Over-the-counter (OTC) medicines are a safe, essential, accessible, and affordable 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 50 million U.S. citizens without health insurance coverage or those without a drug plan.

In fact,

• A 2012 Booz & Co. study found that OTC medicines provide $102 billion in annual savings for the U.S. healthcare system: $77 billion in clinical savings including avoided doctor’s visits and diagnostic testing, and $25 billion in drug cost savings;
• The 2012 study also found that for every dollar spent on OTC medicines, the U.S. healthcare systems saves $6 to 7;
• By keeping the American workforce healthy and at work, OTC medicines offer $23 billion in potential productivity benefits from avoided doctor’s office visit and time not having to be away from work for medical appointments, the 2012 Booz & Co. study discovered;
• A 2010 survey conducted by CHPA found that nearly 9 in 10 physicians recommend their patients attempt to address minor to moderate ailments themselves through the use of OTC medicines before seeking the care of a professional;
• 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.

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 two requirements:

• 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 consumers to be able to safely and effectively use the medicine.

Second only to the medication itself, the OTC medicine label— which with a very few exceptions 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. A 2012 CHPA survey also found that U.S. adults believe OTC medicines are just as safe and effective as prescription medicines when taken according to directions.

OTC Medicines Advance the Quality of Healthcare
Since the mid-1970s, the U.S. Food and Drug Administration (FDA) has switched over 100 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.