1. McNamara, Sherrie MBA, BSN, RN

Article Content

To the Editor,


Nonprescription products are widely used in part because of their convenience, cost-effectiveness, and the consumer's ability to self-diagnose and self-treat commonplace ailments (Bond & Hannaford, 2003). Nonprescription products are more convenient for manufacturers as well because these products take less time to develop and market. They are more cost-effective to produce in large part because of the reduction in spending on government approvals as the product's active ingredient(s) is typically already proven safe and effective (Nichol, McCombs, Johnson, Spacapan, & Sclar, 1992). Consumers and healthcare professionals believe that nonprescription medications are safe and effective by virtue of their being over the counter (D. Balaban, personal communication, October 8, 2011).


Pharmaceutical companies and retailers use direct-to-consumer advertising for marketing purposes, which encourage the consumers to use nonprescription medications for self-treatment, often without full information or understanding about the product (Nichol et al., 1992). The 2006 Institute of Medicine (IOM) report Preventing Medication Errors notes that four of five adults take at least one medication (prescription, over-the-counter, or a dietary [herbal] supplement) and that approximately one-third of adults take at least five such medications regularly. The IOM (2006) also reported that every year, approximately 1.5 million U.S. consumers report adverse events from taking these medications. More than 380,000 of these adverse events may be preventable. As more and more nonprescription products are released and more prescription products are switched to an over-the-counter status, the importance of reporting of adverse events escalates.


Over time, the U.S. government has implemented regulations intended to protect the public and ensure that medicinal products are safe and effective (IOM, 2007). In 2006, Congress amended the Federal Food, Drug, and Cosmetic Act with respect to safety reporting for nonprescription drugs and dietary supplements. The amended act requires the manufacturer, packager, or distributor whose name is listed in the drug facts labeling section on the product's package to submit reports of serious adverse events to the Federal U.S. Food and Drug Administration (FDA) (Kingham, 2009). However, many questions remain regarding the reporting of problems with nonprescription medications.


Do consumers really understand the need to report adverse events they experience and that may be related to the use of these products? Moreover, do healthcare professionals understand their obligation to report adverse effects related to these products? Has the FDA adequately communicated this need to report adverse event information to consumers and healthcare professionals?


Federal (and international) requirements call for manufacturers to report serious adverse events to the FDA within 15 calendar days of receipt of the information (Dietary Supplement and Nonprescription Drug Consumer Protection Act, January 3, 2006). This legislation was drafted in 2006 in response to the rise in the use of nonprescription therapies and the need to reduce the phenomena of underreporting (Kingham, 2009).


To achieve the goal of better public safety, consumers and healthcare professionals must be informed on how to identify and report adverse events related to nonprescription products. The government has paved the way for voluntary reporting by establishing laws that mandate manufacturers post a toll-free number on the drug facts labeling of their products and by posting a link for consumers and healthcare professionals on their Web site to submit adverse reactions associated with these products. For more information, log on to




Sherrie McNamara, MBA, BSN, RN


SGNA Scholar




Global Medical Affairs and Pharmacovigilance


CB Fleet Company, Inc.


Lynchburg, Virginia




Bond C., Hannaford P. (2003). Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Safety, 26(15), 1065-1074. [Context Link]


Institute of Medicine. (2006). Preventing medication errors: Quality Chasm series. Retrieved from[Context Link]


Institute of Medicine. (2007). Challenges for the FDA: The future of drug safety. Workshop summary. Retrieved from


Kingham R. (2009). United States of America. In Klincewicz S., Yap Y., Thomas A.(Eds.), Global pharmacovigilance laws & regulations (pp. 265-273). Washington, DC: FDLI. [Context Link]


Nichol M. B., McCombs J. S., Johnson K. A., Spacapan S., Sclar D. A. (1992). The effects of consultation on over-the-counter medication purchasing decisions. Medical Care, 30(11), 989-1003. [Context Link]