Teaching non-FDA approved nonprescription products: Educating students about potential risks and liability.

INTRODUCTION: University professors who teach self-care and nonprescription products must decide which products and ingredients to recommend to students. The Food and Drug Administration (FDA) has approved many nonprescription ingredients as both safe and effective through the evidence-based FDA Over-the-Counter (OTC) Product Review or New Drug Application (NDA) processes. However, thousands of nonprescription products sold in community pharmacies are of unproven safety and/or efficacy. These include herbs, dietary supplements, homeopathic products, and essential oils. Selling products of unproven safety and/or efficacy can have serious consequences, exposing pharmacists to legal liability due to violations of the principles of implied and/or express warranties, as found in the Uniform Commercial Code. Further, the FDA defines products lacking proven safety and efficacy as health fraud, a crime aggressively pursued by both the FDA and the Federal Trade Commission. COMMENTARY: Faculty members who limit their nonprescription ingredient recommendations to those with FDA approval can justify those recommendations by weight of evidence. If the faculty member recommends ingredients that the FDA has not approved (e.g., kava), students should be taught that those ingredients pose unknown risks and lack proven benefit, and also that their labels virtually always lack doses proven to be safe, precautions, contraindications, and drug interactions. IMPLICATIONS: Selling unproven products can lower trust in pharmacy, cause patient harm, and expose the pharmacist to legal action. These issues should be explained to students whenever unproven products are discussed or recommended.

Liability and litigation risks for colleges and schools of pharmacy.

The potential for legal liability involving faculty members and students in higher education settings is a topic that warrants serious attention by administrators. Specific areas identified as high risk include dismissal of a faculty member, denial of tenure, misappropriation of grant-funding, intellectual property conflicts, Family and Medical Leave Act (FMLA) issues, sexual harassment, student suspension, disabilities, and student privacy issues. Examples of litigation in the higher-education setting are presented, along with a list of online resources for additional information. It is important for higher education administrators, faculty members, staff members, and students to recognize the currently accepted legal rights and responsibilities associated with these high-risk areas.