OTCs
Clarissa Chan, PharmD
Now that COVID-19 pandemic precautions are lifting and people are gathering once again, cold and flu cases are on the rise. Since many individuals will come into pharmacies searching for OTC products for relief, pharmacists will be receiving many questions. But how much is known about the effectiveness of many of these products? Pharmacists can help patients avoid unnecessary costs and delays in self-treatment by knowing which OTC medications are scientifically proven to be ineffective.
Phenylephrine
In the United States, phenylephrine is an ingredient in 261 OTC products for nasal or sinus symptoms. The Consumer Healthcare Products Association estimated that sales of oral phenylephrine–containing products were approximately $1.5 billion per year in 2015, according to Leslie Hendeles, PharmD, professor emeritus at the college of pharmacy and in the department of pediatrics (pulmonary) at the University of Florida in Gainesville, FL.
A March 2022 commentary in Annals of Pharmacotherapy by Hendeles and Randy Hatton, PharmD, FCCP, clinical professor at the college of pharmacy and director of Medication Safety & Quality Systems at the University of Florida in Fernandina Beach, FL, advocates for the removal of OTC products found to be ineffective with compelling evidence, notably oral phenylephrine.
“In my experience, most pharmacists don’t know that oral phenylephrine is ineffective as a decongestant or that it is inactivated in the gut and doesn’t get into the blood,” said Hendeles. “However, this drug is effective as a nasal spray, an eye drop, or an I.V. for hypotension—routes that avoid first-pass metabolism.”
Moreover, it is approved as a decongestant for use in children as young as 4 years old, but safety and efficacy has not been tested in children, Hendeles said.
“Phenylephrine is a scam with false advertising; it has no decongestant effect, and the companies know it,” said Miles Weinberger, MD, FAAAI, ACAAI, professor emeritus at the University of Iowa.
In May 2022, the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology joined forces to endorse a petition to remove oral phenylephrine from the marketplace, but the petition was opposed by FDA without providing any new studies demonstrating efficacy, said Hendeles.
“Awareness will save many patients from not getting relief of a common bothersome symptom and wasting money,” he said.
Guaifenesin
Guaifenesin is an FDA-approved expectorant, but it has questionable data to back up its efficacy in colds and other respiratory infections, according to research published in Respiratory Care by Hoffer-Schaefer and colleagues in 2014.
The 8-day multicenter clinical trial studied the effect of extended-release guaifenesin in patients with productive cough from an acute respiratory tract infection. Results showed no symptom improvement between the guaifenesin and placebo groups, revealing no significant differences.
Antihistamines
The effectiveness of first- and second-generation antihistamines in colds and other respiratory infections are also highly debatable, said Kelly Scolaro, PharmD, clinical pharmacist at Good Samaritan Pharmacy and Health Services in Nokomis, FL and Turning Points Clinic in Bradenton, FL. Antihistamines alone seem to have little effect on colds and other respiratory infections, according to De Sutter and colleagues’ study in Cochrane Database Systemic Review from January 2022.
“Although the studies are small, when first-generation antihistamines are combined with systemic decongestants, the efficacy data improves,” said Scolaro.
Nasal and throat antiseptics
The use of nasal and throat sanitation with antiseptics—such as ethanol, povidone-iodine, cetylpyridinium chloride, and hexylresorcinol—has been popular among consumers, especially during the COVID-19 pandemic.
“The products have been shown to kill viruses and bacteria on contact and the effects may last up to 8 hours for some products,” said Scolaro. “However, studies like Cegolon and colleagues’ 2020 article in International Journal of Hygiene and Environmental Health show that these products do not prevent or shorten the duration of respiratory illnesses.”
Ibuprofen/acetaminophen
The newer OTC combination product ibuprofen/acetaminophen has data supporting its use limited to tooth extractions.
“While this is a great alternative to opioids, it may accidentally be used or recommended to reduce pain and/or fever,” said Bernadette Cornelison, PharmD, MS, BCPS, assistant professor of pharmacy practice at the University of Arizona.
Ensuring safety
It is important that pharmacists treat OTC medications like prescription medications by being aware of the evidence that supports the use of OTC medications, while incorporating their clinical experience to provide appropriate recommendations and counseling to the patients, said Cornelison.
However, this can be very difficult as the regulations required for OTC drugs differ from prescription medications. “OTC drug monographs rely heavily on dosing, formulations, and labeling,” said Cornelison. “The reliance on these aspects shows the importance of ensuring safety of the medication but may not necessarily include data that supports the efficacy of a drug.” ■
Coughs and colds
Reducing symptoms, improving well-being, and preventing the spread of disease are the goals of treatment for most patients.
To prevent spreading a cold to others
■ Frequently wash your hands with soap for at least 20 seconds.
■ Use facial tissues to cover your mouth and nose when coughing or sneezing, and then promptly discard the tissues.
■ Use antiviral products such as Lysol to clean surfaces (e.g., doorknobs, telephones) that you may have touched.
Relief from symptoms of a cold may be found in
■ Getting adequate rest and staying well-hydrated.
■ Using a humidifier or vaporizer to increase the moisture in the air and possibly loosen mucus and promote sinus drainage.
■ Slowly dissolving medicated lozenges and candies in the mouth; do not chew.
■ Gargling with salt water (½–1 teaspoon of salt per 8 ounces of warm water) or drinking fruit juices or hot tea with lemon to soothe a sore throat.
Emphasize to caregivers of children that manufacturers of cough and cold medications have revised the labeling to state that these products should not be used in children younger than 4 years.
Adapted from Chapter 11 of APhA’s Handbook of Nonprescription Drugs, 20th ed.