Cannabinoids are becoming more popular for patients with cancer as a pain management strategy. However, with inconsistent laws across states and federal bodies, it can be difficult for nurses and patients to comfortably discuss cannabinoids and cannabinoid use.

As the public perception and patient success stories with unconventional, alternative, and natural therapeutics shift consumer attitudes, it is important for nurses and their patients to understand the differences in the products and the adverse effects associated with each. According to a study by Butler et al in 2021, nearly half of individuals who participated in a survey who had consumed cannabidiol (CBD) did not disclose use to their health care provider.

“We see a lot of patients who have been trying to talk to us about CBD [cannabidiol], and cannabinoids and THC, [tetrahydrocannabinol]” Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, a professor of nursing at Vanderbilt University School of Nursing, said in a presentation during the Oncology Nursing Society Bridge.

Although Hande stated in her presentation that she was no expert in cannabinoids or medical cannabis, her clinical research primarily focuses on helping patients effectively manage their cancer-related pain. Therefore, she has become very interested in cannabis and has dedicated a lot of time and research to best understand the evidence-based data that exists for these products. In her presentation, “Cannabinoids for Patients With Cancer,” Hande discussed the available evidence on CBD and the possible risks, particularly in vulnerable populations.

“I think it’s just important for under us to understand a kind of broad overview about cannabinoids and THC and CBD, because this gives us a better understanding of where the laws come into play,” Hande said. She added, “It took me quite some time to try to understand all the differences and trying to make sure I give the correct information to my patients.”

A key concept for oncology nurses to understand, according to Hande, is the variations of cannabinoids.

Cannabinoids are compounds found in the cannabis plant. These compounds interact with the human endocannabinoid system. The exact relationship still required further understanding.

“Cannabis has many names for [many] strains, and hemp and marijuana are under this big umbrella of cannabis plants; they are all considered to be 1 species: the cannabis sativa plant,” she said. “This is a genus of flowering plants. And these can contain about over 100 phytocannabinoids, [and] they have a wide range of effects on the body in the brain.”

The following products are derived from cannabis: marijuana, hemp, THC, and CBD. In addition, there are man-made synthetic cannabinoids (K2/Spice); however, these agents are designed to mimic the mind-altering effects of illicit drugs. For her talk, Hande chose to focus on the products derived from the plant itself, as oncology nurses are more likely to encounter patients using plant-derived products.

If a patient reports marijuana use, this means they are using the dried flowers, leaves, stems, and seeds of the cannabis plant. Marijuana is also known as cannabis, weed, pot, or dope. Specifically, it can be defined as a plant with at least 0.3% delta-9 THC by weight. It is consumed by smoking (joints, blunts, bongs), vaping (vaporizing electronics devices), or by mixing or infusing it into foods or drinks (edibles).

“This is an important differentiating factor that I’ll be highlighting regularly through this talk,” Hande said during her presentation. “Marijuana is more than 0.3% of THC by weight.”

Marijuana is the most used federally illegal drug in the United States, with approximately 18% of Americans reported using it at least once in 2019 (~48.2 million Americans).1

Because marijuana has THC, it is associated with the following health risks: alterations in memory, learning, attention, decision-making, coordination, emotion, and reaction times.2 In terms of long-term health, marijuana has been linked to an increased risk of psychosis and schizophrenia,3 and, like other drugs, it’s use during pregnancy may increase the risk of embryo-toxicities.4 Moreover, this drug, depending on where it is sourced, may be laced with other substances. Consumers may or may not be aware of other substances in their product.

Using marijuana in combination with other agents may also result in impairment and can increase the risk of overdose.

Federally, marijuana is illegal as a recreational drug. It is classified as a schedule 1 drug, per the Drug Enforcement Agency. Although it is legal in some states for medical for nonmedical adult use, this does not mean that is safe, Hande noted. Specifically, smoking marijuana can expose users to harmful chemicals, and insufficient evidence exists to document the safest method for consuming.

Legally, hemp must contain a THC concentration of less than 0.3% by dry wright. It is the same species of plant as the cannabis plant and, along with bamboo, it is one of the fastest growing plants on Earth. There are almost no restrictions on hundreds of compounds made by the plant. Industrial hemp is cannabis sativa plant grown specifically for industrial or medicinal use.

“Many states across the country have hemp cultivation,” Hande said. “This allows cultivation of hemp from commercial or research or pilot programs. There are only a few states that do not allow cultivation of hemp.”

In 2018, the farm bill legalized the production and sale of hemp and its extracts, removing the product from the controlled substance act. Of note, per federal law, hemp cannot contain greater than 0.3% THC. If the concentration of THC surpasses this measurement, it is classified as marijuana.

As of September 2022, 47 states have enacted legislation to establish hemp production programs or cultivation research.

THC is a compound of the cannabis plant. This psychoactive agent causes, what is known as a high. It is consumed via dabbing—a specific method for inhaling THC concentrates.

Unfortunately, the concentrated forms of THC mean that there is an increased risk of additives or contaminating substances existing in the product.

CBD is another active cannabinoid found in the cannabis plant. This agent is not psychoactive and consequently does not cause a high.

CBD can be derived either directly from the cannabis plant or from a hemp product. The key difference between cannabis- and hemp-derived CBD is the concentration of THC. Hemp-derived CBD must have a THC concentration less than 0.3% to be federally legal. CBD products containing greater concentrations are federally illegal but are legal under some states.

“The main difference between cannabis and hemp-derived CBD is the amount of THC that it can contain,” Hande stressed. “Hemp-derived CBD includes less than 0.3% of the THC. [Therefore,] it’s federally legal to use hemp-derived CBD, but CBD products that contain more than 0.3% of THC are federally illegal. This is where the conflict between the state and the federal laws [can arise].”

The extraction process for CBD and THC are similar; farmers harvest the hemp and it is sent to an extractor. If the extraction is not performed with pharmaceutical grade standards, the CBD may become contaminated with THC, chemical solvents, or even pesticides. This is compounded by the fact that the US does not hold CBD supplies to a standard, and federal enforcement is lacking.

CBD can be converted into delta-8-THC, delta-9 THC, and other THC isomers through a solvent, acid, and heat. These products end up with higher concentrations of delta-8 THC than those which occur naturally in the cannabis plant. Consequently, these products may create harmful by-products that presently are not well-characterized.

Delta-8 THC products are increasing in popularity, in both marijuana- and hemp-based markets. It is appearing in markets that are operating legally under state, territorial, or tribal laws.

As of 2022, most states and territories permit full and restricted marketplaces where consumers can purchase hemp and hemp-derived CBD products.

According to Hande, there are a wide variety of delta-8 THC-containing products in the market. For example, vapes, smokable hemp sprayed with delta-8 THC extract, distillates, tinctures, gummies, chocolates, and even infused beverages can fit into this category. Moreover, the testing method for these products are still under development. This means that Delta-8 THC products may not be systematically tested for contaminants such as heavy metals, solvents, or pesticides which can cause adverse health effects.

How to Talk to Your Patient About Cannabinoid Use

Nurses hold a key role in discussing not only the risks of cannabinoid use but providing educational information for the safe consumption. Should a patient be interested in trying CBD products, counsel on the lack of evidence, contaminants, misleading labels, and legal issues of surrounding use. One approach to counter the “buyer beware” notion is to provide evidence-based patient education and to screen for any drug/drug interactions that may occur should the patient consume CBD products.

Additionally, assessing the patient’s baseline knowledge base before use will be beneficial and open communication may help establish trust and increase reported use between the patient and the health care provider. Finally, addressing the topic early on in care may remove the barrier of the stigma surrounding cannabinoid use.

Hande concluded by adding that many trials are ongoing in the cannabinoid arena and that results are expected to be published over the next several years. She noted that the oncology nurses should be up-to-date on the latest findings to provide guidance.

Marijuana and public health data and statistics. Centers for Disease Control and Prevention. June 8, 2021. Accessed September 14, 2022. bit.ly/3ROqaoi

Testai FD, Gorelick PB, Aparicio HJ, et al. Use of marijuana: effect on brain health: a scientific statement from the American Heart Association. 

. 2022;53(4):e176-e187. doi:10.1161/STR.0000000000000396

Di Forti M, Quattrone D, Freeman TP, et al. The contribution of cannabis use to variation in the incidence of psychotic disorder across Europe (EU-GEI): a multicentre case-control study. 

. 2019;6(5):427-436. doi:10.1016/S2215-0366(19)30048-3

Health effects of marijuana and cannabis-derived products presented in new report. National Academies. January 12, 2017. Accessed September 14, 2022. 

Articles

Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, explains the difference between some of the popular cannabinoid products that patients with cancer may be taking.

Oncology Nurses: What Cannabinoid Is Your Patient Taking?

New findings suggest that virtual frailty assessments are both safe and feasible for older adults with blood cancers; however, investigators note that they may be less sensitive to severe cases of severe frailty compared with in-person assessments, according to a study published in 

Geriatric and frailty assessments are recommended for all older adults undergoing systemic treatment for cancer. However, the COVID-19 pandemic has brought into question the feasibility of depending on in-person appointments and has highlighted the need for alternative appointment style options. Videoconferences or telephone visits have represented a potential solution to these challenges, but analyses regarding the feasibility of these assessments are largely insufficient. Moreover, to date, most virtual assessments consist of patient-reported measures without objective performance measures such as standardized tests of mobility and cognition—measures which have demonstrated predictive value in this setting.

In light of this, investigators sought to test a virtual frailty assessment which combine both patients-reported outcomes and standardized assessments.

The observational study assessed the feasibility of these reports for patients with blood cancer who were transplant ineligible and who were enrolled in the Older Adult Hematology Malignancies Program at Dana-Farber Cancer Institute in Boston, Massachusetts. Patients were divided into 2 cohorts based on the type of visit: in-person (age ≥ 75 years) or via telehealth (age ≥ 73 years).

Patients who were seen in-person were given a geriatric screening by a research assistant on the same day as their initial hematologic oncology consultation. The geriatric assessment inquired about patient-reported and objective measures, including comorbidity, functional status, physical performance, and cognition.

The study included 185 virtual patients after reaching out to 254 eligible patients. Of the 185 participants, 150 (81%) completed the virtual assessment. The in-person cohort included 876 patients out of 1017 possible recruits. Baseline assessments were consistent across the 2 groups, although a slightly lower proportion of pre-frail and frail patients were calculated in the group of virtual patients. Frailty measures included overall frailty status, frailty phenotype, and frailty by deficit accumulation.

Overall, the virtual assessments demonstrated a trend toward lower likelihood of identifying patients as frail by the phenotypic approach (odds ratios [OR], 0.66; 95% CI, 0.45-0.98), and as frail by the deficit accumulation approach (OR, 0.75; 95% CI, 0.51-1.11). Of note, the investigators identified weakened associations among patients depending on age, gender, disease type, and ECOG performance status, suggesting that differences in populations completing each assessment type may be linked to the findings rather than the assessments themselves.

“Even if our virtual frailty assessment is less sensitive at detecting frailty, the degree of reduced sensitivity is small and must be balanced against the increased burden and risk of in-person assessments,” the study authors wrote. “In our example, our virtual frailty assessment allowed our research and clinical program for older adults with blood cancers to continue through several waves of the pandemic and could allow for decentralization of assessments beyond the pandemic to potentially reach more older adults with blood cancers.”

DuMontier C, Jaung T, Bahl NE, et al. Virtual frailty assessment for older adults with hematologic malignancies. 

 Published online May 26, 2022. doi:10.1182/bloodadvances.2022007188

Investigators at Dana-Farber Cancer Institute are developing a virtual frailty assessment, which combines both patient-reported outcomes and standardized performance measures.

New Virtual Frailty Assessments Seek to Standardize Performance Measures for Older Adults With Blood Cancer

African American patients with cancer are more likely to enroll in a clinical trial if their primary oncologist is one of the trial investigators, according to a presentation from the 

 Moreover, findings showed that African American patients with lung cancer are just as, if not more, knowledgeable about clinical trial enrollment as White patients with lung cancer, and highlighted that 1 key barrier to enrollment between the 2 groups may be an issue of trust.

“The way [respondents] expressed themselves was telling in terms of the trust for the physician,” Faith Mutale, CRNP, of the Abramson Cancer Center at the University of Pennsylvania, who presented the findings during the meeting, said in an interview with 

. “Some of the participants would say, ‘I don’t trust the medical system, but I trust my physician because they’ve shown interest in my individual well-being.’ ”

Understanding the role that trust plays in clinical trial enrollment is crucial for efforts to diversify research, Mutale added, particularly among the African American community, where there has been a history of abuse and misinformation.

Less than 5% of patients in the general population with cancer enroll in clinical trials.

 Among African American patients with cancer, enrollment rates are even fewer, even though African Americans comprise about 13% of the United States population.

 For other minorities, enrollment numbers are even lower.

The reason for lower enrollment rates is multifaceted, Mutale said. However, obtaining a better understanding of what motivates these patients to enroll was part of the impetus behind a clinical project that Mutale helped launch at her institution.

The study looked at 2 different sites within the Matrix Cancer Centers, comprising different ethnic populations. One center has a mixed racial population and the other primarily treats African American patients. The cohort size was 65 patients, and the primary end point was to explore clinical trial knowledge and factors that influence attitudes and willingness to enroll onto a clinical trial among African American patients with lung cancer using a survey.

“We were going into this project with several assumptions, one of which was [that] participants from the primary site were more likely to have clinical trial knowledge and interest to enroll, as opposed to the affiliate site,” Mutale said. “But that wasn’t [the case].”

How can oncology nurses address this lack of trust?

According to Mutale, nurses will be at the forefront of bridging this barrier to care. Specifically, nurse navigators may play a role in helping keep patients both informed, and well-advocated, as they navigate the process of clinical trial enrollment.

“Nurse navigators have the ability to inform or educate patients about what’s available,” Mutale explained. “Patients may not be very comfortable discussing these things upfront, particularly after the first visit. However, they may then go the navigator and talk about what [clinical trials] are and what this may mean for them.”

Alongside nurse navigators, social workers have the potential to make patients feel both at ease, and well supported throughout their cancer journey, Mutale added. “Some of our patients just felt very comfortable talking to someone who looked like them,” she said, emphasizing that it’s not just the information that matters, but feeling as though your provider understands you and is invested in your well-being that is critical as well.

“In my experience, having a navigator and a social worker has always been very helpful. Their presence can [have] a calming effect in a nonthreatening way,” she said.

Overall, a paradigm shift is necessary in oncology, according to Mutale. At an institutional level, there is a need is a need to develop nurse-driven programs to combat disparities in clinical trial enrollment. There also needs to be a push for specific training for the role of the “clinical trial educator,” as Mutale calls them. “I coined this particularly nurses who are members of minority groups. Patients must feel and know that the providers interest goes beyond the trial but for each individual patient outcomes as well.”

Based on these findings from the phase 1 part of the study, investigators are now launching a phase 2 study.

Mutale FA. Sandy B. Inclusion of minorities in cancer clinical trials: where are we now? Presented at: 6th Annual School of Nursing Oncology®; July 29-30, 2022; San Diego, CA.

Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;35:185-198. doi:10.1200/EDBK_156686

Siegal RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33. doi:10.3322/caac.21654

Faith Mutale, CRNP, discusses the paradigm shift needed in oncology to address clinical trial enrollment hesitancy among African American patients with lung cancer.

Nurse Navigators Can Help Alleviate Medical Distrust, Improve Clinical Trial Enrollment

Nurse navigators may play a key role in mitigating toxicities from chemotherapy and perform geriatric assessments for patients treated at hematology/oncology clinics, according to data from a pilot project presented at the 2022 ASCO Annual Meeting.

Investigators assessed the use of the G8 questionnaire to identify vulnerable geriatric patients with cancer and the Cancer and Aging Research Group (CARG) scoring tool to calculate chemotherapy toxicity risk among patients aged 65 years or older. These tools are used to stratify those at-risk for severe adverse effects using information beyond age as a guide for treatment decisions and improve outcomes. The tools also aid in the referral of patients with vulnerabilities to external services for follow-up treatment.

Completion rate of these assessments is between 20% and 35% when administered by physicians and investigators sought to improve completion rates with assistance of nurse navigators.

Seven community cancer centers were included in the pilot program and the study period lasted from May 1, 2021, to December 31, 2021, G8 assessment was administered at all 7 sites and CARG plus G8 assessments were administered among patients with solid tumors receiving chemotherapy at 4 of the 7 sites.

In total, 1372 patients were eligible to undergo G8 assessment and 563 were eligible for CARG assessment. The completion rates of the assessments were 78.9% and 91.6%, respectively, when administered by a nurse navigator.

“Nurse navigators can successfully implement G8 and CARG toxicity tool in hematology-oncology clinics in a broad range of cancer types at a high rate with resultant referrals to multiple supportive services in real-world settings,” the study authors wrote in a poster of the data.

Referrals to external services were also initiated among the population and included 193 referrals for nutrition services, 30 for audiology, 18 for physical therapy, 5 for psychiatry, and 5 for neurology. The median age of patients in the eligible population was 74 years (range, 65-100) with a near even split between men (48%) and women (52%). Patients has a range of cancers including genitourinary (18%), breast (17%), upper gastrointestinal (15%), and thoracic cancers (13%).

The G8 assessment produces a score ranging from 0 to 17 based on fitness characteristics of patients.

Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties?

Mobility (ie, able to get out of bed/chair)

Neuropsychological problems (ie, severe dementia or depression)

Heath assessed in comparison with other individuals the patient’s age

The CARG tool is used to predict cardiac toxicity based on a range of factors including the following

Primary tumor site (ie, genitourinary or gastrointestinal cancer)

Laboratory results (ie, hemoglobin and creatinine clearance)

Socialization (ie, observed decreases because of physical and emotional health)

ASCO guidelines for geriatric oncology recommend that patients aged 65 years and older should undergo assessment to identify risks that not routinely captured in clinical assessments. The recommendations include both the G8 and CARG tools as supplemental assessments for geriatric assessment in the clinic.

Shaia JL, Liu R, Sun H, et al. Nurse navigator–initiated geriatric assessments in hematology/oncology clinics. 

. 2022;40(suppl 16):12051. doi:10.1200/JCO.2022.40.16_suppl.12051

Bellera CA, Rainfray M, Mathoulin-Pélisser S, et al. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. 

. 2021;23(8): 2166-2172. doi:10.1093/annonc/mdr587

Kim J, Hurria A. Determining chemotherapy tolerance in older patients with cancer. 

. 2013;11(12):1494-502. doi:10.6004/jnccn.2013.0176

Mohile SG, Dale W, Somerfield MR, et al. Practical assessment and management of vulnerabilities in older patients receiving chemotherapy: ASCO guideline for geriatric oncology. 

Nurse navigators may play a key role in mitigating toxicities from chemotherapy and perform geriatric assessments for patients treated at hematology/oncology clinics.

Geriatric Assessment Rates Improve With Nurse Navigator Intervention

Black patients with metastatic breast cancer were less likely to have a discussion about clinical trials with their health care providers, were less likely to trust the trials in general, and had greater reservations about the safety of investigational agents, compared with their White counterparts, according to findings from a recently completed survey.

Specifically, the survey found that although 83% of Black patients with metastatic breast cancer would be interested in participating in clinical trials, only 40% reported their provider having a conversation with them about a trial.

The results of the survey, which were presented during a press briefing ahead of the 

, show that action needs to be taken to address these barriers and ensure more Black patients with metastatic breast cancer are included in clinical trials, according to Stephanie Walker, a patient living with metastatic breast cancer and an advocate with the Metastatic Breast Cancer Alliance, who led this survey.

Walker, who is Black, said that only when a trial population represents the diversity of the general population can oncologists truly evaluate how a treatment works across different populations.

The purpose of the survey, which is a part of the BECOME initiative, was to better understand the barriers Black patients with metastatic breast cancer face in regard to participating in clinical trials. It was administered via social media, as well as by members of the Metastatic Breast Cancer Alliance and included 424 patients with metastatic breast cancer, 102 who self-identified as Black.

Black respondents trust and satisfaction rates with their oncology team were high, above 90%, and 83% of Black respondents were somewhat or very likely to consider participation in a clinical trial. However, 40% reported that their care team had not discussed clinical trials with them.

Additionally, Black respondents were more likely than non-Black respondents to believe unstudied treatments may be harmful (57% vs 31%) and were less likely to trust trials (73% vs 91%).

Other reasons for not participating in a clinical trial included worry about side effects (73%) and effectiveness (63%), as well as logistics such as travel and added cost.

Black respondents were also less likely than non-Black respondents to trust that people of all race and ethnicities would be given fair treatment in a trial (32% vs 56%) and would be more motivated to participate if there were assurance people of their race would benefit (83%).

Furthermore, Black respondents were more likely than non-Black respondents to value information on clinical trials if given by someone who is same race or ethnicity (67% versus 10%), has had breast cancer (73% vs 44%) or metastatic breast cancer (73% vs 51%).

As noted in the results, Black patients with metastatic breast cancer are willing to participate in clinical trials; however, more must be done to increase their participation. Walker said taking action to better inform patients, inspire their trust, ensure access to clinical trial and address their concerns could increase this participation.

As noted in the results, Walker said that bringing in people who have been through a similar journey with race and breast cancer could help inspire this participation and trust.

“We want to inspire Black people with metastatic breast cancer to participate in these clinical trials,” Walker explained. “So, in order for that to happen, we trust people that look like us, that are from the same racial or ethnic background, those that have … participated in clinical trials, those that have had breast cancer or metastatic breast cancer.”

Walker added that clinical trials are often held at teaching/university-based cancer centers, and not community-based cancer centers where some of these patients may be receiving treatment; therefore, they don’t know about them nor do they have access to them, another barrier Black patients with metastatic breast cancer may face.

“To address the concerns that we have, you need to communicate clearly about the issues and worries that metastatic breast cancer patients have. You have to understand that some of the compelling motivation for Black patients to participate in clinical trials is to ensure that people like (them) will benefit,” Walker said.

Additionally, Walker said all stakeholders have a role to play in increasing participation. This includes expanding the survey-respondent base, meaning investigators hope to reach a broader group of people to better represent the Black patient experience. Members of the BECOME initiative will also meet with other groups to share results and create strategies to improve care, she said.

Other initiatives that could increase participation, Walker added, include improved patient education, training health care providers on effective patient communication and helping patients find and access clinical trials.

She highlighted that healthcare providers should be educated on how to communicate with Black patients because they go through a different experience, and they need to better understand those who are in rural communities might not have the access they would need to participate in a clinical trial.

“You need to know where we are coming from. You need to know what we go home to everyday isn’t always what you believe it be, as the white patient has all the support and resources that they need,” she concluded.

Walker S, Carlson M, White CB, Howell J, Felder TM. Increasing Black patient participation in metastatic breast cancer clinical trials: the BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project. 

. 2022;40(suppl 16):1014. doi:10.1200/JCO.2022.40.16_suppl.1014

Although 83% of Black patients with metastatic breast cancer expressed interest in clinical trials, only 40% reported having a conversation about enrollment with their health care provider, highlighting one of many potential barriers to achieving clinical trial diversity.  

Black Patients With Metastatic Breast Cancer Experience More Hesitancy With Clinical Trial Enrollment

As biosimilars continue to be approved for cancer-specific agents, the role of the oncology nurse in implementing and educating patients about their use becomes more pronounced, according to Kellie Zeichner, RN, BSN, OCN.

“[The Biologics Price Competition and Innovation Act of 2009] generated a licensure pathway for biologic products which [have been] proven to be biosimilar to or interchangeable with FDA[-approved] biologic products,” Zeichner, an oncology nurse with the Rutgers Cancer Institute of New Jersey who has experience working with biosimilars, said in an interview with 

Frequently used agents in oncology care—trastuzumab (Herceptin), rituximab (Rituxan), and pegfilgrastim—all have approved interchangeable products. Most recently, bevacizumab (Avastin) added a third FDA-approval biosimilar, bevacizumab-maly (Alymsys) in April 2022.

In the discussion, Zeichner highlighted the vital components of the development of biosimilars and interchangeable products that oncology nurses need to know.

 Please contextualize how biosimilars compare with their reference products.

[Biosimilars] are large, complex molecules made from living sources that are not identical but very similar to approved reference or brand drugs [with slight alterations and inactive components]. There are no clinically meaningful variants in safety, purity, or strength.

Biosimilars differ from generic drugs in their complexity and the manner [in] which they are manufactured. The cell lines that are processed [for reference products] are proprietary for biologics; therefore, the original product can never be duplicated precisely, and an exact copy of a biologic cannot be made. This is different from a small molecule drug, which can be copied with insignificant or no variable change from the original. The process of biosimilar manufacturing is rigorous [and is conducted] in a highly controlled environment.

The products are tested on several levels, which include preclinical, structural, and operational levels for safety, efficacy, and immunogenicity. [The biosimilars] must meet FDA standards—they have to be manufactured in an FDA-licensed facility, and they must be tracked as part of post marketing surveillance to ensure continued safety, which is of the utmost importance.

What is the approval process for a biosimilar?

Following the approval of [an] original brand drug, there is a period of market protection. For [approximately] 10 years there is an order to safeguard the reimbursement of research and developmental costs—which are quite high—for [the reference] biological agents.

Once this period has expired, biosimilars are legally allowed to be created. At this point, submission can be placed for a licensed application of biosimilar or an interchangeable [biosimilar product]. Then, through analytical data, animal testing, and clinical studies, an applicant must prove that there is no clinically meaningful difference in safety, purity, and strength between the biosimilar and the reference drug. Biosimilars can be approved as interchangeable either at initial approval, or at supplemental approval, if switching studies are conducted.

Please expand on the differences of an interchangeable biosimilar.

What is an interchangeable? This is a biosimilar product that can be substituted for a brand product without the intervention of the health care provider who prescribed it.

 To demonstrate interchangeability, [the FDA] requires that the biosimilar will produce the same clinical result as a brand product for any given patient and that it presents no additional risk to the patient if a switch between a product had occurred.

All biosimilars have a nonproprietary name and a suffix that is attached to the [reference product name], [this] always has a hyphen at the end [followed by 4 lowercase letters, of which 3 are distinct. They don’t carry any meaning at all, [but are there to ensure] that the biosimilar cannot be capable of being mistaken for the name of a current drug that is marketed already.

The intent for this is 2-fold. [One purpose] is patient safety, [specifically] to prevent patients from receiving medication that was not the intended biologic product prescribed and to avoid switching [to] biologics that are not deemed interchangeable. [The hyphen also serves] for tracking. It allows manufacturers specific tracking and most importantly, the remediation of adverse events should one occur.

Why is immunogenicity important when discussing a biosimilar?

Immunogenicity is an immune response [triggered by] a host against the therapeutic protein or the drug. It is an important concern regarding the efficacy and safety of biologics.

Biologics are more structurally complex than chemical drugs, and even a small variation in their manufacturing can cause undetected changes in [the] biologic composition of the product. These minor differences between a biosimilar and a reference biologic product could lead to the development of an anti-drug antibody.

At least 1 comparative parallel arm clinical trial must be done to assess the potential difference in immune response between the reference product and the biosimilar. Most importantly, the biosimilar approval process should prove that the biosimilar does not present a greater risk than the [reference] or the brand drug does. This is done through a highly complex and fully validated approach for detecting anti-drug antibodies and a head-to-head comparison of immunogenicity testing between the biosimilar and the reference product.

Implementation of the biologics price competition and innovation act of 2009. FDA. Updated Feburary12, 2016. Accessed June 2, 2022. 

FDA approves Alymsys (bevacizumab-maly), a biosimilar of bevacizumab by Amneal Pharmaceuticals, Inc., developed by mAbxience. News release. Brand Institute, Inc. April 18, 2022. Accessed June 2, 2022. https://prn.to/3k7MGt7

Biosimilar and interchangeable biologics: more treatment choices. FDA. Updated October 12, 2021. Accessed June 2, 2022. 

Kellie Zeichner, RN, BSN, OCN, discusses the production of biosimilars, their approval and naming processes, and why immunogenicity is important when discussing these agents. 

The Basics of Biosimilars for Oncology Nurses

For patients with cancer who are at the end of their life, being afforded the same level of autonomy in death as they experienced is life can be a vital component in providing quality care for the patient and their family, according to Lisa Vigil Schattinger, MSN, RN.

Schattinger is the founder and Executive Director of Ohio End of Life Options, a nonprofit organization that advocates for and provides education on medical aid in dying laws. In addition to being a nurse advocate, she also brings a unique personal perspective to her career.

Schattinger’s stepfather electively chose medical assistance in end-of-life care under Oregon’s Death with Dignity Act

 after he received a myelodysplastic syndrome diagnosis and learned he was not eligible for blood marrow transplant. He opted not to start chemotherapy but enrolled in hospice and received palliative packed red blood cell transfusions before electing to pursue a medically assisted death.

Her stepfather’s death was incredibly peaceful and in accordance with his wishes: he was able to walk himself into his room, sit down on the bed, and be surrounded by family as he took the medication.

“He felt empowered,” she recalled, noting that the family was grateful that the state of Oregon had allowed them this option.

At that moment, Schattinger and her mother, who is also a nurse, recognized that this option is potentially groundbreaking for certain patients and their families. As a result, they decided to learn more about the processes in place and to share their own personal experiences. Recently, the duo presented on the topic at the 

47th Annual Oncology Nursing Society Congress

 , specifically on the role of oncology nurses in end-of-life care and the key components of medical aid in dying (MAiD) or dying with dignity laws.

®, Schattinger provides a quick overview of her presentation and key takeaways for nurses seeking to provide quality care.

: Please provide a brief overview of medical aid in dying.

 Medical aid in dying is a law that allows terminally ill and mentally capable adults the ability to request a prescription that will hasten their imminent death. The process is patient directed; it is a voluntary process that has multiple safeguards. It is for an [individual] who understands that they are at the end of their life, understands that they are dying, and wants to determine the time and the place and [the company present] at the end of their lives.

Each state can determine if they are going to pursue the process of passing an aid [with the establishment of a] dying law or medical aid in dying law. The first one that [was passed] was in Oregon, and it is called the Death with Dignity Act. I always consider that one as kind of a baseline. As other states passed [similar] laws, they put their “thumbprint” on that law— they made it work for their state.

Currently it is legal in Oregon, Washington, California, Hawaii, Colorado, New Mexico, Vermont, Washington, DC, New Jersey, and Maine. [In addition], there was a Montana State Supreme Court decision that allows [MAiD], but it is not exactly the same as in places that have actual laws.

[To qualify], patients have to be capable of making decisions. If there is any concern that the person is not capable of making decisions, then they can be referred for a mental health evaluation. Then there are timeframes in place [these vary by state, as well]. A patient also needs a written request that is witnessed by 2 people, of whom at least 1 cannot be related to or benefit in any way from the person’s death. Then, after qualifying for the prescription, they must wait 48 hours before filling. Patients must also be able to self-administer the medication.

Anybody involved in this process can opt out at any time, physicians, pharmacists, nurses, [or] any other care provider can opt not to participate [in the process]. Of course, the patient themselves can change their mind at any time and stop the process as well.

It is also important to note that when a physician gets this request, they must inform the person of all [available end-of-life options], including hospice care.

[Interestingly] we have learned that [approximately] a third of the [individuals] who get this prescription never end up taking it. There are a combination of things going on there. [Some] say that they can relax knowing that they are able to determine if [and when] their suffering becomes too great. Others, [unfortunately,] do decline in health. And [those] who are not able to self-administer, are no longer capable of making that decision

Should oncology nurses only be familiar with these laws if they live in a state where it is legal? How might nurses support a patient who wants MAiD, yet lives in a state where it is not an option?

The American Nurses Association put out a statement saying that because so many people now have access to this option at the end-of-life that they feel nurses are ethically bound to be knowledgeable about it. This means being able to have non-judgmental conversations about MAiD, and to be able to [inform individuals] about what end of life options are available [including hospice care and pain management].

So if, as a nurse, you live in a state without a [MAiD] law, and someone asks you about it, [best practice] is taking a moment to really focus on that person and that request and ask: What does this mean to you? What does that request mean to you? Do you understand what all your options are for care at the end of life, and that we live in a state that does not have a law?

Then, if [end-of-life medical assistance] is important enough to patient, they [might consider if they’re willing] to move to a state with a law? This is a very big question. At the end of a person’s life, that is a really big step: to decide to pull out roots from their community, their community of support, and their healthcare community of support, and move to another area, to go through the process of establishing residency–depending on where you're living—and finding 2 doctors who will participate in this program [is a big commitment].

However, some will decide that it is important enough to them and they do want to do that. But others [will not] and so everyone needs to understand what end-of-life care options are available to them. It is important to have that full conversation to understand that their personal beliefs, values, and goals are, and to see what types of care match their needs, as well as what is available in their community.

What are some misconceptions or things that nurses may not understand about MAiD that makes it difficult for them to support it?

A lot of times [individuals] do not understand [how it is] a self-directed process. This is the patient who wants this and it is vital that they determine what the end of their life looks like.

I remember a person who said, “When I got this diagnosis years ago, I knew that my treatment options would probably run out at some point. So, I became a partner with my health care team in making medical decisions moving through the course of my illness—I made decisions on what type of treatments [I took], what surgeries, and everything else that was possible.” When it came time for [the health care team] to say, there are no longer treatments for you, [the patient] said, “I made all of those decisions as a partner up to that point, why would it change?”

the ethical value of medical aid and dying and the impact that it does have on the patient.

I think that concept of autonomy and self determination to some [individuals] is paramount. Its who they are. They want partners in their health care [team] who will work with them to provide that care. Some health care providers also believe that providing compassionate care is one that meets the [patient's] goals.

Ultimately, the concept of suffering is for the patient to determine, not for us to judge.

Until we get to know these [individuals] and fully [understand] why they are making these requests [we cannot fully understand their needs]. Whatever a patient’s definition of suffering is, compassionate care means granting their requests to manage it.

Death with dignity act. Oregon Health Authority. Accessed June 1, 2022. bit.ly/390VQW4

Lisa Vigil Schattinger, MSN, RN, discusses her experience with medical aid in dying, and what oncology nurses need to understand when supporting patients at the end of their lives. 



What Oncology Nurses Should Understand About Medical Aid in Dying 

Addressing access to care is the first steps to improving patient outcomes, according to investigators with Yale Cancer Center and Moffitt Cancer Center. Ensuring that patients reach the right providers at the right team is key in being able to provide potentially life-saving agents and personalized treatments.

“Access is a multifaceted construct. It’s not just about the onboarding process or the amount of time that it takes to get that first appointment. It also ensures that the patient can reach a live person when they make a phone call, that they can be seen in a convenient location be seen by a clinician who is an expert in their specific disease, that they [can] access information about their diagnosis that’s readily available, and be able to afford their care,” Sarah Mougalian, MD, said during the 2022 National Comprehensive Cancer Network (NCCN) Annual Conference.

 She added that treatment should not only be prompt, but also have seamless transitions from the first appointment through every phase of the cancer care continuum. Mougalian is chief ambulatory officer at Yale Cancer Center/ Smilow Cancer Hospital and an associate professor of medicine in medical oncology at Yale School of Medicine in New Haven, Connecticut.

Sustainable care following the first point of contact the management of logistics of care affects both the patient and the provider. “The moment that one has a diagnosis [of cancer], they are overcome with a sense of fear and urgency,” Christie Pratt, MA, DHSc, said on a panel at the 2022 NCCN Annual Conference. “At that moment both patients and their loved ones need help. It’s about more than just getting them to the best care. It’s deeper than that,” Pratt is the senior director of Moffitt Medical Group at Moffitt Cancer Center in Tampa, Florida.

Data from a recent meta-analysis of mortality rates across the most common cancer types— bladder, breast, colon, rectum, lung, cervix, and head and neck—demonstrated that delays in cancer treatment initiation were associated with increased risk of death if delayed by 4 weeks or more.2 For example, a 13% increased risk of death was associated with a 4-week delay in adjuvant systemic treatment for patients with colorectal cancer.2 Hazard ratios for delays in systemic treatments had singificant associations with delays of 4 weeks in neoadjuvant treatment of bladder cancer (HR, 1.24; 95% CI, 1.03-1.50), adjuvant treatment of breast cancer (HR, 1.09; 95% CI, 1.07-1.11). Additionally, radiotherapy delays in head and neck cancer (HR, 1.09; 95% CI, 1.05-1.14) and cervical cancer (HR, 1.23; 95% CI, 1.00-1.50) were deemed significant.

Investigators cited patient, disease, and system factors all play a role in delays to care, the most cited reasons being workups and specialist consultations. To alleviate the burden of even one of these factors could significantly improve delays in treatment.

Mougalian and Pratt presented 2 initiatives to improve new patient access to cancer care at Yale Cancer Center/Smilow Cancer Hospital and Moffit Cancer Center, respectively.

 The programs focused on systemic hurdles, namely reducing delays for patient appointments with disease specialists.

Developing a system with a patient-centric focus, investigators at Yale Cancer Center initiated a pilot program to offer patients next day access to care following a diagnosis of cancer. Mougalian and her colleagues began with 2 subspecialty clinics at the institution—breast and gynecologic oncology. “We want it to be easy [for the patient following their] initial consultation to self-refer [and] for the scheduling process to be efficient,” Mougalian said. “We want the patient to be able to see a provider who is expert in their diagnosis in a timely fashion or institutional goal is within 5 days. Both before and after the first appointment, the patient should be able to speak with someone knowledgeable in the process and understanding of the plan of care.”

Investigators in the breast and gynecologic clinics were tasked with developing individual implementation plans that included an algorithm to define which patients were eligible for next day access (

). Selected patients typically included those who had received a diagnosis of cancer or suggestion of cancer prior to referral. The institutional goal of the pilot program was to have patients obtain appointments within 5 days. Early findings of the program were presented at the 2021 American Society of Clinical Oncology Quality Care Symposium.

The analysis included 3107 new patients who had a referral meeting across 4 sites of the institution. The primary efficacy measures of the program were to evaluate the number of patients who were seen within 1 business day of their referral, time to their first visit, the number of patients who accepted a next day appointment, and to obtain a descriptive analysis of the reasons why a next day appointment was not taken. Among the entire population of patients seen, 900 were eligible for next day visits with 12% of patients accepting the appointment. More patients with breast cancer (17%) accepted next day visits than those who received a diagnosis of gynecologic cancer (9%).

The median time to first visit was measured at 2 time points: December 2019 through February 2020, and December 2020 through February 2021. The median time to next visit in the first year was 13 days vs 9 days in the second year.

Mougalian stressed the importance of care team coordination through the process. “For providers who refer to us, the process should also be seamless and efficient,” she said. “Appointments should be scheduled quickly and follow-up and notes from the first consultation should be relayed back to the referring physician.” Mougalian added that special attention should also be paid to internal staffing challenges with even distribution of patient cases among appropriate specialists within the disease state. “Each team reviewed historical data to estimate the volume of new patient slots [and] made the appropriate adjustments in scheduling,” she said.

In contrast with their internal goal, investigators also strived to meet patient where they were. “The patient was at the center of this initiative and the No. 1 goal was to honor the patient’s choice, offering an appointment as soon as the patient wants it, and where the patient prefers,” Mougalian said. In tandem with this, she noted that managing patient expectations was also a critical component of the process, including the limitations that come with a next day appointment and other options that were available to them. An example roadmap for implementation is outlined in 

In an analysis of patients with a data cutoff of February 2021, reasons why patients did not accept a next day appointment included the availability of a specific provider (49%) or a specific date was requested (27%). These rates dropped in an analysis between August 2021 and January 2022 to 38% and 20%, respectively.

Pilot programs based out of Yale Cancer Center and Moffitt Cancer Center seek to improve access for newly diagnosed patients with cancer. 



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