OTC Case Studies: Inflammation

CASE 1: LOWER BACK PAIN

Q: CH is a 48-year-old woman who is complaining of lower back pain. She had been traveling for work the past few days and thinks that the bed was making her back ache. CH ranks her pain level at 4 out of 10, and she would like a recommendation for pain relief, preferably something natural. She wants to avoid ibuprofen because of her hypertension. CH exercises regularly and is in good shape. Except for her acute back pain and hypertension, she has no other medical conditions. What recommendations can the pharmacist make?

A: The American College of Physicians recommends using heat therapy for patients suffering from acute or subacute back pain.¹ The mechanism of heat therapy is not fully understood, but it may increase blood flow and relieve stiffness. Heat can be used in many forms, including hot-water bottles, heat adhesives such as ThermaCare, heating pads, or warm-water compresses. Heat can be used up to 8 hours with most products within a 24-hour period. Heat adhesives come in many shapes and sizes, depending on the type of pain. If CH tries to use heat adhesives, it is important she follows the package directions. She should make sure that her skin is clean, dry, and free of lotions, makeup, or moisturizer. Instruct CH to place the darker heat cells flat on the skin. Counsel CH to remove the patch if the pain persists for more than 7 days, worsens, or if she experiences burning, discomfort, rash, swelling, or other changes to the skin where the wrap is worn. Patients older than 55 should place the patch over a layer of clothing to prevent burns.² If CH’s pain persists for more than 7 days, she should see a health care professional for further evaluation.

CASE 2: HAND OSTEOARTHRITIS

Q: NM is a 64-year-old man who is looking for something to relieve pain in his hand. He complains of mild pain and stiffness in the morning when he wakes up. NM says the pain typically goes away after he starts moving. His doctor diagnosed him with osteoarthritis (OA) 2 years ago, but he said the pain was manageable. Now NM's pain has increased, and he would like to take an OTC medication. He rates his pain level as 5 out of 10 most days, though sometimes it is 3 out of 10. When NM was diagnosed, his doctor recommended using acetaminophen, because he has no medical conditions. However, because that was several years ago, NM is seeking advice on the use of acetaminophen with osteoarthritis. What should the pharmacist advise?

A: Acetaminophen has been used for many years to treat OA. However, the 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee concluded that acetaminophen should be conditionally recommended. The results of a meta-analysis showed that acetaminophen was not effective in reducing OA pain. Based on these findings, the updated first-line recommendation is an oral nonsteroidal antiinflammatory drug (NSAID) for knee, hip, and hand OA. NSAIDs are strongly recommended over all other oral medications. The guidelines did not evaluate the different types of NSAIDs. However, each patient should be evaluated for potential risk of cardiovascular, gastrointestinal, and renal adverse effects.³ Ideally, lower doses of a shorter duration show fewer adverse effects, and patients should be titrated down if the drugs are tolerated.

CASE 3: ELDERBERRY IN CORONAVIRUS

Q: RG is a 28-year-old woman who is looking for elderberry syrup. She has been taking it for the past several months to prevent coronavirus disease 2019 (COVID-19). RG has a fear of being hospitalized because she has diabetes and hypertension. She started taking elderberry syrup because a friend uses it to prevent influenza. RG also is concerned about the coronavirus vaccine, and she wants to know if it can be administered with the influenza vaccine. What should the pharmacist recommend?

A: A few double-blind, placebo-controlled, randomized trials evaluated elderberry for treatment of influenza. They found that elderberry may reduce symptom duration. Although the study results showed benefits, they showed that the trials that did not reflect the general population.^4-6 There are no data to support the use of elderberry syrup for the prevention or treatment of COVID-19. There has been controversial evidence on elderberry increasing the cytokine storm, which is linked to COVID-19. However, the data are not strong enough for basing recommendations. RG should focus on preventive measures, such as avoiding close contact, cleaning and disinfecting often, frequent handwashing, social distancing of at least 6 feet, and wearing a mask in public places.⁷ In terms of vaccine administration, pharmacists cannot make any recommendations without the prescribing information of an FDA-approved product. However, most vaccines can be safely given on the same day.

CASE 4: GLUCOSAMINE IN OAQ: TT is a 75-year-old woman who is complaining about pain in her knees. She has had osteoarthritis for several years with minimum pain. TT says that her pain level is now 3 out of 10, and she can tolerate it. At this time, she is not interested in taking an OTC medication. She spoke to a friend who recommended glucosamine chondroitin. TT likes the idea of using something natural but understands that sometimes natural products have adverse effects. What advice should the pharmacist give TT?

A: Glucosamine has been widely used over the past decade to treat osteoarthritis. The American College of Rheumatology changed its position in its 2019 guidelines. The guidelines recommend against the use of glucosamine for OA for the knee, hip, or hand. Multiple studies have shown a benefit. However, discrepancies in efficacy reported with industry-sponsored studies versus public studies have raised serious concerns about publication bias. Although glucosamine can be used safely without harmful adverse effects, the guidelines recommend against the use of glucosamine. In the 2019 guidelines, the panel also recommended against the use of chondroitin sulfate for knee/hip OA but recommend it conditionally with hand OA. If TT is interested, there are other nonprescription options, such as exercise, tai chi, and weight loss.³

Ammie J. Patel, PharmD, BCPS, BCACP, is a clinical assistant professor of pharmacy practice and administration at the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, in Piscataway, and an ambulatory care specialist at RWJBarnabas Health Primary Care in Shrewbury and Eatontown, New Jersey.Rupal Patel Mansukhani, PharmD, FAPhA, NCTTP, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.

REFERENCES

• Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514-530. doi:10.7326/M16-2367
• ThermaCare HeatWraps lower back and hip. Pfizer. Accessed September 29, 2020. http://labeling.pfizer.com/ShowLabeling.aspx?id=1807
• Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020;72(2):149-162. doi:10.1002/acr.24131
• Zakay-Rones Z, Varsano N, Zlotnik M, et al. Inhibition of several strains of influenza virus in vitro and reduction of symptoms by an elderberry extract (Sambucus nigra L)during an outbreak of influenza B Panama. J Altern Complement Med. 1995;1(4):361-369. doi:10.1089/acm.1995.1.361
• Zakay-Rones Z, Thom E, Wollan T, Wadstein J. Randomized study of the efficacy and safety of oral elderberry extract in the treatment of influenza A and B virus infections. J Int Med Res. 2004;32(2):132-140. doi:10.1177/147323000403200205
• Kong HF. Pilot clinical study on a proprietary elderberry extract: efficacy in addressing influenza symptoms. Online J Pharmacol Pharmacokinet. 2009;5:32-43.
• How to protect yourself & others. CDC. Updated September 11, 2020. Accessed September 29, 2020. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html