New OTC drugs and devices 2003: a selective review.
OBJECTIVE
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.


METHODS
Recently published clinical and pharmaceutical industry literature.


METHODS
By the authors.


METHODS
By the authors.


RESULTS
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).


CONCLUSIONS
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.
Newton
Gail D
GD
School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, Indiana, USA.
Pray
W Steven
WS
Popovich
Nicholas G
NG
D004348:Drug Labeling; D004864:Equipment and Supplies; D006801:Humans; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011933:Reagent Kits, Diagnostic; D012651:Self Medication / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
D004366:Nonprescription Drugs; D011933:Reagent Kits, Diagnostic