The issues relating to biosimilar misinformation have spurred calls for improving the level of knowledge of practicing healthcare providers. This effort must also seek to educate tomorrow’s healthcare providers about biosimilars today. BR&R spoke with two of the key forces behind the FDA’s important initiative to provide biosimilar education at the schools of medicine, nursing, and pharmacy.
Laura Pincock is a Health Communications and Education Specialist and Sarah Ikenberry is a Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars, Center for Evaluation and Research, Food and Drug Administration.
BR&R: We’ve been talking as a community for some time about countering the amount of biosimilar disinformation and the type of disinformation that is available. What are your own views on the FDA’s project to bring biosimilar education to the medical, nursing, and pharmacy schools?
Sarah Ikenberry: It seemed to me that the FDA was taking a proactive approach to educating healthcare providers and other audiences about biosimilars and interchangeable products.
We’ve conducted research projects to understand what people know about biosimilars and what they don’t appreciate. We used that to inform the educational materials that we’ve developed. In a nutshell, that’s how we approached it.
BR&R: Was the impetus more to help future healthcare professionals understand the difference between an interchangeable biosimilar and a conventional biosimilar, or the more basic difference between a biosimilar and a reference product? Did you find that there was much more need for information on the former or the latter?
Ikenberry: There’s a definite lack of understanding about the differences between a biosimilar and interchangeable agent. We’re trying to address that in the best ways we can.
From Landscape Research to Toolkit
BR&R: Please tell us about the steps involved in bringing this project to completion.
Laura Pincock: First, we wanted to get a baseline understanding of what’s being taught. Second, we attempted to evaluate what needs to be taught about biosimilars. And third, we needed to develop the kind of materials that would be best for the faculty to use in teaching these topics.
Ikenberry: We started by contacting those schools’ accrediting organizations, before speaking with the schools themselves, to pick their brain about how to go about this project. Our contractor, Booz Allen, conducted interviews with a small sample of deans and faculty at medical nursing, and pharmacy schools to better understand their main education needs. We wanted to address the unmet needs of the faculty with educational materials they can utilize in their own teachings.
Pincock: We also spoke to our colleagues internally at FDA and considered the research that had already been available.
We didn’t interview students though; we assumed they know little about biosimilars before being exposed to teaching materials.
BR&R: One of the things that we heard in 2019–2020 during our own initial investigations with schools of pharmacy and medicine was that their curriculums are so packed already. We heard a lot of comments like, “How can we fit or utilize this in the current curriculum?” Educators were looking for other ways to incorporate biosimilar learning into the students’ experience.
A couple of schools had developed an elective symposium to provide upwards of four hours of vital but basic information on biosimilars. This was not part of the formal curriculum, however. Did the individual schools you spoke with indicate that one type of approach would be better than another?
Pincock: We found that the method of educating students about biosimilars is not at all consistent. Pharmacy, physician, physician assistant, and nursing students receive biosimilar information at different times in their training. This may be as part of the didactic work, coursework, or educational module about the FDA regulation or manufacturing. In some cases, the schools themselves may not provide any education on biosimilars; students may not be exposed to biosimilar information until they begin rotations or even start their clinical practice.
As a result, we wanted to create a variety of materials that could be used in different stages of the students’ training and in a variety of mediums. In the digital world today, some students learn more effectively through videos; some would prefer to read more comprehensive, printed materials; and some would prefer just the facts. Making this information available in a variety of ways provides faculty with the flexibility to incorporate these topics into their own curriculum.
We published the curriculum toolkit in December 2021, and it’s available on our website (https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars). It’s the culmination of all of these efforts.
We will now begin to add additional materials and updating the current information. We’re already starting to look forward and how we can improve on the toolkit. We’re doing presentations and trying to increase awareness and understanding of the materials.
BR&R: The key here seems to be flexibility.
Pincock: And you’re right about the density of the curriculum. There is just so much information these schools need to teach, and there’s no clear consensus on the best time to teach it. That’s why we developed two levels of education in the toolkit: (1) basic, high-level information that is probably more appropriate for newer students and (2) in-depth materials, based in more regulation and science for healthcare professionals who are near the end of their training or about to start clinical practice. Those Level 2 materials are specifically for people who will be working with pharmacists or need to know real-world concepts on how biosimilars or interchangeables will be used, prescribed, dispensed, and monitored.
Biosimilar Education for Clinicians
BR&R: The timing of the toolkit’s completion has coincided a very interesting period for biosimilars: The designation of the first interchangeable biosimilars, and the approval of the first biosimilars for ophthalmologic use, and we’re on course now for next year’s launch of adalimumab biosimilars and interchangeables. It seems the toolkit’s release couldn’t come at a better time. What’s the next steps?
Pincock: This particular project has targeted student education. We will also be working with Medscape on developing and updating new continuing education programs for practicing healthcare professionals.
Ikenberry: It’s very hard you know with the different ways that these products are administered (e.g., in providers’ offices, hospitals, or outpatient facilities) and delivered by specialty pharmacies. Other than insulin, you can’t obtain these medicines at a community pharmacy.
We have other general educational materials that we’ve been putting out to try to provide information about interchangeability and the fact that biosimilars are just as safe and effective as the reference product.
BR&R: Is the FDA planning to hold any webinars or individual sessions targeted for plans or health systems (other than working with Medscape), discussing the availability of the toolkit?
Pincock: I think that’s the goal. We did disseminate information about the toolkit very widely when it was made available in December, sending it out to deans of the various schools of pharmacy, medicine, and nursing that worked with us in addition to the ones that didn’t. We also disseminated it to other associations that work with or represent healthcare professionals who use biosimilars. Sarah Yim (the Director of FDA’s Office of Therapeutic Biologics and Biosimilars) has been actively presenting on the need for biosimilar education and discussed the materials as well.
The materials are primarily geared for student learning, but the Medscape webinars will be for practicing clinicians. We really think we’ll be able to reach the folks that need it.