Over-the-counter (OTC) medicines are an essential, safe, cost-effective, and convenient component of the nation’s healthcare system. The expanding OTC options available today not only treat the symptoms of common ailments, but they also can help prevent a number of more serious illnesses and enhance quality of life.

OTC Medicines Serve an Important Healthcare Need
Consumers have more healthcare choices today than ever before. OTC medicines often do more than relieve aches, pains, and itches. Some can prevent diseases like tooth decay; cure diseases such as athlete’s foot; and help manage recurring conditions like vaginitis, migraine, allergy, and minor pain in arthritis. By using OTC medicines, consumers are saving billions annually through fewer unnecessary doctors’ visits, less time lost from work, and the relatively lower costs for nonprescription medications than for prescription drugs. OTC medicines provide Americans with effective, affordable, and convenient means of helping address their healthcare needs.

OTC Medicines Provide Consumers Real Savings
People actively participating in their healthcare, often with the help of OTC medicines, is an essential part of any affordable healthcare system. OTCs save on doctor’s fees, travel costs, and time off from work that would be required to obtain a prescription medication, which can be a tremendous burden for the estimated 46 million U.S. citizens without health insurance coverage or those without a drug plan.

In fact,

• Northwestern University researchers determined in 2004 that the use of certain OTCs in the treatment of upper respiratory infections saves the U.S. healthcare system and economy $4.75 billion annually.
• The Nielsen Company, on behalf of CHPA, estimated in 2009 that consumer use of OTC heartburn medications saves the U.S. healthcare system $757 million annually, and saves the average consumer $174 annually.
• Studies for OTC nicotine replacement therapy have concluded it is cost-effective and is less costly per year per year of life saved than other widely accepted medical practices to help consumers quit smoking (Wasley 1998 and Croghan 1998).
• A health plan study of one managed care organization found an annual cost savings of $190,000, thanks to the switch of H2s to OTC status for certain gastrointestinal conditions (Andrade 1999).

OTC Medicines Are Proven Safe and Effective
OTC medicines have a wide margin of safety and have been proven safe and efficacious when used according to labeling. In fact, for a product to be granted nonprescription status, it must meet three requirements:

• The product must be used to treat a condition or symptom consumers can recognize themselves, either on a first occurrence or after an initial diagnosis by a doctor.
• The product must have a wide margin of safety. No product—medicine or otherwise—is completely safe, but nonprescription medications need a wide margin of safety when used as directed.
• Labeling must be provided for safe and effective use by consumers.

Second only to the medication itself, the OTC medicine label—most of which are in the Drug Facts label format—is the most important element of a nonprescription drug. The Drug Facts label is easy to read and consistent from product to product. It clearly lists a product’s active ingredient, purpose, uses, warnings, directions, other information, and inactive ingredients.

OTC Medicines Are Convenient and Increasingly Popular with Americans
While prescription drugs are available at only approximately 58,000 pharmacies nationwide, OTC medicines are conveniently available for consumers at over 750,000 retailers in the United States. And studies show that Americans are making more use of widely available OTC medicines each year.

• 59 percent of Americans say they are more likely to treat their own health condition now than they were a year ago (Roper Starch Worldwide 2001).
• 73 percent of Americans would rather treat themselves at home than see a doctor, and six in 10 say they would like to do more of this in the future (Roper Starch Worldwide 2001).

OTC Medicines Advance the Quality of Healthcare
Since the mid-1970s, the U.S. Food and Drug Administration (FDA) has switched over 80 ingredients, dosages, or indications from prescription (Rx) to nonprescription status, making them more widely available to consumers. The success of what is known as Rx-to-OTC switch has stemmed from industry and FDA working in partnership to evaluate the specific merits of each potential switch. They work together to make a scientifically documented, data-driven decision that serves and protects consumers. Rx-to-OTC switch has a strong track record of providing new safe and effective options for a variety of diseases and conditions, advancing the quality of healthcare for all Americans.