OTC Reflux Medications: Concerns for Patients and Proactive Roles for Compounding Pharmacists
Rich used to experience frequent heartburn, but he simply popped antacid tablets and went on with life. Then one night he woke with sharp and unbearable chest pain. When the symptoms didn’t subside, he went to the emergency room and spent the rest of the night being tested and monitored for a heart attack. Since he didn’t associate heartburn with reflux, he didn’t think to mention it to the ER staff. After being discharged with a diagnosis of reflux, he took OTC proton pump inhibitors. They were so effective that he continued to take them daily for quite some time without bothering to follow-up with his doctor, not realizing the potential risks associated with long-term use of OTC reflux medications. Compounding pharmacists may be the only health care professionals positioned to educate patients like Rich about proper use and pitfalls.
Prevalence and Market Motivate Outreach Efforts
In America, 20 to 40 percent of all adults have chronic heartburn or regurgitation symptoms. At the low end, that translates into roughly 47 million adults. Reflux symptoms are severe enough to prompt nine million visits yearly to primary care providers, leaving millions with nagging symptoms who don’t visit a doctor.1 They find relief by going to the local pharmacy for OTC reflux medications, creating a market for OTC antacids and proton pump inhibitors that reached nearly 1.9 billion dollars in 2015.
You already know reflux medications have the potential to make a difference to your bottom line, but it’s interesting to note that private label products accounted for 43 percent of the total OTC sales in 2015.2 With an outreach plan, you could tap into this segment of the market and offer individualized compounded options. Beyond building your business and providing individualized treatments, remember that this very large group of patients don’t know about the risks associated with long-term use of reflux medications.
Adverse Effects, Drug Interactions and Nutritional Deficiencies from OTC Reflux Medications
In the wake of heightened concerns about acetaminophen, you might expect consumers to be more savvy about heeding warning statements on all OTC medications—but don’t count on it. A meta-analysis found that warning labels attract attention, yet they’re unlikely to influence perceptions of hazards. Since patients don’t consult physicians before self-medicating for heartburn—and they may not read the fine print about side effects and proper use—pharmacists should be prepared to warn them about adverse effects such as:
- Vitamin and mineral deficiency: Suppression of stomach acid interferes with the absorption of vitamin B12, calcium, iron and magnesium. While studies have produced different conclusions, sufficient results consistently point to the potential for nutrient deficiencies.
- Medication malabsorption: PPIs affect drug metabolism by inhibiting or inducing enzymes. Watch for patients taking PPIs together with medications such as Plavix, ketoconazole, digoxin, Atazanavir and ampicillin.3
- Weakened bones and fractures: Due to potential calcium malabsorption, patients at a higher risk for osteoporosis should be warned to avoid chronic use of acid-reducing products, which includes women, older adults, patients with an overactive thyroid and those taking corticosteroids, anticoagulants and immunosuppressants.
- Cardiovascular abnormalities: While the risk may be small and has yet to be verified with randomized, controlled trials, chronic use of PPIs—but not H2 blockers—may promote myocardial infarction. The most critical information reported after investigators reviewed more than 16 million trials was that the danger might extend to the general population.4
- Increased risk of infections: Medications that reduce gastric acid also diminish the stomach’s ability to fight bacteria, which can lead to bacterial overgrowth in the stomach and upper gastrointestinal tract. Hospitalized patients, the elderly and those who take broad-spectrum antibiotics along with PPIs have a higher risk of Clostridium difficile infection.
- Calcium-alkali syndrome: Once known as milk-alkali syndrome, this health concern has reemerged as the third most common cause of hypercalcemia, thanks to increased use of calcium supplements and calcium-containing antacids.5 Patients with a higher chance include the elderly, postmenopausal women, pregnant women, bulimic patients and those on dialysis.
Outreach Includes Assessment and Compounded Options
Outreach takes a two-pronged approach—counsel patients taking prescription meds likely to interact with reflux medications about their OTC usage and target patients purchasing OTC antacids. As always, staff at the counter should ask specific questions rather than the generic, “Do you have questions for the pharmacist?” Staff should also have handouts providing information about the recommended use and potential side effects, as well as an invitation to a free appointment with the pharmacist. Consultation talking points include:
- Assess for warning signs: Ask anyone self-treating for reflux whether they have chronic coughing, persistent hoarseness, or difficulty swallowing. Have they unexpectedly lost weight, vomited blood or have black stools? Have symptoms returned in spite of OTC treatment? If they answer yes to any of these questions, refer them to a primary care physician. Make sure they know that heartburn accompanied by nausea, sweating, shortness of breath or radiating pain demands immediate medical attention.6
- Screen for medications that irritate the GI tract: Patients may not suspect their prescriptions of causing reflux. Many medications are associated with GI problems, but be on the lookout for patients taking bisphosphonates, theophylline, quinidine, calcium channel blockers, benzodiazepines, tricyclic antidepressants and nitrates. Also check to see if the patient uses OTC aspirin and NSAIDs.
- Offer compounded options: Sublingual delivery of reflux medications—or the melt-in-your mouth formulation of dexlansoprazole approved in January 2016—should prevent side effects. Patients taking aspirin or NSAIDs will benefit from delivery options that bypass the GI tract. When your reflux patient is a child, let parents know you can formulate a flavored omeprazole suspension.
- Discuss dietary and lifestyle changes: Talk about identifying and avoiding foods that may trigger reflux. While there isn’t a one-size-fits-all approach to dietary changes, here’s a short list of problem-causing foods: coffee, caffeinated and carbonated beverages, peppermint, chocolate, tomatoes, citrus fruits, alcohol, black pepper, garlic and onions. Some patients may need to avoid spicy, high-fat or fried foods. Patients should not lie down after eating and it helps to elevate the head of their bed. Discuss weight loss if appropriate and recommend smoking cessation programs for smokers, as nicotine weakens the lower esophageal muscle.
When Pharmacists Intervene, Quality of Life Improves
When pharmacists take the time to counsel patients with gastrointestinal symptoms, they accurately separate those who can effectively self-medicate from those who need to consult a physician. In the process, they can recommend the best medication options, significantly contribute to their patients’ health, and create a loyal customer base that helps build their business.
Pharmaceutica North America provides high-quality bulk active pharmaceutical ingredients, unit-dose APIs and effective delivery bases to help patients experiencing side effects from OTC medications. Contact us today to learn more about how our products can meet your pharmaceutical needs.
- “GERD Symptoms in the General Population: Prevalence and Severity Versus Care-Seeking Patients,” October 2014, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4275099/ ↩
- “Leading Antacid Tablet Brands in the United States in 2015, Based on Sales,” 2016, http://www.statista.com/statistics/194544/leading-us-antacid-tablet-brands-in-2013-based-on-sales/ ↩
- “PPIs and Other Drugs,” 2016, http://www.pdrhealth.com/proton-pump-inhibitors/proton-pump-inhibitors-and-other-drugs ↩
- “Chronic Use of Proton Pump Inhibitors Increases Heart Risk,” June 2015, http://www.medscape.com/viewarticle/846202 ↩
- “Calcium-Alkali Syndrome in the Modern Era,” November 2013, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3875933/ ↩
- “Self-Treatment Tips for Heartburn,” May 2009, http://www.pharmacytimes.com/publications/issue/2009/2009-05/counselingheartburn-0509 ↩