Over-the-counter (OTC) drugs and infectious disease

ALSO KNOWN AS: Nonprescription 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 healthcare-related preparations that are considered both effective and safe for use by consumers without a doctor’s prescription. More than 100,000 OTCs are available in the United States and Canada, which contain more than 700 active ingredients. 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 US 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 cough and cold medications also include aspirin or another pain reliever to treat the muscle aches and low-grade fever associated with respiratory infections.

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 drugs as OTCs since 1980. Acid reducers and antihistamines are also 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 countertops 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 US 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. Depending on the grade, between 2.4 and 4 percent of teenagers in the United States abuse cough syrups containing DMX. In 2021, this percentage for twelfth-grade students reached its lowest point since data began being collected in 2006 at 1.7 percent. However, the rate increased once again in subsequent years. Although there is no federal legislation controlling the sale of medications containing DMX, some states require proof that a would-be purchaser is eighteen or older at the time of sale.

Impact

Over-the-counter medications represent a considerable portion of the money spent on healthcare in the United States. In the mid-2020s, sales of OTCs for minor health conditions reached $43 billion per year. Nonprescription drugs are also widely available for purchase online, in supermarkets, and other retail outlets without pharmacies.

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 healthcare. 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, editor. The Practitioner’s Quick Reference to Nonprescription Drugs. American Pharmacists Association, 2009.

Griffith, Henry Winter. Complete Guide to Prescription and Nonprescription Drugs. Rev. and updated by Stephen W. Moore. Penguin Books, 2009.

Knowles, Johanna. Over-the-Counter Drugs. Chelsea House, 2008.

"The Over-the-Counter Drug Facts Label." Food and Drug Administration, 25 Oct. 2024, www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-drug-facts-label. Accessed 18 Dec. 2024.

"Over-the-Counter Medicines." Medline Plus, 7 Aug. 2023, medlineplus.gov/ency/article/002208.htm. Accessed 18 Dec. 2024.

"Over-the-Counter Medicines: What's Right for You?" Food and Drug Administration, www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-medicines-whats-right-you. Accessed 18 Dec. 2024.

"Prescription to Nonprescription Switch List." Food and Drug Administration, 16 July 2024, www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/prescription-nonprescription-switch-list. Accessed 18 Dec. 2024.

"Using Over-the-Counter Medicines Safely." Mount Sinai, 23 July 2024, www.mountsinai.org/health-library/special-topic/using-over-the-counter-medicines-safely. Accessed 18 Dec. 2024.