Pharmacy Practice News - August 2022

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ASHP asks for clarification

HHS: Prescriptions For Repro Health A Civil Rights Issue

By Gina Shaw

CLINICAL Finding the right formula for IFALD patients..................4 Is de-escalation an effective ABx stewardship strategy? .......10 Feeling the pain of continued drug shortages ...................... 16

O

n July 13, the Department of Health and Human Services issued a warning to pharmacies that refusing to fill orders for contraception or abortion medication, or discriminating when filling prescriptions based on a person’s pregnancy status, will put them in violation of federal civil rights law.

Although ASHP stated that it supports the federal directive, the group said language in the document might undermine pharmacists’ ability to ensure safe medication use. “We 100% share the administration’s concern about appropriately prescribed medications,” including those for reproductive health, Michael Ganio,

Volume 49 • Number 8 • August 2022

PharmDs, AMA in Another Face-Off Over Paxlovid Rx

By Marie Rosenthal

T

he American Medical Association (AMA) is doubling down on its contention that state-licensed pharmacists don’t have the requisite clinical skills to prescribe nirmatrelvir+ritonavir (Paxlovid, Pfizer).

When President Joe Biden’s “test-to-treat” initiative governing COVID-19 therapeutics was first announced in March 2022, the AMA blasted the plan, saying that “leaving prescribing decisions this complex in the hands of [pharmacists] without knowledge of a patient’s medical history is dangerous in practice and precedent.”

The AMA hasn’t changed its tune in the wake of a new FDA plan, announced in July, that authorizes statelicensed pharmacists to prescribe

Continued on page 34

Continued on page 31

POLICY 6 steps for sending clean claims to payors .......32 OPERATIONS & MGMT ASHP survey shows health-systems’ growing specialty skills ....................... 36 Shields Health streamlines prior authorizations ...........40 How 2 health systems navigated EUAs for COVID-19 .................................. 42

TECHNOLOGY

Gender-Affirming Cancer Screening A Hem/Onc Issue

100% remissions reported

Is ‘Thrilling’ Rectal Cancer Study Really a Practice Game Changer?

By Gina Shaw

Boston—With an estimated 3% of the U.S. population now identifying as transgender (although the percentage varies across the age spectrum), oncologists and oncology pharmacists need to be prepared to provide gender-affirming and inclusive care, including screening and treatment, experts noted during the Hematology/Oncology Pharmacy Association (HOPA) 2022 annual meeting.

Many transgender and nonbinary people report experiencing discrimination and stigmatization when Continued on page 18

By Marie Rosenthal and Chase Doyle

A

phase 2 trial of dostarlimab in patients with early-stage rectal cancer that yielded never-before-seen results—complete remission in 100% of patients—might be a game changer for cancer therapy, but then again, it might not be.

It’s really too early to tell and more data are needed, experts said, including Lisa Holle, PharmD, BCOP, a clinical professor of pharmacy practice in the Department of Pharmacy at UConn School of Pharmacy, in Storrs. “This was just one study,” Dr. Holle strressed. “It has to translate into a longterm outcome of improving survival.”

The trial results, which were presented at the 2022 annual meeting of the American Society of Clinical Oncology (abstract LBA5), in Chicago, showed that all of the 14 patients with locally advanced colorectal cancer treated with neoadjuvant dostarlimab (Jemperli, GSK), a programmed death-1 (PD-1) inhibitor, experienced a complete response (N Engl J Med 2022 Jun 5. doi:10.1056/NEJMoa2201445).

In the study, patients received 500 mg of dostarlimab intravenously every three weeks for six months and then underwent radiological and endoscopic evaluation. The

App may help cut costs from OR drug budget ....... 46

Special Focus:

5 tips for applying the heat to USP compliance See page 45

Continued on page 8

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

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4 Clinical

Pharmacy Practice News • August 2022

Hepatology

Finding the Right Formula for IFALD Patients

By Donavyn Coffey

With no one-size-fits-all approach, physician, pharIn the early 2000s, it became clear that liver disease macist and dietitian experts discussed how they inter- was happening by two different mechanisms, she said. pret and apply the available data on IFALD nutrition.

Without fat, patients would develop steatosis due to de novo lipogenesis. However, patients receiving high Finding a Formulation doses of soybean oil lipid emulsions also ended up with For Essential Nutrients liver disease because the emulsion can be hepatotoxic.

Soybean oil emulsions are actually a very good source The challenge lies in ensuring patients have essential nutrients, and children get enough nutrition to grow, of essential fatty acids even when given at a low dose, while avoiding toxicity. IFALD is characterized by pro- Dr. Gura said. But physicians and researchers hypothegressive cholestasis and biliary fibrosis, and steato- size that the emulsion lacks sufficient alpha-tocopherol hepatitis in adults, after prolonged TPN (Hepatol Int or contains too many phytosterols that infants can’t 2020;14[3]:305-316). Although ‘If there is any way I can rehabilitate TPN is necessary, it’s a highrisk therapy, Dr. Gura said. the remnant bowel, I think it offers Overfeeding dextrose and lipids the best potential for health and

by IV can injure the liver, she noted. Moreover, the IV catheimproved quality of life.’ ter required to deliver nutrients puts patients at risk for infection —Laura Matarese, RDN and sepsis, which also can contribute to liver injury.

These risks exist for anyone on TPN, but for young properly metabolize. It’s also possible that excessive children—premature infants especially—their imma- inflammatory omega-6 fatty acids in soybean oil emulture livers can’t withstand much to begin with. So, sions and reduced amount of omega-3 fatty acids may they are “less able to tolerate [TPN] than an adult or prevent hepatocytes from resisting oxidative stress, older child,” Dr. Cohran said. Jaundice and liver injury according to an FDA webinar in May 2022.

“There’s no prospective data that composite lipids”—a often don’t show up in adults until the disease has progressed much further, according to Dr. Gura. In con- mixture of oil emulsions such as SMOFlipid (Fresenius trast, infants can start to show symptoms within three Kabi), an injectable emulsion, rather than just soybean oil alone—“is different, but that’s the conventional weeks of starting TPN, she said.

One of the reasons that care for IFALD patients has thought,” Dr. Cohran said.

In 2013, the FDA mandated postmarketing safety improved so dramatically since the early 2000s is a better understanding of how different IV lipid emul- studies of Nutralipid, a 20% soybean oil IV fat emulsions affect patients. For decades after the emulsions sion (B. Braun); Intralipid, an IV emulsion of soybean were introduced in the United States in the 1970s, no oil (Baxter/Fresenius Kabi); and Clinolipid, a 20% one suspected they contributed to IFALD, Dr. Gura lipid injectable emulsion (Baxter). The agency called said. That’s because patients appeared to develop for the studies based on new data that implicated phytosterols, found in abundance in soybean oil–containIFALD with lipid emulsions and without them. ing emulsions, in IFALD. According to the FDA, phytosterols are largely unabImmature enterohepatic sorbed in the gastrointestinal tract and even prevent Longer exposure to PN circulation, accumulation the absorption of cholesterol. However, when infused, of toxic bile acids phytosterols can accumulate and decrease bile acid Duration of PN synthesis. This in turn increases the phytosterol conPrematurity tent in bile, which can lead to cell lysis and damage Lack of enteral feedings, small bowel bacterial hepatocytes. That damage is compounded by common overgrowth, dilated bowel conditions in neonates such as gut resection, sepsis and immaturity, according to an FDA webinar presentation by Camelia Martin, MD, the chief of newborn medicine at Weill Cornell Medicine, in New York City.

PN Component A study in pigs, published in the Journal of Parenteral Toxicity—Lipid and Enteral Nutrition in March 2022, found normal phytosterol concentrations (such as that in Intralipid Soybean-based lipid contains 100% soybean oil) and enriched phytosterol concenhigher omega-6 PUFA trations caused higher direct bilirubin concentrations Infection precursors of pro-inflammatory Sepsis than emulsions with depleted phytosterol content eicosanoids and increased Endotoxemia amounts of plant sterol (JPEN J Parenter Enteral Nutr 2022;46[1]:160-171).

CLABSI A study of neonates by Fresenius Kabi found those Surgical procedures receiving the company’s low-phytosterol lipid emulCirculating endotoxin sion, SMOFlipid, were less likely to develop parenteral activates hepatic nutrition–associated cholestasis (PNAC) (2/83; 2.4%), macrophages within the Intestinal failure which is a precursor to IFALD, than those receiving a liver, simulates the release of 100% soybean oil emulsion (9/78; 11.5%). Most cases of pro-inflammatory cytokines parenteral nutrition–associated liver disease (PNALD) Figure. Modifiable and non-modifiable risk factors for PNALD/IFALD. occurred after 28 days, suggesting long-term use was a significant contributor (ClinicalTrials.gov Identifier: CLABSI, central line bloodstream infection; IFALD, intestinal failure–associated liver disease; PN, parenteral nutrition; PUFA, polyunsaturated fatty acids.

Source: FDA Workshop on the Role of Phytosterols in PNALD/IFALD (bit.ly/3A4RWqu).

NCT02579265).

G

iven the role many pharmacists play in managing orphan disease medications, it’s important for them to understand the interplay between intestinal failure–associated liver disease (IFALD) and parenteral nutrition (PN)—a relationship that could significantly affect clinical outcomes, according to several nutrition experts.

At least one IFALD drug in the pipeline, if approved, is projected to receive orphan drug designation. So keeping an eye on drug development also is key. But the PN component of care requires more immediate attention, according to Kathleen Gura, PharmD, the board director at the American Society for Parenteral and Enteral Nutrition (ASPEN).

In the 40 years Dr. Gura has been studying IFALD, academic centers identified many potential contributing factors to the disease’s development, including the microbiome and the oil content of the IV fat emulsions. Physicians created nutritional strategies that allow these vulnerable patients to improve. Over time, they can even come off TPN entirely.

“When you look at how we care for these children, we are doing much better than 20 to 25 years ago,” said Valeria Cohran, MD, the director of intestinal rehabilitation at The Ann & Robert H. Lurie Children’s Hospital, in Chicago. However, the evidence on the nutritional strategies used in this patient group remains scant. It’s a small, heterogeneous group and each patient’s treatment varies based on their unique intestinal anatomy.

Furthermore, in her four decades working in intestinal rehabilitation, Laura Matarese, RDN, a researcher and dietitian at ECU Health, in Greenville, N.C., said she had never had any two patients who were exactly alike.

In addition, liver biopsies are nearly impossible to safely perform in infants, according to Dr. Gura. “It’s very, very dangerous; they could potentially bleed to death,” she said.

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6 Clinical

Pharmacy Practice News • August 2022

Hepatology

IFALD FORMULA

protection against PNALD (Cochrane Database Syst Rev 2019;6:CD013163). continued from page 4 Even with a better understanding of the limitaIn a 2020 study of neonates diagnosed with IFALD, tions of soybean oil, the choice of lipid emulsion for switching to 100% fish oil (Omegaven, Fresenius Kabi) patients coming into the neonatal ICU isn’t always reversed the liver disease in 11 of 15 infants (J Clin Med straightforward. Drs. Cohran and Gura said they continue to use soybean oil for their patients. Dr. Cohran 2020;9[11]:3393).

However, a meta-analysis from 2016 did not find prefers a composite lipid emulsion, one made of mulfish oil containing SMOFlipid to have a strong protec- tiple lipid types such as soybean oil, olive oil, MCT tive effect against IFALD compared with 100% soy- (or medium-chain triglycerides) oil and fish oil. She bean oil, despite a sevenfold reduction in phytosterols uses soybean oil in low amounts and carefully moni(J Pediatr Gastroenterol Nutr 2016;62[5]:776-792). tors total and direct bilirubin. When bilirubin reaches Similarly, a Cochrane Review did not find any lipid 2 mg/dL, an indication of IFALD, she switches patients emulsions with or without fish oil to provide better to Omegaven.

Lifestyle Changes Improve Pediatric NAFLD

By Kate O’Rourke

P

harmacists often are relied on by their physician colleagues for their medication management expertise. But their worth on the care team also hinges on the ability to recommend non-pharmacologic therapy when appropriate.

A new study of pediatric patients with nonalcoholic fatty liver disease (NAFLD) suggests that may indeed be the best approach.

The study—results of which were presented at the 2021 Liver Meeting (abstract 45) and published in Clinical Gastroenterology and Hepatology (2021 Dec 4. doi:10.1016/j.cgh.2021.11.039)—found that an intensive multidisciplinary lifestyle management program resulted in significant weight loss and reduced steatosis and fibrosis in pediatric patients with NAFLD. The results are an encouraging development, given the prevalence of the disease, noted investigator Sander Lefere, MD, PhD, a postdoctoral researcher in the Department of Gastroenterology and Hepatology at Ghent University, in Belgium. Secondary to increasing rates of obesity in children and adolescents, pediatric NAFLD is now the most common pediatric liver disease worldwide (J Pediatr 2016;172:9–13), he noted.

The prospective study included children and adolescents with NAFLD admitted for severe obesity at a tertiary center, the Zeepreventorium De Haan, in Belgium, between July 2019 and January 2021, who were placed on an intensive lifestyle regimen composed of caloric restriction, physical activity, education and psychosocial support in a residential multidisciplinary setting.

To assess liver steatosis and fibrosis, the researchers performed liver ultrasonography and transient elastography with controlled attenuation parameter (CAP) and liver stiffness measurement at baseline and after six and 12 months. Fibrosis was defined as a liver stiffness measurement of at least 7 kPa for F2 fibrosis, at least 9 kPa for F3 and at least 11 kPa for F4; CAP values of at least 248 dB/m were considered elevated.

The median age of the 204 patients was 14.0 years, and the median body mass index z score was 2.8.

NAFLD was found on ultrasound in 71.1% of patients, whereas 68.6% had CAP values measuring at least 248 dB/m. In the cohort, 32.8% of patients had at least F2 fibrosis, including 10.3% with transient elastography measurements of at least 9 kPa. After six months, median weight loss was 16% in the 167 patients who were evaluated. Liver steatosis and fibrosis also were markedly improved, with regression and resolution of fibrosis occurring in 73.1% and 61.5%

of patients who had fibrosis at baseline, respectively.

Resolution of steatosis occurred in 47.1% of patients with steatosis at baseline, the investigators reported.

Fasting serum alanine aminotransferase (ALT) levels and for insulin resistance decreased significantly over the one-year period (P<0.001).

“To our knowledge, this is the largest study to date to investigate the efficacy of a structured weight loss program on improving NAFLD in children and adolescents with severe obesity (aged 8-18 years). Our findings are strengthened by the use of transient elastography for the diagnosis and follow-up of liver fibrosis in the study population,” Dr. Lefere said, noting that previous studies that have investigated the efficacy of lifestyle intervention for pediatric NAFLD have relied on serum ALT levels or liver ultrasound, which are suboptimal and do not provide data on liver fibrosis, the key outcome marker in these patients.

“Based on our results, prompt careful hepatic examination of children and adolescents with severe obesity is warranted, as well as timely referral to weight loss programs,” Dr. Lefere Median weight loss said. “These data further support the importance of the development and evaluation of alternative and Liver steatosis effective weight loss proresolution grams for NAFLD in the outpatient setting.”

16% 47.1%

61.5% Liver fibrosis

Comprehensive Approach Is Needed

resolution

Ali Mencin, MD, the director of the Pediatric Fatty Liver Clinic and Pediatric Endoscopy at Columbia Doctors Children’s Health, in New York City, said the study demonstrates the importance of healthy lifestyle in improving liver injury in NAFLD. “Previous studies have shown that weight loss through diet and exercise or bariatric surgery result in improvements in ALT and liver histology.

However, most patients struggle with adhering to a healthy lifestyle recommendation.

“The degree of NAFLD improvement in Dr. Lefere’s study can likely be attributed to the intervention— intensive lifestyle changes in a residential setting with education and psychosocial support,” Dr. Mencin said.

“This highlights the need for a more comprehensive approach to lifestyle management beyond standardof-care counseling to achieve improved outcomes in NAFLD. Unfortunately, few patients have access to such programs.”

Dr. Mencin said it would be interesting to know “the specifics of the intervention in this study and more details about their success in reducing BMI.” Drs. Lefere and Mencin reported no relevant financial disclosures.

Dr. Gura said each lipid source has its limitations and its place in treating unique patient cases. A soybean oil such as Nutralipid or Intralipid has a long history of use, is efficient in terms of required fatty acids and is well tolerated for a short duration of therapy, she noted.

Beyond lipids, experts said prioritizing enteral nutrition in neonates and oral feeding in adults is crucial. In infants, feeding enterally helps the remaining intestine adapt and improves patient safety and the likelihood they can transition from parenteral nutrition (PN) entirely. With “[adult] oral intake, the liver gets first pass at those nutrients,” Ms. Matarese said. In contrast, with PN, the liver typically is last for nutrient delivery. Oral feeding in adults also stimulates enteral hepatic circulation, villus height and crypt depth, she said.

“If there is any way I can rehabilitate the remnant bowel, I think it offers the best potential for health and improved quality of life,” Ms. Matarese stressed.

Team Effort Best for Care Transitioning from PN requires a team of experts.

In addition to gastroenterologists, surgeons and neonatologists, pharmacists and dietitians are necessary to ensure patients are receiving the appropriate formula based on their intestinal anatomy. The pharmacists and dietitians are also integral for assessing the TPN to ensure patients receive the appropriate vitamins and minerals, especially in the current time of shortages, and that enteral nutrition is formulated for a patient’s unique anatomy and limitations. As an example, if a patient lacks their distal small bowel, they’re likely to have a vitamin B12 deficiency and also absorb fat-soluble vitamins poorly, Dr. Cohran said.

If patients are missing their proximal small intestine, they are more susceptible to iron deficiency.

Pharmacists and dietitians are also essential as teams work with healthcare companies to access products and reconcile PN recipes, Dr. Cohran said.

This collaboration is likely to be one reason that patients who receive treatment at a specialized center have better outcomes. There’s a bigger opportunity for out-of-the-box and holistic thinking with a multidisciplinary team, Dr. Gura said. Dr. Cohran has patients who travel more than five hours to be seen by her team in Chicago.

But “everybody can’t jump on a plane to fly to Boston, Cincinnati or Chicago,” Dr. Cohran said.

If a provider is trying to support a patient who has IFALD but is not located near a major center, getting in touch with a large center can be critical, Dr. Gura said, as is diving into the rapidly evolving literature on IFALD. It may be useful to ask nearby professionals such as pharmacists, dietitians, social workers or neonatologists to help. At first, a gastroenterologist may need to mentor a pharmacist because most don’t receive formal training in this area, Dr. Gura said. However, it will become a very useful partnership quickly, she said.

All three experts said there is a way to see patients return to a more normal life, to see children safe to swim and rough-house with their siblings, Dr. Cohran said. “What drives me is tapering children from PN and allowing them to live their best life.”

Dr. Cohran reported financial relationships with Abbott Nutrition, Nutricia and Takeda. Dr. Gura reported financial relationships with Alcresta, Fresenius Kabi, Lexicomp, NorthSea Therapeutics and Otsuka Pharmaceutical Factory. Dr. Matarese reported no relevant financial disclosures.

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8 Clinical

Pharmacy Practice News • August 2022

Oncology

No Game Changer in Rectal Cancer? continued from page 1

study’s primary end points were overall response rate to PD-1 blockade with or without chemoradiation, and pathologic complete response or clinical complete response rate at 12 months after PD-1 blockade with or without chemoradiation.

All patients had dMMR and BRAF V600E wild-type tumors, and the mean tumor mutational burden was 67, explained lead study author Andrea Cercek, MD, the head of the colorectal cancer section and codirector of the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center, in New York City. Most patients enrolled had big bulky tumors, 94% had node-positive disease and approximately half had Lynch syndrome, he added.

At the meeting, Dr. Cercek called the findings “unprecedented” and “thrilling.”

“We’ve now treated a total of 14 patients, and 100% have had a clinical complete response to dostarlimab alone,” Dr. Cercek said. “No patients have required chemotherapy, radiation or surgery. There have been no disease recurrences observed, though longer followup is certainly required to establish the durability of this treatment.”

‘Intriguing’ But Many Caveats “It’s been one of the first studies ever to really show a complete response, especially in rectal cancer, which is difficult to treat,” Dr. Holle said.

Although the results were intriguing, it was done “in a very small number of patients at one institution. It looked at the response rate, which is important, but there hasn’t been enough time to see if dostarlimab improves survival in these patients.”

‘Right now, we don’t know if [patients in the phase 2 trial will experience a durable response on dostarlimab] because it is early in the course of disease ....’

—Lisa Holle, PharmD, BCOP

before the surgery. That means a six-month complete response has not even taken the patients beyond the neoadjuvant period. “So, we don’t know if this actually increased survival longer than normal treatment,” Dr. Holle said. “The normal treatment is about six months, then you have surgery, and you follow patients very closely for five years. If they’re completely free of disease, we consider them cured.”

The hope is that by that time, the patient will live the remainder of his or her life without rectal cancer, because most patients will have a recurrence within five years if it is going to recur, she added.

Genetic Mutations a Limiting Factor Patients and healthcare providers have the same goal: to see patients live a long, cancer-free life. “Right now, we don’t know if that is going to be the case with this drug because it is early in the course of the disease for these patients,” Dr. Holle explained. “Although they had a complete response, we don’t know if that will be a durable response.”

Although the median follow-up is only 6.8 months, Dr. Cercek said at the ASCO meeting that four patients have been followed nearly two years, and only four have received less than six months of the required treatment—very small numbers. The study does suggest, however, that giving immunotherapy in the neoadjuvant setting could be a viable and effective option, and in this case meant that patients did not need neoadjuvant radiation and then surgery, Dr. Holle said.

“In rectal cancer that is locally advanced, the goal is to shrink all of the tumor as much as possible, so that you can remove everything with surgery,” she explained.

In conventional rectal cancer treatment, neoadjuvant cancer therapy typically takes six months

‘We’ve now treated a total of 14 patients, and 100% have had a clinical complete response to dostarlimab alone. No patients have required chemotherapy, radiation or surgery [and] there have been no disease recurrences ….’

—Andrea Cercek, MD

Video Exclusive Lisa Holle, PharmD, discusses how to put the NEJM study results into perspective when talking with rectal cancer patients.

Visit pharmacypracticnews.com and click on the multimedia tab.

Another caveat is the patient population. This study is only relevant to a small number of patients with rectal cancer. To understand why this is, it’s important to know how dostarlimab works, which goes back to understanding the biology behind it.

The body contains mismatch repair (MMR) genes that are involved in correcting mistakes or mutations made when DNA is copied in cells. Some people, however, have a deficiency in MMR (dMMR), which makes it easier for cells that have many DNA mutations to proliferate, leading to the growth of cancer.

The body has several checkpoints within the immune system to kill cancer cells, including programmed death 1 (PD-1), a protein found on T cells.

PD ligand 1 (PD-L1) is often found on cancer cells or other immune cells invading the tumor. When PD-1 binds to PDL-1, it prevents the T cells from killing cancer cells. So, PD-1 inhibitors such as dostarlimab prevent PD-1 from binding to PDL-1 and enables the immune system to effectively kill the cancer cells.

Patients with dMMR tend to respond to checkpoint inhibitors due to the high number of DNA mutations, which are thought to stimulate immune responses, such as those from checkpoint inhibitors.

Only about 5% to 10% of rectal cancer patients have a dMMR mutation.

Results Not Yet Practice-Changing The study results were meaningful and promising, but require more study before they will change practice, according to Kimmie Ng, MD, MPH, who was invited to comment during the ASCO session.

“The 100% clinical complete response rate is unprecedented in rectal cancer, and the potential to decrease morbidity by eliminating pelvic radiation and surgery for our patients is huge,” said Dr. Ng, an associate professor of medicine at Harvard Medical School and the co-director of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, both in Boston.

Dr. Ng called neoadjuvant dostarlimab a “promising new treatment for patients with stage II to III dMMR rectal cancer,” but also reiterated the need for longer follow-up as well as additional patients.

“These findings are clinically meaningful and scientifically plausible, but more data are needed before they become practice-changing,” Dr. Ng concluded.

The single-arm phase 2 study will ultimately enroll 30 patients with newly diagnosed clinical stage II and III, mismatch repair–deficient (dMMR) rectal cancer.

Dr. Cercek reported a financial relationship with Bayer, GlaxoSmithKline, Incyte, Janssen, Merck, Regenix and Seattle Genetics Dr. Ng reported a financial relationship with for Bayer, Bicara Therapeutics, BiomX, GlaxoSmithKline, Redesign Health, Seattle Genetics, and X-Biotix Therapeutics. Dr. Holle reported no relevant financial disclosures.

P<0.0001 GIAPREZA plus background standard-of-care (n=163)

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10 Clinical

Pharmacy Practice News • August 2022

Infectious Disease

Is De-Escalation an Effective Stewardship Strategy?

By David Wild

W

hile a number of organizations recommend “spectrum de-escalation” have narrowing the spectrum of antibiotic therapy not convinced her that it is in hospitalized patients in light of laboratory find- necessary to pursue this meaings, some are questioning the primacy of the prac- sure to prevent resistance. tice, including one expert who said there are no For example, a single-center convincing data concerning spectrum de-escalation retrospective study of 7,118 patients with severe sepsis or to judge whether it improves outcomes.

“I would question whether it really should be the septic shock showed that each standard of practice based on the available data,” said additional day of treatment Meghan Jeffres, PharmD, an associate professor in the with anti-pseudomonal betaDepartment of Clinical Pharmacy at Skaggs School of lactams increased the chances Pharmacy and Pharmaceutical Sciences, University of of developing new resistance by 4% (Pharmacotherapy 2019;39[3]:261-270), Colorado Anschutz Medical Campus, in Aurora.

Transitioning from a broad-spectrum antibiotic and a follow-up analysis of those data found resisto that of a narrower spectrum based on culture tance to these broad-spectrum agents increased results is one form of antibiotic de-escalation, a from around 2% during the first three days to broader term encompassing, for example, discontin- roughly 10% between 10 and 18 days, rising slightly uing redundant or unnecessary antibiotics or switch- more between 19 and 21 days (Infect Control Hosp Epidemiol 2020;41[4]:484-485). ing from IV to oral antibiotics.

“While the authors’ theory is that resistance conWhile Dr. Jeffres said she does not dispute that use drives antibiotic resistance, she said the data behind tinues to increase with prolonged duration of these

‘We know that shortening the length of antibiotic administration is arguably the highest-impact measure we can take to prevent antibiotic resistance and improve patient outcomes.’

—Meghan Jeffres, PharmD broad-spectrum agents, I would suggest the same phenomenon would be present if they looked at a different narrower spectrum antibiotic,” Dr. Jeffres asserted. “Why would we assume this relationship to be unique to the antipseudomonal beta-lactams?”

Other studies supporting the practice of spectrum de-escalation may not have adequately accounted for possible confounding variables, she said, pointing to findings that show administering antipseudomonal beta-lactams for longer than 48 hours in patients with Enterobacteriaceae bloodstream infections leads to a higher risk for Clostridioides difficile infection (CDI) within 90 days (7% for >48 hours vs. 1.8% for ≤48 hours) (Clin Infect Dis 2019;69[3]:414-420).

In this case, Dr. Jeffres said, the risk factors for longer treatment—such as older age, female sex, more comorbidities and bacteremia, and longer lengths of hospital stays prior to bloodstream infections—are some of the same established risk variables for CDI. “Arguably, this study does not support the early discontinuation of antipseudomonal beta-lactams in decreasing CDI risk,” Dr. Jeffres said.

Other data are “at best, indifferent to the idea that spectrum de-escalation is important,” she said.

For example, a trial of 116 patients with severe sepsis who received empiric treatment and were then randomly assigned to undergo spectrum deescalation or continue with this treatment found that ICU stays were longer among the de-escalation group (median 3.4 days longer), that de-escalation was associated with more days of antibiotic use (14 vs. 10 days) and that the practice was linked with higher rates of superinfections (27% vs. 11%; P=0.03) (Intensive Care Med 2014;40[10]:1399-1408). The authors’ finding that 44% of those who underwent de-escalation and had a superinfection developed resistance to the index pathogen, compared with 67% of those who continued empiric treatment, provides insight into the mechanism behind these results, she said.

“It looks like when you de-escalate and expose patients to a second antibiotic, you may raise the risk of developing resistance to additional pathogens,” said Dr. Jeffres, noting the study’s small size and that results need to be validated in larger trials.

Shorten Duration Rather than focusing on spectrum de-escalation efforts, Dr. Jeffres suggested implementing other stewardship interventions, such as shortening the duration of antibiotic exposure.

“We know that shortening the length of antibiotic administration is arguably the highest-impact measure we can take to prevent antibiotic resistance and improve patient outcomes,” she said. see STEWARDSHIP, page 12

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12 Clinical

Pharmacy Practice News • August 2022

Infectious Disease

Rx for Highly Treatment-Experienced People With HIV

By Milena Murray, PharmD, MSc, BCIDP, AAHIVP, FCCP

T

he treatment of HIV has dramatically advanced over the past 40 years. Clear data show a decreased occurrence of AIDS and an increased life expectancy.1,2 However, a small percentage of the overall population with HIV cannot achieve treatment goals. People with HIV who are highly treatment-experienced (HTE) may have limited antiretroviral therapy (ART) options due to resistance or tolerability issues. This population may have problems with virologic suppression, immune function, toxicities, and drug–drug interactions.

These challenges may lead to an overall decrease in health-related quality of life (HRQOL).3 HTE people with

HIV need novel ART effective and to rapidly identify cases options and classes with of virologic failure.4 improved tolerability Overall resistance rates to 4 ART and no cross-resistance classes are thought to be low; howto current ART classes. ever, reported prevalence rates to 3 and Both transmitted and 4 ART classes are estimated to be 5% acquired resistance must to 10% in Europe and less than 3% in be considered in the North America.1,5 In the United States, HIV treatment discus- approximately 12,000 people with sion. In a World Health multidrug-resistant HIV need novel Organization survey agents.2,6 When HIV RNA undetectreport, there was more than 10% resis- ability cannot be achieved, a secondary tance to nevirapine or efavirenz in peo- goal is to reduce the HIV RNA levels as ple with HIV initiating therapy.4 This much as possible and maintain immuglobal prevalence of resistance to the nologic function.7 Entry inhibitors are nonnucleoside reverse transcriptase second-line agents that prevent HIV-1 inhibitors emphasizes the need to use cellular entry by binding a cellular tarART with long-term efficacy and dura- get.1 Enfuvirtide (Fuzeon, Genentech) bility.4 There is also a need to retain and maraviroc were the first agents in these patients in care and encourage this class; however, there are several adherence. Global access to HIV RNA disadvantages to these agents, includtesting is needed to ensure that ART is ing the route of administration, pill

STEWARDSHIP continued from page 10

Jonathan Ryder, MD, a fellow in the Division of Infectious Diseases at the University of Nebraska Medical Center, in Omaha, said the evidence supporting use of spectrum de-escalation is hampered by design limitations, such as small sample sizes and observational research that has yielded conflicting results, but well-designed randomized controlled trials are underway. “For now, physicians should know that antibiotic spectrum de-escalation has an important role in clinical practice and antimicrobial stewardship programs, although many questions persist in how best to incorporate this efficiently in antimicrobial stewardship programs and what the broader ecologic consequences are,” Dr. Ryder said.

Dominic Chan, PharmD, an infectious diseases specialist and the director of pharmacy at Legacy Emanuel Medical Center, in Portland, Ore., said evidence on the practice of spectrum de-escalation is lacking, specifically on “the outcomes we care about: mortality, notable resistance rates and long-term consequences of microbiota disruption.”

Additionally, he said, there are cases where spectrum de-escalation following use of a broad-spectrum antibiotic does not significantly alleviate the antibiotic pressure on the microbiota.

“For example, the difference in bacterial spectrum of activity between meropenem and ceftriaxonemetronidazole may be large, but the collateral damage that ceftriaxone-metronidazole has on commensal bacteria is still tremendous,” Dr. Chan said.

“The questions we likely should be asking are, ‘Does this patient need any antibiotics, or are they on the correct, most valuable, antibiotic,’ rather than ‘Should we decrease the spectrum of the antibiotics?’” he said.

Much of this information was presented at IDWeek 2021.

The sources reported no relevant financial disclosures.

burden, and lower virologic efficacy compared with other ART options.1 The newest agents in the entry inhibitor class are fostemsavir (Rukobia, ViiV) and ibalizumab-uiyk (Trogarzo, Theratechnologies).

Fostemsavir is an HIV-1 attachment inhibitor that binds the gp120 envelope glycoprotein and prevents viral connection to CD4 T cells. The drug was approved in July 2020 and has no apparent cross-resistance to other ART classes.3 Within the same drug class, there is no cross-resistance with ibalizumab-uiyk or maraviroc.8,9 Fostemsavir is dosed as 600-mg tablets orally twice daily without regard to food.1 One concern with twice-daily administration is that nonadherence may have led to virologic failure, and adhering to a twice-daily regimen may see HIV OPTIONS, page 14

Vancomycin Diagnostic Stewardship Initiative Is a Winner

By David Wild

A

successful stewardship initiative requires robust planning, needs buy-in from stakeholders and should demonstrate its impact after implementation.

According to one stewardship expert, data should be at the center of every stewardship project.

“There are a million ways to improve patient care and only so much time during the day, and I’m a firm believer in letting the data drive what you do,” said Erin McCreary, PharmD, an infectious diseases pharmacist at UPMC, a clinical assistant professor of medicine at the University of Pittsburgh School of Medicine and the director of Stewardship Innovation for Infectious nfectious Disease Connect, in Pittsburgh. gh.

-19 panIn the midst of the COVID-19 Creary and demic in June 2020, Dr. McCreary d to impleher colleagues still managed wardship iniment several diagnostic stewardship d toward tiatives. These were targeted ge decreasing vancomycin usage er a in light of data gathered over iod 16-month pre-pandemic period comyshowing the duration of vancomycin treatment was “through the mycin roof” and that 31% of vancomycin e kidrecipients experienced acute eived ney injury because they received eata high dose or underwent treatple. ment for too long, for example. rapy To shorten duration of therapy myin patients receiving vancomyeary’s cin for pneumonia, Dr. McCreary’s m team proposed moving from ethchromogenic agar–based methcus icillin-resistant Staphylococcus aureus nares testing to poly-merase chain reaction (PCR)) testing, which would reduce the urs turnaround time from 48 hours sting to one hour and increase testing 8%. sensitivity from 65.7% to 91.8%.

However, it would also raise the cost per test from $5/$6 to $25/$35.

“We launched the project as a small-scale pilot to see if outcomes would justify the increase in testing expenditures,” she said. They collaborated with infection prevention staff to create a unique pharmacy-placed order for the rapid diagnostic test, and provided education and tracked outcomes.

The initiative proved successful, as data gathered over a six-month period after implementation in June 2020 showed. Vancomycin was discontinued for nearly all patients with a negative test, and 15% were able to avoid va vancomycin altogether because of the fast turnaround turn of PCR testing. Of note, the med median number of days on vancomycin fell from three to one, Dr. McCreary said.

“This led to a drop in demand for vancomycin monitorin monitoring, less lab time due to less vancomycin levels leve being sent, less pharmacy time spent o on pharmacokinetics consults, fewer inst instances of acute kidney injury, and it de decreased the overall cost of patient care,” Dr. McCreary said. She did not share cost data but said the program program’s success has led to the interve intervention being implemented at other ssites across UPMC. Dr. McCreary M noted that educating stak stakeholders about the stewardship ini initiative was “really challenging, especia especially at a larger center like ours where y you have to keep making adjustm adjustments to your protocol.

“But over time, all providers have embrac embraced the policy of PCR testing when wh initiating vancomycin in patient patients with pneumonia,” she said.

Dr. McCreary M reported serving on the advisory boards for AbbVie, Cidara, ad Entasis, Ferring, MeMed, Merck, Shionogi and Summit.

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14 Clinical

Pharmacy Practice News • August 2022

Infectious Disease

HIV OPTIONS continued from page 12

be an issue for some people with HIV.6 Common adverse reactions with fostemsavir include nausea, diarrhea, headache, abdominal pain, dyspepsia, fatigue, rash, and sleep disturbances.6 Fostemsavir was studied in people with HIV who failed to respond to their current ART, and this agent also may be used for tolerability issues.10 This drug, combined with optimized background therapy, showed robust and sustained virologic and immunologic responses.11 Patient-reported outcomes from the BRIGHTE trial showed improved HRQOL outcomes.3 These improved outcomes are thought to increase overall adherence to ART, leading to better health outcomes. A case report of the use of fostemsavir to overcome a drug– drug interaction issue also has been published.12 Ibalizumab-uiyk is a long-acting post-attachment inhibitor.13 It is a humanized immunoglobulin G4 (IgG4) monoclonal antibody targeting CD4 receptors of T cells to interfere with the binding of HIV-1 gp120.1 The medication was approved in March 2018 and is given as a twice-monthly parenteral infusion (2,000-mg loading dose, followed by subsequent doses of 800 mg every 2 weeks).2 The most common adverse reactions reported in trials were diarrhea, dizziness, nausea, and rash. Monotherapy with ibalizumabuiyk is not recommended due to the development of resistance in 1 to 2 weeks.2 The parenteral administration of ibalizumab-uiyk presents logistical barriers to patient care implementation. Adherence may be an issue when clinic visits or home infusions are needed every 2 weeks.2 Missed infusions may lead to resistance.

Several clinical trials reported a decrease in HIV RNA and virologic suppression after therapy with ibalizumabuiyk.2,14 Pharmacoeconomic studies have reported that ibalizumab-uiyk represents a cost-effective and affordable option for HTE people due to an increase in quality-adjusted lifeyears.13,15 Successful treatment of panresistant HIV has been described with ibalizumab-uiyk used as an “induction treatment” followed by an optimized “maintenance treatment.”5 A case report of a switch to ibalizumab as a “bridge therapy” due to a drug– drug interaction with chemotherapy showed an alternative use when other ART options are not available.16 Another novel therapy is lenacapavir (Gilead) in the newest ART class of capsid inhibitors, which works by disrupting the functioning of the HIV capsid across multiple steps in the viral life cycle.17 Lenacapavir is

Adhering to a twice-daily regimen may be an issue for some people with HIV.

an investigational agent and can be administered orally, either daily or weekly, and subcutaneously up to every 6 months.17 It is being investigated in both HTE and treatment-naive people with HIV. No overlapping resistance with other classes or preexisting resistance mechanisms is known; however, emergent resistance during treatment has been reported.17,18 Results from the CAPELLA and CALIBRATE studies reported a rapid reduction in HIV RNA and no serious adverse events.17 After submission to the FDA, the manufacturer received a complete response letter in March 2022 detailing chemistry, manufacturing, and controls concerns relating to the compatibility of lenacapavir with the proposed borosilicate glass vial.19 Gilead is working with the FDA to resolve the issues.19 Transmitted and acquired resistance leading to virologic failure remain a global issue in the treatment of HIV. Recently approved agents represent a step forward toward virologic control for all people with HIV, including those who are HTE. However, there is still a need for more options in novel classes to overcome resistance, tolerability, and drug–drug interaction issues.

References 1. Berruti M, Pincino R, Taramasso L, et al.

Evaluating fostemsavir as a therapeutic option for patients with HIV. Expert Opin Pharmacother. 2021;22(12):1539-1545.

2. Chahine EB, Durham SH. Ibalizumab: the first monoclonal antibody for the treatment of HIV-1 infection. Ann Pharmacother.

2021;55(2):230-239.

3. Anderson SJ, Murray M, Cella D, et al.

Patient-reported outcomes in the phase III BRIGHTE trial of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals. Patient.

2022;15(1):131-143.

4. World Health Organization. HIV drug resistance. November 22, 2021. Accessed April 26, 2022. https://www.who.int/news-room/ fact-sheets/detail/hiv-drug-resistance 5. Canetti D, Muccini C, Spagnuolo V, et al.

Achieving virological control in panresistant HIV-1 infection: a case series.

EBioMedicine. 2022;77:103906. doi:10.1016/j. ebiom.2022.103906 6. Chahine EB. Fostemsavir: the first oral attachment inhibitor for treatment of HIV-1 infection. Am J Health Syst Pharm.

2021;78(5):376-388.

7. Department of Health and Human Services.

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. Updated January 20, 2022. Accessed April 26, 2022. https://bit.ly/38ybb0p-IDSE 8. Muccini C, Canetti D, Castagna A, et al.

Efficacy and safety profile of fostemsavir for the treatment of people with human immunodeficiency virus-1 (HIV-1): current evidence and place in therapy. Drug Des Devel Ther. 2022;16:297-304.

9. Rose R, Gartland M, Li Z, et al. Clinical evidence for a lack of cross-resistance between temsavir and ibalizumab or maraviroc. AIDS. 2022;36(1):11-18.

10. Hiryak K, Koren DE. Fostemsavir: a novel attachment inhibitor for patients with multidrug-resistant HIV-1 infection.

Ann Pharmacother. 2021;55(6):792-797.

11. Ackerman P, Thompson M, Molina JM, et al.

Long-term efficacy and safety of fostemsavir among subgroups of heavily treatmentexperienced adults with HIV-1. AIDS. 2021;35(7):1061-1072.

12. Pecora Fulco P, Nixon D, Gomes DC. Novel use of fostemsavir for 2 multidrug-resistant persons with human immunodeficiency virus.

Ann Pharmacother. 2022;56(4):501-502.

13. Brogan AJ, Talbird SE, Davis AE, et al. The cost-effectiveness and budget impact of ibalizumab-uiyk for adults with multidrugresistant HIV-1 infection in the United States.

Pharmacoeconomics. 2021;39(4):421-432.

14. Gathe JC, Hardwicke RL, Garcia F, et al.

Efficacy, pharmacokinetics, and safety over 48 weeks with ibalizumab-based therapy in treatment-experienced adults infected with HIV-1: a phase 2a study. J Acquir Immune Defic Syndr. 2021;86(4):482-489.

15. Millham LRI, Scott JA, Sax PE, et al. Clinical and economic impact of ibalizumab for people with multidrug-resistant HIV in the United States. J Acquir Immune Defic Syndr.

2020;83(2):148-156.

16. Dickter JK, Martin AL, Ho S, et al.

Ibalizumab-uiyk as a bridge therapy for a patient with drug-resistant HIV-1 infection receiving chemotherapy: a case report. J Clin Pharm Ther. 2021;46($):1185-1187.

17. Dvory-Sobol H, Shaik N, Callebaut C, et al.

Lenacapavir: A first-in-class HIV-1 capsid inhibitor. Curr Opin HIV AIDS. 2022;17(1): 15-21.

18. Margot N, Vanderveen L, Naik V, et al.

Phenotypic resistance to lenacapavir and monotherapy efficacy in a proof-of-concept clinical study. J Antimicrob Chemother.

2022;77(4):989-995.

19. Gilead receives complete response letter from U.S. FDA for investigational lenacapavir due to vial compatibility issues [press release].

Business Wire; March 1, 2022. Accessed April 26, 2022. https://bwnews.pr/3yWvaAi

Milena Murray, PharmD, MSc, BCIDP, AAHIVP, FCCP, is an associate professor, College of Pharmacy, Midwestern University, in Downers Grove, Illinois.

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16 Clinical

Pharmacy Practice News • August 2022

Medication Safety

Drug Shortages Continue … And Proliferate

By Bob Kronemyer

Erin Fox, PharmD, the senior director of Drug Information and Support Services at University of Utah Health, in Salt Lake City, agreed that a lack of transparency is a concern. Without complete disclosure from the pharmaceutical manufacturing sector, it will continue to be difficult for pharmacies to get ahead of a potential shortage, she told Pharmacy Practice News.

M

any medications commonly used in anesthesiology and pain medicine are in serious shortage, according to an American Society of Health-System Pharmacists (ASHP) member survey (bit.ly/3M6CxsR).

“Although I am not surprised by [these] drug shortages, I am quite alarmed by the impact they are having,” said principal investigator Michael Ganio, PharmD, a senior director of pharmacy practice and quality for ASHP, in Bethesda, Md. “Drug shortages have been problematic for 20 years now, but we had been doing fairly well until recent years.”

Dr. Ganio noted that Hurricane Maria had caused shortages of some saline products and sterile water in Puerto Rico in 2017. “We then did better until the COVID-19 pandemic hit,” he said.

“We had problems securing anesthesiology medications and drugs for ventilators. Then things seemed to improve some. But now, with supply chain issues and workforce challenges, drug shortages are becoming very prevalent again.”

The survey, conducted in March 2022, was inspired by anecdotal reports of drug shortages by ASHP members and an increase in the number of reports of shortages in the ASHP service database.

“There was also an overall concern for the availability of some of these products,” Dr. Ganio said.

Almost Everyone Affected Of the 345 respondents, most worked primarily in a hospital setting. More than 99% of participants reported being negatively affected by shortages of critical drugs.

“A lot of other surveys show a high percentage, but rarely are they nearly 100%,” Dr. Ganio said. “I think our finding underscores how severe the shortages are at the moment.”

Moreover, 50% of respondents were severely affected by basic sterile injectables like sterile water and flush syringes, local anesthetics, injectable narcotics, saline bags, pre-filled emergency syringes, concentrated electrolyte injections, and some heparin products.

In addition, 7% of respondents reported more than one drug shortage–related medication safety event that caused at least temporary patient harm. These medication safety events most often involved drugs in short supply: pre-filled 50% dextrose syringes or other dextrose solutions, heparin, injectable opioids, and antibiotics. (A July check of the ASHP Drug Shortages list showed that many of these agents, including 10% dextrose injection, still were in short supply.)

Incentives Needed

‘Now, with supply chain issues and workforce challenges, drug shortages are becoming very prevalent again.’

—Michael Ganio, PharmD

of respondents increased internal/ To combat shortages, individual cen- insourced sterile preparation producters should consolidate inventory and tion and that about one-third of respondetermine how many days supplies will dents repackaged 0.9% saline and/or 5% last. Perhaps the center will need to dextrose from large bags, while more ration supplies or seek alternate suppli- than 20% purchased drugs from a gray ers. “Centers might also be able to pur- market wholesaler. chase from a 503B outsourcing facility, which can sometimes meet some of the Incentives Needed demand that the commercial manufacAs noted in a joint statement from ASHP turers cannot meet,” Mr. Ganio said. and the American Medical Association, Therapeutic alternatives also can alle- the American Society of Anesthesiologists, viate drug shortages, although these the Association for Clinical Oncology and alternatives may not be as effective, USP (bit.ly/3a09Orx), incentivizing the have different side effects or may be development of advanced manufacturing more expensive, he noted. “During the technology for critical drugs and active beginning of the pandemic, it was very pharmaceutical ingredients is one of five common for anesthesiologists not to recommendations to bolster the quality have their anesthesia agent of choice and resilience of the U.S. healthcare supand have to use a second-line treatment.” ply chain.

Implementing alternative drugs also The other recommendations are: entails considerable effort in educat- • improving the function and coming staff and updating electronic health position of the Strategic National records and dispensing cabinets.

Stockpile (SNS); “There are also usually anesthesia trays • engaging pharmacists, physicians, in the OR that are stocked uniformly, so other clinicians and supply chain if you have to change out a product in experts to develop processes for one tray, you have to change it out in all maintaining and refreshing products trays,” Dr. Ganio said. “Communication in the SNS; and education are vitally important to • incentivizing quality and resilience; prevent errors when you are used to a and specific product or concentration of a • replicating requests for critical drug product being in a specific location. You manufacturing transparency and cannot overcommunicate a change, paroversight for medical devices and ticularly for concentration changes.” ancillary supplies, such as personal The survey found that roughly 75% protective equipment.

How to Combat Shortages

There also is a lack of clarity about the larger supply chain, Dr. Ganio noted.

“What do [those disruptions] mean?” he asked. “Product that has been shipped and waiting to arrive at port? Trucks moving across country? Raw materials?

There is certainly some workforce concern. I know there are drug manufacturers that have had omicron outbreaks within their staff, which reduces attendance and productivity.”

One long-term solution advocated

by ASHP is improving transparency to identify and begin addressing some of the root causes of drug shortages.

“Some of our proposals reimagine the SNS to keep a buffer inventory, so there would be prespecified amounts of product—maybe a two- to threemonth supply—available immediately to help mitigate that type of shortage,” Dr. Ganio said.

New forms of manufacturing technologies that are more reliable would help, too.

However, medications that are made exclusively in the United States are just as vulnerable to supply interruptions as those produced internationally. “We have found that anytime you concentrate drug manufacturing to any one region, especially to one facility, you are predisposed to a supply disruption,” said Dr. Ganio, who cited the example of shortages of injectable morphine, hydromorphone and fentanyl from a plant in Kansas in 2018 and 2019, due to quality concerns and difficulty acquiring raw materials.

The war in Ukraine has likely caused shortages in plastic because of oil disruptions. “There could also be raw material issues with plastic over time here in the U.S.,” he said.

Over time, Dr. Ganio said he expects some of these drug shortages to return to baseline. “Unfortunately, though, baseline still represents more than 100 drugs in shortage at any given time for the past 10 to 15 years,” he said. Some projections anticipate a return to baseline by fall of 2022, while others predict a full year.

Dr. Ganio reported no relevant financial disclosures.

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18 Clinical

Pharmacy Practice News • August 2022

Oncology

Gender-Affirming Care continued from page 1

seeking healthcare, noted Maya Leiva, “We ask these questions to validate them PharmD, a hematology/oncology clini- as an individual and show them that we cal pharmacy specialist at Inova Schar care and want to know who they are.”

Cancer Institute, in Fairfax, Va. “The Validate patients’ gender iden2015 U.S. Transgender Survey [the largtity and/or sexual orientation in est such survey in the country, with all elements of your practice. “When ‘All breast tissue has the potential to mutate and go more than 27,000 respondents] found we ask someone their name and proon to develop a cancer [and should be screened], that 33% of those who saw a healthcare nouns, we use those in all recordkeepprovider reported having at least one ing and communications with patients, whether that breast tissue has been present since a negative experience related to being consultants, family members and partcisgender woman’s original puberty in her teens or transgender, with higher rates for Black, ners,” Dr. Goldstein said.

Indigenous and other people of color, Recognize that everyone is developed later in life for a transgender woman.’ as well as persons with disabilities,” human and can make mistakes.

Dr. Leiva noted. “And 23% said that they “In practice, when you make a mistake, —Robbie Goldstein, MD did not see a doctor when they needed such as referring to someone by the to because of fear of being mistreated as wrong pronouns, that means you need “At the higher level within our insti- has the potential to mutate and go a transgender or nonbinary person.” to apologize for the mistake when you tution, we have worked very hard to on to develop a cancer, whether that Robbie Goldstein, MD, the founder recognize it and correct it,” he said. ensure that there is visibility for both breast tissue has been present since and medical director of the Transgender Remember that anatomy doesn’t patients and providers into those high- a cisgender woman’s original puberty Health Program at Massachusetts define the patient. “We keep an impact questions, to make sure there in her teens or developed later in life General Hospital, in Boston, agreed that anatomic inventory for our patients, so are places to document pronouns, gen- for a transgender woman. On the flip transgender patients have been con- we know what anatomy is present,” he der identity and other data in the record. side, for trans men who have gone ditioned to fear inadequate care—and, said. “Don’t make assumptions that a As patients register or re-register with through top surgery like a mastectomy, unfortunately, sometimes to avoid that person may or may not have a cervix, the hospital, we work to update the the assumption is often that it was a care. “Transgender and nonbinary peo- prostate or breast tissue that needs records to ensure that those questions complete mastectomy similar to what ple are nervous about how they may be screening, or anything else about what are answered and we can lower barriers is done with a cancer diagnosis. But, in treated because of their gender iden- anatomy may or may not be present.” across the institution to using a person’s reality, it is often a cosmetic and not tity when they walk into any healthcare right name and pronouns.” an oncologic surgery. Some breast tispractice, be it oncology or another spe- Language Counts Moreover, cancer screening among sue usually remains and is used to concialty, which means that they’re much Dr. Leiva recommended applying transgender and nonbinary individu- tour and shape, and that certainly has less likely to come in for the routine gender-neutral language, or terms the als should be organ-based, noted Karen the risk of developing into a cancer care and screening tests that they may patient uses, to describe body parts. “For Gunning, PharmD, a clinical professor and should be screened—often through need, such as mammography and colo- example, if you are meeting with a trans- of pharmacotherapy at the University physical examination and ultrasound, noscopy,” Dr. Goldstein said in a sepa- masculine patient, when doing pelvic of Utah College of Pharmacy, in Salt because mammography is not as effecrate interview. or chest examinations, refer to a chest Lake City. “If an individual has a par- tive in transgender men.”

There are four key principles to prac- exam rather than a breast exam, bleeding ticular body part or organ, and otherFew pharmacy schools provide speticing gender-affirming care in oncology instead of menstruation or cancer screen- wise meets the criteria for screening cific education for their students in and other clinical settings, Dr. Goldstein ing rather than Pap smear,” she said. based on risk factors or symptoms, then gender-affirming care, Dr. Gunning said. said: In larger institutions, this may require screening should proceed regardless of But she cited the work of Cheyenne Do not assume anything about a further effort beyond your individual gender identity or hormone use. But Frazier, PharmD, an assistant profespatient’s identity, but ask department or division. “In our clinic, these conversations need to be very sor of pharmacotherapy at Washington respectfully. “Every patient who walks we ask a patient’s name and pronouns at nuanced and patient-centered. For State University in Spokane, as a leadin is asked their name, pronouns, gen- every visit, because we know that these example, Pap smears are uncomfortable ing model for incorporating transgender and sexual orientation,” he said. are sometimes fluid,” Dr. Goldstein said. and can be traumatic for a transgender der care into the pharmacy curriculum. man if the medical provider isn’t sensi“There also have been more continutive to their patient’s needs, but on the ing education programs presented other hand, these patients are poten- recently at meetings like HOPA and tially at increased risk for HPV and the American Society of Health-System here are no established cancer screening guidelines or protocols for transdeserve to have that screening.”

Pharmacists,” said Dr. Gunning, who gender and nonbinary patients at any point in their transition.

“Everyone with a cervix is at risk for with Dr. Frazier co-presented the sesMoreover, large databases in the United States, such as the National Cancer cervical cancer, whether you are a sion “Caring for Transgender People: Database, do not capture nonbinary gender identity, making it difficult to estitransgender man, a cisgender woman or Insights and Points of Controversy mate whether cancer risk for transgender people differs from that of the gennonbinary,” Dr. Goldstein agreed. “And in Medication Therapy” at the ASHP eral population (Transl Androl Urol 2020;9[6]:2771-2785). But there are other information sources clinicians can turn to for help it doesn’t matter what your sexual ori- 2021 Midyear Clinical Meeting and “Probably the best reference for the clinician is the University of California, San entation is or who you’re having sex Exhibition. “But this is still an area that Francisco’s guidelines for primary care of the transgender patient,” said Karen with. Studies show that trans men, non- most oncology pharmacists, or pharGunning, PharmD, a clinical professor of pharmacotherapy at the University of binary individuals and lesbian women macists in general, have probably not Utah College of Pharmacy, in Salt Lake City. “They have several sections on canhave much lower rates of cervical can- experienced in their training. There is cer screening that review best practices, including the general approach to cancer cer screening because of preconceived still not a lot of evidence in this area, screening, breast cancer screening in transgender women, prostate and testicular cancer concerns in transgender women, breast cancer screening in transgender notions among healthcare providers and there is significant need for more men, screening for cervical cancer in transgender men, and ovarian and endothat these individuals may not be at risk. information, discussion and research to metrial cancer considerations in transgender men. Cancer screening is also menA lot more education is needed [Can inform best practices. But providing an tioned in the Endocrine Society’s transgender health clinical practice guideline [J Fam Physician 2019;65(1):e30-e37].” inclusive environment in your practice Clin Endocrinol Metab 2017;102(11):3869-3903] and the standards of care from the Breast cancer screening also is a is always an essential first step.”

World Professional Association for Transgender Health [bit.ly/3PBzydB], but those major area where transgender patients are less detailed, so the UCSF guidelines are most useful at the moment.” may not be appropriately served, —Gina Shaw The sources reported no relevant financial disclosures.

Dr. Goldstein said. “All breast tissue

A Lack of Official Guidelines

T

Corporate Profiles 2022–2023 Acute Care Pharmaceuticals American Health Packaging Equashield® Compounding Technologies International Medical Industries, Inc. La Jolla Pharmaceutical Leiters. Compounding Health™ Medi-Dose/EPS Pharmacy Practice News Pharmacy Technology Report QuVa Pharma

Special Advertising Section

The profiles in this section were submitted and/or reviewed by the advertisers.

Acute Care Pharmaceuticals AT A GLANCE 12195 Dearborn Place Poway, CA 92064 (888) 909-7700 www.pharma-choice.com

For decades, Acute Care Pharmaceuticals has been the pharmacy cleanroom supplier of choice, delivering exceptional products and service to healthcare providers nationwide. We were pioneers in the industry long before the guidelines became requirements.

This history has placed us at the forefront of the pharmacy compounding market and as true experts in the day-to-day, real-world requirements of USP and regulations.

Acute Care Pharmaceuticals offers an unparalleled range of USPcompliant disposable products that are manufactured under the highest standards. This unique dedication to compliance, coupled with our decades-long commitment to partnering with hospital pharmacies and critical environments, has helped make Acute Care a market leader. As part of the Hospeco Brands Group, Acute Care Pharmaceuticals has access to the entire Hospeco family of cleaning and safety products, making us even better equipped to satisfy your facilities’ critical environment needs. This new broader range of products has given us the capability to be the supplier of choice to a wide range of healthcare-related entities, including independent (non-hospital) pharmacies, labs, veterinary pharmacies, nursing homes, aerospace manufacturing, food processing, medical device manufacturing and more.

Product Overview Our broad range of products and services affords us the opportunity to supply your facility with all your most important safety and cleaning needs for USP Chapters <797> and <800>. With 20 group purchasing organization (GPO) and integrated delivery network contracts in place, our goal is to make your buying experience simple

and easy. Our Pharma-Choice™ brand of products is stocked at a variety of national distribution partners including AmerisourceBergen, Cardinal, McKesson and Medline, where you can receive your special discounted contract pricing.

We supply: • sterile alcohol • non-linting wipes (dry and pre-saturated) • disinfectants • media test kits • gloves • disposable apparel • personal protective equipment • cleaning equipment • spill kits

Key Business Partners • • • • •

AmerisourceBergen Cardinal McKesson Medline AvMEDICAL

Markets Served • • • • • • • •

Hospital/Acute Clinic HMO Home Health Care Home Infusion Surgery Centers Retail Long-Term Care

GPO Affiliations • • • • • • • • • •

Vizient Premier HealthTrust GPO Affiliations American Pharmacy Cooperative, Inc. Ascension (The Resource Group) Asembia Fairview Pharmacy Services GeriMed Managed Health Care Associates Inc. Northside Hospital System To order our full line of USP-compliant products, visit us at www.Pharma-Choice.com or speak directly to a product and contract order expert at (888) 909-7700.

Corporate Profiles 2022–2023

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 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

Patient Safety

Ensuring the right medication is given to the (800) 700-4621 right patient at the right time, and in the right customersupport@ strength, is imperative. Pharmacies can facilitate americanhealthpackaging.com effective execution of these “rights” by prowww.americanhealthpackaging.com viding 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 labeling 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 2022–2023

Equashield® Compounding Technologies AT A GLANCE 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 Compounding Technologies is a leading developer, manufacturer and wholesaler of compounding technologies.

The company was established in 2009, with a mission to provide healthcare workers— primarily pharmacists and nurses—with a simple and efficient plug-and-play closedsystem transfer device (CSTD), which later developed into robotics for the automated compounding of hazardous drugs.

Equashield’s CSTD is unparalleled in safety due to its unique patented, closed pressure-equalizing mechanism and dry disconnection system, which features its flagship closed-back syringe. The EQUASHIELD® Pro is the only CSTD that uses automated compounding to ensure the utmost protection to all hospital healthcare workers and patients throughout the healthcare facility from the health risks associated with exposure to residues and vapors resulting from the preparation and administration of hazardous drugs.

The Equashield CSTD portfolio includes a wide array of patented closed-back syringes and adaptors to accommodate any vial size and shape and all IV bags in the pharmacy. Equashield also has developed a patented selection of connectors and tubing sets for the safe and easy compounding and administration of hazardous drugs by pharmacists and nurses.

The EQUASHIELD Pro takes CSTD compounding beyond the industry standard with the first-ever CSTD compounding robot. The EQUASHIELD Pro’s image processing–based artificial intelligence (AI), multitasking, versatility and automated capability allow for a compounding rate of up to 70 doses per hour with the highest level of assured dosage accuracy and air bubble detection.

Equashield Compounding Technologies is compliant and cleared for the following: • FDA approved for preventing microbial ingress for up to seven days • FDA ONB code product clearance for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs • Passed National Institute for Occupational Safety and Health for alcohol vapor containment performance test

EQUASHIELD Pro Automated Pharmacy Compounding System Working in tandem with the Equashield CSTD, the EQUASHIELD Pro is the first CSTD-enabled automated compounding system that uses a CSTD throughout the entire compounding process. Unlike other automated compounding systems, the EQUASHIELD Pro is designed to prevent the escape of hazardous drug vapors and drug residues during the compounding process through the use of the CSTD. The EQUASHIELD Pro automated compounding system provides additional layers of protection to pharmacy workers and, in addition, provides the following benefits: • high throughput, meeting compounding demands during peak hours • medication error prevention through image processing–based AI • small footprint (similar size to a standard biological safety cabinet) • low capital acquisition cost The EQUASHIELD Pro was designed to reimagine the automation process safely and efficiently and to operate like a factory line, with eight simultaneous compounding workstations that deliver high throughput, shortening the duration of the entire process. In addition, the image processing cameras detect air bubbles, and verify and validate the dose accuracy.

EQUASHIELD Pro’s automated compounding system outperforms other robotic technologies with: • • • • •

Equashield Compounding Technologies CSTD: A Proven Closed System Equashield Compounding Technologies’ innovative design makes its CSTD the preferred system to prevent syringe plunger contamination by hazardous drugs, covering most routes of exposure during your daily hazardous drug preparations and IV pushes. The unique and exclusive closed-back syringe proved its performance across multiple independent and peer-reviewed studies focused on vapor contamination, optimization of sterile use, plunger contamination, surface contamination and efficiency of use.

Unlike standard luer-lock syringes, an Equashield Compounding Technologies syringe unit can be used safely even at its full volume, as the encapsulated plunger rod is secured by its closed back. This feature prevents the potential for spillage. Due to its leak-safe membranes, the Equashield syringe unit has FDA approval to be used for up to 10 manipulations. The Equashield closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposures to drug vapor, aerosols and spills, and also prevents microbial ingress for up to seven days.

Corporate Profiles 2022–2023

proprietary CSTD ability to accommodate a wide variety of vial sizes high syringe unit and vial storage capacity versatility to compound patient-specific prescriptions image recognition–based AI technology The EQUASHIELD Pro can be used for high-throughput, patient-specific dose preparation, storing 67 syringes and up to 60 large drug vials, allowing it to produce up to 70 individual doses per hour. It also offers medication error control by using image processing–based AI algorithms and software for each dose and detection of air bubbles, which could result in inaccurate dosing. The factory-style lineup is housed in a machine comparable in size to a standard biological safety cabinet.

Equashield invites you to find out how it can help keep your healthcare teams safe and efficient when compounding and administering hazardous drugs.

For more information about Equashield Compounding Technologies’ award-winning CSTDs and the EQUASHIELD Pro automated compounding system for cytotoxic drugs, contact us at info@ equashield.com.

Special Advertising Section Pharmacy Practice News

Pharmacy Technology Report This biannual supplement to Pharmacy Practice News and Specialty Pharmacy Continuum covers best practices in automation, informatics and patient safety.

AT A GLANCE 545 W. 45th Street, 8th Floor New York, NY 10036

Featured Content Pharmacy Technology Report (PTR) includes articles on real-world methods for adding technology to pharmacy operations. rations. For example, in the September 2022 issue, several le eading hospitals will detail how they are using teleph harmacy to ensure cancer patients receive top-notc ch follow-up care. Developed during the height of the e COVID-19 pandemic, these telepharmacy models are continuing to be useful for health systems that want to remain nimble and flexible amid an unpredictable pandemic caseload.

Other technologies on tap in the September issue include “smart” programmable infusion pumps, radiofrequency identification, robotics, and d how to encourage more widespread adoption of IV Vworkflow management systems (IV-WMS).

We will continue to keep an eye on technology th hat has the potential to improve pharmacy practice.

A Digital Home for PTR Readers looking to access PTR content can easily find it by choosing “Pharmacy Technology Report” under the “Sections” tab of the pharmacypracticenews.com homepage. Once there, a dedicated PTR landing page serves as an easily navigable portal to all of our technology content.

To ensure PTR readers don’t miss a single article from the print issue—as well as late-breaking technology news posted to the web— we send out a dedicated PTR e-Newsletter twice monthly. To sign up, visit www.pharmacypracticenews.com/ Registration.

Advisory Board The editorial advisory board for PTR includes some of the top experts in the field, including Mark Sullivan, PharmD, MBA, BCPS, the executive director of pharmacy operations at Vanderbilt University Hospital, in Nashville, Tenn.; Beth Prier, PharmD, MS, CPHIMS, the associate director of pharmacy informatics at The Ohio State University, in Columbus; and Mark

Special Advertising Section Pharmacy Practice News

Phone: (212) 957-5300 Fax: (212) 957-7230 pharmacypracticenews.com

Editorial Director David Bronstein davidb@mcmahonmed.com Ext. 212

Publication Director

Ne euenschwander, the presiden nt of The Neuenschwander Comp pany, in Bellevue, Wash., and founder of THRIVE, a coalition to promote mor more widespread use of IV-WMS technology.

Each of these board members helps ensure PTR is a must-read in this challenging area of pharmacy practice.

A Proven Formula PTR is the only supplement distributed to key readers of both PPN N and SPC, with bonus distribution from our booth at 13 pharmacy meetings over a 12-month period. PTR provides advertisers with an entry point to the pharmacy market via ads that are the least expensive of any national pharmacy publication in the United States.

Plus, starting in 2023, PTR will be published twice yearly!

Dave Kaplan dkaplan@mcmahonmed.com (973) 885-2315

Senior Editor Marie Rosenthal mrosenthal@mcmahonmed.com Ext. 265

Associate Editor Kate Baggaley kbaggaley@mcmahonmed.com (973) 768-2185

Sales Account Manager Lillie Onday londay@mcmahonmed.com (732) 979-7009

Corporate Profiles 2022–2023

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.

pharmaceutical 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 laborreducing solution to incorporating RFID into your drug doses. With a simple twist of a syringe, your CSPs are equipped with renowned tamper-evident 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 TamperEvident Caps, facilities can significantly reduce their cost of RFID implementation with little time-to-live, 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 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

Corporate Profiles 2022–2023

Special Advertising Section Pharmacy Practice News

La Jolla Pharmaceutical La Jolla Pharmaceutical Company is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. Giapreza® (angiotensin II) is approved by the FDA as a vasoconstrictor indicated to increase blood

pressure in adults with septic or other distributive shock. Xerava® (eravacycline) is approved by the FDA for the treatment of complicated intraabdominal infections.

AT A GLANCE

For more information, please visit www.ljpc.com.

201 Jones Road, Suite 400 Waltham, MA 02451 ljpc.com

Product Portfolio Product

Indication

Pivotal Studies

Regulatory Status

GIAPREZA® (angiotensin II)

Septic or other distributive shocka

321-patient, multinational, double-blind, randomized, placebo-controlled study

FDA-approved (December 2017)

XERAVA® (eravacycline)

Complicated intraabdominal infectionsb

538-patient, multinational, double-blind, randomized, active-controlled study

FDA-approved (August 2018)

499-patient, multinational, double-blind, randomized, active-controlled study a

GIAPREZA® is a vasoconstrictor used to increase blood pressure in adults with septic or other distributive shock.

b

XERAVA® is a tetracycline-class antibacterial indicated for the treatment of complicated intraabdominal infections in patients 18 years of age and older.

Limitations of Use: XERAVA® is not indicated for the treatment of complicated urinary tract infections.

XERAVA® (eravacycline) for injection Warnings and Precautions • Hypersensitivity Reactions: Life-threatening hypersensitivity (anaphylactic) reactions have been reported with tetracycline antibacterial drugs, including XERAVA®. Avoid use in patients with known hypersensitivity to tetracyclines.

• Tooth Discoloration and Enamel Hypoplasia: The use of XERAVA® during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

• Inhibition of Bone Growth: The use of XERAVA® during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

• Clostridium difficile–associated diarrhea: Evaluate if diarrhea occurs For more information on XERAVA®, including important safety information and full prescribing information, please visit www.XERAVA.com.

Special Advertising Section Pharmacy Practice News

GIAPREZA® (angiotensin II) injection Warnings and Precautions • There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA®. Use concurrent venous thromboembolism prophylaxis.

For more information on GIAPREZA®, including important safety information and full prescribing information, please visit www.GIAPREZA.com.

Corporate Profiles 2022–2023

Leiters. Compounding Health™ This is the place where quality means something

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

Leiters, founded in 1926, is an FDAregistered 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-the-art 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

• 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

• 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.

• FDA-Compliant Repackaged Avastin® Service – Multiple presentations available based on physician preference

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.

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 healthcare 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.

• Compatible with Besse Medical’s inventory management systems

Corporate Profiles 2022–2023

Special Advertising Section Pharmacy Practice News

Medi-Dose/EPS 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.”

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 70 Industrial Drive medication administration systems require. PopuIvyland, PA 18974 lar 1D and 2D barcode formats can be created Phone: (800) 523-8966 with National Drug Code numbers, beyond-use Fax: (800) 323-8966 dates, lot numbers and special codes. Plus, MILT info@medidose.com 4 suggests tall man lettering options (e.g., DOPawww.medidose.com mine 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.

AT A GLANCE

To get started, all you will need is:

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.

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

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

• • • •

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.

Special Advertising Section Pharmacy Practice News

Corporate Profiles 2022–2023

Pharmacy Practice News AT A GLANCE 545 W. 45th Street, 8th Floor New York, NY 10036 Phone: (212) 957-5300 Fax: (212) 957-7230 pharmacypracticenews.com

Editorial Director David Bronstein davidb@mcmahonmed.com Ext. 212

Publication Director Dave Kaplan dkaplan@mcmahonmed.com (973) 885-2315

Senior Editor Marie Rosenthal mrosenthal@mcmahonmed.com Ext. 265

Launched 40 years ago, Pharmacy Practice News remains loyal to an editorial mission focused on giving health-system pharmacists the information they need to deliver highquality, cost-effective patient care.

Meeting Coverage To achieve that goal, our editors follow the latest developments in hospital practice. Much of our content comes from attending meetings convened by the major pharmacy groups, such as ASHP and the American College of Clinical Pharmacy. But we also attend smaller, more focused conferences to keep our readers abreast of the latest trends in patient care, including the annual meetings of the Hematology/Oncology Pharmacy Association and MAD-ID: Making a Difference in Infectious Diseases.

We also rely on content partnerships to keep our readers informed, such as one with the American Society for Parenteral and Enteral Nutrition, which contributes annual review articles and access to webinars on several hot topics in the field.

Peer-to-Peer Content

Associate Editor

Pharmacy Practice News welcomes contributions from readers to facilitate a peer-to-peer exchange of best practices. Recent examples include an article on emergency preparedness by the University of Illinois at Chicago, which details Sales Account Manager how the hospital kept serving the medication Lillie Onday therapy needs of its patients during the height londay@mcmahonmed.com of civil unrest triggered by the George Floyd (732) 979-7009 protests (bit.ly/3OC5ddB).

We continue to feature regular contributions from thought leaders in pharmacy, including Bonnie Kirschenbaum, MS, FASHP, who pens the monthly “Reimbursement Matters” column. Our newest addition, “TechTrends,” is coordinated by series editor and new advisory board member David Aguero, PharmD, the director of medication use systems and informatics, Division of Pharmaceutical Services, at St. Jude Children’s Research Hospital, in Memphis, Tenn.

Kate Baggaley kbaggaley@mcmahonmed.com (973) 768-2185

Video interviews with the nation’s top health-system pharmacy experts continue to post to the website. One recent example is a discussion with Lisa Holle, PharmD, BCOP, a hem/onc pharmacist at the University of Connecticut School of Pharmacy, in Storrs. In a wideranging interview, Dr. Holle offers more of her insights on the breakthrough study of rectal cancer detailed in this issue (page 1), including how to manage the expectations of patients who have heard of the 100% remissions reported, and who expect similar results.

Supplements Pharmacy Practice News publishes educational supplements such as Special Reports and Literature Reviews bound inside the newsmagazines. These supplements are produced by our Special Projects division and can be accessed via the “Medical Education” tab on our website.

Website Enhancements Given the increasing importance of providing Pharmacy Practice News in multiple engaging digital formats, we have introduced several online enhancements. For example, we’ve added a Conference News landing page, where readers can find our pharmacy meeting coverage arranged chronologically. We also added a Digital Issue page, which features all articles from our monthly print issues for easy access.

All of these print and digital innovations are the reason why Pharmacy Practice News continues to be a leading source of information in a challenging practice environment. Our goal is to help our readers meet those challenges on a daily, weekly and monthly basis, for year-round relevance.

Home Delivery Now Available!

Given the variable nature of working onsite during the COVID-19 pandemic, many of our readers are opting for home delivery. It’s a great way to ensure you won’t miss a single FREE issue. Rest assured, we value your privacy and will not share your address with third parties. To get home delivery for new subscriptions, visit www. pharmacypracticenews.com/NewSubscription; for renewals, visit www.pharmacypracticenews.com/RenewSubscription

Special Sections Our special sections focus on important clinical and operational areas of pharmacy practice. Topics that receive this in-depth coverage include medication safety, biosimilars, sterile compounding, oncology, drug diversion, cold chain shipping, accreditation, antibiotic stewardship and more.

Review Articles One of the core editorial features of Pharmacy Practice News is our review articles. Written by pharmacists with specialized clinical training and experience, the reviews offer comprehensive summaries of state-of-the-art clinical care. Topics this year included parenteral nutrition and ISMP’s exclusive annual review of top medication errors. Many of these reviews are featured in Pharmacy Practice News Special Edition, our annual print compendium that mails in October.

Multimedia Initiatives Each month, print articles are posted to pharmacypracticenews.com and promoted on the leading social media platforms, including Facebook, Twitter and Instagram. Web-only, breaking news stories are posted daily. We deliver this content right to you through our thrice weekly e-newsletters. To subscribe to our e-newsletter, visit www.pharmacypracticenews.com/Registration.

Corporate Profiles 2022–2023

Special Advertising Section Pharmacy Practice News

Your Containment and Protection Ally

Put your mind and hands at ease with true containment.

True drug containment that offers comfort and peace of mind, HALO® CSTD is your complete solution for hazardous drug preparation and administration.

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1. Health and Human Services, Federal Drug Administration, 510(k) Clearance Letter, July 24, 2015.

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OSHA 3125 2000 (Revised).

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4. Internal study, data on file.

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2392-HALO-05-01/22

QuVa Pharma 503B: Resiliency, Reliability & Transparency

AT A GLANCE

QuVa Pharma is a leading national 503B outsourcing services company, covering all 50 states, providing ready-to-administer sterile injectable medicines critical for highquality patient care. QuVa was purpose-built to change the 503B industry for the better, and with unmatched expertise in Current Good Manufacturing Practices and deep experience in sterile pharmaceutical manufacturing, achieves the highest quality and safety standards. Through our products and services, hospitals gain resiliency, reliability and transparency. Our reliable and accountable service has delivered the answers needed by thousands of hospitals, and more than 90% of the customers who started with us three years ago are still customers today. With QuVa, always have an answer.

3 Sugar Creek Center Boulevard Suite 250 Sugar Land, TX 77478 (888) 339-0874 QuVaPharma.com

Deep & Broad Product Portfolio As a full-service 503B service provider, our portfolio of ready-toadminister sterile products supports hospital OR, post-op, ICU, labor and delivery, ER and general medicine areas. We also service hospitals through our robust and proven product development capabilities that have resulted in many new products that are requested by hospitals to meet their evolving treatment needs and that are essential for clinical care.

Capacity & Scale to Deliver Today and Tomorrow Our redundancy and scale, including 300,000 square feet of capacity across four facilities, and diverse supplier relationships enable us to operate as one of the largest 503B outsourcing companies in the industry.

QuVa services 90% of America’s Best Hospitals* and provides high-quality resources, processes and technologies so they can focus more time on improving healthcare delivery, patient safety and clinical outcomes. We continue to invest significantly in our Production Innovation Program, incorporating automation and integrated technologies that support increased resiliency and reliability.

Our product presentations span syringes (including Kit Check® RFID tagging), IV bags, CADD cassettes, PCA vials, Monoject Barrel syringes and pharmacy bulk bag packages.

Pharmacy Solutions Consulting QuVa offers a complimentary, confidential medication management assessment to support your process improvement projects, data analysis, regulatory compliance and clinical implementations to help your pharmacy and hospital excel. We partner confidentially with hospital pharmacy leadership, as well as anesthesia, OR and ICU/CCU clinical leaders to help design and implement strategies that increase operational efficiency between your pharmacy and other clinical departments.

Find out more about this service offering by visiting QuvaPharma.com/PSC. * U.S. News & World Reportt 2021-22 Annual Best Hospitals Rankings

Corporate Profiles 2022–2023

Special Advertising Section Pharmacy Practice News

Policy 31

Pharmacy Practice News • August 2022

COVID-19 Pandemic

Paxlovid Face-Off continued from page 1

interactions; or how many times have the pharmacist prevented the patient from being harmed by medications.”

The FDA did state that after testing positive for COVID-19, “patients should first consider seeking care from their regular healthcare provider or locating a Test-to-Treat site in their area.”

The community pharmacies not already participating as a Test-to-Treat site can

state-licensed pharmacist to review for kidney or liver problems.”

If pharmacists need more information, they could also receive this information through a consult with the patient’s healthcare provider.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Dr. Cavazzoni said.

nirmatrelvir+ritonavir to eligible knowledge of a patient’s medical history patients, but with certain limitations to and the ability to follow up. To ensure the ensure appropriate patient assessment best possible care for COVID-19 patients, we urge people who test positive to disand prescribing of the drug.

“While the majority of COVID-19 pos- cuss treatment options with their physiitive patients will benefit from Paxlovid, cian, if they have one.” it is not for everyone and prescribing it requires knowledge of a patient’s medi- AMA Stance ‘Extremely ‘Pharmacists receive far more cal history, as well as clinical monitor- Disappointing’ education on pharmacology, ing for side effects and follow-up care to Pharmacists said Dr. Resneck’s comdetermine whether a patient is improv- ments demonstrate a lack of underpharmacotherapeutics, pharmaing—requirements far beyond a phar- standing about the profession’s high ceutics [and] pharmacodynamics macist’s scope and training,” said Jack level of education and the important Resneck Jr., MD, the president of the role it plays in patient therapy. In than physicians.’

AMA, in a statement. fact, the ASHP told Pharmacy Practice The FDA’s new initiative is part of News that it has been working with the —Michael J. Cawley, PharmD a revised emergency use authoriza- administration, including the FDA and tion (EUA) for nirmatrelvir+ritonavir the White House, to expand pharmacist aimed at improve access to the medi- prescribing authority for oral antivirals.

The ASHP agreed with Dr. Cavazzoni. cation for some patients at high risk for “ASHP is pleased to see the FDA remove “As a clinical pharmacist and acaCOVID-19. The agency said it made the demician for 30 years, I have this barrier to patients’ access to this change because nirmatrelvir+ritonavir educated at least 1,000 phycritical treatment,” said Tom can reduce severe consequences of the sicians during my cliniKraus, the group’s vice presidisease, such as hospitalization and cal career,” said Michael J. dent of government relations. death, but it must be taken early in the Cawley, PharmD, RRT, CPFT, “Pharmacists have played a vital course of the disease. role in our pandemic response the chair of the Department of “Since Paxlovid must be taken within Pharmacy Practice at Temple efforts and are well positioned to five days after symptoms begin, autho- University School of Pharmacy, help patients, particularly those in rizing state-licensed pharmacists to pre- in Philadelphia, who was not rural and underserved communities, scribe Paxlovid could expand access part of the ASHP lobbying effort. benefit from this medication.” to timely treatment for some patients “Pharmacists educate medical stuDr. Cawley echoed the important role who are eligible to receive this drug for dents, medical interns and resipharmacists can play in this care setthe treatment of COVID-19,” explained dents, and routinely provided grand ting. “Pharmacists have the knowledge Patrizia Cavazzoni, MD, the director of rounds presentations to physicians in drug therapy utilization and laborathe FDA’s Center for Drug Evaluation on the appropriate use of drug thertory interpretation to assess and preand Research, in a statement. scribe Paxlovid,” and their accessibility apy. I find it extremely disappointing that Stuart Monk However, as noted, the agency the AMA makes statements that ‘this is and past work during the pandemic are stock.adobe.com placed some limitations on the author- far beyond the scope and training of a an advantage in this situation, he told ity given to pharmacists. Specifically, Pharmacy Practice News.

‘Pharmacists have played a vital role state-licensed pharmacists should refer More Resources Needed patients for clinical evaluation with a in our pandemic response efforts and To Meet COVID-19 Mission physician, an advanced practice regare well positioned to help patients, istered nurse, or a physician assistant However, pharmacists might need licensed or authorized under state law more resources to carry out this pandemic particularly those in rural and to prescribe drugs, if any of the followmission, Dr. Cawley admitted. “Although ing apply: [they] would be the perfect healthcare underserved communities, benefit • Sufficient information is not available provider to prescribe Paxlovid, the major from this medication.’ to assess renal and hepatic function. problem is pharmacists are understaffed, • Sufficient information is not available overwhelmed and simply ‘burned out’ in —Tom Kraus to assess for a potential drug interactin. the community setting,” he said.

• Modification of other medications pharmacist’ when their knowledge of decide if or how they will offer this serThat burnout is due to pharmais needed due to a potential drug pharmacy education is very limited or vice to patients, the agency said. cists having had “more responsibilities, In addition, the FDA recommended including COVID-19 testing and vacciinteraction. absent. Pharmacists receive far more Although the AMA agreed that education on pharmacology, pharmaco- that COVID-19–positive patients who nations on top of all their other responnirmatrelvir+ritonavir was a “critical therapeutics, pharmaceutics, pharmaco- want to know if they are eligible for sibilities, including providing a variety of nirmatrelvir+ritonavir at locations where other immunizations, hundreds of pretool in the fight against COVID-19,” the dynamics than physicians.” limitations set by FDA were not enough Dr. Cawley added that he routinely prescribing by state-licensed pharma- scriptions needing to be filled, calling to ensure patient safety. works with physicians, as well as ensur- cists is available, bring enough infor- physician offices, answering hundreds of “In the fight against a virus that has ing patient safety and preventing med- mation to ensure the state-licensed phone calls and many other responsibilikilled more than a million people in the ication errors. “When interacting with pharmacist has sufficient information ties,” Dr. Cawley added. “Unless pharmaUnited States and is still extremely pres- physicians, many times I have heard, ‘I to determine their eligibility to receive cists are given the quality time to assess, ent and transmissible, patients will get had no idea you had this much knowl- nirmatrelvir+ritonavir. Such informa- prescribe, monitor and follow up with the best, most comprehensive care from edge and education in drug therapy use’; tion includes a list of all the medications patients on Paxlovid, I am concerned physician-led teams—teams that include how many times as a part of the medical they are taking, as well as “electronic patients’ safety may be at risk.” pharmacists,” Dr. Resneck said. “But, team the pharmacist prevented medica- or printed health records less than 12 whenever possible, prescribing deci- tion overdoses, wrong doses, drug-drug, months old, including the most recent The sources reported no relevant financial disclosures. sions should be made by a physician with drug-disease and drug-laboratory [test] reports of laboratory blood work, for the

32 Policy

Pharmacy Practice News • August 2022

Reimbursement Matters

6 Steps for Sending Clean Claims to Payors Hospital revenues are plummeting, so it’s time to take action!

T

he pressures wrought by COVID-19 on business are still with us, and it’s turning out to be a long road to recovery. Providers and health systems are looking for ways to navigate from financial uncertainty to financial viability, and are exploring ways to garner and protect earned revenue for 2022 and beyond. Pharmacy leaders must answer

the call for change and innovation and, like all leaders, need to be adaptive when confronted with unknowns or “dangers” to their routines.

With these financial pressures, stress is real and often causes “threat rigidity”—a mindset that freezes innovation and a tendency to keep relying on what has worked in the past. It’s so

crucial to avoid these crisis missteps and address three common traps—narrow thinking, deferring to leaders who don’t embrace the need to respond proactively to these business pressures, and conformity.

Fortunately, there are several techniques for recovering revenue, managing changing payment models, building

“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.

Bonnie Kirschenbaum, MS, FASHP, FCSHP

A Reimbursement Lexicon APC, ambulatory payment classification; CMS, Centers for Medicare & Medicaid Services; EHR, electronic health record; HCPCS, Healthcare Common Procedure Coding System; LCD, local coverage determination; MAC, Medicare administrative contractor; NCD, national coverage determination; NDC, National Drug Code; OPPS, Outpatient Prospective Payment System; SI, status indicator

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better payor–provider relationships, and enhancing the patient financial experience.

One of the first goals is focusing on the importance of getting claims right the first time and eliminating denials.

It’s so much better to be right the first time instead of, sometimes fruitlessly, chasing denials. Complex payor rules and potential shifts in your payor mix— which are often due to massive unemployment—most likely have caused disruption in claims and payment. It’s now more critical than ever to maximize reimbursement from payors as soon and as smoothly as possible. This translates to strategies for managing denials and underpayments, improving up-front processes to prevent denial.

None of this will proceed smoothly without an awareness of your facility’s revenue cycle shortcomings. For that, you’ll need to do an honest selfassessment. One overarching question: Do you lack the knowledge, experience and discipline necessary to register, bill and collect correctly? Are you confident that you’re getting patient data right the first time, recognizing that it’s the key to reducing payor denials? Without a clear answer and a plan for improvement, you may well be one of those hospitals or healthcare systems that leave millions of dollars on the table every year.

Processes to Ensure Reimbursement What can you do to ensure clean claims get to the payors in a timely fashion and your organization is receiving payment for expensive medications?

Consider these six key steps:

1

Begin with an easy audit step.

Determine which drugs are attached to miscellaneous HCPCS codes

Policy 33

Pharmacy Practice News • August 2022

Reimbursement Matters J3490 and C9399. Use a spreadsheet or other sortable database copy of the complete pharmacy CDM(s) from across your system. Sort on the HCPCS column and focus on codes J3490 and C9399.

These codes are to be used only until a specific code is assigned to a product.

Once this occurs, continuing to use the old codes renders the claim denied. If you find any of these cases, correct them by linking the assigned specific code.

Continued appropriate use requires submission of the NDC number. Has the file build for these drugs included that?

5

Don’t ignore benefits investigations. This is the most complex of the essential steps to receiving payment and one in which pharmacy must step out of its silo and be an active participant.

Determine whether your EHR system can be an active tool in such efforts and who will be responsible for this

coordination. Put simply, for every patient, you must investigate what their insurance covers (sometimes specifically by the NDC), what is required to show medical necessity for the use of the product, and whether a prior authorization (PA) is required (inevitable for expensive medications). Note that CMS may use LCDs and NCDs found on the MAC websites in lieu of PAs. Because virtually every type of coverage requires a patient copay, verifying any out-of-pocket amount due and its collection from a coinsurer or the patient represents a

substantial amount of revenue that shouldn’t be lost or written off. not schedule a payment for 6 Do outpatient treatment before a PA

is approved, or is denied and must be challenged. Determine an allowable time—for instance, seven days—for this to be completed. Then proceed with patient scheduling, with a checkpoint reminder to reschedule if problems arise.

Remember that all PAs have expiration dates. Use your EHR system to track them and provide timely alerts.

■

2

Look for billing unit conversion miscalculations. A red flag for these miscalculations is payment that is very much lower or significantly higher than anticipated. The revenue cycle team may have alerted you to these errors or you can request them for review. Alternatively, pick the 10 most expensive agents (usually SI G products) and the 10 most frequently used agents (a mix of SI G and SI K products) used in the outpatient setting, and review the accuracy of the billing unit conversion crosswalk. Correct issues discovered and rebill if still in the open window for reimbursement resubmission. (As a refresher, SIs describe how particular HCPCS codes and APCs are paid—or not paid—under OPPS.)

Now approved for all ages and stages

what to expect from 3 Understand payor contracts. Under OPPS

rules, CMS pays 80% for outpatient Part B medications on an ASP-based fee schedule, and the patient or their coinsurance is responsible for 20%. The sequestration pause is over, with a full 2% deducted from the CMS portion; the copay remains at 20%. Each state’s Medicaid program has its own fee schedule. Learn what yours is and the requirements for getting paid. I’m continually amazed at how many facilities write this off and don’t even try to get paid!

4

Remember that commercial payors use many different payment models. For example, some payors might use a fee-for-service contract, with an ever-decreasing number based on a percentage of billed charges. Most payors are moving to ASP plus a percentage markup. Others have developed a capitated model with global budgeted revenue and flat payments. You must understand who your payors are and what your facility has contractually agreed to before you can determine whether the payments received are appropriate. Although this may be a new conversation for you, it’s one you must have with your finance team!

Include other issues such as whether or not they have agreed to white bagging even though you vehemently oppose it or it’s banned in your state.

Innovations that deliver

SMOFlipid is the first and only lipid injectable emulsion for adult and pediatric patients, including term and preterm neonates, in the U.S. that delivers a unique blend of 4 oil sources: soybean oil (30%), medium-chain triglycerides (30%), olive oil (25%), and fish oil (15%). It’s just one of our innovations that nourish.

Discover the SMOF difference at:

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SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Contraindications: Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients in SMOFlipid. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).

Please see Brief Summary of Prescribing Information for SMOFlipid on the next page.

34 Policy

Pharmacy Practice News • August 2022

Healthcare Access

REPRO HEALTH

The new guidance, sent by HHS to reproductive health and other types of more than 60,000 community phar- care.” continued from page 1 macies, states that, “under federal civil PharmD, ASHP’s senior director of phar- rights law, pregnancy discrimination A Refusal to Fill macy practice and quality, told Pharmacy includes discrimination based on current In the aftermath of the Dobbs Practice News. “Patients should not lose pregnancy, past pregnancy, potential or v. Jacksonville Women’s Health access to medications that are appro- intended pregnancy, and medical condi- Organization Supreme Court decision priately prescribed. But the guidance as tions related to pregnancy or childbirth.” overturning Roe v. Wade and Planned “We are committed to ensuring that Parenthood v. Casey legalizing aborwritten leaves out what pharmacists do for patient safety. It should recognize everyone can access health care, free tion nationwide, there have been multhe clinical role of the pharmacist and of discrimination,” said HHS Secretary tiple reports of pharmacies in states … include mention of our normal rou- Xavier Becerra in a release announc- that have banned abortion refusing to tine review of medication therapy for ing the guidance. “This includes fill lawful and medically appropriate access to prescription medications for prescriptions. appropriateness.”

Examples of Legal Violations

T

he HHS guidance included several examples of situations that could be a legal violation, including: • a pharmacist refusing to fill a prescription for pretreatment with mifepristone followed by treatment with misoprostol for a person experiencing an early miscarriage; • methotrexate to end an ectopic pregnancy; • methotrexate to treat rheumatoid arthritis; and • emergency contraception.

hypertriglyceridemia may have worsening of their hypertriglyceridemia with administration of SMOFlipid.

Excessive dextrose administration may further increase such risk.

SMOFLIPID (lipid injectable emulsion), for intravenous use BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information for intravenous use at www.freseniuskabinutrition.com.

INDICATIONS AND USAGE SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

DOSAGE AND ADMINISTRATION The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. Pediatric dosage is in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour.

SMOFlipid 1000 mL is supplied as a Pharmacy Bulk Package for admixing only and is not for direct infusion.

Prior to administration, transfer to a separate PN container for individual patient use. Use a non-vented, nonDEHP 1.2 micron in-line filter during administration. Protect the admixed PN solution from light.

Table 1: Recommended Pediatric Dosage Pediatric Age group

Initial Dose

Maximum Dose

Duration of infusion

Birth to 2 years of age (including preterm and term neonates*)

0.5 to 1 g/kg/day Increase the dose by 0.5 to 1 g/kg/day

3 g/kg/day

2 to <12 years of age

1 to 2 g/kg/day Increase the dose by 0.5 to 1 g/kg/day 1 to 2 g/kg/day

3 g/kg/day

20 to 24 hours for preterm and term neonates 12 to 24 hours for patients 1 month to 2 years 12 to 24 hours

2.5 g/kg/day

12 to 24 hours

12 to 17 years of age

* The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age).

CONTRAINDICATIONS • Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients in SMOFlipid.

• Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).

WARNINGS AND PRECAUTIONS • Risk of Parenteral Nutrition-Associated Liver Disease (PNALD) and Other Hepatobiliary Disorders: PNALD, or Intestinal failure associated liver disease (IFALD) can present as cholestasis or hepatic stenosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plantderived lipid emulsions, including SMOFlipid, have been associated with development of PNALD. In a randomized study of neonates and infants expected to be treated with PN for at least 28 days, parenteral nutrition-associated cholestasis (PNAC), a precursor to PNALD, developed less frequently in SMOFlipidtreated patients than in 100% soybean oil lipid emulsion-treated patients.

Monitor liver tests in patients treated with SMOFlipid and consider discontinuation or dosage reduction if abnormalities occur.

Other Hepatobiliary Disorders Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some parenteral nutritiontreated patients without preexisting liver disease. Monitor liver tests when administering SMOFlipid. Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to SMOFlipid use.

• Death in Preterm Neonates: Deaths in preterm neonates after infusion of lipid injectable emulsions containing only soybean oil have been reported in the medical literature. Autopsy findings in these preterm neonates included intravascular lipid accumulation in the lungs. Preterm and small-for-gestationalage neonates have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. This risk due to poor lipid clearance should be considered when administering intravenous lipid emulsions. Monitor patients receiving SMOFlipid for signs and symptoms of pleural or pericardial effusion.

• Hypersensitivity Reactions: SMOFlipid contains soybean oil, fish oil, and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut protein, or to any of the active or inactive ingredients in SMOFlipid. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid immediately and initiate appropriate treatment and supportive measures.

• Infections: Lipid emulsions, such as SMOFlipid, can support microbial growth and are an independent risk factor for the development of catheter-related bloodstream infections. To decrease the risk of infectious complications, ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of SMOFlipid. Monitor for signs and symptoms of infection including fever and chills, as well as laboratory test results that might indicate infection (including leukocytosis and hyperglycemia).

Perform frequent checks of the intravenous catheter insertion site for edema, redness, and discharge.

• Fat Overload Syndrome: This is a rare condition that has been reported with intravenous lipid emulsions, and is characterized by a sudden deterioration in the patient’s condition (e.g., fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, hepatomegaly, deteriorating liver function, and central nervous system manifestations such as coma). A reduced or limited ability to metabolize lipids, accompanied by prolonged plasma clearance (resulting in higher lipid levels), may result in this syndrome.

Although fat overload syndrome has been most frequently observed when the recommended lipid dose or infusion rate was exceeded, cases have also been described when the lipid formulation was administered according to instructions.

If signs or symptoms of fat overload syndrome occur, stop SMOFlipid. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.

• Refeeding Syndrome: Administering PN to severely malnourished patients may result in refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as patients become anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, closely monitor severely malnourished patients and slowly increase their nutrient intake.

• Hypertriglyceridemia: The use of SMOFlipid is contraindicated in patients with hypertriglyceridemia with serum triglyceride concentrations >1,000 mg/dL. Patients with conditions such as inherited lipid disorders, obesity, diabetes mellitus, or metabolic syndromes have a higher risk of developing hypertriglyceridemia with the use of SMOFlipid. In addition, patients with

Fresenius Kabi USA, LLC Three Corporate Drive, Lake Zurich, IL 60047 Phone: 1.888.386.1300 www.fresenius-kabi.com/us

Evaluate patients’ capacity to metabolize and eliminate the infused lipid emulsion by measuring serum triglycerides before the start of infusion (baseline value) and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the SMOFlipid infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia such as pancreatitis. In pediatric patients with hypertriglyceridemia, lower triglyceride levels (i.e., below 400 mg/dL) may be associated with adverse reactions. Monitor serum triglyceride levels to avoid potential complications with hypertriglyceridemia such as pancreatitis, lipid pneumonitis, and neurologic changes, including kernicterus.

To minimize the risk of new or worsening of hypertriglyceridemia, assess high-risk patients for their overall energy intake including other sources of lipids and dextrose, as well as concomitant drugs that may affect lipid and dextrose metabolism.

• Aluminum Toxicity: SMOFlipid contains no more than 25 mcg/L of aluminum. Prolonged PN administration in patients with renal impairment may result in aluminum reaching toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

• Essential Fatty Acid Deficiency: Treatment-emergent cases of moderate or severe essential fatty acid deficiency (EFAD) (defined as the triene [Mead acid] to tetraene [arachidonic acid] ratio >0.2 and >0.4, respectively) were not observed in pediatric clinical trials of SMOFlipid up to 28 days. However, cases of EFAD have been reported in adults and pediatric patients in the postmarketing period with the use of SMOFlipid.

The median time to onset was greater than 28 days among cases that reported time to onset. Monitor patients for laboratory evidence (e.g., abnormal fatty acid levels) and clinical symptoms of EFAD (e.g., skin manifestations and poor growth) because these signs may emerge before laboratory evidence of EFAD is confirmed. Laboratory testing using the triene to tetraene ratio may not be adequate to diagnose EFAD, and assessment of individual fatty acid levels may be needed. Ensure patients are receiving recommended dosages of SMOFlipid to prevent EFAD. • Monitoring/Laboratory Tests: Throughout treatment monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, coagulation parameters, and complete blood count including platelets.

The lipids contained in SMOFlipid may interfere with some laboratory blood tests (e.g., hemoglobin, lactate dehydrogenase [LDH], bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream. Conduct these blood tests at least 6 hours after stopping the infusion. SMOFlipid contains vitamin K that may counteract anticoagulant activity.

ADVERSE REACTIONS Most common adverse drug reactions >1% of adult patients who received SMOFlipid from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, urinary tract infection, anemia and device-related infection.

Less common adverse reactions in ) 1% of adult patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gammaglutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis.

The most common adverse drug reactions in >1% of pediatric patients who received SMOFlipid anemia, vomiting, gamma-glutamyltransferase increased, nosocomial infection, cholestasis, pyrexia, C-reactive protein increased, hyperbilirubinemia, abdominal pain, bilirubin conjugated increased, diarrhea, tachycardia, thrombocytopenia, hyperglycemia, sepsis.

Less common adverse reactions in )1% of pediatric patients who received SMOFlipid were decreased hematocrit, metabolic acidosis, increased blood triglycerides, infection, increased blood alkaline phosphatase, increased alanine aminotransferase, fluid overload, hypertension, hypertriglyceridemia, and rash.

The following adverse reactions have been identified during post-approval use of SMOFlipid in countries where it is registered. Cardiac disorders: palpitations; General disorders and administration site conditions: chills, chest pain, malaise; Hepatobiliary disorders: cholestasis; Infections and Infestations: infection; Metabolism and nutrition disorders: fatty acid deficiency; Respiratory, Thoracic and Mediastinal Disorders: dyspnea; Skin and subcutaneous tissue disorders: hyperhidrosis; Vascular disorders: phlebitis.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS Soybean and olive oils in SMOFlipid contain vitamin K1 which may counteract the anticoagulant activity of vitamin K antagonists such as warfarin. In patients who receive concomitant SMOFlipid and warfarin, increase monitoring of laboratory parameters for anticoagulant activity.

USE IN SPECIFIC POPULATIONS • Pregnancy and Lactation: Administration of the recommended dose of SMOFlipid is not expected to cause major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with SMOFlipid. Administration of the recommended dose of SMOFlipid is not expected to cause harm to a breastfed infant. There are no data on the presence of SMOFlipid in human or animal milk or its effects on milk production.

• Pediatric Use: The safety and effectiveness of SMOFlipid have been established as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated in pediatric patients, including term and preterm neonates. Use of SMOFlipid in neonates is supported by evidence from short-term (i.e., 1- to 4- week) studies, and one study following neonates beyond 4 weeks [see Clinical Studies (14.2)]. Use of SMOFlipid in older pediatric patients is supported by evidence from a short-term (i.e., <28 days) study in pediatric patients 28 days to 12 years of age and additional evidence from studies in adults [see Clinical Studies (14)]. The most common adverse reactions in SMOFlipid-treated pediatric patients were anemia, vomiting, gamma-glutamyltransferase increased, and nosocomial infection [see Adverse Reactions (6.1)]. PNALD, also referred to as IFALD, has been reported in pediatric patients who received SMOFlipid for more than 2 weeks. PNAC (a precursor to PNALD) was reported less frequently in SMOFlipid- treated patients compared to soybean oil lipid emulsion-treated patients in Pediatric Study 1 [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Although clinically significant cases of EFAD were not observed during short-term use in pediatric clinical studies, cases of EFAD have been reported with the use of SMOFlipid in the postmarketing setting [see Warnings and Precautions (5.9), Adverse Reactions (6.1)]. Monitor pediatric patients for laboratory evidence of EFAD because they may be particularly vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided [see Warnings and Precautions (5.9)]. Deaths in preterm infants after infusion of lipid injectable emulsions containing only soybean oil have been reported in medical literature [see Warnings and Precautions (5.2)]. Because of immature renal function, preterm infants receiving prolonged treatment with SMOFlipid may be at risk for aluminum toxicity [see Warnings and Precautions (5.8)].

OVERDOSAGE In the event of an overdose, fat overload syndrome may occur. Stop the SMOFlipid infusion until triglyceride levels have normalized and symptoms have abated. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from plasma.

Fresenius Kabi USA Nutrition ©2022 Fresenius Kabi USA, LLC. | All Rights Reserved. | 2325-SMF-05-04/22

For example, when Alexandra Weiss Band, DO, a staff physician at the Ochsner Clinic Foundation in New Orleans, prescribed misoprostol (Cytotec, Pfizer) to make the insertion of an intrauterine device (IUD) for contraception less painful, the Walgreens pharmacy called to ask whether the prescription was associated with an abortion. Although the doctor said it was for an IUD insertion, the pharmacist still refused to dispense the medication, according to an affidavit submitted (bit.ly/3obgxCN) on July 5 in a New Orleans Civil District Court case challenging Louisiana’s abortion law.

Press reports have recounted situations in which pharmacies have refused to fill prescriptions for methotrexate, a folate antagonist that can cause miscarriage at high doses and is the preferred treatment for ectopic pregnancy, and is also one of the most commonly used drugs for the treatment of inflammatory conditions such as rheumatoid arthritis, lupus, psoriasis and psoriatic arthritis, and Crohn’s disease (lat.ms/3PyRVQ3).

The Lupus Foundation, American College of Rheumatology and the Arthritis Foundation have all made statements in support of continued access to the medication.

These refusals are impermissible for pharmacies that receive federal funding, based on provisions in the Affordable Care Act and the Rehabilitation Act of 1973, the HHS memo said, noting that such pharmacies cannot discriminate based on their views on contraception and abortion “in regard to supplying medications; making determinations regarding the suitability of a prescribed medication for a patient; or advising patients about medications and how to take them.” (See box.)

Depending on the circumstances, these refusals would be considered discrimination on the basis of sex or disability, the guidance noted.

The guidance also stated that the Church Amendments, which protect healthcare personnel from discrimination related to their employment because they refused to perform or assist in the performance of abortion or sterilization because of their religious beliefs or moral

Pharmacy Practice News • August 2022

AVOID UNEXPECTED OUTCOMES

Policy 35

Healthcare Access

On June 22, ASHP issued a statement (bit.ly/3AUqegx) supporting patients’ rights to access comprehensive reproductive healthcare services, including care for pre-conception, conception, post-conception and termination of pregnancies. The group also stressed that such access isn’t just an issue facing community pharmacies.

“We are concerned about patient access to healthcare and medications, regardless of the dispensing location,” Dr. Ganio said. “The laws and regulations are just as concerning for clinicians in ambulatory and hospital settings, in that they restrict professional autonomy and clinicians’ ability to use their expertise, introduce barriers that disrupt patient care, and endanger the patientprovider relationship.”

But as noted, ASHP has some hesitations about the language of the guidance; the group feels that it could be misinterpreted to undermine the professional role of the pharmacist.

On July 15, ASHP President Paul Abramowitz, PharmD, sent a letter to President Joe Biden asking him to direct the HHS to clarify that the guidance is not intended to limit the pharmacist– patient relationship or pharmacists’ clinical decision making (bit.ly/3RKc738).

“Specifically, the guidance states that ‘pharmacies may not discriminate against pharmacy customers on the bases prohibited by Section 1557 and Section 504—including with regard to supplying medications; making determinations regarding the suitability of a prescribed medication for a patient; or advising patients about medications and how to take them’ [emphasis ours],” the letter said. “Medication review and medication counseling are key elements of pharmacists’ clinical scope of practice.

“Although we understand the intent of the guidance is to protect patient access to medications that may have reproductive health indications, the language used is so broad that it could be read to limit the current obligations and authorities pharmacists have as statelicensed autonomous healthcare professionals and providers,” the letter said.

“Pharmacists are expected to provide all

Paralytic agent warning products improve error prevention initiatives and help protect patient safety.

Conflict With State Laws?

The ASHP also called for the agency to provide additional details about the interaction of federal discrimination and state laws regarding reproductive health, noting that it “also potentially conflicts with state laws regarding pharmacy practice and clinical decision-making, adding to the confusion and apprehension around state and federal laws pharmacists and other clinicians face in the aftermath of the Dobbs v. Jackson Women’s Health Organization decision.”

“There are potential criminal repercussions in some instances with state law,” Dr. Ganio said. “We are seeing sites err on the side of caution, being extremely conservative with how they approach these prescriptions. We need further guidance from states that have laws banning abortion to let us know what the onus on the clinician is. For example, the Kentucky Board of Pharmacy [BOP] has issued a memo stating that if you don’t have an indication on a prescription for methotrexate, you should assume it’s for something other than abortion. Now, that might give a pharmacist the ability to go ahead and confidently process that prescription, but we really should know the indication to make sure the dose is safe and appropriate for that patient.”

Although the Kentucky BOP regulation “may seem fine on the surface, what if a local prosecutor decides that they want to start investigating and prosecuting these prescriptions anyway? The majority of practicing pharmacists don’t have a law degree, and it’s extremely murky when you intertwine law and medicine.”

Dr. Ganio said ASHP is working on advocacy efforts to seek clarity from policymakers, legislative bodies and regulatory agencies about the expectations of pharmacists. The group’s letter also called for HHS to create and maintain regular communication on this issue with ASHP and other state and national organizations representing pharmacists.

“HHS should also consider adopting the [FDA’s] practice of establishing Memoranda of Understanding with groups to allow the agency to seek subject-matter expert input outside of notice-and-comment rulemaking processes,” the letter stated. “Open, direct communication could help the agency create tailored guidance and solutions for emergent issues, while avoiding confusion or misinterpretations.”

The sources reported no relevant financial disclosures.

WARNING: PARALYZING AGENT -CAUSES RESPIRATORY ARRESTPATIENT MUST BE VENTILATED

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ASHP Supports Patient Rights, But Has Questions

patients with comprehensive medication therapy management and to act in the best interest of the patient, ensuring their medication therapy is optimal, safe, and effective.”

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convictions, or because they performed or assisted in the performance of abortion or sterilization, also are enforced.

However, the guidance does not address how the Church Amendments would apply in a given case. “OCR [the Office for Civil Rights] will evaluate and apply the Church Amendments on a case-by-case basis,” the guidance said.

Patients who believe they were discriminated against at a pharmacy can file a complaint at www.hhs.gov/ocr/ complaints.

GoHCL.com

1.800.848.1633

36 Operations & Management

Pharmacy Practice News • August 2022

Practice Trends

Survey Showcases Health-System Specialty Care

By Karen Blum

Phoenix—Health-system specialty pharmacies (HSSPs) have developed robust patient care services 30,001-45,000, that encompass the patient journey from before spe16% cialty medication selection through treatment mon340B-covered itoring and optimization, according to results of entity, 99% the 2022 ASHP National Survey of Health-System Specialty Pharmacy Practice. >45,000, 30% Survey results, presented at the 2022 ASHP Summer Meetings and Exhibition, also found that HSSPs col10,001-30,000, Have offered 20% lect and use patient outcomes to drive monitoring specialty pharmacy and interventions, and that HSSP pharmacists and services for technicians integrated into specialty clinics serve as <5,000, 20% 7+ years, 48% a valuable clinical and educational resource for other clinic staff.

5,001-10,000, 0 00 However, there is room for improvement for HSSPs 12% in areas such as communicating outcomes metrics with stakeholders, using collaborative prescribing agreements and contributing to scientific literature, Affiliated with an said Autumn Zuckerman, PharmD, AAHIVP, BCPS, Figure 2. Prescription volume. academic medical CSP, the director of health outcomes and research at center, 64% Vanderbilt Specialty Pharmacy, in Nashville, Tenn.

The survey, developed by ASHP and the Vanderbilt Health System Specialty Pharmacy Outcomes Research Unsure, ure, >$20 Consortium, involving 26 health systems, built on 10% % million, ASHP’s first national survey on health-system spe14% Not cialty pharmacy practice from 2020 (Am J Health Syst tracked, racked, Pharm 2021;78[19]:1765-1791), Dr. Zuckerman said.

7% Figure 1. Characteristics of This year’s survey was designed to demonstrate the $10 million<$1 survey respondents. $20 million, million, benefits of HSSPs by showcasing clinical services they 10% 7% provide, she said. It contained 119 questions in six domains: general capabilities, pretreatment, treatment $5 millioninitiation, treatment monitoring, continuity of care always review provider medication selection and alert $10 million, them with concerns, Dr. Zuckerman said. Other comservices, and education and research.

13% The online survey was open in March and April 2022, mon roles were discussing medication selection with $1 million-$5 million, and representatives from 127 organizations partici- providers or making therapy selection.

39% For pretreatment assessments, all respondents said pated, representing a wide range of practice sites and demographics based on such factors as 340B eligibility they use EHRs to assess patients’ baseline disease status, comorbidities and conditions, and current medand prescription volume (Figures 1 and 2). ication list and previous therapies taken, and 51% Following are some survey highlights: General capabilities. More than half of respon- said pharmacists actively coordinate with clinics and dents said they provide services such as prior authori- patients to complete pretreatment workup when Figure 3. Amount of funds zation (PA) completion and denial assistance, financial needed. Counseling patients before medication selecgained from financial assistance enrollment, and specialty medication selec- tion occurs occasionally, and when it does, it is usually assistance programs annually. tion or recommendations for all patients prescribed during an in-person provider visit.

Treatment initiation. Nearly all respondents said specialty medications at their health system, regardless of where they fill their prescriptions. More than they use patient assistance programs, manufacturer Approximately 71% said a single negative response half also said they provide enhanced services such as copay and free drug programs, and disease state foun- or side effect in patients will trigger pharmacist interinjection training, transitions of care coordination and dation support to reduce patient financial burden vention, while 54% said a negative trend will trigger disease monitoring for patients who fill their prescrip- (Figure 3), with some respondents reporting fund col- pharmacist intervention. Standard clinic protocols lections in excess of $20 million, said Nicholas Gazda, and patient/disease factors were the most commonly tions at the HSSP. In other findings, at least 80% said they frequently PharmD, BCPS, CSP, the assistant director of phar- reported considerations to determine the frequency or always documented services such as process and macy at Cone Health, in Greensboro, N.C. of assessments, with medication adherence, duration Initial medication counseling most often is con- of therapy and patient complexity being the biggest status of insurance navigation and financial assistance procurement; patient response to therapy; initial ducted by telephone, 73% of respondents said, but determining factors. Telephone was the most common patient counseling notes; and medication reconcilia- some do this during separate clinic visits, provider method used for monitoring patients. tion results in electronic health records (EHRs) visi- visits or via video, Dr. Gazda said. Additionally, more Continuity of care. About 69% of HSSPs go beyond than 80% reported that pharmacists were involved traditional fulfillment to offer clinical services such as ble to providers and clinic staff, Dr. Zuckerman said.

Collaborative practice agreements and collaborative in screening and/or counseling for recommended chronic disease therapy management, collaborating drug therapy management programs were uncommon immunizations. with other team members to help with social deterTreatment monitoring. About 79% said patients minants of health, being involved in preventive wellin HSSPs, with 47% saying they did not use them in any of their clinics. HSSPs were most likely to report receive one to 10 touch points during their first year, ness programs and more, said Melissa Ortega, PharmD, their financial performance, prescription volume and exclusive of refill assessments, Dr. Zuckerman said, FASHP, the system executive director of ambulatory other metrics to health-system leadership, followed by and 95% reported tracking disease-specific outcomes services at Wellforce, the parent of Tufts Medical health clinic providers and staff, but were much less in at least some patients. Most (92%) said they use Center, in Boston (Figure 5, page 38). likely to report metrics to patients.

In addition, 22% reported managing Risk Evaluation disease-specific outcomes reporting to meet accrediPretreatment. Respondents reported that 63% of tation requirements, although many other uses were and Mitigation Strategies, or REMS, program medications the time, pharmacists embedded in specialty clinics cited (Figure 4, page 38). see SURVEY, page 38

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38 Operations & Management

Pharmacy Practice News • August 2022

Practice Trends

TOC Team Addresses Polypharmacy, Cuts Readmissions

By Sherree Geyer

The interventions included Phoenix—A pharmacist-led transi- medication deprescribing and tions of care (TOC) program achieved dose adjustment, improving modest reductions in hospital readmis- medication access, performing sions among geriatric patients, a group medication reconciliation, and challenged by polypharmacy, inade- addressing medication adherence.

To assess the effectiveness quate follow-up and other issues that can compromise post-discharge care, of this approach, Dr. Shieh and according to a new study presented at her colleagues conducted a prothe 2022 ASHP Summer Meetings and spective, single-center study of patients who were discharged Exhibition.

The study is the first of its kind to home from the Senior Care evaluate the effects of a pharmacist Clinic between October 2020 TOC service on hospital readmissions and January 2021. Using elecwithin a senior care primary care set- tronic health record data, they ting, reported lead researcher Jennifer compared patient outcomes of Shieh, PharmD, a pharmacy resident at that group with a historical conStanford Health Care, in Cupertino, Calif. trol group of patients who were The TOC program was facilitated discharged between October 2019 and The pharmacist identified 65 interventions, of which 49 (75.38%) were impleby a collaborative practice agreement January 2020.

Thirty-two patients in the interven- mented by the PCPs. between pharmacists and primary care As for readmissions, although the providers (PCPs) in Stanford Health’s tion group and 37 patients in the historical control group were included in the numbers were small, Dr. Shieh and Senior Care Clinic, she noted. her colleagues documented modest “Our goal was to implement post- final data analysis.

One key finding was the success the improvements: five (15.63%) patients in discharge TOC pharmacists in the Senior Care Clinic at Stanford,” Dr. Shieh team had in quickly reaching a high the intervention group were readmitexplained. “We notified a pharmacist proportion of patients with their inter- ted within 30 days post-discharge, comwhenever a geriatric patient in their ventions: Of the 32 patients in the pared with seven (18.92%) patients in clinic was discharged from the hospital intervention group, 28 (87.5%) were the historical baseline group.

“The results of our project were, gento home to conduct three- to five-day contacted within three to four days after erally, all very positive,” Dr. Shieh post-discharge phone calls to identify discharge, Dr. Shieh reported.

Moreover, PCPs accepted the majority said. “We saw all-cause, 30-day readpotential needed interventions aimed at of pharmacist-proposed interventions. mission rates lowered by 3.3% and ED optimizing medications.”

ASHP SP SURVEY continued from page 36

for all referred patients, and 86 respondents reported being involved in efforts to avoid medication waste, such as ensuring on-hand medication quantity is assessed prior to requesting refills. About half of HSSPs participate in managed care activities such as collaborating with health-system accountable care organizations to influence risk-based contracts or formulary decisions, and 48% are involved in population health efforts.

[emergency department] visits reduced by about 2.3%. When we look at the pilot versus control group, our small sample size was, most likely, the limiting factor that prevented statistical significance. If we extrapolate to a full-time pharmacist, we would see more readmissions, ED visits and adverse drug events prevented, which would produce a cost avoidance.”

The global COVID-19 pandemic also impeded research efforts.

“It [the research] occurred during COVID-19, so some patients may have been hesitant to present to the hospital. We targeted a very high-risk population, but want to expand it,” added Dr. Shieh, who called geriatric patients “the most high-risk at our facility.”

The stakes are high for addressing readmissions in this vulnerable patient population, she noted. Nearly 20% of Medicare patients are readmitted to the hospital within 30 days after discharge, and more than half of those readmissions are caused by medication-related adverse events.

Dr. Shieh reported no relevant financial disclosures.

Furthermore, 61% noted that pharmacists are staff each year, said Jennifer Donovan, PharmD, the involved in identifying and managing social determi- vice president of clinical services at Shields Health nants of health variables such as financial resource Solutions, in Stoughton, Mass. That education is most strain and health literacy, and 79% of respondents said often provided by an embedded pharmacist or inpharmacists were involved in transitions of care coor- services to other healthcare professionals. Additionally, dination in areas such as arranging for delivery of med- 62% provide education to medicine learners in areas ication to the home at the time of hospital discharge. such as specialty pharmacy services and insurance Most HSSPs use the EHR patient portal to communi- requirements. cate with patients.

Education and training. More than 80% of HSSPs The speakers reported no relevant financial disclosures. provide one or more education sessions to clinic Preconception care services

Waste avoidance programs

Sexual health counseling

Reporting for payor contracts

Other

69% of HSSPs offer more than fulfillment services

Nutrition support services Reporting to manufacturers

Genetic counseling

Adjusting frequency of patient monitoring

Preventative/wellness health screenings

Reporting to clinic providers

Smoking cessation programs Immunization clinic Non-specialty chronic disease management (e.g., diabetes, COPD) Provision of urgent or emergent medication supply when necessary Referral to health-system services such as nutrition, social work, etc.

Does not apply

Developing and executing quality improvement and/or research projects Identifying patients who need a pharmacist intervention Accreditation requirements 0 10 20 30 40 50 60 70 80 90 100

Figure 4. How data on disease-specific outcomes are used.

0

10

20

30

40

Figure 5. HSSP services offered beyond specialty medication fulfillment.

COPD, chronic obstructive pulmonary disease; HSSPs, health-system specialty pharmacies.

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40 Operations & Management

Pharmacy Practice News • August 2022

Practice Trends

A Virtual Solution for Taming Prior Authorizations

By Karen Blum

Phoenix—A novel virtual networking and education initiative established by Shields Health Solutions for pharmacists, pharmacy technicians and other providers at its more than 20 health-system partners has succeeded in streamlining prior authorizations (PAs) and copay assistance for patients.

Shields Health Solutions established its specialty pharmacy Community of Practice (CoP) program in late 2020 to aid in the management of four disease states: diabetes, infectious diseases, autoimmune conditions (rheumatology) and neurology. The CoP program incorporates continuous learning opportunities and a platform for collaboration, said Kuwan Blake, CPhT, the company’s manager of communities of practice, who presented early results of the program at the 2022 ASHP Summer Meetings and Exhibition (poster 26M).

Each disease community has its own subject matter expert (a pharmacist) and three pharmacy technicians who help with training and patient support. The technicians are trained to handle all pharmacy needs for patients, including submission of PAs, investigation of financial assistance options and coordination of timely medication refills.

Each community hosts virtual monthly meetings and quarterly webinars led by the leadership team or guest speakers, covering topics aimed at improving patient outcomes, as well as manufacturer-led sessions about PA criteria, copay assistance programs and new drug approvals. All meetings are recorded and archived for later viewing by community members as needed, Mr. Blake said. Teams also conduct one-on-one meetings with health-system staff.

Topics for the meetings and webinars originate from the leadership team based on observations and recommendations from the communities and business analytics reports.

Since launching, the CoP program has grown to 185 members in the infectious disease community, 205 in the autoimmune community, 112 in the diabetes community and 117 in the neurology community. The program attracted an average of 180 attendees across all meetings from January to March 2022.

Initial review of inhouse data for a disease state supported by a CoP versus a disease state unsupported by a CoP showed an 18% average increase in PA approval rates. Specifically, PA

approvals in 2021 were 79% for rheumatology and 74% for neurology versus 61% for oncology and 64% for transplantation. The latter two areas were not covered

by CoP programs. The average medication copay was $8 for rheumatology and $5 for neurology, compared with $10 for oncology and transplant medications.

A subsequent review of the data comparing each specific CoP disease state from the second quarter of 2020, before the communities launched, with the second quarter of 2022 demonstrated a 27% average increase in PA approval rates, and maintained or reduced patients’ out-of-pocket expenses.

“For [professionals working with] a lot of our disease states, specifically diabetes, sometimes it’s a pharmacy desert,” Mr. Blake said. “They may feel isolated and not close to other pharmacy technicians or pharmacists.” In contrast, being part of the CoP community, which is virtual, connects those professions “to someone who’s just like you, and who supports the business just like you,” he said. “It increases employee satisfaction, because you feel like you have resources. But also, you’re learning, which is helping our patients.”

Shields Health Solutions is expanding the initiative, Mr. Blake noted, starting with the launch of an oncology community in May 2022 and the impending launch of a transplant community.

Mr. Blake reported no relevant financial disclosures other than his stated employment.

Adding a Pharmacist Enhances Dermatology Specialty Clinic

By Sherree Geyer

Phoenix—Adding a dermatology pharmacist to the care model improved continuity and access to specialty drugs, according to a presentation at the 2022 ASHP Summer Meetings and Exhibition.

The initiative extended a service model that succeeded previously in digestive health and rheumatology, according to lead author Youna Kang, PharmD, BCPS, a pharmacy resident at Yale New Haven Health in Woodbridge, Conn.

For the new initiative, Dr. Kang and her colleagues set a goal of phasing in five pharmacists and 2.5 technicians over a year, with three pharmacists aligned with specific dermatologists, regardless of practice sites. The study set several prescription target goals between Oct. 1 and Dec. 31, 2021, including 56 referrals (55 received), 77 prescriptions captured (44 predetermined), and 28 adjudicated or dispensed (37 predetermined).

“Our first pharmacist was implemented in the clinic six or seven months ago, in addition to the two implemented in March,” Dr. Kang told Pharmacy Practice News. “So, the data’s still young.

We’re looking at how many patients

are being referred to our pharmacist; who typically present with psoriasis, how many prescriptions are sent to eczema and alopecia, Dr. Kang noted. our health-system pharmacy; and how These diseases “are difficult to manmany of those we adjudicate and dis- age,” she said. “The population seemed pense. Sometimes we’re playing a little like a good fit for what we could provide. They use a lot of medicines offcatchup to reach our target.”

Payor requirements have been a chal- label, and many are high-cost specialty lenge, she noted. “A lot of patients are drugs that can be difficult to access. We locked out because of insurance require- tweaked the [care] model, based on disments and can’t fill with us. We’re hop- cussions with our dermatology clinician ing by the end of the fiscal year, we’re champion who provided great feedback able to catch up to where we need to be.” to make it fit for that population.”

There were several barriers to achieving There also are clinical roadblocks to overcome in ambulatory outpatients, service outcomes. “The biggest limitation

was the dermatology pharmacist wasn’t implemented until about November or early December, kind of end of the quarter of the fiscal year,” Dr. Kang said. “So, a lot of the data looks a little low for Q1, but it wasn’t a full quarter.”

As noted, insurance barriers also emerged, including delays in prior authorization (PA) approvals. Despite those delays, “we’ve exceeded the target for [PAs], but those dispensed prescriptions are the kind of limitations we’re running into. Some of the logistical things are not in our control because of time delays. So, there is still a little bit of a ramp-up we’re still doing.”

Future directions, Dr. Kang noted, include confirmation and assessment of clinical outcomes, continued optimization of the model, and expansion of services to additional dermatologists.

Assuming those results confirm the encouraging initial findings, Dr. Kang said she believes her team’s project can serve as a model for the implementation of an integrated dermatology pharmacist for other health systems.

Dr. Kang reported no relevant financial disclosures.

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42 Operations & Management

Pharmacy Practice News • August 2022

COVID-19 Pandemic

Navigating the Pandemic With EUA Therapies

By Gina Shaw

I

nfusion and specialty pharmacies have been playing a critical role in navigating a frequently changing menu of infused monoclonal antibody therapies authorized for COVID-19 patients.

The process began on Nov. 9, 2020, when the FDA issued an emergency use authorization (EUA) for bamlanivimab (LY-CoV555, Lilly) for the treatment of mild to moderate COVID-19. One of the

first pharmacies to begin providing bamlanivimab was the pharmacy of Nebraska Medicine, in Omaha, the primary clinical teaching partner for the University of Nebraska Medical Center.

“We gave our first dose the last week of November, so we were a bit ahead of the curve compared with some other institutions,” said Colleen Malashock, PharmD, BCPS, Nebraska Medicine’s acute care pharmacy clinical manager.

Without preexisting personnel and equipment to provide these infusions in a space not already dedicated to infusion care, organizational leadership elected to repurpose one of Nebraska Medicine’s three oncology-based infusion centers solely for the purpose of COVID-19 monoclonal antibody (MAb) infusions. All patients originally scheduled for other treatment in this infusion center were rescheduled to one of

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• The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

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• Monitor for signs or symptoms of hypersensitivity reactions.

1. Granato D, et al. JPEN J Parenter Enteral Nutr, 2000;24:113-8 2. Buenestado, et al. JPEN J Parenter Enteral Nutr 2006;30:286-296.

3. Olthof ED, et al. Clin Nutr. 2013;32(4):643-649.

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the other two locations to avoid infection control challenges. This move led to increased workload for providers and patient relations personnel in communicating the changes to patients, required increased staffing and infusion capacity in the other centers, and was associated with a revenue loss of approximately $1 million.

“From an equity standpoint, we tried to flag patients who met the criteria for the antibodies based on the BLAZE-1 trial that led to the EUA and reach out to them, rather than requiring a provider to recognize that they needed therapy and go through the hoops to get them the drug,” Dr. Malashock said.

Working with infectious disease physicians, Nebraska Medicine’s infectious disease pharmacy specialists drafted a weighted, point-based scoring system, which was then translated into the electronic health record to screen all newly positive patients (Table).

Patients with the highest scores were prioritized for outreach calls to schedule therapy. Pharmacists working in patient-centered medical home clinics contacted patients who had been tested at primary care and immediate care clinics or at pre-procedural testing stations, while emergency department pharmacists contacted patients tested through the emergency department or

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Operations & Management 43

Pharmacy Practice News • August 2022

COVID-19 Pandemic

Amber Specialty Pharmacy’s 5 Skills for Managing MAbs LAS VEGAS—At the AXS22/Asembia Specialty Pharmacy Summit 2022, Amber Specialty Pharmacy shared five key operational skills it exercised during the early days of the pandemic, when it was one of the initial participants in a bamlanivimab pilot program established in partnership between the National Home Infusion Association (NHIA) and federal and state government agencies, initially focused on patients in long-term care facilities.

A willingness to collaborate. “It took some time for us to become accredited with the program, and the first shipment showed up at our pharmacies on Dec. 24, 2020—Christmas Eve,” recalled Vickie Sykes, Amber’s senior sourcing manager. “The allocation of supplies was fairly simple; once we needed more, we would send in the re-dispense data to NHIA, showing them which states were moving and which weren’t. They would evaluate if we needed more product and if so, they would put in the order.”

A readiness to work with federal health officials. As additional therapies were approved, in the spring of 2021, supplies were opened up not only to those in long-term care facilities but to true home

1.

2.

employee health.

Within three weeks after beginning to offer MAb infusions, the team also realized that they needed to add further qualifying criteria focused on symptom onset. “The initial EUA said that therapy should be initiated no later than 10 days after symptom onset, so we added that question to the algorithm,” said Andrea Keifer, PharmD, Nebraska Medicine’s specialty and ambulatory care pharmacy manager. “Then the window between symptom onset and starting therapy began to shorten, so outreach became more challenging, and by the time we reached some people they were out of the window for treatment.”

(For another specialty pharmacy’s approach to managing MAb EUAs, see sidebar.)

Meeting the Delta Challenge After some initial supply issues,

infusion patients. “At that point, we were able to request stock directly through AmerisourceBergen,” Ms. Sykes said. “But we went back to federal allocation in the summer of 2021 as the delta wave started ramping up. We could order from AmerisourceBergen, but they had to hold the shipment until they got approval from the Department of Health and Human Services.”

The patience to wait—and then react. Waiting for direction from HHS took some patience and planning, Ms. Sykes noted. “Every Monday, the federal team says, ‘These are the total number of doses available in each state,’ and every week we have to report our dispenses and the inventory on hand. All of that goes into a larger database so that the federal government knows where the product is and how fast it’s moving. They don’t want inventory sitting on the shelves gathering dust. We thought returning to federal allocation might be for just a 90-day window to get through the surges, but that’s still the process today.”

A willingness to educate health officials.

Getting the therapies allocated for home infusion also has required some education of statelevel officials. “At first, a couple of states weren’t

3.

4.

Nebraska Medicine usually was able to meet the needs of all patients who were interested in receiving therapy, even during the delta wave late in the summer of 2021—but then the omicron wave hit in December 2021. “We had hundreds of patients on the list, and we were allotted five doses a day,” Dr. Keifer said. “At that point, sotrovimab [VIR-7831, GSK] was the only authorized agent available, and you just couldn’t get it, so we had to manage our small stockpile plus the few extra doses we had trickling in. During that period, there were times when we weren’t able to meet the needs of all the patients who qualified for therapy.”

By that time, the National Institutes of Health had issued criteria for the monoclonal antibody therapies that shifted the focus to the unvaccinated population, so Nebraska Medicine added that criterion into its algorithm. “We gave see EUA THERAPIES, page 44

allocating any product to anyone other than acute care systems and outpatient centers within hospitals,” Ms. Sykes said. “They weren’t thinking about the community patient who has trouble getting to an outpatient site or is truly homebound. One state we serve, as recently as this month, hadn’t even created the process for us to be able to request Evusheld [tixagevimab co-packaged with cilgavimab, AstraZeneca], because they had kept that product in the transplant centers and oncology centers. We have to go through a whole process of educating them about Amber and how we have gotten these therapies to our patients.”

A willingness to educate patients. Such outreach is critical, noted Kelli Wyant, PharmD, Amber’s vice president of operations. “Evusheld is also available for preexposure prophylaxis in highrisk patients, and we have to get those patients to understand that it is available and that they are eligible, and educate them about the difference between this treatment and the vaccine and the fact that both still have a place in therapy for them,” Dr. Wyant said.

“Fortunately, since we started as a transplant pharmacy, we have strong relationships with the transplant patients and centers that we’ve served for 20 years.”

5.

The sources reported no relevant financial disclosures.

44 Operations & Management

Pharmacy Practice News • August 2022

COVID-19 Pandemic

EUA THERAPIES continued from page 43

evverybod a score, and every day, we everybody took t ok the to th group with the top scores and randomized five of them to get a d ran an therapy,” t erapy Dr. Malashock said. th (In April 2022, due to the rise A of the omicron BA.2 subvariant, against which sotrovimab is unlikely to be effective, the un FDA had paused distribution of this thi therapy. As for the drug’s current status, it is no longer curre authorized to treat COVID-19, author according to the agency.)

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Transitioning the Model Transition After th the first oral therapy, nirmatrelvir+ritonavir (Paxlovid, Pfizer) was approved in December 2021 and then became more widely available in late winter and early spring of 2022, Nebraska Medicine transitioned its COVID-19 MAb program from a pharmacist-run model to a prescriberbased model.

“With pharmacy owning this for 18 months, the providers hadn’t had to keep up with all of the changes, so we had to develop tools and resources to turn it over to the providers and have them feel comfortable managing this therapy while our role is now more one of support,” Dr. Malashock said. “Our IT [information technology] analytics expert, who built the initial scoring system, developed a COVID-19 therapy SmartSet in OneChart for the available therapeutic options, to give providers initial guidance on what the best therapy might be for a specific patient.”

As of the spring of 2022, Nebraska Medicine had infused more than 1,800 patients with MAb therapies. “Given the circumstances, I think we did a lot of things right in terms of establishing that outreach program to target the highest-risk patients,” Dr Malashock said. “It would have been beneficial if we hadn’t had to do retrospective telephone outreach; there were a lot of people who were difficult to reach by phone after we got back their positive test results, but at the time, results weren’t coming back fast enough for test to treat.”

Dr. Keifer emphasized the importance of flexibility in any EUA management plan. “At the time, most of Nebraska Medicine’s resources with regard to COVID-19 were directed toward inpatient care, and our focus was on finding ways that pharmacy could help in the ambulatory setting and keep people out of the hospital,” Dr. Keifer added.

“Overall, I think we adapted well to all of the changes.”

The sources reported no relevant financial disclosures.

Pharmacy Practice News • August 2022

Operations & Management 45

Compounding

5 Tips for Bringing the Heat to USP Compliance

By David Bronstein

A

s the summer doldrums hit most parts of the country and staffers begin to take vacation, it’s easy to slip into complacency when it comes to sterile compounding compliance. But experts warn that this is no time to ease up in this critical practice area. Keeping up-to-date on the various USP chapters on sterile and nonsterile compounding and radiopharmaceuticals, a readiness to take a critical look at your environmental sampling processes, and a willingness to invest in compounding technologies that promote healthcare worker safety are just a few of the areas requiring your team’s vigilance.

To help facilitate these efforts, here are five compounding compliance tips based on interviews with some of the leading experts in the field.

Start with a brushup on proposed USP chapter updates. It may be tempting to gloss over this step, since revisions to USP General Chapters <795> (nonsterile compounding) and <797> (sterile compounding), proposed in 2021, have not been finalized. That would be a mistake “because those revisions represent a baseline level of safe compounding practice that all health systems should be following,” said Patricia Kienle, RPh, MPA, BCSCP, the director of accreditation and medication safety at Cardinal Health. Moreover, don’t just aim for USP chapter compliance and then ignore quality improvement. “The standards as written by USP are minimum standards,” Ms. Kienle said. “The best practices that come out of what we all do drives improvement.”

To stay current, institutions should subscribe to the USP Compounding Compendium and follow the USP compounding page (www.usp.org/ compounding), she noted.

Become familiar with newly revised compounding guidelines from the Institute for Safe Medication Practices. At the heart of the revised ISMP guidelines is a strong recommendation to implement automation, including robotics and IV workflow management systems “that can prevent or catch compounding errors and provide safe patient care,” said Kevin Hansen, PharmD, MS, the systemwide director of pharmacy at Cone Health, in Greensboro, N.C. “It has become inexcusable to not use some extent of compounding technology or automation in most pharmacy practice settings that perform sterile compounding,” said Dr. Hansen, who was a member of the expert panel that took part in ISMP’s virtual summit last September to revise the organization’s existing compounding guidelines with a new focus on evolving technology.

The 24-page document is packed with administration of cytotoxic medications, concise bullet points—more than 160 in according to data cited by the CDC (bit. all—designed to boil down complex advi- ly/3OA0hGn). Such findings explain why sory information into the most essential use of the devices is mandatory when and practicable form possible: the essen- preparing antineoplastic agents listed in tial technology attributes, safe pharmacy Table 1 of a key guidance document from processes, safety gaps, and best practices the National Institute for Occupational for automated compounding devices, IV Safety and Health, Ms. Kienle noted. workflow management systems and IV Despite these data and the strengthrobots. The guidelines also specify nearly ened regulatory push to use CSTDs, three dozen general best practices for some health systems have resisted sterile compounding safety, and look at investing in the devices. Indeed, several what technology vendors and designers, practice surveys have shown that finanmoving forward, can do to advance com- cial concerns are the most commonly pounding safety. cited reason for hesitating on investFor more details on the new ISMP ing in CSTDs. Fortunately, there are guidelines, visit bit.ly/3PRNOP3. ways to offset some CSTD-related costs,

Don’t skimp on continuous including using the devices to extend process improvement. Your hos- the beyond-use dating (BUD) of chemopital may have the best cleanroom in therapy drug vials, noted Jim Jorgenson, town, built with the help of the best RPh, MDS, the CEO of Visante, which sterile compounding consultants and consults on CTSD implementation and the most advanced equipment. However, other pharmacy operations.

“USP standards mandate a six-hour if you’re not regularly checking the actual performance of those systems, expiration for single-use vials if the vial that can leave you vulnerable to break- is entered and maintained in ISO [class] downs in quality and safety. That’s why 5 conditions,” Mr. Jorgenson said. “But a team at Moses Cone Memorial by using a CSTD, compounding pharHospital took a page out of the Lean macists can maintain sterility beyond management training book and selected that six-hour time frame.”

That ability to extend BUD allows the “Gemba Walk” as its preferred tool for performing daily checks of all sterile for a related practice, drug vial optiand non-sterile compounding areas. mization (DVO), which can drastically Using specialist pharmacy technicians, reduce waste from chemotherapy drug the team conducts daily Gemba safety vials, Mr. Jorgenson noted. Indeed, the walks, looking for what the FDA deems University of North Carolina Medical “insanitary conditions,” such as rust or Center reported saving $43 million paint chips, signs of water leakage and annually with a CSTD-enabled DVO visible microbial contamination. “We do strategy (bit.ly/3OBrPev).

Ms. Kienle agreed that there is great this walkthrough every day, constantly visualizing things that might not look potential for offsetting CSTD costs via right,” said Kathleen Forbis, CPhT, such practices. But she added a caveat: CSPT, AAS. “If things are not running robust BUD sterility and stability testsmoothly, we troubleshoot and take ing needs to be done to ensure safety— tests that not all health systems are immediate actions.”

Consider adding closed system capable of conducting. “I really want drug-transfer devices (CSTDs) this extended BUD approach to work— to your compounding operations. I’ve been saying so for years,” she said.

When appropriately designed and used, “If it helps fund a portion of CSTD purCSTDs protect healthcare workers from chases—which really should be considexposures to hazardous drugs (HDs) ered a priority investment based on the during the compounding and devices’ safety benefits alone—I am in

favor of it. But I would not do it at the expense of safety to the patient; the BUD testing component really needs to be nailed down.”

Have a robust environmental sampling process in place, and be ready for several rounds of process and facility improvement. This was a valuable lesson learned for Bridget Gegorski, PharmD, the medication safety officer at University Hospitals Health System, in Cleveland. Despite having established a very thorough set of procedures for preventing HD contamination, including engineering controls such as biological safety cabinets, proper ventilation and negative pressure rooms, along with repeated staff education, a series of surface contamination tests showed that something was amiss at several University Hospital sites. “The tests showed that we were still getting at least low positives in the environment in places where we wouldn’t expect it—areas where we know the operators are doing things correctly,” Dr. Gegorski said. “So this was a big surprise.”

Her team responded by taking all the recommended steps that should follow a finding of HD contamination, including cleaning the location with a deactivation/decontamination agent, evaluating proper use of CSTDs, and revisiting personal protective equipment procedures.

“But we still found low positives even after taking these steps,” she said.

The solution that finally worked was to consider an often overlooked source of chemotherapy contamination—HD particles on the outside of chemotherapy vials shipped by the hospital’s wholesaler. Such contamination has been well documented, including a 2020 literature review of 24 articles from 11 countries concluding that the majority of antineoplastic vials have surface contamination when they arrive (Eur J Hosp Pharm 2020;27[5]:313-314).

In response, University Hospitals added several new steps to its HD mitigation processes, such as having their wholesaler label chemotherapycontaining totes so health-system staff could wipe them down in protected areas to remove any HD particles.

Even that step did not eliminate HD contamination. A “refresh” of some of the older compounding facilities was required to ensure “that just about every one of our sites has a sterile compounding suite that is, if not brand new, at least refurbished, including deep cleaning of older hoods that was able to cut contamination back,” Dr. Gegorski said.

Additional reporting by Bruce Buckley, Gina Shaw and Karen Blum

46 Technology

Pharmacy Practice News • August 2022

Informatics

Looking for OR Drug Savings? There’s an App for That

By Michael Vlessides

San Diego—Health-system pharmacy leaders tasked with cutting drug budgets may find that a simulated anesthesia app may help save both time and money in in the near future.

Researchers at the University of Florida College of Medicine, in Gainesville, said the panoramic, screenbased simulator is particularly adept at assessing the cost of administering, monitoring and reversing neuromuscular blockade, while also considering drug costs and the cost of associated operating room time.

“Given the continued incidence of residual postoperative neuromuscular blockade, along with the fairly recent FDA approval of sugammadex [Bridion, Merck], there is renewed interest in fine-tuning the monitoring and reversal of neuromuscular blockade,” said Samsun Lampotang, PhD, the Joachim S. Gravenstein Professor of Anesthesiology at the University of Florida Health. With this in mind, Dr. Lampotang and his colleagues developed the interactive app, which he said was specifically designed to enable users to practice the administration, monitoring and reversal of neuromuscular blockade.

The app was built in Adobe Director, a now-discontinued authoring platform for multimedia applications, to simulate various anesthesia activities in the OR. Although the app uses only one computer screen to simulate the entire OR environment, users can pan around the entire room.

A range of simulated activities and equipment are represented, including video clips of intubation and laparoscopy. The app also simulates such equipment as a neuromuscular blockade monitor, an anesthesia machine with user-adjustable flow meters and vaporizers, gas analysis (which models breathing circuit dynamics like wash-in and washout), and physiologic monitoring.

Pharmacokinetic and pharmacodynamic parameters from official package inserts were used by the developers to mimic a host of related drugs, including sevoflurane, isoflurane, glycopyrrolate, neostigmine, succinylcholine, fentanyl, propofol, rocuronium and sugammadex.

Navigating the Simulation To help users assess the clinical and financial effects of their actions, the app incorporates an event log, which captures all user actions throughout the simulated case. This tool allows clinicians to go back in time and undo mid-case events, and even make a different decision without restarting

the scenario. The models then forecast relevant parameters for each new user interaction for up to three hours.

Finally, a scrolling time line gives users the opportunity to jump forward and backward in time, either to skip periods of inactivity or to undo a previous action. It is this kind of functionality, Dr. Lampotang explained, that allows users to see the potential costs and savings inherent in using a particular

neuromuscular blockade reversal strategy.

Using an innovation the researchers call a “taxi meter,” the app also displays the cost of the procedure on a minute-by minute basis. Using a baseline OR cost of $100 per minute, it illustrates the financial impacts of clinicians’ decisions, such as the time to complete recovery from deep neuromuscular blockade.

“This is where sugammadex shines,” Dr. Lampotang said. “Using a typical simulated patient, we assume that a drug like rocuronium will take considerably more than 40 minutes to clear out of the patient’s system on its own.

Using neostigmine or glycopyrrolate, that drops to approximately 20 minutes. But if you use sugammadex, you’re going to reverse the patient in a minute or two. So you’ve saved 18 minutes,

Technology

Pharmacy Practice News • August 2022

47

Informatics which we calculate as an immediate savings of $1,800.”

The researchers verified the app, which was presented at the 2022 Society for Technology in Anesthesia annual meeting, in Las Vegas, by comparing the output of each model with its source material, such as the package insert. It was found that drug concentrations, clinical durations and recovery times on the app matched these

materials. Anecdotally, anesthesiologists who used the app said its output also matched their clinical practice.

Unique App Ratan Banik, MD, PhD, an assistant professor of anesthesiology at the University of Minnesota Medical School, in Minneapolis, and the cocreator of an iPhone app that assesses the train-of-four ratio, said he believes the app

helps fill a void in the simulation world, and will likely improve clinical practice. “Many clinicians have a hard time grasping the concept of quantitative neuromuscular blockade because these devices are unavailable at many institutions. Even when they are available, we tend to use them only for research purposes,” he said. “So if we can teach people through a simulated environment, all the better.”

Drs. Banik and Lampotang reported no relevant financial disclosures.