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.

Orrin hatch and the dietary supplement health and education act: Pandora's Box revisited.

Products of unknown safety and efficacy were once referred to as "quackery," and the US Food and Drug Administration (FDA) was empowered to protect public health by preventing their sale and forcing them from the market. However, in 1994, the Dietary Supplement Health and Education Act legitimized their sale as "dietary supplements." Sales increased dramatically, and many Americans now use herbals, homeopathics, and other so-called supplements. The Food and Drug Administration cannot act against them until patients have already been harmed, a dangerous situation. Furthermore, no governmental agency has the authority to force the manufacturers to furnish proof of efficacy. It is vital for physicians to warn their patients that they should use these unproven products only with great caution, and must never discontinue legitimate medical therapy in lieu of unproven products.

Status and recommendations for self-care instruction in US colleges and schools of pharmacy, 2006.

Teachers of pharmacy self-care courses have met annually since 1998 at the Nonprescription Medicines Academy (NMA) held in Cincinnati, Ohio. During these meetings, self-care faculty members discuss methods of enhancing the teaching of self-care in US colleges and schools of pharmacy. Self-care courses are taught using a variety of methods and content is woven into pharmacy curricula in many different ways. This manuscript sets forth the current state of self-care instruction in pharmacy curricula including the recommended core curriculum, instructional methodologies, course mechanics, existing standards, and assessment and curricular placement, and makes recommendations for the future.

Ethical, scientific, and educational concerns with unproven medications.

Quackery (promotion of products that do not work or have not been proven to work) was once a commonly used term within the pharmacy and medical communities. However, an increasingly anti-scientific national climate culminated in passage of the 1994 Dietary Supplement Health and Education Act, which granted unprecedented legitimacy to "dietary supplements" that had not been scientifically proven to be effective and/or safe. In part, this was facilitated when professional pharmacy magazines and journals published advertisements and articles promoting these unproven medications. Gradually, pharmacy codes of ethics eliminated references to quackery, and some pharmacy organizations seemed to accept the unproven medications they once exhorted the pharmacist not to sell. The profession's shift in attitude toward unproven medications occurred as the medical community at large began to realize the value of evidence-based medicine. Academicians must resist pressure to present unproven therapies as realistic alternatives for medications with scientific proof of safety and efficacy. They must stress the value of evidence-based medicine and urge students and pharmacists to recommend only those medications with evidence-based proof of safety and efficacy.

New OTC drugs and devices 2003: a selective review.

OBJECTIVES: To present current information about trends development and marketing of over-the-counter (OTC) medications and dietary supplement products and describe new products, delivery systems, home monitoring devices, and home accessories in these markets that are likely generating questions from or posing potential problems for patients. DATA SOURCES: Recently published clinical and pharmaceutical industry literature. STUDY SELECTION: By the authors. DATA EXTRACTION: By the authors. DATA SYNTHESIS: Last year witnessed the first effort of the Food and Drug Administration (FDA) to remove a dietary supplement from the U.S. market. Ephedra, because of its imminent danger when used for weight reduction and athletic enhancement, was the target of FDA action. FDA has issued a final rule implementing this ban, which prohibits the sale of dietary supplements containing ephedrine alkaloids (e.g., ephedra). Two newer diet-aid products are being actively promoted with little or no safety and effectiveness data. Thus, pharmacist's vigilance is important along with sensible advice on how to lose weight safely and effectively. Further, two independent organizations have created certification programs for dietary supplements that ensure product purity, active ingredient strength, and compliance with good manufacturing practices. In addition, through recent changes in federal legislation, consumers are now able to obtain reimbursement for their nonprescription purchases through flexible spending accounts. Information is presented in this article about selected products in these OTC, home care, and dietary supplement categories: heartburn (proton pump inhibitors), allergy (second-generation antihistamines), constipation (laxatives), diabetes mellitus (blood glucose monitoring systems), home testing (fertility monitoring), nicotine addiction (smoking cessation products), otic disorders (ear syringes), contraceptives and sexual aids (condoms and lubricants), and dermatology (wart removal). CONCLUSION: Patients continue to increase their reliance on self-care. To assist them, pharmacists must remain up-to-date on trends and have an understanding of the nuances of consumers' behavior and thinking in relation to OTC products and their use.

OTC medicines update. In the over-the-counter market, new products and added indications provide an important opportunity for pharmacists.

The OTC market is constantly evolving and represents an excellent opportunity for pharmacists to expand their services to patients. Many patients require guidance to ensure that they are using OTC medicines appropriately. Several laxative products have been reformulated recently, which may necessitate that pharmacists help patients rethink their therapeutic options. Reusable cold packs and continuous low-level heat wraps are excellent new options for patients with sports injuries.

New OTC drugs and devices 2002: a selective review.

OBJECTIVES: To create a heightened awareness of two consumer issues confronting pharmacists in the self-care arena--consumers' need for accurate information about over-the-counter (OTC) products and consumers' attitudes and beliefs about OTC drugs--and to educate pharmacists about newly introduced nonprescription products, home screening devices, and home accessories. DATA SOURCES: Recently published clinical and pharmaceutical industry literature and survey results from the National Council on Patient Information and Education. DATA SYNTHESIS: Although changes have been made to labeling for OTC products to heighten consumers' awareness of the dangers associated with misuse of these products, consumers need the expertise of the pharmacist to guide them toward effective and safe self-care. It remains critical that pharmacists be knowledgeable about the numerous nonprescription products that become available on the U.S. market each year and take the initiative to counsel patients appropriately on the benefits and risks associated with their use. CONCLUSION: Patients will continue to place an increasing emphasis on self-care. To assist them, pharmacists must remain up-to-date on trends and have an understanding of the nuances of consumers' behavior and thinking in relation to OTC products and their use. The new nonprescription medications and diagnostic screening devices discussed in this review article represent valuable additions to the growing array of self-care products.

New OTC drugs and devices 2001: a selective review.

OBJECTIVES: To create a heightened awareness of two important issues that arose over the past year with respect to over-the-counter (OTC) drugs-the possible switching of nonsedating second-generation antihistamines to OTC status and the continuing need for pharmacists to learn about dietary supplements and herbal products-and to educate pharmacists about newly introduced nonprescription products, devices, and diagnostic products. DATA SOURCES: Recently published clinical and pharmaceutical industry literature. DATA SYNTHESIS: In a historical precedent, a third party insurer rather than a pharmaceutical company is attempting to force the switching of several prescription nonsedating antihistamines to OTC status. In addition, several developments related to the manufacture and use of dietary supplements have created concern for consumers and the pharmacists who advise them. It is critical for pharmacists to become knowledgeable about dietary supplements so they can appropriately counsel patients on the benefits and risks associated with supplement selection and use. In addition, numerous nonprescription products, including home diagnostic products and accessories, will continue to become available on the U.S. market. It is important that pharmacists become as knowledgeable as possible about these and be capable of educating the consuming public about their appropriate use. CONCLUSION: Patients will continue to place an increasing emphasis on self-care. To assist them, pharmacists must remain up-to-date on trends and have a balanced understanding of new nonprescription products and dietary supplements. The new nonprescription medications and diagnostic products discussed in this review article represent valuable additions to the growing array of self-care products.