SUMMARY

This narrative describes a case-based exercise for teaching fourth-year health science professional students about regulatory agencies and processes surrounding the development and safety of products that impact health or the provision of health care. Alternatively, this exercise could be expanded to interdisciplinary teams that include both health professionals and engineers.

TARGET AUDIENCE

Health science students or interdisciplinary teams of students who use or develop medical products, or products that impact health.

INFORMATION LITERACY LEARNING OUTCOMES

• In response to a given clinical adverse event, identify relevant laboratory testing and regulatory agencies, and find online reporting portals or registries.
• Evaluate currency, authority, and purpose of relevant online information from professional organizations, government agencies, laboratories, manufacturers, and scholarly publications.
• Identify potential standards or regulations relevant to development and safety of medical products, or products that impact the health of all species.

DESCRIPTION OF INSTRUCTION

This is a 100–120-minute synchronous exercise for small groups of 5–7 health science students in the final clinical year of their curriculum. It is case based with individual students selecting and presenting their decision-making process in response to pre-posted short clinical scenarios with regulatory aspects. These scenarios are provided with other course materials a week in advance of the flipped classroom exercise. Students take turns leading discussion of their cases for approximately 15 minutes per case. The exercise can be taught in person using a technology-enabled conference room with students in control of the keyboard, or online using screen share video conferencing. An experienced health information specialist with clinical knowledge, or working in collaboration with a clinician, fills a role as facilitator. Students are directed to state specific logistical actions taken in response to a food, drug, or device adverse event, and to demonstrate resources consulted, rather than focusing on broad or theoretical answers. This is taught within the context of a variety of other scenarios that include infectious disease reporting, travel regulations, and food safety, though it could focus exclusively on medical products. Scenarios arise from emerging public health concerns that appear in international, national, or local news, or cases presented to partnering diagnostic laboratories. Scenarios intentionally do not provide all details to encourage students to both adapt them to their own intended specialty or geographic area (country/state), and to encourage discussion of the role, if any, that circumstances play in decision making. The scenarios provided are short 2–3 sentence descriptions. One example is a dog presenting with hypoglycemia and liver failure secondary to ingestion of a drug formulation containing the sugar substitute xylitol, a food additive generally recognized as safe (GRAS) for human consumption by the FDA. Adverse events involving this product are optionally reported to the FDA through their consumer safety reporting portal. In response to consumer complaints, the recent Paws Off Act of 2021 (H.R. 5261) was introduced, calling for amendment of the Food, Drug, and Cosmetic Act to require labeling of xylitol products for their toxicity to dogs.

This session is guided using essential questions that frame the unit of study as a problem to be solved [1] These may include questions about diagnostic testing in response to an event, making this exercise applicable to both clinical and regulatory science learning. At the same time, it grants students decision-making opportunities and acknowledges them as future creators of systems [2]. In addition to guiding questions accompanying each scenario, overarching questions about what agency to report adverse events to or where to find information for consumers are presented at the beginning of the discussion to encourage exploration beyond the immediate case or client.

Students lead the group through online resources and data dashboards developed by professional organizations, laboratories, academic institutions, local health departments, and state and federal government agencies, as well as state legal code, scholarly publications, and consumer information. In the process, students evaluate information literacy concepts of currency, relevance, authority, and purpose. In using a flipped learning model, where students complete work in advance, this exercise attempts to provide students with low-stakes decision-making authority in an environment that provides immediate peer and mentor feedback [3].

While the session described is taught to health science students in a regulatory context, it could be expanded to interdisciplinary teams working to create or assure quality and safety of medical products. If teams have collective health science and engineering knowledge, potentially group presentations could look at both reporting systems for adverse events, and dive deeper into applicable standards for product development.

DESCRIPTION OF INSTRUCTIONAL ACTIVITIES MATERIALS

This exercise requires the development of brief case studies by a subject expert pathologist or clinician in collaboration with a librarian, or alternatively, a librarian with subject expertise. These cases change frequently in response to current events and changing regulations and reporting systems.

The session may benefit from the maintenance of a library guide of relevant government and organizational sites and relevant news stories. This site is not provided to students; however, it assists the facilitator in rapidly providing example resources to students in the midst of the educational session as is relevant to discussion.

ASSESSMENT

Student presentations and participation is assessed through observation, direct facilitator participation in discussion, and completion of a prescribed MedHub eValue web-based form. This evaluates communication, engagement, knowledge, and integrative abilities. Routine student evaluations of teaching indicate that participating health science students find the session “practical” and “clinically relevant,” and value the open and informal facilitator and peer discussion.

REFERENCES

1. 1 C. C. Kuhlthau, L. K. Maniotes, and A. K. Caspari, Guided inquiry learning in the 21st century, 2nd ed. Santa Barbara: CA; Denver, CO: Libraries Unlimited, 2015.
2. 2 American Library Association, “Framework for information literacy for higher education,” Association of College & Research Libraries (ACRL), Feb. 9, 2015. https://www.ala.org/acrl/standards/ilframework
3. 3 C. Duijn, L.S. Welink, M. Mandoki, et al., “Am I ready for it? Students’ perceptions of meaningful feedback on entrustable professional activities,” Perspectives on Medical Education. 6, pp. 256–264, 2017.