Health care consumers are becoming increasingly involved in the diagnosis and treatment of common ailments. This has led to a great increase in the use of nonprescription or over-the-counter (OTC) drugs. More than 80 classes of OTC drugs are marketed to treat a variety of illnesses ranging from acne to cough and cold, pain relief, and weight control. There are currently more than 300,000 OTC products containing over 800 major active ingredients. OTC medications now account for about 60% of all medications used in the United States. Health care consumers use OTC drugs to treat or cure more than 400 different ailments. Over 40 medications that formerly required a prescription are now available OTC. Some 40% to 87% of people 65 years of age or older use one OTC product regularly, and 5.7% take five or more OTC or dietary supplements daily. Some of the most commonly used OTC products include acetaminophen (see Chapter 10), aspirin (see Chapter 44), ibuprofen (see Chapter 44), famotidine, omeprazole and antacids (see Chapter 50), loperamide (see Chapter 51), and cough and cold products (see Chapter 18).

For nurses to understand current OTC classification, it is helpful to have some knowledge of the U.S. Food and Drug Administration (FDA) approval process for these medications. In 1972, the FDA initiated an OTC Drug Review to ensure the safety and effectiveness of the OTC products available, as well as to establish appropriate labeling standards. As a result of this review, approximately one-third of the OTC products were determined to be safe and effective for their intended uses, and one-third were found to be ineffective. A small number were considered to be unsafe, and the remainder required submission of additional data before their safety and effectiveness could be established. Products determined to be unsafe were removed from the market. Some established products that were found to be ineffective but not unsafe were “grandfathered” in and allowed to remain on the market. Many of these have gradually slipped into obscurity and are no longer sold. The FDA now requires new stricter “drug facts” labeling for OTC products that includes information on the following: purpose and uses of the product; specific warnings, including when the product should not be used under any circumstances; and when it is appropriate to consult a doctor or pharmacist. This labeling also describes side effects that could occur; substances or activities to avoid; dosage instructions; and active ingredients, warnings, storage information, and inactive ingredients.

Another result of the OTC Drug Review was the reclassification from prescription to OTC status of more than 40 primary product ingredients. The FDA’s Nonprescription Drugs Advisory Committee is responsible for the reclassification of prescription drug products to OTC status. A drug must meet the criteria listed in Box 7-1 to be considered for reclassification. The required information is obtained from clinical trials and postmarketing safety surveillance data, which are submitted to the FDA by the manufacturer. Although this reclassification procedure has been criticized as overly time consuming, it is structured to ensure that products reclassified to OTC status are safe and effective when used by the average consumer.

Reclassification of a prescription drug as an OTC drug may increase out-of-pocket costs for many patients because third-party health insurance payers usually do not cover OTC products. However, overall health care costs tend to decrease when products are reclassified as OTC due to a direct reduction in drug costs, elimination of prescriber office visits, and avoidance of pharmacy dispensing fees. Some examples of drugs that have recently been reclassified as OTC products appear in Box 7-2.

The importance of patient education cannot be overstated. Many patients are inexperienced in the interpretation of medication labels (Figure 7-1), which results in misuse of the products. This lack of experience and possibly a lack of information or knowledge may lead to adverse events or drug interactions with prescription medications or other OTC medications. Small print on OTC package labels often complicates the situation, especially for elderly patients. According to a report of the Institute for Safe Medication Practices, one study found that parents gave children incorrect doses of OTC fever medications over 50% of the time. Use of OTC medications can be hazardous for patients with various chronic illnesses, including diabetes, enlarged prostate, hypertension, cardiovascular disease, and glaucoma. Patients are encouraged to read labels carefully and consult a qualified health professional when in doubt.

Another problem associated with OTC drugs is that their use may postpone effective management of chronic disease states and may delay treatment of serious and/or life-threatening disorders. This is because the OTC medication may relieve symptoms without necessarily addressing the cause of the disorder. This situation is often complicated when patients are afraid to visit a provider, are uninsured/underinsured, have impaired health literacy (see Chapter 6), or simply want to avoid the inconvenience of visiting a provider and instead are hoping for a “quick fix” for themselves or their children.

OTC medications also have their own toxicity profiles. For example, cough and cold products usually include one or more of the following ingredients: nasal decongestants (for stuffy nose), expectorants (for loosening chest mucus), antihistamines (for sneezing and runny nose), and antitussives (for cough). In 2008, the FDA issued recommendations that OTC cough and cold products not be used in children younger than 2 years of age. This followed numerous case reports of symptoms such as oversedation, seizures, tachycardia, and even death in toddlers medicated with such products. There is also evidence that such medications are simply not efficacious in small children. A study in 2010 showed a dramatic decrease in young children emergency department visits since the FDA recommendation (Shehab et al., 2010). The FDA continues to evaluate the safety and efficacy of cough and cold products for children 2 to 11 years of age but has issued no guidelines to date. Parents are advised to be mindful of how much medication they give to their children and to be careful not to give two products that contain the same active ingredient(s).

Two other examples of OTC drug hazards include products containing acetaminophen (e.g., Tylenol) and nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen (e.g., Advil, Motrin) and naproxen (e.g., Aleve). Hepatic toxicity is associated with excessive doses of acetaminophen and is a leading cause of liver failure. Acetaminophen doses are not to exceed a total of 3 to 4 g/day. The use of NSAIDs is associated with gastrointestinal ulceration, myocardial infarction, and stroke. Patients may sometimes choose excessive dosages of these and other OTC medications out of ignorance or simply in hopes of easing their symptoms. In 2009, the FDA finalized regulations requiring specific labeling for acetaminophen, aspirin, and NSAIDS to enhance consumer awareness of these risks.

Abuse can also be a potential hazard with the use of OTC drug products. Pseudoephedrine is found in a variety of cough and cold products (see Chapter 17); however, this drug is also used to manufacture the widely abused street drug methamphetamine. Because of the potential for abuse, products containing pseudoephedrine must be sold from behind the pharmacy counter, and patients must sign a log book held by the pharmacist. Many patients become addicted to OTC nasal sprays because they can cause rebound congestion and dependency. Dextromethorphan (used as a cough suppressant) is also commonly abused. It is known by the brand name of Robitussin, and abusing it is called Robotripping.

Several other OTC products can cause specific problems. The use of sympathomimetics (see Chapter 18) can cause problems in patients with type 1 diabetes and patients with hypertension or angina. Aspirin is not to be used in children as it can cause a rare condition called Reye’s syndrome (see Chapter 44). Long-term use of antacids can result in constipation or impaction (see Chapter 50).

Normally, OTC medications are used only for short-term treatment of common minor illnesses. An appropriate medical evaluation is recommended for all chronic health conditions, even if the final decision is to prescribe OTC medications. Patient assessment includes questions regarding OTC drug use, including what conditions are being treated. Such questions may help uncover more serious ongoing medical problems. Inform patients that OTC drugs, including herbal products, are still medications. Their use may have associated risks depending on the specific OTC drugs used, concurrent prescription medications, and the patient’s overall health status and disease states.

Health care professionals have an excellent opportunity to prevent common problems associated with the use of OTC drugs. Up to 60% of patients consult a health care professional when selecting an OTC product. Provide patients with information about choice of an appropriate product, correct dosing, common adverse effects, and drug interactions with other medications.

For specific information on various OTC drugs, see the appropriate drug chapters later in this text. (Table 7-1 provides cross-references to these chapters.)

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