Pharmacy Times

OTC Medication Safety

Author: Yvette C. Terrie, BSPharm, RPh

Pharmacists—an essential patient resource for the proper selection and use of OTC products.
Every year, new or former prescription products are approved by the FDA for OTC use, joining the host of OTC products on the market. Medications indicated for self-treatment are regulated by the FDA’s Center for Drug Evaluation and Research. Treatment can be classified into 3 general categories: nonprescription medications, nutritional supplements, and natural/homeopathic remedies.1,2

Americans spent about $40 billion on OTC medications in 2014.3,4 Research shows that 81% of adults use OTC medicines as a first response to minor ailments.3 Results from a survey show that 73% of individuals would prefer to self-treat with OTC drugs than visit a physician, and more than 87% believe these agents are safe and effective when used as directed.2 According to the Consumer Healthcare Products Association (CHPA), more than 240 million Americans use OTC drugs annually.3

The more than 80 therapeutic categories of OTC drugs can be narrowed to 12 general therapeutic categories.2,5 According to the FDA, there are more than 300,000 marketed OTC drug products and the number increases annually as some medications move from prescription to OTC status.6

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 possible risks if they are not properly used (Online Table 12,5). Studies have shown that individuals older than 65 years account for up to 40% of OTC drug use, and this patient population is at greater risk for potential drug interactions and contraindications because they are more likely to also be taking prescription medications and have 1 or more medical conditions.7,8 Moreover, an estimated 7 of 10 parents have given their child an OTC drug late at night to treat an abrupt onset medical symptom, and 81% of adults elect to use OTC drugs for minor symptoms before seeking medical care.9

Pharmacists are in a pivotal position to increase awareness about the safe use of OTC products, as well as inform patients about potential adverse effects. As one of the most accessible health care professionals, they can provide patients with essential information needed to make appropriate selections when choosing OTC products and advise them on the proper uses of these products. To ensure that patients are properly educated about the use of OTC products and to decrease the potential for medication errors, during counseling, pharmacists should encourage patients to thoroughly read each product label, adhere to the recommended directions, and ask questions if uncertain about the selection and use of these products.

A Growing Need for Safety
According to the CHPA, the OTC products consumers use most often for self-treatment of acute and chronic conditions include allergy, analgesic, antifungal, cough/cold/flu, lower and upper gastrointestinal, and dermatologic products.10 A 2011 study reported that the most commonly used OTC drugs include analgesics, cough/cold/ flu, allergy, and heartburn medications.2,5

Many consumers may find the use of multiple-ingredient combination products very convenient; however, the use of these products may increase the risk of therapeutic duplications and/or unnecessary drug use. One-third of Americans report they combine OTC medicines when they have multiple symptoms, and only 1 of 10 reads the entire label.11 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 OTC drugs on the market continues to increase and the FDA approves more prescription drugs for OTC status, the potential for drug interactions increases. According to the CHPA, since 1975, more than 100 ingredients, indications, or dosage strengths have transitioned from prescription to OTC status, and more drugs are added every year.12 In 2013, the FDA approved Nasacort Allergy 24HR nasal spray as an OTC medication, which became the first in its drug class to be available without a prescription.13 Then, in early 2014, the FDA approved Flonase Allergy Relief for OTC use, as well. A complete list of drugs that have transitioned from prescription to OTC status can be found on the FDA website at www OfficeofMedicalProductsandTobacco/ CDER/ucm106378.htm.

The FDA has implemented various patient education programs to increase awareness about the safe use of OTC medications. These resources can be found on the FDA website at Drugs/ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/UnderstandingOver- the-CounterMedicines/ ucm277845.htm.

Role of the Pharmacist
Pharmacists can be an essential resource for patients regarding the selection and proper use of OTC drugs (Online Table 22,7) and should seize every opportunity to educate their patients about using OTC drugs safely and wisely. Although proper selection is important for all patients, due to the potential for drug interactions and contraindications, it is especially critical for older individuals, pregnant/lactating women, individuals with preexisting medical conditions (such as diabetes or cardiovascular disease), the pediatric population, and those currently using prescription drugs.

Prior to recommending any OTC drug, pharmacists should evaluate each patient’s medical history, medication profile, and allergy history to screen for potential drug interactions and contraindications. During counseling, pharmacists should ascertain if self-treatment is appropriate and direct patients to seek further medical care when warranted. If they have concerns, patients should be advised to always consult with their primary health care provider regarding the use of any medications, especially if they are taking other medications and have a preexisting medical condition. Patients using multiple OTC products should be reminded to always read labels and check the active ingredients of these products to avoid possible therapeutic duplications and potential toxicities.

When used as directed, OTC 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 proper use of these 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. OTC value. Consumer Healthcare Products Association website. Accessed February 15, 2015.
  4. IRI. 2015.
  5. Over the counter medications: use in general and special populations, therapeutic errors, misuse, storage and disposal. American College of Preventative Medicine website. Accessed February 15, 2015.
  6. Drug applications for over-the-counter (OTC) drugs. Food and Drug Administration website. Accessed February 15, 2015.
  7. 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.
  8. Glaser J, Rolita L. Educating the older adult in over-the-counter medication use. Medscape website. Accessed February 16, 2015.
  9. Statistics on OTC ue. Consumer Healthcare Products Association website. Accessed February 15, 2015.
  10. Key findings: the value of OTC medicine to the United States. Consumer Healthcare Products Association website. Accessed February 15, 2015.
  11. 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. National Council on Patient Information and Education website. Accessed February 15, 2015.
  12. Rx-to-OTC switch. Consumer Healthcare Products Association website. Accessed February 15, 2015.
  13. FDA approves Sanofi's Nasacort Allergy 24 HR for OTC use. Sanofi website. Accessed February 15, 2015.