Counseling is particularly important for pediatric patients or those with other medical conditions
Every year, millions of consumers across the country elect to use the various OTC cough and cold products to treat the fever, cough, sneezing, sore throat, nasal congestion, muscle aches, and/or headaches associated with the common cold, influenza, COVID-19, or other respiratory viruses.
During this time of the year, pharmacists are likely to encounter patients seeking guidance on the various OTC products marketed for the relief of mild to moderate symptoms. These include cough expectorants, cough suppressants, antipyretics and analgesics, decongestants and antihistamines, and anesthetic and antiseptic products, which are available as single-entity or multi-ingredient products. These products are also formulated in various dosages and forms, including oral and topical products, to meet the needs of adult and pediatric patient populations.1 A well-known brand, Coricidin HBP (Bayer), is formulated for patients with hypertension, and there are also several sugar-free products for patients with diabetes, such as Diabetic Tussin (Hi-Tech Pharmacal Co, Inc).
Pharmacists will also likely encounter patients seeking guidance on dietary supplements marketed for immune support that may contain one or more of the vitamins A, C, D, and E, along with essential trace elements of zinc and selenium.1 Some also contain echinacea, ginger, elderberry, garlic, other herbal ingredients, prebiotics, and probiotics for immune enhancement. Findings from one study showed that essential nutrients such as vitamins C, D, and E; zinc; selenium; and ω-3 fatty acids have well-defined immunomodulatory effects, including protective clinical benefits in some infectious diseases.2
Literature indicates that since the start of the COVID-19 pandemic, there has been an augmented interest and use of dietary supplements among the general public. Sales of cold, influenza, and immunity supplements accounted for an estimated $6 billion by the end of 2020, up from $3.4 billion reported in 2019, and immune health supplements represented an estimated 10% of all supplement sales in the United States.3
Pharmacists can be instrumental in counseling patients on the proper use of OTC cough and cold products. They can also ascertain if self-treatment is appropriate and direct patients to seek further care from their primary health care provider when warranted. This is particularly important for pediatric patients, patients with preexisting medical conditions or those taking prescription medications, and patients without a confirmed diagnosis or experiencing severe symptoms. The FDA does not recommend using OTC cough and cold medicines in pediatric patients younger than 2 years due to efficacy and safety concerns.1,4 Manufacturers voluntarily label these cough and cold products to state, “Do not use in children under 4 years of age,” and have added precautions to products containing antihistamines against their use for sedation purposes.1
NEWS AND RECENT CLINICAL DATA
In September 2023, the FDA held a Nonprescription Drugs Advisory Committee meeting to discuss the effectiveness of oral phenylephrine as an active ingredient in OTC cough and cold products. The FDA press release indicated that current data do not support the use of orally administered phenylephrine as a nasal decongestant. Importantly, however, neither the agency nor the committee raised safety concerns about its use at recommended doses.5 More information is available on the FDA website.
According to recently published data from a scientific review, in Clinical Infection in Practice, researchers concluded that when no contraindications are present, OTC medications utilized for the symptoms of common cold and influenza-like illnesses caused by respiratory viruses are safe and effective treatments for similar symptoms associated with COVID-19 infections.6
In study findings published in Nutrients, the researchers had conducted a systematic review to assess the supposed benefits or possible harms of dietary supplement ingredients commonly marketed to enhance immune system response or promote immune system health. Based on their findings, the authors wrote: “There is little evidence to suggest [that] certain ingredients, if taken prior to getting sick, will reduce the severity or duration of any acute respiratory infection, versus not taking a dietary supplement prophylactically or as compared [with] placebo.”3
Further, in an article published in Heliyon, data indicated that with regard to immune-boosting supplements, there are only a few clinically proven natural products, vitamins, and minerals. These include vitamin C, vitamin E, and zinc, and these supplements can be considered as an alternate option for protection against certain types of immunologic and inflammatory diseases.7
When used as directed and with no contraindications, OTC cough and cold medications marketed for the relief of mild to moderate symptoms are safe and effective. Before recommending these products, pharmacists should always review for potential allergy sensitivities, drug-drug interactions, and possible contraindications. To avoid medication errors, patients should be prompted to read labels before administration, review ingredients to avoid therapeutic duplications, always check the expiration dates, and adhere to the recommended dosages and administration guidelines.
Before administering medications to pediatric patients, parents or caregivers should be reminded to always use calibrated measuring devices provided by the manufacturer for liquid medications and read all labels carefully. When in doubt regarding the appropriateness or dose of the medication, caregivers should always consult their pediatrician or pharmacist. Patients should be encouraged to seek medical attention from their primary health careprovider if symptoms worsen or linger or if they experience high fever or signs of infection.
Implementing preventive measures for potentially decreasing the risk of contracting or preventing transmission of colds, such as routine handwashing and using hand sanitizers when soap and water are unavailable, is also very effective. Pharmacists can also seize this opportunity to encourage eligible patients to obtain the recommended vaccinations if appropriate. They can also advise patients exhibiting signs of influenza and COVID-19 infections to get tested so that therapy with recommended prescription antivirals can be initiated as soon as possible when appropriate to improve clinical outcomes.
ABOUT THE AUTHOR
Yvette C. Terrie, BSPHARM, RPH, is a clinical pharmacist and medical writer based in Northern Virginia.