Pharmacy Practice News - September 2021

The Best-Read Pharmacist’s News Source

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CLINICAL

Pharmacists help boost adherence to oral chemotherapy ...................

3

Specialty pharmacists put more PEP in HIV prophylaxis ......................... 6

TECHNOLOGY

Patient portals drive better outcomes ..............

8

POLICY

Pharma fires another salvo in 340B wars ....... 14 SPECIALTY PHARMACY

ASHP Summit eyes future direction for hospital-based specialty care .................

New CLL Data Point to ‘Durable, Lasting Response’

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series of studies and trials conducted in chronic lymphocytic leukemia (CLL) suggest that an increasing proportion of patients are surviving without disease progression for extended periods. The durable responses, including undetectable minimal residual disease (uMRD) status, have been impressive. At the 2021 meeting of the American Society of Clinical Oncology (ASCO), new data from the CAPTIVATE trial were the latest to suggest new therapies are altering the prognosis of CLL. The CAPTIVATE trial is evaluating the all-oral combination of ibrutinib (Imbruvica, Pharmacyclics/ Janssen) and venetoclax (Venclexta, Genentech/AbbVie) for first-line treatment of CLL. Two cohorts were studied. One, the MRD cohort, was presented at the American Society of

his May, Scripps Health, in San Diego, was hit by a ransomware attack that forced the health system into electronic health record (EHR) downtime. Hospitals in four locations had to divert emergency stroke, heart attack and trauma patients to other hospitals, and the online patient portal was temporarily taken offline. Further compounding the disruptions, clinicians were forced to use paper records because telemetry was affected at most locations and access to medical imaging also was temporarily disrupted.

Scripps is far from alone. Researchers at the cybersecurity website Comparitech found that 92 individual ransomware attacks affected more than 600 separate clinics, hospitals and organizations and more than 18 million patient records last year, at an estimated cost of $21 billion (bit.ly/3APEepv). That’s a 60% increase over 2019.

Ransomware is malicious software designed to deny an individual or organization access

Continued on page 4

Continued on page 12

For Ransomware Hacks, Planning Ahead Is Crucial T

21

New ASHP survey:

CMS waiver extended during delta variant surge

Health Systems Still Fighting for Specialty Access

Hospital-at-Home Gains Traction

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The Only Antiemetic Approved for Rescue Treatment of Postoperative Nausea and Vomiting After Failed Prophylaxis See insert after page 4.

Volume 48 • Number 9 • September 2021

ealth systems continue to make significant inroads into the specialty pharmacy market, with more than two-thirds of multihospital systems launching programs in a recent five-year period. But despite those gains, the sector still faces major roadblocks, including a lack of access to limited distribution drugs (LDDs) and payor contracts, according to ASHP’s inaugural National Survey of Health-System Specialty Pharmacy Practice.

Continued on page 15

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efore November 2020, the biggest obstacle to delivering hospital-level care to acutely ill patients at home was a rule restricting Medicare fee-for-service payments to brick-and-mortar hospitals.

But with U.S. COVID-19 cases rising again at year-end, the Centers for Medicare & Medicaid Services (CMS) issued a waiver that effectively gave qualified hospitals the flexibility to provide acute home care to Medicare patients and get paid for it as if they were occupying a hospital bed.

Community-acquired pneumonia, heart failure, asthma and chronic obstructive pulmonary disease were among the more than 60 acute conditions that CMS considered treatable at home.

Review Article:

Parenteral Nutrition Safety See page 17.

The waiver was set to remain only for the duration of the public health emergency.

However, the financial benefit of inpatient diagnostic-related group payments has accelerated adoption of the hospital-at-home model. By August, more than 140 hospitals in 32 states, most in large health systems, had been approved under CMS’s Acute Hospital Care at Home program. The surge in delta variant cases has all but ensured that the waiver will remain into 2022.

Mount Sinai Hospital, in New York City, and Brigham and Women’s Hospital, in Boston, were two of the six health systems first authorized under the waiver.

Both hospitals have extensive experience Continued on page 10

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Clinical

Pharmacy Practice News • September 2021

3

Oncology

Increasing Patient Adherence to Oral Chemotherapy W

ith more than 115 oral agents approved by the FDA to manage different types of cancer, oral oncolytics “have solidified their place in cancer treatment,” a pharmacist said at the virtual 2021 ASHP Specialty Pharmacy Conference. However, patients must remain adherent to these therapies to maximize their effectiveness, and that’s where a collaborative effort between clinical and specialty pharmacists can have a significant impact.

oncology patients, given that most data are available only in clinical trial settings, Dr. Segal said. “Ideally, a medication adherence [program] will be costeffective, user-friendly, easy to administer, highly reliable, flexible and practical. But keep in mind there is no gold standard.”

Strategies to improve adherence are not well established, Dr. Segal noted, but they should begin with patient education. Such education can provide valuable information to patients, empha-

• drug–drug and drug–food interactions; • adverse effects; • when to contact the health care team or seek immediate attention; • safe handling and disposing of medications; and • plans for follow-up care.

Because these sessions are “jammed with a lot of information,” Dr. Segal said, routine assessments for patient adherence and drug toxicity are imperative.

Patients also should know how to obtain their medication and the role of the specialty pharmacy and financial assistance.

Closing the Loop

There are many barriers to adherence, such as low health literacy, complex administration instructions, challenging adverse effects and high out-of-pocket costs, said Eve Segal, PharmD, BCOP, the lead clinical pharmacist at the University of Washington Medical Center/Seattle Cancer Care Alliance, during a clinical gems session. Specialty pharmacists can keep tabs on patient adherence through methods such as patient self-reports, prescription refill history, monitoring plasma levels or using medication event monitoring systems.

Unfortunately, it’s challenging to identify which strategy should be used for

size the benefits of remaining adherent to therapy and reduce patient anxiety.

Nonadherence to oral oncolytics often is caused by symptom burden, she said; when this is the case, patients benefit from routine adherence checkups. Other strategies to use include low- and hightech reminders, such as pill boxes and smartphone apps to address patient forgetfulness.

Materials to review during patient counseling should include the following types of information: • diagnosis; • course, duration and schedule of treatment;

An integrated, closed-loop, pharmacist-led oral chemotherapy management program can be an effective tool for managing these challenging patients, according to a team at the University of North Carolina (UNC) at Chapel Hill Medical Center. In 2014 to 2015, Benyam Muluneh, PharmD, BCOP, CPP, an assistant professor of pharmacotherapy and experimental therapeutics at the UNC Eshelman School of Pharmacy, helped set up a process by which patients with cancer prescribed oral chemotherapy drugs were seen in clinic by pharmacists and received their medication directly from the university’s specialty pharmacy. In the clinic, pharmacists saw patients directly after the physician, educating them about their therapy and the importance of adherence and doing a full medication review and clinical assessment. Next, the clinical pharmacists sent the prescription

EDITORIAL BOARD ADMINISTRATION Robert Adamson, PharmD, Livingston, NJ

—Karen Blum The sources reported no relevant financial disclosures.

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to the specialty pharmacy and served as a liaison, letting the pharmacy know whether to expedite the medications and about any social determinants of health to consider when delivering the drug, such as if a patient was homeless or needed instructions to be translated to a different language. The clinical pharmacists continued to follow patients throughout their care via clinic visits or phone calls, and ensure drugs and doses were still appropriate.

With the pilot program, patients’ comprehension of oral chemotherapy increased from 43% to 95%, Dr. Muluneh said. Adherence rates were 86% among gastrointestinal and breast cancer patients, and nearly 95% among hematologic oncology patients. The program also resulted in a higher molecular response rate—83%—in patients with chronic myeloid leukemia than published clinical trial rates of 40% to 60%, noted Dr. Muluneh, who is a co-author of the Hematology/Oncology Pharmacy Association’s “Best Practices for the Management of Oral Oncolytic Therapy” guideline in 2018.

With the recent “explosion of oral oncolytics” in the market, Dr. Muluneh is looking to expand and optimize the adherence intervention to include newer drugs, and to improve adaptability and sustainability. “Stay tuned,” he said.

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4 Clinical

Pharmacy Practice News • September 2021

Oncology

A Durable CLL Response

Dr. Ghia, noting that symptomatic AEs “were primarily grade 1 or 2.”

continued from page 1

GLOW Study: Fixed Duration In Older CLL Patients

Hematology (ASH) meeting last December. The second, called the fixed-duration cohort, was presented at the most recent ASCO meeting. The combination showed strong benefit in both cohorts.

“When administered over a fixed duration, the combination of ibrutinib and venetoclax provides deep, durable responses, including in those with genomic high-risk features,” reported

fixed-duration cohort, but those who achieved uMRD were then randomized to receive one more cycle of ibrutinib plus venetoclax or placebo. Those who did not achieve uMRD were randomized to continue on ibrutinib alone or the combination of ibrutinib plus venetoclax.

One year after achieving uMRD on the combination of ibrutinib and vene-

The fixed-duration regimen of ibrutinib and venetoclax is also highly effective when used as a first-line regimen in older CLL patients. In the randomized phase 3 GLOW study, presented as a late breaker at the 2021 European Hematology Association meeting (abstract LB1902), the same regimen employed in CAPTIVATE (three cycles

Data RESONATE:

RESONATE-2 Trial: Ibrutinib First Line in Older Patients

PFS at

6.5

years highly favored ibrutinib (61% vs. 9%) Only

11.5% of patients required a dose reduction due to an AE

1%

Only (one patient) needed dose reductions for grade 3 or higher AEs AE, adverse event; PFS, progression-free survival

Paolo Ghia, MD, PhD, from the University of Vita-Salute San Raffaele, in Milan, who presented the fixed-duration findings at ASCO. In both cohorts of CAPTIVATE, treatment-naive CLL patients received three cycles of ibrutinib alone followed by 12 cycles of ibrutinib plus venetoclax.

In the fixed-duration cohort (ASCO abstract 7501), the primary end point was complete response (CR). After a mean time of 27.9 months on study, 88 (55%) of the 159 patients achieved CR. The CR rate was essentially the same for those with or without 17p deletions or TP53 mutations. Of those who achieved CR, 89% sustained this response for at least one year. The objective response rate was 96%. The uMRD rate was 81% in the peripheral blood and 44% in the bone marrow.

The results in the fixed-duration cohort are consistent with those of the MRD cohort presented at ASH (abstract 123).

The 164 CLL patients who were enrolled in the MRD cohort received the same 15-cycle regimen of ibrutinib plus venetoclax as those in the

toclax, the diseasefree survival was 100%, whether patients were randomized to placebo or an additional cycle of ibrutinib and venetoclax. In the group that did not initially achieve uMRD, more than 95% achieved uMRD on extended treatment whether with ibrutinib alone (95.2%) or ibrutinib plus venetoclax (96.7%).

The depth of response achieved with first-line ibrutinib plus venetoclax “is reflected in the 30-month PFS [progression-free survival] rate of about 95% across all treatment groups,” according to William G. Wierda, MD, PhD, a professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, in Houston, who presented the MRD cohort data at ASH. In both groups, the combination of ibrutinib and venetoclax was well tolerated, with no episodes of tumor lysis syndrome. As in the MRD cohort, the most common grade 3 adverse event (AE) among those in the fixed-duration cohort was neutropenia, reported

and chlorambucil plus obinutuzumab were 51.9% and 17.1%, respectively, in the bone marrow (P<0.0001) and 54.7% and 39.0%, respectively, in the peripheral blood (P<0.001).

Dr. Kater said, “uMRD was largely maintained one year after treatment was completed.”

He noted that the safety profile in the relatively older patients was consistent with that previously reported in younger patients. The most common grade 3 or higher AEs were cytopenias. The most common nonhematologic AEs of grade 3 severity were diarrhea (10.4%) and hypertension (7.5%).

of ibrutinib alone followed by 12 cycles of ibrutinib plus venetoclax) achieved far higher rates of response and significantly longer PFS than chlorambucil plus obinutuzumab (Gazyva, Genentech).

Unlike CAPTIVATE, for which patients aged 70 years or younger were eligible, the GLOW study required patients to be 65 years of age or older.

The median age was 71.

After a median follow-up of 27.7 months, “the median PFS was 21 months for the combination of chlorambucil and obinutuzumab but has not yet been reached in the group randomized to ibrutinib plus venetoclax,” reported Arnon Kater, MD, PhD, the deputy head of the Department of Hematology at Amsterdam Medical Center.

For the risk for progression or death, this translated into a hazard ratio (HR) corresponding to a nearly 80% relative risk reduction in favor of ibrutinib plus venetoclax (HR, 0.216; P<0.0001).

The advantage for PFS was consistent across predefined subgroups. The rates of uMRD for ibrutinib plus venetoclax

Another trial evaluated older patients with CLL treated with ibrutinib or chlorambucil as first-line therapy. After a median follow-up of more than six years (74.9 months), substantial benefits have been maintained (ASCO abstract 7523).

The trial, RESONATE-2, which randomized 269 previously untreated CLL patients at least 65 years of age to daily ibrutinib until disease progression or unacceptable toxicity or to chlorambucil for 12 cycles, the rate of PFS at 6.5 years highly favored ibrutinib (61% vs. 9%).

“The PFS benefit relative to chlorambucil was observed across all subgroups, including those with high-risk genomic features, such as unmutated IGHV [immunoglobulin heavy-chain variable region gene] or del(11q),” reported Paul M. Barr, MD, the director of the Clinical Trials Office at the University of Rochester’s Wilmot Cancer Institute, in New York.

Consistent with other studies, ibrutinib has been well tolerated over extended exposure. In follow-up to date, 31 patients (11.5%) required a dose reduction due to an AE, but dose reductions for grade 3 or higher AEs has been required in only one (1%) patient who remained on therapy more than five years.

Of the patients initially randomized to receive ibrutinib and who have remained on therapy for up to seven years, 47% are still taking ibrutinib monotherapy, according to Dr. Barr. He noted that a modest increase in CR rates in extended follow-up suggests “responses continued to deepen over time.”

ELEVATE-TN and ELEVATE-RR; Acalabrutinib In previously treated patients, data from two large multicenter trials presented at ASCO suggest that the second-generation Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence, AstraZeneca) is associated with sustained efficacy in previously treated CLL patients. In one of the trials, acalabrutinib was directly compared

Clinical

Pharmacy Practice News • September 2021

5

Oncology with ibrutinib in this population and associated with a more favorable tolerability profile.

In a long-term follow-up of the ELEVATE-TN trial, after a median of 46.9 months of follow-up, the median PFS still has not been reached in an acalabrutinib monotherapy arm or in an arm that combined acalabrutinib with obinutuzumab (abstract 7509). In the comparator arm of chlorambucil plus obinutuzumab, the median PFS was 27.8 months.

In this trial, investigators randomly assigned 535 treatment-naive CLL patients to one of the three treatment arms. The PFS advantage for both arms containing acalabrutinib relative to the comparator arm was highly significant (P<0.0001). This PFS advantage was observed across subgroups, including those with adverse cytogenetics.

“Earlier results from ELEVATE-TN also associated both of the acalabrutinib arms with superior efficacy to the control arm,” reported Jeff Porter Sharman, MD, a staff oncologist at Willamette Valley Cancer Institute and Research Center, in Eugene, Ore. Even though crossover from the comparator arm at time of progression was permitted, “the efficacy advantage of the arms with acalabrutinib was maintained.”

Overall survival (OS) is trending toward an advantage after four years of follow-up for the group randomized to acalabrutinib plus obinutuzumab relative to chlorambucil plus obinutuzum-

of leukemia research at The Ohio State University College of Medicine, in Columbus.

This included the risk for atrial fibrillation or flutter, which occurred at a rate that was about half as great in the acalabrutinib arm as in the ibrutinib arm (0.366 vs. 0.721; P=0.02). In patients with no history of these arrhythmias, the risk reduction was nearly 60% (6.2% vs. 14.9%). Rates of treatment discontinuation for AEs (14.7% vs. 21.3%) and death (6.4% vs. 9.5%) also were substantially lower.

The advantage of acalabrutinib with regard to AEs is credited to its greater specificity of BTK inhibition, leading to fewer off-target effects, according to Dr. Byrd.

Enduring uMRD Achieved Positive results also have been reported in the relapsed-refractory setting.

About 25% of relapsed-refractory CLL patients who achieved uMRD while taking venetoclax-rituximab (VenR) and stopped treatment after two years have not yet progressed after three more years of follow-up, according to longterm results of the MURANO trial. The trial had shown VenR to be superior to the previous standard of bendamustinerituximab (BR), but the new data indicate some patients may reach indefinite

‘Closely monitoring adherence to oral oncolytics is of critical importance in clinical practice. Several studies have demonstrated gaps in adherence.’

—Benyam Muluneh, PharmD ab (93% vs. 88%; P=0.06). The 88% rate of OS in the acalabrutinib monotherapy arm was not different from the control arm. The discontinuation rate for AEs was slightly lower in the acalabrutinib combination and monotherapy arms (12.8% and 12.3%, respectively) than in the control arm (14.7%).

In the ELEVATE-RR trial, investigators randomly assigned 533 treatmentexperienced patients to receive acalabrutinib or ibrutinib therapy, testing the premise that acalabrutinib was noninferior to ibrutinib for PFS. After a median followup of 40.9 months, the median PFS was 38.4 months in both arms, but acalabrutinib was better tolerated (abstract 7500).

“Acalabrutinib demonstrated lower frequencies of common adverse events, grade 3 or higher adverse events, serious adverse events, and treatment discontinuations due to adverse events,” reported John C. Byrd, MD, the chair

disease control.

In the published results of the phase 3 MURANO trial, VenR was superior to BR for PFS in a trial that randomized 389 patients (N Engl J Med 2018;378[12]:1107-1120). Subsequent follow-up associated VenR with an OS advantage, producing an estimated OS of 81.1% for VenR versus 62.2% for BR (HR, 0.40; P=0.0001).

In the analysis presented at ASH (abstract 125), survival rates were even greater among the 118 patients who reached MRD or uMRD at the end of treatment. The estimated survival three years after treatment was 85.0% and 95.3% in these two groups, respectively.

Of the 83 patients with uMRD at the end of treatment, 32 have not yet shown progressive disease and remain uMRD at this five-year update.

Overall, the five-year data from MURANO associate VenR with

CAPTIVATE-ing Results:

55% of patients on ibrutinib and venetoclax achieved a complete response

89% sustained the response for at least one year The objective response rate was

96% sustained PFS and OS benefit over BR with 36 months of follow-up, Dr. Kater reported. The relative benefit is even greater in those who achieved uMRD by the end of treatment, with a small but meaningful proportion yet to demonstrate disease relapse.

A Pharmacist’s Perspective For pharmacists, it is important to recognize that standards have been moving quickly since the introduction of BTK inhibitors, such as ibrutinib, and the BCL-2 inhibitor venetoclax. Optimal treatment in CLL has been in a near constant state of evolution, according to Benyam Muluneh, PharmD, an assistant professor of pharmacotherapy and experimental therapeutics at UNC Eshelman School of Pharmacy, in Chapel Hill, N.C. He emphasized the role of pharmacists in staying on top of evolving standards to help patients reach deeper responses.

“First, closely monitoring adherence to oral oncolytics is of critical importance in clinical practice. Several studies have demonstrated gaps in adherence,” he said.

In a review by Partridge et al, for example, adherence rates ranging from less than 20% to 100% have been reported, with certain populations, such as adolescents, posing particular challenges (J Natl Cancer Inst 2002;94[9]:652-661).

“Additionally, it is well established that high rates (>95%) of dose intensity are needed to achieve optimal outcomes,” Dr. Muluneh added, citing a retrospective analysis of data from the RESONATE trial (Blood 2017;129[19]:2612-2615).

“When looking at common barriers to adherence, the three that pharmacists can help mitigate are forgetfulness, toxicities and cost. One role of the pharmacist at the initiation of therapy is to educate patients on how to integrate administration of oral oncolytics into their daily routine,” Dr. Muluneh said.

For helping patients with toxicities, Dr. Muluneh recommended tackling these from two perspectives. One involves informing patients about the relatively minor AEs they can monitor from home. The other involves teaching patients about side effects that should be brought to the clinic.

“Lastly, the pharmacist can work with specialty pharmacies or other medication access specialists to proactively address cost barriers,” he said.

“All in all, the pharmacist is a critical team member in the management of hematologic malignancies, serving to clear the barriers that reduce the likelihood of achieving the deep remissions associated with improved survival,” Dr. Muluneh said.

In CLL, specifically, he indicated that pharmacists who help patients weather AEs and remain closely adherent to prescribed therapies could change outcomes.

—Ted Bosworth Dr. Wierda reported financial relationships with AbbVie, Acerta, Genentech, Genzyme, Gilead, GlaxoSmithKline, Janssen, Juno, Kite, Loxo, Miragen, Novartis, Oncternal, Sunesis and Xencor.

Dr. Ghia reported financial relationships with AbbVie, AstraZeneca (AZ), BeiGene, Bristol Myers Squibb (BMS), Celgene, Gilead, Janssen, Juno and Lilly. Dr. Kater reported financial relationships with AbbVie, Genentech, Janssen and Roche. Dr. Sharman reported financial relationships with AbbVie, Acerta, AZ, BeiGene, BMS, Celgene, Genentech, Pfizer, Pharmacyclics and TG Therapeutics. Dr. Byrd reported financial relationships with Acerta, AZ, Genentech, Jazz, Novartis, Pharmacyclics, Syndax and Trillium. Dr. Barr reported financial relationships with AbbVie, AZ, Bayer, BeiGene, BMS, Genentech, Infinity, Janssen, Mei, Merck, Novartis, Pharmacyclics and Seattle Genetics. Dr. Muluneh reported no relevant financial disclosures.

6 Clinical

Pharmacy Practice News • September 2021

Infectious Disease

Specialty Pharmacists Improve HIV Prophylaxis in the ED

I

ntegrated health-system specialty pharmacy services in the emergency department (ED) can enhance care for HIV post-exposure prophylaxis (PEP) patients, according to a study presented at the virtual ASHP 2021 Specialty Pharmacy Conference.

The initiative used electronic health record (EHR) alerts to prompt the specialty pharmacy interventions. It resulted in better access to PEP therapy,

more consistent post-discharge followup care and several financial gains, including a boost in revenue from retained PEP prescriptions, reported Daniel Jude, PharmD, a clinical pharmacy specialist at North Memorial Health, in Robbinsdale, Minn., and lead author of the study.

Dr. Jude and his specialty pharmacy colleagues worked with their information technology department to create

an alert in the EHR that summons the on-site specialty pharmacist focused on infectious diseases whenever an antiretroviral was ordered by an ED provider, signaling an indication for PEP for a person living with HIV. The pharmacist then visits or calls the ED to provide specialized services for the patient, including support for medication access, medication counseling and education, mental health and primary

care access, and assessment of insurance coverage.

“If there was an opportunity to do so, our team made an intervention, trying to increase the ability of these patients to access future care,” Dr. Jude said. “We also did follow-up calls at five days, and lab reminders at three weeks and six months after exposure.”

During the 15-month study period, the specialty pharmacy service at

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North Memorial Health connected with a total of 89 individuals for PEP initiation. The group included 49 survivors of sexual assault (55.1%), 23 needlesticks (25.8%), eight occupational fluid exposures (9.0%), six checks for sexually transmitted infections (6.7%), two altercations (2.2%), and one good Samaritan (1.1%). PEP medications were given to 86 patients, while three of the occupationally exposed patients declined therapy after the orders were issued and did not receive any doses.

“We discontinued those orders if patients did not pick them up after the prescription was issued to the pharmacy, to prevent accidental fulfillment of these medications in a fashion that would not have shown benefit to prevent HIV and could possibly make the clinical situation worse,” Dr. Jude said.

Most PEP orders (88.9%) were filled

Clinical

Pharmacy Practice News • September 2021

7

Infectious Disease

80% of patients by the hospital system’s in-house specialty pharmacy, which resulted in better follow-up care, the authors found. “For the prescriptions filled at outside pharmacies, 80% of patients (eight of 10) were lost to follow-up after three months. For patients receiving their medication from our in-house specialty pharmacy, that number was less than 40%,” Dr. Jude said. “This really helped us drive the point home to our ED providers that they should keep these patients internal so we can continue working with them.”

Among the 77 total interventions undertaken by the specialty pharmacy, there were multiple referrals to mental health and primary care providers.

“We also successfully got four patients onto active insurance through referrals to a local AIDS service organization,” Dr. Jude added.

Before implementing this program, all of these interventions were left to the contracted sexual assault nurse examiner in the ED. “The patients were given a packet of information and told to follow up here, do this, call these people,” Dr. Jude said. “It was all up to them.

The prescriptions went to a local pharmacy that dealt with HIV treatment and also provided some services, but it was a central location, and it’s not clear what happened with the patients after that.

We know that the pharmacy didn’t necessarily make those interventions for things like access to primary and mental health care and insurance. We knew we could do a lot more for these patients.”

with HIV PEP prescriptions filled at outside pharmacies were lost to follow-up after three months,

versus 40% using an in-house specialty pharmacy.

PEP, post-exposure prophylaxis

The sources reported no relevant financial disclosures.

Read Specialty Pharmacy Continuum Anywhere, Anytime!

DRIVEN TO FULFILL THE PROMISE OF BIOSIMILARS— THE PFIZER WAY The Pfizer Promise is simple: To help you provide patients with more treatment options while delivering the largest portfolio of potentially cost-saving biosimilars.1-3

Breadth of offerings Pfizer has the largest portfolio of oncology biosimilars on the market, including both cancer therapies and supportive care with HIV PEP products, to give patients more treatment options.2,3

80% of p

Kudos for Specialty Outreach The North Memorial Health strategy is a novel one, said Nicole Acquisto, PharmD, an ED clinical pharmacy specialist at the University of Rochester Medical Center, in New York. “Typically, ED pharmacists are involved in setting up the process for patients to get HIV PEP medications following an exposure, but as far as screening of current medications, patient counseling and longerterm follow-up, that’s unfortunately not usually part of normal practice, due to competing clinical roles. This is a definite improvement, and I think it’s a model and partnership with specialty pharmacy that could be used elsewhere to help with PEP compliance and ensure appropriate post-exposure follow-up.”

Retained Revenue Justifies Costs “Our study [proves] that all specialty pharmacies in a health system should be supporting their EDs in this way,” Dr. Jude said. “Not only do they advance care for underserved populations, they

also minimize revenue loss from outside worker’s compensation claims, while retained revenue from the antiretroviral prescriptions justify the pharmacy care service. These are grand opportunities to show the value of the pharmacist through not only education but [also] connection to future services and, ultimately, building trust and lasting relationships with those patients.”

—Gina Shaw

filled at outsid were lost to fo Quality focused Pfizer oncology biosimilars are all produced to meet the same three m

versus

high-quality standards as its biologics—using the same robust protocols for monitoring quality throughout every stage of the an in-ho using manufacturing process.4

pharm

Manufacturing and supply experience

PEP, post-expos

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

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

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

www.specialtypharmacycontinuum.com PP-BIO-USA-0633

© 2020 Pfizer Inc.

All rights reserved.

June 2020

Sign up @ PharmacyPracticeNews.com/ Registration Get the latest news from the most widely read hospital pharmacy publication in the United States, including multimedia and web-only content, delivered directly to your inbox!

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8 Technology

September 2021

Specialty Pharmacy

Johns Hopkins Embraces Portal-Based Communication

O

n any given day, staff at the Johns Hopkins Home Care Group specialty pharmacy, in Baltimore, make up to 300 outbound patient calls and receive up to 150 additional calls from patients.

Trying to arrange medication deliveries and conducting clinical assessments by phone is time-consuming, to say the least. So, when they identified a way to make this process more efficient, they jumped at the opportunity.

To make their patient communication more efficient, they decided to use patient portals. This method provided an alternate route through which they could potentially evaluate medication efficacy, safety and adherence, and coordinate refills and medication delivery.

“One great thing about using a patient portal to communicate is that the pharmacist can answer any questions a patient has and offer recommendations right within the platform, and patients can reply on their own time,” said LaTasha Riddick, PharmD, a clinical coordinator at Johns Hopkins Home Care Group.

Since the hospital uses an Epic electronic health record system, Dr. Riddick and her team were able to access the MyChart patient portal. When setting out to implement the technology in their workflow, the pharmacy team and their colleagues in the information technology (IT) department decided to pilot the platform in the small population of their patients with migraine.

The pharmacy team developed six migraine medication–specific questionnaires to document the same type of information they were obtaining by phone— medication start dates, adherence rates, drug tolerance and efficacy—and the IT team built the questionnaires into Epic for use within the MyChart portal.

During the pilot, which was conducted in early 2020, 53 migraine patients received questionnaires one week after treatment initiation, and a subgroup who kept their prescriptions with the Johns Hopkins Home Care Group specialty pharmacy also received another questionnaire three months after initiation of the medication.

“The one-week questionnaire is much shorter than the three-month questionnaire, and simply asks patients what date they started their medication and whether they had any side effects,” Dr. Riddick said.

The overall response rate to the first questionnaire was 86%, she noted. Her team has yet to analyze three-month questionnaire response data.

A significant benefit of gathering information through a patient portal is that it flows to the pharmacist much faster than it typically does through phone-based contact, Dr. Riddick said.

“When we contact a patient by phone, we make our initial call, and if we don’t reach them, we call the patient again three business days later, and then again three days after that if we still can’t reach them. So, up to nine days can go by before we reach a patient by phone.”

In contrast, questionnaire responses submitted through MyChart arrived an average of 4.5 days after surveys were sent, she said.

Additionally, in an analysis comparing the time spent on 12 phone calls and 12 MyChart communications, Dr. Riddick’s team found pharmacists used a total of 137 minutes on calls versus 47 minutes for portalbased communication. That difference translated to an average of 11.4 minutes per call, in contrast to 3.9 minutes for a portal interaction.

“In our workflow, that’s a really noticeable time savings,” she said, noting that her team has not been billing for their portal interactions, but they may look for reimbursement opportunities in the future.

Selecting the right patients for portal engagement can help increase the odds of a questionnaire response, Dr. Riddick said. She and her colleagues only send questionnaires to patients who have already been using the portal to communicate with other physicians and nurses. “We also look at refill history in the pharmacy dispensing system, because we have more confidence that a patient who consistently refills their medication on time will respond to a questionnaire sent through MyChart.”

Portal-Based Communication ‘the Way of the Future’ With the success of the pilot for migraine patients, Dr. Riddick and her team have created questionnaires for other patients, including solidorgan transplant patients and those with inflammatory conditions. “Initially, we weren’t thinking that virtual health would be the norm, but with the

Technology

Pharmacy Practice News • September 2021

9

Patient Assistance

Standardization a Barrier to Tech Adoption in Health Care

T

he health care industry has been slower than others to adopt new technologies for many reasons. But in the case of patient assistance programs (PAPs), several e-tools are available to streamline and improve PAP offerings, speakers said during Informa’s PAP Critical Update 2021 virtual event.

The biggest challenge with point-ofcare health care has been standardization, said Steve Stidheim, the principal of product management for Cardinal Health. Mr. Stidheim works with the company’s Fuse Innovation Lab, a team of 350-plus experts in modern product technology, user experience design, data science and software engineering that creates PAP-specific and other commercial products in the health care space.

Finally, a lot of people don’t like or trust technology in health care.

“If I think about an artificial intelligence–driven chatbot, I’ll let it pick my ink cartridge for my printer, but I’m not going to let it diagnose my health care problem,” Mr. Stidheim said.

That being said, there have been several large-scale technology implementations in health care, including electronic health records (EHRs) and

inventory management tools.

“Technologies can be wrapped into PAPs at every stage—enrollment, qualification, communication and dispensing,” said Jon Kwiatkowski, the director of pharmacy services for Cardinal Health Sonexus Access and Patient Support. But it pays to really understand the users and the solutions they seek, Mr. Stidheim noted.

For enrollment, it’s key to maximize

use of EHR systems, Mr. Stidheim said.

One solution in place is electronic prescribing, in which clinicians through one click in the EHR can submit a prescription without having to log in to a different system to do so. Then, other services such as electronic benefit verification and electronic prior authorization can be automated once a prescription is received. see STANDARDIZATION, page 10

The ‘Snowflake’ Effect Hospitals and health care systems are “snowflakes,” he said, meaning they all have unique processes, while traditional technology systems are made standard to be adopted by many. The learning curve also can be quite long for some technology solutions that are complex, he said. Adding that to a dynamic changing workforce is bound to create issues.

In addition, he noted, health care workers are fairly risk-averse and don’t want to try things that aren’t proven to work.

COVID-19 pandemic, it seems like virtual health will remain an integral part of our pharmacy practice,” she said.

Matthew Rim, PharmD, the associate director of specialty pharmacy services at the University of Illinois Chicago College of Pharmacy, echoed that sentiment: “EHR portal communication for pharmacies is definitely the way of the future.”

Dr. Rim acknowledged that some patients such as older individuals may feel more comfortable with “old-fashioned conversations” with the pharmacist by phone or in person, but portal-based communication is an attractive option for the growing number of younger patients.

“Whether it’s for scheduling refills or doing monthly clinical assessments, connecting with patients through the electronic medical record can save a huge amount of time for both pharmacists and pharmacy technicians,” said Dr. Rim, who helped create a MyChartbased patient communication initiative at another institution.

—David Wild The sources reported no relevant financial disclosures. Dr. Riddick presented the data during the ASHP 2020 Virtual Midyear Clinical Meeting and Exposition.

Discover the S.M.O.F. difference

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live oil = omega-9 monounsaturated fatty acids ish oil = omega-3 fatty acids containing EPA and DHA Learn more about the SMOF difference and innovations that nourish at www.FreseniusKabiNutrition.com.

SMOFlipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of Use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in SMOFlipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. Contraindications: Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients. Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1,000 mg/dL.

WARNING: DEATH IN PRETERM INFANTS • Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.

• Autopsy findings included intravascular fat accumulation in the lungs.

• Preterm infants and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

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

10 Operations & Management

Pharmacy Practice News • September 2021

Ambulatory Care

Hospital-at-Home continued from page 1

in home-based hospital care. And at a recent Hospital at Home Users Group webinar, leaders from the two systems, including two physicians and a pharmacist, spoke about the divergent paths their programs had taken.

They also described how the addition of inpatient pharmacy oversight had increased the safety and efficiency of medication delivery to patients at home.

“When we were in the outpatient setting, we didn’t have the awesome power of our pharmacists doing a lot of the order checking,” said David Levine, MD, MPH, MA, the medical director of strategy and innovation at Brigham Health Home Hospital. But last year, the program switched to Brigham’s inpatient electronic health record system, and “with that came an inpatient build and

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

WARNING: DEATH IN PRETERM INFANTS • Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.

• Autopsy findings included intravascular fat accumulation in the lungs.

• Preterm infants and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

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

Limitations of Use The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in SMOFlipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

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. 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.

CONTRAINDICATIONS Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients.

Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides > 1,000 mg/dL. WARNINGS AND PRECAUTIONS • Death in Preterm Infants: (see BLACK BOX WARNING) • 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 oil. Signs or symptoms of a hypersensitivity reaction may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, or chills. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid immediately and undertake appropriate treatment and supportive measures.

• Risk of Catheter-Related Infections: Lipid emulsions, such as SMOFlipid, can support microbial growth and is an independent risk factor for the development of catheter-related bloodstream infections. The risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions or drugs.

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

• Refeeding Syndrome: Reintroducing calories and protein to severely undernourished patients with PN may result in the refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop.

• Aluminum Toxicity: SMOFlipid contains no more than 25 mcg/L of aluminum.

During prolonged PN administration in patients with renal impairment, the aluminum levels in the patient may reach 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 renal impairment, including preterm infants, who receive parenteral intakes of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of PN products.

• Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): PNALD has been reported in patients who receive PN for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. Intravenously administered phytosterols (plant sterols) contained in plant-derived lipid formulations have been associated with development of PNALD, although a causal relationship has not been established. If SMOFlipid-treated patients develop liver test abnormalities, consider discontinuation or dose reduction.

• Hypertriglyceridemia: Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome.

• Monitoring/Laboratory Tests: Routinely monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, blood count including platelets, and coagulation parameters throughout treatment.

Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended.

• Interference with Laboratory Tests: Content of vitamin K may counteract anticoagulant activity. The lipids contained in this emulsion 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.

ADVERSE REACTIONS Most common adverse drug reactions >1% of 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 patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis.

The following adverse reactions have been identified during post-approval use of SMOFlipid in countries where it is registered. Infections and Infestations: infection.

Respiratory, Thoracic and Mediastinal Disorders: dyspnea.

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 Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters.

USE IN SPECIFIC POPULATIONS • Pregnancy and Lactation: There are no available data on risks associated with SMOFlipid when used in pregnant or lactating women.

• Pediatric Use: The safety and effectiveness of SMOFlipid have not been established in pediatric patients.

• Hepatic Impairment: Parenteral nutrition should be used with caution in patients with hepatic impairment. Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive PN, including cholestasis, hepatic steatosis, fibrosis and cirrhosis (PN associated liver disease), possibly leading to hepatic failure.

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

REFERENCE: 1. Deckelbaum RJ, et al. Biochemistry (Mosc). 1990;29(5):1136-1142.

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

STANDARDIZATION continued from page 9

Qualifying patients for PAPs typically has been a time-consuming process, Mr. Stidheim said. The use of tools such as electronic income and benefit verification to automate the process makes sense.

Another evolving area to watch is blockchain technology, which allows systems to query huge databases of patient information, but only have access to pertinent information for a limited period of time.

PAPs started as “white glove” companies to provide lots of hands-on communication and service, Mr. Kwiatkowski said. But evolutions in technology could move some facets to more of a self-service approach.

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

More on PAPs Patient Assistance Programs Flexed Their Muscles in Response to COVID-19 Pandemic

bit.ly/3gtEpht Data Mining, Other e-Tools Help Boost Patient Assistance Programs

bit.ly/3kmtK9B PAPs Help Hospitals Recover Lost Funds

bit.ly/3D8fc5Y ©2021, Fresenius Kabi USA, LLC. | All rights reserved. | 1252-SMF-05-12/20

Operations & Management

Pharmacy Practice News • September 2021

11

Ambulatory Care all of the inpatient pharmacy tools and workflows that allowed our inpatient pharmacy to directly dispense to us.

Our clinicians now have access to our inpatient pharmacy 24/7.”

Brigham pharmacists restock the “mini pharmacy” that physicians carry on home visits. “The packs contain first- and urgent-dose medications that are dispensed as needed to patients,” Dr. Levine said. They include “workhorse antibiotics, diuretics and a whole slew of other medications.”

Bringing it Inside At Mount Sinai, Linda DeCherrie, MD, the clinical director of the Hospitalization at Home initiative, said until last summer, the program was considered an outpatient practice. Oral and injectable medications were obtained from the hospital’s outpatient pharmacy, she said, and IV drugs were electronically prescribed to an outside infusion pharmacy.

The CMS waiver changed that, Dr. DeCherrie said. “Now, inpatient pharmacists review all the home orders,” she said, “and they reach out to us about any questions or concerns they have.” The change also eliminated infusion delivery delays that often held up timely treatment.

Dr. DeCherrie also said a newly adopted order set had eliminated confusion over where to electronically prescribe medications for the two classes of patients admitted into the program: those in a Medicare fee-for-service group, whose medications go to the inpatient pharmacy, and patients admitted under the hospital’s contract with insurance companies managed through Contessa Health for 30-day bundles of care. (In the latter case, these are patients who need to use an outpatient pharmacy for their oral and injectable medications, which are covered

by Medicare Part D.) The new order set allows prescribed drugs to be channeled seamlessly to the appropriate pharmacy.

A Cost-Saver Research has shown that the hospitalat-home care model can reduce healthsystem costs and lower readmission rates, among other clinical and financial benefits. In one study, researchers at Presbyterian Healthcare Services in Albuquerque, N.M., reported 19% cost savings for home-based hospital care versus inpatient stays (Health Aff 2012;31[6]:1237-1243).

At Brigham Health, a small, physicianled study found that patients who are normally hospitalized for acute conditions

4 Challenges to the Hospital-at-Home Model

A

lthough multiple clinical benefits are ascribed to hospital-at-home care— including avoidance of hospital-acquired infections—challenges also exist.

Donald Mashni, PharmD, the system director of the Mount Sinai Specialty Pharmacy, in New York City, outlined some pharmacy-specific issues that need to be addressed:

Labeling. Requirements for hospital-administered medications are very different from those required for retail pharmacy drugs, Dr. Mashni said.

The regulations of state boards of pharmacy may have evolved differently for hospital-at-home patients, so it’s probably smart to label all medications for hometreated patients as outpatient medications to ensure that the strictest safety requirements are met. This is particularly important for controlled medications.

Documentation. How to document medication administration and potential side effects is a key consideration, he said. Perhaps the greatest opportunity lies in mobile health technologies that can capture when a patient scans a barcoded prescription bottle or blister card and reports any side effects and symptoms. Dose alerts also can be transmitted via mobile devices. Timely documentation can ensure no payments will be lost. If dispensing five-day supplies, Dr. Mashni said, be assured that the charges will drop accordingly.

Storage and refrigeration. Ideally, medications that need temperature control should be stored in a dedicated, temperature-monitored refrigerator, Dr. Mashni said. Practically speaking, that may not be possible in a patient’s home, so it’s important to protect medications in plastic food storage bags and segregate them in the home refrigerator. Medications that don’t need refrigeration should be stored in a cool dry space, not a bathroom cabinet.

Patients’ home medications. It’s important to document all medications in the home, including over-the-counter products and nutritionals, to ensure there are no potential interactions or therapeutic duplications.

—B.B.

Dr. Mashni reported no relevant financial disclosures.

‘Now inpatient pharmacists review all the home orders, and they reach out to us about any questions or concerns they have.’

—Linda DeCherrie, MD can achieve positive outcomes at lower costs when they are given hospitallevel treatment at home. The pilot study helped launch the Brigham program (J Gen Intern Med 2018;33[5]:729-736). A larger study later confirmed the results (Ann Intern Med 2020;172[2]:77-85).

Tech for Acute Care at Home At Brigham Health Home Hospital, the home-based clinical team of nurses and mobile integrated health paramedics has begun using a portable documentation system that uses smartphones to scan medication barcodes and transmit the information to patients’ electronic health records. “It’s another great example of an evidence-based practice leading to fewer patient safety events,” Dr. Levine said. Clinical decision making also is enhanced by the continuous biometric monitoring of patients with wearable patches.

Dr. DeCherrie said Mount Sinai patients who are discharged from an emergency department to hospital-at-home care are supplied with a telehealth kit that includes “an iPad-like device” plus a Bluetoothenabled scale, blood pressure monitor and pulse oximeter. At the beginning, she said, nurses teach the patients how to use the device, but “when they move into the monitoring phase after discharge, the patient starts engaging with the device.”

—Bruce Buckley Dr. Levine reported grants from Biofourmis and IBM. Dr. DeCherrie is a full-time employee of the Icahn School of Medicine, which has an ownership interest in a joint venture with Contessa Health, a venture that manages acute care services provided to patients in their homes through prospective bundled payment arrangements.

Dr. DeCherrie has no personal financial interest in the joint venture.

12 Operations & Management

Pharmacy Practice News • September 2021

Cybersecurity

Ransomware continued from page 1

to files on their computer or entire computer systems; the hackers then demand a ransom payment to unlock the system. Health care providers are particularly vulnerable to the attacks, given that shutting down access to their IT systems can threaten patients’ health and lives. Indeed, last September, a German woman with an aortic aneurysm had to be diverted from University Hospital Düsseldorf, which had just experienced a ransomware attack, to another hospital 32 kilometers away (bit.ly/3i0lKK9). The diversion delayed treatment by an hour and the patient died soon after.

Active Strategizing Is Crucial Experts say it’s essential for your pharmacy team to play an active role in efforts to prevent, plan for and recover from ransomware attacks at your institution. “Pharmacies are just as much at risk to be targeted for ransomware

as any other health care provider or any other part of the hospital,” said cybersecurity expert John Gomez, the founder and CEO of Sensato. “If you’re using any type of pharmacy management system that has remote access and allows users to work on it from home, or if you have contract pharmacists, that raises the risk, because there is more access.”

Vendors are another point of vulnerability for pharmacies, he added. “We just worked on a [case] recently that started because a vendor was hacked and the attackers got into the pharmacy systems that way,” Mr. Gomez said.

“Hackers attack the supply chain and send something nefarious as if they’re a trusted partner.”

Mr. Gomez also noted that the COVID-19 pandemic has created entry points for ransomware because so much more electronic information is being shared across systems.

The Cost of Ransomware Nationwide Tops $20 Billion • 92 individual ransomware attacks on health care organizations— a 60% increase from 2019 • More than 600 separate hospitals, clinics and organizations potentially affected • 18,069,012 individual patients/records affected—a 470% increase from 2019 • Average ransom demand in 2020: $169,446. Estimated total ransom demands: $15.6 million • The overall cost of attacks: $20.8 billion

Methods for Prevention There are several different ways cybercriminals can gain access to your pharmacy’s computer systems. They can use sophisticated attack programs to exploit network security vulnerabilities; they can hack passwords by using special programs or trial and error; and they can use phishing techniques designed to trick authorized users into providing sensitive information, such as account credentials.

How can you guard against each of these approaches?

Update systems regularly. Ensure all of your pharmacy’s computerized prescription order entry (or CPOE) and any other health IT systems are updated regularly with the latest security. “Make sure your firewall is maintained and the security patches on these systems are all up-to-date,” Mr. Gomez said. “Ensure that hospital IT overall is aware of the IT security needs of the pharmacy information systems. Sometimes they think of that as a separate entity.”

Use multi-factor authentication (MFA). Adopt MFA on all remote access methods—for example, if you have pharmacists or pharmacy technicians logging in to your systems from home or from satellite locations. You’ve used MFA if you’ve ever tried to log in to your bank account online and had the system send a code number to your phone that you were required to enter before gaining access.

To get into your account, it wouldn’t be enough to have your password; the

cybercriminal also would uld need to have your actual phone, or also havee been able to hack into your phone messages. “With MFA, if your passswords are compromised, attackers still till have another barrier keeping them from logging in,” said Nathan Little, the vice president of digital forensics and incident response and a partner at Tetra Defense (www.tetradefense.com), a cybersecurity firm based in Madison, Wis. Minimize access. A common mistake that many health systems make is what experts call “over-provisioned access.”

For example, you have an external partner that needs remote access to part of your systems for billing. “Instead of giving them an account that allows access only to the elements of the system they need to interact with and is firewalled against any other access, many institutions will just set them up as a full user with the same privileges as internal users,” said Chester Wisniewski, a principal research scientist at the cybersecurity firm Sophos. “If that third-party entity is compromised, the hackers can access a lot more than just a firewalled billing system; they can run roughshod through your network.”

Use detection tools. “Install end point detection and response tools—the next generation of what was previously called antivirus software—on your workstations and servers,” Mr. Little said. “These tools monitor for threats that are hard to detect. Then, you have to actually

Ransomware Guidance and Resources

A

re you looking to learn more about the growing threat of ransomware? The federal government’s Ransomware Guide (www.cisa.gov/ransomware) is a great place to start. The guide, released in September 2020, is a joint effort of the Cybersecurity & Infrastructure Security Agency and the Multi-State Information Sharing and Analysis Center. The document includes industry best practices and a response checklist that can serve as a ransomware-specific addendum to your organization’s cyber incident response plans. Several other resources, including a fact sheet on recommended actions to reduce the risk for becoming a victim of ransomware, are included on the site.

Operations & Management

Pharmacy Practice News • September 2021

13

Cybersecurity

monitor the these tools. We have a lot of incidents where people have good protecwh tools in place that are alerting them tion to potential vulnerabilities in their netto po work, and eventually hackers find a way w to get in. The challenge is that often, the most important alerts will be on the servers’ screens, and no one is looking at those all the time like they do on a desktop. Instead, you should set up these tools so that the alerts are sent as emails to a specific set of people, whether that’s your own internal security team or an outside contractor, who are responsible for monitoring them.”

prepare for what you will do if those prevention efforts fail.

The top preparation tool: backups.

“Back up your data, system images and “Ba configurations; regularly test them; and configu keep the backups offline,” cautioned Anne Neuberger, the deputy assistant An to President Biden and deputy national security advisor for Cyber and Emerging Technology, in a June 2 open letter to U.S. businesses, warning about the threat from ransomware (bit.ly/3wyf6jx).

“Ensure that backups are regularly tested and that they are not connected to the business network, because many ransomware variants try to find and encrypt or delete accessible backups. Maintaining current backups offline is critical because if your network data is encrypted with ransomware, your organization can restore systems.”

Mr. Little echoed the need for a robust backup plan. “If you walk into your office and every single computer and server is encrypted, what is your restoration plan with your backups?

How long will it take? When is the last time you tested it? You wouldn’t want to find out during a crisis that your backups haven’t been working for the last six months.”

A Place for Pharmacy At the IT Table If a representative of pharmacy is not included in contingency planning

A Sampling Of Cyberattacksa • In March 2020, Champaign-Urbana Public Health District, in Illinois, paid more than $300,000 because the district didn’t have time to wait for the data to be saved or restored.

• In June 2020, the University of California, San Francisco (School of Medicine) paid $1.14 million to NetWalker to regain access to its data, which were needed to “serve the public” with its COVID-19 research.

• In September 2020, the University Hospital New Jersey paid a negotiated $672,744 to prevent hackers from publishing stolen data. The initial ransom demand was $1.7 million.

Source: Comparitech (bit.ly/3APEepv). a

Attacks have increased 60% since 2019.

a cyberattack, your issue is how quickly you can get systems back online. In [the case of a cyberattack], however, you also need the involvement of law enforcement and probably a computer security firm. Many big institutions already have internal security teams with a firm like ours on retainer already, but if you’re a smaller hospital and don’t have that level of an operation, you should at least

‘I’ve literally been on the phone with [ransomware attack] victims and heard someone turn around in their chair and throw up into a bucket.

When … someone is demanding millions of dollars from you and it’s potentially affecting patient care, you want a checklist you’ve prepared in advance and experts helping you who have dealt with this before.’

—Chester Wisniewski Train pharmacy staff. Provide IT security training for your pharmacy staff. “People need to understand that you can receive an email that looks very real, as if it comes from a trusted organization, and that you always need to think before you click on a link or open a file,” Mr. Gomez said. “If you get a file or a link out of the blue and didn’t just have a conversation with someone who said they were going to send it to you, taking 10 to 15 seconds to make a call or do some research to confirm could make the difference in falling victim to a ransomware attack.”

Preparation and Recovery Although you can take steps to prevent ransomware attacks and reduce the chance that one will happen to you, nothing is foolproof—and hackers are determined. So, you should also

for ransomware attacks at your institution, make sure someone is in the room for these meetings. “If a pharmacy is in any way connected to the larger hospital network, they should always be included in recovery planning for these attacks,” Mr. Gomez said. “Hospitals will often run some form of tabletop simulation for [cyberattacks] and pharmacy may not always be included. You are critical to response and recovery, and you need to be sure that you’re at the table.”

Your hospital and pharmacy almost certainly have an emergency continuity plan for natural disasters such as floods or hurricanes. “We recommend to health care providers that they reassess those [plans] and then add them into cybersecurity incident plans,” Mr. Wisniewski said. “Whether it’s a storm that takes out your computers or

establish some relationships ahead of time. Call your FBI field office and find out who to contact if you have a cybersecurity incident, then ask for the best practices they recommend.”

Furthermore, just as with disaster recovery plans, you need to practice your recovery plan for a ransomware attack. “How do you recover and operate in a situation where the technology you rely on is completely gone—not for a few hours or a couple of days, but possibly for several weeks to months for full recovery?” Mr. Gomez asked.

“Think about how you will get orders to the pharmacy from the floors, for example. Do you have pharmacy technicians running handwritten orders back and forth throughout the hospital? What about IV workflow management systems? How often are you practicing manual steps? How will you

do protocol recalculations in oncology?

And if you have to do all of this by hand, what are your staffing requirements?”

Don’t Be Stuck in Reactive Mode These questions are not ones you want to be asking yourself after an incident has already happened, Mr. Wisniewski said. “I’ve literally been on the phone with victims and heard someone turn around in their chair and throw up into a bucket. When you’re under that kind of pressure and someone is demanding millions of dollars from you and it’s potentially affecting patient care, you want a checklist you’ve prepared in advance and experts helping you who have dealt with this before.”

How long will it take to recover from a ransomware attack? That depends on how prepared you were ahead of time.

This May, the Conti ransomware attack led to a shutdown of Ireland’s health service, with cancellations of elective surgeries, appointments for x-rays, CT scans and the processing of nonemergency blood tests. Some hospitals were hit harder than others, but overall, it may take as long as six months to bring all the associated systems back to full operation, according to Mr. Wisniewski. “But they had a serious security deficit and weren’t doing everything they should have been doing, so now they need to be bringing everything up to better standards. Doing that ahead of time would have made recovery much less stressful and more affordable. Recovery can take a long time, but to quote the president, you want to ‘build back better.’ Don’t make the same mistakes as before.”

—Gina Shaw The sources reported no relevant financial disclosures beyond stated employment.

14 Policy

Pharmacy Practice News • September 2021

Finance

ASHP Among Stakeholders Blasting Actions Against 340B

M

erck has fired another salvo in the war over the federal 340B Drug Pricing Program. Last month, the company announced that it was giving 340B-covered entities a deadline of Sept. 1 to provide 340B claims data for all claims originating from contract pharmacies.

The manufacturer’s move came despite warnings that requiring such data is prohibited: The Health Resources

and Services Administration (HRSA) has said efforts by manufacturers to constrain 340B contract pharmacies violate the 340B statute.

For any covered entities that do not comply with Merck’s request, according to a letter dated August 2021, the company “will no longer voluntarily honor 340B discounts or chargebacks for contract pharmacy transactions,” unless the entity designates a single contract

pharmacy of its choice to be eligible for 340B pricing. Merck exempted several care sites from the mandate, including nonhospital federal grantee covered entities such as federally qualified health centers, Ryan White clinics and state-operated AIDS drug assistance programs. However, the company’s letter suggested this could change.

“Merck will continue to voluntarily honor 340B discounts and chargebacks

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for contract pharmacy transactions for these federal grantee-covered entities,” the letter stated. “We continue to encourage federal grantee covered entities to collaborate with us as part of this program integrity effort by participating in the Merck Program and providing claims-level data for contract pharmacy transaction. We will continue to evaluate program participation of federal grantees to determine if further action is warranted.”

In May, HRSA warned AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics that similar restrictions the companies placed on 340B contract pharmacies violate the 340B statute. HRSA warned it would levy fines against the companies if they did not remove those restrictions.

Professor of Medicine Consultant, Division of Hematology, Department of Internal Medicine Mayo Clinic Cancer Center Rochester, MN

At press time, it was unclear whether Merck’s Sept. 1 deadline would succeed in putting any constraints on a contract pharmacy’s ability to access 340B drug pricing. Regardless of how that particular move pans out, Tom Kraus, ASHP’s vice president of government relations, made it clear that the group is firmly opposed to such efforts. Specifically, he called on the Department of Health and Human Services (HHS) to take immediate enforcement actions against manufacturers that pursue these policies.

“HHS has made clear that drug manufacturers [are obligated] to provide 340B pricing, including when patients access needed medications through retail pharmacies,” he said. “Drug manufacturers do not get to impose arbitrary conditions on when they will comply with the law.”

If successful, Mr. Kraus added, “Merck’s actions will undermine the functioning of the 340B drug pricing program that Congress created to support patients and the safety-net hospitals that serve them.”

Peggy Tighe, counsel to Ryan White Clinics for 340B Access, told Pharmacy Practice News that this was just more defiance of the law by manufacturers.

“Merck’s claim that it is ‘voluntarily’ denying hospitals 340B discounts unless the hospitals provide ... pharmacy claims [data] represents additional unilateral defiance of the 340B statute,” she said.

“We are hopeful that the courts will see these actions for what they really are— [attempts] to diminish safety-net providers’ access to 340B savings provided by manufacturers as a condition of manufacturers’ participation in Medicaid.”

—Gina Shaw The sources reported no relevant financial relationships beyond their stated employment.

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HSSPs Still Fighting continued from page 1

Still, many health systems have succeeded in overcoming those challenges, in part by leveraging the superior continuum of care they claim is a hallmark of their practice model. Whether it’s streamlining the prior authorization (PA) process, reaching for legal tools to break down payor walls, or speeding the pharmacy and therapeutics (P&T) specialty drug approval process, health systems have shown they are up to the challenge, as outlined in several presentations at the 2021 virtual ASHP Specialty Pharmacy Conference.

LDD Disconnect Only

37.7%

nly

of respondents reported gaining access to LDDs

ed Ds

%

rer e” ck

%

en rs”

rugs

tem tice.

15

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Brought to you by

82.1% cited “manufacturer refusal to engage” as major roadblock

71.7% said they were “frozen out or blocked by payors” LDD, limited distribution drugs Source: ASHP National Survey of Health-System Specialty Pharmacy Practice.

The conference kicked off with a presentation of the new survey, with several of the findings underscoring key practice issues and frustrations for health-system specialty pharmacies (HSSPs). The survey was sent to 230 contacts at 206 different HSSPs; 114 (53%) completed the survey. The survey included 99 questions over eight domains addressing demographics, workforce issues, operations

and payor access, among others.

Most HSSPs dispense fewer than 45,000 specialty prescriptions per year and have an annual gross revenue of less than $100 million, the survey found.

Most of these specialty pharmacies are relatively new, with 73.8% of survey respondents saying their organization has offered specialty pharmacy services for six years or less.

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

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

Pharmacy versus medical benefit.

The HSSP business model is focused on self-administered (96.2%) and clinic-administered medications (80.2%) under the pharmacy benefit.

Only a small number of HSSPs provide self-administered (31.1%) or clinicadministered medications (22.6%) under the medical benefit. “What I’ve seen in most health systems is that the medical benefit is typically managed by another area of the pharmacy enterprise, but that is changing,” said Ms. Stubbings, a member of the Pharmacy Practice News editorial

advisory board. “There is significant overlap, and we are starting to see HSSPs building infusion suites and enter home infusion, and this is becoming increasingly important. We hope to identify these trends in a future survey.”

Access still a challenge. HSSPs have had only moderate success in gaining access to LDDs, with resistance from manufacturers and payors cited as major roadblocks (Figure).

Inflammatory conditions No. 1. The most common therapeutic categories served were inflammatory conditions and hematology/oncology (both 92.4%), hepatology/hepatitis C (85.7%), neurology/multiple sclerosis (78.1%) and infectious disease/HIV (70.5%). More than half of all respondents indicated that their HSSPs also provided care in cardiology, endocrinology, cystic fibrosis, respiratory/pulmonary arterial hypertension and solid-organ transplant, and 90% said they offer PA support.

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

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

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

Legal Tools Help Protect Specialty Pharmacies HSSPs have some legal tools they can use to address network access and other practice challenges cited in the ASHP survey, Jesse Dresser, Esq, an attorney with Frier Levitt LLC, noted during a conference session on legal conundrums in specialty pharmacy.

Mr. Dresser advised that no matter the issue—compliance, network admission, site-of-care policies or reimbursement— it’s important to start with the patient and their type of plan. “That will dictate what laws and rules apply and what your rights and obligations are,” he said.

As an example, he pointed to the three types of specialty pharmacy networks: 1. Closed or exclusive. “These are

the ones where the sponsors are not allowing anyone in except their own wholly owned specialty pharmacy,” Mr. Dresser said. “We typically see these arrangements in the employersponsored commercial market. Large plan sponsors with thousands or hundreds of thousands of employees, like Pepsi-Cola, typically self-insure rather than spend an extra 10% to 15% on premiums on behalf of their employees, but they will still contract with an insurance company to administer their claims and PBMs to administer their pharmacy benefits. In this context, state laws don’t really apply and federal rules like those involving Medicare or Medicaid don’t really apply.” Plans like these, he noted, are subject only to the Employee Retirement Income Security Act (ERISA), which is silent on what pharmacies must be in a network.

2. “Open,” but with heightened admission criteria. Such criteria include requirements for multiple forms of accreditation or licensure in all 50 states.

3. Truly open specialty pharmacy networks. “These are typically found in Medicare networks, where there is a robust federal Any Willing Provider law and a prohibition on payors from limiting who can be in the network,” Mr. Dresser said.

White and Brown Bagging Still a Concern As for specific legal strategies to deploy, that depends on the practice challenge, he noted. One of the most problematic issues is the growing trend among PBMs to move claims processing from the medication side to the pharmacy side, requiring more white and brown bagging—a hot topic throughout the conference. The practice has had a major effect on hospital infusion, Mr. Dresser said. “About this time last year, several large payors took virtually identical steps to require that in-office infused medications be filled at their wholly owned specialty pharmacies, and placing limitations, or removing altogether, providers’ ability to source and seek reimbursement for medications administered in their facilities.”

There are laws being proposed in some states that would make mandatory see HSSPs FIGHTING, page 21

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Clinical

Pharmacy Practice News • September 2021

17

Review Article

Parenteral Nutrition Safety JAY M. MIRTALLO, MS, RPH, BCNSP, FASHP, FASPEN Professor Emeritus The Ohio State University College of Pharmacy Columbus, Ohio Clinical Practice Specialist The American Society for Parenteral and Enteral Nutrition Delaware, Ohio

PHIL AYERS, PHARMD, BCNSP, FMSHP, FASHP Chief Clinical Pharmacy Services Baptist Health Systems Clinical Associate Professor University of Mississippi School of Pharmacy Jackson, Mississippi

P

arenteral nutrition (PN) is a complex therapy that requires a robust system to ensure its safety and efficacy. Since its inception, PN has been associated with serious issues, ranging from catheter complications,

such as thrombosis and infection, to metabolic complications, such as hyperglycemia, refeeding syndrome, and fluid/electrolyte disorders.

Although adverse events (AEs) related to PN rarely are reported, they are likely to be associated with harm when they occur. PN-related mortality has occurred due to contaminated PN admixtures, precipitates of calcium and phosphorus in PN, omission of vitamins from PN (as during a multivitamin shortage in the United States), poorly controlled levels of glucose and electrolytes, and dextrose admixture errors.

PN-specific errors that have been reported to a medication error reporting system, such as Quantros’s MEDMARX, have resulted from performance and knowledge deficits, communication issues, and procedures not being followed. Errors occurred at every level of the PN process, including prescribing, preparation, distribution, monitoring, and evaluation.

Early PN AEs led to the recommendation that interdisciplinary teams manage IV catheters in addition to PN.1 Such interdisciplinary care may help improve the safety of PN. This review aims to: • describe PN as a system of care and identify processes that are

prone to error; • provide evidence to explain why PN errors are likely to reach patients and cause harm; • explain the rationale for a standardized process for PN therapy; and • provide resources that every pharmacy/pharmacist can use to evaluate their PN system and resolve potential problems.

The PN System PN, like the medication-use system, is a system of care, the key components of which are assessment, order, order review, preparation, delivery, administration, and monitoring (Figure). The procurement process (with potential drug shortages and supply chain issues), the nutrition care plan, and transitions of care are components that have an indirect effect on the quality of the PN system. By its nature, PN is an interdisciplinary process involving a dietitian, physician, pharmacist, nurse, and/or patient caregiver. Each of these participants represents a node that can be evaluated in medication safety reviews.

Errors in the PN Process Errors with the PN system have been measured and reported. Sacks et al found the overall error rate to be 74 per 4,730 PN prescriptions (1.6%), or 15.9 errors per 1,000 PN prescriptions filled.2 The majority of errors (39%) were associated with the transcription process, a wrong electrolyte dose or salt, the wrong protein source, or the omission of a medication (most commonly insulin).2 The harm score distribution of errors, based on the MEDMARX Database Severity Scale (Table 1), was as follows: 15% “near miss” events (categories A and B), 91% “no harm” events (categories C and D), and 8% “harmful” events (categories E and F).

Harmful events included a central PN formulation infused peripherally, PN formulations cycled inadvertently, wrong infusion rates causing severe hyperglycemia (glucose: 500 mg/dL), and incorrect electrolyte salt exacerbating existing metabolic alkalosis.2 This report is important because it demonstrates that PN errors occur within our system and that organizations claiming to have

no problems with the PN system probably are not looking for them.

In fact, results from a survey by the American Society for Parenteral and Enteral Nutrition (ASPEN) indicate that errors are observed frequently.3 Almost two-thirds of the survey respondents reported observing 1 to 5 PN-related errors per month. Most errors (71%) were related to PN electrolytes. In addition, respondents estimated that 35% of the errors required increased monitoring, 25% resulted in harm, 3.3% were almost fatal, and 1.5% were fatal.3 In preparation for development of the ASPEN guideline,4 Boullata et al conducted a PN-use survey with a section evaluating PN-related medication errors.5 All 895 respondents to the survey, which included dietitians, physicians, nurses, and pharmacists, indicated that they believed PN required a multidisciplinary process, but few reported that they had a PN quality improvement process in place at their institutions (39%). In organizations that had a process, it was performed by a single department see PN SAFETY, page 18

18 Clinical

Pharmacy Practice News • September 2021

Review Article

PN SAFETY continued from page 17

or discipline. In addition, 44% of the respondents reported that their organization did not yet track PN medication errors. Most respondents (58%) also reported that they did not know where in the process errors were occurring.

Mirtallo et al reported on isolated PN errors that occurred between 1992 and 2007 (Table 2).6 This report indicates that there is a low frequency of reported events, but when they occur, they are likely to cause permanent and severe harm, especially in children. PN events occurred across all patient ages and health systems—in hospitals (ICU-medical/ surgical units), extended care facilities, at home, and, importantly, during transitions of care. They occurred as a result of individual error (performance), process issues (preparing PN without having completed training), not using safety alerts in software, and hardware malfunction.

Another source of data on PN errors is the Institute for Safe Medication Practices (ISMP) Medication Error Reporting Program (MERP).

Using MERP data, Cohen reviewed the typical PN errors causing severe harm and found the following sources of errors7: • wrong dextrose concentration; • confusion of 5% dextrose with concentrated potassium chloride; • catheter misconnections; • infusion of PN via epidural catheter; and • insulin/heparin additives (due to confusion with units and dosage designations).

The ISMP’s MEDMARX Database Evaluation is another source of information on PN errors. In this national, anonymous, subscription-based medication error reporting system, individuals completing reports describe errors and assign them a severity level (Table 1). The reported errors tend to be low in severity, with no or little patient harm reported.

In 2012, Storey et al evaluated PN errors reported to the MEDMARX system and characterized them by node (process), severity, ingredient, and type.8 The noteworthy findings of the evaluation are shown in Table 3.

All PN nodes have errors reported, with errors most frequently occurring during ordering, transcribing, and administration. Each ingredient class is involved as well, with the following being most problematic: fat emulsion, electrolytes, and insulin (other).

The most frequent type of error found is omission; it occurs in all nodes but is most often found in ordering

Figure. Parenteral nutrition: a system of care.a a

This process involves multidisciplinary care that incorporates the health-system medication safety system for error reporting.

b

Prescribers include physicians, physician assistants, nurse practitioners, pharmacists, and dietitians.

c

The multidisciplinary team includes a physician, nurse, pharmacist, and dietitian.

ACD, automated compounding device; PN, parenteral nutrition Adapted from: Mirtallo JM. Parenteral nutrition: can outcomes be improved? JPEN J Parenter Enteral Nutr. 2013;37(2):181-189.

Table 1. MEDMARX Database Severity Scale Severity

Description

A

Circumstances or events that have the capacity to cause error An error occurred:

B

Did not reach the patient

C

Reached the patient but no harm resulted

D

Required monitoring to confirm that it resulted in no harm and/or required intervention to prevent harm

E

May have contributed to or resulted in temporary harm or required intervention

F

Contributed to or resulted in temporary harm and required initial or prolonged hospitalization

G

Contributed to or resulted in permanent harm

H

Intervention required to sustain life

I

Resulted in patient death

Sources: National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) and reference 8.

and transcribing.8 Common problems leading to these error reports are individual performance factors (competence) or a breakdown in the

PN system. In response to PN safety issues, ASPEN developed statements that address competency in PN prescribing9 and PN standardization.10

Product Shortages Affecting PN One variable that has continually affected PN system safety and

Clinical

Pharmacy Practice News • September 2021

Review Article effectiveness has been PN product shortages.11 PN product shortages highlight the weaknesses in the overall PN system related to inconsistent PN practices. Safety issues related to PN shortages arise from use of a product that is less desirable or familiar, confusion in the prescribing process due to substitution, and frequent changes in compounding and distribution. In addition, workarounds in ordering and compounding processes can circumvent safety checks. Sterility issues occur, especially when organizations repackage lipid injectable emulsions to conserve supply. Accuracy, stability, and compatibility issues also have been reported.11 During periods when supplies were conserved, doses of PN ingredients were reduced and maintained at suboptimal levels, predisposing patients to nutrient deficiencies that required increased monitoring (eg, periodic trace element levels).11 The types of PN safety issues related to micronutrients that have resulted from PN product shortages are shown in Table 4.12 Continual PN product shortages over the past 10 years are a barrier to appropriate PN dosing and may lead to nutrient deficiencies and impairment of growth and development.13 The realization that clinicians have not been able to properly dose PN ingredients and adapted the routine practice of underdosing nutrients has led ASPEN to develop recommendations for PN. These include appropriate PN nutrient requirements and dosing recommendations for adult, neonatal, and pediatric patients.

Best-practice recommendations are outlined below13: • Do not ration nutrients for PN if the supply of those components is sufficient to provide the full daily dose.

• During component shortages, follow the PN management recommendations available on the ASPEN website at nutritioncare. org/ProductShortage/.

• Return to appropriate dosing as soon as the component shortage has resolved.

• Rationing and conservation strategies are intended to be used only during shortages.

• The lack of observed AEs/ deficiencies and the potential cost savings associated with “partial” dosing should not be an impetus to continue less than optimal dosing.

Table 2. Selected Serious Events Related to PN System Failures Patient Age

Event

see PN SAFETY, page 20

Contributing Factors

Calcium/phosphorus precipitation

Adult

Death, respiratory distress

• Improper compounding sequence

Glucose overdose

Pediatric

Death

• Misinterpretation of product label and order

Glucose underdose

Infant

Death

• Final concentration of dextrose compounded as 1.75% instead of 17.5%

Hyperkalemia

Pediatric

Death

• Error in manual preparation of PN

Hypermagnesemia

Neonate

Toxicity

• Compounder malfunction

Iron overload

Pediatric

Liver toxicity

• Misinterpretation of label, 50-fold dosing error

No dextrose in PN

Neonate

Permanent brain damage

• Compounding error

Zinc overdose

Neonate

Death

• Performance deficit; training not completed • Compounder safeguards not used • Dose not assessed for appropriateness

PN, parenteral nutrition Based on reference 6 and ISMP Medication Safety Alert. 2007;12(8):1-4.

Table 3. PN Errors Reported to MEDMARX by Node and Ingredient Severity, N A-D

Severity, N E-I

Type

Ordering

472

8

Improper dose, omission

Transcribing

360

3

Omission, prepared incorrectly

Compounding

90

1

Deteriorated product, omission

Administration

487

10

Expired drug, deteriorated product, omission

Dextrose

21

3

NA

Fat emulsion

254

3

NA

Electrolyte

92

2

NA

Othera

74

5

Ordering, preparation, and administration

Parameter Node

Ingredient

a

Insulin was the most frequent drug in the ”Other” category related to more harmful events.

NA, information not available Based on reference 8.

Table 4. Cases of Micronutrient Deficiencies Resulting From PN Shortages Nutrient

Age, y

Disease/Complication

Cause

Copper

62

Fatigue, poor exercise tolerance, lower extremity edema

Copper intentionally withheld from PN due to shortage

Selenium

2, 3, 4, 5, 13

Biochemical decrease in levels

Selenium intentionally withheld from PN due to shortage

Thiamine

16

Dizziness, vertigo, diplopia, horizontal nystagmus, confusion, and disorientation

Multivitamins inadvertently omitted from PN due to shortage

Process Standardization for PN Inconsistency in PN practice has the potential to cause PN errors. A

Outcome

Based on reference 12.

19

20 Clinical

Pharmacy Practice News • September 2021

Review Article

PN SAFETY continued from page 19

factor that contributes to this issue is the inconsistent training of health professionals, including pharmacists, in PN therapy. Mirtallo noted that the number of ways a PN order may be written—based on rate (mg/kg/ min), amount (g/kg/d, g/d, g/L), or percent concentration (volume of % original concentration, % final concentration)—can contribute to confusion.14 Best practices provide order templates and expert consensus recommendations for ordering PN.4 However, a survey of practice found poor adoption of best practices.5,15 Boullata et al identified barriers to adopting safe PN practices during the ordering process, with respondents indicating that either a nutrition support team was involved in ordering PN, so a standard process was not needed (33%), or orders were received from multiple facilities, as with home infusion (20%).5 In 2007, ASPEN formed a task force and created a “Statement of Parenteral Nutrition Standardization,” which states that a standardized process may include use of standardized PN formulations (including commercial PN products) but also includes aspects of ordering, labeling, screening, compounding, and administration of PN.10 This important concept was reiterated in the 2014 ASPEN Parenteral Nutrition Safety Consensus Recommendations,16 which emphasize the importance of standardization, especially during transitions of care. The consensus paper refers readers to additional documents discussing the importance of PN standardization.

Supply Chain Beginning in 2019, PN products began moving through the FDA Unapproved Drug Program. So far, selenium, cysteine, zinc, and ethanol have achieved FDA approval, with other unapproved products being removed. A major issue with this is the sometimes-extreme increase in price of the FDA-approved product.

This hinders patient access to home PN when providers turn away patients due to lack of reimbursement, providers are unable to stay in the market, or the high-priced product is withheld, putting patients at risk for developing a deficiency. All PN products have already gone through the process and FDA has discontinued the program due to its disruption of the pharmaceutical supply chain. It is never too early to evaluate the safety of PN and develop processes to adequately manage this problem.

New Lipid Injectable Emulsions Soybean oil–based lipid injectable emulsion (ILE), formally known as intravenous fat emulsion (IVFE), began to be used in the United States in the 1970s. Soybean oil–based ILE was first used in practice to prevent essential fatty acid deficiency, then later incorporated into PN regimens as a source of calories to aid in the reduction of carbohydrate load from dextrose.6 It has been the primary lipid used in PN regimens.

Recently, 3 new ILEs have been introduced into the US market.

SMOFlipid, a 4-oil emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil17; Clinolipid, a soybean oil/olive oil– based emulsion18; and Omegaven, a fish oil–based ILE.19 These products have been used worldwide and have demonstrated benefits in specific patient populations. However, incorporating these ILE products could create safety issues due to practitioner inexperience. This along with gaps in ILE practice previously identified,20 led ASPEN to publish information on ILE safety considerations.21 The primary medication safety issues related to ILE involve stability, compatibility, inprocess or in-use contamination, filtration, and systems issues, especially with prescribing and administration nodes.21 More detailed information may be found on the ASPEN website at https://bit.ly/3kYGlBK. Policies and procedures must be developed if the new ILE products are added to a facility’s formulary. These products should be filtered using a 1.2-micron filter, and a vented infusion set should be used when Omegaven is infused from the bottle.17-19 Compatibility and stability data associated with soybean oil–based ILE may not be applicable to the newer ILE products. As noted earlier, fat emulsion (lipid) was the most common ingredient associated with PN errors reported to MEDMARX.8

PN and Electronic Health Records In 2018, ASPEN along with the American Society of Health-System Pharmacists and the Academy of Nutrition and Dietetics published A Call to Action for Optimizing the Electronic Health Record in the Parenteral Nutrition Workflow. This paper identified 5 key areas for optimization of the electronic health record (EHR) in the PN process22: 1. standardized PN order and label; 2. clinical decision support and warnings for macronutrient and micronutrient dosing, toxicity, and incompatibilities;

3. EHR interfaces, interoperability, and workflow involving automated compounding devices (ACD) functionality to improve safety and minimize risk for errors; and 4. ordering cyclic PN, taper up and taper down; and 5. transition of PN from hospital to home or other alternative care settings and vice versa.

The use of the EHR for PN ordering has lagged behind use for other medications. Surveys conducted in 2003, 2011, and 2014 revealed electronic ordering of PN occurred in 29%, 33%, and 63%, respectively. Interface with an ACD occurred in 16% (2003), 19% (2011), and 28% (2014).23 A recent gap analysis conducted by a 22-hospital system revealed the top 5 areas for opportunity for PN and its EHR24: 1. direct transmission of PN orders from the EHR to the ACD without manual reentry; 2. EHR and ACD interfaces that are modifiable simultaneously such that changes to individual product ingredients can be made to reflect availability and/or conservation; 3. tools within the EHR and ACD to capture failed message transfers 4. tools within the EHR and ACD to support downtime of the interface; and 5. outsourcing of PN compounding without manual transcription of PN order, supported by the EHR.

PN and Filters In-line IV filters are critical in reducing exposure to particulate matter during the administration of PN. A 2017 ILE survey with gap analysis noted 20.6% of respondents did not filter total nutrient admixtures (TNAs) in adult patients and 18.6% did not filter TNAs in their pediatric population.20 The same survey revealed that 15.1% did not filter ILE infused as a separate infusion in adults. In the pediatric population, 9.7% did not filter, and in neonates, 19.4% ILE infused separately.

ASPEN recently published a position paper updating the use of filters in PN and recommending use of a 1.2-micron in-line filter for administration of TNAs and ILE.25 For TNAs, place the filter as close to the catheter hub as possible. For dextrose-amino acid admixtures, place the filter below the Y-site where the dextrose-amino acid admixture and ILE co-infuse.

The position paper recommends that health care organizations not filtering PN and ILE reevaluate their decision and consider the potential for increased morbidity and mortality from not using filters.

Conclusion The safety of PN is influenced by systems issues related to PN, including errors in the ordering, preparation, delivery, and administration nodes, which can be complicated by supply chain problems with PN products.

Health systems need a systematic approach to PN that begins with adequate reporting of and response to errors and includes the standardization of PN processes within organizations and at every point of transition of care. The ability to use the EHR for safe prescribing of PN continues to evolve, and facilities should work with their vendors to ensure optimization of this process.

References 1.

Maki DG, et al. Ann Intern Med. 1973;79(6):867-887.

2. Sacks GS, et al. Pharmacotherapy.

2009;29(8):966-974.

3. Seres D, et al. JPEN J Parenter Enteral Nutr.

2006;30(3):259-265.

4. Boullata J, et al. JPEN J Parenter Enteral Nutr. 2014;38(3):334-377.

5. Boullata JI, et al. JPEN J Parenter Enteral Nutr. 2013;37(2):212-222.

6. Mirtallo J, et al. JPEN J Parenter Enteral Nutr. 2004;28:(6)S39-S70.

7. Cohen MR. JPEN J Parenter Enteral Nutr.

2012;36(2 suppl):14s-19s.

8. Storey MA, et al. Nutr Clin Pract.

2016;31(2):211-217.

9. Guenter G, et al. Nutr Clin Pract.

2015;30(4):570-576.

10. Kochevar M, et al. J Parenter Enteral Nutr.

2007;31(5):441-448.

11. Mirtallo JM, et al. Nutr Clin Pract.

2012;27(3):385-391.

12. Mirtallo JM. Nutr Clin Pract. 2015;30(1):86-91.

13. ASPEN. Appropriate Dosing for Parenteral Nutrition: ASPEN Recommendations.

January 2019. Accessed August 12, 2021. http://www.nutritioncare.org/PNDosing 14. Mirtallo JM. JPEN J Parenter Enteral Nutr.

2012;36(2 suppl):29S-31S. 15. O’Neal BC, et al. Am J Health Syst Pharm.

2002;59(3):264-269.

16. Ayers P, et al. JPEN J Parenter Enteral Nutr.

2014;38(3):296-333.

17. SMOFlipid (package insert). Fresenius Kabi; 2015.

18. Clinolipid (package insert). Baxter Healthcare Corporation; 2016.

19. Omegaven (package insert). Fresenius Kabi; 2018.

20. Christensen ML, et al. Nutr Clin Pract.

2017;32(5):694-702.

21. Mirtallo JM, et al. Nutr Clin Pract.

2020;(35):769-782.

22. Vanek VW, et al. Nutr Clin Pract.

2018;33:e1-e21.

23. Vanek VW, et al. Nutr Clin Pract.

2016;31:401-415.

24. Ayers P, et al. Nutr Clin Pract. Published online February 2020. Accessed August 12, 2021. https://doi.org/10.1002/ncp.10463 25. Worthington P, et al. Nutr Clin Pract.

2021;36:29-39.

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HSSPs FIGHTING continued from page 15

white bagging illegal, but what can hospital and health-system specialty pharmacies do in the meantime?

“Depending on the type of plan involved, you might be able to deploy Any Willing Provider” legislation, Mr. Dresser said. “All 50 states and the District of Columbia, through Medicare Part D, are subject to the federal Any Willing Provider law, meaning that any willing pharmacy able to participate in a network’s terms and conditions has to be allowed in. The law is fairly robust, and its guidance requires that those terms and conditions have to be reasonable and relevant. It has been used successfully to protect not only network access, but fair and appropriate reimbursement for specialty pharmacies to participate in Medicare Part D programs.”

There also are some state-based Any Willing Provider laws as well as state laws banning mandatory mailorder pharmacy. “About 33 states have some level of this kind of protection,” Mr. Dresser said. “I would encourage anyone facing any kind of exclusion to figure out what type of network the patients you are not being able to fill for are in, and then see if you can use some of these legal tools to your advantage.”

Audits, Other Challenges Mr. Dresser stressed that white bagging, although a big challenge, isn’t the only concern that HSSPs have to address with legal tools, citing the following: Fair pharmacy audit laws. “These laws apply at the state level, typically in the context of commercial insurance and not necessarily ERISA or Medicare,” Mr. Dresser said. “They provide time limits on PBM audits, as well as audit appeal procedures. They often limit the number of prescriptions that can be looked at in a given audit and, helpfully, prohibit recoupment for clerical errors or things that can be ‘cured.’”

Prompt payment laws. “These include look-back periods limiting PBM audits,” Mr. Dresser explained. “Florida, for example, says you can’t go back more than 30 months in terms of a repayment demand. They also prohibit PBMs from unilaterally offsetting claims to recoup on audits, saying, ‘You owe us $100,000, and we’re going to recoup it immediately. You can appeal but we’re going to start now.’ If you’re facing an audit and potential recoupment, this is a good tool to have in your arsenal.”

Mr. Dresser also spotlighted recent actions by PBMs in the 340B space.

“They are trying to retain the spread between the costs of the 340B drug and the PBM reimbursement,” he said. “They send out notices to pharmacies requiring

them to submit 340B claims with a submission clarification code to signal to the PBM that it is a 340B claim.”

This typically involves the use of a Submission Clarification Code of “20” in the NCPDP Field 420-DK. If a claim is 340B, the PBM then reimburses the pharmacy at a lower rate—for example, average wholesale price (AWP) – 30%, compared with a rate of AWP – 15% for non-340B claims.

“Essentially, PBMs are looking to usurp that savings for themselves,” Mr. Dresser said. “This is not necessarily limited to Medicaid programs managed by PBM; it could include commercial plans and often does. They are also using third-party administrators to get access to this information. Some PBMs own their own third-party administrators, so they might have the ability to make the determination, even if the pharmacy didn’t submit the clarification code at the point of sale.”

Mr. Dresser noted that there has been some success in pushing back against these efforts. “The tides have turned a bit in state legislation,” he said. “Some states, including most recently Ohio, have passed laws prohibiting PBMs from differentiating 340B and non-340B pricing. So, if you are facing mandates from a PBM that you use the clarification code, or otherwise encountering 340B-specific pricing, I encourage you to speak to counsel who can guide you on some of the recent tools that are available.”

Speeding Access To Medications As noted, timely access to specialty medications was a key concern cited by respondents to the ASHP practice survey. At Mass General Brigham, in Boston, the solution to this challenge was to employ integrated specialty pharmacists in its health-system clinic to mitigate treatment delays.

In a retrospective chart review of 121 patients being prescribed specialty medications from an ambulatory autoimmune/allergy practice, the median time to dispense from prescription receipt was four days for the health-system specialty pharmacy and 13 days (P<0.001) for an outside specialty pharmacy. Using an integrated specialty pharmacy model versus a standard clinical workflow also yielded other benefits, including decreased time between PA requests and PA submission (one day vs. 12 days; P<0.001); and decreased time between the PA submission and recorded PA outcome (one day vs. 3.5 days; P=0.03).

“Timely medication access is a primary barrier in the treatment of patients with autoimmune disease,” said lead author Soha Elshaboury, PharmD, a pharmacist clinical coordinator for the health system. “This is mainly due to the cumbersome process around prior

Ascending the Specialty Summit

D

uring a town hall session at the 2021 virtual ASHP Specialty Pharmacy Conference, ASHP shared highlights from its February 2021 Specialty Pharmacy Future Directions Summit.

One key accomplishment of the summit was the preparation of 71 consensus recommendations. The recommendations covered 13 practice domains, including specialty pharmacy practice model and performance; patient care services and access; workforce competency, credentials and culture; and safety, quality, outcomes and value, among others. More details on the recommendations will be published in a fall issue of the American Journal of Health-System Pharmacy.

Udobi Campbell, PharmD, MBA, the regional executive director of pharmacy at UNC Health, in Chapel Hill, N.C., and the chair of the Summit Steering Committee, started the town hall with some observations on why the summit was such a timely and important initiative. She cited market forces as one powerful driver: Spending in the United States on specialty medications is projected to exceed 50% of overall drug expenditures in 2021, she noted. Vertical integration and the increasing adoption of limited drug distribution models for specialty drugs are other factors driving health systems into the specialty space, she noted.

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

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

—David Bronstein

authorization and the resources it takes to coordinate this process.”

For the study, Dr. Elshaboury and her colleagues completed a retrospective chart review for patients receiving prescriptions for self-administered specialty medications between Feb. 26 and Dec. 24, 2020. These were largely for injectable medications such as dupi-

who received a refill after that date, in which they had a PA completed by clinic staff to start their therapy, were classified as standard of care.

The investigators gathered data using electronic health records (EHRs), patient management software, adjudication software and records of phone calls to outside pharmacies.

‘Timely medication access is a primary barrier in the treatment of patients with autoimmune disease. This is mainly due to the cumbersome process around prior authorization and the resources it takes to coordinate this process.’

—Soha Elshaboury, PharmD lumab (Dupixent, Sanofi/Regeneron), benralizumab (Fasenra, AstraZeneca) and mepolizumab (Nucala, GSK).

Patients receiving a new prescription after Feb. 26 who required a PA to start therapy were categorized as the intervention group, for whom the specialty pharmacy staff processed the PA, reviewed therapy and consulted providers as needed for clarifications. Patients

The standard-of-care workflow started with a provider discussing therapy with a patient and asking them to complete the manufacturer’s hub form. The provider would then notify the medical assistants that therapy was to be initiated and would provide completed chart notes, the specialty medication prescription and completed hub form. The medical see HSSPs FIGHTING, page 22

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HSSPs FIGHTING continued from page 21

assistant would then request a benefits investigation via the hub by submitting the appropriate forms. After the benefits investigation, the clinic would submit the PA. If it was approved, they would send the prescription to the patient’s dispensing pharmacy or the provider would have to work on a PA. In contrast, the specialty pharmacy intervention workflow focused on a realtime benefits investigation after the provider entered the prescription and submitted the PA as needed in real time. If a PA was approved, the prescription would be reviewed clinically and sent to an outside specialty pharmacy to dispense

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or to the integrated specialty pharmacy if they were a contracted pharmacy. If the PA was denied, a specialty pharmacy clinical pharmacist would work with the provider to either appeal the process or choose a different therapy.

Overall, time to medication access was reduced in the intervention group compared with the standard of care when an outside specialty pharmacy was used for dispensing, with the benefit compounded when the HSSP was used for dispensing (seven vs. 37 days; P<0.001).

Dr. Elshaboury and her colleagues attributed the reduction in time to medication access to the following features of the intervention workflow: • complete access to patients’ electronic medical records;

• use of software to manage PA requests; • prescription capture at the time of prescribing; • real-time benefits investigation; • on-site PA submission; • comprehensive clinical pharmacy review; and • on-site medication dispensing.

The specialty pharmacy already had a relationship with the rheumatology, dermatology and inflammatory bowel disease clinics before the study. The autoimmune group was the last discipline being rolled out.

“We have gotten excellent feedback from our physicians,” Dr. Elshaboury said. “Everybody had a sense that we had drastically improved this process, but we really wanted to put a number on what that impact was, and we picked patient medication access, ultimately, as the best marker of that impact, and decreasing the time to medication access.”

Kudos for Brigham’s Effort To Embed Pharmacists Embedding pharmacists directly in specialty clinics in this manner is what HSSPs should do, commented Josephine Hurtado, BSPharm, the director of specialty pharmacy for Texas Children’s Hospital, in Houston. Doing so at her

hospital has led to patients receiving new prescriptions for specialty medications in less than a day, as opposed to four days through outside specialty pharmacies, or about 9.5 days for new prescriptions needing a letter of necessity or PA. These pharmacists are trained in specific diseases, and being housed in a clinic, patients get to know them, noted Ms. Hurtado.

“When the physician writes the prescription, we’re right there able to do any prior approvals, or ask any questions if there’s an error,” she said. “We can literally get up, go down the hall and have a conversation with a physician. Then we have access to all the labwork, so we can provide letters of medical necessity, or if there are any lab values or clinic notes that need to be reviewed, we can do so.

“I honestly believe that being part of a medical care team and being able to have that conversation where you know the physician by first name is very beneficial for us,” she added. “Otherwise, those outside pharmacies are calling and leaving a voice mail potentially and waiting for it to be returned.”

—Karen Blum The sources reported no relevant financial disclosures.

Vanderbilt Software Tool Hastens Benefits Review for Specialty Medications

A

software tool developed by pharmacists at Vanderbilt University Medical Center, in Nashville, Tenn., has helped address a major practice hassle discussed during ASHP’s National Survey of Health-System Specialty Pharmacy Practice: navigating the coverage issues that crop up when inpatients need nonformulary specialty medications.

“An increasing number of specialty medications have recently been approved by the FDA that may require inpatient administration or are given in combination with IV therapy, such as oral oncolytics and hepatitis C medications,” said Houston Wyatt, PharmD, CSP, the program director for complex projects at Vanderbilt’s specialty pharmacy. Managing these medications on the inpatient side presents several complex issues when it comes to billing and coordination that often are not considered, Dr. Wyatt noted. He cited, as an example, having to navigate limited distribution networks or Risk Evaluation and Mitigation Strategies programs that may exclude the inpatient hospital pharmacy. Then there is the challenge of managing inventory with expensive, infrequently used specialty medications. In addition, he said, part of the decision to initiate therapy depends on the ability of patients to access the medication for continued treatment when they are discharged.

To try to overcome some of these challenges, in 2019, the P&T committee devised a plan to communicate updates on specialty medications needed for inpatients using a software tool developed at the medical center several years before, called REDCap (Research Electronic Data Capture).

With Vanderbilt’s revised workflow, when nonformulary medications are ordered in the EHR, a REDCap link alerts the provider to enter a rationale for the medication’s use and to provide any relevant clinical information for the P&T committee. Then, REDCap sends an email alert to the ordering provider,

P&T committee, specialty pharmacy, inpatient central pharmacy and procurement team. While the request is being reviewed, the specialty pharmacy completes a benefits investigation to ensure the medication can be obtained for outpatient use at discharge. The pharmacy also coordinates with any external specialty pharmacies if the medication must be dispensed after discharge, and completes its part of the REDCap survey to alert the P&T committee about the benefits investigation outcome.

If the P&T committee approves the request, the central pharmacy is alerted to procure the medication for inpatient use and completes its part of the form, showing the product was obtained. At discharge, the specialty pharmacy provides a 30-day supply of medication or ensures the medication can be supplied to the patient through an external pharmacy. Each request is stored as a record in REDCap so the P&T committee can decide whether to add the medication to the formulary based on volume.

The P&T committee receives one to two requests for nonformulary medications per week, generally for oral oncolytics such as venetoclax (Venclexta, AbbVie/ Genentech), midostaurin (Rydap, Novartis), dasatinib (Sprycel, Bristol Myers Squibb), or hepatitis C antiviral medications for patients receiving a liver transplant from a hepatitis C–positive donor, Dr. Wyatt said.

“It’s definitely helped expedite the P&T decision process and medication procurement, so patients aren’t starting IV therapy without oral treatment,” he said.

The team also can see the status of all orders in real time on REDCap, and they are reimbursed for outpatient medications given at discharge. “Usually this process is turned around in 24 to 48 hours. Everyone involved has voiced how easy it’s been, and how transparent it is to help get medication to the patient. And it also provides reporting capabilities.”

—K.B. The sources reported no relevant financial disclosures.

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