Over-the-counter (OTC) medicines provide a convenient, cost-effective means to treat self-identified symptoms and help to lessen the burden on the health care system by reducing the number of doctor visits and associated prescription costs. Containing either a single active ingredient or a combination of multiple active ingredients, OTC medicines are used by consumers for a number of reasons, including familiarity with self-treatment, perception that symptoms can be managed without health care provider intervention, and time and money savings. There are more than 80 therapeutic categories of nonprescription—or OTC—products available today. Common uses of OTC medicines include treatment of symptoms associated with the common cold, allergies, constipation, diarrhea, heartburn, mild pain, hemorrhoids, dental caries, smoking cessation, weight loss, emergency contraception, and most recently, overactive bladder control.1 This article will review the benefits associated with OTC combination products surrounding cost, ease of dosing, and adherence.
Combining two OTC active ingredients into one product, often referred to as a “combination product,” is officially recognized2 by FDA as an “OTC drug combination.” These products, available to treat a wide range of conditions and symptoms, provide a safe, effective and low-cost means to dose multiple ingredients accurately for the treatment of a single symptom or a set of symptoms that frequently occur concurrently. Combinations often employ ingredients with differing pharmacological mechanisms of action to alleviate underlying symptoms, whether they are associated with a singular complaint (e.g., headache, first aid) or with multiple symptoms (e.g., pain, the common cold, etc.). Thus, using combination products with distinct mechanisms of action often provides ease of administration for the patient compared with multiple single-ingredient products.
There are numerous conditions for which symptoms appear simultaneously, including cough with a cold3,4; diarrhea and gas5; pain from a minor cut, insect bite, or poison ivy6; and pain with sleeplessness.7–11 When multiple symptoms are present, combining active ingredients from different therapeutic categories allows tailored treatment and may help to reduce incorrect dosing and medication errors by decreasing the number of medications taken. In some cases, active ingredients from the same therapeutic category but with different mechanisms of action are combined to treat a single symptom. This may allow the dose of a single active ingredient to be lowered, thereby potentially decreasing the likelihood for adverse events. By eliminating the need for purchasing multiple single–active ingredient products, combination OTC products can provide cost-effective relief and, like all OTC products, save patients time and effort spent on health professional visits to obtain prescriptions.
More than $36 billion was spent on OTC products in the past year (Symphony IRI data for the 52 weeks ending November 4, 2012). OTC medicines provide consumers access to safe and effective treatment options for numerous health conditions and provide significant cost savings to the U.S. health care system. In fact, a recent study estimated that for every dollar spent on OTC medicines, the U.S. health care system saves $6 to $7—providing $102 billion in value each year.12
Combination OTC products provide consumers the benefit of treating multiple symptoms with a single product, eliminating the need to treat symptoms individually. Studies have shown that combination products improve medication adherence and may enhance recovery compared with single ingredient medications in patients with chronic conditions.14
As with all drugs, OTC medicines are not free of risk, and it is important that consumers carefully read and follow all labeling instructions. If patients are unsure about taking an OTC medicine or have concerns, they should contact their health care provider or pharmacist. While all medicines sold OTC must have a demonstrated history of safe use, adverse effects can occur, and interactions with other OTC or prescription drugs or dietary supplements are possible. For this reason, it is important that consumers using OTC products to treat their symptoms are aware of all of the medicines they are taking, especially when there are multiple active ingredients contained in a single dosage form.
Safe and effective use of OTC medicines requires that consumers accurately self-diagnose their conditions and adhere to usage instructions. Pharmacists can play a key role in each of these areas, helping consumers choose the right medication to effectively treat their symptoms and highlighting important safety information. Studies have shown that there is an increased medication error risk when patients take more medications.14,15
Adherence refers to whether patients take their medications as directed. According to studies of patients taking prescription medications, nonadherence to therapy is associated with adverse outcomes and higher costs of care.16
One important factor with a demonstrated effect on adherence to prescription therapy is dosage form convenience.13,17–19 The combination of multiple OTC ingredients in a single dosage form allows patients the convenience of treating multiple symptoms with a single product and may therefore promote improved adherence and outcomes for patients suffering from milder symptoms.
Consumers frequently cite convenience and accessibility as reasons for using OTC medicines.1 The convenience aspect of OTC medicines is often overlooked. These products are available at a number of different retail locations, including grocery stores, convenience stores, and warehouse outlets. The availability of OTC medicines—off the shelf, without a prescription—provides symptomatic relief for an estimated 60 million people who otherwise would not seek treatment.12
Access to OTC medications is further enhanced through the 24-hour availability at many of these locations, offering patients relief from self-identified symptoms at any time of the day or night. This increased accessibility saves consumers time, as it precludes visiting a health care provider and/or picking up a prescription.
Combination products have been shown to be efficacious in the treatment of a number of different conditions. Below is a brief overview of results demonstrating the effectiveness of combination products in the treatment of pain, the common cold, and allergic rhinitis.
Although millions of people in the United States suffer from various degrees of acute and chronic pain, undertreatment of pain has long been recognized as a serious problem. Pain can be associated with injury or disease, and its associated costs are significant.
There are a number of OTC medicines available to treat different pain states. Pathophysiological mechanisms underlying various pain states are complex, involving both the central and peripheral nervous systems, so using a combination of analgesic agents acting at multiple sites can facilitate relief. As the ingredients in OTC combination products indicated for relief of pain typically act through unique mechanisms and often in a synergistic fashion, these products may provide an additional benefit over single ingredient products.
The most common OTC agents available to relieve pain in the United States are acetaminophen, ibuprofen, aspirin, and naproxen. Each of these drugs has a long history of safe and effective use for the treatment of pain. Ibuprofen, aspirin, and naproxen are NSAIDs used to treat fever, pain, and inflammation caused by various conditions. All of these drugs are available OTC as single-ingredient products, and most, with the exception of naproxen, are available OTC in combination with other medications. These pain relievers are also commonly combined with other ingredients, including decongestants, cough suppressants, antihistamines, or diuretics, to treat concurrent symptoms such as nasal congestion, cough, sleeplessness, or bloating.
Adults in the United States experience an average of two to four colds per year, and children may experience up to twice that number.20 It is well established that the common cold presents with a multitude of symptoms, including sore throat, pain, fever, nasal congestion and/or discharge, sneezing, and cough.21–23 The common cold also has a substantial impact on a number of social and monetary factors, including significant loss of school or work days and visits to a health care provider.24,25
Symptomatic treatment for the common cold frequently involves the use of OTC medicines. Combinations of OTC cough and cold ingredients are available in a number of different formulations.26 Multiple studies support the effectiveness of combination OTC products in the treatment of the common cold.
In a recent meta-analysis27 of 27 trials totaling 5,117 participants, researchers examining the efficacy of common cold treatments found a benefit associated with these treatments in adults and older children with regard to general recovery and symptoms. An antihistamine–decongestant was found to be the most effective combination.21,28–33 OTC combination products containing an oral decongestant and an analgesic34–36 or an antihistamine/decongestant/analgesic combination37 also provide relief from nasal congestion. The American College of Chest Physicians recommends treatment with a preparation containing a first-generation antihistamine and sustained-release pseudoephedrine for cough associated with the common cold.38
Approximately 10% to 30% of the adult United States population is affected by allergic rhinitis. Typical symptoms include sneezing, nasal congestion, rhinorrhea, and itchy, watery eyes. Antihistamines provide symptomatic relief and are indicated for symptoms such as itching, sneezing, and rhinorrhea.39 As many allergy sufferers also experience congestion, combination of a newer-generation antihistamine with a decongestant, typically pseudoephedrine, can offer a number of benefits, including increased convenience and improved patient adherence to therapy.40
Results from a number of clinical trials have shown that combination therapy with a decongestant and antihistamine such as fexofenadine, loratadine, desloratadine, or cetirizine is significantly more effective than individual ingredients in improving allergic rhinitis symptoms such as sneezing; rhinorrhea; itchy nose, palate, and/or throat; itchy, watery, red eyes; and nasal congestion.41–48 In patients with seasonal allergic rhinitis, addition of ibuprofen to a combination of chlorpheniramine and pseudoephedrine resulted in greater relief of pain and allergy symptoms than treatment with pseudoephedrine–chlorpheniramine alone.49
Pharmacists are the only health professionals specifically trained in nonprescription therapeutics and are thus well positioned to make recommendations concerning OTC combination products. Pharmacists are also trained to ask patients about symptoms of their condition in order to assess their chief complaint and determine the best course of therapy.
Most self-care conditions are acute in nature, and pharmacists know what products or active ingredients treat these conditions. While a single-entity product is often all that is needed, there are times when combination products may be the best course of action.
APhA conducts an annual survey to determine the OTC products most frequently recommended by pharmacists.50 This survey lists the top five OTC drugs in different therapeutic categories recommended by community pharmacists. While the top recommended products in this survey were most commonly single ingredient, combination products with multiple active ingredients were also commonly recommended (see Table 1).
Table 1. OTC combination products commonly recommended by pharmacists
|Acetaminophen/diphenhydramine||Pain with sleeplessness products||Tylenol PM (McNeil)|
|Loratadine/pseudoephedrine||Adult multisymptom allergy and hay fever products||Claritin D (Merck)|
|Acetaminophen/aspirin/caffeine||Migraine headache products||Excedrin Migraine (Novartis)|
|Ibuprofen/pseudoephedrine||Sinus headache products||Advil Cold & Sinus (Pfizer)|
Source: Pharmacy Today Annual Over-the-Counter Product Survey (March 2013)
For migraine headaches, 17% of pharmacists recommended a combination product with aspirin, acetaminophen, and caffeine. In the cough and cold category, combination products are recommended when patients complain of more than one symptom. So when patients complained of congestion only, however, pharmacists recommended a single-entity decongestant the majority of the time (79%). In the allergic rhinitis category, pharmacists reported using several different products, with second-generation antihistamines the most common recommendation (63%). Pharmacists always recommended combination decongestants and antihistamines for patients requiring multisymptom allergy and hay fever products, however. Pharmacists also recommended those products for patients complaining of ophthalmic allergies only. The survey findings illustrate that pharmacists recommend a range of OTC single-ingredient and combination medicines and provide helpful guidance and counseling to consumers.
OTC combination products are available to treat a wide variety of symptoms and in many cases offer a convenient, cost-effective alternative to treating with multiple single-ingredient products. When selecting an OTC medication to treat self-limiting symptoms, it is critical that patients are aware of the active ingredients within a particular product. Pharmacists, trained to identify the active ingredients that alleviate patients’ primary complaints, are often instrumental in assisting with product selection to ensure that patients receive the correct medication to achieve maximum relief from their symptoms.
The Drug Facts box on the product label assists both pharmacists and patients in identifying the appropriate product and provides important safety and usage information. Pharmacists can also answer questions concerning active ingredients, highlight important labeling information, and identify any potential drug interactions with other medications the patient is taking.
Multisymptom products have a valuable place in the market, and pharmacist-assisted self-care can help ensure that patients receive the right medication to achieve maximum relief from their symptoms.