OTC Medication Safety

JUNE 11, 2014
Yvette C. Terrie, BSPharm, RPh
Medications that are indicated for self-treatment are regulated by the FDA’s Center for Drug Evaluation and Research. These agents fall into 3 general categories, including nonprescription medications, nutritional supplements, and natural/homeopathic remedies.1,2 Each year, new products or former prescription drugs are approved by the FDA for nonprescription use and join the host of nonprescription drugs currently on the market.

Americans spent more than $23 billion on nonprescription medications in 2010.1 An estimated 35% of Americans use nonprescription drugs on a regular basis, and this percentage is increasing annually.3 Results from a survey report that 73% of those surveyed would prefer to self-treat with nonprescription drugs rather than visit a physician, and more than 87% say that they believe these agents are safe and effective when used as directed.2

Although OTC products are easily accessible to the general public, it is important for consumers to be educated about their safe use, potential drug interactions, contraindications, and potential risks if they are not properly used (Table 12,3). Millions of patients annually elect to self-treat common mild to moderate ailments with various nonprescription drugs. The more than 80 therapeutic categories of nonprescription drugs can be narrowed to 12 therapeutic categories.2,3 According to the Consumer Healthcare Products Association (CHPA), more than 100,000 OTC products are on the market.4 Studies have shown that individuals older than 65 years account for up to 40% of nonprescription drug use, and these patients are more likely to be susceptible to potential drug interactions and contraindications because they are more likely to be taking prescription medications as well.5-7

Pharmacists can provide consumers with essential information needed to make proper selections when choosing nonprescription products. They can encourage patients to thoroughly read the labels of nonprescription products and to ask questions if uncertain about the selection and use of these products. It is important to encourage consumers to consult pharmacists to ensure that patients are properly educated about the use of OTC products and to decrease the potential for medication errors.

Most Common OTCs
A study conducted in 2011 reported that the most commonly used nonprescription drugs include analgesics; allergy medications; heartburn medications; and cough, cold, and flu medications.2,3 Use of multiple-ingredient combination products increases the risk of therapeutic duplications and/or unnecessary drug use. For example, many cough/cold and allergy products contain multiple ingredients that may not be needed by patients, or patients may be unaware that an active ingredient is in another medication they are taking, thus increasing the potential for toxicity.2

As the number of nonprescription drugs on the market continues to increase and the FDA approves more prescription drugs for nonprescription status, the potential for drug interactions increases. According to the CHPA, since 1975, 109 ingredients, indications, or dosage strengths have transitioned from prescription to nonprescription status, and drugs are added annually.9 A list of these ingredients can be found at www.chpa.org/SwitchList.aspx.

The FDA has implemented various patient education programs to increase awareness about the safe use of prescription medications. These resources can be found on the FDA website at www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm296593.htm.

Role of the Pharmacist
Although it is impractical for pharmacists to counsel every patient who uses a nonprescription product, pharmacists are an essential resource for their patients regarding the selection and proper use of these agents (Table 22,4). Pharmacists should seize every opportunity to educate their patients about the importance of using nonprescription drugs safely and wisely. Proper selection of nonprescription drugs is important for all patients, but it is particularly critical for individuals of advanced age, pregnant/lactating women, individuals with preexisting medical conditions (such as diabetes), the pediatric population, and those currently using prescription drugs. These patients should always consult a health care professional before using a nonprescription product, to avoid possible contraindications, drug–drug interactions, food–drug interactions, drug–alcohol interactions, and/or dosing errors.

Pharmacists are a patient’s best resource and should assess the patient’s symptoms/condition to ascertain if self-treatment is appropriate or if medical treatment is warranted. Prior to recommending any OTC drug, pharmacists should evaluate the patient’s medical and medication profiles, as well as evaluate for potential allergies. Patients using multiple nonprescription products should be reminded to always check the active ingredients of these products to avoid possible therapeutic duplications and potential toxicities.

When used correctly, nonprescription products are safe and effective for treating a variety of common ailments. Recommendations from pharmacists enable patients to make safe and informed decisions regarding their health and the use of nonprescription products.

Ms. Terrie is a clinical pharmacist and medical writer based in Haymarket, Virginia

  1. Consumer health: United States. Euromonitor International: Market Insight, February 2011.
  2. Henderson M. Self-care and nonprescription pharmacotherapy. In: Krinsky D, Berardi R, Ferreri S, et al, eds. Handbook of Nonprescription Drugs. 17th ed. Washington, DC: American Pharmacists Association; 2012.
  3. Over the counter medications: use in general and special populations, therapeutic errors, misuse, storage and disposal. American College of Preventative Medicine website. http://c.ymcdn.com/sites/www.acpm.org/resource/resmgr/timetools-files/otcmedsclinicalreference.pdf. Accessed May 2014.
  4. Brown L, Isetts B. Patient Assessment and Consultation. In: Krinsky D, Berardi R, Ferreri S, et al, eds. Handbook of Nonprescription Drugs. 17th ed. Washington, DC: American Pharmacists Association; 2012.
  5. Glaser J, Rolita L. Educating the older adult in over-the-counter medication use. Medscape website. www.medscape.com/viewarticle/705665. Accessed May 2014.
  6. Oxytrol For Women patch. Watson Pharma Inc website. www.oxytrolforwomen.com. Accessed May 2014.
  7. Jackson Allen P, Simenson S. Management of common cold symptoms with over-the-counter medications: clearing the confusion. Postgrad Med. 2013;125(1):73-81.
  8. Harris Interactive/National Council on Patient Information and Education (NCPIE). Attitudes and beliefs about the use of over-the-counter medicines: a dose of reality. www.bemedwise.org/survey/final_survey.pdf. Accessed May 2014.
  9. FAQs about Rx-to-OTC switch. Consumer Healthcare Products Association website. www.chpa.org/FAQsSwitchPP.aspx. Accessed May 2014.

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