What are over-the-counter (OTC) drugs?

Definition

Over-the-counter (OTC) drugs are medications that can be purchased and used without a doctor’s prescription. Some OTC medications, however, are restricted and require proof of age or a consultation with a registered pharmacist before purchase.

Types

OTCs are drugs or health-care-related preparations that are considered both effective and safe for use by consumers without a doctor’s prescription. As of 2010, more than 100,000 OTCs were available in the United States and Canada, according to the Consumer Healthcare Products Association (CHPA). Most OTCs are used to maintain good nutrition or to treat minor illnesses or conditions that do not require a doctor’s attention. These nonprescription drugs can be grouped into the following categories:

Nutritional aids. These OTCs include vitamin and mineral supplements and, sometimes, herbal teas, capsules, and similar products considered
nutrition-related OTCs because they are sold without a prescription. Unlike
vitamins and mineral supplements, however, herbal products are not regulated by
the U.S. Food and
Drug Administration (FDA).

Digestive aids. OTCs in this category include antiemetic preparations to relieve nausea and
vomiting, laxatives to treat constipation, antidiarrheal preparations to stop
diarrhea, antacids to relieve acid indigestion by neutralizing stomach
acid, and acid reducers that work to relieve heartburn or acid reflux by lowering
the amount of acid produced by the stomach. Some preparations in this category can
serve more than one function. For example, bismuth subsalicylate, a liquid
preparation sold under the trade name Pepto-Bismol, can be used to treat nausea,
heartburn, and diarrhea.

Relief of upper respiratory infections and allergies. OTCs can
treat coughing, sneezing, and watery eyes associated with colds and seasonal allergies. OTC cough medicines, such as expectorants, are designed to
help a person cough up mucus; others, such as antitussives, are designed to stop
coughing. Some cough medicines contain both types of ingredients. Allergy
medications and cold medications contain antihistamines to stop sneezing and decongestants
to clear stuffy nasal passages. Decongestants are also available as nasal sprays.
Some cold medications also include aspirin or another pain reliever to
treat the muscle aches and low-grade fever associated with colds.

Pain relief. OTCs can help to relieve mild pain from such conditions as muscle or menstrual cramping, toothache,
arthritis, colds, and tension headache. There are two major categories of pain
relievers: those containing acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs, or NSAIDs. NSAIDs
include such drugs as aspirin, ibuprofen (Advil), and naproxen (Aleve). Acetaminophen is an OTC pain reliever that should
be used with caution because it can cause liver damage in high doses.

Topical medications. Topical OTCs, which are products applied to the skin and other surface tissues of the body (such as the eyes or lining of the mouth), include such medications as moisturizing or redness-relieving eye drops; anti-itch creams or lotions to relieve discomfort from sunburn, poison ivy, or other minor skin irritations; soaps and cleansers for treating acne; liniments and gels to relieve the pain of arthritis; local anesthetic gels or liquids to treat mouth ulcers; rubbing alcohol and hydrogen peroxide solutions to cleanse and disinfect minor cuts and scrapes; and anti-cavity, dental sensitivity, tartar control, and tooth-whitening toothpastes.

Regulation and Advertising

In the United States, OTCs have been regulated by the FDA since Congress passed the
Federal Food, Drug, and
Cosmetic Act (FFDCA) of 1938. This legislation was introduced
after a tragic mass poisoning in the fall of 1937, in which more than one hundred
people died after taking a sulfanilamide medication that had been made with
diethylene glycol, a solvent that is poisonous to humans. The then-new medication
had not been tested on animals before being sold, even though diethylene glycol
was known at the time to be poisonous. The FFDCA replaced the Pure Food and Drug
Act of 1906, which did not require companies to submit safety data to the FDA
before marketing and selling their products.

Manufacturers of drugs seeking FDA approval for sale as nonprescription items must follow one of two main paths. The first path is to state that the OTC complies with an existing FDA monograph (set of rules) for a specific category of OTC. According to the FDA, these monographs, which are published in the Federal Register, “state [the] requirements for categories of non-prescription drugs, such as what ingredients may be used and for what intended use.” Examples of OTCs covered by FDA monographs include sunscreen, acne soap and cream, and dandruff shampoo. FDA monographs also cover OTCs that were in use long enough before the 1938 passage of the FFDCA to be considered “generally recognized as safe and effective” when used as directed. This phrase, taken from the FFDCA, is abbreviated as GRAS or GRAS/E. Aspirin is an example of an OTC that is considered GRAS/E.

The other path to FDA approval for an OTC is obtaining a new drug application, or NDA. The manufacturer or sponsor of the proposed drug must show that it is safe and effective and that its benefits outweigh any risks. An NDA must be obtained if the product does not fit within any of the existing FDA monographs for OTCs.

The NDA system is also used to move drugs that were first approved as prescription-only into the OTC category. In addition to determining that OTCs are safe and effective when consumers use them according to package directions, the FDA has the authority to decide that drugs formerly available only with a prescription can be safely sold to consumers as an OTC. This change, which the FDA calls an Rx-to-OTC (“Rx” meaning “prescription”) switch, has made available about seven hundred new drugs as OTCs since 1980. Acid reducers and antihistamines are recent examples of the Rx-to-OTC switch.

The major difference between FDA oversight of prescription drugs and its oversight of OTCs is a matter of advertising. In the case of prescription drugs, the FDA regulates advertising and approval for use. Advertising of nonprescription drugs, however, is regulated by the Federal Trade Commission.

An important aspect of FDA regulation of OTCs is labeling. Each OTC approved for sale in the United States must carry a “Drug Facts” label on the product or its package. The label has a standard format and must be clearly and simply written. It has the following parts: product name, active ingredient or ingredients, purpose, uses, warnings, directions, inactive ingredients, and other information.

Safety

Although the FDA’s definition of OTCs includes the assurance that OTCs are “safe and effective,” this assurance assumes that the medications are used correctly by consumers. There are several steps consumers should follow to make sure that they are using nonprescription medications correctly. These steps include the following:

Read the Drug Facts label carefully. It is especially important
to note the active ingredients in the medicine, particularly when using two or
more OTCs to treat the same condition or illness, such as the common cold.
It is possible to take an accidental overdose of the active ingredients in cough
and cold medicines because many of these preparations contain several active
ingredients. The Drug Facts label will also contain important warnings about
drug
interactions (particularly interactions with alcohol),
activities to avoid while taking the medicine (usually driving and operating heavy
equipment), and dosage instructions.

Persons should never take more than the recommended dosage or take the medicine more often than recommended. If one’s symptoms do not improve within a few days, that person should see a doctor. Persons should also consult a doctor or pharmacist if they have any questions about the medication, particularly its possible side effects or possible interactions with other drugs.

Check for tampering. Before purchase, one should check the tamper-evident packaging (TEP) features, such as internal plastic seals or blister packaging, to ensure the medication has not been tampered with. TEPs are safety features that were mandated by the FDA in 1983 following a still-unsolved crime in which seven people in Chicago died after taking a pain reliever that had been poisoned with potassium cyanide. If the package or the contents look suspicious in any way, the consumer should return the OTC to the store or pharmacy where it was purchased.

Store medication in a childproof cabinet or medicine chest. Also, one should keep all medicines away from children. OTCs should never be left on counter tops or tables where curious children can open and use them. Medications should always be kept in their original containers so that no one in the household can take the wrong drug by accident. Expiration dates should be checked periodically; medicines with expired dates should be discarded safely.

OTC Abuse

The purchase of some OTCs is restricted in the United States because these medications have been abused or have been used illegally. The purchaser may be required to show proof of age before buying the product or may have to ask a registered pharmacist for the product.

The two major types of OTCs in this category are cold and allergy medications
containing ephedrine or pseudoephedrine, which are decongestants, and cough medicines
containing dextromethorphan (DMX), a cough suppressant. Ephedrine and
pseudoephedrine can be used to make methamphetamine, a dangerous drug of
abuse. To prevent the illicit production of methamphetamine from OTCs, the U.S.
Congress passed the Combat Methamphetamine Epidemic Act, or CMEA, in 2005. The CMEA sets monthly
limits on the amount of these products that consumers can purchase and requires
that consumers show proof of identity to a pharmacist before purchase.

Cough medicines containing DMX have been abused by teenagers and others who consume large amounts of the preparations to get intoxicated. According to the CHPA, about 6 percent of teenagers in the United States abuse cough syrups containing DMX. Although there is no federal legislation controlling the sale of medications containing DMX, some states require proof that a would-be purchaser is eighteen years of age or older at the time of sale.

Impact

Over-the-counter medications represent a considerable portion of the money
spent on health care in the United States. In the first decade of the twenty-first
century, sales of OTCs for minor health conditions came to $20 billion per year,
with dietary
supplements accounting for another $12 billion.
Nonprescription drugs are also widely available for purchase on the Web and in
supermarkets and other retail outlets that do not have pharmacies. OTCs can be
purchased at more than 750,000 locations in the United States.

The widespread availability of nonprescription products and the ongoing
transfer of some classes of prescription drugs into the OTC category make it
easier for consumers, particularly older adults, to take a more active part in
their health care. The FDA notes that increased access to nonprescription drugs is
beneficial to people age sixty-five years and older, 80 percent of whom have some
type of chronic health problem that can be managed effectively with OTCs. In terms
of infectious diseases, however, it is unlikely that many anti-infective drugs
will be switched into the OTC category because of concern about the potential
overuse of antibiotics, commonly used for bacterial
infections, and concern about the risk of developing even
more drug-resistant disease organisms.

Bibliography

Dlugosz, Cynthia Knapp, ed. The Practitioner’s Quick Reference to Nonprescription Drugs. Washington, D.C.: American Pharmacists Association, 2009. Intended for health care professionals, this guide organizes its discussion of nonprescription drugs according to the twenty-five most common conditions consumers treat with OTCs, including acne, allergic rhinitis, tooth hypersensitivity, and warts.

Griffith, Henry Winter. Complete Guide to Prescription and Nonprescription Drugs. Rev. and updated by Stephen W. Moore. New York: Penguin Books, 2009. This reference work, updated annually, covers more than five thousand OTCs by brand name and eight hundred more by generic name. Written for nonprofessionals, it includes information on side effects, potentially dangerous drug interactions, and FDA changes in drug labeling or classification.

Knowles, Johanna. Over-the-Counter Drugs. New York: Chelsea House, 2008. This book is not a reference guide to OTCs but a discussion of the abuse of OTCs by adolescents and the scope of the problem. Also includes advice about where and how to get help.

2011 PDR for Nonprescription Drugs, Dietary Supplements, and Herbs. Toronto, Ont.: Thomson Health Care, 2010. The basic drug reference book for health care professionals, this PDR guide to nonprescription drugs is updated yearly with information about commonly used OTCs, organized alphabetically by manufacturer’s name. The book also includes photographs of OTCs to simplify identification.