What are over-the-counter medications? |

Indications and Procedures

Drugs or medications that can be purchased directly, without a prescription, are called over-the-counter (OTC) medications or drugs. These medications may be suggested by physicians or simply purchased for consumption as a result of self-diagnosis and self-prescription. Most of the common OTC medications are used to treat common ailments such as cold and fever symptoms, headache, coughs, and similar complaints. Such self-treatment may be initiated at will and discontinued at any time.

Dozens of pharmaceutical companies produce and market hundreds of drugs for sale as over-the-counter medications, but they fall into only a few categories. The basic types of OTC medications, along with some brand examples, include analgesics (Advil, Tylenol), antacids (Milk of Magnesia), antidiarrheal medications (Imodium), antifungal agents (Tinactin), antihistamines (Benadryl), antiacne treatments (Clearasil), anti-inflammatory drugs (Motrin), decongestants (Sudafed), motion sickness (Meclizine), laxatives (Metamucil, Dulcolax), dandruff treatments (Selsun Blue), expectorants (Robitussin), hair
growth formulas (Rogaine), and sleep
aids (L-Tryptophan).

The most frequently used category of OTC medications is analgesics, which are more popularly known as painkillers. Analgesics include a diverse group of drugs that are used to relieve soreness, general body pain, and headaches. Probably the most common analgesic is aspirin, which is part of a group of medications termed nonsteroidal anti-inflammatory drugs (NSAIDs) that chemically affect the central and possibly the peripheral nervous system by leading to a decrease in prostaglandin production. Many analgesics are used in combination with other drugs such as vasoconstriction drugs that contain pseudoephedrine, which is especially important for the relief of sinus congestion, and in combination with antihistamine drugs, which relieve the worst symptoms of allergy.

Decongestants
must certainly rank as the second most common category of OTC medications. Generally, decongestants are taken to relieve nasal congestion and allied symptoms of colds and flu by acting to reduce swelling of the mucous membranes of the nasal passageways. A recurring problem with most nasal decongestants is that they increase hypertension, but this effect is lessened by including one or more antihistamines in the preparation. The brand name drug Dimetapp, for example, is both an antihistamine and a decongestant, while various Tylenol products may contain drugs that collectively work to soothe sore throat, relieve nasal congestion, or suppress coughing.

Despite the fact that over-the-counter drugs are available to everyone, their marketing and use is restricted by the Food and Drug Administration (FDA) in the United States and similar agencies with regulatory powers in many other countries. The FDA mandates ingredients and labeling of OTC drugs and specifies rigid testing and safety standards that must be met prior to marketing. Pharmaceutical companies must apply to the New Drug Agency (NDA) for the approval of drugs. The NDA specifies testing requirements prior to issuing a license for the sales and marketing of the proposed new drug. Following approval, the FDA regularly reviews and maintains the right to remove or restrict marketing and sales of OTC drugs that create adverse side affects or are potentially addictive.

Following discovery, testing, and FDA approval of a new drug, it is given a unique trade name or brand name. The pharmaceutical company is awarded an exclusive patent to manufacture and market the drug for a specified period of time, usually seventeen years in the United States but of variable length in other countries. At the end of this time, the company no longer has proprietary rights to the drug, which may then be manufactured and marketed by other pharmaceutical companies. These drug companies may choose to market the drug under a new brand name of their choosing but not under the original label, which may still be manufactured by the original pharmaceutical company that designed and patented the drug. Spin-off products of these companies must still pass rigid FDA quality control standards which demonstrate that their product contains sufficient amounts of the active ingredients to promote bioequivalency before it can be marketed as an OTC medication—that is, the new drug has to be the therapeutic equal of the original drug.

Drugs manufactured by other pharmaceutical companies following patent expiration are typically called generic drugs and are strictly regulated by the U.S. Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Act), which was enacted in 1984. Tylenol, for example, is the exclusive brand name of an analgesic over-the-counter medication that contains the active chemical ingredient acetaminophen. Following the release of its patent, many other pharmaceutical companies started marketing pain relief drugs containing products for pain relief under the their own trade name or brand name. These copies are considered generic drugs and provide the consumer with a wide choice of the most popular drugs, usually at greatly reduced cost.

Manufacture and marketing of a generic drug by new companies usually means that their product costs considerably less, partly because of competition but mostly because the new drug companies did not bear the initial costs of development, marketing, and promotion that were part of the original financial investment of the parent company. Furthermore, manufacturers of generic drugs enjoy all the benefits of prior marketing, public acceptance, and possibly dependence on the most popular OTC medications. Generally, however, the parent company enjoys a certain competitive advantage of brand name recognition that promotes continued use of their marketed product, thereby reducing the impact of cheaper competition.

Over-the-counter medications may take the form of packets, tablets, capsules, pills, drops or droplets, ointments, inhalants, lotions, creams, suppositories, or syrups. Except for creams and topical ointments, OTC medications are administered orally, in contrast to drugs that are taken by injection. This mode of delivery places natural limits on their therapeutic effectiveness in several ways.

After being swallowed, OTC medications pass down the esophagus, through the stomach, and into the small intestine, where they are digested and absorbed. This mode of delivery requires a certain time interval between oral intake of the drug and its arrival in the bloodstream that transports it to target cells, tissues, and organs, thus delaying the effects of the drug. Tablets or capsules sometimes get stuck in the back of the mouth or on the lining of the esophagus, where they start to dissolve. When this happens, the ingredients may cause irritation, nausea, and sometimes vomiting, and the therapeutic value is lost. Furthermore, a certain amount of each key ingredient will be destroyed by the digestive enzymes of the gastrointestinal system, may be metabolized by cells of the intestinal epithelia, or may simply pass through the gut without being absorbed. Even following absorption into the blood, a certain amount of the drug may be lost because liver and other body cells set about removing foreign substances in the blood almost as soon as they are detected, generally by metabolizing the ingredient into a harmless chemical that will be excreted into the bile or be removed by the kidneys. This process explains
why all drugs, including OTC medications, must be taken in repeated doses at regularly prescribed intervals in order to obtain maximum therapeutic value.

A final factor complicating delivery efficiency and thus the therapeutic value of OTC medications involves their packaging. Capsules, tablets, and pills in particular all contain substances in addition to the chemical ingredient, such as coatings, fillers, stabilizers, and often color additives. These substances, called excipients, do not contribute to the actual working of the drug itself, but they often modify both the rate and the extent of dissolution of the drug as it travels the gastrointestinal tract. While most excipients ultimately reduce the overall degree of delivery, some have important functions of permitting them to transit through the stomach, which has limited absorption ability, and into the small intestine, where chemical dissolution and absorption occurs at an optimum rate. For some drugs, the natural limits placed on delivery efficiency by gastrointestinal processes and excipient components can be sharply reduced by placing the capsule or tablet directly under the tongue, thus entirely bypassing the alimentary tract.

Uses and Complications

Primarily because of liability issues, all OTC medications include labels that are sometimes extensive. Label components typically consist of a list of one or more symptoms addressed by the medication, active ingredients contained in the drug, warnings, directions for use, and the date after which the medication should be discarded. For example, the label on a common OTC medication used to treat severe colds notes that it is to be used to relieve symptoms of nasal congestion, cough, sore throat, runny nose, headache and body ache, and fever. Directions for use are specific as to number of times a day, hours between use, and factors involving taking the medication, such as with or without glasses of water prior to or following administration and limits regarding food intake.

Most labels also carry prominent warnings regarding use with respect to age, alcohol consumption, sedatives or tranquilizers, and combinations of medications. Most over-the-counter medications also state that use should be continued only for a specified time and that, if symptoms persist, the user should stop taking the medication and consult a physician. Finally, the user is usually cautioned to stop taking the OTC medication immediately if headache, rash, nausea, or similar symptoms appear. Despite these warnings, even commonly used OTC medications pose certain health hazards, and the user is advised to take these medications with full recognition of potential problems.

In the United States, while the FDA periodically issues warnings regarding OTC medications, their actual use by consumers normally is not regulated, documented, or monitored. This has led to a number of concerns regarding real and potential overuse of OTC drugs, particularly for reasons unrelated to their medicinal intent. It has also led directly to the modification of certain OTC medications to engineer drugs that are highly addictive.

Because their use is unregulated—or, more correctly, cannot be regulated—over-the-counter medications can be deliberately abused. Overdosing with certain types of painkillers, for example, has become a frequent method of suicide attempt. The use of Tylenol in suicide attempts is increasing. Tylenol overdosing causes the destruction of liver cells that synthesize blood coagulants. Loss of these blood coagulants results in uncontrolled bleeding, most evidently through the eyes, nose, and mouth but also internally. Internal bleeding continues until death occurs, usually within a few days following onset.

Perhaps the most egregious misuse of OTC medications is to induce or achieve temporary “highs” that parallel those obtained by use of street or hard drugs. Cough suppressants that contain the drug dextromethorphan, for example, affect the central nervous system and can be used as mood-altering drugs that cause brain damage and even death at high doses. An even more serious abuse is the cooking of common drugs to obtain the highly addictive drug methamphetamine, popularly called meth. Also known as ice or speed, meth is a highly addictive drug that is often devastating and sometimes deadly. In some regions of the United States, it ranks with heroin and cocaine as the popular drug of choice. Record growth in use and the ability to cook meth from readily obtained OTC drugs has led to the creation of National Methamphetamine Awareness Day to draw attention at all levels to this problem.

This cooking process involves the conversion of certain OTC medications into meth. Some other sources for cooking meth include diet aids, tincture of iodine or other iodine solutions, and household cleaning solutions. In response to the widespread home manufacture of meth, a national federal law was enacted to require pharmacies to check photo identification and keep records of over-the-counter sales of cold medications that contain pseudoephedrine and ephedrine, which are the two popular ingredients in many cold medications. By-products of in-home meth cooking labs are garbage cans filled with Sudafed packages and a distinct odor of cat urine. The cooking process itself releases potentially harmful toxic chemicals that can pose serious health hazards to lungs and the respiratory system and also poses the risk of fire.

Perspective and Prospects

Originally, OTC medications were available for purchase only at pharmacies, along with physician-prescribed drugs. Today, a varied selection of OTC medications is available at many retail outlets, including supermarkets, food stores, and even convenience stores, although pharmacies still continue to offer the greatest selection. This can lead to a confusion of terms, as such medications or drugs are often no longer sold “over the counter” but instead can be found on shelves alongside other items for sale.

To complicate matters, certain drugs are offered as OTC medications at low dosages but must be obtained by prescription at higher dosages. For example, the popular analgesic ibuprofen (Advil, Motrin) can be purchased as an OTC medication at dosages of less than 200 milligrams, but higher dosages can be obtained only via prescription. Similarly, the antidiarrheal medication Imodium, an opiate, is available as an OTC medication in liquid form, while tablets of Imodium are available only by prescription.

The status of over-the-counter medications may change over time, depending on effectiveness and safety issues. While some OTC drugs are removed from the general market following various concerns regarding safety, other drugs are transferred from prescription drugs to OTC medications. Examples include the antihistamine drug Benadryl, which is used to relieve symptoms of allergy and guard against allergic reactions, and the painkiller ibuprofen, both of which were, until recently, sold as prescription drugs only but are now available as OTC medications.

While the distribution and sale of over-the-counter medications is strictly regulated by state and federal laws in the United States, certain drugs that are deemed harmless may be offered for sale as medical cures for many ailments and thereby compete with OTC medications. These so-called miracle drugs have become increasingly popular because of the Web, which opens the door to purchases without prescription. Media promotions also sometimes offer these medications, complete with testimonials that dramatically describe their success as a cure-all for ailments. These types of medications are often labeled “quack” drugs. They pose a threat to users of prescription and OTC medications in several ways. First, they are generally useless, offering a nonexistent cure for health problems. Second, they are manufactured without regard to quality control measures that legitimate drug manufacturers must follow. Third, time may be lost in using the quack drug, especially if the condition is chronic and the symptoms need to be treated immediately. Finally, while some may be harmless, other quack drugs contain chemical ingredients that are potentially dangerous when used in combination with genuine over-the-counter medications.

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