al Heller

the two required shots. That said, let’s also hope that a one-shot vaccine will be developed shortly.” —Al Heller The sources reported no relevant financial disclosures.

22 Operations & Management

Pharmacy Practice News • February 2021

Finance

Millions in Cost Savings continued from page 1

June 2020, said Jon Knezevich, PharmD, the hospital’s diabetes stewardship pharmacist (abstract BP-4). “This translates to an estimated cumulative length of stay reduction of 0.46 days and greater than $690,000 in cost avoidance annually, along with an additional $150,000 in cost savings from formulary management strategies,” he said. Some of those savings, he noted, were due to reducing/streamlining insulin analog formulations on the inpatient formulary, and incorporating multiuse insulin vials into the nursing workflow to diminish waste. UNMC launched the diabetes stewardship position in January 2016, hiring Knezevich as its first steward. One of the biggest challenges Knezevich said he found was trying to quickly and effectively identify, triage and intervene in real time when patients experienced fluctuations in blood sugar or were treated with a non–evidence-based insulin regimen. He worked with the information technology department to develop a novel dashboard, constructed using the hospital’s electronic health record system (EPIC), to provide real-time surveillance of glycemic fluctuations among patients hospital-wide, and collaborated with team-based rounding pharmacists to promote evidence-based glycemic recommendations and provide timely interventions from a central location. (For more success with dashboards, see article on page 26.) Knezevich also developed and disseminated an acute glycemic management credentialing competency in the winter of 2017, after he couldn’t find any commercially available programs. The module reviews organizational policies, protocols and workflows; provides guidance with transition of nonformulary agents; and offers recommendations for dealing with special populations, such as transplant patients, those on the labor and delivery unit and those with steroidassociated hyperglycemia. The module empowers clinical pharmacists to take an increasing role in

monitoring and managing patients receiving insulin therapies, he said. “Many health care organizations are finding it difficult to address the increasingly acute medical needs of the growing diabetic patient population they serve,” Knezevich added. “Given the unique skill sets and diverse knowledge [of our] profession, pharmacists can serve as the leaders championing change and delivering interventions to improve patient care. Much of the outcome-related success our institution has experienced is the result of an empowered clinical pharmacy team.”

The stewardship model is easily translatable to other organizations with broad patient populations where high-risk medications are warranted, he noted. Examples could include anticoagulation stewardship, pain stewardship and geriatric stewardship.

Removing IV Acetaminophen: $450K Savings Taking IV acetaminophen off the formulary at Memorial Medical Center, in Springfield, Ill., helped the pharmacy save an estimated $600,000, without adversely affecting clinical outcomes, Kayla DuBois, PharmD, MBA, and her colleagues showed (abstract P-9 ).

The medical center had been spending nearly $600,000 per year for IV acetaminophen, largely driven by surgical patients, said DuBois, a clinical pharmacist at the facility. The drug had been offered to reduce opioid consumption and was available in many perioperative order sets and enhanced recovery after surgery protocols. However, increasing evidence demonstrated that the IV form of acetaminophen was not better than the oral form (Am J Health Syst Pharm 2018;75[6]:367-375), DuBois said, and an in-house medication use evaluation in 2019 found opioids continued to be used at higher levels than benchmarked. Specifically, IV fentanyl use was greater than 1.25 times that of similar size teaching hospitals, while hydrocodone-acetaminophen and acetaminophen-codeine were used over 2.8 times more, tramadol was used over 2.3 times more, and oxycodone ER was used over 1.7 times more, she said. DuBois presented these results to the Pharmacy and Therapeutics Committee, surgical department heads and other key players. Subsequently, they put in place a plan to remove IV acetaminophen from the formulary and order sets as of June 2019. Order sets were updated to include appropriate alternatives, such as oral or rectal acetaminophen, oral nonsteroidal antiinflammatory drugs and adjunctive non-

opioid analgesics such as orphenadrine and gabapentin. Education on alternative analgesics was provided to pharmacists, physicians and other clinical staff through targeted live education sessions, email communication, educational slides and a newsletter. Next, DuBois and her colleagues looked at clinical and financial outcomes before and after removing the drug. They checked use of morphine, hydromorphone and fentanyl, as well as hospital lengths of stay and drug costs. In particular, the team evaluated metrics among eight diagnostic groups associated with higher use of IV acetaminophen: major chest procedures, major small and large bowel procedures,

gastrointestinal obstruction, esophagitis, spinal fusion, nonmalignant uterine procedures, cesarean delivery, and septicemia or severe sepsis. Any use of more than one standard opioid dose (morphine 2 mg, hydromorphone 1 mg, fentanyl 50 mcg) was deemed clinically relevant. The team found only three instances of significant increases in opioid use after IV acetaminophen was removed, all for fentanyl for gastrointestinal obstruction, esophagitis and nonmalignant uterine procedures. In addition, significant reductions were observed, including an approximately 8 mg decrease in morphine for small and large bowel procedures and for gastrointestinal obstruction, DuBois said. Changes in length of stay related to IV acetaminophen removal varied, including up to 14.5 fewer hours for gastrointestinal obstruction and up to 7.5 additional hours for major small and large bowel procedures. These changes could be attributed to several factors, DuBois said, including changes in prescribers and prescribing habits, and alternative opioid delivery methods. Cumulative savings from July 2019 through March 2020 (the study period) found drug savings reached $450,000; projected savings through 2020 were $610,780. Taking IV acetaminophen off the formulary had “widespread impact,” DuBois said, “which required the pharmacy department to [deliver] a very strong argument to high users of this drug. We had to come forward with undisputable evidence that alternative oral agents were appropriate and effective.” DuBois also reiterated the importance of her team’s “extensive education rollout program house-wide, with pharmacists in particular getting education so they would have the foundational knowledge to be able to defend the removal as well as the opportunity to offer alternatives.” Although generic IV acetaminophen is available, this did not change the hospital’s view on using it, DuBois said. “Literature evidence still supports there is no benefit over oral administration, and the cost of generic IV dosage forms still far exceeds that of oral tablet, oral liquid and rectal dosage forms.”

Operations & Management

Pharmacy Practice News • February 2021

Finance Punting a PBM Saves $1.19 Million Involving pharmacy stakeholders and selecting a pharmacy benefit manager (PBM) that offered a superior employee prescription benefit helped Kalispell Regional Medical Center, in Montana, save $1.19 million in the first year of its switch, according to another study (abstract P-6) presented at the ASHP annual meeting. Historically, selection of PBMs was handled by the human resources department, without the pharmacy’s participation, said Hugh Easley, PharmD, the director of pharmacy services. But in 2016, hospital administrators asked the pharmacy for help managing employee prescription costs in its self-funded plan, which at the time were $94.93 per member per month (PMPM). The hospital’s contracted PBM had set up barriers to pharmacy’s access to line-item prescription details to save money. After participating in a process improvement network collaborative, HR leadership formally requested that their health insurer’s PBM vendor provide line-item prescription details, such as medication costs, pharmacy dispensing fees, PBM administrative fees and rebates shared. They submitted these data to their group purchasing organization insurance consulting team for an external market competitive review. The consultants compared this information with other third-party PBMs to identify a best fit with the medical center’s existing formulary, copay structure and employee benefit philosophy. Easley and his pharmacy colleagues offered guidance toward selection of the new PBM partner, which manages employee eligibility and provides a complete set of administrative data, including rebate management and claims-denial appeal processes, and optional free and fee-based clinical services focused on employee wellness. In the first year alone, the switch resulted in a 17% reduction in costs—to $78.82 PMPM—yielding an estimated total savings of $1.19 million. Most of the PMPM savings were achieved by in-sourcing pharmacy services and maximizing the purchase of preferred generics and tier 1 formulary

drugs. The health system also rewarded employees by lowering out-of-pocket expenses if they used entity-owned pharmacies and educated them on the cost savings in this self-funded plan. Easley and his team also made plan design changes with their PBM related to specialty medications. Although these previously were handled through an outsourced mail-order pharmacy, the health system brought the medications back to their own in-house pharmacy to lower costs and improve convenience for employee patients. Easley encouraged health systems with self-funded pharmacy benefit plans “to contract with a third-party PBM that is committed to price transparency and employ a business model with practices more closely aligned with the health system, to ensure cost savings will benefit their employees and dependents.”

Harnessing PGY-1 Residents: $398K Return on Investment Using PGY-1 pharmacy residents’ time and keen insights in developing cost savings initiatives yielded Baylor University Medical Center, in Dallas, a nearly $400,000 return on investment (ROI) in fiscal year 2019. This was enough to more than support the implementation of two PGY-2 pharmacy residency programs in hematology/oncology and solid organ transplantation, investigators reported (abstract P-4). “As the financial landscape of health care changes, we are tasked to reduce costs to meet shrinking financial margins while continuing to maintain quality in an ever-expanding patient care environment,” said Allison Bass, PharmD, BCOP, the hospital’s director of the PGY-2 oncology residency program. “Pharmacy departments have the potential to play a significant role in identifying creative ways to meet patient care needs, expand services and capitalize on cost savings.” Bass and her team developed a pilot program in which a PGY-1 pharmacy resident led daily coverage of the abdominal transplant and hematology/oncology services. During a 15-day pilot in the hematology/oncology service, the residents documented 169 interventions, such as providing antibiotic stewardship or alternatives to high-cost chemotherapy. Sixtynine of these interventions saved more than $20,000. During a four-week pilot in the abdominal transplant service, the residents documented 213 interventions, including IVIG and antibiotic stewardship efforts, with the latter yielding a

reduction in antibiotic treatment by at least 44 patient-days. Residents also acted as record-keepers, logging 43 notes on transplant pharmacists’ clinical interventions during eight kidney/liver selection committee meetings. Such documentation complies with standards for transplant center accreditation from the Centers for Medicare & Medicaid Services and United Network for Organ Sharing. Additional successes included more than $68,000 saved via formulary adherence and alternative therapy recommendations. Some of those recommendations came out of a resident-led drug information on-call pager program, where clinicians and pharmacy staff could consult residents using the call pager service during busy off-hours. High-impact interventions included recommendations for costeffective alternatives to agents such as isoproterenol, and for minimizing doses of high-cost antidotes such as digoxin immune Fab through more consistent use

of toxic drug level assessments. Residents also spearheaded medication use evaluations (MUEs). One focused on ensuring that thresholds of crystalloid administration were met before albumin was ordered for cardiothoracic surgery patients. MUEs achieved $430,000 in potential annual savings, Bass noted. Additionally, costs were reduced by more than $175,000 by using two residents in lieu of two pharmacists, he noted. The team estimated an ROI of $398,007 during the first year of the transplant residencies. Upon presentation of these results to senior leadership, the pharmacy received funding for PGY-2 solid organ and PGY-2 oncology residencies. Both programs started last July, with residents recruited from their PGY-1 year. “Implementing residencies can be an effective way for pharmacies to increase quality and improve affordability of care for the patients we serve,” Bass said. “Our model offers a path to leverage the impact of PGY-1 pharmacy residents to justify the expansion of services through PGY-2 residency programs.” —Karen Blum The sources reported no relevant financial disclosures.

24 Technology

Pharmacy Practice News • February 2021

Automation

Harnessing ADC Data Bolsters Inventory Control

A Boon During COVID-19 Surge Without the use of ADC optimization software, 23,000 additional stock-outs at Strong Memorial Hospital would have occurred over several years, requiring more than 4,000 additional hours to manage.

nowing how to use the big data generated by automated dispensing cabinets (ADCs) can improve workflow efficiency and reduce the frustrations related to inventory stock-outs and the hefty toll of expired medications. But getting there can be overwhelming. Aryana Sepassi, PharmD, a senior analyst for health economics and outcome research at BD, said a “recurring theme” for hospitals is that big data is useful, but “it can be time-consuming and cost-intensive to wade through” the vast quantity of data produced by ADCs. Indeed, at the University of Rochester Medical Center (URMC) in New York, about 74 million data messages per year pass to and from ADCs at its Strong Memorial Hospital and Highland Hospital, according to David Webster, RPh, MSBA, the director of acute care operations. Those messages, he said, result in more than 5 million doses being dispensed from the two hospitals’ nearly 200 ADC units. Hospital systems such as URMC typically have relied on cumbersome

manual processes to collect and analyze ADC data flow. “Historically, and even today,” said Doina Dumitru, PharmD, MBA, the senior director of medical affairs at BD, “organizations address the challenges by extracting raw data from various system sources and dumping them into Excel and using spreadsheet tools like pivot tables to crunch the data and perform simple analyses. “But spreadsheets won’t cut it in this case,” Dumitru told Pharmacy Practice News. “We need something more sophisticated that provides deeper understanding and uncovers trends that we just have no way of seeing in spreadsheets.” For URMC, that deeper insight was provided by BD’s HealthSight Inventory Optimization tool, which offered a single, automated source for adjusting par levels, as opposed to the multiple reports and manual adjustments that the center had relied on in its initial phase of inventory optimization. Still, that earlier project had yielded strong gains. In a recent

Success Achieved On a Small Scale

nventory optimization also can be accomplished on a smaller scale without sophisticated analytical tools to provide real-time par level adjustments. Olean General Hospital, a 186-bed acute care facility in Olean, N.Y., is an example. In one year, the value of inventory in the hospital‘s 39 ADCs increased by 10%, to about $165,000 in January 2018 from $150,000 the year before. “We wanted to assess what had happened and how we could get it back down,” said Paul Green, PharmD, MHA, the system director of pharmacy at CompleteRx/Upper Allegheny Health System. Teams of pharmacists and technicians were assigned to evaluate ADC inventories in each of the hospital’s specialized units. Nonessential medications without active orders were removed, to start the process. Currently, based on daily reports generated by the ADC software and printed out in the pharmacy, medications that haven’t been ordered or used in 30 days are returned to the pharmacy for possible redistribution to more active units. “So we don’t have as much waste,” Green said. He added that as a result of the increased monitoring, inventory value has fallen to about $133,000 from the previous high of $165,000. —B.B.

BD-sponsored webcast, Webster reported that starting in 2016, Strong Memorial was able to reduce expired medication costs by about $100,000 per year, while inventory-carrying expenditures decreased by $200,000 and the stock-out rate for a selected group of medications fell by more than half, to 0.5% from 1.2%. Inventory optimization also improved at Highland Hospital, which uses a decentralized distribution model versus Strong’s 50/50 hybrid prototype. The ADC vend/refill ratio increased to 10.5 from 8.7, and ADC refills decreased by about 80 per day. Additionally, the proportion of medications dispensed by ADCs rose to 89% from 85%, just short of the 90% goal. As robust as the gains were, the team driving the optimization process thought they could do better. “Instead of a lot of calculations around inventory par levels,” Webster said, “we wanted it to happen automatically, based on algorithms that made sense.” BD’s optimization tool provided the solution. Starting in 2017, the tool demonstrated that positive results could be achieved using far less staff time. At Strong Memorial Hospital, the stock-out rate “started out at a pretty good place—0.7% to 0.8%,” Webster said. “It continued to drop, down to around 0.5%, as par levels were adjusted.” But focusing just on the pockets that were optimized by the tool, Webster said the stock-out rate, which was already at 0.57%, decreased to 0.26%. Without the optimization, he said, 23,000 additional stock-outs would have occurred over several years, requiring more than 4,000 additional hours to manage. At Highland Hospital, the stock-out rate dropped to 0.4% from just under 1.0%. For the pockets adjusted by the tool, stock-outs fell to 0.6% from 2.3%,

t the University of Rochester Medical Center’s Strong Memorial Hospital, an inventory optimization tool demonstrated its value during a rapid build-up to meet an anticipated surge in COVID-19 patients. “We had to go quickly from about 900 beds to 700 additional beds,” said David Webster, RPh, MSBA, the director of acute care operations at the New York hospital. The hospital’s cafeteria, gymnasium and some underused ambulatory clinics were among the areas designated to fill the expected demand. Fortunately, the number of cases never tested the increased capacity. Still, Webster noted, with cases rising, the challenge was how to increase and repurpose automated dispensing cabinets to meet the needs of this new critical patient population. “Early on,” he said, “we decided to prebuild some machines in anticipation of this surge.” Some were pulled back and new ones ordered. In a conference room, he added, an ICU and a non-ICU setup sat ready to deploy, connected to the network and prefilled with medications. “We had to use this several times as we opened areas and moved patients into them. “Very valuable in that process was knowing what our data told us were the typical medications and par levels we needed for the type of patients moving into those areas,” Webster added. “The advantage of having this tool live was that we could look at what we needed to load into those machines. We used it pretty extensively as we saw patient populations shifting pretty quickly.” —B.B.

the latter figure reflecting some “lowhanging fruit” that had yielded fast results. Without the tool, Webster said, there would have been almost 13,000 additional stock-outs, at a cost of more than 2,000 hours to manage. —Bruce Buckley The sources reported no relevant financial disclosures.

Technology

Pharmacy Practice News • February 2021

Addiction Medicine

Machine Learning May Bolster Opioid Stewardship Efforts

pioid stewardship is most often a multidisciplinary effort, but at Lifespan health system in Rhode Island, an unusual team “member”— artificial intelligence—is being recognized for its contribution. Employing physician education and machine learning led to significant reductions in prescribed opioid doses, decreases in benzodiazepine co-prescribing, and increased naloxone coprescribing, as Ashley Rimay, PharmD, a controlled substance pharmacist at Lifespan, said during a virtual poster presentation at the ASHP 2020 Midyear Clinical Meeting and Exposition (Best Practice poster 1). “The collaboration between the pharmacists, data scientists, physicians and leadership was essential to making this program a success,” she said. Rimay and a team of hospital and pharmacy leaders, a pharmacy data scientist, a pharmacy informatics coordinator, a senior clinical pharmacist specialist, and the chief medical officer set out to develop an opioid stewardship program. They wanted to capitalize on the wealth of electronic health record (EHR) data at their disposal and did so by providing a machine-learning model with two years of EHR-based opioid prescribing data from their institution, which it has used to identify outlying prescribers. Each day, the software generates a scatterplot image plotting out that day’s prescribing practices, positioning prescribers on the graph according to whether or not their opioid prescribing falls in line with appropriate opioid prescribing. Once an outlier is identified, the controlled substance pharmacist selects 15 opioid prescriptions at random and audits them for compliance with controlled substance laws. The findings are then passed on to physician leadership for peer clinical evaluation, provider education as well as possible follow-up audits, the researcher said. In addition to providing outlier physicians with information on appropriate opioid prescribing, Rimay and her team educated them on the consequences of inappropriate opioid prescribing and opioid diversion, presented them with license reprimands issued by Rhode Island’s Medical Board, and detailed the state’s controlled substance law on prescribing for acute and chronic pain. Between January and December 2019, the machine-learning software identified 25 outlying prescribers, Rimay reported. Additionally, more than 240 attending physicians and 900 residents participated in the system-wide opioid education initiatives. In 2019, after the opioid stewardship program was rolled out, the health system

saw a 14.4% decrease in average morphine equivalent daily doses (MEDD) among those provided with opioid education, including both outliers and the general physician population. In contrast, average MEDD increased by 0.39% during the same period among a group of Lifespan physicians not provided with opioid prescribing education. During the same time, among physicians who received opioid prescribing

education, there was a 9.7% decrease in benzodiazepine co-prescribing and a 15.7% increase in naloxone co-prescribing—both of which are in line with practices recommended by the CDC for those receiving opioids for chronic pain. In contrast, there was only a 4.35% drop in benzodiazepine co-prescribing and a 5% increase in naloxone co-prescribing among those who did not receive education on appropriate

opioid prescribing, Rimay said. “Health systems should foster collaboration between pharmacists, data scientists, physicians and leadership to develop a controlled substance prescription stewardship program,” the researcher concluded. —David Wild Rimay reported no relevant financial disclosures.

We’ve Got You

Covered

FULL LINE OF USP <797> & <800> COMPLIANT PRODUCTS Pre-Saturated Wipers by Pharma-ChoiceTM

» » » » »

Cleaners & Disinfectants Sterile & Non-Sterile Wipers Disposable Cleanroom Apparel Enviromental Controls Cleanroom Supplies

» » »

70% IPA / 30% WFI Available in multiple sizes Sterile & Non-sterile

In Stock & Available at

AmerisourceBergen Cardinal McKesson SPEAK DIRECTLY WITH A PRODUCT EXPERT 888.909.7700 | pharma-choice.com info@acutecareonline.com Poway, CA

Featured: Pharma-SatTM Canister, Pharma-SatTM Plus in Sterile & Non-sterile

COMPANY

26 Technology

Pharmacy Practice News • February 2021

Workflow

Dashboards Drive Better Medication Management T

wo new studies have underscored that clinical dashboards can be a powerful medication management tool—in one case during yet another surge in COVID-19 cases.

Tackling TNF Inhibitors A real-time clinical dashboard to monitor patients taking tumor necrosis factor-alpha (TNF-alpha) inhibitor drugs could save the Durham Veterans Affairs Health Care System at least $302,000 per year and potentially improve medication adherence and patient safety, according to a poster presented at the American College of Clinical Pharmacy 2020 virtual annual meeting. When the pilot project began in 2019, pharmacists at the health system reviewed patients’ lab values for safety before they were started on these therapies, but pharmacists weren’t necessarily involved in any needed longterm monitoring for safety and adherence, said lead study author Anna Hu, PharmD, BCPS, a drug information specialist with the University of Texas Medical Branch, in Huntsville. She was a PGY-2 pharmacy resident with the Durham VA at the time of the study. In a quality improvement project conducted between August 2019 and April 2020, in collaboration with other pharmacists and specialty providers in rheumatology, gastroenterology and dermatology, Hu developed a clinical dashboard to capture high-risk patients. Patients with active or recently expired outpatient prescriptions or IV orders for adalimumab, certolizumab (Cimzia, UCB), etanercept, golimumab (Simponi/ Simponi Aria, Janssen) and infliximab were included. Dashboard criteria flagged patients with new infection in the past 30 days, heart failure exacerbation in the past seven days, new malignancy in the past 30 days, use of biologic medications, high treatment doses of etanercept or adalimumab, overdue or critical lab results, emergency department visits in the past 30 days, and inpatient admissions in the most recent 30 days. The dashboard also flagged patients who had overdue refills by more than seven, 14 or 30 days based on the previous fill, or with the last infusion administered more than eight, 10 or 12 weeks ago. Of 431 patients receiving TNF-alpha inhibitor treatment at the institution, the dashboard flagged 304 circumstances involving 223 unique patients. Among them, 27% of patients had overdue refills, 9% had overdue monitoring labs, 6% had an emergency department visit, 5% had a critical lab result, and 2% were on two biologic agents or had an inpatient admission. Of those with overdue refills, 13% had a refill overdue exceeding 30 days

and 6% had their last infliximab infusion more than 12 weeks before. In addition, Hu and her colleagues found that 17% of patients were on a high dose of inhibitors, with 5% prescribed etanercept 50 mg more often than once weekly, and 12% of patients prescribed adalimumab 40 mg more often than once every other week. These dosages represented an estimated potential annual cost savings of $302,497 if half of the patients were successfully changed to the labeled dosing, Hu said, and this would also reduce patient risk from unnecessary drug exposure. Patient outcomes could be further improved by working with patients on adherence or refill issues and/or expanding the dashboard to include other highcost specialty medications, she said. Another factor to consider: patients taking these medications are susceptible to infections, so continuation of therapy needs to be reviewed carefully. However, providers did not always document whether continuation of the TNF-alpha inhibitor treatment was appropriate. For these situations, Hu said, pharmacists could assess patient-specific risk factors for infection and recommend to hold, continue or discontinue the treatment. Pharmacists also could play a role in discontinuing duplicate therapy for patients prescribed more than one biologic. “There is potentially an opportunity to discuss nonadherence with patients and the reasons behind it,” Hu said. “If they have been nonadherent for a long period of time, does that mean they are stable enough to maybe no longer need the medication?” Based on the findings, the VA was planning to implement the dashboard, she said. Dashboards could be helpful for TNFalpha inhibitors, but it may be beneficial to break patients down further by disease state, commented Erin Hamai Tom, PharmD, a specialty pharmacy supervisor with the University of California, Davis Health System. “There’s a different acuity for GI [gastrointestinal] patients compared to those in rheumatology or dermatology,” Tom said. “For example, it may be more common to have a GI patient on what’s considered a high dose of medication because it’s more frequent that an inflammatory bowel disease patient will require escalation of therapy to reach remission of their disease.” Pharmacists also can get involved by ensuring all prescreenings recommended in the package insert, for conditions such as tuberculosis and hepatitis B, are completed before therapy is started, Tom added. At her institution, pharmacists use dashboards to monitor patients in the longer term for new malignancies and new or recurring infections. They

Figure. Daily usage of selected COVID-specific medications at Massachusetts General Hospital. Hydromorphone (orange line), norepinephrine (gray line), and dexmedetomidine (blue line) represent internally made products that required dynamic changes in a previous, predefined batch compounding schedule. Propofol (yellow line) represents a commercially prepared product that required rapid changes to medication distribution strategies.

also do a biannual assessment for efficacy and safety, and monitor for medication adherence and appropriateness of therapy, she said.

Staying in Lane During COVID Many hospitals experiencing a COVID-19 surge may be overwhelmed by the increase in drug utilization for many agents, including sedatives and vasopressors. In a poster presented at the ASHP 2020 Midyear Clinical Meeting and Exposition, pharmacists from Massachusetts General Hospital (MGH) described a daily dashboard they created to evaluate the use of key agents required for managing COVID-19 patients. “We have access to so many different sources of data, including ADCs [automated dispensing cabinets] on the floor, carousels in the central pharmacy and IV room workflow systems,” said lead author Blake Barlow, PharmD, MBA, a PGY-2/MS health-system pharmacy administration and leadership resident at MGH. “But a lot of these systems aren’t designed to talk to each other, and many departments of pharmacy have no way to pool all that data together and visualize them at once. When COVID first hit, we were flying blind. We did anticipate that there might be drug shortages, but we did not consider just how large the increase in drug utilization was going to be.” For example, Barlow said, before the first surge in COVID-19 patients at the end of last March, MGH’s IV hoods might produce 30 1-mg/mL 25-mL bags of hydromorphone daily. “That’s our average use throughout the hospital, but during COVID, that increased 500% to 1,000%.”

(In mid-April, at the hospital’s COVID-19 peak, more than 350 bags per day were made.) “We had to scramble to make a lot of the new medications that our typical batch schedule could no longer handle, so we needed to figure out a way to collect electronic health record data on medication use, along with data from the ADCs in all the COVID ICUs and the COVID non-ICU settings, as well as our central pharmacy storage carousel, and pool it all in a central database that could be visualized via a dashboard,” Barlow said. Based on previous information technology projects he undertook during residency, Barlow was already familiar with the systems from which reporting was required, so the initial build of the database and dashboard took only a day. “Every time we ran it, we still needed to do about 15 to 20 minutes of manual manipulation and validation to be sure the data we were presenting to departmental and hospital leadership was correct,” he said. “But then we were able to send this information out daily to leaders in pharmacy operations, clinical pharmacy and supply chain. It allowed us to implement multiple different medication distribution shifts throughout the day for COVID-specific medications, and to predict how many medications we would need to start making ahead of time in the IV room every day.” For more cost-saving interventions, see page 1; for more on MGH’s COVID-19 response, see page 14. —Karen Blum and Gina Shaw The sources reported no relevant financial disclosures.

Like What You Read in Pharmacy Practice News?

Be sure to say you read

5 4 out of 4 An independent readership survey may be emailed to you soon. If you like how we cover the news in PPN, say you read 4 out of 4 issues cover to cover!

What is the power of the microbiome?

...and how can it be unlocked to treat disease?

UNLOCK THE POTENTIAL AT POWEROFMICROBIOME.COM Ferring is committed to exploring the crucial link between the gut microbiome and the threat of recurrent Clostridioides difficile infections. With the 2018 acquisition of Rebiotix and several other alliances, Ferring is rapidly advancing its microbiome research, ÂŠ2020 Ferring B.V. US-MBIO-2000020

developing novel therapies to address significant unmet needs in deadly and debilitating diseases, and helping people live better lives.

Pharmacy Practice News - February 2021

Articles inside

ISMP survey reveals gaps in compounding compliance

Dashboards drive better medication management

POLICY

Drug diversion: yet another pandemic challenge

Muscle relaxants and pain a dangerous mix