Yvette C. Terrie, BSPharm, RPh

Recent research suggests that climate change is making things worse for patients who suffer from allergies, which can cause symptoms including a cough resulting from postnasal drip, to headache, itchy eyes and throat, nasal congestion, sneezing, and watery eyes.

Left unmanaged, these symptoms can significantly affect an individual’s quality of life and productivity. An estimated 60 million individuals deal with allergy symptoms annually, according to the CDC. Up to 30% of the general population experiences ocular allergies and up to 70% experiences allergic rhinitis.

Additionally, individuals with respiratory issues such as asthma usually are more sensitive to pollen.

Pharmacists can guide patients in selecting OTC products for the prevention and treatment of seasonal allergies, such as intranasal corticosteroids, mast cell stabilizers, ocular and oral antihistamines, and oral and topical decongestants. Pharmacists also can counsel patients about the proper use of these products and make clinical recommendations based on a patient’s medical and medication history while taking into consideration factors such as cost, ease and frequency of use, potential adverse effects, and route of administration. They should direct patients to seek further evaluation and medical care from allergy specialists when warranted.

Results of a study by investigators from the University of Michigan (UM) showed that allergy season will likely become longer and more intense because of climate change.

 The investigators noted that the annual amount of pollen emitted each year could increase by up to 200% because of rising temperatures and expanding carbon dioxide levels. Hotter temperatures may increase the amount of pollen produced by grass, trees, and weeds. By the end of the century, they noted, pollen emissions could start 40 days earlier in the spring than observed between 1995 and 2014 and allergy season may last an additional 19 days before high pollen counts wane. The investigators developed a predictive model that assessed 15 of the most common pollen types and how their production will be affected by projected changes in precipitation and temperatures. They combined climate data with socioeconomic scenarios, correlating their modeling with data from 1995 through 2014. They then used their model to predict pollen emissions for the first 2 decades of the 21st century.

“Pollen-induced respiratory allergies are getting worse with climate change. Our findings can be a starting point for further investigations into the consequence of climate change on pollen and corresponding health effects,” Yingxiao Zhang, a UM graduate student research assistant in climate and space sciences and engineering and lead author of the study,

“The modeling developed by the team could eventually allow for allergy season predictions targeted to different geographical regions,” said Allison Steiner, the study’s other author and a professor of climate and space sciences at UM.

The National Science Foundation supported the project.

In other news, on March 17, 2022, Perrigo announced that its intranasal corticosteroid, Nasonex 24HR Allergy, had received final FDA approval for OTC use. Nasonex 24HR Allergy is indicated for the management of nasal symptoms of allergic rhinitis, nasal congestion associated with seasonal allergic rhinitis, nasal polyps, and the prophylaxis of seasonal allergic rhinitis. This is the first OTC formulation for Nasonex, and it will be available in full prescription strength. Each nasal spray delivers 50 g of mometasone furoate monohydrate. Perrigo expects the OTC product to be available later in 2022.

On March 15, 2022, Allergan announced that Lastacaft (alcaftadine ophthalmic solution 0.25%) now is available without a prescription for the estimated 40% of Americans with ocular allergies. The FDA approved the switch to OTC in December 2021. The histamine receptor antagonist is indicated in patients 2 years and older for the temporary relief of itchy eyes resulting from animal hair, dander, pollen, and ragweed allergies. In clinical trials, 1 drop of Lastacaft worked in as little as 3 minutes to provide relief from itchy eyes and lasted
for 16 hours. Lastacaft is available in a 5-mL multidose bottle containing a 60-day supply, as well as a twin pack with two 5-mL multidose bottles for a 120-day supply.

Meanwhile, the American College of Allergy, Asthma & Immunology (ACAAI) said recently that because COVID-19 symptoms, especially for the Omicron variant, often resemble symptoms commonly associated with allergies, patients should get tested if they suspect they have the virus. The ACAAI noted that allergies rarely cause a fever. The ACAAI also suggested that individuals with seasonal allergies identify their triggers if possible and discuss other therapies if OTC allergy medications are not managing symptoms.

 The ACAAI provides tips for managing spring allergies on its website.

Pharmacists can suggest the use of various mobile applications that monitor the pollen counts across the United States to help patients manage symptoms.

Pharmacists can help patients with seasonal allergy symptoms select and properly use nonprescription products. They can also counsel patients about the most efficacious means of preventing or reducing allergy symptoms. In addition, pharmacists can screen for potential contraindications and drug/drug interactions before recommending the use of OTC allergy medications. Patients with other medical conditions and/or those taking prescription medications should consult their primary health care providers to ascertain appropriateness of use. Pharmacists should encourage patients with severe or unmanaged allergy symptoms to seek further care from their primary health care providers.

Treatment of allergy symptoms may include a combination of allergen avoidance and environmental control measures when feasible, as well as immunotherapy and pharmacologic therapy. Many patients try several options before finding the most effective treatment.

, is a consulting pharmacist and medical writer in Haymarket, Virginia.

1. Allergens and pollen. CDC. August 21, 2020. Accessed March 28, 2022. https://cdc.gov/climateandhealth/effects/allergen.htm

2. Zhang Y, Steiner AL. Projected climate-driven changes in pollen emission season length and magnitude over the continental United States. 

. 2022;13(1):1234. doi:10.1038/s41467-022-28764-0

3. Longer, more intense allergy seasons could result from climate change. University of Michigan. March 16, 2022. Accessed March 28, 2022. https://news.umich.edu/longer-more-intense-allergy-seasons-could-result-from-climate-change/

4. Perrigo announces US FDA approval for OTC use of Nasonex 24hr Allergy. Perrigo. News release. March 17, 2022. Accessed March 18, 2022. https://www. prnewswire.com/news-releases/perrigo-announces-us-fda-approval-for-otc-use-of-nasonex-24hr-allergy-301505410.html

5. Now available over the counter, Lastacaft provides eye allergy itch relief in minutes that lasts through 16 hours. AbbVie. News release. March 15, 2022. Accessed March 15, 2022. https://www.prnewswire.com/news-releases/now-available-over-the-counter-lastacaft-provides-eye-allergy-itch-relief-in-minutes-that-lasts-through-16-hours-301501288.html

6. Covid’s not gone, and spring allergies could hit hard. American College of Allergy, Asthma, & Immunology. February 22, 2002. Accessed March 28, 2022. https:// acaai.org/news/what-allergists-want-you-to-know-about-the-2022-spring-allergy-season/

Articles

With climate change potentially affecting pollen counts, new OTC products can relieve symptoms.

Help Patients Prepare for Allergy Season

Although cardiovascular disease (CVD) continues to be the leading cause of death among all ethnic groups globally, including in the United States, many cases are preventable. “Heart disease is 90% treatable. Everyone can prevent heart disease anywhere in the world, especially by eating foods that are low in salt and cholesterol, exercising regularly, and not smoking. Even if a person has a family history of heart disease, we can still prevent and treat heart disease, thanks to incredible advances in medicine,” Leslie Cho, MD, section head for preventive cardiology and cardiac rehabilitation at Cleveland Clinic in Ohio, said recently.

Because many individuals take proactive roles in their overall health, pharmacists can help them select and use nutritional supplements marketed for cardiovascular health. Examples include coenzyme Q10 (CoQ10), garlic, omega-3 fatty acids, and plant sterols, as well as specialty mineral and multivitamin supplements that are formulated with a blend of essential nutrients specifically targeted for cardiovascular health.

Research results show some supplements may decrease the risk of CVD, whereas others may cause harm to individuals with CVD risk factors. Findings from clinical trials have also produced mixed results.

Manufacturer Piper Biosciences recently released clinical data demonstrating the efficacy of its Cholesterol Wellness gummies, which contain plant sterols that help lower cholesterol. Results show that among participants who completed the 3-month study, there was a statistically significant (P =.03) reduction in low-density lipoprotein cholesterol (LDL-C) of 5.8%, and more than 90% of participants indicated interest in using the gummies long term if recommended by their physicians. The investigators concluded that supplementation with plant sterols can be effective in lowering LDL-C levels.

Another recent publication on the Cleveland Clinic website explored the benefits associated with cardiovascular health supplements based on clinical data. The cardiologist featured in the article indicated that patients should always discuss the use of these supplements with their primary health care providers to ascertain appropriateness. The cardiologist also indicated that although some supplements may not be harmful, some may carry risks that can affect cardiac function.

The results of a study assessing the use of CoQ10 in individuals with congestive heart failure show that participants who took 100 μg per day had fewer major adverse cardiac events than those who took a placebo.

 Although other studies that involved a small number of patients indicate that use of CoQ10 was associated with improvements in cardiovascular risk factors, such as blood glucose control, hyperlipidemia, and hypertension, more research is warranted.

 indicated that individuals with vitamin D deficiency are more likely to have CVD and hypertension. The findings show that for participants with the lowest concentrations of vitamin D, the risk of CVD was more than double than in those with sufficient concentrations.

However, the results of a meta-analysis of clinical trials and prospective cohort studies conducted by the American Heart Association (AHA) showed that mineral/multivitamin supplementation does not improve cardiovascular outcomes in the general population.

 The results of another AHA study showed that no effect was observed for commonly used multivitamins, vitamins C and D, calcium, and, to date, there is no conclusive evidence for the benefits of supplements. The authors of the study also noted that consuming plant-based food is a safe approach to increasing micronutrient intake.

An article in Current Cardiology Reports noted that, despite the popular use of supplements, there is no evidence to support the routine supplementation of oral multivitamins and minerals for the prevention or treatment of CVD.

Patients with preexisting medical conditions and/or those taking other medications should always consult their primary health care providers before using any supplements. Encourage patients to discuss individual nutritional needs based on their medical and medication history. During counseling, pharmacists can remind patients about the importance of knowing about and discussing their modifiable and nonmodifiable CVD risk factors, including blood pressure values, family history, and lipid levels with their primary health care providers. Pharmacists can also encourage patients to implement healthy dietary and lifestyle measures into their daily routine, lose weight if needed, and maintain routine health care visits, which are essential to overall cardiovascular health. It is also important to remind patients who use prescription medications for the prevention and treatment of CVD to adhere to these medications as directed by their primary health care providers.

, is a consulting pharmacist and a medical writer in Haymarket, Virginia.

1. 90 percent of heart disease is preventable through healthier diet, regular exercise, and not smoking. News release. Cleveland Clinic; September 29, 2021. Accessed January 12, 2022. https://newsroom.clevelandclinic.org/2021/09/29/90-percent-of-heart-disease-is-preventable-through-healthier-diet-regular-exercise-and-not-smoking/

2. Clinical study shows gummy containing plant sterols significantly lowers cholesterol. News release. Piper Biosciences; September 27, 2021. Accessed January 12, 2022. https://www.prnewswire.com/ news-releases/clinical-study-shows-gummy-containing-plant-sterols-significantly-lowers-cholesterol-301385051.html

3. Do heart health vitamins work? Cleveland Clinic. December 23, 2021. Accessed January 12, 2022. https://health.clevelandclinic.org/ heart-health-vitamins-ally-or-false-friend/

4. Mortensen AL, Rosenfeldt F, Filipiak KJ. Effect of coenzyme Q10 in Europeans with chronic heart failure: a sub-group analysis of the Q-SYMBIO randomized double-blind trial. 

. 2019;26(2):147- 156. doi:10.5603/CJ.a2019.0022

5. Ayers J, Cook J, Koenig RA, Sisson EM, Dixon DL. Recent developments in the role of coenzyme Q10 for coronary heart disease: a systematic review. 

. 2018;20(6):29. doi:10.1007/ s11883-018-0730-1

6. Zhou A, Selvanayagam JB, Hyppönen E. Non-linear Mendelian randomization analyses support a role for vitamin D deficiency in cardiovascular disease risk. 

. Published online December 5, 2021. doi:10.1093/eurheartj/ehab809

7. Kim J, Choi J, Kwon SY, et al. Association of multivitamin and mineral supplementation and risk of cardiovascular disease: a systematic review and meta-analysis. 

. 2018;11(7):e004224. doi:10.1161/CIRCOUTCOMES.117.004224

8. Jenkins DJA, Spence JD, Giovannucci EL, et al. Supplemental vitamins and minerals for cardiovascular disease prevention and treatment: JACC Focus Seminar. 

. 2021;77(4):423-436. doi:10.1016/j.jacc.2020.09.619

9. Ingles DP, Cruz Rodriguez JB, Garcia H. Supplemental vitamins and minerals for cardiovascular disease prevention and treatment.

. 2020;22(4):22. doi:10.1007/s11886-020-1270-1

Taking appropriate doses of vitamins and minerals may aid in lowering the risk of cardiovascular disease.

Help Patients Navigate Array of Heart Health Supplements

The severity of annual cold and flu season can be very unpredictable from year to year.

Each year, millions of individuals use the various nonprescription medications marketed for the management and treatment of symptoms that are generally associated with colds and influenza. Pharmacists can be indispensable resources in aiding patients in the selection and proper use of these products. For the management of mild to moderate common cold and influenza symptoms, nonprescription products include analgesics, anesthetics, antihistamines, antipyretics, antiseptics, cough suppressants, decongestants, and expectorants, available in multi-ingredient or single-entity formulations.

Findings from 2 recently published studies predicted the impact of the 2021-2022 flu season. According to the results from one, there could be 100,000 to 400,000 more influenza hospitalizations in the 2021-2022 flu season compared with a typical season. But the investigators found that the predicted increase in those hospitalizations could be avoided if the percentage of Americans vaccinated against influenza increased from the typical 50% to 75%.

 In the second study, investigators suggested that the 2021-2022 season could see a 20% increase in cases compared with a typical season and that children younger than age 2 would be particularly at risk for influenza because they are unlikely to have any previous exposure to the virus.

 The results of both studies suggested that a flu season with high activity could be avoided if vaccination rates increased by 20% to 50% compared with those in a typical year.

On November 1, 2021, Reckitt, the manufacturer of the OTC cold, cough, and influenza product Mucinex, announced the launch of a new product line called Mucinex InstaSoothe, which includes lozenges and spray designed to numb, relieve, and soothe sore throat pain. The new products are Mucinex InstaSoothe
Sore Throat + Cough Relief Lozenges, Mucinex InstaSoothe Sore Throat + Pain Relief Spray, and Mucinex InstaSoothe Sore Throat + Soothing Comfort Lozenges.

To gain a better understanding about the impact of sore throat pain on patient quality of life, Reckitt conducted a random double opt-in survey of 2005 Americans between August 26 and August 30, 2021.

The results showed that sore throat pain is 1 of the top 3 most incapacitating symptoms, alongside fever and migraine. Despite this, 55% of individuals are most likely to “power through” a sore throat, meaning that they continue completing housework, going to school, running errands, and working while dealing with difficult sore throat pain.

Prior to recommending any OTC cold and cough products, pharmacists should always screen for a patient’s allergy and medical history and medication profile
to check for possible contraindications or interactions. Individuals with medical conditions and/or who are taking other medications should always consult with their primary health care providers before using any nonprescription medications to ascertain appropriateness. During counseling, pharmacists should remind patients to read labels prior to self-administration and to check for expiration dates and ingredients, particularly if using multiple products, to avoid therapeutic duplications or excessive dosing. Pharmacists should also remind patients to adhere to the recommended administration guidelines, dosages, and duration of use.

Additionally, remind caregivers and parents to always read all labels prior to administering medications to children and use the calibrated drug measuring devices provided with the selected OTC products when administering liquid medications to ensure proper accuracy and dosage. Caregivers and parents should only give children those OTC products manufactured specifically for the pediatric population, and when in doubt regarding the appropriateness or dose of a medication should consult their pediatricians or pharmacists.

During counseling, pharmacists should stress the importance of obtaining an annual influenza vaccination, as well as suggest various nonpharmacologic measures that may provide relief of cold and influenza symptoms. These include humidifiers, nonmedicated nasal strips, saline nasal sprays, and vaporizers. Patients should also maintain adequate hydration and rest. Encourage patients to seek medical attention from their primary health care provider if a cough lasts more than 14 days, a fever is high, a sore throat persists, symptoms linger or worsen, or there are signs of infection. Study results have shown that the implementation of various preventive measures, such as avoiding direct contact with an individual with a cold or influenza, routine handwashing, and use of hand sanitizers when soap and water are not available, is effective for decreasing or preventing the transmission of colds and influenza.

1. Rettner R. Flu season will be bad this year, research predicts. LiveScience. September 1, 2021. Accessed November 3, 2021. https://www. livescience.com/flu-season-comeback-covid-2021-2022.html

2. Lee K, Jalal H, Raviotta JM, et al. Predicting the impact of low influenza activity in 2020 on population immunity and future influenza season in the United States. medRxiv. Preprint posted online August 30, 2021. doi:10.1101/2021.08.29.21262803

3. Krauland MG, Galloway DD, Raviotta JM, Zimmerman RK, Roberts MS. Agent-based investigation of the impact of low rates of influenza on next season influenza infections. medRxiv. Preprint posted online August 26, 2021. doi:10.1101/2021.08.18.21262185

4. Painful sore throats meet their match  -Mucinex introduces Mucinex InstaSoothe, a new line of lozenges and spray to help fight against sore throat pain and irritation. News release. Mucinex. November 1, 2021. Accessed November 3, 2021. https://www.prnewswire.com/ news-releases/painful-sore-throats-meet-their-match-mucinex-introduces-mucinex-instasoothe-a-new-line-of-lozenges-and-spray-to-help-fight-against-sore-throat-pain-and-irritation-301412676.html

Help patients prepare for these winter ailments and choose the appropriate nonprescription medications.

Here Comes Cold and Flu Season

Patients commonly self-treat pain with nonprescription analgesics, and pharmacists can help them choose the correct OTC products.

Acute pain typically initiates abruptly and can often be attributed to a known cause such as an injury or surgery.

 Chronic pain typically lasts for 3 or more months and can be caused by a condition, disease, inflammation, an injury, medical treatment, or an unknown reason.

Pain is a complex symptom that affects individuals differently, and therapy should be tailored to the individual’s needs. Left untreated, pain may affect quality of life, including cognitive, emotional, and physical functions.

Because of the opioid crisis in the United States, many health care professionals are exploring alternative approaches to pain relief, such as cognitive therapy, cold and heat treatments, physical therapy, and OTC oral and topical analgesics.

Many individuals frequently use nonprescription oral and topical analgesics to self-treat mild to moderate pain because the products are accessible, easy to use, and reasonably priced. Consumers spent $4.5 billion on oral analgesics and $1.1 billion on topical analgesics in 2020, according to a Consumer Healthcare Products Association report.

Selecting an appropriate nonprescription product may be overwhelming for many patients, especially if they have other medical conditions and/or are taking other medications. Therefore, pharmacists are in a critical position to advise patients on oral and topical nonprescription analgesics, as well as direct them to seek counsel from their primary health care providers when warranted. That is especially important if further evaluation is needed, the pain is severe, or self-treatment is not appropriate.

The American Academy of Family Physicians and the American College of Physicians (ACP) in August 2020 recommended the use of topical nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line therapy for treating acute, non–low back pain from musculoskeletal injuries in outpatient settings.

 Evidence has shown that topical NSAIDs are among the most effective options for pain reduction, physical function, symptom relief, and treatment satisfaction, and they have not been linked with any considerable adverse effects. The ACP guidelines suggest other treatment options when appropriate, including oral NSAIDs to diminish or relieve symptoms and acupressure and transcutaneous electrical nerve stimulation to decrease pain.

“These types of injuries and associated pain are common, and [as physicians] we need to address them with the best treatments available for the patient,” Jacqueline W. Fincher, MD, MACP, president of the ACP, said. “The evidence shows that there are quality treatments available for pain caused by acute musculoskeletal injuries that do not include the use of opioids. There are a number of recommended interventions that are not opioids to choose from, and topical NSAIDs should be the first line of treatment.”

 indicated that pain has been frequently described as a clinical feature of COVID-19, and the main pain syndromes that have been linked with the acute phase of the virus are arthritis, headaches, myalgia, and neuropathic pain.

issued a consensus statement cautioning against the use of nonprescription acetaminophen during pregnancy. The authors warned of possible links to adverse fetal development outcomes, called for additional investigation, and encouraged additional precautions prior to use in pregnancy.

However, some experts have indicated that more research is warranted and that the findings from the study should not change clinical decision-making.

In response to the publication, medical societies including the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have made statements continuing to encourage the safe administration of acetaminophen to patients who need it during pregnancy.

National Health Interview Survey data published in Pain stated that 50.2 million, or 20.5%, of adults in the United States in 2019 experienced chronic pain.

 The estimated total value of lost productivity due to chronic pain is nearly $300 billion annually.

Pharmacists should advise patients about the proper use of the selected product, including adherence to manufacturer directions, dosage, potential adverse effects, and recommended duration of use. Pharmacists also serve as excellent resources in identifying possible drug-drug contraindications and interactions. Patients taking other medications and those with chronic medical conditions should always consult their primary health care providers before taking any nonprescription drugs. Pharmacists can also make recommendations about using nonpharmacological measures to alleviate joint and muscle pain.

For example, the RICE protocol (rest, ice, compression, elevation) helps diminish inflammation and swelling associated with acute joint and muscle injuries, and localized heat therapy may be beneficial for patients with noninflammatory pain.

Encourage patients with continual, severe, or recurring pain to seek additional care from their primary health care providers, especially if pain worsens or they see no signs of progress after using nonprescription analgesics. Advise patients to limit the use of systemic analgesics to 10 days unless otherwise directed by their primary health care providers. 

1. Safely and effectively managing pain without opioids. CDC. June 11, 2021. Accessed October 14, 2021. https://www.cdc.gov/drugoverdose/ featured-topics/pain-management.html

2. OTC use statistics. Consumer Healthcare Products Association. Accessed October 28, 2021. https://www.chpa.org/about-consum- er-healthcare/research-data/otc-use-statistics

3. ACP, AAFP release new guideline for treatment of non-low back pain from musculoskeletal injuries in adults. American College of Physicians. August 17, 2020. Accessed October 14, 2021. https://www. acponline.org/acp-newsroom/acp-aafp-release-new-guideline-for- treatment-of-non-low-back-pain-from-musculoskeletal-injuries-in

4. Oguz-Akarsu E, Gullu G, Kilic E, et al. Insight into pain syndromes in acute phase of mild-to-moderate COVID-19: frequency, clinical characteristics, and associated factors. Eur J Pain. Published online October 8, 2021. doi:10.1002/ejp.1876

5. Bauer AZ, Swan SH, Kriebel D, et al. Paracetamol use during pregnancy - a call for precautionary action. Nat Rev Endocrinol. Published online September 23, 2021. doi:10.1038/s41574-021-00553-7

6. D’Ambrosio A. Warning on Tylenol in pregnancy no cause for alarm. MedPage Today. October 11, 2021. Accessed October 12, 2021.https:// www.medpagetoday.com/obgyn/pregnancy/94967

7. Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in the United States. Pain. Published online April 2, 2021. doi:10.1097/j.pain.0000000000002291

Pharmacists Can Provide Advice on Pain Products’ Directions, Dosage, and Duration of Use

Counsel Patients on OTC Analgesics

The significance of overall digestive health is often underestimated until an issue arises. The digestive system includes the gallbladder, gastrointestinal (GI) tract, liver, and pancreas.

 Digestion is important for breaking down food into nutrients, which the body uses for cell repair, energy, and growth.

 Research results have clearly established the relationship between gut microbiota and human diseases, which has been a major topic of interest for many studies, and ever-increasing evidence has suggested that disturbances in the gut microbiota play an important role in the development of and exacerbation of certain diseases, affecting the immune system and overall health.

 Other research results have indicated that the gut microbiome has a major role in the digestion of food and in the central nervous and immune systems, as well as other physiological processes.

Everyone experiences digestive issues from time to time, and many mild to moderate GI issues are amenable to self-treatment. However, some individuals frequently experience uncomfortable GI issues, such as acid reflux, bloating, constipation, and indigestion, which can negatively affect productivity and quality of life. It is critical that patients experiencing severe GI symptoms, or whose symptoms are not improving or worsening despite self-treatment, seek immediate medical care.

An estimated one-third of the world’s population has some form
of digestive symptoms, most commonly bloating and constipation, according to the World Gastroenterology Organisation.

 Additionally, there is a considerable percentage of Americans who regularly experience GI symptoms but do not seek care from clinicians.

 Less than 20% of individuals with abdominal pain, bloating, or diarrhea consult health care providers for evaluation and management of their symptoms.

 Examples of some of the most common GI complaints include dyspepsia and heartburn, with an estimated 60 million individuals in the United States experiencing heartburn at least once a month and more than 15 million experiencing heartburn daily.

The pharmacy shelves are lined with products marketed for digestive health and the treatment of common GI ailments, and the selection of these products may be overwhelming for many patients, especially individuals with other medical conditions and/or who take other medications.

Pharmacists are well positioned to help patients select the appropriate nonprescription products and encourage individuals with chronic and/or recurring GI symptoms to seek further medical evaluation and treatment. Some of the most common nonprescription GI products to treat and prevent mild to moderate GI issues” to promote digestive health include antacids, antidiarrheals, fiber supplements, H

 blockers, proton pump inhibitors, prebiotic supplements, and probiotics. Individuals with mild to moderate GI issues, such as constipation, flatulence, heartburn, and indigestion, may opt to self-treat these ailments with the appropriate agents.

Results from a recent global survey involving 16 countries regarding probiotic use showed that, globally, an estimated 47% of survey participants were familiar with probiotics, which increased from 42%, as reported in the 2019 survey.

 They also noted that the reasons for taking probiotics were to promote bone, digestive, immune, and joint health.

Results from another study from the journal Gut showed the benefits of psyllium in the reduction of inulin-induced colonic gas in patients with Rome IV criteria irritable bowel syndrome.

Study results published in Gut showed that association between gut microbiota composition, levels of cytokines, and inflammatory markers in patients with COVID-19 suggest the gut microbiome is involved in the magnitude of COVID-19 severity, possibly via modulating host immune responses. However, more research is warranted.

Research results published in the journal Gastroenterology indicated that vitamin D has been implicated in the pathogenesis of colorectal cancer (CRC), but it remains unknown whether total vitamin D intake is correlated with early-onset CRC and precursors diagnosed before 50 years of age. The authors concluded that in a cohort of younger women, higher total vitamin D intake was correlated with a decreased risk of early-onset CRC and precursors. However, more research is warranted.

Pharmacists can be instrumental in identifying patients at risk for or exhibiting signs and symptoms associated with GI conditions that warrant further medical evaluation and treatment. They can also encourage patients to be proactive about their digestive health and discuss their risk of GI conditions with their primary health care providers. Because colon cancer is on the rise, especially among younger patients, and the COVID-19 pandemic decelerated colon cancer screenings, it is imperative that pharmacists seize every opportunity to encourage patients to discuss colon cancer awareness and prevention with their primary health care providers. In October 2020, the US Preventive Services Task Force recommended beginning CRC screening at 45 years of age, aligning its guidelines with those of the American Cancer Society.

 The American College of Gastroenterology also changed its guidelines in March 2021.

As the gatekeepers of ensuring and promoting the proper and safe use of both nonprescription and prescription medications, pharmacists should provide patients with guidance on the correct use of products marketed for digestive health and those available for the prevention and treatment of mild to moderate GI ailments amenable to self-treatment.

During counseling, pharmacists can also remind patients of nonpharmacological measures that can be used for digestive health, such as eating a balanced diet, exercising, hydrating, maintaining a healthy weight, obtaining the recommended daily fiber intake, quitting smoking, and reducing stress.

The American College of Gastroenterology provides an excellent resource for patients about digestive health on its website.

is a consulting pharmacist and a medical writer in Haymarket, Virginia.

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https://www.niddk.nih.gov/health-information/digestive-diseases

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Moayyedi P, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG clinical guideline: management of dyspepsia. 

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Robertson R. Why the gut microbiome is crucial for your health. 

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https://www.healthline.com/nutrition/gut-microbiome-and-health

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https://www.worldgastroenterology.org/wgo-foundation/digestive-health-resources

Almario CV, Ballal ML, Chey WD, Nordstrom C, Khanna D, Spiegel BMR. Burden of gastrointestinal symptoms in the United States: results of a nationally representative survey of over 71,000 Americans. 

. 2018;113(11):1701-1710. doi:10.1038/s41395-018-0256-8

Masterson D. Survey: 1 in 4 global consumers used probiotics in the last 6 months. NutraIngredients. Updated August 12, 2021. Accessed September 9. 2021. 

https://www.nutraingredients-usa.com/Article/2021/08/12/Survey-1-in-4-global-consumers-used-probiotics-in-last-6-months

Gunn D, Abbas Z, Harris HC, et al. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and 

. 2021;gutjnl-2021-324784. doi:10.1136/gutjnl-2021-324784

Yeoh YK, Zuo T, Lui GC-Y, et al. Gut microbiota composition reflects disease severity and dysfunctional immune responses in patients with COVID-19. 

. 2021;70(4):698-706. doi:10.1136/gutjnl-2020-323020

Kim H, Lipsyc-Sharf M, Zong X, et al. Total vitamin D intake and risks of early-onset colorectal cancer and precursors. 

 2021;161(4):1208-1217.e9. doi:10.1053/j.gastro.2021.07.002

Bankhead C. USPSTF: start CRC screening at age 45. 

 October 27, 2020. Accessed September 10, 2021. 

https://www.medpagetoday.com/hematologyoncology/coloncancer/89352

Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG clinical guidelines: colorectal cancer screening 2021. 

. 2021;116(3):458-479. doi:10.14309/ajg.0000000000001122

But pharmacists can offer guidance on self-treatment vs more serious issues requiring evaluation.

Patients May Find Nonprescription Options for GI Symptoms Overwhelming

Great strides have been made in understanding, preventing, and treating severe COVID-19 infections.

The emergency use authorization by the FDA for the available COVID-19 vaccines and the recent full FDA approval of the Pfizer COVID-19 vaccine were monumental moments in the fight against this relentless virus. As the COVID-19 pandemic persists, pharmacists continue to be instrumental in providing patients with reliable information about the prevention, detection, treatment, and management of COVID-19. Pharmacists can be influential in dispelling common misinformation and myths about the COVID-19 virus, its variants, and the available vaccines. In the beginning of the pandemic, there were initial concerns about the safety of individuals with COVID-19 taking ibuprofen, but these claims originated from anecdotal and low-quality evidence.

 Major public health organizations around the globe do not advise against using ibuprofen to ease COVID-19 symptoms or the adverse effects (AEs) associated with the vaccine.

 As accessible health care providers, pharmacists are likely to encounter patients seeking counsel on the use of nonprescription analgesic/antipyretics, such as acetaminophen, and the non-steroidal anti-inflammatory agents (NSAIDS), such as ibuprofen and naproxen sodium, for the symptomatic relief of some of the common mild to moderate symptoms associated with COVID-19 that may be amenable to self-treatment and to manage AEs, such as fever and pain, associated with the COVID-19 vaccines.

In a recent publication on the Medical News Today website, the author indicates that the CDC recommends consulting a health care professional about taking analgesics/antipyretic to manage the AEs of the COVID-19 vaccine.

The CDC stated, “It is not recommended you take over-the-counter medicine, such as ibuprofen, aspirin, or acetaminophen, before vaccination for the purpose of trying to prevent vaccine-related side effects. It is not known how these medications might affect how well the vaccine works. However, if you take these medications regularly for other reasons, you should keep taking them before you get vaccinated. It is also not recommended to take antihistamines before getting a COVID-19 vaccine to try to prevent allergic reactions.”

In response to the early concerns about the use of NSAIDs and the evolving information about these issues, GlaxoSmithKline (GSK), a leading manufacturer for OTC analgesics issued a statement about the use of ibuprofen and COVID-19 vaccines, saying, “The appropriate use of antipyretics/analgesics, like Advil (ibuprofen), is recommended by public health authorities to help relieve symptoms that may be experienced following vaccination.

 This is consistent with the fact that in the COVID-19 vaccine studies, participants were allowed to use antipyretics/analgesics to treat symptoms.”

Additionally, GSK posted information on its Advil product website about a patient education initiative referred to as #AfterMyShot, which provides patients with valuable information about COVID-19 and the vaccines.

On August 12, 2021, the manufacturer, Janssen also issued a statement about the use of antipyretics and analgesics and the COVID-19 vaccine. In its response, the manufacturer indicated the following:

Pre-vaccination: There are no robust clinical data on how pre-treatment use of antipyretics affects COVID-19 vaccine-induced antibody responses.

Post-vaccination: There is no clinical evidence that the use of antipyretics post-vaccination has a negative effect on COVID-19 vaccine efficacy.

During the Janssen COVID-19 Vaccine clinical trial program, antipyretics were recommended post-vaccination for symptom relief as necessary. Prophylactic antipyretic use was not encouraged. However, in some instances, it could have been considered for participants with special circumstances and/ or comorbidities.

Bayer Consumer Health, the manufacturer of the OTC NSAID marketed as Aleve also has information on its website about the COVID-19 virus and the use of the product, stating: “To date, public health authorities, including the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the European Medicines Agency and the World Health Organization, are not aware of any scientific evidence supporting a link between the use of non-steroidal anti-inflammatory medicines (NSAIDs), such as Aleve, and worsened outcomes from COVID-19.”9

Available clinical evidence regarding other vaccines indicate that analgesics/antipyretics are commonly used around the time of vaccination to ameliorate fever and pain, and the use is primarily post vaccination.

 Although the results of several studies show that prophylactic analgesic/antipyretic administration decreases post-vaccination adverse reactions, there are also study results showing that their use may decrease the antibody responses to several vaccine antigens.

In a recent 2021 publication, Etminan et al, indicated that several regulatory bodies have made statements regarding the use of antipyretics around the time of vaccination. In 2015, the World Health Organization stated that use of antipyretics is not recommended before or at the time of vaccination but approved in the days after vaccination, and the CDC concurs with these recommendations.

 Etminan et al, noted that to date, there are no clinical data on this issue with regard to the COVID-19 vaccines, and the data provided in clinical trials for the mRNA vaccines only mentioned that the use of antipyretics was increased with increasing dose concentrations and dose number, but data on immunogenicity were not given.

 Finally, Etminan et al, indicated that moving forward, clinical trials need to urgently investigate and answer 4 questions: 

Do either acetaminophen or ibuprofen affect antibody response by COVID-19 vaccines, and if so, is there a difference in antibody titers between the 2 agents?

Does a potential interaction with antipyretics vary with different vaccine types (mRNA vs non-mRNA vaccines)?

Does the timing of antipyretic administration (before vaccination or immediately after) affect antibody titers?

Does a possible negative interaction only affect antibody titers for the first dose, second dose, or both? 

As clinicians and patient educators, pharmacists can educate patients about the benefits of vaccines and provide patients with facts and dispel common myths and misconceptions about vaccines particularly the COVID-19 vaccine. Until more clinical data become available, patients should be directed to adhere to CDC recommendations, and when in doubt they should consult their primary health care providers before taking any medications, including OTC drugs.

Kandola A. Ibuprofen and COVID-19: is it safe? 

 August 17, 2021. Accessed August 26, 2021. 

https://www.medicalnewstoday.com/articles/ibuprofen-and-covid

Preparing for your COVID-19 vaccination. CDC. Updated August 19, 2021. Accessed August 26, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/prepare-for-vaccination.html

Possible side effects after getting a COVID-19 vaccine. CDC. Updated August 6, 2021. Accessed August 26, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html

Coronavirus (COVID-19) vaccines. United Kingdom National Health Service. Reviewed August 19, 2021. Accessed August 26, 2021. 

https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

The facts about ibuprofen and COVID-19. GSK. Accessed August 26, 2021. 

https://www.gskhealthpartner.com/en-us/pain-relief/brands/advil/covid19/

#AfterMyShot: what Will You do? Advil. Accessed August 26, 2021. 

https://www.advil.com/coronavirus/vaccination/

Janssen COVID-19 vaccine. Janssen MD. Updated August 27, 2021. Accessed August 31, 2021. 

https://www.janssenmd.com/janssen-covid19-vaccine/clinical-use/concomitant-use/antipyretics/janssen-covid19-vaccine-use-of-janssen-covid19-vaccine-with-antipyretics-and-analgesics

Janssen vaccines & Prevention B.V.. Janssen. December 14, 2020. Accessed August 26, 2021. 

https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protoco

Aleve and COVID-19. Aleve. Accessed August 26, 2021. 

Saleh E, Moody MA, Walter EB. Effect of antipyretic analgesics on immune responses to vaccination. 

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Taddio A, Manley J, Potash L, Ipp M, Sgro M, Shah V. Routine immunization practices: use of topical anesthetics and oral analgesics. 

 2007;120(3):e637-643. doi:10.1542/peds.2006-3351

Manley J, Taddio A. Acetaminophen and ibuprofen for prevention of adverse reactions associated with childhood immunization. 

Pharmacists can review clinical evidence and CDC recommendations before providing information.