safety guidelines

New ISMP Guidelines Address Perioperative Medication Safety

By Kate Baggaley

Anew set of recommendations from the Institute for Safe Medication Practices (ISMP) tackles the issue of perioperative medication safety in both inpatient and ambulatory surgery centers (ASCs). The numerous handoffs and fast pace of patient care present unique challenges for medication safety in these settings, the organization said, motivating it to develop its first best-practice guidelines to help facilities identify and address gaps (https://bit.ly/3AEHuFT).

Within the last five years, “there’s been a better focus and strategic planning toward perioperative services, but more importantly what a vital role pharmacists can play in it,” said Gourang Patel, PharmD, MSc, a clinical pharmacist at the University of Chicago, who headed the American College of Clinical Pharmacy’s Perioperative Practice Research Network, which reviewed the ISMP guidelines before their publication. “With these [guidelines] coming out, there’s finally beginning to be some substance and a foundation regarding medication management and safety in the perioperative area.”

Medication errors are common in all phases of perioperative care, ISMP noted in its new guidelines, estimating that at least 787,218 such errors occur annually in the United States. Medications frequently involved in errors include antibiotics in preoperative settings; analgesics, antibiotics, muscle relaxants and vasopressors in intraoperative settings; and antibiotics and anticoagulants in postoperative sett ings.

Under a contract with the FDA, ISMP released a medication safety selfassessment survey for perioperative settings last year. That assessment “confirmed our suspicions that the perioperative areas may not be using technology for medication safety to the greatest extent as we do in other areas of the hospital,” Susan Paparella, MSN, RN, the vice president of services at ISMP, told Pharmacy Practice News. “We would love to see ways in which barcode technology or other advancing technologies—whether it’s RFID [radiofrequency identification] or other machine-readable coding—can be used to support the anesthesia providers and the inter-op providers as they select and administer medications,” she added.

The final recommendations were informed by best-practice statements that clinical experts, representatives from professional organizations and industry leaders developed during ISMP’s two-day national invitational perioperative medication safety summit, held in November 2021.

The guidelines focus on 10 key elements: • patient information; • drug information; • communication of drug orders and other drug information; • drug labeling, packaging and nomenclature; • drug standardization, storage and distribution; • medication delivery device acquisition, use and monitoring; • environmental factors, workflow and staffing patterns; • staff competency and education; • patient education; and • quality processes and risk management.

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Managing HIV Multidrug Resistance: A Persistent Challenge

RELEASE DATE: DECEMBER 1, 2021 EXPIRATION DATE: DECEMBER 31, 2022

This activity is jointly provided by Global Education Group and Applied Clinical Education.

This activity is supported by an educational grant from ViiV Healthcare and Merck & Co., Inc.

Distributed by Infectious Disease Special Edition and CMEZone.com

Faculty

Paul E. Sax, MD

Clinical Director, Division of Infectious Diseases Professor of Medicine, Harvard Medical School Brigham and Women’s Hospital Boston, Massachusetts

Julia Garcia-Diaz, MD, MSc, FACP, FIDSA, CPI

Director Clinical Infectious Diseases Research Director Medical Student Research Associate Professor, University of Queensland Brisbane, Australia Department Infectious Diseases Ochsner Health System New Orleans, Louisiana

‘The goal is to remove the potential for human error from the equation and make it safer for the patient.’

—Susan Paparella, MSN, RN

Instead of being reactive after an event occurs in an organization, “we’re hoping that these guidelines will represent a way for organizations to more proactively go after some of the risks that we know exist throughout the country in perioperative settings,” Ms. Paparella said.

Such risks frequently involve over- or under-delivery of fluids during infusions and mix-ups among syringes, vials and ampules that resemble each other. To avert these mistakes, the guidelines highlight the importance of implementing technologies such as smart infusion pumps and the use of barcode scanning to identify medications. “The goal is to remove the potential for human error from the equation and make it safer for the patient,” Ms. Paparella said.

Another concern discussed in the guidelines involves monitoring patients after opioid administration in the postanesthesia care unit. “It’s taking the role/responsibility beyond the OR pharmacy itself and reviewing the impact of multiple opioid and pain medications to ensure the drugs, doses and combination thereof are safe for patient care,” Dr. Patel said. “In other words, it’s not just approving in the computer the medication order simply based on the dose or frequency but reviewing it more comprehensively in today’s era of complex pain management.”

A New Road Map

The guidelines are intended to be used by providers in a variety of perioperative facilities.

“What was nice to see is that many of these medication management principles did not necessarily apply to only one area or type of setting, [and] some of them can be extended to ambulatory care settings,” Dr. Patel said.

ASCs represent a growing segment of healthcare delivery and “merit the same level of attention to medication safety practices and standards as acute care facilities,” ISMP wrote in its guidelines.

There are more than 10,000 ASCs in the United States., Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), the president emeritus of ISMP, previously told Pharmacy Practice News. “There is a lot of work to be done in ambulatory surgery because most don’t have pharmacies; they don’t have a full-time pharmacy operation,” he said (https:// bit.ly/3wsEV7w).

The new guidelines add up to a “pretty comprehensive list,” Ms. Paparella acknowledged. “It’s not something that, we recognize, will happen in a short time.”

Many organizations are approaching this task in an interdisciplinary way. “There are guidances here that are going to cross pharmacy, nursing, anesthesia, surgery, etc., so we want to make sure that no decisions are made for practice without everyone at the table,” Ms. Paparella said. “We want to make sure that as they look to these guidelines for direction, it’s a road map for how to reduce risk and where interdisciplinary practitioners can work together to accomplish best practices.”

Some of the recommendations represent practices that are already widely applied; for example, many practitioners participate in organization-wide quality and safety committees focused on perioperative and procedural medication use. Other recommendations, such as using printed barcode labels on practitioner-prepared syringes to ensure the correct medication and dose are administered, will be new territory for many organizations.

“It’s up to each organization to look at these guidelines in their entirety, evaluate themselves against these guidances to see what’s already in place and what they need to work on, and then prioritize them internally,” Ms. Paparella said. “We’re hoping the organizations that may implement some of these guidances will evaluate themselves over time, so a couple of years from now [they will] take the opportunity to again pull out the assessment tool and look at where they may still have some opportunities for improvement” (https://bit.ly/3Ct9SMB).

ISMP Guidelines Focus On 10 Key Elements

1Patient information: Essential patient information is obtained, readily available in useful form and considered when prescribing, dispensing and administering perioperative medications, and when monitoring their effects. 2 Drug information: Essential drug information is readily available in useful form and considered when prescribing, preparing, dispensing and administering perioperative medications, and when monitoring their effects. 3 Communication of drug orders and other drug information: Methods of communicating drug orders and other drug information in the perioperative setting are streamlined, standardized and automated to minimize the risk for error. 4 Drug labeling, packaging and nomenclature: Strategies are undertaken to minimize the possibility of perioperative errors with manufacturerprepared, pharmacy-prepared or commercially prepared drug products that have similar or confusing labeling/packaging and/or drug names that look and/or sound alike. 5 Drug standardization, storage and distribution: IV and regional anesthesia solutions, drug concentrations, doses and administration times are standardized whenever possible. 6 Medication delivery device acquisition, use and monitoring: The potential for human error is mitigated through careful procurement, maintenance, use and standardization of devices used to prepare and administer medications in the perioperative setting. 7 Environmental factors, workflow and staffing patterns: Medications are prescribed, transcribed, prepared, dispensed and administered in the perioperative setting within an efficient and safe workflow and in a physical environment that offers adequate space and lighting, and allows practitioners to remain focused on the medication-use process. 8 Staff competency and education: Perioperative practitioners receive sufficient orientation to the perioperative medication-use process and undergo baseline and annual competency evaluations of knowledge and skills related to safe medication practices. 9 Patient education: Patients are included as active partners in their perioperative care and are educated about their medications and ways to avert errors. 0 Quality processes and risk management: A safety-supportive culture (e.g., just culture) and model of shared accountability for safe system design/redesign and safe behavioral choices are in place and supported by perioperative leaders, managers and the associated board of trustees/directors.

The sources reported no relevant financial disclosures.

Practical Considerations For Implementing Biosimilars In Oncology Practice

DOUGLAS HACKENYOS, PHARMD, BCOP

Oncology Pharmacy Clinical Coordinator Department of Pharmacy UConn Health Farmington, Connecticut

Nearly 8 years have passed since the 2015 FDA approval of filgrastim-sndz (Zarxio, Sandoz) under the Biologics Price Competition and Innovation Act of 2009.1,2 During that time, 35 more biosimilars—biologics that are highly similar to and have no clinically meaningful differences from a previously approved reference product in terms of safety, purity, and potency—have reached the US market.2,3

Although the introduction of biosimilars in oncology came with the hope of significant healthcare savings, individual institutions continue to struggle with formulary management and optimization of biosimilar use. This article serves as an update on the practical management, uptake, and optimization of biosimilars in oncology practice, covering factors related to product selection, information technology (IT) integration, and the role of the pharmacist in educating providers and patients about these agents.

Selecting a Preferred Product

Although it is becoming increasingly difficult to select a single preferred biosimilar for a hospital formulary, selecting a preferred product out of the competing biosimilars and reference products remains an important first step (Table 1).4-17 Two key processes are involved in evaluating biosimilar product selection:

1. Clinical review and comparison. As with any agent being considered for formulary addition, a thorough review of the safety and efficacy data is a necessary first step. When reviewing and deciding among biosimilar products, consider the potential for varying levels of supporting data for each agent. Biosimilars receive FDA approval based on analytical studies of structure and function, animal studies, and clinical studies. The data from these studies are used to compare pharmacokinetic, pharmacodynamics, safety, and efficacy end points of the medications under review.18 Depending on the provided data, the FDA may allow extrapolation and approval of indications without additional clinical studies. Although the FDA approval process for biosimilars helps to reduce significant clinical differences among products, pharmacy and therapeutics committees must ultimately choose among products and establish any restrictions in use.

One key factor is the approved indications for a biosimilar, which may not include all of the approved indications of the reference product. For example, the indications for rituximab (Rituxan, Genentech) include pemphigus vulgaris and certain pediatric indications, while its biosimilars (rituximab-abbs; Truxima, Celltrion; rituximabpvvr; Ruxience, Pfizer) are not approved for those 2 therapeutic uses.4-7 Providers should consider the patient populations seen at their institutions when deciding among products, given potential coverage issues resulting from different approved indications. Additional factors to weigh include the reliability of the manufacturer in terms of product quality and availability.

Of note, some institutions have avoided the need to bring biosimilars through the full pharmacy and therapeutics committee approval process by creating policies establishing equivalence and interchangeability of biosimilars within the walls of the hospital. Such policies place emphasis on financial considerations and allow the pharmacy to drive much of the product selection process. 2. Pharmacoeconomic evaluation. In tandem with any clinical review is the necessary pharmacoeconomic evaluation of available biosimilars. Historically, the average wholesale price is approximately 20% to 30% lower for biosimilars compared with reference products.19 Additional savings may be realized through participation in group purchasing organizations (GPOs). A further benefit of many GPOs is their ability to provide ongoing evaluation of available biosimilars and coverage considerations, thus shifting some of this process away from the individual institution. A growing trend is a push toward “portfolio” contracts in which a manufacturer negotiates cost savings through GPOs that utilize all the biosimilars they offer, such as the

Table 1. Approved Antineoplastic Biosimilars and Reference Products

Reference product Biosimilar FDA approval date

Bevacizumab (Avastin, Genentech) Bevacizumab-awwb (Mvasi, Amgen) September 2017 Bevacizumab-bvzr (Zirabev, Pfizer) June 2019 Bevacizumab-maly (Alymsys, Amneal) April 2022

Rituximab (Rituxan, Genentech) Rituximab-abbs (Truxima, Celltrion) November 2018 Rituximab-arrx (Riabni, Amgen) December 2020 Rituximab-pvvr (Ruxience, Pfizer) July 2019

Trastuzumab (Herceptin, Genentech) Trastuzumab-anns (Kanjinti, Amgen) June 2019 Trastuzumab-dkst (Ogivri, Mylan) December 2017 Trastuzumab-dttb (Ontruzant, Samsung Bioepis) January 2019 Trastuzumab-pkrb (Herzuma, Celltrion) December 2018 Trastuzumab-qyyp (Trazimera, Pfizer) March 2019

following biosimilars marketed by Amgen: bevacizumab-awwb (Mvasi), trastuzumab-anns (Kanjinti), and rituximab-arrx (Riabni). This may be another strategy to consider in maximizing cost savings with biosimilar optimization.

Coverage and reimbursement may be the biggest factors in any biosimilar formulary decisions, given that the majority of their use occurs in the outpatient setting. Familiarity with an institution’s payor mix and the formulary preferences of major commercial payors is essential in biosimilar implementation. The Centers for Medicare & Medicaid Services (CMS) has incentivized utilization of newly approved biosimilars compared with older biosimilars or reference products via 340B pass-through status; however, in June 2022, the US Supreme Court ruled unanimously in favor the American Hospital Association and others to end varying CMS reimbursement cuts for 340B hospitals.20-21 While a final ruling is expected in November 2022, biosimilars that have lost pass-through status would be expected to revert from a payment rate of average sales price (ASP) minus 22.5% to ASP plus 6% in 2023. This would stand to significantly change strategy for reviewing reimbursement in biosimilar product selection.

Implementing Biosimilar Use

After selecting a formulary-preferred product, full implementation involves IT integration as well as significant provider and patient education; these areas will be the focus of subsequent articles in this series. The overall approach to implementation may involve use in only newly started patients or active conversion of those established on therapy with a reference product. In either approach, careful coordination with care team members and prior authorization (PA) staff is necessary.

MANAGING EXCEPTIONS AND CHANGES

The ever-changing landscape of biosimilar approvals and insurance formularies makes it nearly impossible for most institutions to select a single biosimilar to replace any given reference product. Making preferred product selection clear across systems may help minimize inappropriate orders and support PA requests; however, a successful biosimilar implementation process will allow conversion to a reference product or nonpreferred biosimilar in cases of insurmountable insurance restrictions or rare clinical exceptions. Additional patient-specific exceptions may be required for clinical trials and mail-order or specialty pharmacy-supplied medications.

INNOVATION IN REFERENCE PRODUCT LINES

Competition breeds innovation, and this can be seen via additional non-biosimilar products that are poised to draw away from biosimilar use (Table 2).4,12,22-24 Monoclonal antibodies with hyaluronidase intended for faster, more convenient subcutaneous administration, for example, are attractive treatment options compared with existing IV reference products and biosimilars.26 However, insurance authorization hurdles, site-of-care issues, and narrower FDA-approved indications hamper widespread utilization of these subcutaneous agents. As more innovative formulations reach the market and lists of approved indications grow, competition with biosimilars will undoubtedly increase.

Table 2. Reference Products and Innovative Subcutaneous Formulations Adding Competition to the Biosimilar Market

Intravenous reference product Rituximab (Rituxan, Genentech) Novel subcutaneous formulation

Rituximab and hyaluronidase (Rituxan Hycela, Genentech) June 2017 • Chronic lymphocytic leukemia • Diffuse large B-cell lymphoma • Follicular lymphoma

Trastuzumab (Herceptin, Genentech)

Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo, Genentech)

Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech)

Based on references 4, 12, and 23-25.

FDA approval date Indication(s)

June 2020 • Breast cancer, early adjuvant or neoadjuvant • Breast cancer, metastatic February 2019 • Breast cancer, early adjuvant • Breast cancer, metastatic

THE UNBRANDED REFERENCE PRODUCT

Although yet to be seen in oncology, Janssen introduced another strategy to compete with biosimilars by introducing unbranded infliximab. Marketing materials heavily emphasize that unbranded infliximab is “the same product as Remicade with the same patient support.”26 As such, it carries the same indications as the reference product, including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis, among others. Although the strategy seems to undermine the foothold of biosimilars, the release of unbranded biologics comes as a clear acknowledgment of the shifting market and overall price reductions brought forth by competition. Unbranded biologics will undoubtedly emerge in oncology in the near future.

Biosimilar IT Integration

ELECTRONIC MEDICATION RECORD BUILD

Successful incorporation of biosimilars into the electronic prescription record begins with well-constructed building blocks: electronic prescriptions or medication records. Unlike interchangeable generic and brand-name medications, it is important to recognize that biosimilars have distinct National Drug Codes and billing codes. Biosimilar electronic medication records should include the unique National Drug Code, Healthcare Common Procedure Coding System (HCPCS) code, generic name (with 4-letter suffix), and brand name associated with each unique product. Comprehensive biosimilar builds can help to minimize look-alike/sound-alike (LASA) errors that may arise with order entry, verification, preparation, and administration (Table 3). LASA warnings also may be added to each build to appear on the medication administration record and drug labels.

BIOSIMILAR ORDER SETS

In addition to their many other benefits, electronic order sets and oncology treatment pathways can greatly aid biosimilar uptake. A formulary-preferred biosimilar may be set as the default agent in any given plan to bolster use and avoid provider confusion at order entry. Practice advisories or other wording may be added to treatment plans, and electronic consent forms may be used, to further highlight formulary preferences and promote patient education on biosimilars. Defaulted treatment plans also may assist in streamlining the PA referral process and make the preferred biosimilar selection clear to authorization staff.

ADDRESSING PAYOR PREFERENCES

Unfortunately, using 1 preferred biosimilar is becoming unrealistic as payors become increasingly divided in the products they will cover. An effective order set will allow flexibility in accommodating third-party payor preferences and products supplied by specialty pharmacies or manufacturer assistance programs. While there are many ways to approach this problem, 2 options are worth highlighting: 1. Placeholder orders in treatment plans. Use of a placeholder or “dummy” biosimilar order in a treatment simplifies the product selection process by allowing PA staff to determine which biosimilar(s) will be covered up front. A pharmacist may review the authorized product(s) for the plan, substitute an actual order, and route for a co-signer as needed. This strategy requires a close relationship between pharmacy and PA staff; reports to identify “dummy” orders needing replacement; and general acceptance of biosimilar equivalency from providers.

2. Automatic substitution based on authorized

product. Sophisticated electronic health records may automatically drive product selection based on a patient’s insurance type with rules defining the payor’s covered biosimilar(s). In this case, the payor type or HCPCS code entered in an authorization note triggers a change in the ordered biosimilar to the covered product. This strategy also requires collaboration between pharmacy and PA staff and acceptance of biosimilar equivalency from providers.

With any strategy, careful review of the authorized versus ordered biosimilar is essential to avoid denied insurance claims. Finally, efforts to minimize or avoid use of brand names in oncology treatment pathway titles, plan parameters, and other order set fields outside of the specific medication order may make future substitutions or product conversions more efficient.

DISPENSING TECHNOLOGY

Technology within the pharmacy can drastically improve an institution’s ability to incorporate biosimilars into practice. Inventory management systems with electronic barcode scanning can help pharmacy staff differentiate between biosimilars and reference products as soon as medications enter the pharmacy. Biosimilar products may be assigned segregated locations using inventory

BIOSIMILARS

continued from page 15

management technology to avoid confusion in stocking and picking physical inventory. Barcode scanning, image capturing, and dose compounding verification technology also can minimize preparation errors that may result from LASA biosimilar products. Dose preparation and verification technology also can aid in avoiding preparation errors that may result from differences in specific product preparation. For example, vial sizes, reconstitution instructions, and the need for sterile water for injection (SWFI) versus bacteriostatic SWFI vary between single- versus multidose trastuzumab products.12,17 Inventory management and dose preparation may be further complicated by the need to stock multiple biosimilars as well as subcutaneous formulations for any given reference product; barcoding technology is essential to avoid errors in such scenarios.

MEDICATION ADMINISTRATION TECHNOLOGY

Technology greatly facilitates safe administration of all medications, including biosimilars. The use of barcode scanning and smart infusion pumps can reduce errors that may come with multiple product options. Many institutions are opting to minimize build and maintenance work for their smart pump libraries by using a single entry under a generic name to address both reference and biosimilar products with identical administration instructions. Some medication administration records also may allow the addition of intranet links to drug information and patient education resources for biosimilar products for easy access at the point of care.

The Pharmacist’s Role

BECOMING INFORMED

The rapid introduction of multiple biosimilar agents has challenged all clinicians, including pharmacists, to stay informed. In a 2019 survey conducted by the International Society of Oncology Pharmacy Practitioners, 3 key areas were identified by respondents as requiring more training: biosimilar comparative efficacy to innovator products (74%), practical guidance managing biosimilar conversions (74%), and biosimilar medication safety, including immunogenicity (74%).27 Pharmacists must have a fundamental understanding of biosimilars to be in a position to implement and educate providers and patients on their use. Numerous biosimilar review articles are available, including publications geared specifically toward oncology pharmacists.28,29 Pharmacists also may stay abreast of the most recent biosimilar approvals through resources such as FDA alerts and weekly FDA briefings from the Hematology/ Oncology Pharmacy Association (HOPA).30,31

EDUCATING THE CLINICIAN Several studies have identified areas for improvement in oncology clinician understanding of biosimilars, and pharmacists may play a key role closing these knowledge gaps.32-34 Survey findings shared at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) indicated 88% of responding oncologists had used biosimilars, but nearly half lacked knowledge on key concepts such as interchangeTable 3. Tips for Minimizing Look-alike/ ability.35 Position statements and Sound-alike Medication Errors With resources from ASCO, HOPA, the Biosimilar Implementation National Comprehensive Cancer Network, and the Oncology Nursing Administration • Barcode scanning Society are extremely helpful in sup• Discrete medication records for each porting pharmacist-led education of biosimilar with full generic name, clinicians and ultimately increasing 4-letter suffix, and brand name acceptance and understanding.36-39 • Segregated inventory locations in auto- Education efforts and the identifimated dispensing cabinets cation of a physician champion for Order entry • Discrete medication records for each biosimilar use are critical steps in sucbiosimilar with full generic name, 4-let- cessful biosimilar implementation. ter suffix, and brand name In addition to clinician education, • Default order sets/treatment pathways support staff should be informed of to formulary product preference new considerations with the addition Preparation • Barcode scanning of biosimilars. Pharmacists may facil• Segregated inventory locations for ref- itate the education of patient access erence, biosimilar, and subcutaneous and PA staff by explaining care plan product formulations changes, emphasizing changes in preVerification • Discrete medication records for each ferred products, and providing clinical biosimilar with full generic name, rationale for biosimilar PAs. Pharmacy 4-letter suffix, and brand name technicians also should be educated • Minimize need for substitution upon to minimize risk for LASA errors in verification compounding and dispensing.

CURBING BIOSIMILAR MISINFORMATION

Given patients’ and providers’ relatively limited experience with biosimilars, some key concepts may be poorly understood. For example, the term “similar” may be misunderstood as implying a clinical difference rather than its true intention of emphasizing inherent variability among biologic products.40 The “abbreviated” approval pathway for biosimilars also can be misinterpreted as being more lenient or cutting corners compared with that of reference products. Pharmacists play an important role in educating and avoiding the negative impact that misinformation can have on biosimilar uptake. Although retrospective reviews continue to be published comparing real-world clinical outcomes between biosimilar and reference products, providers may find internal data more comforting and convincing. Pharmacists may promote further biosimilar uptake by reviewing their institutions’ biosimilar and reference product data and comparing factors such as incidence of infusion-related reactions and clinical outcomes, where available.

EDUCATING THE PATIENT

Patient education remains a vital component to cancer care utilizing antineoplastic biosimilars. The education of new-start patients on biosimilars is comparable to that of other patients initiating treatment with a biologic. Given the growing potential for changing payor formularies and institutional cost savings with change in formulary preferences, it may be appropriate to introduce patients to the term “biosimilar” and explain key concepts of biosimilar “switching,” safety, immunogenicity, and production (Table 4).

The massive influx of information that patients must process at the start of a new regimen necessitates succinct, patient-friendly written information. Biosimilar manufacturers often provide helpful explanations and figures if branded patient education materials may be used at your institution. The FDA also has a host of unbranded materials with infographics that quickly explain key biosimilar concepts in patient-friendly terms.41

Education at the time of conversion from an antineoplastic reference product to a biosimilar is an important, sensitive step to maintaining a respectful patient–provider relationship during implementation. Conversions may be driven by institutional cost-savings opportunities or insurance formulary preferences; in either case, it is important to be open about general motivation for increasing biosimilar use. In the outpatient setting, education should be coordinated in advance of order conversion, PA, and actual treatment with the biosimilar. An example conversion time line may include patient education on the biosimilar in person or via phone at the time of their treatment with a reference product, PA between treatments, order conversion, and follow-up at the first biosimilar infusion.

The need to re-consent patients upon conversion to an antineoplastic biosimilar is a frequently asked question. Reviewing institution-specific consenting policies and consulting in-house legal

Table 4. Key Patient Counseling Points For Biosimilar Medications

What are biosimilars?

Why use biosimilars?

Is it safe to switch to a biosimilar?

• These biologic agents are highly similar to a reference product and safe and effective. • Biosimilars are tested and compared with reference products before FDA approval. • These agents are not generic versions. As biologics, they are large, complicated molecules made by living cells that cannot be copied exactly. • These agents provide more treatment options. • They enhance competition and increase cost savings in healthcare. • Biosimilars improve access to care. • Insurance coverage may require use of biosimilars. • There are no meaningful differences in effectiveness or side effects compared with reference products. • The function, purity, potency, and immunogenicity of biosimilars are similar to those of reference products. • Biosimilars use the same dosage and administration as reference products and are produced in FDA-licensed facilities. • Safety tracking continues after the biosimilar has been approved and reaches the market.

counsel, if available, may be helpful steps in determining the most appropriate course of action. In either case, it may be appropriate to update consent forms or policies to contain broader wording (eg, “treatment with: x drug and similar products”) to allow for future conversions.

References

1. FDA. Drugs@FDA: FDA-approved drugs.

Filgrastim-sndz. Accessed August 10, 2022. www.accessdata.fda.gov/scripts/cder/daf/ index.cfm 2. FDA. Biosimilar product information.

Accessed August 10, 2022. www.fda.gov/ drugs/biosimilars/biosimilar-productinformation 3. FDA. Title VII—improving access to innovative medical therapies. Subtitle A—

Biologics Price Competition and Innovation.

Accessed August 10, 2022. www.fda.gov/ media/78946/download 4. Rituxan [package insert]. Genentech, Inc; 2018. 5. Truxima [package insert]. Celltrion, Inc; 2022. 6. Ruxience [package insert]. Pfizer, Inc; 2021. 7. Riabni [package insert]. Amgen, Inc; 2020. 8. Avastin [package insert]. Genentech, Inc; 2020. 9. Mvasi [package insert]. Amgen, Inc; 2019. 10. Zirabev [package insert]. Pfizer, Inc; 2019. 11. Alymsys [package insert]. Amneal

Pharmaceuticals, LLC; 2022. 12. Herceptin [package insert]. Genentech, Inc; 2018. 13. Ogivri [package insert]. Mylan; 2017. 14. Herzuma [package insert]. Celltrion, Inc; 2018. 15. Ontruzant [package insert]. Samsung

Bioepis Co, Ltd; 2019. 16. Trazimera [package insert]. Pfizer, Inc; 2019. 17. Kanjinti [package insert]. Amgen, Inc; 2019. 18. FDA. Guidance document: scientific considerations in demonstrating biosimilarity to a reference product.

Accessed August 10, 2022. bit.ly/3CaGY3y 19. Mulcahy AW. Rand Health Q. 2018;7(4):3. 20. Centers for Medicare & Medicaid Services.

Fed Regist. November 21, 2018. Accessed

August 10, 2022. bit.ly/3zXRcSl 21. American Hospital Association et al v.

Becerra, Secretary of Health and Human

Services, et al. No. 20-1114. (Supreme Court of the United States 2022). Accessed

August 10, 2022. bit.ly/3K1LhjW 22. Herceptin Hylecta [package insert].

Genentech, Inc; 2019. 23. Phesgo [package insert]. Genentech, Inc; 2020. 24. Rituxan Hycela [package insert].

Genentech, Inc; 2017. 25. Anderson KC. Future Oncol. 2019;15(28):3267-3281. 26. Unbranded infliximab [package insert].

Janssen; 2021. Accessed August 10, 2022. www.infliximab.com 27. Chan A. J Oncol Pharm Pract. 2020;26 (3 suppl):11-21. 28. Cuellar S. Am J Health Syst Pharm. 2019;76(21):1725-1738. 29. Foreman E. J Oncol Pharm Pract. 2020;26(3 suppl 2). 30. FDA. Get email updates. Accessed August 10, 2022. bit.ly/3QxrCuC 31. Hematology/Oncology Pharmacy

Association. Drug updates. Accessed

August 10, 2022. bit.ly/3w83E0S 32. Cook JW. Ther Adv Med Oncol. 2019;11:1758835918818335. 33. Williamson C. Am J Manag Care. 2019;25 (6 Spec No.):SP188-SP191. 34. Edgar BS. J Manag Care Spec Pharm. 2021;27(8):1129-1135. 35. Peipert J. J Clin Oncol. 2021;39 (28 suppl):Abstract 35. 36. Zelenetz AD. J Natl Compr Canc Netw. 2011;9(4 suppl):S1-S22. 37. Lyman GH J Clin Oncol. 2018;36(12): 1260-1265. 38. Hematology/Oncology Pharmacy

Association. Biosimilars issue brief: an important new category of medications for cancer patients. Revised December 2015.

Accessed August 10, 2022. bit.ly/3QwhhPi 39. Vizgirda V. Clin J Oncol Nurs. 2017;21(2):E54-E60. 40. Cohen HP. BioDrugs. 2020;34:407-414. 41. FDA. Patient materials: biosimilar basics for patients. Updated October 7, 2020.

Accessed August 10, 2022. bit.ly/3QsmSGl

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