Considering the current low levels of biosimilars knowledge among many pharmacists, a group of researchers has developed a framework for integrating education about biosimilars into the Doctor of Pharmacy (PharmD) curriculum.
The guide, published in the American Journal of Pharmaceutical Education, suggests that future pharmacists will need to be knowledgeable about all facets of biosimilars, from development to regulation to pharmacy practice laws, especially as more and more biosimilars are approved and enter the market.
Biosimilars teachings, the authors write, could be integrated into the 4 main domains of pharmacy education: biomedical sciences, pharmaceutical sciences, clinical sciences, and social/administrative/behavioral sciences. They proposed 4 “key educational parameters” for biosimilars that could be taught throughout the PharmD program, along with suggestions on how students’ understanding could be evaluated.
- What is a biologic product? This beginner-level concept should be placed in the curriculum within the first year of the program to teach students the definition of a biosimilar and how it differs from a generic drug. Programs should also explain the risks of immunogenicity and the need to carefully evaluate safety data; this knowledge can be assessed with objective exams. “Understanding these concepts will reinforce to the PharmD graduate the importance of establishing pharmacovigilance processes to go along with the medication use processes at their institutions and practices,” the authors write.
- How are biosimilars developed and regulated? This intermediate-level lesson should be offered in the first 2 years of the 4-year doctoral program, allowing future pharmacists to learn about the biosimilars development process, the FDA’s biosimilar approval pathway, and the data required to demonstrate extrapolation and interchangeability. “Debates surrounding the guidances in draft form by the FDA would reinforce the complex issues of naming, interchangeability, and pharmacovigilance,” according to the authors, by demonstrating that biosimilar policies are controversial.
- State pharmacy practice laws. This intermediate-level lesson would be included in other courses about medication dispensing in order to educate students about the federal and state laws surrounding biosimilar substitution, as the complexities of biosimilars make substitution more difficult than with generic small-molecule drugs. It will also review whether substitution laws apply to pharmacists practicing in non-community settings. The authors write that after presenting these lessons in lectures, “lab-based activities should be developed to ensure that students follow the proper procedures for biologic substitution, in accordance with specific state pharmacy practice laws.”
- Pharmacy practice management issues. This advanced-level concept would be taught in context with other clinical therapeutics courses as a way of tying together the previously learned biosimilars information. Students would learn how to deal with biosimilars at the practice level and educate others on their use. The authors write that students could “evaluate the rationale and impact of biosimilars and require them to write policies aimed at reducing medication errors” as well as “prepare comprehensive summaries for an FDA-approved biosimilar and participate in a mock pharmacy and therapeutics committee review for formulary consideration.”
By incorporating these concepts into the pharmacy curriculum, students will graduate with an understanding of the role of biosimilars in pharmacy practice and the ability to weigh their advantages and risks.
“With this education, pharmacists will be able to provide leadership in balancing financial considerations with clinical safety and efficacy considerations in both the pharmacy and therapeutics formulary decision process as well as in the community setting,” the authors concluded. “Ensuring that graduating pharmacists are equipped with the necessary knowledge to manage daily responsibilities with regard to biologics and biosimilars will contribute toward ensuring the appropriate use of these new agents.”
Study coauthor, Edward Li, PharmD, MPH, BCOP, associate professor, Department of Pharmacy Practice, University of New England College of Pharmacy, is also an editorial board member of The Center for Biosimilars.