Pharmacy Practice News - August 2021



The Best-Read Pharmacist’s News Source

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Don’t leave ‘money on the table’

SPECIAL SUPPLEMENT

PPN 2021-2022

Corporate Profiles Section begins on page 33.

Act Now to Get Paid for Novel ABx Under NTAP

H

CLINICAL

Managing shortages of multivitamins, plus other PN pearls ...............

4

Why do 86% of pharmacists still use vanco trough dosing? ... 6 OPERATIONS & MGMT

A powerful tool for assessing leaders ...

24

Clinic manages anticoagulation and cancer ......................

26

as your hospital pharmacy and antimicrobial stewardship program taken advantage of the new technology add-on payment (NTAP) that applies to inpatients? The funds don’t last forever, so now is the time to review your options.

The Centers for Medicare & Medicaid Services (CMS) released new rules in the fall of 2019 designed to ensure that more antimicrobials qualify for its NTAP program. This was a way for CMS to incentivize the adoption of novel antibiotics.

“If you’re not capturing NTAP, you’re leaving money on the table,” said Kate DeSear, PharmD, BCPS, a clinical specialist in infectious diseases at the University of Florida Health Shands Hospital, in

Volume 48 • Number 8 • August 2021



Avoiding Rx Delays Amid Oral Chemotherapy Surge O

ral oncolytics are hardly new. Breast cancer patients have been taking tamoxifen for more than 40 years. But the pace of approval of these drugs has increased dramatically, and the complexity and cost of the newer oral therapies create challenges for patients, clinicians and health systems.

Getting patients on treatment with oral oncolytics is not simple. Delays in processing these medications and initiating therapy are common and often related to insurance coverage and prior authorization, specialty pharmacy requirements and the need for financial assistance.

A single-center retrospective review of adults who were newly prescribed an oral oncolytic at Northwestern Medicine, in Chicago, found that of 270 successfully filled prescriptions, the mean time to receipt was 7.3 days, with a range of zero to 109 days (J Oncol Pharm Pract 2020;26[2]:279-285). Patients with h Medicare experienced longer waits than patients

Continued on page 28

Continued on page 12

POLICY

Knowing terms a key to reimbursement ...........

29

TECHNOLOGY

e-Tools aid patient assistance programs .... 31 SPECIALTY PHARMACY

ASHP survey: 72% of health systems frozen out by payors ................

32

PRODUCT NEWS Introducing Allevacaine, the same Unit Dose 20% Benzocaine at a NEW low price!

See page 32.

ESBLs on the Rise During COVID-19; ASPs Show Worth

T

he COVID-19 pandemic appears to have led to some increases in hospital-onset resistant infections such as methicillin-resistant Staphylococcus aureus (MRSA), along with potential changes for community-onset infections, according to preliminary analyses presented by experts at the 2021 MAD-ID (Making a Difference in Infectious Diseases) virtual annual meeting.

According to unpublished data from the CDC provided to session presenters, the agency and public health partners responded to 20 Continued on page 10

Skilled Pharms Use T Technology h l Tools to Ensure PN Order Safety

E

ven with multiple steps in place to improve the safety of parenteral nutrition (PN) prescribing and order reviews, mistakes can occur. That’s why it’s crucial for health systems and long-term care facilities to have skilled pharmacists complete the order review and verification steps for this complex therapy, panelists said during the virtual ASPEN 2021 Nutrition Science and Practice Conference.

In one of the largest published data samples on PN interventions, pharmacists who reviewed 37,634 PN prescriptions from 232 hospitals and other customers using Central Admixture Pharmacy Services (CAPS) found 248 PN prescriptions (0.66%) requiring at least one intervention. The top three

Focus On

Oncology More coverage begins on page 14.

intervention types were electrolyte dose clarification, calcium/phosphorus incompatibility and amino acid dose clarification. The study, led by researchers with the American Society for Parenteral and Enteral Nutrition’s (ASPEN’s) PN Safety Committee, the University of Michigan and CAPS, was published in Nutrition in Clinical Practice (2021;36[2]:480-488).

Parenteral nutrition is a life-sustaining therapy for those who cannot tolerate oral nutrition but also very complex, containing upward of 30 to 40 individual components depending on the formulation, said lead study author Michael Kraft, PharmD, BCNSP, a clinical professor of pharmacy and the Continued on page 3

A VICIOUS CYCLE WITH SIGNIFICANT BURDEN WHAT COULD BE THE CONSEQUENCES OF RECURRENT C. DIFFICILE INFECTION?

Learn why it requires aggressive action

THE CDC ACKNOWLEDGES C. DIFFICILE INFECTION AS A MAJOR AND URGENT THREAT.1

IT RECURS IN UP TO 35% OF CASES WITHIN 8 WEEKS AFTER INITIAL DIAGNOSIS.2,3

THE CONSEQUENCES OF RECURRENCE ARE SIGNIFICANT, POTENTIALLY DEADLY.2

Now is the time to learn how Ferring is shedding light on the link between disease and disruptions in the gut microbiome, exploring the potential for repopulating its diversity and restoring hope to patients.

References: 1. Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides Difficile. https://www.cdc. gov/drugresistancxqe/pdf/threats-report/clostridioides-difficile-508.pdf. Accessed April 8, 2021. 2. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834. 3. Cornely OA, Miller MA, Louie TJ, Crook DW, Gorback SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012;55(suppl 2):s154-s161.

LEARN MORE NOW ©2021 Ferring B.V. US-MBIO-2100122

Clinical

Pharmacy Practice News • August 2021

3

Nutrition

Parenteral Nutrition Safety continued from page 1

assistant director of pharmacy education and research at the University of Michigan, in Ann Arbor. The PN-use process also is complex, involving multiple steps, disciplines and technologies, he said. As a result, “there has been a significant effort, especially in the past 10 years, to reevaluate and improve PN safety.”

Favoring Electronic Prescribing Efforts implemented by health care facilities to improve safety include increasing electronic over handwritten orders, limiting order entry errors by auto-populating fields and adding automatic electronic interfaces between the pharmacy system and electronic medical records. However, these haven’t been used as effectively or as widespread as they could be, Dr. Kraft said.

For the study, CAPS pharmacists reviewed every PN order received from participating sites during October 2016, using a paper-based novel error intervention tool designed to capture data on potentially unsafe prescription elements, said Sharon Durfee, RPh, BCNSP, the CAPS clinical nutrition support pharmacist. Completed forms were sent to Ms. Durfee, who coordinated data entry into a secure electronic database.

Participating centers included 177 hospitals, 33 long-term acute care facilities, eight hospital/home care facilities, seven home care facilities and six long-term

care facilities, with a range of bed sizes and geographic locations nationwide.

Roughly two-thirds used CAPS-only compounded PN formulations, while the rest used both CAPS compounded formulations and multi-chamber bag PN products not supplied by CAPS. Forty-three percent of ordering providers were physicians. Half of customers used CAPS-specific minimum/ maximum limits, with deviation due to institution-specific limits predominantly in pediatric and neonatal populations.

These limits are defined as the high and low amounts of specific nutrients set in the automated PN-compounding device that will alarm if the PN prescription falls outside these limits.

Overall, 248 prescriptions from 59 customers required intervention from CAPS pharmacists prior to compounding, with 97% of those prescriptions from hospitals, 1% each from long-term acute care facilities and home care facilities, and 0.4% from long-term care facilities, said Anne Tucker, PharmD, BCNSP, a clinical pharmacy specialist in critical care and nutrition support at The University of Texas MD Anderson Cancer Center, in Houston. Among these, 252 individual interventions were identified, as some prescriptions required more than one intervention.

Among calcium/phosphate incompatibility interventions, 60 (94%) orders

were not changed, primarily because of institution-specific limits that differed from the default limits set et by CAPS for its customers. mers.

Forty-seven (19%) orders consisting of 53 intervennterventions led to changes in n the PN prescription. These included dose clarifications of nutrients and insulin, osmolality issues related to peripheral PN, calcium/phosphate incompatibility, and amino acid omission. A greater number and percentage of interventions were required for neonatal prescriptions (47%) compared with both adult (30%) and pediatric (23%) prescriptions.

Of note, approximately 63% of the 59 customers whose orders required intervention had a formal nutrition support service (NSS). The intervention rate for customers with an NSS was 1.8%, compared with 0.53% among customers who did not have an NSS. The rate of change in the PN order upon CAPS pharmacist intervention was 14% in customers with an NSS team and 42% for customers without an NSS. In addition, almost 97% of participants said they had a dedicated clinical person to review PN orders prior to transmission to CAPS. It’s possible the NSS teams were handling higher acuity, more complex patients, Dr. Tucker said, or they may have been interdisciplinary services with higher-level training and more comfort with out-of-the-box PN

EDITORIAL BOARD ADMINISTRATION Robert Adamson, PharmD, Livingston, NJ

59 customers required pharmacist interventions prior to compounding.

management strategies. Both rationales can lead to orders falling outside traditional patient minimum/maximum limits, and “requires an astute pharmacist with special knowledge and training to be able to question these prescriptions and reach out to those who are ordering them,” she noted. “It brings into play the importance of the order review process.”

In one case, a CAPS pharmacist discovered a 10-fold dosing error for zinc, copper and selenium, but was able to intervene, so the prescription was changed, Dr. Tucker said.

The study illustrates that the use of safe practices such as standardized PN orders and double checks for order review and verification “does not eliminate the need for an independent review and verification of PN orders by a knowledgeable and skilled pharmacist,” Dr. Tucker stressed.

“It really relies on that last check.”

—Karen Blum Dr. Kraft’s institution is a customer of CAPS, and Ms. Durfee is employed by CAPS. Dr. Tucker reported no relevant financial disclosures.

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4 Clinical

Pharmacy Practice News • August 2021

Nutrition

Newer ILE formulations, stretching multivitamin supplies:

Parenteral Nutrition Pearls From NHIA Meeting N

ewer IV lipid emulsion products (ILEs) have given parenteral nutrition (PN) prescribers a significantly greater range of options for meeting patients’ nutritional needs, with different roles for each oil type, according to nutrition experts.

The ILEs are an essential component of PN formulations, preventing essential fatty acid deficiencies, providing a calorically dense source of calories, and decreasing insulin requirements by cutting the patient’s total carbohydrate intake, noted Kathy Gura, PharmD, BCNSP, the pharmacy clinical research program manager at Boston Children’s Hospital. The PN formulations “are very important for hormone and prostaglandin synthesis,” Dr. Gura said during the 2021 virtual annual meeting of the National Home Infusion Association.

Until recently, there was only one type of ILE product on the U.S. market, available as Baxter’s Intralipid or B. Braun’s Nutralipid, composed of 100% soybean oil. Over the past several years, however, the FDA approved three additional products: • Clinolipid (Baxter), composed of 80% olive oil and 20% soybean oil; • SMOFlipid (Fresenius Kabi), consisting of 30% soybean oil, 30% mediumchain triglycerides (MCTs), 25% olive oil and 15% fish oil; and • Omegaven (Fresenius Kabi), made of 100% fish oil.

Although pediatric studies are ongoing, SMOFlipid and Clinolipid are not indicated for pediatric use. Omegaven, approved specifically for the pediatric population, can be used off-label in adults, Dr. Gura noted, with a weightbased dosage of 1 g/kg per day, although doses as high as 1.5 g/kg per day have been used off-label.

“Now that we have a choice in the marketplace, the influence of various oil sources can be considered, so it is important for prescribers to understand the differences,” Dr. Gura said. “There are different roles for each oil type, and mixing oils can optimize the fatty acid profile for your patient. Soybean oil serves as a source of calories and essential fatty acids. MCTs are a source of rapidly available energy, spare larger amounts of essential fatty acids for incorporation into cell membranes, and exert less stress on emulsifiers. Olive oils have an indirect anti-inflammatory effect by replacing omega-6 fatty acids with oleic acid. Fish oils inhibit inflammation and cytokine release, and serve as a source of DHA [docosahexaenoic acid].”

Each of the approved ILEs varies in phytosterol content, vitamin E content

5 Strategies for Managing Multivitamin PN Shortages Use 5 mL of adult vitamins in all children weighing more than 2.5 kg or of 36 weeks’ gestation, saving the pediatric product for smaller neonates to conserve the supply.

Supplement IV vitamin K daily (total daily dose, 200 mcg).

Note the vitamin K content of the adult multivitamin product when supplementing.

Infants weighing less than 2.5 kg or who are less than 36 weeks’ gestation should receive an adult IV multivitamin at a daily dose of 1 mL/kg up to a maximum of 2.5 mL daily.

Be aware that some brands of adult IV multivitamin products contain propylene glycol and polysorbate, which may be toxic to neonates.

Source: Kathy Gura, PharmD, BCNSP.

and inflammatory characteristics—factors that are not typically noted on the product label. “Soybean oils are rich in phytosterols, which undergo hepatic metabolism and can contribute to PN-associated liver injury,” Dr. Gura said (JPEN J Parenter Enteral Nutr 2017;41[3]:404-411). Due to their hepatic immaturity, she noted, pediatric patients are susceptible to this complication, as are critically ill patients and those with preexisting liver disease.

‘Very Exciting’ Choice of ILEs “It’s been very exciting over the past few years with the advent of the newer ILE products,” said Phil Ayers, PharmD, BCNSP, the chief of clinical pharmacy services at Mississippi Baptist Medical Center, in a separate interview with Pharmacy Practice News. “The new ILE formulations can be used in patients with inflammatory states and those with infections. There have been some data to indicate reduced morbidity and mortality, and even reduced length of hospital stay, for patients receiving ILEs containing fish oil. The newer ILEs have also been shown to be beneficial in reducing liver function issues among patients receiving long-term TPN [total PN]” (Am J Health Syst Pharm 2017;74[12]:904918; Crit Care 2015;19[1]:167; Clin Nutr 2018;37[3]:1075-1081).

Newer ILE formulations are particularly suited for the care of patients receiving long-term home PN and those who are critically ill, noted Dr. Ayers, a member of the American Society for Parenteral and Enteral Nutrition (ASPEN) board of directors. “In addition to neonatal and pediatric patients, soy-based lipid

emulsions that we have used since the 1970s can certainly still be used in shorter-term patients, such as those receiving PN for less than two weeks, unless they have some inflammatory process.”

In the event of an ILE shortage, neonatal and pediatric hospitalized or home care patients should be prioritized, Dr. Gura said. “Provision of intravenous fat emulsion is critical in these patient populations; therefore, continue the same therapy as before the shortage.”

Shortages of other products, such as multivitamin formulations, continue to pose challenges for PN providers as well, Dr. Gura said. For multivitamin shortages, she offered a list of key guidelines (box).

More Shortage Guidance In March 2021, ASPEN issued a detailed set of recommendations for managing IV multivitamin shortages, with specific guidance for both adult and pediatric formulations. The documents “encourage clinicians to offer oral or feeding tube vitamins when possible, and in those situations where we do have severe shortages, reserving the IV multivitamins for children weighing less than 2.5 kg or less than 36 weeks’ gestation,” Dr. Ayers said. “The key concern is that we want to make sure pediatric multivitamins are not used in place of adult vitamins when there is an adult shortage, which unfortunately has happened in some cases and puts pediatric patients at more risk of malnutrition.”

He described a recent case in which an adult home PN patient had been

given pediatric IV multivitamins when the adult formulation was not available.

“This may deplete the supply in pediatric patients, who are much more at risk than adults,” Dr. Ayers said. “The ASPEN guidance offers an evidencebased, detailed reference to determine the most appropriate way to deal with both pediatric and adult shortages.”

If your organization has inadequate supplies of both adult and pediatric IV multivitamin formulations, the ASPEN guidelines also stress the individual vitamins that must be given daily even when others are not available: thiamine, ascorbic acid, pyridoxine (B-6) and folic acid.

ASPEN’s product shortages website provides a continuously updated reference on what PN products are in shortage and resources for managing shortages.

“PN is a high-risk therapy,” Dr. Gura said. “Regardless of the method used, pharmacists must be aware of compatibility issues and changes in formulations. Never assume that your referring hospital is perfect; what’s appropriate for the hospital setting may not be appropriate for home use. Never substitute anything without confirming with the prescriber.”

—Gina Shaw Dr. Gura reported the following: Scientific/ pharmaceutical advisory board: B. Braun, Baxter, Fresenius Kabi, Pfizer; Consultant: Alcresta, B. Braun, Fresenius Kabi, Northsea Therapeutics, Otsuka Pharmaceutical Factory, Pfizer Pediatric Center of Excellence, Xellia Pharmaceuticals; and patents/royalties for use of Omegaven. Dr. Ayers reported that he has been a speaker for Fresenius Kabi.

New products Reference guide Hospital unit dose AB 8-digit #

Cardinal Health #

McKesson #

Morris & Dickson #

Product description

Strength

UD size

NDC 11

10251783

5686407

1581669

930750

Atomoxetine Capsule

25 mg

30 UD

60687-0567-21

10254220

3703665

2302917

981878

Budesonide Capsule (Enteric Coated)

3 mg

20 UD

60687-0596-32

10124030

4907010

2027480

612515

Calcium Acetate Capsule

667 mg

100UD

68084-0479-01

10251956

5687223

1583525

921866

Diltiazem HCL Tablet

60 mg

100 UD

60687-0573-01

10251974

5687330

1584333

921882

Diphenoxylate HCL / Atropine Sulfate Tablet (CV)

2.5 mg / 0.025 mg

100 UD

60687-0569-01

10254113

5703590

3790623

981910

Famotidine Tablet

20 mg

100 UD

60687-0595-01

10258312

4149654

3274917

956623

Fenofibrate Capsule (Micronized)

200 mg

30 UD

68084-0329-21

10258877

5728696

2334258

040410

Fenofibrate Tablet

145 mg

30 UD

60687-0629-21

10254284

5704143

3901725

982025

Fluphenazine HCL Tablet

5 mg

100 UD

68084-0846-01

10254285

5704150

3901741

982033

Fluphenazine HCL Tablet

10 mg

100 UD

68084-0950-01

10252050

5688189

1584887

921783

Gabapentin Capsule

100 mg

100 UD

60687-0580-01

10252051

5688197

1584903

921791

Gabapentin Capsule

300 mg

100 UD

60687-0591-01

10252014

5688205

1584911

921817

Gabapentin Capsule

400 mg

100 UD

60687-0602-01

10254190

5703012

2302966

981886

Hydrochlorothiazide Tablet

25 mg

100 UD

60687-0593-01

10258311

5724828

2329746

032094

Hydromorphone HCL Tablet (CII)

2 mg

100 UD

60687-0579-01

10258383

5724836

2329761

032110

Hydromorphone HCL Tablet (CII)

4 mg

100 UD

60687-0590-01

10254966

5709282

2303436

045013

Ketorolac Tromethamine Tablet

10 mg

30 UD

60687-0104-21

10252801

5692983

1591213

944314

Levothyroxine Sodium Tablet

200 mcg

100 UD

60687-0552-01

10254154

5703616

3409216

042218

Lisinopril Tablet

2.5 mg

30 UD

68084-0765-21

10252199

5689559

1585892

922336

Mesalamine DR Capsule

400 mg

20 UD

60687-0556-32

10258394

4858015

2016327

257253

Potassium Chloride ER Tablet

10 mEq

100 UD

68084-0632-01

10255420

5711163

2308062

019042

Prazosin HCL Capsule

5 mg

20 UD

60687-0572-32

10250600

5687215

1575356

927640

Propafenone HCL Tablet

150 mg

100 UD

60687-0537-01

10258893

5728688

2333243

039784

Propranolol HCL Tablet

10 mg

100 UD

60687-0587-01

10254155

5703574

3691490

981803

Rifampin Capsule

150 mg

30 UD

60687-0575-21

10254131

5703582

3693793

981845

Rifampin Capsule

300 mg

100 UD

60687-0586-01

10258214

5726450

2329555

035055

Ropinirole Tablet

0.25 mg

100 UD

60687-0577-01

10258196

5726468

2329571

035220

Ropinirole Tablet

1 mg

100 UD

60687-0588-01

10180508

5391024

3700200

075291

Tolterodine Tartrate ER Capsule

4 mg

30 UD

60687-0330-21

10258624

5728233

2333557

039560

Valsartan Tablet

40 mg

30 UD

60687-0612-21

10258623

5728241

2333581

039602

Valsartan Tablet

80 mg

100 UD

60687-0623-01

10258635

5728258

2333649

039594

Valsartan Tablet

160 mg

100 UD

60687-0634-01

Liquid unit dose AB 8-digit #

Cardinal Health #

McKesson #

Morris & Dickson #

Product description

Cup delivery

Cup strength

Pack size

NDC 11

10249925

5676135

1574276

914382

Atovaquone Oral Suspension

5 mL

750 mg / 5 mL

42 ct

60687-0534-78

10258469

5725668

2328805

034397

Midazolam HCL Syrup (CIV)

2.5 mL

5 mg / 2.5 mL

30 ct

60687-0576-10

10258500

5725676

2328821

034371

Midazolam HCL Syrup (CIV)

5 mL

10 mg / 5 mL

30 ct

60687-0576-86

10251651

5699970

3579828

971820

Milk of Magnesia Saline Laxative (Magnesium Hydroxide)

30 mL

2400 mg / 30 mL

100 ct

60687-0429-76 AH-100109 21.07

Hitting the mark AHP unit dose simplifies one of the most complex parts of your job – reliably obtaining ready to dispense medications – in a format that promotes positive outcomes for your patients.

800.707.4621 americanhealthpackaging.com

6 Clinical

Pharmacy Practice News • August 2021

Infectious Disease

Making the switch to AUC dosing for vancomycin

Why Are 86% of Pharmacists Still in the Trough?

A

lthough 98% of pharmacists believe new vancomycin dosing guidelines, which recommend using area under the curve (AUC) instead of trough-based dosing for certain patients, will yield superior outcomes, 86% say they are still using the older calculation in their institutions.

That’s according to a new survey of more than 120 U.S. pharmacists and pharmacy leaders conducted by Sage Growth Partners and commissioned by InsightRx. Asked about future plans, 31% of the respondents said they planned to shift to AUC-based dosing, while 60% said they might do so and 10% said they would not.

Although some of that resistance has been in evidence for years, it may have deepened during the COVID-19 pandemic, according to Emily Heil, PharmD, an associate professor in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy, in Baltimore.

Indeed, getting buy-in for such a big change is a big lift in the middle of a pandemic, she noted during a session on implementing the new vancomycin dosing guidelines during the MAD-ID (Making a Difference in Infectious Diseases) 2021 virtual meeting.

“When we first went live with the new guidelines, it took five to 10 minutes to process each vancomycin order,” said Dr. Heil, who also serves as the coordinator of the antimicrobial stewardship program at the University of Maryland Medical Center, in Baltimore. “Now we’re into our groove and it only takes two to three minutes, but the transition is a time commitment for the pharmacy up front.”

A Collaborative Effort The guidelines, released in 2020 by ASHP, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society and the

Society of Infectious Diseases Pharmacists (SIDP), were developed to reduce nephrotoxicity, an issue that affects an estimated 23% of patients who receive vancomycin. Almost 6% experience stage 2 or 3 acute kidney injuries (AKIs) (Mayo Clin Proc 2019;94[1]:17-26).

“Many hospitals and health systems are assessing whether to make the transition from trough-based dosing to AUC,” said InsightRx founder and CEO Sirj Goswami, PhD, in an on-demand webinar conducted by Becker’s Hospital Review. “For those that do, a number of outstanding questions remain, related to selecting the right methodology, the right software tools, implementation policies and even return on investment.”

One early adopter of the new dosing approach was OSF HealthCare, a 14-facility health system based in Peoria, Ill. During the webinar, infectious disease pharmacy coordinator Julia Giddens, PharmD, explained that clinicians in her system were initially skeptical of the idea that they had any problems with their AKI rates using trough-based dosing for vancomycin. “We needed to figure out our baseline AKI to set out the case for change,” she said. “When we did that, we found that we did have a problem with AKI and were able to justify AUC dosing, using Bayesian software with a platform that was able to integrate into Epic.”

She noted that providers remained reluctant to make the change at first, expressing concerns that it could lead to more aggressive dosing that would actually increase AKI rates. “Some facilities thought that they already had very good AKI rates and didn’t need to make any change,” she said. “We found out that some practitioners were not measuring AKI correctly using the KDIGO [Kidney Disease: Improving Global Outcomes] clinical practice guidelines. Once we made sure we

were measuring all the same way and were able to convey to providers exactly how AUC dosing works, we were able to get better buy-in.”

pharmacists’ workload and time. Many institutions are also not good at ordering peaks and troughs at certain times, which is what’s needed for the manual method.”

2 Calculation Strategies

Implementation Tips

There are two options for calculating AUC-guided dosing: single-sample calculations using the aforementioned Bayesian software, or a two-sample equation-based methodology. In one recent study, investigators from the University of Southern California and HarborUCLA Medical Center reported that both methods offered significant cost savings over trough-based dosing, with twosample AUC saving an average of $846 per patient encounter, and single-sample

The University of Maryland Medical Center’s Dr. Heil suggested piloting the transition in a specific unit or for particular indications. “You don’t have to do AUC-guided dosing for every patient started on vancomycin, although it might be easier to do for simplicity’s sake so the pharmacist doesn’t have to think about a lot of if/then scenarios,” she said. “Most of the data that drives AUC-guided dosing comes from retrospective studies of MRSA [methicillin-

‘Most of the data that drives AUCguided dosing comes from retrospective studies of MRSA, so I would certainly recommend at minimum AUC-guided dosing for confirmed or suspected MRSA infections. In other indications, the juice may not be worth the squeeze.’

—Emily Heil, PharmD Bayesian AUC saving an average of $2,065 per patient encounter (Clin Microbiol Infect 2020;S1198-743X[20]:30704-7).

“This translates into annual cost-savings of $846,810 and $2,065,720 for two-sample and single-sample Bayesian methods versus trough dosing, respectively, assuming 1,000 vancomycin-treated patients per year,” they wrote. Assuming a cost of approximately $100,000 for the acquisition of Bayesian software, they estimated that an institution would break even after treating at least 41 patients with vancomycin for at least 48 hours, been some criticism of although there has bee (Clin Microbiol Infect their methodology (C 2021;27[6]:927-928).

At OSF, Dr. Giddens ssaid they saw a 30% reduction in AKIs (from reducti 19% to t 14%) when they made the initial shift to AUC dosing using A the B Bayesian method.

“As w we have aligned more mor with the guidelines, lin we expect that we will continue to experience further ex reductions,” she said. red “This allowed us to “Th continue using the con Bayesian platform and Baye have to go to mannot h ual en entry, increasing our

resistant Staphylococcus aureus] bacteremia, so I would certainly recommend at minimum AUC-guided dosing for confirmed or suspected MRSA infections. In other indications, the juice may not be worth the squeeze, such as surgical prophylaxis or other anticipated short durations. For example, we have a revolving door of cellulitis in the ED [emergency department], and they are typically admitted, given 24 hours of IV vancomycin, then switched to oral on discharge the next day. If we calculated levels on all those cases, you can imagine some excess lab utilization.”

Pre-rollout education is critical to adoption of the new guidelines, she said.

The University of Maryland took a multipronged approach. “We developed a 30-minute ‘goodbye troughs, hello AUC’ program that was offered live twice, and also made available on our institutional website. Then we also held 60-minute live training sessions that were offered at various times over a two-week period to capture all shifts, led by an infectious disease pharmacist,” Dr. Heil said.

“These sessions were case-based, so people could play with the calculators and try things out.” In addition, the pharmacy created a comprehensive guidebook for pharmacists available on the hospital intranet, and a laminated trifold process see VANCOMYCIN, page 8

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8 Clinical

Pharmacy Practice News • August 2021

Infectious Disease

VANCOMYCIN continued from page 6

guide was placed at all satellite pharmacy workstations.

MAD-ID offers a tool kit for making the transition to AUC-based dosing at mad-id.org/vancomycin, as does the SIDP, at sidp.org/Vancomycin-AUCImplementation-Toolkit-Guide.

AUC Not Fail-Safe The move to AUC-based dosing has not been met with unanimous acclaim.

In an article appearing in Clinical Infectious Diseases in May 2021, Sarah Jorgensen, PharmD, an antimicrobial stewardship pharmacist at Mt. Sinai Hospital in Toronto, and her colleagues argue that the approach hasn’t been properly evaluated in well-designed randomized clinical trials (Clin Infect Dis 2021;72[9]:1502-1506).

“Even the strongest preclinical data and observational data has frequently led us astray with other interventions, especially in infectious diseases and more broadly in other areas of

medicine,” she told Pharmacy Practice News. “For example, one that’s very relevant to vancomycin is the targeting of troughs of 15 to 20. Prior to the publication of the first vancomycin guidelines, there were concerns that the vancomycin minimum inhibitory concentrations [MICs] needed to eradicate MRSA was increasing, something called ‘MIC creep.’ Associated treatment failures prompted recommendations to use more aggressive dosing and target higher troughs. We’ve since learned that this was more an artifact

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Manufacturing and supply experience Pfizer leverages more than 30 years of state-of-the-art manufacturing and supply-chain experience in biologics to reliably deliver biosimilars to patients.4

To learn more about Pfizer’s oncology biosimilars, visit us online at PfizerBiosimilars.com References: 1. IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. Parsippany, NJ: IMS; March 2016. 2. Drugs.com. How many biosimilars have been approved in the United States? https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/. Updated December 8, 2019.

Accessed April 6, 2020. 3. McGowan S, Jesse M. Biosimilars Pipeline Report. AmerisourceBergen. https:/www.amerisourcebergen.com/-/ media/assets/amerisourcebergen/biosimilars-pipeline-report_0420_v3.pdf?la=en&hash=1071304C7B66ED62628201B8268C0B633 627CB6B. Updated May 1, 2020. Accessed June 4, 2020. 4. Data on file. Pfizer Inc., New York, NY.

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June 2020

OSF HealthCare saw a

30% reduction in acute kidney injuries after switching to AUC dosing using the Bayesian method.

of variability in our testing platforms, and the rationale for more aggressive dosing was based on incomplete understanding of the problem. That strategy didn’t lead to improved outcomes, but did lead to higher rates of AKI. We went ahead without appropriate supporting evidence and caused unnecessary harm. It seems like we’re going down that path again.”

Dr. Jorgensen acknowledged that the preclinical and observational data seem compelling, but she also argued that the classification and regression tree analysis (CART), a statistical method used to derive the thresholds for efficacy or toxicity, are not well suited to exploring exposure–response relationships. “As statisticians say, if you torture data enough, it will confess to anything,” she said. “In still unpublished work, my colleagues and I have done simulation studies using CART analysis to highlight how this method can find spurious ‘threshold values’ in data that has no underlying relationship at all.

And that’s how the vancomycin AUC/ MIC threshold of greater than or equal to 400 for efficacy was derived, which many people don’t realize can be traced back to a very small, single-center retrospective study in Staphylococcus aureus pneumonia. Subsequent studies trying to validate that threshold have all failed.”

Mt. Sinai is staying with trough-based dosing for now, Dr. Jorgensen said. “I have to admit that the data on this is just as limited as the data to support AUC, but trough-based monitoring doesn’t come with the added expense and resource utilization. I think what’s needed now is a three-arm trial: no therapeutic dose monitoring, trough and AUC. We probably all do therapeutic drug monitoring for many more patients than can benefit from this.”

—Gina Shaw Dr. Giddens reported that her health care system works with Venture Investments in supporting new startup companies, such as InsightRX. Dr. Heil reported no relevant financial disclosures. Dr. Jorgensen reported that she has received a speaker’s honorarium from Sunovion.

Clinical

Pharmacy Practice News • August 2021

9

Infectious Disease

Stewardship and Communication Boost Appropriate ABx

T

he promotion of antimicrobial stewardship programs (ASPs), as well as close collaboration between pharmacists and other clinicians on the care team, can optimize antibiotic prescribing among patients with febrile neutropenia (FN), according to a study presented at the 2021 annual MAD-ID (Making a Difference in Infectious Disease) virtual meeting (poster A23).

The results may help medical centers cut down on the significant morbidity and mortality associated with FN, and clarify how to best manage patients who develop this oncologic emergency, according to the investigators.

(n=20/23) of empirical regimens, 75% (n=12/16) of regimens with deescalation opportunities, and 91% (n=22/23) of antibiotic durations.

“During this process, we provided several educational sessions and collaboration with our stewardship and hematology/oncology group, which we think contributed to the success,” Dr. Ketema said. “Although our sample size was small, we were able to show that discontinuation

of antipseudomonal agents in stable patients did not lead to secondary events (i.e., transfer to ICU level care, mortality and other safety concerns).” The team also added methicillin-resistant Staphylococcus aureus risk factor indication to its antibiotic management protocols, which “allowed [for] fewer vancomycin therapy in FN patients.”

Although the results are encouraging, Dr. Ketema stressed that work has

only just begun. “Because we had a low patient sample, we want to continue to investigate prescribing patterns and applicability in a larger scale.”

She added that recurrent education programs for hematology/oncology team members are being developed.

—Ethan Covey Dr. Ketema reported no relevant financial disclosures.

NOW AVAILABLE

The First and Only Antiemetic Approved for Rescue Treatment of PONV Despite Prophylaxis Appropriate Antibiotic Prescribing At baseline:

28% Post-intervention:

70% “The duration of empiric antibiotics in FN patients remains controversial,” said Pawlose Ketema, PharmD, a PGY-2 infectious disease pharmacy resident at Boston Medical Center. “The IDSA [Infectious Diseases Society of America] guideline was last updated in 2010, and since then, there have been a number of retrospective studies to support early discontinuation of antibiotics in patients who are hemodynamically stable, irrespective of their absolute neutrophil count.”

Previous data collected at Boston Medical Center found that only 27.9% of patients received appropriate antibiotic courses based on national FN guidelines. To boost compliance with the guidelines, Dr. Ketema and her colleagues employed several interventions, including ASP pharmacist reviews, regular educational programs and updates to existing FN treatment protocols. When FN was diagnosed, the ASP included pharmacist evaluation of antibiotic choices and communication with clinical oncology and primary care team members.

From November 2020 through April 2021, 23 FN occurrences were identified. The composite outcome of appropriate antibiotic prescribing was 70% (n=16/23). Antibiotic therapy was found to be appropriate for 87%

• Barhemsys is a selective dopamine-2 and dopamine-3 receptor antagonist, TKKJWNSL F UMFWRFHTQTLNHFQ TUYNTS \NYM IJRTSXYWFYJI XFKJY^ FSI JK‫ ܪ‬HFH^ at the doses approved for PONV management1 • Barhemsys 10 mg was more effective than placebo at treating PONV in patients who failed prophylaxis: 42% vs 29% achieved the primary endpoint of complete response; P=0.0031,2,* • In patients who failed prophylaxis, 70% (160/230) of patients met the criteria for complete response at 2 hours after receiving a 10 mg dose of Barhemsys compared with 49% (116/235) of placebo-treated patients (secondary endpoint)2,* • The most common adverse reaction reported for Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416) was infusion site pain (6% vs 4%)1,†

Scan for additional information or visit Barhemsys.com

Indications

Packaging and vial shown are not actual size.

Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for: • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis

Select Important Safety Information Contraindication: 'FWMJRX^X NX್HTSYWFNSINHFYJI್NS UFYNJSYX \NYM PST\S M^UJWXJSXNYN[NY^ YT FRNXZQUWNIJ ್ QT Prolongation: Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage NX ್RL್TW ್RL FX F XNSLQJ NSYWF[JSTZX .; ITXJ NSKZXJI T[JW YT RNSZYJX &[TNI 'FWMJRX^X NS UFYNJSYX \NYM HTSLJSNYFQ QTSL 69 X^SIWTRJ FSI NS UFYNJSYX YFPNSL IWTUJWNITQ *QJHYWTHFWINTLWFR *(, RTSNYTWNSL NX WJHTRRJSIJI NS UFYNJSYX \NYM UWJ J]NXYNSL FWWM^YMRNFX HFWINFH HTSIZHYNTS INXTWIJWX JQJHYWTQ^YJ FGSTWRFQNYNJX J L M^UTPFQJRNF TW M^UTRFLSJXJRNF HTSLJXYN[J MJFWY KFNQZWJ FSI NS UFYNJSYX YFPNSL TYMJW RJINHNSFQ UWTIZHYX J L TSIFSXJYWTS ್TW \NYM TYMJW RJINHFQ HTSINYNTSX್PST\S YT UWTQTSL YMJ 69 NSYJW[FQ Please see Brief Summary of Prescribing Information for Barhemsys on next page. *Barhemsys was evaluated as rescue treatment of PONV in a randomized, double-blind, multicenter trial in adult patients who had undergone elective ambulatory TW NSUFYNJSY XZWLJW^ ZSIJW LJSJWFQ NSMFQFYNTSFQ FSJXYMJXNF FSI KFNQJI UWNTW FSYNJRJYNH UWTUM^QF]NX 9MJ UWNRFW^ JK‫ ܪ‬HFH^ JSIUTNSY \FX HTRUQJYJ WJXUTSXJ IJ‫ ܪ‬SJI FX FGXJSHJ TK FS^ JUNXTIJ TK JRJXNX [TRNYNSL TW WJYHMNSL TW ZXJ TK WJXHZJ RJINHFYNTS \NYMNS YMJ ‫ ܪ‬WXY MTZWX FKYJW YWJFYRJSY J]HQZINSL JRJXNX NS YMJ ‫ ܪ‬WXY RNSZYJX Ѫ7JUTWYJI NS Մ TK FIZQY UFYNJSYX YWJFYJI \NYM 'FWMJRX^X RL FSI FY F MNLMJW WFYJ YMFS UQFHJGT KWTR YMJ 543; YWJFYRJSY FSI WJXHZJ YWJFYRJSY YWNFQX PONV=Postoperative nausea and vomiting.

1. 'FWMJRX^X @UFHPFLJ NSXJWYB .SINFSFUTQNX .3 &HFHNF 5MFWRF .SH 2. -FGNG &8 JY FQ Anesthesiology. 2019;130:203-212.

10 Clinical

Pharmacy Practice News • August 2021

Infectious Disease

ESBLs on the Rise continued from page 1

outbreaks of antibiotic-resistant pathogens in COVID-19 treatment and observation units since April 2020. These included two outbreaks involving organisms designated “urgent threats”: 34 cases of carbapenem-resistant Acinetobacter baumannii attributed to changes in infection prevention and control practices at an acute care hospital in New Jersey (MMWR Morb Mortal

Delivers when it matters most

Wkly Rep 2020;69[48]:1827-1831), and 39 cases of Candida auris attributed to unconventional personal protective equipment practices and environmental contamination in a COVID-19 specialty care unit at an acute care hospital in Florida (MMWR Morb Mortal Wkly Rep 2020;70[2]:56-57).

These outbreaks resolved after the surge, but the long-term impact of the

pandemic on the spread of antibioticresistant pathogens in an area is uncertain, said Kerry LaPlante, PharmD, the senior director of the Rhode Island College of Pharmacy Infectious Diseases Research Program, in Kingston.

“COVID-19 can create a perfect storm for antibiotic-resistant infections in health care settings,” Dr. LaPlante said, citing factors such as increased length of stay, increased number of patients, staffing shortages, sicker patients, increased antibiotic use and challenges implementing infection prevention and control.

COVID-19 created “a perfect storm” for antibiotic-resistant infections to take hold in health care settings, including (top to bottom) Acinetobacter baumannii, Candida auris and methicillin-resistant Staphylococcus aureus.

™

Brief Summary of Prescribing Information for Barhemsys® (amisulpride) Injection See package insert for full Prescribing Information Indications: Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for: • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis Dosage & Administration: The recommended adult dosage of Barhemsys: • Prevention of PONV, either alone or in combination with another antiemetic: 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia.

• Treatment of PONV: 10 mg as a single intravenous dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

Protect from light. Barhemsys is subject to photodegradation. Administer Barhemsys within 12 hours of removal of the vial from the protective carton. See full prescribing information for preparation and administration instructions.

Dosage Forms and Strength: Injection: 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) as a clear, colorless sterile solution in a single-dose vial.

Contraindication: Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation: Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes. Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions: Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%). Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients. The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Drug Interactions: • Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.

• ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).

• Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.

Postmarketing Experience: The following adverse reactions have been identified during postapproval chronic oral use of amisulpride outside of the United States (Barhemsys is not approved for oral dosing or chronic use). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and Lymphatic System Disorders: agranulocytosis; Cardiac Disorders: bradycardia, torsades de pointes, ventricular tachycardia, prolonged QT by electrocardiogram; General Disorders: neuroleptic malignant syndrome; Immune System Disorders: angioedema, hypersensitivity, urticaria; Hepatic Disorders: increased hepatic enzymes; Nervous System Disorders: agitation, anxiety, dystonia, extrapyramidal disorder, seizure; Psychiatric Disorders: confusional state, insomnia, somnolence; Vascular Disorders: hypotension.

Use in Specific Populations: Pregnancy—Risk Summary: Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of amisulpride in rats and rabbits during the period of organogenesis at exposures about 43 and 645 times, respectively, the exposure delivered by the highest recommended human dose (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data—Animal Data: Reproduction studies of amisulpride were conducted in pregnant rats administered oral doses up to 160 mg/kg/day (43 times the exposure based on area under the curve (AUC) at the highest recommended dose of 10 mg) throughout the period of organogenesis. No adverse embryo-fetal developmental effects were observed at any dose level. Maternal animals exhibited a dose-related decrease in overall mean body weight gain. In rabbits administered amisulpride throughout the period of organogenesis, oral doses up to 210 mg/kg/day (645 times the exposure based on AUC at the highest recommended dose of 10 mg) had no adverse developmental effects on the fetus. Maternal animals exhibited reduced mean body weight gain at doses of 100 and 210 mg/kg/day and reduced food intake was observed at 210 mg/kg/day. The pre- and post-natal developmental effects of amisulpride were assessed in rats administered oral doses of 60, 100 or 160 mg/kg/day during the periods of organogenesis and lactation. At 160 mg/kg/day (43 times the exposure based on AUC at the highest recommended dose of 10 mg), maternal animals exhibited a reduction in mean body weight gain and decrease in food intake during lactation.

Amisulpride had no effect on maternal pregnancy parameters, litter survival or pup growth, development or maturation at any dose tested. Lactation—Risk Summary: Based on case reports in published literature, amisulpride is present in human milk at concentrations that are 11- to 20-fold higher than human plasma in patients taking multiple oral doses of amisulpride (200 to 400 mg/day). The estimated infant daily dose ranged from 5% to 11% of the maternal dose. There are ways to minimize drug exposure to a breastfed infant (see Clinical Considerations). There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production. The pharmacological action of amisulpride, a dopamine-2 (D 2) receptor antagonist, may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Barhemsys and any potential adverse effects on the breastfed child from Barhemsys or from the underlying maternal condition. Clinical Considerations: A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after Barhemsys administration to minimize drug exposure to a breastfed infant. Females and Males of Reproductive Potential—Infertility: In animal fertility studies, administration of repeated doses of amisulpride over a 10-day period to female rats resulted in infertility that was reversible. Pediatric Use—Safety and effectiveness in pediatric patients have not been established. Geriatric Use—No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Renal Impairment—Avoid Barhemsys in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials.

Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions. No dosage adjustment is necessary in patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2).

Overdosage: Doses of oral amisulpride (Barhemsys is not approved for oral dosing) above 1200 mg/day have been associated with adverse reactions related to dopamine-2 (D2) antagonism, in particular: • cardiovascular adverse reactions (e.g., prolongation of the QT interval, torsades de pointes, bradycardia and hypotension).

• neuropsychiatric adverse reactions (e.g., sedation, coma, seizures, and dystonic and extrapyramidal reactions).

There is no specific antidote for amisulpride overdose. Management includes cardiac monitoring and treatment of severe extrapyramidal symptoms. Since amisulpride is weakly dialyzed, hemodialysis should not be used to eliminate the drug.

How Supplied/Storage and Handling: Barhemsys is supplied as follows: • NDC 71390-125-20: Package of 10 cartons. Each carton (NDC 71390-125-21) contains one single-dose vial of Barhemsys (amisulpride) injection, 5 mg in 2 mL (2.5 mg/mL).

• NDC 71390-125-50: Package of 10 cartons. Each carton (NDC 71390-125-51) contains one single-dose vial of Barhemsys (amisulpride) injection, 10 mg in 4 mL (2.5 mg/mL).

Store vials at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Patient Counseling Information: QT Prolongation—Instruct patients to contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode. Drug Interactions—Advise patients to report to their healthcare provider if they are taking drugs which prolong the QT interval.

Lactation—Women may consider reducing infant exposure through pumping and discarding breastmilk for 48 hours after Barhemsys administration.

BAR HCP BS 10/2020

Barhemsys® is a registered trademark of Acacia Pharma Limited. © 2021 Acacia Pharma Inc. All rights reserved. PP-BAR-1863 04/2021 Acacia Pharma Limited and Acacia Pharma Inc. are wholly owned subsidiaries of Acacia Pharma Group Plc.

COVID-19 posed another challenge: Antimicrobial stewardship programs (ASPs) came to a virtual halt during the pandemic. In a Twitter poll conducted by the Society of Infectious Diseases Pharmacists in August 2020, nearly 40% of respondents said between 34% and 66% of their local ASP efforts were shifted away to other areas due to COVID-19, while another 30% reported that 67% to 100% of those efforts were diverted.

“Regular stewardship initiatives essentially ceased in the near term,” said Julie Ann Justo, PharmD, BCPS-AQ ID, a clinical associate professor in the Department of Clinical Pharmacy and Outcomes Sciences at the University of South Carolina College of Pharmacy, in Columbia, in a separate interview with Pharmacy Practice News. “Anything decentralized could keep going, but boots-on-the-ground reviews got shifted, because pharmacists’ time as front-line stewards suddenly became all things COVID-19, at least for a couple of months. They were doing literature reviews, developing guidelines and protocols, monitoring the use of remdesivir [Veklury, Gilead], setting up programs for the use of monoclonal antibodies, enrolling patients in clinical trials, you name it. That diverted resources away from day-to-day stewardship activities, resulting in transient changes in antimicrobial use and potentially transient changes in antimicrobial resistance rates.”

The preliminary CDC data showed that the rate of recovery of antimicrobial resistance in hospitalized patients with hospital-onset infections was significantly higher for patients with COVID-19 than for patients with influenza-like illness (ILI): 57% higher for MRSA and 176% for extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales.

“This could be due to the fact that mean length of stay for COVID-19 was significantly longer at 8.44 days than ILI patients at 5.88 days,” Dr. LaPlante said.

Hospital antibiotic prescribing use

Clinical

Pharmacy Practice News • August 2021

11

Infectious Disease during d urin ng thee pandemic showed signifivariability, she said. “While there ccant ant var riab b were overall w we eree ov veraa increases in some agents, ssuch su ucch h aass aazithromycin and ceftriaxone, particularly at facilities with more o ne, par articu ar r u COVID-19 C OVID D-19 cases, CDC preliminary data suggest that ssu uggges estt th h there were no national iincreases ncr creases in broad-spectrum agents, some facilities have seen shiftaalthough ltho ough so o iing. in ngg.. IIn n tthe he outpatient setting, there was significant a ssi ign gniffican n drop in antibiotic prescribduring iing in ng du uringg the height of the pandemic.

Although iic c. A lth hougg that appears related to a decrease d decr de ecrreasse iin n health care utilization, antibiotic use has remained lower than prebiio b ottiicc u se h pandemic even as health care utilid i levels l zation has risen.”

Dr. Justo and her colleagues compared antibiotic use in their system’s COVID-19 admitting hospitals with those that did not admit COVID-19 patients during two periods: March to June 2019 versus all of 2020. In COVID-19 hospitals in 2020, they found a 6.6% overall increase in antibiotic use, and a 16.6% increase in antibiotic use for agents used to treat hospital-acquired infections. Hospitals not admitting COVID-19 patients had no significant changes in antibiotic use.

They also compared antimicrobial use at two hospitals within the system: one (Campus A) that experienced periodic ASP personnel shifts due to COVID-19, and a larger and more acute campus with a Level I trauma center (Campus B) that was able to avoid ASP personnel shifts and mitigate the impact of the pandemic on stewardship. “Campus A had a greater issue with cefepime use over time, as well as increases in ceftriaxone prescribing during local surges,” Dr. Justo said.

Spikes in cefepime, vancomycin and ciprofloxacin use also occurred during the first surge in March to April 2020, when the hospital’s ASP pharmacist hours were shifted to other duties by 30% to 50%, as well as the third surge in December 2020.

“Campus B did not have stewardship personnel shifts, and, thus, had no significant increases in antimicrobial use,” she said.

Dr. Justo noted that although the CDC’s preliminary data suggest that overall antimicrobial use has plateaued at about the same level as before the pandemic, there is significant variability at the state and health-system level. “Some institutions shifted toward agents that were much more focused on respiratory infections, particularly community-onset [infections],” she said. “We saw that ceftriaxone and azithromycin use were both up when an institution was admitting a lot of COVID patients, which makes sense.”

She expressed concern over the increased rates of ESBL-producing organisms noted in the CDC data. “That’s something all of us stewards are keeping an eye on to see if we have an increase in these organisms as a result of local shifts in the types of antimicrobials used.”

The antibiotic stewardship team

benefited from being in the limelight during COVID-19. “Many individuals in health care administration were introduced to front-line members of the stewardship team by virtue of our being part of the COVID-19 incident command [response],” Dr. Justo said. “They realized there is a group of professionals who are focused on quality, who have ways to assess prescribing patterns, and who can get process and culture change to happen in the institution.”

Now that Dr. Justo’s ASP team is starting to get back to day-to-day initiatives,

she noted, they have been able to look at local antibiotic use and antibiotic resistance rates. But she stressed the benefits that have accrued throughout the entire pandemic. “We’ve been able to leverage the respect we gained to secure the time, personnel and technology needed to get the job done. The pandemic proved that our [ASP] methods work.”

—Gina Shaw

Video Exclusive

Dr. LaPlante reported no relevant financial disclosures. Dr. Justo reported financial relationships with bioMérieux, Merck & Co. and Vaxart

Debra Goff, PharmD, a leader in antibiotic stewardship at The Ohio State University, discusses the steward’s role during the pandemic at bit.ly/3eUn9Bq.

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12 Focus on Oncology

Pharmacy Practice News • August 2021

Coordinating ChemoRx

prescription to start of therapy greatly reduced.”

continued from page 1

Patient Education And Monitoring

who had commercial insurance, and uninsured patients experienced the longest delays (Table). Pharmacy transfers and cost assistance programs also were significantly associated with longer time to receipt of therapy.

Transitions Can Cause Delays “Transitions of care, whether you are starting a patient on a new oral oncolytic in the outpatient setting or moving them from inpatient to outpatient, as in the case of hematologic malignancies, can cause delays in therapy, especially if your institution does not have a specialty pharmacy on-site, or the patient’s insurance dictates a different specialty pharmacy,” said Lisa Holle, PharmD, BCOP, an associate clinical professor of pharmacy practice at the University of Connecticut (UConn) School of Pharmacy, in Storrs. “It’s not uncommon for these delays to be up to three or four weeks.”

The prior authorization process is a significant challenge in oral oncolytic therapy transitions of care, said Julie Kennerly-Shah, PharmD, the associate director of pharmacy at The Ohio State University Comprehensive Cancer Center–James Cancer Hospital, in Columbus. “The turnaround time can vary greatly from one payor to another. They often request detailed clinical information, which requires a large dedicated team of prior authorization specialists.

Despite significant clinical evidence, the claim often is denied. While we typically are successful in overturning denials, this process leads to delays in access to cancer medication for our patients. If the payor mandates that we use an outside specialty pharmacy, there are additional delays.

Our physicians and pharmacists strongly prefer to use our specialty pharmacy due to their clinical expertise in oncology and faster access to oral oncolytics.”

Payor Overrides For patients with an urgent need to start therapy, pharmacists from the internal specialty pharmacy at Yale New Haven’s Smilow Cancer Hospital are sometimes able to reach an agreement with the insurance provider for a one-time only override of the requirement to use the payormandated outside specialty pharmacy.

“Some payors do allow that, so we can at least get the patient initiated on treatment and then work on the second fill with their designated specialty pharmacy with a little more lead time, but it doesn’t work with every insurance company,” said Sarah Perreault, PharmD, BCOP, a clinical pharmacy specialist for the bone marrow transplant program at Smilow.

Regardless of where a patient is having their oral oncolytics filled, Dr. Perreault said, Smilow’s pharmacists and Yale Specialty Pharmacy closely monitor their care. “They still follow up each month that [patients] are on the medication, making sure they are getting their refills on time, monitoring side effects and reviewing labs so that we can make real-time dosage recommendations.

Clinical pharmacists who work with the patients in our cancer clinics will often go back and forth with the outside specialty pharmacy to review issues such as dose adjustments.”

But these oncology pharmacists agreed that having an internal specialty pharmacy manage the oral oncolytic

Detailed patient education also is critical, especially in cases where the patient is receiving the specialty drug for the first time. “Most people don’t realize there are different types of pharmacies and don’t know why specialty pharmacies exist,” Dr. Holle noted. “So it’s important to explain that these drugs come only from particular pharmacies and are shipped to their home if they do not receive them from the specialty pharmacy on-site. Make sure they know that they need to answer the phone, even if the call is from an unfamiliar number.

If they are receiving the oncolytic from the outside specialty pharmacy in the mail, you won’t necessarily get a notifica-

Table. Time From Prescription to Receipt Of Therapy Patient Group

Wait Time, days

Overall

7.3±10.3

Commercial insurance patients

4.4±3.3

Medicare patients

9.1±13.1

Uninsured patients

15.7±7.8

significant toxicities from higher drug exposure may be warranted.”

Dr. Kim, who is also a member of the Pharmacy Practice News editorial advisory board, noted that pharmacists must be vigilant and actively screen for DDIs in all cancer patients, particularly those who are initiated on oral oncolytics, and educate patients who are moving from the inpatient to the outpatient setting about what to expect in terms of toxicities, how to manage them and when to contact their doctor. “If their home medication was changed during hospitalization,” she stressed that “patients will need to be educated on the change in the therapy and instructed not to continue their home medication upon discharge.”

Patient education also must emphasize the fact that many oral therapies are still chemotherapy. “We make sure our patients understand that these are not

In 2019 and 2020,

73% and 40% of new cancer drug approvals, respectively, were oral agents, up from about

25% to 35% a decade ago.

Sources: J Natl Compr Cancer Netw.

2008;6(suppl 3):s1-s14; bit.ly/3xt7r7w.

Source: J Oncol Pharm Pract. 2020;26(2): 279-285.

initiation and transitions is ideal.

With that in mind, UConn Health established its own specialty pharmacy within the past two years. Before that, prescriptions for oral oncolytics had to be filled using a variety of outside specialty pharmacies, according to Dr. Holle, who is also a member of the Pharmacy Practice News editorial advisory board. “We tried to develop ongoing relationships” and use specialty pharmacies “where things went particularly smoothly, as much as possible, although insurance often dictates that.”

Since opening the specialty pharmacy, Dr. Holle said, the process is more streamlined. “We have two dedicated pharmacy technicians who receive the prescription and treatment plan and are able to assess whether the oral oncolytics can be filled at our specialty pharmacy and, if not, what specialty pharmacy is approved by the insurer. They automatically assess if there are any patient assistance programs and opportunities for foundation support if copays are unaffordable for the patient, and will work to get those ducks aligned. We have not yet done a full analysis, but, anecdotally, it’s clear to us that we have seen the time from

tion if it’s not your own in-house pharmacy, so make sure the patients know to call you once the shipment has arrived so you can document their start date.”

Oral oncolytics come with toxicities unique to their mechanism of action and drug–drug interactions (DDIs) that can interfere with adherence to therapy, said Sara Kim, PharmD, BCOP, a senior clinical oncology pharmacy specialist at Northwell Health, in New York. “For example, AML [acute myeloid leukemia] patients typically receive antifungal prophylaxis during neutropenia with either posaconazole or voriconazole, both of which are strong inhibitors of CYP3A4. Therefore, we need to be mindful of significant interaction issues with medications that are strong substrates of CYP3A4, including many of the available oral oncolytics, such as venetoclax (Venclexta, Genentech/AbbVie), dasatinib and ibrutinib (Ibrutinib, Pharmacyclics/ Janssen), statins, and direct oral anticoagulants. A significant dose reduction may be required for some medications if dose attenuation guidance is available in the prescribing information. Otherwise, an active surveillance of potentially

‘safer’ than IV chemotherapy and that they still require frequent monitoring.

To ensure regular in-person assessment, especially with patients who are new to oral therapy, we limit the number of refills we give,” Dr. Kennerly-Shah said.

“This [limit] is medication-specific, depending on toxicity profiles, but for the majority of regimens we allow only one month at a time. For some drugs with lower toxicities and patients who are on more chronic therapy, it may be every two or three months. As oncology becomes more of a chronic disease, some patients will be on the same oral agent for four or five years,” she said.

“We want to be thoughtful of those people who are stable on long-term oral therapy and know what to expect and when to contact us, so that we are not unnecessarily burdening them with toofrequent visits.”

—Gina Shaw Drs. Kim and Holle reported no relevant financial disclosures. Dr. Kennerly-Shah reported financial relationships with Alexion, Bristol Myers Squibb, CBPartners, Heron, Juno, Sanofi, Seattle Genetics and Tesaro.

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14 Focus on Oncology

Pharmacy Practice News • August 2021

Maximizing the Benefit of Venetoclax in AML T

he approval of venetoclax in combination with hypomethylating agents (HMAs) or low-dose cytarabine provides significant benefit for older adults with newly diagnosed acute myeloid leukemia (AML). But the therapy also comes with a specific set of challenges that clinicians are learning to tackle.

Venetoclax (Venclexta, AbbVie/Genentech) has been a “huge medical breakthrough and a much-welcomed addition” to AML therapy, one of the most aggressive leukemias, said Sara Kim, PharmD, BCOP, a senior clinical oncology pharmacy specialist at Northwell Health, in New York. With the lowest survival rate for all leukemia types, AML is particularly deadly in older populations: Among patients 75 years of age or older, the fiveyear overall survival (OS) rate is only 2.7%, compared with 10.8% among those diagnosed between 65 and 74 years of age and 26.3% among those aged 50 to 64 years.

Originally granted provisional approval in 2018 under the FDA’s accelerated pathway for adults with AML who are at least 75 years of age or have comorbidities that preclude use of intensive induction chemotherapy, venetoclax received full approval for this indication in October 2020.

The oral BCL-2 protein inhibitor showed only modest activity as a single agent in the relapsed/refractory setting, but when combined with existing backbone therapies used among newly diagnosed older AML patients who are typically considered not suitable for intensive chemotherapy, it turned out to be a powerhouse (Blood Adv 2019;3[24]:43264335). In this setting, “venetoclax plus an HMA, such as azacitidine or decitabine, has a 70% complete response rate in clinical trials and is a great option for older patients and/or patients with comorbidities who may not be a candidate for an intensive induction therapy with 7+3,” Dr. Kim said. (The 7+3 regimen consists of seven days of continuous cytarabine infusion, along with an anthracycline drug, either daunorubicin or idarubicin, on each of the first three days as a short IV bolus or IV push.)

The clinical trials leading to its approval also found that venetoclax extended OS, with a median OS of 14.7 months in patients receiving the combination compared with 9.6 months among those who received azacitidine alone.

But the treatment comes with the cost of profound cytopenia for many patients, including neutropenia and neutropeniarelated infections. “In the trials, up to 47% required interruption of venetoclax, most frequently from persistent cytopenia at the end of the first cycle. Managing cytopenia so that our patients can continue therapy without much interruption

Table. Managing Cytopenia During Venetoclax Combination Therapy for AML The main features of Roswell Park Cancer Institute’s protocol for managing cytopenia in patients with acute myeloid leukemia being treated with venetoclax combination therapy include: Blood counts three times weekly to daily.

Neutropenic prophylaxis, with dose reductions of venetoclax for azole antifungals as needed.

in between cycles is one of the main challenges that clinicians have faced with this therapy,” said Dr. Kim, who is a member of the Pharmacy Practice News editorial advisory board.

Venetoclax dosing is given in a 28-day cycle, beginning with a ramp-up phase consisting of 100, 200 and 400 mg given on days 1, 2 and 3, respectively; for day 4 and beyond, the venetoclax dose is 400 mg per day when given in combination with azacitidine or decitabine and 600 mg per day when given in combination with low-dose cytarabine. A bone marrow (BM) biopsy/aspirate usually is performed after cycle 1 (around day 28) to assess for treatment response.

Recent publications, however, recommend performing a day 21 BM biopsy/ aspirate and holding venetoclax if complete remission has been achieved, to allow for blood count recovery.

In the VIALE-A study leading to venetoclax’s approval in this setting, the majority of responding patients in the venetoclax plus azacitidine arm required dosing modifications to manage cytopenia, most commonly delays between cycles or within-cycle reductions of venetoclax (Blood 2020;136[suppl 1]:51-53).

Dose Reductions, Extended Timing Dose reduction options can involve either venetoclax, HMA or both, said Molly Schiffer, PharmD, BCOP, a hematology/oncology clinical pharmacist at Yale New Haven Health’s Smilow Cancer Center, in Connecticut. “In our center, we will more frequently reduce the dosage or frequency of the hypomethylating agent, but I have seen this done with both agents to reduce the myelosuppression. Often our providers will extend the cycles to be approximately five- to six-week cycles instead of changing any doses to allow more time for count recovery. In my experience, sometimes when you hold dosing for a week, that can help patients recover their counts before starting the next cycle.”

At day 21, if BM biopsy reveals no evidence of AML, hold venetoclax and start granulocyte colony-stimulating factor if counts are low. Await count recovery to start the next cycle, and consider decreasing the venetoclax from 28 days to seven to 21 days, or reducing the hypomethylating agent by 33% to 50%.

If AML persists at day 21, continue venetoclax dosing and start cycle 2 on day 29 with no delay. Continue the second cycle and repeat BM biopsy between day 21 and 28 of the cycle.

AML, acute myeloid leuakemia; BM, bone marrow Source: Hematology Am Soc Hematol Educ Program. 2020;2020(1):57-66.

Several major cancer centers have published their experience and recommendations for managing cytopenia during venetoclax combination therapy for AML. Investigators at Roswell Park Cancer Institute, for example, described their protocol in a report in Hematology, ASH Education Program (2020;2020[1]:57-66) (Table).

A Balancing Act In a 2019 publication in Leukemia, Brian Jonas, MD, PhD, an associate professor of medicine (hematology) at the University of California, Davis, and Daniel Pollyea, MD, the clinical director of leukemia services at the University of Colorado Medicine, in Aurora, noted that they have treated many patients with venetoclax-based regimens who are in long-term remission and are cytopenic but have no notable clinical consequences from their counts (2019;33[12]:2795-2804).

“We have found that for the majority of patients, cytopenias can be successfully managed,” they noted. “Primarily, until a response is assessed, we strongly advocate continuing this regimen with aggressive supportive care and discourage treatment interruption or dose reductions in either therapy.

Those who regularly treat AML are accustomed to the principle that initial therapy, whether it is intensive or less intensive, mandates this approach.

This should extend even more so to venetoclax-based regimens, with their high-response rates, rapid remissions

and low early death rates (3%), which translates to a lower risk: benefit ratio than conventional therapies.”

When to Pause For patients who have achieved a morphologic remission and have failed to achieve count recovery, they recommended a pause of up to 14 days from both therapies. “We find that G-CSF [granulocyte colony-stimulating factor] support can rapidly correct neutropenia in many cases,” they noted. On the other hand, for patients in whom residual disease remains and for whom more therapy may be beneficial, they argue for starting the next cycle without delay and withholding G-CSF support until complete remission has been achieved.

“We’re still learning to figure out the best approach to deliver this regimen to minimize the risk of complications related to significant treatment-related BM suppression, while optimizing efficacy of the therapy. It is all about a balancing act,” Dr. Kim said. “There are no hard-and-fast rules. We have to tailor each cycle to how the patient is tolerating the therapy. Younger patients, of course, tolerate it better, but we are now treating patients in their 70s and 80s, and we really have to personalize the scheduling of these therapies so that they can tolerate them and continue to benefit.”

—Gina Shaw Drs. Kim and Schiffer reported no relevant financial disclosures.

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16 Focus on Oncology

Pharmacy Practice News • August 2021

HOPA pearls:

Telehealth, Enriching Residents During Pandemic

U

sing video appointments to manage stem cell transplant patients and employing innovative approaches to ensure PGY-1 oncology residents get the most out of their rotations are among the strategies that pharmacists have used to counter challenges brought on by COVID-19.

‘The Future Is Virtual’

O

ne positive change in health care accelerated by the COVID-19 pandemic that is expected to linger is a transition to telehealth, said Julianna Merten, PharmD, BCPS, BCOP, an ambulatory care pharmacist with Mayo Clinic in Rochester, Minn.

Pharmacists at Dr. Merten’s institution have participated in video visits with bone marrow transplant patients since 2016, but these visits increased during the pandemic, she said during a pearls session at the 2021 virtual annual meeting of the Hematology/Oncology Pharmacy Association.

“I have long been an advocate of video appointments,” she said. “To me, this was work utopia.”

Dr. Merten listed several benefits of video calls. Patients don’t have to wait until clinic space is available for video appointments; patients don’t need to make two trips to the medical center if their pharmacy and provider appointments are not scheduled consecutively; and, because patients are at home during the video calls, they have access to their medications.

Mayo Clinic built video visit capabilities directly into the electronic health record (EHR), enabling Dr. Merten and her colleagues to share screens to show patients lab test or imaging results, or which eye drops or dry mouth

products they recommended, for example. They also could easily invite other providers or caregivers to visits using the telehealth system.

In an ongoing in-house survey of patients seen by pharmacists, 95% said they were highly or very highly satisfied with the overall quality of care and services received via video visits, which averaged 18 minutes. Some systemic barriers to telehealth, such as billing allowed by the Centers for Medicare & Medicaid Services, have been lifted during the pandemic, Dr. Merten said. Now, any patient requesting a video visit with their provider also is offered a video visit with the pharmacist.

“The future is virtual,” she said.

“Pharmacists don’t physically examine patients, so video is a great venue for care.” Her service proposed a change to its scheduling module to conduct in-person visits for new patients, annual visits, and those on day 100 of treatment; the remainder offered via video with telephone as backup.

Dr. Merten acknowledged that some patients may not fare as well with these visits, especially if they have complex social problems, impaired hearing or vision, cognitive impairment or slow internet speed. But she said she was

surprised by some of the patients who liked video appointments. Dr. Merten said people she never expected to try or like video actually loved it. “Be sure not to judge the book by its cover when it comes to offering patients video appointments,” she advised.

Getting Creative To Enrich Residencies

R

esident education is another area challenged by the pandemic, due to limitations on patient contact and onsite clinical experiences. es.

Using guidelines and nd recommendations ASHP released d on telehealth services, virtual ual rotation policies and other ther approaches to help resisidency directors mininimize disruptions in n the educational pro-cess (bit.ly/3ezgU61), Sonia Amin Thomas, PharmD, BCOP, a clinical oncology specialist and clinical pharmacist with Wellstar North Fulton Regional Hospital, in Roswell, Ga., used creative ways to o maintain her oncolology residents’ educational onal pathways.

After the release of the recommendations, institutions used residents “in many ways in addition to th their rotational duties,” Dr. Thomas said. At her institution and nationwide, re residents were called in to plan for the surge of COVID-19 patients, su she said. They helped write policies and research proto protocols, plan for emergency department preparedness, conduct medication medicati inventories, and create innovative schedules for chemoinnova therapy patients to maintain thera treatment and participate in trea clinical trials. cli As visitor policies tightened at hospitals, in many e cases residents had limited on-site experience and direct patient contact, Dr. Thomas said.

At her site, residents were not allowed in the hospital from March to November 2020. So, she N

and other preceptors came up with innovative solutions, such as holding up a mobile device during patient rounds so residents could watch or listen, holding case presentations and journal clubs online, and granting remote access to EHR systems.

What worked well at her hospital was having virtual rotations, with independent time at home for residents to work up patients. Outpatient rounding using Zoom and FaceTime also was helpful, Dr. Thomas said.

Inpatient rounds did not work as

well, however, because in many cases patients did not want cellular devices used, and residents lost their face-toface time with oncologists.

Looking ahead, residency program directors should try to restructure programs to incorporate telehealth experiences, Dr. Thomas said. Oncology residents also could participate in leadership opportunities in community settings, such as partnering with cancer survivor groups, or in residentrun clinics where they use telehealth and phone calls for patient follow-up and counseling. In addition, residents could participate in virtual tumor board meetings and provide oncology pharmacy education for staff in-person or remotely.

—Karen Blum The speakers reported no relevant financial disclosures.

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18 Focus on Oncology

Pharmacy Practice News • August 2021

Survey Highlights Underused Skills of Onc Pharms T

he oncology pharmacy community is well aware that its clinical services can profoundly improve patient outcomes and reduce costs. Now, researchers hope that documenting and publicizing the types of clinical activities that these pharmacists provide will lead other health care stakeholders to take notice

oncology pharmacy leaders at nine academic centers and 11 community centers across the country between November 2017 and August 2018. They administered a 49-item survey to find out what types of activities oncology pharmacists participate in at the individual institutions, which outcomes they measure, what payment models are in place and what trends pharmacy leaders are seeing in oncology care.

There are

3,503 board-certified oncology pharmacists across the United States. as well, and employ pharmacists to their full potential.

“I don’t think all health systems and hospitals are maximizing the use of clinical oncology pharmacists,” said Lisa Holle, PharmD, an associate clinical professor at the University of Connecticut School of Pharmacy, in Storrs, and a past president of the Hematology/Oncology Pharmacy Association.

Robert Ignoffo, PharmD, a professor emeritus in the Department of Clinical Pharmacy at the University of California, San Francisco and Touro University California, in Vallejo, believes there is an urgent need to get the word out that oncology pharmacists can play a critical role in oncology care. He pointed to a shortage of oncologists and an anticipated 40% increase in demand for cancer care over the next several years (bit.ly/3pRsi0j).

Dr. Ignoffo and his colleagues estimated that the oncology pharmacist workforce can alleviate the anticipated burden on the health care system by caring for up to 4 million more patients annually than they currently see (Pharmacy 2020;8[1]:43).

“It’s very important that we assess pharmacist involvement in oncology care so that we can help address gaps in care,” Dr. Ignoffo said.

Seeing that “most published papers that talk about the oncology workforce forget to include oncology pharmacists,” Dr. Ignoffo and several colleagues set out to describe the work that oncology pharmacists do—and don’t do—at hospitals and health systems. They interviewed 20

In a recent publication of their findings (J ( Oncol Pharm Pract 2021;27[1]:5-13), Dr. Ignoffo’s team identified a list of frequently reported clinical activities (box). They found that almost all respondents said oncology pharmacists provided education to other pharmacy staff as well as providers, students, residents and patients.

also expected to see a corresponding increase in the number of oncology physicians, oncology pharmacists, pharmacy technicians, oncology nurses and advanced practice practitioners hired over the same period. Most oncology pharmacy leaders believe oncology lead pharmacists will be more involved with administration of immunotherapy and oral oncolytic drugs, for which the authors said wh oncology pharmacists on must be prepared.

Despite the value of clinical clini oncology pharmacists, cists Dr. Ignoffo’s team found th that only 40% of pharmacy leade leaders reported engagement in pra practice-related groups, such as committees focused on com quality improvement, policy and impr order set development, disease d state treatm treatment guidelines and patient education. educatio There also was limited reported pharm pharmacist involvement in quality measurement measureme and development of value-based reimbursement systems. reim Only half of the organizations had color laborative care agreements for oncolag ogy pharmacists tto practice within, the investigators foun found.

Dr. Ignoffo cited another key finding: Many respondents reported difficulty in collecting the data needed to demonstrate their value, such as measures of cost savings and the positive impact of pharmacist care on patient outcomes and patient satisfaction, medication adherence and health care utilization due to averted drug-related adverse events.

‘To optimize our role in team-based patient care, pharmacists need to be more involved in value-based models, which requires greater participation in quality outcome measurements.’

—Robert Ignoffo, PharmD As for training oncology pharmacists, it usually occurred on the job or through PGY-2 oncology pharmacy residencies, the survey found. Although there were 110 centers with PGY-2 oncology residency programs at the time of the study, that number has increased to 120 in 2021, and there are currently 3,503 board-certified oncology pharmacists across the United States, Dr. Ignoffo noted.

The need for oncology care providers is imminent, as most respondents indicated. Many of them expected to see an increase in the volume of cancer patients at their institution and across the country in the two to five years after the survey, and indeed most respondents

“To optimize our role in team-based patient care, pharmacists need to be more involved in value-based models, which requires greater participation in quality outcome measurements,” Dr. Ignoffo said.

Reimbursing for Value Douglas Hackenyos, PharmD, the oncology pharmacy clinical coordinator in the Department of Pharmacy at UConn Health, in Farmington, Conn., said he was “heartened that the survey responses almost unanimously confirm that oncology pharmacists are performing diverse clinical functions and playing significant roles in educating other health care

Most Common Clinical Oncology Pharmacist Activities • Carrying out protocol-based initiatives • Assessing and issuing recommendations about chemotherapy-related toxicities, such as nausea and vomiting, as well as cancer pain • Issuing recommendations about disease symptoms • Providing patient education and counseling • Drafting chemotherapy orders, including for prophylactic drugs • Adjusting chemotherapy agents

professionals. However, as the authors mentioned, I think an area of concern is the lack of pharmacist engagement in value-based care reimbursement.”

Payment Remains a Challenge Financial constraints are one of the barriers that prevent oncology pharmacists from making use of their full clinical skill set, and “better billing and reimbursement for pharmacist care is needed,” Dr. Hackenyos said. “If we’re anticipating trends of increased patient volume and a growing need for oncology pharmacists, it will be more important than ever that we get involved in these emerging payment models.”

Dr. Holle, a member of the Pharmacy Practice News editorial advisory board, echoed Dr. Hackenyos, saying that reimbursement mechanisms for pharmacy services are needed if oncology pharmacists are to practice at the top of their license.

The current study, she noted, could help health-system administrators become familiar with the skills and competencies that oncology pharmacists bring to the table, and might lead to greater inclusion in payment models, she indicated.

“We need to keep documenting our value and continue educating health care professionals about our capabilities,” Dr. Holle said.

—David Wild The sources reported no relevant financial disclosures.

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20 Focus on Oncology

Pharmacy Practice News • August 2021

Watch for DILI in Cancer Patients T

here are several types of druginduced liver injury (DILI) that may appear in patients treated for cancer even years after exposure, and diagnosing it can be tricky, according to a speaker at the 2021 virtual annual meeting of the Hematology/Oncology Pharmacy Association. That’s why “DILIgence” is required on the part of clinicians.

“While DILI on its own is difficult to diagnose and manage, cancer patients and their therapies have characteristics that make it a uniquely challenging task,” said E. Dan Nichols, PharmD, BCOP, a clinical pharmacy specialist with The University of Texas MD Anderson Cancer Center, in Houston.

Although it can be difficult to determine the propensity of a medication to cause DILI, several patient- and drugspecific risk factors have been identified, Dr. Nichols said, such as older age, malnutrition, comorbidities, genetic variability, polypharmacy, and medications with multiple mechanisms of hepatotoxicity. Many of these characteristics are prevalent among cancer patients.

Managing DILI is relatively straightforward but can be strenuous, Dr. Nichols added. The condition is a diagnosis of exclusion, he said, “so before pointing to a medication as the cause of the patient’s liver impairment, it’s crucial to rule out other potential causes, such as biliary abnormalities, viral hepatitis, alcohol use and hemodynamic instability.”

Cancer patients require an even wider differential diagnosis because disease involvement in the liver, such as metastasis, also may need to be ruled out. With no reliable marker yet identified to establish DILI as a definitive cause of injury, most regulatory bodies use the Roussel Uclaf Causality Assessment Method (RUCAM), an objective, point-based system that combines clinical, biochemical, serologic and radiological features of liver injury to assign an overall score that reflects the likelihood that hepatic injury is due to a specific medication. This assessment method accounts for variables such as onset of symptoms, risk factors, age, and medication or nonmedication causes. If several potential hepatotoxic agents are used simultaneously, a separate score should be calculated for each, Dr. Nichols said.

Once a medication has been implicated as the cause of liver injury, the treatment is simple: Stop the offending agent. “Most cases of DILI will resolve spontaneously once exposure is halted, and continuing therapy increases the risk for more serious or chronic damage,” he said. Supportive care including fluids, antiemetics or steroids can

dive. DILI is described in a wide variety of ways across medication package inserts and rarely includes classifying information. Information on liver toxicity in the labels of oncology agents is based mostly on hepatotoxicity identified during clinical development rather than post-marketing data, which may underestimate the real-world risk for DILI, he cautioned. Data on hepatotoxicity also may vary according to patient populations and the ways in which therapies were used.

Useful Database

be implemented. Resuming medications generally is strongly discouraged, but it may be reasonable for cancer therapies if no alternative agents exist and the patient has curable disease.

When seeking hepatotoxicity data of particular drugs, clinicians often first turn to package inserts, or databases such as Lexicomp, Dr. Nichols said. But there are several limitations that warrant a deeper

A valuable resource to check is the LiverTox database (livertox.nih.gov) produced by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Library of Medicine, Dr. Nichols said. It includes descriptions of the hepatotoxicity of more than 1,000 drugs, and allows users to submit case reports. Clinicians also can report drug-related adverse effects, including hepatotoxicity, to the FDA’s MedWatch database at www.fda. gov/medwatch.

—Karen Blum Dr. Nichols reported no relevant financial disclosures.

Geriatric Screening Tools Flag Issues Among Senior Ca Pts

G

eriatric screening and assessment of older patients presenting with cancer represent best practice and should be standard, according to geriatric oncology experts.

It is feasible to integrate short screening tools into practice and electronic medical record systems to assess items such as activities of daily living, cognition, nutrition and quality of life, said Martine Extermann, MD, PhD, the program leader of senior adult oncology at Moffitt Cancer Center, in Tampa, Fla., in a presentation during the 2021 virtual annual meeting of the Association of Community Cancer Centers.

About 90% of patients presenting to cancer clinics have comorbidities, twothirds have dependence with activities of daily living, one-fourth have issues with depression and 20% have cognitive issues, Dr. Extermann said. “We are facing a major issue and have to find ways to provide proper care for these patients.”

Several studies have demonstrated that incorporating geriatric screening and care into cancer care can result in decreased toxicities from chemotherapy, fewer days in the hospital during treatment and better quality of life, she noted (J Clin Oncol 2020;38[15 suppl]. doi:10.1200/JCO.2020.38.15_suppl.12011, and others).

The senior adult oncology program at Moffitt has conducted geriatric screening for new patients for nearly 30 years using its own tool. Before the intake appointment, a nurse asks patients

questions by phone about activities of daily living, sleep and appetite, and a short cognitive evaluation is given when the patient arrives. If no issues are identified, physicians do a typical oncology workup; if issues are found, physicians do oncology and geriatric workups in parallel.

In the two to three weeks it often takes to get testing done, “we can do a lot of geriatric assessment and management.” This could include having a pharmacist conduct a polypharmacy intervention, a social worker assess

distress or set up supports, and a dietitian address nutritional deficiencies.

“It’s not just patients’ chronological age” that matters, noted Melissa (Kah Poh) Loh, MBBCh BAO, a senior instructor and geriatric hematologist/oncologist with the University of Rochester Medical Center’s James P. Wilmot Cancer Center, in New York, stressing the importance of such programs. It also involves knowledge about patients’ health that may help “predict their tolerance to cancer treatment and introducing interventions that may improve tolerance.”

—Karen Blum Dr. Extermann reported no relevant financial disclosures. Dr. Loh has served as a consultant to Pfizer and Seattle Genetics.

To download the Moffitt screening questionnaires, visit bit.ly/3iEQ5hO.

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22 Clinical

Pharmacy Practice News • August 2021

Opinion

The Hidden Pandemic of Misdosing Rachel Eyler, PharmD, BCPS Project Clinical Lead Lexicomp Reference Content at Clinical Effectiveness Wolters Kluwer Health Ann Arbor, Michigan

Bruce Mueller, PharmD, FCCP, FASN, FNKF Interim Dean and Professor of Clinical Pharmacy University of Michigan College of Pharmacy Senior Editor Lexicomp Reference Content at Clinical Effectiveness Wolters Kluwer Health Ann Arbor, Michigan

P

harmacists and clinicians adjust drug doses for patients every day.

Yet determining the correct dosage is one of the most difficult aspects of the prescribing process. This is due in part to the complexity involved in tailoring to an individual patient’s condition, age, organ function, comorbidities, and concurrent medications. Kidney dysfunction, in particular, presents unique challenges that clinicians calculating medication dosages.

Renal Dosing: A Common Yet Complex Task About 14% of the world’s population has chronic kidney disease (CKD)1 and almost one-fourth of hospitalized patients develop acute kidney injury (AKI).2 The risk is even greater in the ICU, where more than half of patients develop AKI.3 Accurate dosing and monitoring in these patients is complex and crucial.

Dosing of anticoagulants provides a clear example. Anticoagulants are high-risk medications. Clinicians must carefully balance the risks for causing bleeding associated with higher doses with the potentially catastrophic consequence of the patient suffering a clot or stroke if the dose is too low.4 Estimating a patient’s kidney function and subsequent drug clearance is the first step in the renal dose adjustment process and can be quite difficult. Several equations are available for estimation, but there are strengths and weaknesses in each formula and limited applicability to certain populations (eg, those with AKI, hepatic dysfunction, and other conditions).5-7 Hospitalized patients may experience dynamic changes in their kidney function, making dose estimation even more difficult. For patients who require renal replacement therapy, each type of therapy (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy) can affect drug removal.8 Once kidney function and drug removal are evaluated, the next step

is tailoring dose adjustments to kidney function.

This step is also lacking in good references to assist pharmacists and clinicians in making the proper dose recommendations. Khanal et al highlighted this dynamic in their study that pulled 5 different renal dosing guides and compared recommendations for 61 commonly adjusted medications.9 According to their review, many of the sources offered ambiguous recommendations, such as “increase dosing interval” or “seek specialist advice in severe i m p a i r m e n t ,” and often disagreed on the reported availability of clinical trials.

The variability in drug dosing recommendations is not surprising. Before 1998, the United States did not provide structured regulatory guidance to pharmaceutical companies about how, and for which drugs, such renal dosing evaluations should be conducted.10 This has improved somewhat with guidance from the FDA. One ongoing problem is the lack of pharmacokinetic trials and studies that thoroughly evaluate dosing implications for patients with kidney dysfunction.

Many dose recommendations are based on single-dose pharmacokinetic trials and studies to quantify the impact of renal replacement therapies that were conducted for only 21.6% of the 194 new chemical entities for which new drug applications were approved by the FDA between 1999 and 2010. Only 4 of those studies evaluated patients on peritoneal dialysis and 1 evaluated patients receiving continuous renal replacement therapy.10 That means for some medications, there are no data or only case reports available to advise clinicians about how to dose these drugs. For other medications, the various pharmacokinetic studies draw different conclusions based on the population studied. Some references have not been updated in over a decade.

For example, the last edition of the oftencited Drug Prescribing in Renal Failure,

by Aronoff et al, was published in 2007.11

Critical Information Gap There is a clear need to improve the quality of renal dosing recommendations in clinical drug references

our clinicians finally will be equipped with the tools they need to truly individualize care for their patients.

The authors thank senior editors Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, University of Queensland, Australia, and Michael Heung, MD, MS, University of Michigan, for reviewing this article. Drs Eyler and Mueller reported no relevant financial disclosures other than their stated employment.

References that clinicians consult every day at the point of care. Teams behind evidence-based medicine tools should consist of a panel of consultants that include experts specialized in reading and interpreting pharmacokinetic literature, experts in caring for patients with kidney disease, and others who know how to use the medication in question in clinical practice. These teams should review and debate gray areas in the literature to develop concise, clinically helpful recommendations, so overworked clinicians at the bedside can provide safe, effective, patient-centered care.

Regulatory agencies, too, need to continue to push for well-designed studies of patients with CKD, AKI, and those receiving renal replacement therapies.

Rigorous studies should be mandated as part of the approval process, and postmarketing drug optimization research should be encouraged to include patients with altered kidney function.

The FDA has signaled its intention to address some of these concerns. In September 2020, the FDA issued a draft guidance on the evaluation of pharmacokinetics in patients with impaired renal function.12 The guidance includes advice on how to use population pharmacokinetics and phase 2 and 3 trials to inform dosing in patients with kidney dysfunction and how to conduct studies in patients receiving continuous renal replacement therapy.

Addressing the challenges in proper renal dose adjustments will require regulatory changes and new approaches to scientific research to include access to real-time data. Once this is achieved,

1. US Department of Health and Human Services. Office of Disease Prevention and Health Promotion. National Action Plan for Adverse Drug Event Prevention. 2014. Accessed July 26, 2021. http://bit.ly/3pAnn3Y 2. Hill NR, Fatoba ST, Oke JL, et al. Global prevalence of chronic kidney disease—a systematic review and meta-analysis. PLoS One. 2016;11(7):e0158765.

3. Wang HE, Muntner P, Chertow GM, et al.

Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-355.

4. Hoste EA, Bagshaw SM, Bellomo R, et al. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study.

Intensive Care Med. 2015;41(8):1411-1423.

5. Jones GR. Estimating renal function for drug dosing decisions. Clin Biochem Rev. 2011;32(2):81-88.

6. Raman M, Middleton RJ, Kalra PA, et al.

Estimating renal function in old people: an in-depth review. Int Urol Nephrol.

2017;49(11):1979-1988.

7. Sherman D, Fish DN, Teitelbaum I. Assessing renal function in cirrhotic patients: problems and pitfalls. Am J Kidney Dis. 2003;41(2):269-278.

8. Mueller BA, Smoyer WE. Challenges in developing evidence-based drug dosing guidelines for adults and children receiving renal replacement therapy. Clin Pharmacol Ther.

2009;86(5):479-482.

9. Khanal A, Castelino RL, Peterson GM, et al.

Dose adjustment guidelines for medications in patients with renal impairment: how consistent are drug information sources? Int Med J. 2014;44(1):77-85.

10. Matzke GR, Dowling TC, Marks SA, et al.

Influence of kidney disease on drug disposition: an assessment of industry studies submitted to the FDA for new chemical entities 19992010. J Clin Pharmacol. 2016;56(4):390-398.

11. Aronoff GR, Brier ME. Drug Prescribing in Renal Failure. 5th ed. American College of Physicians; 2007.

12. FDA. Pharmacokinetics in patients with impaired renal function—study design, data analysis, and impact on dosing and labeling.

September 2020. Accessed July 26, 2021. http://bit.ly/3otVxFa

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24 Operations & Management

Pharmacy Practice News • August 2021

Leadership in Action

The power of 7:

More on Measuring Leadership With the LeadRight Assessment Tool ‘How we think shows through in how we act. Attitudes are mirrors of the mind. They reflect thinking.’

—David Joseph Schwartz

I

n our last installment (bit.ly/3y0Eekr), we looked at measuring leadership using the LeadRight assessment tool from LionsLead (www.lionslead.com). In this installment, we will drill down a bit deeper to see how the LeadRight tool works in practice.

First, it is important to know that most assessment tools measure personality.

LeadRight, in contrast, identifies the most desirable behaviors of the best leaders. Then those behaviors are measured using statistically validated formulas. But it’s not just a bunch of math:

The goal is to build personal growth and character development through the assessment process, which in turn can have a profound influence on individuals, teams and entire enterprises.

Another major component of LeadRight is an emotional intelligence assessment. This “lens,” if you will, recognizes that effective self-leadership requires skills development, personal growth through revealed insights, and detection of blind spots to examine oneself and grow as a leader personally, then as a leader of others. All of these

skills can be assessed and honed with the LeadRight assessment tool.

The Assessment Report The LeadRight report consists of seven competencies and 27 attributes (Table 1). The scoring for each, on a scale of 1 to 10, is determined through completing 315 statements in the assessment tool.

The leader works with a LionsLeadcertified coach to review the assessment and develop an action plan for personal growth and transformation. The tool identifies three top strengths and three top challenges. Let’s look at a few example competencies and their attributes.

Table 1. The 7 Competencies and 27 Attributes Of the LeadRight Report Competencies

Attributes

Score

Self-leadership

Self-awareness

5

Manages emotions

3

Manages stress

1

Top challenge

Apprehension

10

Top challenge

Rationality

3

Leadership presence

4

Purpose-directed

8

Top strength

Boldness

2

Top challenge

Perseverance

5

Transparent

2

Strategic

6

Creativity

4

Achievement

5

Organized

6

Applies judgment

4

Team player

2

Builds trust

4

Attentiveness

5

Builds relationships

2

Empowers others

5

Reasoning

2

Analytical thinking

3

Vigilance

7

Leadership essentials

Getting things done

Leading others

Composure

Resilient

6

Tension

7

Candidness

Candidness

3

Personal values factor

Personal values

6

Comments

“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

the highest. The four quadrants can be likened to the following muscle analogy: Quadrant A: The muscle exists but is not used.

Quadrant B: There is inconsistent exercise—not regular.

Quadrant C: Muscles are exercised regularly.

Quadrant D: The conditioning level is high, but could be overtraining.

As can be seen in this example, the leader did not score in the desired sweet spot for any of the attributes.

What’s in a Score?

We can drill down even more to explore this leader’s score, as shown in Table 3. In this case, we are looking at self-awareness, where the leader scored a 5. Think of this as a results page, with guidance for the leader on what a score of 5 means in terms of behaviors to avoid, areas for improvement, and so forth. The coach works with the leader to deter-

Self-Leadership

Top strength

Top strength

Self-leadership measures the competency and skills required for leaders and managers to truly know and lead themselves. This self-knowledge is critical to developing the skills needed for building effective relationships and leading others. High-performing leaders/managers diligently sharpen their emotional intelligence to know and integrate their values and beliefs as a compass to help them monitor and manage their emotions. They practice integrity, and are persistent and continuously open to learning new ways to be effective.

The attributes listed under each of the several competencies individually and collectively frame patterns that set extraordinary leaders and managers apart from the rest.

An example of how the LeadRight assessment tool yields scores for each of the attributes within the seven competencies is shown in Table 2. There is a score represented by the star in one of four quadrants, with a possible score of 1 through 10 for each attribute. The yellow squares indicate the desired score range or “sweet spot” for each attribute.

Note that the desired score is not always

mine a plan to address which desired behaviors need work and which undesired behaviors are to be avoided. Review of the recommendations further helps to develop the transformation plan for this attribute.

This process is repeated for each attribute. An example of a low score being desirable is the Apprehension sweet spot in the 3, 4 and 5 range. This leader scored a 10 in Apprehension and was given the following feedback: “Leaders and managers who score in this range are often anxious and worried. They carry tension and stress from situations and relationships.

Your score tells us that you intensely pick up on and feel the strain and tension of other people and issues around you. You hold yourself overly responsible for these worries. Leaders and managers who practice wisdom

Operations & Management

Pharmacy Practice News • August 2021

25

Leadership in Action

Table 3. Self-Awareness: A Key Attributea

Table 2. Self-Leadership Attribute

Quadrant A

Quadrant B Quadrant C Quadrant D

✪ ✪

Apprehension Rationality

The ability to know one’s strengths and areas of improvement. Leaders possessing strong self-awareness understand their goals, values, beliefs, feelings, strengths and limitations. They use this information to guide decision making.

Why is it important?

An accurate knowledge and understanding of yourself as a leader or manager who wants to lead is the most important piece of self-leadership. Without this understanding, almost all of the other attributes lose value.

Desired behaviors

❏ Accurately understands personal abilities and

✪

Managing emotions Managing stress

What is it?

✪

Selfawareness

competencies

✪

❏ Understands what factors affect their performance ❏ Knows their values, goals and beliefs and uses them effectively to guide their decisions and actions

understand these tensions and strains as you do. However, they learn how to manage their reactions to avoid being overpowered by them.”

As an additional example, this leader scored a 3 in rationality, with the desired sweet spot being in the range of 6, 7 and 8. Rationality is a seldom understood attribute that leaders and managers use to process their emotions, decisions and reactions before they act and speak. Behaviors generally are considered desirable when they unfold in a logical, methodical, systematic and reflective manner. A score of 3 in quadrant A indicates a “quick trigger on emotional responses.” A score in quadrant B indicates “erratic/selective in contemplating timing of responses to initiate leadership.”

Quadrant C indicates “thinks through reactions/circumstances.” Quadrant D indicates “weighs circumstances before reacting.”

Leadership Essentials

Let’s take a look at leadership essentials—one of the seven competencies listed in Table 1—as another example of how the LeadRight assessment can offer insights into key leadership attributes.

Leaders who exert a positive influence over their employees often do so via diligent attention to a handful of key leadership strategies and behaviors. Such leaders typically possess presence and are self-directed, bold, persevering and transparent. Awareness and practice of these attributes will advance the leader’s skill and performance. Being open to feedback and use of the findings in this quadrant can push the leader to new levels of effectiveness. A sample result of the attributes in leadership essentials is shown in Table 4.

The same process to review the scores in each attribute and determine behavior modifications will help the leader in

❏ Takes time to think about important issues quietly

their personal transformation process in this competency.

and alone

❏ Strikes a balance between self-criticism and hopefulness

Getting Things Done

Execution is the discipline of getting things done. Extraordinary leaders understand that talking about and promising performance is empty unless it is achieved through proven, measurable results. Getting things done is driven by quality, action and decisiveness.

Behaviors to avoid

❏ Is uncertain or doubts their personal abilities and competencies

❏ Does not understand what factors affect their performance

❏ Forgets about their values and goals when making decisions

❏ Misunderstands their effect on others ❏ Struggles with self-criticism and negative attitudes

Leading Others

Extraordinary leaders and managers understand that before they can lead others effectively, they must first know and lead themselves. Finding ways to equip people to perform as a team is an art. The leader’s pallet for effectiveness is being a team player, building trust and practicing attentiveness to others. Highly effective leaders build and sustain relationships, and empower others to lead.

Composure

A much-overlooked factor in leadership effectiveness is the need for leaders to possess a challenging combination of attributes to truly excel. For example, exceptional leaders develop a compelling combination of intelligent reasoning and analytical thinking. They also are intentional in how they think and continuously sharpen their leadership skills. Effective leaders also are mindful that accepting and forgiving others along with remaining composed during tense situations are traits that people respect.

Candidness

Candidness is possessing a healthy and accurate view of oneself. Exceptional leaders are susceptible to wanting to be as accomplished as their peers, but stay true to who they are rather than projecting a false or desired image.

Personal Values

Possessing and intentionally living by personal values is critically

Your result:

5 a

Leaders and managers whose score lands in this range usually know and follow their beliefs, values and goals.

Being understood by others and understanding other people and situations sometimes challenges them. It can be hard for them to understand their own reactions and their effect on others. Picking up hidden undertones in situations also can be challenging.

This portion of the LeadRight assessment may include additional reflections and recommendations.

Table 4. Leadership Essentials Attribute

Quadrant A Quadrant B Quadrant C

✪

Leadership presence

✪

Purpose-directed Boldness

✪ ✪

Perseverance Transparent

Quadrant D

✪

important to exceptional leaders. They use those values as a compass to navigate through competing personal and leadership demands. Leader who can balance these demands often enjoy an incredible level of personal and profession success.

LionsLead is a powerful leadership measurement tool. A free sample “SelfAssessment” can be completed at LionsLead.com under “assessment portal.” ■

Next column, we will look at the impact of LionsLead on your team.

26 Operations & Management

Pharmacy Practice News • August 2021

Anticoagulation

Anticoagulation Clinic Focuses on Cancer Patients A

team of clinical pharmacists at Atrium Health, in North Carolina, has begun a specialized anticoagulation clinic to reduce the high risk for primary or recurrent venous thromboembolism (VTE) in patients with gastrointestinal, genitourinary and other types of cancer. In patients receiving outpatient chemotherapy, VTE is a leading cause of death (J Thromb Haemost 2007;5[3]:632-634).

So far, the program’s introduction has been smooth and underscores the power of a team approach to managing these high-risk patients, according to Kristyn DiSogra, PharmD, BCOP, a clinical pharmacist coordinator at Atrium Health Specialty Pharmacy Service.

Dr. DiSogra described the pharmacists’ collaboration and investigation that led to the establishment of the Coagulation and Cancer Clinic in a study presented at the American College of Clinical Pharmacy 2021 Virtual Poster Symposium.

The collaborative project included pharmacists from Atrium Health’s Specialty Pharmacy Service and Levine Cancer institute, both in Charlotte, N.C., and Atrium Health Chronic Care Medication Management in Concord, N.C. The project began with an evaluation of 40 cancer patients who were given a direct oral anticoagulant (DOAC). The team found no thrombotic events had occurred in the study group within six months of the DOAC’s start, and therapy was discontinued in only one patient.

They also looked at the use of anticoagulant prophylaxis in patients with the highest risk for VTE, including those with stomach, pancreatic, lung and bladder cancers, and lymphoma. They found that 55% of the patients were candidates for thromboprophylaxis, but only 2.5% had received the therapy.

The findings suggested that “clinicians may not be eager to start anticoagulants despite guideline support,” and “the broad consideration of DOACs and slow adoption of thromboprophylaxis in practice offers an opportunity for pharmacy services to support this patient population,” the team reported.

Dr. DiSogra explained how the collaborative process has been working in its earliest stage. The long-term goal is to expand it to additional sites within Atrium Health and develop a screening process to identify patients at highest risk for VTE and recommend appropriate DOAC thromboprophylaxis.

But for now, she said, the “collaboration has worked out seamlessly. Our clinical pharmacist colleagues screen for eligible consults in clinic (in addition to provider consults), and we have

Practice check

55% of patients were candidates for thromboprophylaxis, but only

2.5% had received the therapy.

‘We do a full medication review, checking not just for issues with their anticoagulant and oncolytic but their whole regimen to make sure it is safe and effective.’

—Kristyn DiSogra, PharmD been able to utilize the care model at the anticoagulation clinic in the building across the street from the [Levine Cancer Institute in Charlotte], making appointments around the times patients have hematology/oncology visits, if possible.” The aim, she added, is to reduce travel time to the clinic.

Dr. DiSogra added: “We utilize the current practices of our ambulatory colleagues for scheduling, follow-up and documentation, and they have graciously allowed us an office to use each Thursday to see our patients. The technicians and staff at the coagulation clinic help us with scheduling and billing.”

Preparation Is Key In an interview, Dr. DiSogra told Pharmacy Practice News that she and her partner in the Coagulation and Cancer Clinic, Justin Arnall, PharmD, BCOP, a hemophilia/hematology and oncology clinical specialist pharmacist, perform much of the preparatory work before patients arrive at the clinic. Their course of treatment often is highly complicated, she said. They may have drug–disease or drug–drug interactions, as well as organ dysfunction or more profound thrombocytopenia.

“We do a full medication review, checking not just for issues with their anticoagulant and oncolytic but their whole regimen to make sure it is safe

and effective,” Dr. DiSogra said. “For patients on a low-molecular weight heparin [LMWH] who need anti–factor Xa monitoring, we’ll have a lab drawn before they come to clinic.”

Drs. DiSogra and Arnall alternate shifts at the weekly clinic. "We'll talk to the patients about the plan for their anticoagulation,” Dr. DiSogra said. “For patients on a new DOAC or LMWH regimen, we do a full counseling session, including what to look for if there is an embolism and the need to call the doctor immediately if one develops. A lot of patients are elderly, so we counsel them on the risk for falls.” Once the appointment is over, the pharmacists make sure patients pick up their prescriptions, which have received prior financial approval.

Dr. DiSogra said they’re aiming to make sure their weekly clinic is just the beginning of the initiative. "There is definitely room for expansion,” she said. “With more clinic days, we could offer to see warfarin patients. Warfarin for us would be a third-line choice behind low-molecular-weight heparins and DOACs. However, there are circumstances when warfarin would need to be used. But with the INR [international normalized ratio] checks, we’d have to have more staffing.”

She added that the poster results represented only the first step in a longer

objective of expanding the service and publishing patient outcomes.

‘A Great New Initiative’ Lisa Holle, PharmD, BCOP, an associate clinic professor at the University of Connecticut School of Pharmacy, in Storrs, said the Coagulation and Cancer Clinic was “a great new initiative” that the specialty pharmacists at Atrium Health are providing. “There is a lot you need to consider when you’re managing patients with cancer who need direct oral anticoagulants, including the increased potential for drug interactions that can sometimes be missed if a patient is getting prescriptions from multiple pharmacies,” said Dr. Holle, who is a member of the editorial advisory board of Pharmacy Practice News.

She added: “Having a pharmacist look at all of that information and assess appropriateness, as well as evaluate changes in kidney and liver function that need to be considered in dosing decisions, can be really beneficial.”

Identifying cancer patients who may benefit from thromboprophylaxis is another important function that pharmacists can provide, added Dr. Holle, whose clinical practice site at the UConn Health Neag Comprehensive Cancer Center, in Farmington, Conn., treats many patients who are on anticoagulation, including DOACs. Cindy O’Bryant, PharmD, BCOP, a professor at the University of Colorado School of Pharmacy and Pharmaceutical Sciences, in Aurora, who is also a member of the editorial advisory board of Pharmacy Practice News, noted that “for decades, pharmacist-led anticoagulation management has resulted in improved outcomes. This cancer-specific coagulation clinic is an interesting twist on something pharmacists do very well.”

Dr. O’Bryant said “the utilization of hematology/oncology pharmacists in this setting allows for better integration of coagulation therapy with a patient’s anticancer therapy, enhances monitoring and streamlines communication for patients with cancer-related VTE. It will be important for this group to report long-term outcomes for their patients, especially as they expand into thromboprophylaxis management. Results related to the impact of an oncology pharmacy intervention in this patient population can pave the way for other cancer centers across the country to develop similar pharmacistdriven clinics.”

—Bruce Buckley Drs. DiSogra and Holle reported no relevant financial disclosures. Dr. O'Bryant reported research funding from Pfizer.

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28 Policy

Pharmacy Practice News • August 2021

Reimbursement

Tapping Into NTAP Funds continued from page 1

Gainesville, at the 2021 MAD-ID (Making a Difference in Infectious Disease) virtual annual meeting.

NTAP’s goal is to provide temporary additional reimbursement for new drugs or devices that demonstrate substantial improvement over existing technologies, but whose costs exceed the standard diagnosis-related group (DRG) amount allotted to a single episode of hospital-based care for Medicare and Medicaid patients. To qualify, a technology must exceed the DRG payment; must be “new” (a designation that lasts until claims data reflecting the use of that technology become available) and not “substantially similar” to existing technologies; and must significantly improve clinical outcomes compared with available treatments.

5 Barriers To NTAP Success Can be burdensome to set up in an electronic health record.

Reimbursement goes back into a “positive account” for payments and does not tie back to drug budget or antibiotic expenditure.

Many NTAP antibiotics are not included in treatment guidelines, which precludes adoption.

Susceptibility testing may not be readily available.

Hospitals with long, drawnout formulary review processes may miss out.

Because most antibiotics are approved by the FDA based on noninferiority trials, that requirement for substantial improvement has proven difficult to meet, Dr. DeSear explained, and few antibiotics qualified for NTAP during the first two decades of the program, which was created by Congress in 2000. The three exceptions were fidaxomicin (Dificid, Merck), meropenem-vaborbactam (Vabomere, Melinta Therapeutics), and plazomicin (Zemdri, Cipla Therapeutics).

“Indeed, half of previous antibiotic applications for NTAPs have been rejected because of a failure to satisfy [the substantial improvement] criterion,” wrote then-CMS administrator Seema Verma, MD, in the Health Affairs blog in August 2019, announcing the changes. She also noted that Medicare beneficiaries account for most of both

new antimicrobial resistance cases and fatalities in the United States.

To ease some of those rejections, the Fiscal Year 2020 Inpatient Prospective Payment System (IPPS) Final Rule included an “alternative pathway” for antibiotics that does not contain the requirement for substantial clinical improvement, and raises the additional reimbursement level from 50% to 75% for all new antibiotics that have been designated as Qualified Infectious Disease Products by the FDA. The IPPS tweak was CMS’s attempt to give clinicians access to “a new antibiotic quickly before resistance develops,” said pharmacy consultant Bonnie Kirschenbaum, BSc, MS, a member of the Pharmacy Practice News editorial board, in a separate interview.

Dr. DeSear provided a list of six antibiotics that qualify for NTAP payments in 2021 and their current maximum payments (Table). The payments last no longer than three years; meropenemvaborbactam’s NTAP period expired in 2020. (For more information, read Ms. Kirschenbaum’s “Reimbursement Matters” November 2020 column at bit.ly/3xvMqch; it provides a more comprehensive list.)

A Ticking Clock When does the three-year window open and close for a new antimicrobial?

“The clock starts ticking when the FDA gives approval and CMS classifies the drug as an NTAP,” Ms. Kirschenbaum explained. “So, if your hospital has a long, drawn-out process for formulary review, that can eat up at least one of those three years pretty easily. If you want to take advantage of NTAP and appreciate that the new technology may bring you some benefits, you need to act quickly.”

Dr. DeSear agreed, urging infectious disease pharmacists to press their hospitals to prepare to seek NTAP payments for new antimicrobials immediately, instead of waiting until they need to use the medication. “Contact patient financial services and revenue integrity, IT and electronic health record [EHR] experts, coders and your chargemaster analyst now and start the conversation,” she said. “You can also contact your medical science liaisons or sales representatives for help. They want to assist.

You can also appeal to leadership by piggybacking onto other, more expensive medications, like oncologics.”

There are some barriers to using NTAP, Dr. DeSear acknowledged. “It can be burdensome to set up in your electronic health record; the reimbursement goes back into a ‘positive account’ for payments and does not tie back to

Table. 6 NTAPs to Target Antibiotic

Reimbursement, $

1. Ceftolozane-tazobactam (Zerbaxa, Merck)

1,836

2. Cefiderocol (Fetroja, Shionogi)

7,919

3. Imipenem-cilastatin-relebactam (Recarbrio, Merck)

3,532

4. Omadacycline (Nuzyra, Paratek)

1,552

5. Plazomicin (Zemdri, Cipla Therapeutics)

4,883

6. Lefamulin (Xenleta, Nabriva Therapeutics)

1,275

NTAP, new technology add-on payment

Source: Kate DeSear, PharmD, BCPS.

‘Contact patient financial services and revenue integrity, IT and electronic health record [EHR] experts, coders and your chargemaster analyst now and start the [NTAP] conversation.’

—Kate DeSear, PharmD drug budget or antibiotic expenditure; many of these agents are not in the ‘guidelines,’ precluding adoption; and susceptibility testing may not be readily available. But these additional payments are worth it and allow us to use these new agents in a more effective way.”

She also recommended working with a data analyst to capture NTAP payments and show cost offsets. “Make sure expenditure reporting includes an asterisk denoting NTAP products in the months they were eligible.”

Although hospital revenue cycle staff are quite accustomed to the “passthrough” payment system of billing individual line items for certain outpatient medications as part of the hospital Outpatient Prospective Payment System— SI (status indicator) G Pass-through drugs are the outpatient equivalent of NTAP—they are less likely to be familiar with NTAP and aware that a few drugs are separately billable outside the DRG for inpatients, Ms. Kirschenbaum said.

“So, if they don’t follow the exact protocol that CMS has laid out for those NTAP

drugs, you’re not going to get any payments. For example, CMS makes crystal clear the ICD-10 [International Classification of Diseases, Tenth Revision] codes under which a drug qualifies for NTAP payments. If you don’t bill under those codes, you won’t get the NTAP payment.

So, if your billing is contracted to an outside service, do you know if they can handle something out of the ordinary like separately billable NTAP charges? Do your prescribing physicians know what documentation needs to be in the EHR to ensure that your revenue cycle people know that this specific ICD-10 code is the one to be listed on the bill?

“Immunology and hematology/oncology are very used to dealing with NTAPs,” Ms. Kirschenbaum noted. “But infectious disease is less familiar with this, so it’s a good idea to get yourself a crash course in the process so that you can make the most of what’s available to you.”

—Gina Shaw The sources reported no relevant financial disclosures.

Policy

Pharmacy Practice News • August 2021

29

Reimbursement Matters

Conquering Terminology: An Essential Component of Reimbursement “Reimbursement Matters” is a tool for maintaining your health system’s fiscal health.

Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered.

methodology to the ASP calculation, if deemed appropriate. The Medicare payment amount for the drug or biological billing code would be the lesser of: • the payment limit determined using the current ASP+6% methodology, or • the ASP+6% amount obtained by excluding the self-administered products identified in an OIG study.

Table 1. A Look at “Lesser of” Payment Method HCPCS Code

Short Description

HCPCS Code Dosage

Payment Limit

Notes

J0129

Abatacept injection

10 MG

45.323

"Lesser of" methodology applied

J0717

Certolizumab pegol inj 1mg

1 MG

6.523

"Lesser of" methodology applied

CMS will apply the lesser-of methodology to the payment limit calculations for billing and payment codes representing certolizumab pegol (J0717) and

abatacept (J0129). The changes are in the July 2021 ASP Drug Pricing Files (go.cms. gov/3r783NS), including the July 2021 see TERMINOLOGY, page 30

Bonnie Kirschenbaum, MS, FASHP, FCSHP

W

hether you’re a new graduate just entering your first professional position, a resident branching out into expanded areas of responsibility, or a seasoned practitioner coping with a flood of pandemic-related practice changes, understanding your role in reimbursement is essential for financial survival. Reimbursement is everyone’s responsibility; it doesn’t just belong to the revenue cycle department.

This month’s column introduces several new payment policy changes, which we will use to illustrate some terms that may not be familiar to you.

The column also provides references to add to your e-library—your “go to” site to search out answers.

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Payment Methodology Changes (from MLN Matters: MM12244 Related CR 12244) This significant change took effect July 1, and stems from Section 405 of the Consolidated Appropriations Act, 2021, which requires the HHS OIG to conduct periodic studies on certain selfadministered drugs or biologicals that are paid under the statutory payment limit. These rules allow for a “lesser of”

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30 Policy

Pharmacy Practice News • August 2021

Reimbursement Matters

TERMINOLOGY continued from page 29

ASP NDC-HCPCS Crosswalk. For any drug or biological that isn’t listed in the ASP or NOC drug pricing files, your MAC will determine the payment allowance limits and any that you bill with the KD modifier (durable medical equipment).

For more information, visit CMS’s MLN Matters: MM12244 Related CR 12244 at go.cms.gov/3hBHRYy. Speaking of MLN Matters, are you on the distribution list for these free critical updates, so you can learn about the latest changes affecting reimbursement? Or are you waiting for someone on your revenue cycle team or in the finance department to forward these essential documents to you? MLN Matters articles explain all key national Medicare policies in an easy-to-understand format. They focus on coverage, billing and payment rules for specific provider types. The articles

routes of administration (Table 2). Here are a few more details to consider: Not covered under Part B. Drugs that are usually self-administered by the patient, such as oral dosage forms or are used by self-injection, are generally not covered by Part B. However, there are a limited number of self-administered drugs that are covered because the Medicare statute explicitly provides coverage.

Examples of these include blood clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients and osteoporosis drugs for certain homebound patients.

Proper coding is essential! No selfinjected medication, although covered, will be paid for without the proper coding. So, I urge you to access an extensive 17-page article replete with many charts listing drugs and biologicals with the appropriate coding instructions. This publication also addresses many other significant issues that often plague

Table 2. New Route of Administration Modifiers Modifier JA

Modifier JB

• Administered iv infusion

• Administered SC or IM

• MLN Matters charts clarified which: – IV drug administration codes apply – drugs are affected – HCPCS codes are affected

• MLN Matters charts charts clarified: – drugs and HCPCS codes affected – which drugs cannot be billed with a chemotherapy administration code – CPT code 96372 mandated for drug administration

are prepared with assistance from clinicians, billing experts and CMS subject matter experts. It’s easy! Follow up! To access the MLN Matters home page, visit go.cms.gov/3i3vEKV.

Quarterly ASP Pricing Files Do you make use of the quarterly ASP Pricing Files? These easy-to-use Excel files are published in three formats: ASP Pricing File, NOC Pricing File and ASP NDC HCPCS Crosswalk, with major changes and newly added products highlighted. This is a heads-up to immediately replace any miscellaneous HCPCS codes you may be using for these products with the specific codes—a critical step, because miscellaneous codes are rejected once specific codes are assigned. As noted above, for the ASP Drug Pricing Files July 2021 Update, visit go.cms.gov/3r783NS.

Serving managed care health-system and specialty pharmacy decision makers Brought to you by the same team who publish

New Route of Administration Modifiers Let’s take a look at an important aspect of hospital outpatient billing for injectable medications—specifically, billing involving self-administered drug policies that some MACs have chosen to invoke. These policies apply to medications that have one J code for multiple

pharmacy, such as waste billing and the relationship between drugs and CPT drug administration codes. To access the document, “Local Coverage Article: Billing and Coding: Complex Drug Administration Coding (A58544),” visit go.cms.gov/3r6bGnd.

Transparency in Pricing The mandatory CMS transparency rule, effective Jan. 1, 2021, has among its primary requirements for hospitals, the display of machine-readable discounted cash prices and payor-negotiated rates, as well as a consumer-friendly tool for searching and viewing the prices of 300 shoppable medical services.

A recent JAMA report (JAMA Intern Med 2021 Jun 14. doi:10.1001/jamainternmed.2021.2531; bit.ly/2VzWhzL) showed that up to 80 of 100 surveyed facilities were inconsistent or noncompliant with at least one of the requirements. CMS has sent out warnings to hospitals failing on price transparency.

The data are pulled from the CDM, which in many cases required a redo to unencumber it from years of bloated duplications with multiple inaccuracies and listings for the same products. Have you done your part to correct and update the pharmacy CDM? Is IT on it?

■

Technology

Pharmacy Practice News • August 2021

31

Finance During COVID-19:

Teamwork, Digital Tools Keep PAPs on Track B

eing flexible, embracing technology and making more coordinated efforts to service providers and patients are all lessons that drug manufacturers and patient assistance programs (PAPs) can take from the COVID-19 pandemic, according to a panel of experts at Informa’s PAP Critical Update 2021 virtual event.

Despite it being a difficult year, there were some positive notes to draw from, said Tommy Bramley, PhD, the president of the Lash Group, a patient support services division of AmerisourceBergen, during a discussion about forging a better path for patients in the wake of a pandemic. Lash Group and others adapted quickly to meet the demands of the COVID-19 crisis in different ways, including working with manufacturers and health care providers to ensure patients received uninterrupted access to their medications.

Remote Teams Ready Xcenda, a consulting and field reimbursement services company that is also part of AmerisourceBergen, already had remote field teams in place that it quickly leveraged to ensure the company was offering engaging services to its providers, said Katie Wilson, the vice president of innovative field solutions. When the pandemic hit, staff had to rapidly determine how best to showcase their program materials and make them available digitally, as well as train employees about having meaningful communications with providers virtually and using web conferencing technology.

“We leveraged our existing provider relationships, and that turned out to be instrumental as the pandemic continued,” Ms. Wilson said. “As [physician] offices figured out how they would see patients and how to use telemedicine, we were able to meet them where they were, give them what they needed and have meaningful interactions.”

With a significant decrease in patients visiting provider offices and job uncertainty amid a spike in unemployment rates, Lash Group worked with manufacturers to identify what they needed for their specific patient populations to ensure the most vulnerable patients would receive care, said Todd Wells, the vice president of operations. They developed multiple contingency plans for how to support patients in a variety of different scenarios, working with manufacturer partners. “Thankfully we didn’t have to implement those extreme contingencies, but we were certainly ready,” he said.

“While we all hope to never experience another pandemic, the experience

showcased a collective ability to embrace virtual interactions and automation,” Mr. Wells said.

“We’ve seen the adoption of a virtual patient portal we launched continue to increase, as well as the use of virtual injection training services,” he added. Manufacturers also were open to accelerating technology to optimize the patient experience.

“I don’t see us going backward,” Mr. Wells said. “In fact, we will continue to automate every step we can to allow our ... counselors to focus on the most complex cases and direct patient contact.”

10 Steps to Ensure PAP Success 1. Leverage existing provider relationships

6. Be flexible 7. See what partners are doing

2. Take a close look at hurdles

Taking a Deeper Dive

3. Close the knowledge gap

8. Give policymakers patient-centric ideas

There’s been a lot of movement from manufacturers and PAP administrators to take a much closer look at the effects of the economy on patients and providers using these program, noted Dale Hanna, the director of product management at Lash Group. One hurdle has been the affordability of treatment, and some of the associated inequities that “really came to light” during the pandemic, Mr. Hanna said.

“A lot of patients actually dropped off treatment,” he added. “As a society, we’re actually going to see a much longer-term impact to overall patient health because of that.”

Many providers and patients are not aware of PAPs, including those offering copay assistance to help overcome financial barriers. This knowledge gap presents an opportunity for manufacturers to build better awareness, Mr. Hanna said. His division has been helping its manufacturer clients look at their flexibility. As just one example, he noted, payors and manufacturers can work together to change thresholds for patient eligibility. Manufacturers also can simplify processes for their providers and patients, perhaps allowing patients to self-manage their own assistance and benefits online or helping providers enroll patients without needing a lot of clicks outside of electronic health records, Mr. Hanna noted.

The presenters cited several additional steps for ensuring PAP success: • Understand the patients and their therapy services, including social and economic barriers to care.

• Use predictive analytics to see where falloff occurs and intervene.

• Be flexible with program design.

• Look to partners to see what’s going on at a broader level.

• Be a part of the solution as it relates to health care policy.

• Approach policymakers with construc-

4. Understand patients and their needs

9. Embrace innovation

5. Use predictive analytics

10. No entity is an island

tive ideas that are patient-centric.

• Embrace innovation, whether digital technologies, automation or other ideas.

• Lean on partnerships. As Mr. Wells noted, “A great business partner has

the benefit of seeing what’s working across the board and can bring those ideas to you.”

—Karen Blum The speakers reported no relevant financial disclosures other than stated employment.

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ASHP Releases Inaugural Survey of Health-System SP H

ealth-system specialty pharmacies (HSSPs) employ a practice model that exceeds industry standards, thanks in part to integration with specialty clinics and providers and access to the electronic health record. The top challenge facing HSSPs is access to payor networks, which limits the health system’s ability to deliver an exceptional level of service and coordinated care to all health-system patients.

Those are several of the key findings from ASHP’s inaugural National Survey of Health-System Specialty Pharmacy Practice, presented at the 2021 virtual ASHP Specialty Pharmacy Conference.

Surveys were sent to 230 contacts at 206 different health systems with known specialty pharmacies, and 114 unique organizations completed the survey, for a 53% response rate. The survey included 99 questions over eight domains, including demographics, workforce issues, operations and payor access, among others.

Most HSSPs dispense fewer than 45,000 specialty prescriptions per year and have an annual gross revenue of less than $100 million, the survey found. Most of these specialty pharmacies are relatively new, with 73.8% of survey respondents saying their organization has offered specialty pharmacy services for six years or less. “We also learned from this survey that HSSPs are primarily regional in their PRODUCT NEWS

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approach,” said Craig Pedersen, PhD, RPh, pharmacy manager at Virginia Mason Medical Center, in Washington state, who conducted survey development and analysis. “The majority have five state licenses or fewer; slightly over one-third only have one, although some have many— even up to 50 if they want to serve all 50 states. But most are like my health system: We are located in Washington and have licensees in Alaska, Arizona, California and Oregon. But we’re not reaching into the Midwest or the East because those aren’t patients our medical center serves.”

Some of the survey’s other takeaways: Integration. The HSSP practice model is integrated into specialty clinics, with 64.9% of respondents reporting that they have HSSP pharmacists dedicated to spe specific clinics and involved ved in treatment decisions and drug therapy erapy selection prior to prescriptions being written. “This finding is consistent across specialty pharmaharmacies regardless of size,” ze,” said JoAnn Stubbings, BSPharm, the former associate director off specialty pharmacy att the University of IllinoisisChicago College of Pharmacy, armacy, who served on the advisory isory committee for the development of th the survey. “Thi “This upstream involvement of HSSPs allows for appropriate drug selection before PA [prior authorization] is submitted, as well as management of safety parameters, leading to faster medication access and better patient outcomes.”

Pharmacy versus medical benefit.

The HSSP business model is focused on self-administered (96.2%) and clinicadministered medications (80.2%) under the pharmacy benefit. Only a small number of HSSPs provide self-administered medications (31.1%) or clinic-administered medications (22.6%) under the medical benefit. “What I’ve seen in most health systems is that the medical benefit is typically managed by another area of the pharmacy enterprise, but that is changing,” said Ms. Stubbings, a member of the Pharmacy Practice News editorial advisory board. “There is significant overlap, and we are starting to see HSSPs building infusion suites and enter home infusion, and this is becoming increasingly important. We hope to identify these trends in a future survey.”

Access still a challenge. Only 37.7% of respondents reported gaining access to limited distribution drugs; 82.1% cited “manufacturer refusal to engage” as a major roadblock, and 71.7% said they were “frozen out or blocked by payors.”

Inflammatory conditions No. 1. The most common therapeutic categories served were inflammatory conditions and

hematology/oncology (both 92.4%), hepatology/hepatitis C (85.7%), neurology/ multiple sclerosis (78.1%) and infectious disease/HIV (70.5%). More than half of all respondents indicated that their HSSPs also provided care in cardiology, endocrinology, cystic fibrosis, respiratory/pulmonary arterial hypertension and solid-organ transplant, and 90% said they offer PA support.

340B, shrinking reimbursements among other challenges. HSSPs see

domains, including specialty pharmacy practice model and performance; patient care services and access; workforce competency, credentials and culture; and safety, quality, outcomes and value, among others. More details on the recommendations will be published in a fall issue of the American Journal of Health-System Pharmacy.

Udobi Campbell, PharmD, MBA, the regional executive director of pharmacy at UNC Health, in Chapel Hill, N.C., and

Defining Specialty Pharmacy

D

efining specialty pharmacy has been an elusive goal, with several organizations taking a stab at it during their conferences and committee meetings. Now, ASHP has its own working definition, based partly on feedback gained from the g group’s inaugural National Survey of Health-System Specialty Pharmacy Practice: “The health-system specialty pharmacy is an integ grated, advanced practice model of care that incorp porates specialty medication use management across tthe continuum of care.”

JoAnn Stubbings, BSPharm, who served on the a advisory committee for the development of the surve vey, added some further guidance: “We intend for you to use this definition in describ“W and justifying our model as leaders in this movement. ing an have a powerful story to tell, and we are in the position We hav to define specialty pharmacy and not be defined by payors or accrediting organizations.”

access to payor networks (82.9%), 340B Drug Pricing Program changes (42.9%) and shrinking reimbursement from payors (40%) as their top challenges, with new populations to serve and new therapeutic categories rated as leading opportunities for growth.

“HSSPs are responding to these challenges by exploring new payment methods, new models such as value-based care, and further integration of services,” Ms. Stubbings said. “Overall, I am optimistic about [trends] that could positively impact our model. Some are legislative, some market-based, some based on our advocacy. Provider status is one change that is getting closer at the state and federal level, and could offer new opportunities for clinic-based pharmacists to be recognized and bill for their services.

Some states are banning white bagging, and we are also seeing legislation proposed at federal level on DIR [direct and indirect remuneration] reform.”

Ascending the Summit During a Town Hall and Networking Session that followed the release of the survey results, ASHP shared highlights from the February 2021 ASHP Specialty Pharmacy Future Directions summit. One key accomplishment of the summit was the preparation of 71 consensus recommendations. The recommendations covered 13 practice

the chair of the Summit Steering Committee, kicked off the town hall with some observations on why the summit is such a timely and important initiative.

She cited market forces as one powerful driver: Spending in the United States on specialty medications is projected to exceed 50% of overall drug expenditures in 2021, she noted. Vertical integration and the aforementioned increasing adoption of limited drug distribution models for specialty drugs are other factors that are making it difficult for health systems to stay on the specialty pharmacy sidelines, she noted.

“Probably just like me,” Dr. Campbell told attendees, “you have to make the case with your leadership every month that if we bury our heads in the sand, [these market forces] all threaten our very existence in the specialty pharmacy space.”

Fortunately, many health-system pharmacies have been responding proactively, she stressed. Indeed, 70% of multi-hospital health systems launched specialty pharmacy services between 2012 and 2017, she noted. Moreover, the prevalence of specialty pharmacy operations in hospitals grew from 7.8% in 2015 and 8.7% in 2016 to 19.9% in 2018 and 26.4% in 2019.

—Gina Shaw and David Bronstein The sources reported no relevant financial disclosures.

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Corporate Profiles 2021–2022

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Accelerate Diagnostics, Inc. Proven Clinical Benefits to Drive Better Stewardship Fast minimum inhibitory concentration (MIC)-based susceptibilities from the Accelerate Pheno® system help improve the stewardship and clinical metrics that count—for patients who need rapid results.

Hospitals nationwide face interrelated challenges in the care of patients with bloodstream infections. Downward reimbursement pressures, the increasing incidence of antimicrobial-resistant infections necessitating costly isolation procedures and delays in actionable diagnostic results limit options for patient treatment.

Forward-thinking stewardship teams seek solutions that can reduce antibiotic use and hospital length of stay, improve patient experience, reduce the per capita cost of care and improve the health of populations in the communities they serve.

Multiple studies show antimicrobial susceptibility test (AST) results from the Accelerate Pheno system are available in about

AT A GLANCE

seven hours direct from positive blood cultures.

These faster results help clinicians optimize 3950 S Country Club Rd, 4th Floor antimicrobial therapy as much as 24 hours fastTucson, AZ 85718 er than existing methods. See the tables below (520) 777-2366 for data from published studies.

Email: fastanswers@axdx.com Now the Accelerate PhenoTest® BC kit comes Website: axdx.com in two configurations—AST with or without ID—to complement your laboratory and clinical workflow. Laboratories with existing rapid molecular or MALDI ID platforms can now get fast, MIC-based susceptibility results in about seven hours to support cascade reporting for their bacteremic patients.

For options, pricing and more information, visit us at axdx.com/ stewardship.

Clinical Endpoints for Bacteremic Patients Before And After Adoption of the Accelerate PhenoTest BC Kit Time to Results—AST With MICs Pre/Post: median in hours

Pre

Post

Delta

P Value

IOAS (multicenter study)

39.7

7.9

-31.8

<0.0001

Allegheny General Hospital (non-ICU)

46.1

6.9

-39.2

<0.001

Allegheny General Hospital (ICU)

49.4

6.6

-42.5

<0.001

St. Jude Children’s Research Hospital

46.5

6.9

-42.5

<0.0001

Time to Optimal Therapy (TTOT) Pre/Post: median in hours

Pre

Post

Delta

P Value

IOAS (multicenter study)

40.9

23.2

-17.7

<0.0001

Allegheny General Hospital (Non-ICU)

32.6

10.5

-22.1

<0.001

University of Arkansas for Medical Sciences

57.6

31.2

-26.4

<0.001

What Accelerate Pheno Users Are Saying

Days of Broad-Spectrum Therapy Pre/Post: median in days

Peninsula Regional Medical Center

Pre

Post

Delta

P Value

3

1

-2

<0.0001

Duration of Therapy Pre/Post: median in days

Pre

Pre

Post

Delta

P Value

Allegheny General Hospital (Non-ICU)

14.2

9.5

-4.7

<0.001

Allegheny General Hospital (ICU)

14.8

10.1

-4.7

<0.001

Length of Stay Pre/Post: median in days

Pre

Post

Delta

P Value

Peninsula Regional Medical Center

8

6

-2

0.002

University of Arkansas for Medical Sciences

8.1

“We’re doing the right thing for patients. We’re taking a guess for a smaller, shorter period of time for these bacteremic patients. And then we get them on optimal therapy much sooner.”

—Scott Morrissey, PharmD, Infectious Disease Pharmacist and Co-head of the Antimicrobial Stewardship Team, ArnotHealth “The attending physicians really appreciated how valuable this tool would be. They appreciated the fact that we would get their patients on the appropriate therapy sooner; that we would do less harm to their patients. All-in-all, it’s better for the patients.”

—Shandurai Takavarasha, MD, Infectious Diseases Physician and Co-head of Antimicrobial Stewardship Team, Arnot Ogden Medical Center, Elmira, N.Y. “When we were able to bring the Accelerate Pheno into the laboratory and make things happen as quickly as we did, we started to really see the difference we were making in patients’ lives. Not only did we identify faster, but [clinicians] were treating differently. When we finally sat down and looked at the first patients to see if we were making a difference, we realized that this was a game changer.”

—Kelly Stefano, PhD, Laboratory Director, Allegheny Health Network

6.3

-1.8

<0.001

See complete data for these studies and others at results axdx.com.

For options, pricing and more information, visit us at axdx.com/stewardship.

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Corporate Profiles 2021–2022

Acute Care Pharmaceuticals The nation’s leader in USP <797> and <800> compliant supplies specifically designed for your advanced health care environment

AT A GLANCE 12195 Dearborn Place Poway, CA 92064 Phone: (888) 909-7700 Fax: (858) 675-9380 Info@acutecareonline.com www.Pharma-Choice.com

Acute Care Pharmaceuticals has been servicing the health care industry for more than 20 years, delivering exceptional products and service to health care providers nationwide. We offer a wide range of USP Chapter <797> and <800> compliant disposPRODUCT LINE able products that are manufactured under • Pharma-Choice™ Brand the highest standards. With numerous group • Full line of USP <797> and <800> purchasing organization (GPO) and integratCompliant Supplies ed delivery network (IDN) contracts, our goal is to make your buying experience simple and easy. Our Pharma-Choice™ brand of products is stocked at AmerisourceBergen, Cardinal, McKesson and Medline, where you can receive your special discounted GPO contract pricing.

• PHARMA-GLOVE CR™ Nitrile 12” Glove, Chemo Approved • Pharma-Choice™ Isolation Gown, Polypropylene, Knit Cuffs, Waist/Neck Ties, Yellow, Level 1 • Pharma-Choice™ Isolation Gown, Polypropylene/PE Laminated, Knit Cuffs, Waist/Neck Ties, Blue, Level 2 • Pharma-Choice™ Isolation Gown, Polypropylene, Knit Cuffs,

Stay tuned for more information about Acute Care Pharmaceuticals’ integration into Hospeco Brands Group. Customers will have an expanded breadth of lines in the Hospeco Signature Bundle of essential products.

Product Overview Improve facility operations with Acute Care Pharmaceuticals’ Pharma-Choice brand of products. The quality manufacturing of our Pharma-Choice brand of cleanroom disposables demonstrates our commitment to the continued success of USP <797> and <800>. All wipers are manufactured to meet International Organization for Standardization Class 5 and USP <161> endotoxin limits for medical devices of 0.06 EU/mL. Our sterile alcohol is manufactured with USP-grade water for injection and is available in various sizes.

From the inception of USP <797>, we have been a trusted provider for the majority of hospitals nationwide in cleanroom disposables. Our constantly expanding USP <797> product line includes sterile alcohol, non-linting wipers, disinfectants, media test kits, gloves, apparel and more.

We have taken the same approach to USP <800> with our comprehensive line of products developed with you in mind, because your safety and the safety of your employees matter. Our USP <800> products include chemo gowns, chemo gloves, goggles, respiratory masks, sterile apparel, chemo spill mats and a two-step neutralizing kit.

PHARMA-CHOICE BRAND OF PRODUCTS INCLUDES: • PHARMA-SAT PLUS™ 70% IPA Polyester/Cellulose Low Endotoxin (Sterile and Non-Sterile) • PHARMA-SAT CANISTER™ 70% IPA Non-Sterile Polyester/ Cellulose • PHARMA-SAT PLUS™ 70% IPA, Poly/Cell, Low Endotoxin • PHARMA-WIPE™ Polyester/Cellulose (Sterile and Non-Sterile) • PHARMA-WIPE PLUS™ Non-Sterile Polyester/Cellulose, Low Endotoxin • PHARMA-POLYESTER WIPE™ 100% Polyester • PHARMA-HOL™ Sterile 70/30 Isopropanol/USP WFI (16 oz, 32 oz and gallons) • PHARMA-D SURFACE DISINFECTANT™ Sterile Quat, Virucide, Fungicide • PHARMA-SURFACE GUARD™ Chemo Spill Wiper + Neutralizing Wiper, 2-Step Kit • PHARMA-MOP COVERS™ Polyester Universal Mopping System • PHARMA-MINI MOP COVERS™ Polyester and Poly/Cell • PHARMA-SAT MOP COVERS™ 70% IPA/30% DI Pre-Saturated Poly Covers • PHARMA-TACKY MAT + FRAME™ Mat removes up to 99% of footborne contaminants • PHARMA-CHEMO MAT™ Sterile Non-Linting, Absorbent Mat with Impervious Poly Backing • PHARMA-GLOVE™ Sterile Nitrile 12”, Chemo Approved-ASTM Tested, PF

Corporate Profiles 2021–2022

Waist/Neck Ties, Yellow, Level 1 • Pharma-Choice™ Isolation Gown, Polypropylene/PE Laminated, Knit Cuffs, Waist/Neck Ties, Blue, Level 2 • PHARMA-COAT™ Lab Coat Polypropylene Elastic Wrist, No Pockets, White • PHARMA-COAT KNIT WRIST™ Lab Coat Polypropylene Knit Wrists, No Pockets, White • PHARMA-CAP™ Polypropylene Bouffant Cap, White or Blue • PHARMA-SHOE COVERS™ Polypropylene Anti-Skid, Blue

GPO/IDN CONTRACTS • • • • • • • • • • • •

Amerinet/Intalere APCI Ascension (The Resource Group) Asembia AvMedical Fairview Pharmacy Services GeriMed HealthTrust (HPG) MHA Northside Hospital System Premier Vizient

MARKETS SERVED • • • • • • • • •

Hospital/Acute Home infusion Surgery centers Clinic Retail Long-term care Veterinary Pharmacies Oncology If you want quality products and customer service you can count on, call us today at (888) 909-7700 or email us at info@acutecareonline.com for more information.

Special Advertising Section Pharmacy Practice News

American Health Packaging Offering a Broad Portfolio of Barcoded Unit-Dose Products With a responsive line of barcoded unit-dose oral solutions, a growing liquid unit-dose offering and individually wrapped inhalants, American Health Packaging (AHP) continues to deliver on its commitment to supporting pharmacy efficiency.

Company Background Located in Columbus, Ohio, American Health Packaging (AHP) is an industry leader in manufacturing serialized, barcoded unit-dose (UD) medications provided for the health care marketplace. As a UD manufacturer, AHP’s commercially available UD products are available to hospital, institutional and long-term care pharmacies nationwide through partner GPOs and wholesalers.

AHP’s reputation for quality is supported by a 30-plus–year history of broad manufacturing expertise—operating a facility that is registered with the FDA, fully adherent to current good manufacturing practices guidelines, and licensed by the Drug Enforcement Administration to package Schedule II to V controlled substances. Synonymous with unit dose, following years of success and leadership in the production of oral solids, AHP expanded its offering in 2017 to include liquid UD cups and inhalants in 2019.

AT A GLANCE

Benefits for Health Systems

2550 John Glenn Avenue, Suite A Columbus, OH 43217 (800) 700-4621 customersupport@ americanhealthpackaging.com www.americanhealthpackaging.com

Patient Safety

Ensuring the right medication is given to the right patient at the right time, and in the right strength, is imperative. Pharmacies can facilitate effective execution of these “rights” by providing caregivers with as many products in a prepackaged UD format as possible. Removing repackaging tasks from the pharmacy eliminates a potential point of failure during the UD process as medications arrive to pharmacies ready to dispense.

Pharmacy Efficiency Pharmacies strive to process orders and supply the proper medications to caregivers for their patients as quickly as possible. Adding potentially complex repackaging steps to the procurement process not only harms the ability of pharmacy to supply caregivers effectively, but also removes clinicians from their core patient care competencies. In addition, prepackaged UD often allows for products to be sourced more quickly than third-party repackaging can support.

Cost-Savings Opportunity

Product Overview AHP is committed to supporting pharmacy efficiency through a diverse range of both high-utilization and niche treatments. Producing nearly 600 UD oral solid stock-keeper units (SKUs) for the health care marketplace, AHP’s broad selection of products is made with quality components and printed with legible barcodes that facilitate effective execution of barcoded point-of-care (BPOC) initiatives. The wide selection of products reduces the gap between what pharmacies are forced to repackage themselves and what is commercially available on the market, thus supporting health systems nationwide in their efforts to create efficiencies throughout the chain of care.

AHP’s tailored offering of UD oral liquids provides similar efficiency, safety and cost-savings benefits as its oral-solids products. Product features include right-sized packaging, thoughtful tray design, differentiated labelling and accurate barcodes. AHP’s UD inhalants provide efficiency and feature individually wrapped vials and pouches barcoded to the dose level. AHP oral solids, liquids and inhalants include major therapeutic classes and product groups to meet unique pharmacy needs. They are continuously evolving to meet the changing demands of caregivers and staff to support more effective medication procurement strategies.

As facilities nationwide compete to demonstrate they provide the highest quality of care, AHP UD products support caregivers as they strive to promote positive outcomes for patients. Pharmacies simultaneously strive to be cost-effective as they provide necessary resources for caregivers. AHP UD supports these objectives while providing cost-savings opportunities. Sourcing prepackaged UD allows pharmacies to obtain adequate supply while mitigating capital expenses, such as those related to repackaging equipment, bulk supply and labor.

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Health systems that choose to package on-site must consider all direct costs, such as purchasing capital equipment for packaging areas and paying highly trained clinical professionals to perform, manage, and support non-core work. AHP UD products allow for pharmacies to avoid these costs while also shifting the potential costs associated with packaging errors. The prepackaged format also prevents additional fees that may result from using third-party repackaging services.

Hitting the Mark for BCMA, USP <800> Support Effective execution of barcoded medication administration (or BCMA) initiatives requires medications that scan correctly at the bedside. With a robust oral-solids portfolio, and a growing offering of UD liquids, AHP UD provides reliable access to UD treatments.

AHP products promote safety toward BPOC and efficiency in pharmacy while freeing up internal resources. AHP UD supports pharmacies as they strive for compliance with USP General Chapter <800> guidelines. As pharmacies craft effective procurement strategies to meet the needs of their facilities, protecting patients and caregivers alike from potential harm while handling hazardous drugs is a priority. AHP’s UD portfolio has many National institute for Occupational Safety & Health and USP <800> products already packaged for bedside dispensing, which supports compliance with USP <800> handling procedures.

Corporate Profiles 2021–2022

Equashield AT A GLANCE Equashield LLC 2 Harbor Park Drive Port Washington, NY 11050 Phone: (516) 684-8200 Fax: (516) 684-8202 Toll-Free: (855) 378-2744 Email: info@equashield.com

Equashield is a leading provider of stateof-the-art closed-system transfer devices (CSTDs) for the safe handling of hazardous drugs. Dedicated to providing a simple and elegant design that is also unparalleled in safety and ease of use, Equashield has created a family of products designed to protect healthcare workers—primarily compounding pharmacists and oncology nurses—from the health risks associated with exposure to hazardous drug residues and vapors when preparing and administering chemotherapy treatments.

The Equashield product portfolio includes a wide array of closed syringes and adaptors for accessing vials and IV bags in the pharmacy, as well as a selection of connectors and tubing sets for nursing and the EQUASHIELD® Pro.

Equashield’s Closed-System Transfer Device: A Proven Closed System Equashield’s innovative design makes its CSTD the only system to prevent syringe plunger contamination by hazardous drugs, a major route of exposure during routine drug preparations and IV pushes.

Unlike standard syringes, an Equashield CSTD can be used safely even beyond nominal capacity as the encapsulated plunger rod can never be detached from the syringe. This feature prevents the potential for spillage. It can also be used for up to 10 connections with the syringe unit without leaks or drug residues on its surfaces and without the risk for transferring environmental contaminants into the vial.

The Equashield system has been cleared by the FDA and is defined in FDA labeling as “Preventing Microbial Ingress for up to 7 Days.” It is also FDA cleared under the ONB code for “Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer Systems.” Equashield complies with the strictest regulatory requirements and passed the National Institute for Occupational Safety and Health “Alcohol Vapor Containment Performance Test.”

EQUASHIELD Pro Automated Pharmacy Compounding System Working in tandem with the Equashield CSTD, the EQUASHIELD Pro—the first CSTD-enabled automated compounding system—is also designed to prevent the escape of hazardous drug vapors and drug residues during the compounding process.

The Pro closed-system robot provides an additional layer of protection to pharmacy workers; a high throughput to meet the compounding demands during peak hours; medication error prevention through proprietary dose verification and image processing systems; and a low capital acquisition cost.

The Pro was designed to reimagine the automation process safely and efficiently and to operate like a factory line, with eight simultaneous workstations to complete the compounding process. Each station is an effective “expert” in its role and performs its task quickly and efficiently, shortening the length of the entire process.

As the Pro utilizes CSTDs, with its syringes and vials all using uniform vial adaptors, it is able to move faster than other robots. This is because the Pro can lift up any sized vial in the same manner and also is able to verify the drug and dosage with visual verification software, as well as efficiently carry it to the next station.

The Pro can be used for both high-throughput patient-specific dose preparation and batch compounding. Equipped for both tasks, it can store over 50 syringes and 70 drug vials, allowing it to produce more than 60 individual doses per hour. It also offers medication

Corporate Profiles 2021–2022

error control by using verification software for each dose and can detect any bubbles in the syringe, which could result in inaccurate dosing. The Pro’s factory-style lineup is housed in a machine that is comparable in size to standard biological safety cabinets.

For more information about Equashield’s award-winning CSTDs and the EQUASHIELD Pro automated compounding system for cytotoxic drugs, and to find out how we can help keep your pharmacy teams safe when compounding hazardous drugs, contact us at info@equashield.com.

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GenMark Diagnostics, Inc. AT A GLANCE 5964 La Place Court Carlsbad, CA 92008 (760) 448-4300 www.genmarkdx.com

Syndromic Testing Puts Patient Care Front and Center At GenMark, we believe in the syndromic approach to diagnosing infectious diseases. Our panels are designed to rapidly detect several of the most common pathogens that cause disease using a single patient sample, allowing clinicians to provide appropriate treatment earlier than permitted with conventional testing methods. In some cases, this may mean a patient does not get treated with an unnecessary antimicrobial agent, eliminating potential adverse effects that may come from prolonged and inappropriate treatment. It also can result in better patient outcomes, more rapid infection control and hospital bed management actions, as well as improved patient satisfaction.

Advance Your Antimicrobial Stewardship Program With ePlex® Blood Culture Identification Panels The ePlex Blood Culture Identification (BCID) Panels are designed to identify gram-positive, gram-negative and fungal pathogens, along with their resistance genes, within about 90 minutes from blood culture positivity/Gram stain. Our panels have the broadest pathogen inclusivity compared with currently available molecular panels.

Our panels include: • Common gram-positive pathogens: Staphylococcus, Streptococcus and Enterococcus • Blood culture contaminants for potential deescalation from vancomycin (or daptomycin) • Important anaerobes and drug-resistant gram-negative organisms requiring potential optimization of empiric therapy • In addition to the most prevalent Candida species, rare and opportunistic fungi

Respiratory Pathogen Panels Identify the Most Common Viral and Bacterial Organisms Associated With Upper Respiratory Infection, Including SARS-CoV-2 Thirty percent of antibiotics are prescribed unnecessarily, and most unnecessary use is for respiratory infections. The ePlex RP/RP2 Panels identify and detect more than 20 of the most common respiratory viruses and bacteria causing respiratory illness in less than two hours, allowing doctors to make informed patient care decisions faster, reducing the use of unnecessary antibiotic use. Rapid diagnosis is especially important for people who are more likely to become seriously ill from complications or require hospitalization, such as young children, adults 65 years of age and older, pregnant women and those with compromised immune systems.

Your Long-Term Partner—Committed to Providing Industry-Leading Support Every Step of the Way The implementation process for molecular BCID can be taxing on a lab’s resources. GenMark offers multiple levels of support to meet the needs of your laboratory and hospital to aid in making the process as simple as possible. Our infectious disease specialists and system integration specialists have extensive experience and training in microbiology, infectious disease pharmacy and antimicrobial stewardship, and we work in partnership with your institution to provide a comprehensive diagnostic solution focused on stewardship initiatives and patient-centered care.

For more information, visit our website or contact us at https://genmarkdx.com/support/contact/.

Corporate Profiles 2021–2022

Special Advertising Section Pharmacy Practice News

Grifols Caring for People and Society

Diagnostic

Grifols is a global health care company founded in Barcelona, Spain, in 1909 committed to improving the health and wellbeing of people around the world. Its four divisions—Bioscience, Diagnostic, Hospital and Bio Supplies—develop, produce and market innovative solutions and services that are sold in more than 100 countries. Grifols, with nearly 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

As a recognized leader in transfusion medicine, the Diagnostic Division offers a comprehensive portfolio of solutions designed to enhance safety from donation through transfusion. The division advances patient care with diagnostic solutions to improve disease detection and management, as well as streamline laboratory operations.

AT A GLANCE 2410 Lillyvale Ave. Los Angeles, CA 90032 (888) 474-3657 www.grifols.com

Hospital INCLUSIV from Grifols is a comprehensive, integrated portfolio of proven technology, software and services designed to meet the safety and compliance challenges of sterile compounding preparation, while optimizing operational efficiencies. INCLUSIV encompasses cleanroom systems, IV robotics, pharmacy operations software and five-year KLAS Category Leader for IV Workflow Management: PharmacyKeeper Verification. (See 2021 Best in KLAS report.)

Bio Supplies The Bio Supplies Division provides high-quality human biological materials for life sciences research, clinical trials, and for manufacturing pharmaceutical and diagnostic products.

Grifols, Commitment to Sustainability

As fundamental corporate values, quality and safety are fostered

by Grifols’ corporate culture and integrated into every stage of the value chain. The company’s vertically integrated business model further enhances its control over production processes.

Grifols, recognized as one of the world’s most sustainable companies, works to make a positive social and economic impact on society, including local jobs and social value creation for donors, patients and communities. Aligned with the United Nation’s plan to achieve the Sustainable Development Goals defined in its 2030 agenda, the company challenges itself every day to do more and do better to contribute to the health and quality of life of people everywhere.

Bioscience

Normal Saline

As pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat chronic, rare and, at times, life-threatening conditions. To ensure a safe and consistent source of plasma-derived medicines worldwide, we have a vertically integrated production process from plasma collection through fractionation and purification at our facilities in the United States and Spain. Key essential plasma-derived products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty plasma products.

Grifols now provides 0.9% Sodium Chloride for injection 500 mL in the United States. The commercialization of Grifols Normal Saline represents an important step forward to mitigate the current shortage that hospitals have been facing since 2014. Grifols Sodium Chloride is provided in the Fleboflex® container that is made with polypropylene and is free of PVC, DEHP and latex.

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Corporate Profiles 2021–2022

International Medical Industries, Inc. Innovation in Secure Drug Delivery

AT A GLANCE 2981 Gateway Drive Pompano Beach, FL 33069 (800) 344-2884 sales@imiweb.com www.imiweb.com

Devoted to the Needs of the Compounding Pharmacist

Founded in 1967 and exclusively devoted to the needs of the compounding pharmacist, creating products for the compounding pharmacist is the sole focus at IMI. As a result, our customers experience the quality, service and value that only a specialized partner can offer. Through our partnerships with compounding professionals, we continue to advance our devices to serve the health care community. From new product developments to customized packaging configurations, IMI’s customer-focused ethos and superior engineering capabilities allow us to be responsive to the needs of our partners and customers.

Our capabilities and highly trained teams are the reasons we have remained the industry standard for tamper-evident cap technology and continue to deliver customer-focused products to enhance pharmacy productivity, safety and security. All IMI products are manufactured in the United States at our FDA-registered, ISO 13485–certified facility under the strictest quality standards.

Innovation in Secure Drug Delivery Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The benefits of tamper-evident products to address this risk have been recognized within the standards and guidelines of multiple influential organizations, including the American Society of Health-System Pharmacists and the FDA. Tamper-evident products increase overall accountability in the chain of custody of mediations, maintain sterility, prevent leakage, ensure patients receive the full intended dose and reduce the risk for contamination. Experts agree that the use of tamper-evident products increases the confidence of pharmacists, health care workers and patients. IMI’s Prep-Lock™ Line of products provides high-value, high-quality, tamper-evident closure devices for a variety of drug delivery containers, including IV, enteral and oral syringes, medication cassettes, and IV bags.

Prep-Lock Tamper-Evident Caps for IV Syringes Hospitals that partner with an outsource compounder may already be familiar with Prep-Lock Tamper-Evident Caps for IV syringes. Over 85% of the top 503B compounding facilities trust IMI Tamper-Evident Caps to secure their preparations. Incorporating these caps for in-house preparations can provide standardization of all syringes throughout the hospital. As a result, clinicians will not need training for administering syringes with multiple tamperevident methods. Tamper-Evident Caps help to ensure the integrity of your compounds by providing a visual indication of tampering, misuse or access. Installation and administration are highly efficient.

Each sterile tray of 10 includes a unique keyed feature that allows the pharmacist to install a cap with a simple twist of the syringe, helping to reduce the risk for touch contamination and enhance aseptic technique. To administer, simply pull off the outer sleeve of the tamper-evident cap and unscrew the remaining luer lock cap.

Clinicians and pharmacists appreciate not having to deal with sticky tapes or frustrating shrink wrap. Tamper-Evident Caps represent a convenient and comparatively low-cost risk mitigation mechanism for pharmacies and health systems.

supply chain benefits by providing item-level inventory visibility down to the National Drug Code and lot. Recognizing the advantages that RFID technology presents, IMI joined industry consortium DoseID to help increase interoperability, quality and performance of RFIDtagged products.

Tamper-Evident Caps with RFID provide a labor-reducing solution to incorporating RFID into your drug doses. With a simple twist of a syringe, your CSPs are equipped with renowned tamperevident protection and powerful analytical automation capabilities.

These two powerful technologies in combination enhance workflow efficiencies, eliminate time-consuming manual inventory control processes, provide assistance with growing regulatory demand, and supply a comprehensive strategy to prevent, detect and resolve drug diversion events. In addition, by incorporating RFID technology into IMI’s industry-leading Tamper-Evident Caps, facilities can reduce their cost of RFID implementation by up to 55% with little time-tolive and minimal staff investment, procedural changes, or capital investment.

Prep-Lock Tamper-Evident Additive Port Caps The Tamper-Evident Additive Port Cap provides remarkable protection and protocol assurance to the medication ports of Baxter, B. Braun and Fresenius Kabi IV bags. The simple one-handed installation and considerable contributions to the integrity of IV compounds have gained acclaim from pharmacists and health care professionals. “I find their products to be the best on the market in terms of the device itself, the functionality and the securement,” said Neil Colby, RPh, the director of Infusion Pharmacy Services at CDRx Infusion. These products extend the intention of USP General Chapter <797> from pharmacy to patient by providing last-mile security that strengthens pharmacist and health care provider confidence and reduces risk for contamination and diversion.

Prep-Lock Tamper-Evident Caps Featuring RFID Radio-frequency identification (RFID) technology continues to garner adherents in hospital pharmacy systems. The technology enables real-time scanning that optimizes inventory management, efficiency and medication safety while creating quantifiable pharmaceutical

Corporate Profiles 2021–2022

Special Advertising Section Pharmacy Practice News

Leiters. Compounding Health™ This is the place where quality means something Leiters, founded in 1926, is an FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services. Our team of industry experts provides a sophisticated understanding of what it takes to elevate quality and consistency of supply in outsourcing.

We combine our team, our robust processes and our state-of-theart outsourcing facility to ensure the highest-quality outsourced medications for you and your patients. Through three key pillars, People, Place and Product, Leiters is elevating the standards in pharmaceutical outsourcing.

People • Our highly trained multifunctional teams of pharmaceutical experts ensure quality and regulatory compliance for all released products.

• Our team has relevant industry experience with sterile injectable pharmaceutical companies, hospital pharmacies and academia.

• Our customer experience team of regionally based account representatives, account managers and customer service specialists work together to provide you with consistent and reliable service.

Place • FDA-registered and inspected Current Good Manufacturing Practices (cGMP)-compliant 503B outsourcing provider • Licensed to ship to all 50 states (and the District of Columbia) • State-of-the-art equipment and automation is used throughout our sterile manufacturing process

Product • All sterile preparations are produced under 503B of the Food, Drug, & Cosmetic Act (503B Guidance), cGMP and USP Chapter <797>.

• Release, stability, potency and sterility testing is performed on every batch made.

• We provide a Certificate of Analysis (CoA) with every shipment.

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Your Journey to Better Medicine Begins Here Leiters provides medicines and pharmacy services across the continuum of care, including hospitals, surgery centers, clinics and physicians’ offices. We are also strategically partnered with many market–leading, innovative health care companies that complement what we do here at Leiters. The products and services offered by these partners—and available through Leiters—may provide additional value to your organization.

We Don’t Want to Simply Tell You About What We Do, We Want to Show You We invite you to visit our facilities to better understand the cGMP regulations, sterile manufacturing processes and automation we use to elevate the quality of our products and services.

Come join the growing list of organizations that have visited our facilities.

To schedule a site visit or learn more about how Leiters is Compounding Health™, please visit www.leiters.com.

AT A GLANCE 13796 Compark Boulevard Englewood, CO 80112 Phone: (800) 292-6772 Fax: (408) 288-8252 info@leiters.com www.leiters.com

Hospital and Surgery Center Products and Services • Prefilled syringes, vials and bags • Avanos ON-Q® Pain Relief System Fill Service • Opioid-free surgical pain services • Compatible with the Kit Check automated medication tray management system • Cardioplegic solutions • Partnered with Prodigy Health to provide access to their innovative pharmacy supply chain services

Ophthalmology Products and Services • Prefilled syringes, vials and dropper bottles • Comprehensive portfolio including: – Injections, antibiotics, dilating agents and topical anesthetics • FDA-Compliant Repackaged Avastin® Service – Multiple presentations available based on physician preference • Compatible with Besse Medical’s inventory management systems

Corporate Profiles 2021–2022

Medi-Dose/EPS AT A GLANCE 70 Industrial Drive Ivyland, PA 18974 Phone: (800) 523-8966 Fax: (800) 323-8966 info@medidose.com www.medidose.com

For over 50 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory.

Medi-Dose began in 1971, when Milton Braverman, a former pharmaceutical company territory manager, formed his own company. Robert Braverman, president, remembers: “My dad was acutely aware of the requirements of hospital pharmacy. He saw the need for inexpensive, manual unit-dose packaging allowing hospitals to convert from traditional dispensing. He developed systems to package, handle and dispense predetermined amounts of medication so they would be accessible for one regular dose.”

Although familiar today, launching the unit-dose packaging was a huge problem the new company faced. “We were one of the pioneers, the innovators promoting unit dose in hospitals,” Mr. Braverman recalled. “Due in part to Medi-Dose’s educational efforts, pharmacists and nurses accepted the validity of unit dose.”

Inexpensive, Easy and Flexible Because of its unique Cold-Seal technology, the Medi-Dose System is simple to use and requires no special in-service training or additional space. Medi-Cup blisters are available in 15 styles and eight sizes to accommodate the largest medications or the smallest storage spaces, and are particularly ideal for USP <800> medications.

Ultraviolet-inhibitant blisters provide additional protection from light.

Plus, a combination of special blister plastics with aggressive tamper-evident label adhesives provides either six-month or one-year beyond-use dating for all your unit-dose packaging needs.

The Medi-Dose System offers these additional benefits: • Sealed units can be left in sheets or easily torn down to individual doses.

• Lid-Label Covers are available in 8” × 11” laser sheets of 25 doses or 4” × 6” direct thermal sheets of five doses.

• Laser Lid-Label Cover Sheets are available in a wide variety of colors to facilitate color coding of medications.

• Circular and Oval Blisters have been designed to fit your dispensing machines and storage cabinets.

• New MPB® - Multi-Purpose Blisters allow you to easily package, label and secure even more sizes and types of medications, including large medications, compounded drugs, double and triple “0” capsules, unit-of-use packaging, repackaged medications and suppositories.

• All Medi-Cup Blisters and Lid-Label Covers work with our MILT 4 Software, which can be used for all your barcoding and labeling needs.

Brightly colored Lid-Label Covers call attention to medication requiring special handling.

Adapts to Your Needs With our MILT 4 Software, you can design your labels any way you want (for solids, liquids, syringes, ampules, IVs—even equipment and supplies). In addition to the ability to use graphics, special fonts and shapes—even logos and symbols—to better identify your medications, MILT 4 has been designed to easily create barcodes with the information your barcode-enabled point-of-care and barcode medication administration systems require. Popular 1D and 2D barcode formats can be created with National Drug Code numbers, beyonduse dates, lot numbers and special codes. Plus, MILT 4 suggests tall man lettering options (e.g., DOPamine instead of DOPAMINE) for medications as recommended by the FDA and the Institute for Safe Medication Practices. In addition, newly entered and previously saved medication names are compared with the CDC’s “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.” If a match is found, the user is notified that this medication may potentially be hazardous to handle.

To get started, all you will need is: • Medi-Cup Blisters: 15 styles to suit your packaging needs.

• Lid-Label Covers: Laser or Direct Thermal labels to seal the blisters.

• MILT 4 Software: Design and manage Lid-Label Cover printing.

• Fil-Form and Roll-E-ZY: Aligns Lid-Label Covers to Medi-Cup Blisters, ensuring a positive seal between labels and blisters.

• Inexpensive. Flexible. Tamper-Evident. If you are looking for a system to handle any or all of your unit-dose or barcoding needs, then the Medi-Dose System is the perfect fit for you!

Products • Medi-Dose® (Solid) and TampAlerT® (Liquid) Oral Unit-Dose Packaging • Medi-Cup® PLUS packaging for extended beyond-use dating • MILT® by Medi-Dose unit-dose and barcoding software • LiquiDose® labeling, IV additive and filtration products • Nultraviolet® ultraviolet light inhibitant bags • Steri-Dropper sterile ophthalmic dropper bottles • High Alert and IV Line Tracing Labels • Resealable bags, bottles, and other pharmacy supplies and disposables

Using our MILT 4 Software, you can label and identify all your medication, complete with graphics and a barcode.

Corporate Profiles 2021–2022

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Mitigating risk:

Payors Eye Risky Opioid-Benzo Combo W

ith the concurrent use of benzodiazepines and opioids involved in approximately 16% of fatal overdoses, according to the CDC, management of the medications represents a significant challenge for payors.

Benzodiazepines are FDA labeled for conditions such as seizures, insomnia, generalized anxiety disorder and panic disorder, and usually are intended for short term—weeks to months, said Kimberly Lenz, PharmD, the director of clinical and operational pharmacy for MassHealth, the Massachusetts Medicaid program, at the University of Massachusetts Medical School, in Worcester. “In practice, they should be prescribed for behavioral health conditions while the primary treatment lines are ramping up, then transitioned to as-needed or breakthrough treatment only. But in reality, they continue to be used as a scheduled medication, while the primary treatment is often stopped or used at subclinical doses,” Dr. Lenz said during the Academy of Managed Care Pharmacy’s 2021 virtual annual meeting.

A common case, she noted, involves a patient with a behavioral health condition, such as anxiety, who is prescribed a benzodiazepine while a selective serotonin reuptake inhibitor (SSRI) medication is being titrated. “After approximately four to six weeks, the benzo should be tapered to PRN [as needed, pro re nata], but many times the patient has side effects from the SSRI or doesn’t feel like it’s helping, and they drop it or remain on a lower dose while continuing the benzodiazepine. Fast-forward down the road and they experience an injury requiring an opioid, and you have a potentially dangerous combination of chronic benzodiazepine use with opioids.”

So, why isn’t everyone managing this high-risk combination more aggressively? Dr. Lenz said although she suspects most payors are likely doing some oversight, such as a “soft edit”—in which the pharmacist is alerted to the safety concern but may override—the circumstances often are complicated.

“It’s hard to work with providers on tapering patients who are stable on these medications, especially with chronic pain, where the opioid can’t be tapered or reduced,” she said. “A critical point is that a benzodiazepine taper needs to be slow. Depending on the dose and duration of therapy, a patient could experience seizures, be

physically dependent or experience worsening anxiety during the taper.”

In late 2019, MassHealth launched its Concomitant Opioid Benzodiazepine Initiative (COBI), aimed at mitigating harm from concomitant prescribing through a combination of claims edits, prior authorization (PA), highrisk member triage and an algorithm to identify those high-risk members.

“We needed to get answers to the questions that would allow us to evaluate clinical cases for appropriateness of prescriptions, and triage those members at highest risk to our therapeutic case management [TCM] group,” said Michael Jones, PharmD, a clinical consultant pharmacist with Commonwealth Medicine at the University of Massachusetts Medical School, who led the COBI initiative.

“Clinically, there are scenarios where the ‘acute’ concurrent use of opioids and benzodiazepines is appropriate, so one of our key tasks was to define chronic use,” Dr. Jones said. “We used claims data to identify any member with overlap of an opioid and a benzodiazepine for at least 60 days within a 90-day period.”

Rejected at the Point of Sale Because there are more agents to recommend as alternative therapies for benzodiazepines than for opioids, the COBI project decided to recommend that the benzodiazepine, not the opioid, be the rejected agent at the point of sale. “If a member has pain severe enough for opioids, alternatives are lacking,” Dr. Jones explained.

As for the benzodiazepine, “our goal was not to get a member already on the drug off that agent completely,” she said. “We looked at each case individually and when clinically appropriate, recommended a slow taper to be used on an as-needed basis. Of course, that is easier said than done.” In other words, this means no outright denials of PA requests for the benzodiazepine—something that is atypical in managed care.

“Every PA request is submitted for varying durations, with the provider receiving a specialized message at the point of rejection regarding what is required for the PA to be approved and the availability of emergency supplies,” Dr. Jones said.

Those requirements included: • documentation of the clinical diagnosis for which the drugs were being prescribed;

63% of all opioid-related deaths also involved other drugs.

34% Cocaine

33% Benzodiazepines

12% Methamphetamine

Source: CDC, 25 states, January-June 2018.

• attestation that the patient had either been prescribed or offered naloxone; and • trial of alternatives.

“The variety of approval durations depended on the clinical picture, but in general, there was a six-month approval duration during which the taper was planned,” Dr. Jones said. Because of the high volume of these prescriptions, the COBI developed an algorithm based on 11 risk factors related to current medications, substance abuse history and demographic factors, such as age and comorbid chronic respiratory disorders, to identify the highest-risk members for the TCM intervention.

Providers were educated about the initiative beginning in early 2019, went live in November 2019 and claims began to be rejected roughly two months later, in January 2020. Dr. Jones cited several key outcomes: • 1,378 members were evaluated for dose changes.

• 79% had no changes in dosage.

The remaining members were split between increases and decreases.

• 37 members had a benzodiazepine dosage decrease of 5% or greater.

“We saw considerable prior authorization volume, with a dip in approvals beginning in April and May 2020, but as the offices began to have a better understanding of the initiative

and what criteria needed to be met, we began to see more approvals,” Dr. Jones said.

Of 67 cases reviewed by the TCM work group, 38.8% resulted in a tapering of either the benzodiazepine or opioid dosage, he reported, and 35.8% had fills of a naloxone prescription after provider outreach.

‘Small but Encouraging’ Gains Reported “Our success in the first year has been small, but encouraging,” Dr. Jones said.

“We’ve had to temper our expectations, given what everyone has had to endure over the last year with the pandemic.

Our greatest impact was with the TCM workgroup, given that these are very difficult patients to treat.”

Dr. Jones stressed the importance of naloxone conversations with providers. “‘I’m not prescribing the opioid, therefore I shouldn’t have to prescribe naloxone,’ is a line I’ve heard many times,” he said. “That’s the wrong stance. Our goal should be to provide high-risk patients with adequate support services and mitigation strategies in any way possible, regardless of who is prescribing what.”

—Gina Shaw The sources reported no relevant financial disclosures.

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7-fold increase in compliance

SPs and Nurses Boost Vaccines in MS Patients

S

pecialty pharmacists and nurses at the University of Rochester Medical Center, in New York, improved pneumococcal vaccination practices among their patients with multiple sclerosis (MS) before starting infusion therapy, a new study showed.

The CDC recommends that patients given disease-modifying therapy such as ocrelizumab (Ocrevus, Genentech)

3 Measures of Success Patients receiving optimal pneumococcal vaccinations prior to first infusion increased from 58% to 84% Patients with unknown vaccination status dropped from 17% to 3% Patients who received recommended follow-up vaccines increased from 9% to 56%

and rituximab first get pneumococcal vaccinations to ensure optimal immune response, said Kristin Reindel, PharmD, a PGY-2 specialty pharmacy administration and leadership resident at the medical center. However, specialty pharmacists and a clinical nurse educator with the hospital’s MS center became aware that these recommendations for optimal immune response were not followed routinely.

Indeed, a medication-use evaluation of 406 patients receiving infusions before September 2019 indicated there was room for improvement, with just 58% of patients receiving their initial optimal vaccines, 17% of patients having unknown vaccination status and 26% not receiving optimal vaccinations, Dr. Reindel reported at the American College of Clinical Pharmacy’s 2021 Virtual Poster Symposium (abstract 93).

In February 2020, the clinical nurse educator trained clinic and infusion center nurses to provide education about the need for these vaccines before treatment. As part of this effort, workflows were adapted so patients could receive the vaccinations at the hospital along with other appointments, instead of being referred out to their primary care providers or local pharmacies.

A repeat analysis of 73 patients starting infusion therapy from February to December 2020 indicated that the interventions significantly improved the percentage of patients receiving optimal pneumococcal vaccinations prior to first infusion, from 58% to 84% (P<0.05). The percentage of patients with unknown

vaccination status dropped from 17% to 3% (P<0.05) during that period, and the percentage of patients who received recommended follow-up vaccines increased from 9% to 56% (P<0.05).

“We’re happy with the results,” Dr. Reindel said, noting that fewer patients than usual started therapy in this period due to the COVID-19 pandemic. “We found that the nursing intervention did

seem to have a large impact on vaccinations, and we found a statistically significant difference among patients confirmed to have received their initial vaccine prior to therapy. That was really great in making sure patients were going to be protected prior to starting infusions. We also found a statistically significant difference in the number of patients who received their follow-up

vaccine after the intervention.”

This project highlights the value of interdisciplinary team collaboration in the care of MS patients between healthsystem specialty pharmacists and nurses, Dr. Reindel said: “Our intervention was effective at increasing adherence to the pneumococcal vaccine recommendations and improving coordination of care, with patients being able to get their immunizations at the MS center.”

‘An Excellent Study’ The effort was impressive, commented

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‘Our intervention was effective at increasing adherence to the pneumococcal vaccine recommendations and improving coordination of care, with patients being able to get their immunizations at the MS center.’

—Kristin Reindel, PharmD Kathleen Love, RN, the clinical program manager of specialty pharmacy for AllianceRx Walgreens Prime. “I thought it was an excellent study and a successful example of improved patient outcomes in regard to the pneumococcal vaccination,” she said. “They

determined the variants for these highrisk patients, which was admirable, and they pulled it all through to execution and definitely had a strategic plan.

They were catching any outliers who may not have followed through, so it was very beneficial.”

At Ms. Love’s organization, pre-infusion vaccinations and their impacts are discussed with patients with MS during medication counseling sessions, Ms. Love said. “With advances in disease-modifying therapies for MS, there’s also a lot to be monitored for patients’ safety. With

each product, we want to communicate and educate, and that’s exactly what they were doing in this study as well.”

MS requires a multidisciplinary approach to management, Ms. Love added: “There are so many facets of education we can relay to patients about their medications and quality of life. That’s a big goal for us within our programs.”

—Karen Blum The sources reported no relevant financial disclosures.