Pharmacy Practice News - January 2022 by McMahon Group

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COVID-19 Vaccine Mix-Ups: What Pharms Can Do

UP FRONT

Provider status gains steam at 2021 ASHP Midyear Meeting ..

By Gina Shaw

POLICY

Not safe to touch: bad ergonomics puts compounders at risk ...... 6 Can new COVID-19 pay codes fuel financial health in 2022? .............. 10 CLINICAL

Substance abuse, mental health still a pandemic challenge ...

OPERATIONS & MGMT

Pharmacy leaders build a better model for infusion services .... Population health approach to diabetes sweetens outcomes.....

n the two months since PfizerBioNTech was granted emergency use authorization (EUA) for its COVID-19 vaccine in children 5 to 11 years of age, the Institute for Safe Medication Practices (ISMP) has received multiple reports of mix-ups between the pediatric formulation and that for individuals 12 years of age or older. Fortunately, pharmacists can use several vaccination handling and administration techniques to help reduce the risk for confusion, according to ISMP and other safety experts. The pediatric dose of the PfizerBioNTech COVID-19 vaccine is 10 mcg per 0.2 mL after dilution, compared with 30 mcg/0.3 mL for those 12 years of age or older. The pediatric formulation is shipped in a multipledose vial with an orange border on

As fatal harms and errors continue …

ISMP Adds New Medication Safety Best Practices

REVIEW ARTICLE By David Wild

A Collaborative, Evidence-Based Approach to Renal Dosing See page 12.

he Institute for Safe Medication Practices (ISMP) is introducing three new Targeted Medication Safety Best Practices for 2022-2023 that should help hospitals prevent errors with oxytocin and high-alert medications and reduce medication use errors by expanding barcode administration to non-inpatient areas. Christina Michalek, RPh, the administrative coordinator of ISMP’s Medication Safety Officers’ Society, shared Continued on page 20

EHR-based protocol cuts hypoglycemia by 50%

Diabetes Deprescribing In the Elderly: Less Is More By David Wild

harmacists are in a good position to identify medications that can be discontinued—or “deprescribed”—for patients and to manage this process, experts said in a session at the 2021 annual meeting of the American College of Clinical Pharmacy (ACCP). There is a strong argument to be made for including deprescribing as part of the pharmacist’s workflow, according to Collin Clark, PharmD, a clinical assistant professor at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, in New York. He pointed out that 30% of adults over 65 years of age receive one or more medications that carry higher potential risks than benefits (J Am Geriatr Soc 2015;63[3]:486-500). “Use of these potentially inappropriate medications has been shown to be an independent risk factor for adverse drug reactions,

Continued on page 18

SPECIALTY PHARMACY

New survey shows biosimilars gaining acceptance .....................

Volume 49 • Number 1 • January 2022

Continued on page 22

As COVID-19 Comes and Goes, Is Remote Work Here to Stay? By Gina Shaw

t press time, COVID-19 cases were back to near-historic surges in some parts of the country, fueled by the omicron variant’s dominance. But even before that surge took hold, a survey done during the 2021 ASHP Conference for Pharmacy Leaders suggested that many aspects of pharmacy practice are likely to stay remote, regardless of the trajectory of the pandemic. Indeed, 82% of meeting attendees surveyed said their pharmacy had staff performing work from home during the past year, and 71% said these arrangements have been ongoing and/or they are planning to continue work-from-home arrangements. Attendees were asked which pharmacy

functions they would be most willing to have performed remotely: acute care rounding or clinical work; order verification; patient onboarding to a new drug therapy; or all of the above. Order verification was selected by 80% of respondents, patient onboarding by 5% and “all of the above” by 14%. (No respondents selected acute care rounding.) When asked which functions they would find most difficult to perform remotely, 71% cited acute care rounding or clinical work, 25% cited patient onboarding, and 3% cited order verification. “Remote work has been around in pharmacy for years, so it’s not like we’re reinventing the wheel,” said session presenter Daniel O’Neil, PharmD, BCPS, the director

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The Best-Read Pharmacist’s News Source

pharmacypracticenews.com

As COVID-19 cases soar …

CLINICAL

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

Muscle relaxants and pain a dangerous mix ...

POLICY

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

OPERATIONS & MGMT

Drug diversion: yet another pandemic challenge .......................... ISMP survey reveals gaps in compounding compliance ......................

TECHNOLOGY

Harnessing big data key to ADC-driven inventory control ..........

Health Systems Stay Vigilant To Rx Shortages

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

Volume 48 • Number 2 • February 2021

Pharmacist-led Initiatives Save Millions

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Up Front

Pharmacy Practice News • January 2022

The ASHP 2021 Midyear Clinical Meeting and Exhibition All articles by Karen Blum, Gina Shaw and David Wild

‘Exciting Progress’ On Provider Status Cited During Town Hall

overnments at the state, local and national levels are increasingly recognizing the roles that pharmacists

For an exclusive video on provider status with Tom Kraus, JD, MHS, ASHP’s vice president of government relations, visit bit.ly/3t5iyEo.

can play and contribute to health care. Gains in practice made during the COVID-19 pandemic can serve as a precedent to keep pushing the boundaries. “We’re still working away at full provider status and, ultimately, recognition in the Medicare program,” said

Tom Kraus, JD, MHS, ASHP’s vice president of government relations, during a town hall meeting on pharmacist provider status. “But we’re making exciting progress, and we’ve seen an acceleration over the past two years.” During the pandemic, some governors used their emergency authority to expand

Important Safety Information ALBUTEIN® 25% (albumin [human] U.S.P.) is indicated for: hypovolemia, cardiopulmonary bypass procedures, acute nephrosis, hypoalbuminemia, ovarian hyperstimulation syndrome, neonatal hyperbilirubinemia, adult respiratory distress syndrome (ARDS), and prevention of central volume depletion after paracentesis due to cirrhotic ascites. ALBUTEIN® 5% (albumin [human] U.S.P.) is indicated for: hypovolemia, cardiopulmonary bypass procedures, hypoalbuminemia, and plasma exchange. ALBUTEIN 5% and 25% are contraindicated in patients with a history of hypersensitivity to albumin preparations or to any of the excipients, and in patients with severe anemia or cardiac failure with normal or increased intravascular volume. Allergic or anaphylactic reactions require immediate discontinuation of the infusion and implementation of appropriate medical treatment. Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of fluid overload, the infusion must be slowed or stopped immediately. Use albumin with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. The colloid-osmotic effect of human albumin 25% is approximately five times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. Patients with marked dehydration require administration of additional fluids. Concentrated (20% - 25%) human albumin solutions are relatively low in electrolytes compared to 4% - 5% human albumin solutions. Regularly monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance when albumin is administered. Regular monitoring of coagulation and hematology parameters is necessary if comparatively large volumes are to be replaced. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes). Regularly monitor hemodynamic parameters during administration of ALBUTEIN® 5% and 25% (albumin [human] U.S.P.). ALBUTEIN 5% and 25% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for ALBUTEIN 5% or 25%. The most serious adverse reactions with use of albumin are anaphylactic shock, heart failure and pulmonary edema. The most common adverse reactions are anaphylactoid type reactions. Adverse reactions to ALBUTEIN normally resolve when the infusion rate is slowed or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment initiated. Please see brief summaries of full Prescribing Information for ALBUTEIN FlexBag 5% and 25%.

see LATE BREAKERS, page 4

4 Up Front

LATE BREAKERS continued from page 3

access to care, including services provided by pharmacists, Mr. Kraus said. Some states authorized pharmacists to provide access to testing and vaccinations. “There’s been this recognition that we need access to pharmacist services and that is an important driver of care and value in communities,” he said. Emergency orders happened on a national level, too, Mr. Kraus noted. The federal government used authority

Pharmacy Practice News • January 2022

under the public health emergency to expand access to pharmacist services nationwide. It was the first time the federal government asked states to permit pharmacists to provide services such as testing, vaccinations and now COVID-19 treatment. “That’s a huge step,” he said. Some states have taken additional measures to authorize payment for pharmacist services. About 40 states now recognize pharmacists as providers

ALBUTEIN

FlexBag 5% (albumin [human] U.S.P.) 5% solution These highlights do not include all the information needed to use ALBUTEIN FlexBag 5% safely and effectively. See full prescribing information for ALBUTEIN FlexBag 5%. ALBUTEIN FlexBag 5% (albumin [human] U.S.P.) 5% solution Initial U.S. Approval: 1978 ------------------------------------------INDICATIONS AND USAGE -----------------------------------------ALBUTEIN 5% is an albumin solution indicated for: • Hypovolemia. • Cardiopulmonary bypass procedures. • Hypoalbuminemia. • Plasma exchange. --------------------------------------DOSAGE AND ADMINISTRATION-------------------------------------For Intravenous Use Only Dosage and infusion rate should be adjusted to the patient’s individual requirements. Indication

Dose

Hypovolemia

Adults: Initial dose of 20 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g.

Cardiopulmonary bypass procedures

Adults: Initial dose of 25 g.

Hypoalbuminemia

Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g.

Plasma exchange

The dose required depends on the volume of plasma removed during the procedure.

ALBUTEIN

FlexBag 25% (albumin [human] U.S.P.) 25% solution These highlights do not include all the information needed to use ALBUTEIN FlexBag 25% safely and effectively. See full prescribing information for ALBUTEIN FlexBag 25%. ALBUTEIN FlexBag 25% (albumin [human] U.S.P.) 25% solution Initial U.S. Approval: 1978 ------------------------------------------INDICATIONS AND USAGE -----------------------------------------ALBUTEIN 25% is an albumin solution indicated for: • Hypovolemia. • Cardiopulmonary bypass procedures. • Acute nephrosis. • Hypoalbuminemia. • Ovarian hyperstimulation syndrome. • Neonatal hyperbilirubinemia. • Adult respiratory distress syndrome (ARDS). • Prevention of central volume depletion after paracentesis due to cirrhotic ascites. --------------------------------------DOSAGE AND ADMINISTRATION-------------------------------------For Intravenous Use Only Dosage and infusion rate should be adjusted to the patient’s individual requirements. Indication

Dose

Hypovolemia

Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g.

Cardiopulmonary bypass procedures

Adults: Initial dose of 25 g.

Acute nephrosis

Adults: 25 g together with diuretic once a day for 7 - 10 days.

Hypoalbuminemia

Ovarian hyperstimulation syndrome

Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary.

and reimburse at least some level of pharmacist services, Mr. Kraus said. Now, attention should be placed on how flexibilities allowed during the pandemic can become permanent, especially as new therapies such as antivirals emerge for the treatment of COVID-19, he said. The demonstration that pharmacists are capable of providing direct patient care services during COVID-19, and ordering and administering therapeutics,

Do not dilute with sterile water for injection as this may cause hemolysis in recipients. ------------------------------------DOSAGE FORMS AND STRENGTHS -----------------------------------ALBUTEIN 5% is a solution containing 50 g per L of total protein of which at least 95% is human albumin. ---------------------------------------------CONTRAINDICATIONS--------------------------------------------• Hypersensitivity to albumin preparations or to any of the excipients. • Severe anemia or cardiac failure with normal or increased intravascular volume. --------------------------------------WARNINGS AND PRECAUTIONS-------------------------------------• Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. • Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. • Monitor electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is given. • Do not dilute with sterile water for injection. • This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. -------------------------------------------- ADVERSE REACTIONS -------------------------------------------The most common adverse reactions are anaphylactoid type reactions. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals LLC at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------------- USE IN SPECIFIC POPULATIONS ------------------------------------• Pregnancy: No human or animal data. Use only if clearly needed. Revised: 07/2021

Manufactured by: Grifols Biologicals LLC 5555 Valley Boulevard Los Angeles, CA 90032, U.S.A. U.S. License No. 1694

3061038

Indication

Dose

Neonatal hyperbilirubinemia

1 g per kilogram body weight prior to or during exchange transfusion.

Adult respiratory distress syndrome (ARDS)

Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary.

is something that can be used as a precedent to further promote pharmacists’ involvement in helping manage other public health burdens, such as HIV and influenza, Mr. Kraus said. “Policymakers can’t put that back in the bottle if you’ve already demonstrated that pharmacists are a great access point for care,” he stressed. State legislatures still control scope-ofpractice issues. Over the past couple of years, some states expanded the scope of practice for pharmacists. Although it may be frustrating when progress is incremental, Mr. Kraus said, “every incremental win is an opportunity to celebrate a recognition of the role of pharmacists in providing access to care. The reality is that incremental progress is only going in one direction—toward expansion of pharmacists’ scope of practice.” Sen. Charles “Chuck” Grassley (R-Iowa) also addressed meeting attendees in a recorded message, thanking pharmacists for being on the front lines of the pandemic. He is a sponsor of the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 2759/S. 1362), a bipartisan bill to amend Section 1861(s)(2) of the Social Security Act to include pharmacists on the list of recognized health care providers in medically underserved areas. “This bill will let pharmacists offer health care services to their patients that they’re trained and licensed to perform,” Sen. Grassley said, and to be reimbursed by Medicare. “Eligible services would include point-of-care testing for infectious diseases, wellness screenings, diabetes management, vaccinations and more.”

Opioid Stewardship Programs Led by Pharmacists Proliferating

Prevention of central volume depletion after Adults: 8 g for every 1000 mL of ascitic fluid removed. paracentesis due to cirrhotic ascites Do not dilute with sterile water for injection as this may cause hemolysis in recipients. ------------------------------------DOSAGE FORMS AND STRENGTHS -----------------------------------ALBUTEIN 25% is a solution containing 250 g per L of total protein of which at least 95% is human albumin. ---------------------------------------------CONTRAINDICATIONS--------------------------------------------• Hypersensitivity to albumin preparations or to any of the excipients. • Severe anemia or cardiac failure with normal or increased intravascular volume. --------------------------------------WARNINGS AND PRECAUTIONS-------------------------------------• Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. • Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. • When concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. • Monitor electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is administered. • Do not dilute with sterile water for injection. • This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. -------------------------------------------- ADVERSE REACTIONS -------------------------------------------The most common adverse reactions are anaphylactoid type reactions. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals LLC at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------------- USE IN SPECIFIC POPULATIONS ------------------------------------• Pregnancy: No human or animal data. Use only if clearly needed. Manufactured by: Grifols Biologicals LLC 5555 Valley Boulevard Los Angeles, CA 90032, U.S.A. U.S. License No. 1694

Revised: 05/2019

3055225

ore and more hospital pharmacies are developing opioid stewardship programs and reducing the risk for related overdoses, experts noted during a press conference at the Midyear Clinical Meeting. Anna Legreid Dopp, PharmD, the senior director of clinical guidelines and quality improvement at ASHP, said the group surveyed thousands of hospitals across the country and found the percentage of institutions with opioid stewardship programs rose from 40.9% in 2018 to about 47.3% in 2019, with programs with pharmacists in leadership

Up Front

Pharmacy Practice News • January 2022

positions growing from 54.8% to 64.8% over the same period (Am J Health Syst Pharm 2020;77[13]:1026-1050) “We’ve seen opioid stewardship programs follow a similar trajectory as with the growth in antimicrobial stewardship programs over the last 10 to 15 years, and we expect that this pattern will continue,” Dr. Legreid Dopp said. Kings County Hospital, NYC Health + Hospitals, recently added a pharmacistguided opioid stewardship programs. Lisa Yamagishi, PharmD, is a clinical pharmacist for opioid stewardship at the institution. During the press conference, she said spearheading the establishment of the program, in 2020, “was a unique opportunity, given pharmacists’ expertise in medications and in determining whether or not patients have tolerance to opioids, doing conversion calculations and developing appropriate nonopioid analgesic pain management strategies.” One opportunity Dr. Yamagishi and her colleagues identified while surveying their institution’s needs regarding better opioid management was being able to offer naloxone to inpatients at high risk for opioid overdose, she said. She noted that the practice was already in place for emergency department patients. “Since the opioid stewardship program was monitoring high-risk inpatients already—determining risk based on their morphine milligram equivalents used per day, history of opioid use disorder and chronic pain medication regimens—we were able to recommend which patients should be provided with naloxone kits upon discharge,” Dr. Yamagishi said. During the six months after implementing an inpatient naloxone dispensing initiative in October 2020, Dr. Yamagishi and her team identified 71 inpatients as being at high risk for opioid overdose; 75% of these patients were prescribed naloxone kits at discharge, according to data she presented at the meeting. In contrast, between June and September 2020, 18% of high-risk inpatients were prescribed naloxone kits. “Providing this many naloxone kits was an extremely great accomplishment for us,” she stressed. Dr. Yamagishi said these encounters also provided an opportunity to educate physicians on the pharmacist-driven naloxone distribution program and to counsel high-risk inpatients and their families and caregivers on naloxone use and overdose risk reduction strategies. Dr. Yamagishi’s program “really highlights the importance of thinking about every setting in which you might see patients and taking every opportunity to make a difference,” said Elizabeth Bentley, PharmD, the director of

clinical pharmacy services, Northwest Region, Kaiser Permanente, in Portland, Ore., who also spoke during the press conference.

Gender-Affirming Hormone Therapy: A Pharmacist’s Guide

ender-affirming hormone therapy (GAHT) is an emerging area of clinical pharmacy, and pharmacists have a significant opportunity to contribute to patient care, said Karen M. Gunning, PharmD, the associate dean of community engagement at the University of Utah College of Pharmacy, in Salt Lake City. “It’s important to understand the limitations and the value of the available evidence,” Dr. Gunning said at a session on caring for transgender people. “While there are guidelines and recommendations galore, there is relatively little that we would consider high-quality, evidence-based medicine in the field of transgender care and GAHT.” She recommended three core resources that provide a good foundation for clinical pharmacists who are interested in learning more about GAHT: 1. The University of California, San Francisco (UCSF) “Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People,” an expert consensus document with peer review, released in 2016: transcare.ucsf.edu/ guidelines 2. The Endocrine Society’s clinical practice guideline, “Endocrine Treatment of Gender-Dysphoric/ Gender-Incongruent Persons,” evidence-based to the extent possible with a systematic review using the GRADE approach and published in 2017: academic.oup.com/jcem/ article/102/11/3869/4157558 3. The World Professional Association for Transgender Health’s “Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People,” published in 2012, based on what it cites as “the best available science and expert consensus”: www.wpath. org/publications/soc

However, there are a lot of resources out there that don’t fit the description, including many single-creator “guidelines” and Reddit discussions that patients may encounter, Dr. Gunning cautioned. “Do not trust everything you read. But ‘Dr. Google’ can actually be helpful for understanding what your patient is asking you about and what they are seeing, hearing and reading about in their communities.” Despite progress, local and regional access gaps in GAHT continue. “At the University of Utah, we see a large number of patients coming to us from states where there is less ability to access this type of care,” Dr. Gunning noted. “For many of these people, there are significant safety concerns as they seek help on the internet or through do-it-yourself hormone therapy. Where care may be available for GAHT, there often is not primary careintegrated GAHT.” She encouraged clinical pharmacists to promote the integration of GAHT into supportive primary care for transgender people in their clinics. “These individuals have many of the same health concerns as our other patients. They need you to answer questions about their diabetes and hypertension, and also about hormone therapy. What all patients need is care. If you can champion primary careintegrated GAHT at your institution, that would serve a significant need.”

Biosimilars Positioned For Continued Growth

ith 31 biosimilar products approved by the FDA in the United States to date, the agents are slowly gaining a foothold. But challenges remain. “Biosimilars offer high-quality treatment alternatives at a fraction of the cost,” thus offering “a strong value proposition,” said Jorge Garcia, PharmD, MBA, the assistant vice president of the system oncology pharmacy service line, at Baptist Health South Florida in Miami. “Unfortunately, we see that many pre- and postmarketing implementation barriers still exist in the marketplace today.” Health care professionals, he noted, are “uniquely positioned to promote the evaluation of the growing body of evidence associated with biosimilars,” Dr. Garcia continued. “Where there is evidence to support safety and efficacy,

it is our role to enable that process.” The cost of biologics has reached an all-time high, he said. In 2019, biologics represented just 2% of U.S. prescription drug utilization, but 43% of the $493 billion drug spend, he said, citing a 2020 report from IQVIA (bit.ly/ 3IPpoDo). These costs could continue to grow, as cancer drugs alone are increasing at twice the rate of general health care costs, he said. One hot topic affecting biosimilars is switching and interchangeability, Dr. Garcia said. Switching refers to the exchange of one medicine for another with the same therapeutic intent. It presents no greater safety or efficacy risk than continuous treatment with the reference product. Interchangeability, the use of a biological product as a substitute for a reference product, is determined by FDA guidelines, while switching is regulated at the state level. At least 45 states and Puerto Rico permit pharmacists to switch a biosimilar if it is considered interchangeable and covered under the payor’s pharmacy benefit. Pharmacists in health-system settings generally, through institutional policy, are able to interchange these products, Dr. Garcia said. “The reality is that many payors are treating these products as interchangeable, because their benefit designs tell us not to use product A but to use product B,” he said. “Those are across reference and biosimilar options.” In July, the FDA issued its first interchangeability designation to insulin glargine-yfgn (Semglee, Viatris), stating it is biosimilar to, and interchangeable with, the reference product insulin glargine (Lantus, Sanofi). The product is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. “This is very exciting because it really impacts a large patient population,” Dr. Garcia said. “This product has [Medicare] Part D or pharmacy benefits, which brings us a step closer to potentially seeing a more sustainable pharmacoeconomic model behind biosimilars.” For up-to-date information on approved biosimilars, check the FDA website (bit.ly/30go5vN) or the Purple Book (bit.ly/3lQADBl). Dr. Collins reported a financial relationship with ASHP Consulting. Dr. Garcia reported no relevant financial disclosures. The remaining sources reported no relevant financial disclosures.

6 Policy

Pharmacy Practice News • January 2022

Sterile Compounding

Revised USP <797> Will Call for More Resources By David Wild

ow that USP has released its longawaited proposed revisions to General Chapter <797>—and assuming the chapter will not change significantly in its finalized form—hospital pharmacies are gearing up to meet the necessary requirements. “Implementing the proposed revisions will come with challenges regarding costs and resources, but the safety of patients and compounding employees far outweigh these costs,” said Mary Nazzal, PharmD, the director of field operations, Kastango Consulting Group, a TRC Healthcare Company. “The USP <797> 2021 proposed revisions address many concerns, including clarifying requirements, providing expanded guidance for assigning beyond-use dates [BUDs], and renaming risk levels, which we saw in the 2019 version and are a move in the right direction for safety.”

Much Attention Paid to BUD Changes in <797> Most of the attention regarding the proposed revisions to USP <797>— which was published in September 2021—has centered on the creation of

Table. Proposed Revisions to USP Chapter <797> Categories Category 1 CSPs

Category 2 CSPs

Category 3 CSPs

May be prepared in a PEC located in an unclassified segregated compounding area

Must be prepared in a cleanroom suite

Have additional requirements that must be met at all times

Assigned a BUD of ≤12 hours at controlled room temperature or ≤24 hours when refrigerated

May be assigned a BUD of >12 hours at controlled room temperature or >24 hours if refrigerated

May be assigned a BUD longer than established for Category 2 CSPs, up to 180 days

BUD, beyond-use date; CSPs, compounded sterile preparations; PEC, primary engineering control

three categories of compounded sterile preparations (CSPs) and their BUD requirements (Table). Under the proposed revisions, compounders who are willing to meet the most stringent quality assurance parameters can assign BUDs up to 180 days, Brenda Jensen, CPhT, CNMT, MBA, the chair of the USP Compounding Expert Committee, explained in a presentation at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. According to Ms. Jensen, the quality assurance requirements for “Category 3” CSPs include stringent sterility testing and endotoxin testing, when compounding from non-sterile starting

ingredients, as well as more frequent personnel qualification evaluations, sterile garbing requirements, increased use of sporicidal disinfectants and more frequent environmental monitoring. However, these very stringent Category 3 BUD requirements are less of a concern for many hospitals, most of which do not compound this category of CSPs, said Kenneth Jozefczyk, MS, the director of central pharmacy services, BayCare Health System, in Tampa, Fla. “I’m pretty sure we won’t be veering into this third category because it requires a significant investment in garb, equipment and workflow,” said Mr. Jozefczyk, who was not

involved with the ASHP presentation. Although Category 1 and 2 compounders do not need to meet the level of stringency required for Category 3 agents, as Ms. Jensen noted during her talk, they will still need to perform more frequent monitoring and testing than was in previous versions of USP <797>. For example, while the still official 2008 version of USP Chapter <797> requires that surface sampling be done “periodically,” the proposed revision would require monthly surface sampling for Category 1 and 2 compounds. The proposed revisions also would mean more frequent evaluation of see USP <797>, page 9

The 10 Principles of Compounding Ergonomics By David Wild

lthough compounding medications can be rewarding, the repetitive tasks involved can strain the muscles and joints. In light of the risk for injury, one expert who spoke on the topic at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually, emphasized the importance of preventing musculoskeletal injuries before they occur. “Every colleague I have talked to has at least one associate with an injury, and recovery can take months and be debilitating for activities of daily living as well as for work,” said Dennis Tribble, PharmD, the director of clinical innovations and medical affairs for Medication Management Systems at BD. To help prevent compounding-related injuries, Dr. Tribble shared 10 principles of compounding ergonomics: Work in a neutral posture. “The first and foremost notion in ergonomics is maintaining an appropriate posture and an ‘S-curve,’ to the spine,” Dr. Tribble said. To help achieve this, use chairs with lumbar support and orient work to keep elbows at the side and to avoid excessive reaching or leaning. Reduce excessive force. “The force required to push 20 mL through a 27-gauge syringe with a 1.5-inch needle over 20 seconds is about 10 pounds, and you can imagine the stress it places on the hands and wrists to do that tens or hundreds of times a day,” Dr. Tribble said. To mitigate this effect, he recommended using the smallest syringe possible to deliver a dose along with the largest needle that will also avoid coring, and to consider using a spike adapter for multiple draws from the same vial. Pharmacy pumps and IV robotics can also help reduce the force required with repetitive dose preparation and delivery, he said. Keep everything within easy reach. “It can be tricky to put everything in the hood within

arm’s reach, but you really want to do that,” Dr. Tribble said. For example, IV workflow equipment should be within easy reach while preserving the direct compounding area. Work at the proper height. “Ordinarily, work at elbow level is the most ergonomic, but there are exceptions,” he said. “If you To avoid repetitive motion injuries, IV workflow equipment should be within have to read documents with easy reach while preserving the direct compounding area. small fonts or perform close visual inspection, working at motions of your job is critical,” Dr. Tribble said. Assess eye level is better than having to bend or extend the compounding area and ensure compounders have the neck.” the clearance needed to do their work, he advised. Reduce excessive motion. “Wrist extension and Move, exercise and stretch. “Doing anything in inflection are probably the two things we do one place for a long time in one position can most when manipulating syringes, so you want to be cause injuries, so you really want to find ways to sure these motions are not exaggerated because it move, stretch and exercise,” he said. Break times can lead to repetitive strain injury,” he said. When should be scheduled, and staff can be rotated drawing multiple doses from large compounding through the cleanroom. vials, a spike adapter and rearranging the working layout to keep the direct compounding area clear can Maintain a comfortable environment. “I’ve minimize the amount of reaching. been in a few cleanrooms where the fan drivers of a hood were out of balance to the point that Minimize fatigue and static load. “If you can someone using a gravimetric system couldn’t get the provide compounders with footrests and other scale to settle because the vibrations were so bad,” accommodations that permit occasional shifting of Dr. Tribble said. Resolve these issues, because physifoot or leg positions and that are easy to disinfect, cal vibrations and noise can also prompt workaround that may keep them more comfortable for longer behaviors that, in turn, lead to inappropriate posture. periods of time,” Dr. Tribble said. For more information, visit the Occupational Minimize pressure points. Squeezing fingers or Health and Safety Agency for Healthcare’s ergonomleaning arms and legs against edges of work ics guide for hospital pharmacies (www.osha.gov/ surfaces can lead to injuries. Padding is the best ergonomics). option to mitigate this. Provide clearance. “We don’t often think of this when we think about ergonomics, but providing an unobstructed ability to perform the ordinary

Dr. Tribble reported that he is an employee and shareholder of BD.

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INDICATIONS AND USAGE Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia. IMPORTANT SAFETY INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning. • Morphine Sulfate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. • Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. • Known or suspected gastrointestinal obstruction, including paralytic ileus. • Hypersensitivity to morphine.

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Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. Common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of Morphine Sulfate Injection or precipitate withdrawal symptoms. Pregnancy: May cause fetal harm. Overdosage: Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose. This important safety information does not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. Please see full prescribing information, including Boxed Warning, for MORPHINE SULFATE INJECTION at www.fresenius-kabi.com/us.

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BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use MORPHINE SULFATE INJECTION, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for MORPHINE SULFATE INJECTION, USP at www.fresenius-kabi.com/us. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing [see Warnings and Precautions]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions and Drug Interactions]. • Reserve concomitant prescribing of Morphine Sulfate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. INDICATIONS AND USAGE Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions], reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., nonopioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia CONTRAINDICATIONS Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions]. • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment [see Warnings and Precautions]. • Concurrent use of mon oamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions]. • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions]. • Hypersensitivity to morphine (e.g. anaphylaxis) [see Adverse Reactions].

WARNINGS AND PRECAUTIONS (also see BOXED WARNING) • Addiction, Abuse, and Misuse: Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death [see Drug Abuse and Dependence]. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions. • Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing [see Overdosage]. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper. • Neonatal Opioid Withdrawal Syndrome: Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations]. • Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Morphine Sulfate Injection with benzodiazepines or other CNS depressants (e.g. non-benzodiazepine sedatives/ hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. Follow patients closely for signs and symptoms of respiratory depression and sedation. • Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during dose initiation and titration. • Interactions with Monoamine Oxidase Inhibitors (MAOIs): Morphine Sulfate Injection should not be used in patients taking MAOIs or within 14 days of stopping such treatment. • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. • Risks of Use in Patients with Gastrointestinal Conditions: Morphine Sulfate Injection is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. • Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients with a history of seizure disorders for worsened seizure control. • Withdrawal: Use of mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms. • Central Nervous System Toxicity: Dysphoric reactions may occur after any size dose and toxic psychoses have been reported. • Exposure, Hypothermia, Immersion and Shock: Caution must be used when injecting any opioid intramuscularly into chilled areas or in patients with hypotension or shock, since impaired perfusion may prevent complete absorption; if repeated injections are administered, an excessive amount may be suddenly absorbed if normal circulation is re-established. • Risks of Driving and Operating Machinery: Morphine Sulfate Injection may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Morphine Sulfate Injection and know how they will react to the medication. ADVERSE REACTIONS [see Boxed Warning and Warnings and Precautions] Serious adverse reactions associated with Morphine Sulfate Injection included: addiction, abuse, and misuse, lifethreatening respiratory depression, neonatal opioid withdrawal syndrome, interactions with benzodiazepines or other CNS depressants, cardiac instability, adrenal

insufficiency, severe hypotension, gastrointestinal adverse reactions, seizures, withdrawal, respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously. The most frequently observed adverse reactions included: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. Other possible adverse reactions include: euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation, constipation, biliary tract spasm, tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, oliguria and urinary retention, pruritus, urticaria, skin rashes, opioid-induced histamine release (flushing of the face, diaphoresis, pruritus, and wheals and urticaria at the site of injection), androgen deficiency, anaphylaxis, serotonin syndrome, and adrenal insufficiency. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Clinically significant drug interactions with Morphine Sulfate Injection: benzodiazepines and other central nervous system (CNS) depressants; serotonergic drugs; monoamine oxidase inhibitors (MAOIs); mixed agonist/ antagonist and partial agonist opioid analgesics; muscle relaxants; cimetidine; diuretics; anticholinergic drugs; and oral P2Y12 inhibitors. USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm [see BOXED WARNING for Neonatal Opioid Withdrawal Syndrome]. • Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Naloxone must be available for reversal for reversal of opioid-induced respiratory depression. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. • Lactation: Present in breast milk. Lactation studies have not been conducted and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Monitor infants for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of opioid analgesic is stopped, or when breast-feeding is stopped. • Females and Males of Reproductive Potential: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible. • Pediatric Use: The safety and effectiveness in pediatric patients below the age of 18 have not been established. • Geriatric Use: Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. Monitor for signs of central nervous system and respiratory depression. Start at the low end of the dosing range, titrate the dosage slowly and monitor for signs of CNS and respiratory depression. • Hepatic and Renal Impairment: Morphine sulfate pharmacokinetics are altered in patients with cirrhosis and renal failure. Start these patients with a lower than normal dosage and monitor for signs of respiratory depression, sedation, and hypotension. OVERDOSAGE Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose. In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Because the duration of opioid reversal is expected to be less than the duration of action of morphine in Morphine Sulfate Injection, carefully monitor the patient until spontaneous respiration is reliably reestablished. For full Prescribing Information please go to www.simplist-us.com

Policy

Pharmacy Practice News • January 2022

Sterile Compounding

USP <797> continued from page 6

compounders’ competencies and more frequent media fill testing, which would require two incubators to accommodate changes in incubation temperatures. “This update seems to be of concern to many in the field, as they often don’t have two incubators available or don’t have the space to add an additional incubator,” Dr. Nazzal said. One tactic that some hospital pharmacies have taken when their incubation needs have exceeded their in-pharmacy capacity has been to ask their hospital’s microbiology laboratory to add “a few extra samples to their incubator, but now they’re going to need a little bit more of a formal plan to get incubator space or, in some cases, purchase incubators,” Mr. Jozefczyk said.

The Ins and Outs of Testing Hospitals that outsource their environmental testing should prepare to perform some testing internally, said Patricia Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, who was not involved with the ASHP presentation but is a member of the USP Compounding Expert Committee. “It’s unlikely that a hospital pharmacy would be able to get their certifiers to perform environmental testing every month, because of the cost and because certifiers are busy, so they’ll need to buy the equipment to do part of this testing themselves,” she said. For these individuals, more frequent testing also will require access to a microbiologist, whether contracted or in-house, as well as additional testing kits or media, if incubating in-house, Ms. Kienle said. “I would encourage hospital pharmacies to get up to speed on this and figure out how they’re going to meet these requirements,” she added.

Changes to Ophthalmic Preparations One concern that came up during the development of the proposed Chapter <797> centered on the revised requirements for preservative-free ophthalmic preparations. “To prevent contamination, these need to be packaged in unit-dose ophthalmic containers, but unit-dose devices are only available to manufacturers,” Ms. Jensen said. “A hospital pharmacy would need to package those preparations in unit-dose syringes instead of containers, which comes with the risk of accidentally being injected.” The USP Compounding Expert Committee ultimately decided to allow ophthalmic compounds to be packaged in multidose containers as long as they are assigned BUDs according to the requirements for Category 1, 2 and 3 CSPs,

Ms. Jensen said. “The caveat is that once opened, the container must be discarded after 24 hours when stored at room temperature and after 72 hours if stored refrigerated.” Despite that accommodation, “the chatter in the field is that this update will significantly impact those who prepare non-preserved ophthalmic CSPs,” Dr. Nazzal said. “Many of these CSPs are antibiotics and given over seven to 14 days, so they are noncompliant with the requirement [for a maximum BUD of 72 hours].”

To be compliant, she said, pharmacies would need to build more robust processes—such as Chapter <51> on antimicrobial effectiveness testing and Chapter <1207> on container closure integrity testing—and potentially dispense separate multiple containers to accommodate the need for shorter BUDs. “I am sure the USP committee will get tons of feedback on this section, and I look forward to seeing what they come up with,” she said. Noting that the proposed USP <797> revisions are open for public comment

until Jan. 31, 2022, Dr. Nazzal said, “I hope that USP and compounding pharmacies can agree on the standards in the next release, so that pharmacies are not afraid to move forward. The longer we wait for the final version, the longer patients may be subjected to suboptimal care by compounding pharmacies doing things they should not be doing.” Ms. Jensen and Ms. Kienle are members of the USP Compounding Expert Committee. Ms. Kienle noted that her comments are her own. Dr. Nazzal and Mr. Jozefczyk reported no relevant financial disclosures.

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10 Policy

Pharmacy Practice News • January 2022

Reimbursement Matters

New COVID-19 codes among key developments

Are You Covering All Avenues That Affect Revenue? B

oth providers such as your health system and the payors you depend on share many challenges in this everchanging health care environment. Rising to the top is trying to manage diverse patient populations covered by a variety of payors. As you’re implementing 2022 payment rules and changes, it’s important to keep those different patient groups in mind, and to also keep an eye on looming federal and state regulations. Your success in those endeavors may well hinge on whether your infrastructure is able to support the business of pharmacy in a fast, reliable and up-todate manner. Or, as I often use the phrase, “Is IT on it?” Bubbling up through the layers and pages of rules are three key areas in which pharmacy has a direct influence: transparency in pricing, prior authorization and data integrity. The common element? The accuracy and completeness of the data that you are creating and reporting through your claims. Keep in mind that claims to payors not only ask for payment but also relay data that tell the clinical story of the encounter/episode/visit. You’re telling this story through electronically reporting the disease state(s) through ICD-10 MS-DRGs; the procedures, tests and some products through CPT codes; and the drugs, biologicals and radiopharmaceuticals used through HCPCS codes. These products are found in the A, C, J, P and Q sections of the HCPCS code table. Modifiers can be added to each of these types of codes to further enhance the information being conveyed. None of these code sets are static, onetime creations, but instead go through numerous updates and revisions. Think of them as living documents that must be incorporated continually into your multiple electronic or computerized systems. Through its MedLearn Matters publications and software downloads to your revenue cycle financial systems, CMS

conveys this information automatically. At no cost, any individual also can receive the MedLearn Matters publications.

A Sampling of Scenarios Your facility or system also may have contracted with an external company to provide “source-of-truth” data. Do you know which ones are already available to you within your facility? This is not the time to be naive, as small changes can have huge implications. The following scenarios are examples of the actions you need to take following any payor announcements of changes and updates. How does IT know they need to be on it? Scenario 1

The CDC announces it is implementing three new ICD-10-CM diagnosis codes for reporting COVID-19 vaccination status, effective April 1, 2022: Z28.310 (Unvaccinated for COVID-19 NonCC 23 95), Z28.311 (Partially vaccinated for COVID-19 NonCC 23 951) and Z28.39 (Other underimmunization status NonCC 23 95). What are the implications? Which of your many computerized and tracking systems are affected by new or changed codes? Is anything in your CPOE or EHR systems affected? Who’s tracking this and making the appropriate modifications in a timely manner? For instance, in this case, is the appropriate use of any medication or therapeutic treatment affected by new requirements for reporting that might entail using these codes? For more information, check out the Dec. 2, 2021 mlnconnects article from CMS’ Medicare Learning Network (go.cms.gov/3diQjsI). Scenario 2

CMS announces it is implementing seven new procedure codes to describe the introduction or infusion of therapeutics, including vaccines for COVID-19 prevention, in the ICD-10-PCS, effective April

01, 2022 (Table). The agency also notes that for hospitalized patients, Medicare pays for the COVID-19 vaccines and their administration separately from the DRG rate. Do you have a mechanism to ensure claims for these separate payments actually are being processed correctly using the appropriate CPT codes when a Medicare beneficiary is administered a vaccine while a hospital inpatient? This tool kit from CMS may help (go.cms. gov/3okwibl).

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

Bonnie Kirschenbaum, MS, FASHP, FCSHP

A Reimbursement Lexicon Scenario 3

The FDA approves a new drug and several physicians begin writing orders for its use in outpatient environments, such as the infusion clinic and specialty clinic areas that are related to immunology. Although it will need to be formally submitted to the P&T Committee for review, with no guarantee of acceptance, the interested medical staff insist it is a “breakthrough therapy” and needs to be made available immediately. They also have indicated that their Medicare Advantage and other commercially covered patients have access through their specialty pharmacy connections that can be used as necessary. You decide that the win-win solution to keep the patients within your system and continue a working relationship with the medical staff, among other factors, is to proceed with the use of the drug in a “non-formulary” status. Does this exempt you from the cascade of activities that are related to adding a new drug to your systems? Absolutely not! As quickly as possible, the same diligence needs to be applied here: addition to the drug masters in your computerized systems, complete with the applicable HCPCS code and NDC number and a billing unit crosswalk. A CDM entry and link is essential. Prior authorization requirements and any other payor requirements need to be noted and

CDM, charge description master; CMS, Centers for Medicare & Medicaid Services; CPOE, computerized provider order entry; CPT, Common Procedural Terminology; DRG, diagnosis-related group EHR, electronic health record; HCPCS, Healthcare Common Procedure Coding System; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification; ICD-10-PCS, International Classification of Diseases, Tenth Revision, Procedure Coding System; IT, Information technology; MS-DRG, Medicare Severity-Diagnosis Related Group ; NDC, National Drug Code; P&T, Pharmacy and Therapeutics

linked. The appropriate drug administration codes need to be identified. These requirements apply to any drug being used in your facility regardless of formulary status! Does your IT support team give this as much credence as they give to clinical file builds?

No Surprises CMS released 11 documents in support of the “No Surprises Act,” which provides federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise bills arise most frequently. Among its provisions is the requirement that providers give patients a good-faith estimate of expected charges by giving them (orally and written) a cost estimate for their care if they are not enrolled in a plan, covered by a federal health care program or aren’t seeking to file an insurance claim for care. For more information, visit go.cms.gov/338taXS ■

Table. Seven New Procedure Codes for COVID-19 and Other Therapeutics Procedure Code

Description

O.R.a

XW013V7

Introduction of COVID-19 vaccine dose 3 into subcutaneous tissue, percutaneous approach, new technology group 7

XW013W7

Introduction of COVID-19 vaccine booster into subcutaneous tissue, percutaneous approach, new technology group 7

XW023V7

Introduction of COVID-19 vaccine dose 3 into muscle, percutaneous approach, new technology group 7

XW023W7

Introduction of COVID-19 vaccine booster into muscle, percutaneous approach, new technology group 7

XW0DXR7

Introduction of fostamatinib into mouth and pharynx, external approach, new technology group 7

XW0G7R7

Introduction of fostamatinib into upper GI, via natural or artificial opening, new technology group 7

XW0H7R7

Introduction of fostamatinib into lower GI, via natural or artificial opening, new technology group 7

Because the procedure codes are designated as non-O.R. procedures, there is no assigned Major Diagnostic Categories or Medicare Severity-Diagnosis Related Group.

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12 Clinical

Pharmacy Practice News • January 2022

Medication Management

A Collaborative, Evidence-Based Approach to Renal Dosing RACHEL EYLER, PHARMD, BCPS Nephrology Senior Content Specialist, Clinical Effectiveness Wolters Kluwer, Health

STACEY MCCOY, PHARMD, MS, BCPS Pharmacy Clinical Program Manager, Clinical Surveillance and Compliance Wolters Kluwer, Health

elivering the right drug dose to the right patient is the cornerstone of precision medicine. When

treating the estimated 37 million people living with chronic kidney disease (CKD) in the United States,1 achieving this goal becomes especially complex.

Optimizing renal dosing poses a persistent challenge to clinicians, who must estimate a patient’s kidney function, find current literature or recommendations regarding proper dosing, and evaluate the patient’s particular clinical situation—all before making a dosing decision. If a dose of a drug that is primarily excreted by the kidneys is not properly reduced, patients with CKD are at increased risk for accumulation, toxicity, and adverse events. Reduce the dose of the medication too much, and the drug may not treat a potentially serious condition.

To make the most informed prescribing decision at the point of care, providers need access to not only the most accurate estimate of a patient’s kidney function but also the most recent related guidelines so they are empowered to take appropriate action to deliver individualized care for their patients. As recommendations for renal dosing and preferred methods for estimating kidney function evolve over time, pharmacists remain steadfast experts in interpreting and applying the latest guidance to optimize and personalize drug regimens.

By combining pharmacist drug expertise with evidence-based and clinically vetted information, health systems can optimize renal dosing to protect patients with kidney impairment from dangerous side effects and improve treatment outcomes.

The Evolution of Kidney Function Estimation The primary measure of a patient’s kidney function is the glomerular filtration rate (GFR), which is best determined by infusing and subsequently measuring a compound known to be cleared exclusively

Table. Pharmacist-Identified Drug-Related Problems in CKD Problem

Total Issues Identified, %

Nonadherence to therapy

Antihypertensives, CKD-MBD medications (phosphate binders, cinacalcet, etc), antihyperglycemics

OTC/natural products not recommended in CKD

Antacids, vitamin A, NSAIDs

Needs additional therapy (uncontrolled hypertension)

Drugs not recommended for degree of CKD

NSAIDS, bisphosphonates, metformin, nitrofurantoin

Drugs requiring dosage adjustment

Anti-infectives, allopurinol

Other

Common Drugs/Drug Classes Involved

CKD-MBD, chronic kidney disease-mineral and bone disorder; NSAIDs, nonsteroidal anti-inflammatory drugs; OTC, over-the-counter Based on reference 22.

by renal filtration, such as inulin.2 Although accurate, this process is time-consuming and labor-intensive, inconvenient to patients, and impractical in most clinical settings. Since creatinine is a natural byproduct of normal muscle function and primarily excreted by the kidneys, most models used in practice rely on serum creatinine levels to estimate kidney function. This approach, although pragmatic, introduces uncertainty when determining renal dose adjustments, because the many options for calculating estimated GFR (eGFR) come with shortcomings, and none are 100% accurate. In addition, having multiple formulas available makes developing a standard approach to dosing in kidney disease difficult, because it is not always clear which equation is best to use in each setting. Published in 1976 using data from a cohort of 249 male participants, the Cockcroft-Gault equation has the longest standing role in guiding renal dose adjustments.3 A patient’s age, sex, weight, and serum creatinine are used in this equation to estimate the kidneys’ ability to filter creatinine, which is then used as a surrogate marker for overall function. However, because creatinine is cleared to a small extent via means other than glomerular filtration and levels can be affected by nonrenal see RENAL DOSING, page 14

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Medication Management

RENAL DOSING continued from page 12

factors, such as muscle mass and diet, the accuracy of using creatinine clearance (CrCl) to estimate kidney function across populations has been called into question. This concern is particularly valid in patients at the extremes for body or muscle mass.4 In 1999, the Modification of Diet in Renal Disease (MDRD) equation was developed using data collected from 1,600 patients with CKD.5 Like the Cockcroft-Gault, the MDRD equation incorporates sex, age, and serum creatinine into a GFR estimation equation, with added multipliers for race. Although the MDRD equation was the most accurate option available at the time of its publication,6 it is limited by its loss of reliability for patients without CKD. Its

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normalization to body surface area (BSA) is also a drawback, because it can result in underestimation of GFR in larger patients and overestimation in smaller patients—a troubling implication when determining appropriate drug dose adjustments. GFR formula development has grown more robust over time with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, which was introduced in 2009 using trial data from more than 8,000 participants.7 Although this formula includes some of the existing limitations of being creatinine based and normalized to BSA, it offers an incremental improvement in accuracy over the MDRD equation.8,9 In September 2021, the Chronic Kidney Disease Epidemiology Collaboration published a new equation, which does not include race as a modifier (the CKD-EPI 2021 equation). This equation is sufficiently accurate for clinical use and will help to ensure more equitable diagnoses and treatment of CKD, given the negative effect race-based calculations can have on access to care.10

A History of Guidance For Industry In 1998, the FDA issued the first industry guidance around renal dosing.11 Referencing the CockcroftGault equation as the commonly used tool for estimating GFR via CrCl, regulators recommended conducting pharmacokinetic studies in patients with kidney impairment and provided standardized suggestions for how to present renal dose adjustments in product labeling. Following the release of this guidance, approximately 70% of new drugs studied between 1999 and 2010 included pharmacokinetic analyses in patients with reduced kidney function, a significant increase from the approximately 56% of new drugs studied from 1996 to 1997.12 In 2010, the FDA introduced new guidance stating that either the Cockcroft-Gault or MDRD equation could be used to assign patients to a renal impairment group,13 resulting in an industry shift toward using the MDRD equation when making recommendations in product labeling.14 The latest draft guidance released by the FDA in September 2020 recommends the Cockcroft-Gault, MDRD, or CKD-EPI equation for estimating kidney function.15 The guidance also includes discussion regarding the disadvantage of BSA normalization for drug dosing and recommends individualizing eGFR by multiplying the standardized GFR by the BSA and dividing by 1.73. In addition to the FDA, professional

organizations dedicated to CKD research and the clinical care of patients with CKD have joined the conversation around how best to evaluate GFR. With eGFR equations directly affecting a patient’s access to care—from receiving a nephrology referral to affecting transplant waitlist eligibility—there has been an increased focus on removing the use of race-based modifiers. Because of the call for a non–race-based, standardized approach for estimating GFR and the results published by the CKDEPI,10 the National Kidney Foundation and American Society of Nephrology now recommend the use of the CKDEPI 2021 equation.16 This move will help eliminate disparities and improve access to safer, more equitable care earlier in the course of kidney disease.

The Pharmacist’s Role With evolving renal dosing research and guidance, providers need support making highly complex dosing decisions that draw on a combination of clinical and pharmacologic expertise. Pharmacists have been experts in personalized medicine since long before recent advances in pharmacogenomics brought this concept to the forefront. Whether assessing the clinical appropriateness of a dose based on weight and age or compounding formulations for a targeted route of administration, the profession is founded on optimizing therapy specific to the patient receiving treatment. Pharmacists play a pivotal role in ensuring the safe and effective delivery of medications, which is especially critical for patients with CKD. With the many nuances of renalbased dosing, it’s essential to adopt a collaborative approach incorporating a pharmacist’s in-depth understanding of how drug and metabolite pharmacokinetics are affected by kidney function. The 81,000 pharmacists practicing in hospitals throughout the United States as of 201917 offer knowledge and specialized training to verify therapeutic appropriateness, recommend alternative treatment options, and determine necessary dose adjustments based on an individual’s clinical characteristics and estimated kidney function. As part of interdisciplinary teams of health care professionals, pharmacists are making complex decisions around renal dose adjustments every day. These adjustments have relied on GFR estimates from the Cockcroft-Gault formula. With evolving science and recommendations, pharmacists will need to evaluate each unique patient and clinical situation when selecting estimating equations and evaluating

drug dosing based on the most up-todate, trusted clinical evidence.

Leveraging Clinical Decision Support Tools Patients with advanced CKD often present with multiple comorbidities and an average of 10 medications requiring 20 to 30 doses throughout the day. Pharmacists have shown their skillfulness in identifying a wide range of drug-related issues associated with complex medication regimens (Table).18-22 In this complex clinical setting, the ability to supplement pharmacist knowledge and training with complementary technology provides a safer patient experience—a significant advantage of modern medicine and recent advances in information technology. Clinical decision support (CDS) and other digital tools help personalize prescribing and renal dosing by automatically calculating eGFR, triggering alerts at the point of prescribing, and proposing algorithm-based dose adjustments. This is particularly useful as prescribing guidelines become more individualized. In addition to providing helpful guidance during prescribing, pharmacists and nurses are able to benefit from the use of advanced software applications to help identify potential opportunities for intervention beyond prescribing. Hospital pharmacists review many medication profiles for patients with varying degrees of acuity throughout a patient’s admission. With a variety of factors affecting therapeutic dosing decisions, real-time monitoring can detect these types of changes continuously to provide clinicians with evidence-based dosing recommendations. Digital tools can provide algorithm-based suggestions alerting bedside clinicians of the need to adjust a patient’s dose based on newly updated laboratory data. This capability is especially important in the CKD population because laboratory findings and medication therapy may be in a continuous state of flux. These tools also may notify pharmacists of a potential mismatch between patient dosing and updated manufacturer recommendations, employing a newer formula for eGFR, such as the CKD-EPI versus Cockcroft-Gault equation. Pharmacists must be nimble in their approach to monitoring each patient along with ensuring that dosing recommendations are adjusted properly as FDA updates occur. Although technology can reinforce the safe delivery of patient care, clinical judgment remains

Clinical

Pharmacy Practice News • January 2022

Medication Management imperative, particularly when assessing dosing regimens for patients who are obese, of advanced age, on multiple medications, or with fluctuating serum creatinine during hospitalization. Pharmacists, in collaboration with clinical care teams and with the assistance of CDS tools, have the skills and expertise needed to ensure patients with CKD receive optimized therapy—the right dose of the right medication at the right time. The authors reported no relevant financial disclosures.

to take the fork in the road. J Clin Pharmacol. 2019;59(2):159-167. 15. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research (CDER). Guidance for industry: Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling. Draft Guidance. Accessed November 16, 2021. https:// www.fda.gov/media/78573/download 16. Delgado C, Baweja M, Crews D, et al. A unifying approach for GFR estimation: recommendations of the NKF-ASN Task Force on reassessing the inclusion of race in diagnosing kidney disease. J Am Soc Nephrol. Published online September 22,

2021. doi:10.1053/j.ajkd.2021.08.003 17. US Bureau of Labor Statistics. Accessed November 16, 2021. https://www.bls.gov/ ooh/healthcare/pharmacists.htm#tab-3 18. Grabe DW, Low CL, Bailie GR, et al. Evaluation of drug-related problems in an outpatient hemodialysis unit and the impact of a clinical pharmacist. Clin Nephrol. 1997;47(2):117-121. 19. Manley HJ, McClaran ML, Overbay DK, et al. Factors associated with medicationrelated problems in ambulatory hemodialysis patients. Am J Kidney Dis. 2003;41(2):386-393. 20. Kaplan B, Shimp LA, Mason NA, et al. Chronic hemodialysis patients. Part II:

reducing drug-related problems through application of the focused drug therapy review program. Ann Pharmacother. 1994;28(3):320-324. 21. Medication use among dialysis patients in the DMMS: United States Renal Data System. Dialysis Morbidity and Mortality Study. Am J Kidney Dis. 1998;32(2 suppl 1): S60-S68. 22. Quintana-Barcena P, et al. Prevalence and management of drug-related problems in chronic kidney disease patients by severity level: A subanalysis of a cluster randomized controlled trial in community pharmacies. J Manag Care Spec Pharm. 2018;24(2):173-181.

References 1.

CDC. Chronic kidney disease in the United States, 2021. Accessed November 16, 2021. www.cdc.gov/kidneydisease/pub-licationsresources/ckd-national-facts.html

2. National Center for Biotechnology Information. PubChem compound summary for CID 24763, inulin. Accessed November 16, 2021. https://pubchem.ncbi. nlm.nih.gov/compound/inulin 3. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. 4. Winter MA, Guhr KN, Berg GM. Impact of various body weights and serum creatinine concentrations on the bias and accuracy of the Cockcroft-Gault equation. Pharmacotherapy. 2012;32(7):604-612.

Discover the S.M.O.F. difference

5. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130(6):461-470. 6. Jones GR. Estimating renal function for drug dosing decisions. Clin Biochem Rev. 2011;32(2):81-88. 7. Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604-612.

SMOFlipid is the FIRST and ONLY lipid injectable emulsion (ILE) with 4 oil sources.

8. Lim AK, Mathanasenarajah G, Larmour I. Assessment of aminoglycoside dosing and estimated glomerular ﬁltration rate in determining gentamicin and tobramycin area under the curve and clearance. Intern Med J. 2015;45(3):319-329.

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9. Pai MP, Nafziger AN, Bertino JS Jr. Simpliﬁed estimation of aminoglycoside pharmacokinetics in underweight and obese adult patients. Antimicrob Agents Chemother. 2011;55(9):4006-4011.

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10. Inker LA, Eneanya ND, Coresh J, et al. New creatinine- and cystatin C-based equations to estimate GFR without race. N Engl J Med. 2021;385(19):1737-1749. 11. Federal Register. Notices. 1998;63(94). Accessed November 16, 2021. https:// www.govinfo.gov/content/pkg/FR-199805-15/pdf/98-12898.pdf 12. Matzke GR, Dowling TC, Marks SA, et al. Inﬂuence of kidney disease on drug disposition: an assessment of industry studies submitted to the FDA for new chemical entities 1999–2010. J Clin Pharmacol. 2016;56(4):390-398. 13. FDA. Guidance for industry: pharmacokinetics in patients with impaired renal function study design, data analysis, and impact on dosing and labeling. Accessed November 16, 2021. https://www.fda.gov/ﬁles/drugs/published/Pharmacokinetics-in-Patients-withImpaired-Renal-Function.pdf 14. Crass RL, Pai MP. Estimating renal function in drug development: time

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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.

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

16 Clinical

Pharmacy Practice News • January 2022

COVID-19 Pandemic Pharmacists can help with screening, other interventions

SUDs, Mental Health Remain a Pandemic Challenge By David Wild

ith new COVID-19 cases surging as the omicron variant takes hold, it’s all the more important to heed the pandemic’s effects on mental health and substance use disorders (SUDs). But even before that surge began, the topic was front-and-center at the

2021 annual meeting of the American College of Clinical Pharmacy, with two pharmacist-administered strategies emphasized: stepped-up screening to identify patients at risk for developing new or worsened mental illness and SUDs, and medication management, which enables the profession to serve as an important “second tier of care”

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.

for this vulnerable patient population. The first step is to know the scope of the problem. As recently as Oct. 19, 2021, the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association declared a national emergency in children’s mental health, urging swift action to address

• 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

the crisis in this younger population. According to the children’s mental health emergency declaration, 140,000 children lost a caregiver during the pandemic, and these were disproportionately children of color (bit.ly/3EfTCfV). Rates of depression, anxiety, trauma and loneliness also have increased, with, for example, emergency department visits

for suspected suicide attempts rising 51% among girls 12 to 17 years of age in early 2021, compared with early 2019. “Anyone who has cared for children is very aware of how life has gotten disrupted during the pandemic, and of the mental health implications of that,” said Jeffrey Bratberg, PharmD, a clinical professor of pharmacy practice at the University of Rhode Island College of Pharmacy, in Kingston. Along with the effects on children, adult caregivers also have been affected, Dr. Bratberg added, pointing to a CDC report that said 70% of parents or caregivers reported adverse mental health symptoms during the pandemic. Of those, 55% reported anxiety or depression, 54% reported COVID-19–related trauma and 32% experienced serious suicidal thoughts (MMWR Morb Mortal Wkly Rep 2021;70[24]:879-887). In-person versus remote schooling during the pandemic has been a polarizing issue. Still, “we have to think about both parents and children and of the amazing benefits of keeping children in school as long as they have deployed COVID-19 mitigation strategies,” Dr. Bratberg encouraged.

Mental Illness and Substance Use In addition to the specific effects on children and caregivers, pandemicrelated stressors have placed individuals with mental illness and SUDs at risk for exacerbations, Dr. Bratberg noted. These stressors have ranged from ongoing exposure to negative news to the

Clinical

Pharmacy Practice News • January 2022

effects of pandemic mitigation measures, such as mask-wearing and social isolation. Although such mitigations help slow transmission of the SARSCoV-2 virus, “[they] can cause significant mental strain,” he said. Dr. Bratberg, who has a research focus on substance use and has served on the Rhode Island Governor’s Overdose Prevention and Intervention Task Force, said he has seen individuals with undiagnosed mental health challenges or substance use issues present with more severe behaviors during the pandemic than they

‘If someone is on lithium, we can help providers determine who is an appropriate candidate to forgo labs, and what signs and symptoms of toxicity we should look for in these patients and how to educate patients to look for these signs.’ —Audrey Abelleira, PharmD Although screening could lead to a subsequent referral, diagnosis and treatment, some individuals might show signs of a disorder but not meet the

diagnostic criteria for a mental illness or SUD, Dr. Arendt noted. “For these patients, we should strive to provide continued proactive support and check

COVID-19 Pandemic in with them so that we can intervene as soon as possible, if things worsen.” People whose substance use might not meet the diagnostic criteria for an SUD, or who might not to be amenable to treatment, can be offered risk reduction support, Dr. Arendt added. “Like other supply chains, the injection drug supply chain has been affected during the pandemic, and individuals are being exposed to more fentanyl,” he explained. Offering fentanyl test strips and clean syringes can limit the risk for see SUDs, page 18

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WE’VE GOT YOU COVERED During the COVID-19 pandemic, users of illicit injected drugs are being exposed to more fentanyl. Thus, offering fentanyl test strips and clean syringes can limit the risk for overdoses and infections.

previously would have. “Instead of going from problematic substance use to substance misuse at the time of diagnosis, they’re now jumping right to a diagnosis of substance use disorder or a mental health disorder,” he said.

Screening At-Risk Patients As noted, pharmacists can help mitigate these risks via stepped-up screening efforts, according to Daniel Arendt, PharmD, an assistant professor of pain stewardship in the Department of Pharmacy Practice and Administrative Sciences, University of Cincinnati James L. Winkle College of Pharmacy. Dr. Arendt said at-risk individuals range from the obvious—people with a medical history of substance use or mental illness—to those with little family or social support, recent trauma or loss, and people who live in communities with high levels of violence. “Screening can be done during an outpatient appointment, during admission to the hospital, in the emergency department, on the general medicine floors of a hospital, at discharge—pretty much anywhere that pharmacists work,” he said, adding that “it’s perfectly reasonable to consider general screenings for a broad population, and then perform more targeted screening afterwards to identify patients who you’re a little bit more concerned about.”

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Pharmacy Practice News • January 2022

Medication Safety

COVID-19 Vax Mix-Ups continued from page 1

the label and an orange cap, whereas the formulation for ages 12 years and older comes in a vial with a purple cap and label border. “However, once the cap is removed or discarded, doses may be prepared one at a time rather than all at once, making cap color irrelevant,” noted the ISMP alert. “Also, it is unlikely the vial will accompany prepared syringes, so the label cannot be verified by individuals administering the vaccine or parents/ patients receiving it.”

Problems Surfaced Quickly “Since the pediatric dosing received the EUA, we have received a number of reports of younger children receiving the vaccine for adolescents and adults, and vise versa” said Rita Jew, PharmD, ISMP’s vice president of operations. “This is similar to what we’ve seen in mix-ups between adult and pediatric vaccines in general; but because a lot of people are getting the COVID vaccines in a short period, we seem to be seeing more of these reports at one time.” Dr. Jew added that no serious adverse events related to vaccine dose mix-ups have been reported to ISMP, but that doesn’t mean there isn’t cause for concern. “During the phase I clinical study, younger children were randomized to receive a vaccine dose of up to 30 mcg. Increased reactogenicity was observed with higher dose levels, and systemic events for the 30-mcg dose were deemed unacceptable,” she explained. Given those findings, “there is an obvious [risk for] adverse reactions in young children who receive higher doses.” But there is “another significant concern,” she stressed—the “limited protection” that may result when older children aged 12 and up “inadvertently receive the lower dose of the vaccine rather than the higher dose they need for optimum protection.” The pediatric and adult vaccines are

SUDs continued from page 17

overdose and infection transmission among injection drug users, he explained.

Freeing Up Limited Psychiatric Services As for medication management, those efforts “allow us to take on a portion of a patient’s care and help increase psychiatrist availability so that they can focus on acute management,” said Audrey Abelleira, PharmD, a clinical instructor of psychiatry at Yale School of Medicine, in New Haven, Conn. “Tools like medication management allow us to take on

also delivered in different injection volumes, which has caused some confusion. As noted, the 12-and-up dose of 30 mcg should be diluted to a volume of 0.3 mL (yielding approximately six doses per vial), whereas the pediatric dose of 10 mcg should be diluted to a volume of 0.2 mL (yielding approximately 10 doses per vial). “We have had a handful of reports stating that pediatric patients may have received 0.3 mL of the pediatric vaccine, as well as a couple of reports where 12 years-and-older patients may have received 0.2 mL of the adult vaccine,” Dr. Jew said. Other errors have occurred in vaccinating children who are near their 12th birthdays. “If a patient turns 12 between receiving the first and second injections of the vaccine, their first injection should be at the pediatric dose and their second at the 12-years-and-up dose.” (See box for more strategies for avoiding mix-ups.) The Pfizer-BioNTech age-related dosing mix-ups were reported through the ISMP National Vaccine Errors Reporting Program (VERP; bit.ly/33jCOHe), which is separate from the federal Vaccine Adverse Event Reporting System (VAERS) (bit.ly/3HS4FgG). Providers should report all vaccination errors internally, as well as to VAERS, which is mandatory for products under an EUA, ISMP noted. The group requested that the errors be reported to VERP as well.

Cast a Wide Safety Net Incorporating medication safety strategies into all aspects of vaccination processes—at the system, hub site and clinic levels—can help safeguard against age-related dose mix-ups, noted Lorrie Burns, PharmD, a medication safety pharmacist at OhioHealth Riverside Methodist Hospital, in Blacklick. At the ASHP 2021 Midyear Clinical Meeting, Dr. Burns presented a poster on OhioHealth’s experience with such an approach for the first

a portion of a patient’s care and help increase psychiatrist availability so that they can focus on acute management,” said Dr. Abelleira, a clinical pharmacy specialist at the VA Connecticut Healthcare System, in West Haven. Such services include refill request assessments and helping with opioid and benzodiazepine tapering for patients—a particular challenge during the COVID-19 pandemic, because many patients ended up having to put tapers on pause for a while. The services also can help facilitate initiating buprenorphine treatment, she noted. “The pandemic has seen a shift in how buprenorphine therapy is initiated, with treatment starts moving from the office to

ISMP’s 6 Tips for Reducing COVID-19 Vaccine Mix-Ups Store adult and pediatric vaccines apart, such as in separate labeled plastic bins. Use barcode scanning wherever possible to verify that the correct product has been retrieved. “I would emphasize leveraging barcode scanning technology as you are preparing these vaccines to validate that you do indeed have the appropriate vaccine for the patient age in hand,” said Rita Jew, PharmD, ISMP’s vice president of operations. “This is the highest-level strategy we would recommend to prevent these errors.” Make it a policy to clearly label all individual syringes containing vaccines. Print labels for each patient or provide vaccine preparers with strips of preprinted labels that differentiate adult and pediatric doses. Take only the intended and labeled COVID-19 vaccine syringe(s) for one patient into the vaccination area at a time. Involve the parent of the patient in verifying the vaccine by reading the labeling to confirm that the correct one is being administered. “Often, the age mixup involves not really validating the age of the patient by double-checking with the parent or guardian or validating the patient’s date of birth in the medical record,” Dr. Jew said. Document the lot number and date of manufacture acture of the vaccine before vaccine administration, and document administration after the vaccine has been given in the patient’s profile, on the vaccination record, and via state or other immunization registries. —G.S. S. Source: ISMP

phases of the COVID-19 vaccine rollout. In the initial five-month period of the public vaccine rollout, beginning Jan. 19, 2021, OhioHealth administered 173,028 vaccine doses during 850 vaccine clinic sessions held at 35 clinic sites within its system. The strategies implemented include: • an online pharmacy “Vaccine Playbook,” continuously updated; • a document developed by a medication safety pharmacist for use by the system’s vaccine steering committee; • competency and training modules for pharmacy and nursing vaccinators; • incorporating a system medication safety pharmacist into clinic staffing, assisting with vaccine dispensing and process improvements; • supply checklists, which later evolved into clinic “packing slips,” detailing vaccines and supplies for each clinic; • lot control strategies and vaccine-

specific syringe labels; and nd • a group chat application for resources and communication between hub and clinic sites. Staffing all vaccine clinics with a medication safety pharmacist was a particularly effective strategy, Dr. Burns said. “It helped us to be both more efficient and more safe to have pharmacists in every vaccine clinic who had process improvement strategies as a part of their professional focus.

the home using low-dose initiations, for example,” Dr. Abelleira said. “Although some clinicians have transitioned back to the in-office buprenorphine starts, some are continuing at-home low-dose starts, and pharmacists have a role to play in helping physicians move to this approach.”

of meeting our patients’ needs while minimizing COVID-19 exposure risk,” Dr. Abelleira said. “For example, if someone is on lithium, we can help providers determine who is an appropriate candidate to forgo labs, and what signs and symptoms of toxicity we should look for in these patients and how to educate patients to look for these signs. “Ultimately, if we can help vulnerable patients get the care they need and would have been cut off from and do so safely, even a small success should be celebrated.”

Other Ways to Help Pharmacists also can help optimize mental health and SUD treatment by providing consultations on therapeutic drug monitoring, conversions to and from long-acting injectables, and by making other changes to treatment plans already in place, “with the goal

The sources reported no relevant financial disclosures.

Web Exclusive ISMP warns about safety issues with Pfizer’s newly authorized nirmatrelvirritonavir (Paxlovid); bit.ly/34BXqvc-PPN

The sources reported no relevant financial disclosures.

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20 Clinical

Pharmacy Practice News • January 2022

Medication Safety

ISMP Update continued from page 1

the new best practices at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Ms. Michalek said she hopes to see “widespread adoption of these consensus-based best practices,” because some actions “continue to cause fatal and harmful errors.”

New Best Practice No. 1 Safeguarding Against Errors in Oxytocin Use

The first of the three new best practices—which will add to the 14 existing Targeted Medication Safety Best Practices—addresses medication safety concerns with oxytocin (bit.ly/3yLEy7O). These problems have included mix-ups between oxytocin and oxyCONTIN, mixups between Pitocin and Pitressin vials, inadvertent administration of unlabeled oxytocin infusion bags instead of plain IV solution, and infusion rate confusion, among other errors, Ms. Michalek said. (See ISMP Medication Safety Alert! Feb. 13, 2020; bit.ly/3J5n23g.) “We actually have five components to this best practice, and each component

Figure. Medications most frequently cited in reports of harm incidents, by health care setting, over a five-year period (Jan. 27, 2015 to Jan 26, 2020). Source: ISMP Canada.

is meant to address one of the risks that we’ve identified,” she said. The new best practice calls for institutions to develop order sets that reflect a standardized clinical approach to labor induction/augmentation and control of postpartum bleeding; to standardize

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to a single concentration and bag size for both antepartum and postpartum oxytocin infusions; to standardize oxytocin doses and rates of administration; to provide oxytocin in a ready-to-use form with bold labeling on both sides of the infusion bags; and to avoid bringing oxytocin infusion bags to the bedside until it is prescribed and administered.

new best practice also specifies that pharmacists or other medication safety specialists should regularly assess the use and effectiveness of the technology by reviewing compliance, as well as metrics such as bypasses and accepted alerts, Ms. Michalek said.

New Best Practice No. 3

New Best Practice No. 2

Layer Strategies to Improve HighAlert Medication Use Safety

Maximize Use of Barcode Verification in Non-Inpatient Care Areas

The third new ISMP Targeted Medication Safety Best Practice aims to improve the safe use of high-alert medications, which can cause “more devastating consequences” than non-high-alert medications, Ms. Michalek said. Indeed, as a Safety Bulletin issued by ISMP Canada in late 2020 reported (bit.ly/ 32ai1WH), ISMP Canada has found that all five of the medications most frequently reported to cause severe harm or death across a variety of care settings were high-alert medications, including insulin, HYDROmorphone, morphine, acetaminophen and methadone (ISMP Canada Safety Bulletin 2020;20[11). “Safety management plans for highalert medications often rely on lowerleverage risk reduction strategies very commonly focused on helping practitioners know which medications are on the higher alert medication list,” Ms. Michalek said. These lower-leverage strategies include labeling, education and “maybe an acronym to help people identify which drugs are considered high alert for the organization in which they work. However, events continue to happen with medications known to be high alert, so we’re asking organizations to layer numerous approaches, including higher level strategies, to improve the safety of these medications.” Higher level strategies include using

The second new best practice encourages hospitals to expand barcoding and thus limit the risk for errors in medication administration in areas such as the emergency department. “Barcoding prior to medication administration is something that’s widely utilized in hospitals in the United States but less commonly used in outpatient care areas,” Ms. Michalek said. “We want organizations to target clinical areas that have a high likelihood of transient, procedural or temporary patient duration, such as the emergency department, perioperative areas, infusion clinics, dialysis centers, radiology, labor and delivery areas, catheterization labs and other outpatient areas.” Including barcode administration in those outpatient settings can avoid errors, such as one reported to ISMP, in which a patient in the emergency department received an infusion of mannitol instead of the 0.9% sodium chloride infusion stated in his order. In this case, which was not published, the patient was not harmed. (For more information on these potential infusion errors, see bit.ly/3F30rkR.) In addition to encouraging expansion of barcode medication administration to these non-inpatient settings, the

Clinical

Pharmacy Practice News • January 2022

Medication Safety forcing functions and including failsafes in the electronic health record (EHR); using more automation and computerization; standardization and protocols; workflow redundancies; and EHR warnings, alerts and reminders. ISMP is requesting organizations to outline a set of processes for managing risk with each medication on their facility’s high-alert medication list and to delineate a robust set of processes for managing risk, covering as many steps in the medication use process as possible and for all health care workers involved in medication use. Additionally, ISMP is asking organizations to regularly assess risk in the systems and practices used to support safe medication use and to establish outcomes and process measures to monitor safety. These outcomes and measures should be routinely analyzed to determine the effectiveness of the implemented strategies, Ms. Michalek said.

2020-2021 targeted medication safety best practices for hospitals found mixed results among the 156 respondents, Ms. Michalek reported at the meeting. One heartening finding was that organizations are 94% compliant with the first best practice specifying that vincristine and other vinca alkaloids should be dispensed in a minibag of a compatible solution and not in a syringe. In 2017, compliance was 86%, she said. “We’ve had a lot of great improvement in this area, probably largely because a mistake with this is surely to cause

patient death,” Ms. Michalek said. Survey findings pointed to another area for improvement: compliance with the third best practice, which asks organizations to weigh each patient as soon as possible upon admission and communicate their weight in metric units. Only 44% of organizations reported weighing patients and 54% said they used the metric system when they did so. “It’s unfortunate that in the U.S., we still struggle with expressing weight in metric units, because if it’s not translated into imperial units,

the dose can be twofold higher than it should be,” Ms. Michalek said. In light of the possibility for severe patient harm when weight is not adequately factored into medication management decisions, institutions need to look at obtaining weight “as a lifesaving vital sign,” she said. The full survey findings will be published in an ISMP newsletter in early 2022. The sources reported no relevant financial disclosures.

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‘A Climb Up the Mountain’ At Smaller Hospitals For smaller organizations with limited resources, implementing medication safety measures such as the ones outlined during the ASHP session can feel like “a climb up the mountain,” said David Caron Jr., PharmD, the director of pharmacy and a hospital compliance officer at Martha’s Vineyard Hospital, in Oak Bluffs, Mass. “Simple things like developing policies and procedures can be cumbersome, but when a safety recommendation rises to the level of an ISMP best practice, it’s not optional; it’s a matter of brainstorming how to comply with their recommendation.” Capitalizing on relationships with colleagues can be key to successfully implementing a medication safety practice. “If you’re trying to implement something like the three new ISMP medication safety best practices, you can spend all the time in the world setting up educational tools and sending emails, but people won’t really grasp the gravity of what you’re trying to promote unless you explain them through personal connections face-to-face,” stressed Dr. Caron, who was not involved with the ASHP presentation. Illustrating the impact of these medication errors through real-world examples, whether they have occurred at the hospital or elsewhere, can drive the point home. “You can have the best policies in the world, but they’re not going to be implemented unless people know how meaningful they can be,” he said.

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22 Clinical

Pharmacy Practice News • January 2022

Medication Safety

Diabetes Deprescribing continued from page 1

hospitalizations, increased costs and lower health-related quality of life,” Dr. Clark said, citing a meta-analysis published in 2019 (Ann Pharmacother 2019;53[10]:1005-1019). There are many reasons to scrutinize diabetes medication regimens in older adults, in particular, Scott Pearson, PharmD, a primary care clinical pharmacist at Abbott Northwestern General Medicine Associates, in Minneapolis, said at the meeting. For example, diabetes medications are associated with an increased risk for hypoglycemia when taken by older patients, given the higher rates of insulin deficiency and renal insufficiency in this group, he said.

“Hypoglycemia is important to consider because it has been associated with an increased risk [for] falls, and severe hypoglycemia is linked to an increased risk [for] dementia [Can J Diabetes 2016;40(1):66-72],” Dr. Pearson explained. He added another reason to consider deprescribing in these patients: Injected diabetes medications can be a challenge for some patients to self-administer (Clin Med Res 2021;30[2]:120-126), and drugs for the disease can be expensive. Furthermore, Dr. Pearson noted, there is a rationale for relaxing the glycemic control goals of diabetes treatment from less than 7% glycosylated hemoblogin A1c (HbA1c) in younger patients to less than

8% HbA1c in older patients with multiple comorbidities, or even avoiding reliance on HbA1c as a treatment guide altogether as patients near the end of life. A more rational approach is basing glucose control decisions on avoidance of hypoglycemia and symptomatic hyperglycemia. “The reason we really try to reach our particular glycemic targets in general for diabetes is to prevent microvascular complications,” he said. However, “it generally takes five to 10 years of treatment to see those benefits.”

The Pharmacist’s Role Given that pharmacists often are closely involved with diabetes management in various practice settings, they are well positioned to identify medications that can be phased out of a diabetes patient’s regimen, Dr. Pearson said. Pharmacists whose scope of practice

‘Pharmacists should learn to recognize clinical situations in which reducing or discontinuing medications could provide benefit or reduce harm for their patients, and to work with their medical teams to take action when appropriate.’ —Rita Hui, PharmD

6 Principles of Deprescribing

lthough deprescribing medications can be a critical part of good pharmaceutical care, it is most safe and effective when it’s planned and structured, according to Collin Clark, PharmD, a clinical assistant professor at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, in New York. “A systematic approach to collecting information, engaging patients, making recommendations and monitoring can help optimize patient outcomes,” Dr. Clark said. Here are the six principles of deprescribing he shared with attendees of the 2021 annual meeting of the American College of Clinical Pharmacy:

Take a comprehensive medication history. Ask the patients and caregivers, if appropriate, about all their prescribed, over-the-counter, and complementary and alternative medicines and supplements; and assess adherence to their medication regimens. “Pay special attention to prescribed drugs not being taken and the reasons why. If it is because of side effects, we may choose to stop the medication or find an alternative. If it is a cost issue, we will look for a cheaper option,” Dr. Clark said. Identify potentially inappropriate medications. Turn to Beers Criteria, STOPP (Screening Tool of Older Persons’ Prescriptions)/START (Screening Tool to Alert to Right Treatment) Criteria, the Medication Appropriateness Index, VIONE and www.deprescribing.org for guidance. (The latter included a deprescribing algorithm for antihyperglycemics [Figure].) Assess eligibility for discontinuation. Medications that are good candidates for possible discontinuation include those without a valid indication, drugs used to treat a side effect of another medication, drugs whose harm clearly outweighs their potential benefits in a given patient, preventive drugs unlikely to confer a benefit in the patient’s remaining years and drugs that impose an unacceptable treatment burden, such as those requiring multiple injections or frequent lab monitoring. Prioritize drugs for discontinuation. Prioritizing which drug or drugs to stop taking first should be based on a number of criteria, including which medications are likely to cause the greatest harm with the least benefit, which drugs

are easiest to discontinue and which medications the patient is most willing to discontinue first. Plan and initiate withdrawal. Gain patient buy-in before attempting discontinuation. If deprescribing multiple medications, stop one drug at a time and taper medications that are more likely to cause withdrawal symptoms. “Communicate the deprescribing plan to all caregivers and health care professionals involved in the patient’s care,” Dr. Clark emphasized. Monitor, support and document. Monitoring can be done by phone or in person, and the degree of monitoring will depend on the medication being deprescribed and tapered. Benzodiazepines, for example, requires frequent monitoring during tapering, while a statin can be discontinued without tapering and require little to no monitoring, Dr. Clark said. Pharmacists can provide support through nonpharmacologic interventions—from dietary to sleep hygiene recommendations—as well as advice on coping strategies or referral to additional services. “Clearly document the rationale for discontinuation and the outcomes of discontinuation, because that will prevent medications from being restarted by other providers who may not be familiar with the patient,” Dr. Clark said. —D.W.

Dr. Clark reported no relevant financial disclosures.

includes managing medications for diabetes “also can be involved in direct deprescribing, and decide when to stop medications,” he said.

Algorithm-Based Approach Dr. Pearson cited an electronic health records (EHR)-based deprescribing program by Kaiser Permanente researchers as a particularly effective approach to diabetes deprescribing (J Manag Care Spec Pharm 2019;25[8]:927-934). The Kaiser investigators used an internally created deprescribing algorithm to check their system’s EHR quarterly for eligible patients. Centrally located pharmacists then contacted the primary care physicians of those patients for permission to deprescribe antidiabetic medications. After receiving physician approval, clinical pharmacists reviewed each patient’s chart and decided which diabetes medications to deprescribe, with priority given to deprescribing medications associated with a higher risk for hypoglycemia, including insulin or sulfonylureas. For inclusion in the study, patients had to be 75 years of age or older and on one or more diabetes medications other than metformin. Additionally, their two most recent HbA1c levels had to have been 6.5% or lower, or 7% or lower if they had been hospitalized or visited the emergency department for hypoglycemia in the preceding two years. A total of 685 patients who had a pharmacist deprescribing intervention and 2,055 patients who did not were included in the analysis. During six months of follow-up, 1.5% of patients in the pharmacist-managed deprescribing group experienced hypoglycemia versus 3.1% of those receiving usual care (P<0.02). Although the mortality rate was significantly lower in the deprescribing group than in the usual-care group (2.3% vs. 5.6%; P<0.01), Dr. Pearson said the study may not have considered all possible confounding variables

Clinical

Pharmacy Practice News • January 2022

Medication Safety

and the finding needs to be confirmed by prospective research. “But these are very promising results from the pharmacist’s standpoint, showing that these interventions can lead to a reduction in rates of hypoglycemia,” said Dr. Pearson, who was not involved in the Kaiser Permanente study. The study’s senior author, Rita Hui,

A Kaiser Permanente, EHR-based deprescribing initiative reduced the incidence of hypoglycemia by approximately

50% Source: J Manag Care Spec Pharm 2019;25[8]:927-934.

PharmD, a clinical pharmacy research scientist at Kaiser Permanente, in Oakland, Calif., believes deprescribing should be taught as a skill and then be used as a tool that pharmacists can readily apply in patient care, “just as pharmacists learn to prescribe and adjust medications during their schooling.” Dr. Hui added that “pharmacists should learn to recognize clinical situations in which reducing or discontinuing medications could provide benefit or reduce harm for their patients, and to work with their medical teams to take action when appropriate.”

Factors to Consider Kaiser Permanente clinical pharmacists consider several factors when assessing opportunities for deprescribing, including drug affordability, use of high-risk medications in older patients, and efficacy and safety. “Time-strapped pharmacists could focus on the interventions that are most likely to have the most impact on the patient moving forward,” said Dr. Hui, who was not involved in the ACCP presentation. “If reducing harms—such as lowering a diabetes medication dose to lower

hypoglycemia risk in aging adults—is one of those high-impact priorities for the patient in front of them, then it should be a priority to deprescribe under a shared decision with the patient and caregivers.” Dr. Hui said Kaiser Permanente’s EHR system is central to its deprescribing approach. Specifically, the EHR is used to pull patient lists based on prespecified criteria. In the diabetes population, these criteria may be older patients with well-controlled HbA1c who use high doses of medications with hypoglycemia risk. “Using that list and an approved protocol from the patient’s primary care physician, a pharmacist can connect with each patient to deprescribe proactively,” she said. “This proactive approach expedites the process, instead of deprescribing reactively after a patient has already suffered an adverse drug event like severe hypoglycemia.”

Beyond Diabetes In partnership with physician experts and researchers at Kaiser Permanente, clinical pharmacists have implemented this proactive

deprescribing approach for other clinical areas, such as use of nonsteroidal anti-inflammatory drugs, fibrates and older adults receiving “hyperpolypharmacy, defined as taking 10 or more medications,” Dr. Hui said. She emphasized partnering with the medical care team, consulting with clinical champions and front-line teams, and including patients and their caregivers in making a shared decision when deprescribing. These decisions also should be based on a thorough discussion of the benefits and risks of medications, recent literature, and patients’ goals for therapy, Dr. Hui noted. Because some patients may have been receiving their medications for “decades,” these conversations may be difficult, Dr. Hui cautioned. “Acknowledge that you are not trying to force a change, but instead are providing a safe space to change their regimen if the patient wishes to do so.” The sources reported no relevant financial disclosures.

For more on diabetes, see pages 28-29.

24 Operations & Mgmt

Pharmacy Practice News • January 2022

COVID-19 Pandemic

Staying Remote continued from page 1

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of pharmacy for West Virginia University (WVU) Medicine’s academic site, WVU Hospitals, in Morgantown. “But it’s vital as we move forward to think about remote work arrangements as a huge piece of recruitment and retention for staff.” Dr. O’Neil cited a Gallup survey conducted between October 2020 and April 2021 finding that 35% of respondents would work from home as much as possible, if given the choice. “Historically, working from home has been viewed as more of a benefit or a privilege, but going forward it’s likely to be more of an expectation,” Dr. O’Neil said. “Employees want it, and most hospitals and health systems are tight on space. So, it’s imperative that we find ways to be employee-focused and best recruit and retain team members.” But some employees may not want to work remotely long term, particularly those who have worked their entire careers on-site, Dr. O’Neil cautioned. “The bottom line is that you need to know your team and understand their preferences. Develop a strategy and think ahead for what positions may be able to complete their duties remotely. Any transitions from remote to on-site or vice versa should be employee-focused, clear and fair, with expectations and time lines laid out in advance.”

Heed Your Board of Pharmacy Health-systems that are developing a long-term strategy for remote work should also thoroughly review their state board of pharmacy’s position, Dr. O’Neil added. Many state boards have been allowing remote work without prior approval during the pandemic, but that may change. “For example, the West Virginia Board of Pharmacy allows remote processing of prescriptions during the pandemic, but

we don’t know what will happen in the future,” he said. “Maybe this shows how we need to rethink our rules and regulations over the coming years to be in line with a more diverse workforce and be flexible about working from home.”

WVU Hospitals Adapts Before the pandemic, remote work was rare at WVU Hospitals, Dr. O’Neil reported. “Although all clinical specialists and generalists were equipped with pagers, laptops and docking stations, order verification and product checking occurred on-site at all times. Pharmacy technician work such as medication histories, prior authorizations, purchasing and inventory occurred on-site except in the case of an emergency. We had a clunky workflow to get on the network from home, and there was no systemwide WebEx or Zoom.” That had to change quickly in 2020. During the height of the pandemic in West Virginia, from October 2020 through January 2021, the system adopted remote work for pharmacy functions including 340B program management; clinical services such as rounding, order verification and profile review; medication history pharmacy technician work; and specialty pharmacy prior authorization management. WVU Hospitals has a system of decentralized pharmacy specialists and generalists, with acute care pharmacists rounding on more than 35 inpatient medical teams and ambulatory care pharmacists. The rounding took place in a variety of outpatient clinics, including heart failure, internal medicine, cystic fibrosis, endocrinology, oncology, neurology, anticoagulation, infectious diseases and family medicine. “Each division kept one pharmacist per week on-site while others worked off-site, with the exception of critical care and emergency medicine,”

A don’t-miss resource for health systems interested in specialty pharmaceuticals and services. Brought to you by the same team who publish During the pandemic, West Virginia University Medicine adopted virtual rounds, which enabled its physicians to open up a Zoom session and include a pharmacist in the clinical discussion.

Operations & Management

Pharmacy Practice News • January 2022

12 Key Questions Can Guide A Transition to Remote Work

t the outset of the COVID-19 pandemic, many institutions did not have the opportunity to carefully plan their transitions to remote work. But there’s still time to make an effective transition, guided by the following key questions, according to Molly Wascher, PharmD, MBA, a clinical programs manager, specialty pharmacy services, at Johns Hopkins kins Home Care Group, in Baltimore. “If you are now starting to move e to remote work, or if you’re planning to go permanent with remote arrangements, make sure you and your employees can answer all of these questions,” Dr. Wascher said. 1. Who is eligible to work from home? Is there an application process? 2. What resources are provided to staff working remotely? 3. Do staff have a specific shift? If yes, how do they log in for their shift? 4. Are staff allowed to work from home any day, or only on certain days? 5. What productivity metrics will be measured, and what is the expectation for each metric? 6. What happens if staff don’t meet the productivity expectations? 7. How and when do you want employees to communicate what they have accomplished? 8. Do staff have to be available via an organizational messaging platform? 9. How will communication occur in an emergency? 10. How and when should staff communicate with their peers? 11. Do staff have to be located close to work in case of an emergency? 12. What happens if staff lose internet connectivity at home?

—G.S.

Dr. O’Neil said. “Codes were covered by the one pharmacist on-site per division. This was a difficult decision, but our priority was keeping our team healthy.” The pharmacy team got creative with options such as virtual rounds. “Our physician colleagues would open up a Zoom session and wheel the pharmacist around on a laptop,” Dr. O’Neil said. “It’s not as good as in person, but in the pandemic, it worked and helped conserve the pharmacist resources we did have.” After the advent of COVID-19 vaccines, WVU Hospitals was able to move all clinical pharmacists back on-site full time. “Most of them preferred that; they are used to being on-site and like the collaborative nature of rounds,” Dr. O’Neil said. But other pharmacy functions may remain remote, at least in part, indefinitely. WVU Hospitals assessed the efficacy of a remote approach to its pharmacy-driven medication history and reconciliation program, conducted by medication history technicians, and found that patients actually were significantly more likely to accept pharmacy-led bedside medication services when conducted over the phone rather than in person (70.9% vs. 57.1%; P<0.001), with no significant differences in 30-day readmission rates. “We will continue to perform medication histories remotely for the foreseeable future,” Dr. O’Neil said. “Our biggest challenges include fostering relationships between the technician and the servicebased pharmacist, new-hire training and onboarding, and team building and interaction as more individuals are added. We

will do follow-up studies to better understand the relationship of patients accepting discharge pharmacy services when remote versus in person.” WVU Medicine’s 340B program management team began working remotely at the start of the pandemic in March 2020, and decided to work permanently from home in March 2021. “We started monitoring productivity by using Excel spreadsheets, but that quickly became tedious,” Dr. O’Neil said. “We then moved to Outlook calendars and blocking 15-minute calendar invitations to ourselves to record time.”

Replacing the Water Cooler Johns Hopkins Home Care Group had already begun a transition to remote work options, even prior to the pandemic, after a bad winter storm in 2020 led them to pilot remote work one day per week. The group includes more than 240 outpatient and infusion pharmacy full-time equivalents in 11 outpatient pharmacies as well as home infusion and ambulatory infusion suites, with 22 specialty clinical coordinators and 33 specialty technicians and financial specialists managing patients in 33 disease categories. “In the spring of 2020, our group all shifted to remote work,” explained Molly Wascher, PharmD, MBA, a clinical programs manager, specialty pharmacy services, at Johns Hopkins Home Care Group, in Baltimore. “We thought that might be temporary, but in the spring of 2021, our leadership made the decision to make it permanent—that anyone who

COVID-19 Pandemic could work remotely would do so.” Dr. Wascher’s group now includes a rremote staff of nine clinical pharmacists aand 10 clinical technicians, one hybrid cclinical pharmacist and one hybrid technician, and an on-site staff of two clinical pharmacists—who were 50% remote during the pandemic—one operations d ccoordinator and three technicians. “There were a few items that we thought needed to be done on-site, but in th many cases, we found workarounds,” she m ssaid. “Those who are on-site conduct a ggood amount of patient education or are directly involved in dispensing.” The group still engages in some onsite activities for remote staff, including three months of on-site training for new-hire pharmacists as well as necessary computer upgrades, scheduled inperson patient consults, and small team meetings and collaboration days. “We are hoping to rotate our staff meetings to alternate between virtual and on-site, but right now they are all still virtual,” Dr. Wascher said.

Adapting to Remote Work Management styles need to be adapted for the remote work environment, she advised. “We developed new mechanisms for immediate communication

throughout the day, such as a chat board for team members [that] also allows disease state–specific teams to create their own chat boards. I’ve also increased my quick phone calls to staff. But you need a context of why you’re calling. I like to think I’m a nice manager, but having your manager IM you to say ‘I’d like to meet with you for a 10-minute phone call’ can be nerve-wracking.” Assessing productivity and quality of work when in a remote setting can be particularly challenging, Ms. Wascher said. “You need predefined mechanisms to assess productivity, and your reports should use as much technology and be as automated as possible. Make sure that it doesn’t take you too long to review these. If it’s more than 30 minutes or so per day, you may have unrealistic expectations.” Finally, she said, it’s important to find ways to replace the “office water cooler” when the majority of your staff are working remotely. “At the beginning of calls with members of my team, I make sure to talk about what’s going on in their life. I need to make sure I find ways to understand what they’re doing outside of work.” The sources reported no relevant financial disclosures.

26 Operations & Management

Pharmacy Practice News • January 2022

Practice Models

Strategy benefits patients, finances

Aligning Infusion Services and Pharmacist Leaders By Gina Shaw

ligning infusion care services under pharmacist leadership can be a win-win strategy for any health system, no matter how large or small, said experts at the 2021 ASHP Conference for Pharmacy Leaders, held virtually. Nancy Palamara, PharmD, the vice president of diagnostics and therapeutics at Holy Name Medical Center, in Teaneck, N.J., shared several strategies that health systems are using to succeed in this competitive market. Although placing infusion services under pharmacy leadership can be done at any health system, regardless of size, there may still be a lack of awareness that such a model can be implemented, at least based on an informal poll of session attendees. Dr. Palamara asked attendees who at their institution had operational oversight of the outpatient infusion center and all of its staff. The most common response was a nurse manager (35%), followed by a nonclinical manager (15%), pharmacist (4%) and physician (2%); 31% of respondents said oversight was handled by a mix of those

roles, while 13% did not know. “These survey results indicate that pharmacists are not very often the ones in charge of the infusion center,” Dr. Palamara said. “We need to make the case that pharmacy is well suited to manage infusion therapy departments or office-based outpatient infusion centers. Pharmacy must ensure that hospital leaders have a full understanding of infusion services, the outpatient infusion revenue cycle and the impact of clinical factors.” She cited her own institution’s experience as an example. “Our infusion services had long been integrated with the cancer center, and the cancer center director always oversaw the infusion space. Over 25 years, that director often reported to the chief nursing officer or the chief medical officer, depending on the individual’s background.” More recently, the institution’s leadership recognized that infusion therapy needed to be a department in its own right because about 25% of its services were unrelated to oncology, including neurology, immunology, rheumatology,

‘We heard loud and clear from our stakeholders that the biggest pain point within infusion was getting the patient to the right place and starting them on an infusion.’ —Mitra Gavgani, PharmD

and other infusion categories such as a dedicated migraine program. “We spend close to $65 million annually supporting outpatient infusion services,” Dr. Palamara said. “Because we are a community hospital and do not do heart transplants and other services that produce a high inpatient drug spend, our outpatient drugs—primarily infusion—now represent about 92% of our drug spend.” When the new department was created with Dr. Palamara as its director, it was the first time that Holy Name had a pharmacist in charge. “It’s so important that pharmacy oversees your infusion revenue cycle all the way back to prior authorization,” she said. “It’s a tough battle to go back if things have been messed up in prior authorization and try to get that reversed, so we fought to get into the drug denial space.”

Educating the Finance Folks Educating financial professionals about the clinical side of outpatient infusion proved very valuable, Dr. Palamara said. “For example, most of our drugs now use weight-based dosing, where your case volume does not directly equal your expense. For a CT of the neck without contrast, your technician time is approximately the same and your scanner time and expense is approximately the same. But that’s not the case with an infused drug. “I had one of our clinical pharmacy specialists put together a presentation to show our accountant with actual

patient cases. One month, we had four patients infused with trastuzumab, and all were over 100 kilos. The previous month, we only had two patients who were over 100 kilos,” Dr. Palamara said. “That produced a significant difference in expenses month over month, and they need to understand that. Having the manager overseeing the pharmacy revenue cycle be a pharmacist has proven to be huge benefit.” With many payors now steering patients to sites of care for which they pay less for the same service, hospitals need to develop new strategies to continue to provide infusion services for their own patients, Dr. Palamara said. Medicare’s most costly “place of service” code is 22, the designation for on-campus outpatient services at a hospital—and Holy Name, like some other small- to mid-sized hospitals, only has an onsite infusion center that bills under 22. “They’re billed less for category 11, office-based services, and 12, homebased services,” Dr. Palamara noted. “But we don’t want to lose our patients to some other office-based provider who doesn’t know them like we do. Some of the drugs that have been deemed ‘safe’ to administer in the home setting—well, if you’ve seen infusion reactions, you’d understand why we don’t want those people to be at home for those infusions. Even if they are rare, when a patient has one of those reactions, you want a robust infusion center with providers who can respond to an emergency situation.” In an effort to hold onto its infusion center patients, Holy Name developed a creative strategy. It established a new office practice, Excel Care infusion services, which rents space within Holy Name’s onsite infusion center. “The

Operations & Management

Pharmacy Practice News • January 2022

Practice Models yourself plenty of time to gather and to analyze, translate and make sense of it before it is broadly shared or decisions are made.”

A Two-Year Optimization Process

9 Key Data Points for Assessing Infusion-Services Readiness 1. Locations and geographic footprint 2. Scope and offerings 3. Payor contracts, incentives, restrictions and partnerships 4. Cost of goods and special drug pricing 5. Ownership and governance structure

4 Principles of an Effective Integrated Infusion Strategy 1. Identify accountable leaders and champions for infusion services, empower them and engage them in planning for the future.

6. Regulatory details, including licensing, credentialing and accreditation

2. Identify barriers to successful delivery of infusion services, and ensure they are addressed by health-system leaders.

7. Program interdependence—for example, as with oncology infusion and other clinic services

3. Proactively manage access to limited distribution drugs and payor contracts.

8. Efficiencies and best practices 9. Challenges and opportunities for improvement

4. Establish shared goals and objectives to drive collaborations and reward teamwork.

Source: Mitra Gavgani, PharmD.

provider is our mid-level nurse practitioner [NP], who works with a collaborating physician, and we are able to bill that care under place of service category 11. By doing that, we are accepting lower rates, but it allows us to hold on to our patients,” Dr. Palamara said. The new approach was launched initially with a group of about a dozen patients who were receiving an infused rheumatologic agent. “We told them that, based on the payor’s requirements, they could either choose to receive the infusion in their home or they could stay with us but that the services would look just a little different,” Dr. Palamara said. “They have to do an initial provider note and visit before each infusion with the NP, whom they already know, but other than that, things would pretty much be the same. “For the most part, they wanted to stay with us. We had one patient who is a nurse, who told us that she didn’t want the drug in her home, that she felt much safer receiving it in the hospital,” she continued. “Another patient said that they want to keep their chronic illness in the hospital, to get their treatments here and then forget about it, and not to ‘invite’ the disease into their home by getting treated there.” In some cases, Dr. Palamara acknowledged, this arrangement produces a financial outcome that’s upside-down

for the hospital. “We may not even make back the cost of the drug in some cases,” she said. “Why are we fighting for these patients even at a financial loss? It boils down to quality and safety. We want to take care of our patients, and we feel it will produce a better outcome. It also can have a downstream revenue impact. If you come to us for infusion, you might also get unrelated lab work done at our lab or do radiology scans with us. If you go where your payor sends you, then you may also go out for those things. We continue to compare payment rates and see if it always makes sense to keep the patient with us. So far, the continuum of care always wins.”

A Bolus of New Infusion Patients The new setup also has yielded an additional bonus: allowing Holy Name to take on new infusion patients whose physicians are not on staff at the hospital. Located just four miles from the major medical centers of New York City, Holy Name has many patients who live near the hospital but travel to the city to see world-renowned specialists. “Those patients would love to come to our hospital just for their infusion, but you have to be on our medical staff to write orders,” Dr. Palamara said. “Now that we have the new office practice, our nurse practitioner can collaborate with the outside treating physician and assume their care for the infusion side of things.” In a larger health system, a strategic, standardized approach to optimizing infusion site of care can maximize quality of care for patients while improving

opportunities to capture revenue, said Mitra Gavgani, PharmD, the vice president of pharmacy services for Johns Hopkins Home and Community-Based Services, in a separate session at the conference. “Hospitals and health systems have been providing infusion therapy successfully for a long time, but with new therapies coming to market, innovative care models are needed,” she noted, such as those involving the provision of care at home, and models that allow for infusing the latest gene therapies.

Doing the Site-of-Service Dance Site-of-care (SOC) optimization is another hot provider trend that stakeholders need to understand. “This is becoming a national strategy on the part of payors,” Dr. Gavgani said. “We are seeing a growing desire for harmonization, alignment, integration and standardization. As payors are pushing care to freestanding ambulatory centers and home infusion, and also imposing more requirements for medical necessity to justify hospital-based infusion, infusion services in a health system really require a systemic approach.” Dr. Gavgani recommended that health systems begin by assessing their current position based on infusion services-related data (box). “If you’re a health system with multiple hospitals, or a small system with reliance on local providers to support the flow of your infusions, due to the nature of the reimbursement model you will find that not all of your data is in one place,” he said. Obtaining these data “is not a small task, so give

As an example, when Johns Hopkins began its two-year process to optimize infusion site of care across its health system, 19 sites were involved, including hospital-based, physician officebased, nurse-managed ambulatory infusion suites, and ambulatory surgery centers. “Not all are owned by the same entity within the health system, and not all follow the same model of care,” Dr. Gavgani said. “We knew the issue was bigger than any one group in the organization could handle.” After first identifying a large group of more than 100 stakeholders from all of the infusion centers—including CEOs of the entities, finance leaders, infusion nursing and pharmacy leaders, and patient and family advisors—who could pinpoint their biggest concerns about central management of infusion site of care, a smaller infusion therapy oversight committee was named from that larger group. Appointed by the health system’s executive leaders, the members’ role was to drive the effort toward integration. “We heard loud and clear from our stakeholders that the biggest pain point within infusion was getting the patient to the right place and starting them on an infusion,” Dr. Gavgani said. “Once the patient was in their seat, everything went smoothly, but the step of getting to the right site and navigating financial clearance was the biggest problem. There was a team at each infusion center dedicated to taking care of the patient’s needs, but what if they got a denial of coverage?” Johns Hopkins established an infusion coordinating center staffed by nurses and financial coordinators, counselors and schedulers, whose job it is to help clinicians navigate prior authorization and utilization management. The process is still ongoing, she noted. “We were working on this effort prior to COVID-19, and implementation is still underway.”

Access a ‘Foremost Priority’ As important as those managed care issues are, it is the patient who should get the lion’s share of attention, Dr. Gavgani stressed. “Our commitment is that patient experience and access are our first and foremost priority, and we believe we can achieve that by centralizing operations and oversight, and making our infusion strategy part of our overall health-system strategy.” The sources reported no relevant financial disclosures.

28 Operations & Management

Pharmacy Practice News • January 2022

Managed Care

Population Health Drives Cost Savings in Diabetes By Jillian Mock

Denver—In North Carolina, a local hospital system partnered with a health insurer to implement a population health program to reduce costs and increase care quality for patients with diabetes. The program illustrates how pharmacists can use detailed data to bolster value-based care efforts, according to the case study presented at AMCP Nexus 2021.

“The key to our population health team is robust data,” said co-investigator Molly Hinely, PharmD, BCPS, the pharmacy clinical coordinator for population health at Atrium Health Wake Forest Baptist. “Where do we get that data? We get it from the health payor.” In the United States, spending on diabetes care doubled in a 10-year period, from $116 billion in 2007 to $237 billion in 2017, according to the American

Diabetes Association (ADA) (Diabetes Care 2020;43[10]:2396-2402). The costs of institutional care decreased from 2012 to 2017, but spending on outpatient services, medications and supplies increased (Diabetes Care 2018;41[5]:929-932). In North Carolina, about 11.3% of the adult population was diagnosed with diabetes in 2019, according to the ADA (bit.ly/3Dxu3WK), compared with

10.8% in the country as a whole, according to the CDC (bit.ly/3pTqy8j). On the payor side, Blue Cross Blue Shield of North Carolina (BCBSNC) has an advanced payment model program (called Blue Premier) that links costs and fees to quality and value of care. As part of that program, the researchers looked at data collected on prescribed medications, fill history and care gaps. “The data we collect support our mis-

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sion of making prescription drugs more affordable and improving outcomes for members,” co-investigator Brenden O’Hara, RPh, BCACP, a clinical pharmacist at BCBSNC, said in an email interview. Improving collaboration between payor and provider groups is a huge focus for the program, he noted. In 2021, Mr. O’Hara and his team focused on providing data to healthsystem pharmacists that could translate into immediate savings. This included identifying opportunities for providers to move patients to more affordable, clinically equivalent alternative medications, prescribing more affordable and effective combination therapies, and implementing real-time benefit checks, Mr. O’Hara said. “I am witness to the fact that the information they’re able to provide for the health systems is extremely helpful to us,” Dr. Hinely said during the meeting presentation. Dr. Hinely’s population health team is heavily focused on value-based pharmacy services, she noted, working in various care settings including rural health in Catawba County and the WinstonSalem urban center. Atrium Health has five campuses, one academic medical facility, four community hospitals, and nine community and specialty pharmacies, she said. Although Dr. Hinely’s team works with Medicare and Medicaid health plans and contracts, the department’s largest contract is commercial

Operations & Management

Pharmacy Practice News • January 2022

Managed Care with BCBSNC, with a patient population made up largely of working families. Day to day, the collaboration between Dr. Hinely’s team and Mr. O’Hara’s team primarily takes the form of data-driven reports, including assessments detailing ineffective medication combinations and total cost of care. The data in these reports include basic biographical information—patient name, date of birth, provider—and the medications the patient is taking, and quality health measures such as hemoglobin A1c, blood pressure and adherence to prescribed antidepressants,

Dr. Hinely said. The reports are built directly into the customized electronic health record (EHR), in which the pharmacists can also document everything, communicate recommendations to providers, and reach out to patients if they cannot be contacted by phone.

Collaborating Across Different Sites of Care “For me, the biggest takeaway I wanted everyone to get was the importance of collaboration among different pharmacy work areas,” Dr. Hinely said. Dr. Hinely’s team of population health pharmacists work with the health payor (BCBSNC), information technology experts, data analysts, quality team, and pharmacy students and residents to make the most of available data, she said. The resulting data reports enable her team to triage patients and determine which patients need a pharmacist’s review, she noted. Within the diabetes case study, BCBSNC and its partners in the program found $36,800 in savings by valueprescribing metformin extended release (transitioning from metformin ER to a more affordable, clinically equivalent alternative medication). This amount was out of an initially projected $64,509 in savings, indicating there are still opportunities to implement education, real-time benefit checks and increase messaging through the EMR, Mr. O’Hara noted. The cost

savings did not include savings generated from requiring prior authorization on some high-cost prescription drugs to treat patients with diabetes, according to Mr. O’Hara. Metformin ER was one of 25 high-cost medications that BCBSNC identified as easy to switch with a lower cost, clinically equivalent alternative. By identifying opportunities to deprescribe ineffective medication combinations (and prescribe more effective and affordable combination therapies), BCBSNC and its partners generated $473,580 in initially calculated savings

by July 2021, out of an initially projected $798,624 in savings, Mr. O’Hara said. “Getting useful data in as close to real time as possible is an ongoing challenge,” he noted, adding that his team also has to figure out how to track progress and create clear reports that provider groups like Atrium Health can use to achieve particular outcomes and benefit patients. At the end of the day, Dr. Hinely and her team of pharmacists continue to rely on providers to look at and accept their recommendations, which can be particularly

difficult when there is no follow-up visit scheduled, she said during the presentation. Furthermore, there are so many diabetes medications out there—an “alphabet soup” of options, she said. “There’s still a lot of education around correct diabetes regimens that still needs to happen,” Dr. Hinely said. “I think diabetes is becoming one of the hardest disease states to treat with the amount of therapies that we have.” The sources reported no relevant financial disclosures.

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New Survey Finds Biosimilars Have Wide Acceptance By Marie Rosenthal

Aurora, Colo.—Nearly two-thirds of managed care stakeholders polled in a recent survey said they are covering some biosimilar products, with most of them reporting “meaningful” cost savings from the formulary strategy. That level of acceptance and savings comes at a time when the market for biosimilars is on the upswing. Indeed, after years of slow market release, “there are now 31 biosimilar products that have been FDA approved, with 20 launches in a variety of therapeutic areas, including supportive care, oncology, inflammatory diseases, insulin products and ophthalmology products,” said Tasmina Hydery, PharmD, the assistant director of integrated technology solutions at AmerisourceBergen/Xcenda, at the AMCP Nexus 2021 meeting. “The biosimilar landscape is on the verge of some pretty big changes with the introduction of the pharmacy benefit biosimilars [such as biosimilars of Humira] that are anticipated in the next few years,” added Jennifer Snow, MPH, the vice president of reimbursement and policy insights at AmerisourceBergen/Xcenda. To find out how formularies were managing the changes, AmerisourceBergen/ Xcenda surveyed 51 of its managed care network advisors to see how biosimilars were being encouraged, used and covered among health plans, integrated delivery networks (IDNs) and pharmacy benefit managers (PBMs). Of survey participants, 35% cover all of the available biosimilars and 65% said they cover some products. Most respondents said they saw cost savings after putting them on their formularies. “Across the board, payors are seeing meaningful cost savings coming from biosimilars,” Ms. Snow said. In fact, 59% said “biosimilars provide meaningful cost-savings” to the organization; 35% said they somewhat agree, and only 6% did not think using biosimilars resulted in meaningful cost savings. Ms. Snow questioned whether the 6% had an unreasonable expectation about how much money could be saved by using biosimilars instead of the reference products, thinking the savings would be like those seen from traditional generic medications, instead of the 20% to 30% that typically accrues from biosimilars.

“We were never going to see the smallmolecule savings,” she said, adding that a 20% to 30% discount—which still would be a considerable amount compared with the cost of the reference product—was “reasonable to expect.” It would probably come as no surprise that price and cost were primary drivers affecting decisions about designating a preferred product, Ms. Snow said. Lower price was listed by 94% as the primary influencer, followed by contracting arrangement at 75%, therapeutic area at 49%, number of indications a biosimilar has versus the reference product at 39%, physician demand at 24%, and time the biosimilar has been on the market at 22%. Patient demand amounted to only 4%. “Two things I find really interesting [about these rankings] are the number of indications approved for the reference products being a decision point for 39%, and then also, physician demand at 24%,” said Ms. Snow, who noted that she wrote an unpublished client report in 2007 about biosimilars, which found that physician acceptance of biosimilars was a serious consideration for payors. “Here we have it, that notion of physician demand starting to drive that preference,” she said.

The coveragea of biosimilar over reference products:

14%

53%

Nonpreferred

33%

Based on a database of 535 coverage decisions, regarding nine available biosimilars, at 17 of the largest commercial health plans in the United States. Adapted from JAMA 2020;323(19):1972-1973.

One of the best ways to encourage use and control costs is by making the biosimilars preferred products. However, just because you lead a physician to a preferred product does not mean they will prescribe it. So, how do you get them to at least consider the biosimilar? The respondents found several ways: 92% require prior authorization; 73% use step edit requirements, which require a patient to fail therapy on a lower-cost product first; 55% use tiering; 45% require patient cost sharing; 33% limit quantities; and 22% have diagnostic limitations. “I was a little sad to see that the step edits were so high,” Ms. Snow said, “especially [for] physician-administered drugs, because that gatekeeper’s already there. I would expect that we will see these trends continue when it came to the pharmacy benefit side.”

Prescribing Considerations

Cost a Major Consideration

There are only two interchangeable biosimilars approved—insulin glargineyfgn (Semglee, Mylan), a biosimilar to

Cost savings was cited as the strongest factor driving biosimilar adoption, the survey found: 65% ranked it as a leading

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Lantus and adalimumab-adbm (Cyltezo, Boehringer Ingelheim) a biosimilar to Humira (AbbVie), which is not yet available. There was a good bit of buzz about finally having interchangeable biosimilars throughout the AMCP meeting and discussion about using a biosimilar offlabel—that is, prescribing it for an indication that the reference product has but the biosimilar does not. An interchangeable biosimilar has all the indications of the reference product and can be changed by the pharmacist rather than requiring prescriber authorization, just as a smallmolecule generic can be switched. Ms. Snow said she was surprised by the number of organizations that would consider an off-label use for a biosimilar. Of the organizations, 55% said they would cover the biosimilar for the same indications as the reference product, including both the FDA and the non–FDA-approved indications; 24% said they would cover the biosimilar only for FDA-approved indications, and the reference product only for the remaining indications; 20% said they would cover only the FDA-approved indications; and 2% responded other (unspecified). No one said they would not cover a biosimilar. Almost all the respondents thought biosimilars were safe and effective for treatment for both starting naive patients (96%) and for switching a patient currently on a reference product (92%). Ms. Snow said she was pleased by the latter response. “Maybe I shouldn’t have been surprised, but so much of my work with patient groups and manufacturers takes it for granted that a patient who already is on treatment should stay on that treatment because it works for them.”

Preferred Product Class

Preferred

factor. Interchangeability and increased regulatory clarity about laws such as the ability to substitute a reference product with a biosimilar were second and third. Other issues were scientific clarity about safety and efficacy data, and increased understanding of biosimilars by prescribers, patients and within an organization. When Cyltezo and other biosimilars of Humira—which will come under the pharmacy benefit instead of the medical benefit—start coming onto the market in 2023, there will be much interest in cost savings, Ms. Snow said. Of the survey respondents, 96% said they expect to see cost savings as the primary benefit of having biosimilars be classified as a pharmacy benefit. Most of the third-party payor respondents said they wanted to see better substitution laws and real-world evidence that the biosimilar can be substituted for the reference product and still be safe and effective. Dr. Hydery said she understood that point of view, which she attributed in part to the increasing complexity of the biosimilars market. “We have products across a variety of specialties, and that means we now have more prescribers and more patients to educate,” she said. “There’s also more competition among the biosimilars; it’s not just one reference product versus one biosimilar.” Cate Lockhart, PharmD, the executive director of the Biologics and Biosimilars Collective Intelligence Consortium, agreed that challenges remain. “Legal and regulatory hurdles still impede biosimilar adoption, and different state laws can cause confusion. So there’s still a lot of work to do to navigate these impediments,” she said. “But there’s also a lot of hope. Many people are invested in [meeting these challenges] because we want patients to get access to biosimilars.” The sources reported no relevant financial disclosures.

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Pharmacy Practice News - January 2022

Articles inside

Not safe to touch: bad ergonomics puts compounders at risk

acceptance

Population health approach to diabetes sweetens outcomes

Provider status gains steam at 2021 ASHP Midyear Meeting

Pharmacy leaders build a better model for infusion services