OTC Focus Case Studies: Pain

CASE 1: HEADACHE TREATMENT DURING PREGNANCY

Q: LP is a 34-year-old pregnant woman who is looking for the best option to treat a headache. The headache began about 10 hours earlier, and the pain has gradually gotten worse. LP is in her third trimester and has a history of episodic tension headaches. She has successfully used ibuprofen in the past for relief. LP denies the use of chronic medications. What recommendations do you have for pain relief?

A: Counsel LP about nonpharmacologic strategies for headache management. These include applying a cold or ice pack with pressure to the areas of pain and relaxation exercises. Also let her know that even though acetaminophen crosses the placenta, at normal doses it is considered safe during pregnancy. However, it is important to tell LP that other combination products may contain acetaminophen as well and to keep track of the total daily dose. Acetaminophen should not exceed 3000 mg/day for Tylenol Extra Strength caplets or 3250 mg/day for Tylenol Regular Strength tablets. A dose of 4000 mg/day can be used, but only if directed by a health care provider.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are contraindicated in the third trimester because of negative effects during labor, such as increased postpartum bleeding, and they may cause negative cardiovascular effects to the fetus, such as premature closure of the ductus arteriosus. Although adequate safety studies have not been conducted in humans, a risk benefit discussion should take place prior to using NSAIDs during any trimester of pregnancy. Aspirin and salicylates should also be avoided during pregnancy, because of negative effects on the fetus and mother.^1-4

CASE 2: LOWER-BACK PAIN

Q: RB is a 55-year-old man who hurt his lower back while playing golf this past weekend. The initial severe pain has subsidized and is now more of an ache. However, RB does get a sharp pain when he bends down to tie his shoes, and it is affecting his daily activities. His medical history is significant for controlled hypertension and dyslipidemia. RB’s medication regimen includes atorvastatin (Lipitor) and lisinopril. He is looking for an OTC remedy for his pain and would prefer a topical agent. What recommendations do you have?

A: Advise RB to use a combination of nonpharmacologic and pharmacologic therapies, including the RICE method—rest, ice, compression, and elevation—for up to 3 days. Nonprescription analgesics are recommended as first-line therapy in addition to RICE therapy, and NSAIDs are recommended over acetaminophen for acute back pain, unless there are precautions to NSAID therapy. RB is a candidate for NSAID therapy, as his hypertension is controlled. He should be counseled to use the lowest effective dose for up to 10 days.

There also are many topical analgesics available containing camphor, capsaicin, histamine, lidocaine, menthol, and/or trolamine. They are recommended as adjuncts to systemic therapy for up to 7 days, because of conflicting and limited evidence. The FDA issued a Drug Safety Communication about serious burns, and all patients should be counseled about identifying and preventing burns. If RB’s pain does not improve or resolve within 1 week, he should seek medical attention. In the future, he should warm up, stretch, and stay hydrated to prevent injuries.^5-8

CASE 3: DIABETIC NEUROPATHY

Q: MK is a 63-year-old woman with a 15-year history of diabetes. Her medication regimen includes long-acting insulin and metformin. MK has been nonadherent to her medications, which resulted in kidney disease, peripheral neuropathy, and poor diabetes control. Her neuropathy causes significant discomfort, which she describes as a severe burning pain and tingling in her feet and toes. MK is skeptical of modern medicine and is interested in an herbal remedy. She has heard alpha lipoic acid is being studied for diabetic neuropathy. What suggestions for use of this supplement can you provide?

A: Alpha lipoic acid is found naturally in broccoli and spinach. It is also available as an intravenous (IV) and oral supplement. The oral supplement dosage ranges from 600 mg once daily to 3 times daily and should be taken on an empty stomach, as food decreases absorption. A commonly studied loading dose strategy is 600 mg 3 times daily for 4 weeks followed by 600 mg once daily. Patients who responded well to the higher dose continued to see improvements in symptoms when the dose was reduced to once daily. Common adverse effects include additive hypoglycemic effects, diarrhea, headache, nausea, and rash.

Like many other herbal supplements, the evidence for oral alpha lipoic acid is inconsistent, and many studies evaluated only IV therapy. In 2018, a small prospective, interventional study of 600 mg orally once daily for 40 days concluded that alpha lipoic acid reduced neuropathic symptoms, including disability. In addition, an older meta-analysis concluded that IV supplementation of 600 mg daily for 3 weeks is beneficial, as is oral supplementation of 600 mg daily for up to 5 weeks. Both IV and oral routes were found to be well tolerated. MK can attempt a trial of alpha lipoic acid with close supervision by a health care provider.^9-14

CASE 4: OPIOID-INDUCED CONSTIPATION

Q: RJ is a 54-year-old man with chronic back pain. He has failed acetaminophen and NSAID therapies and was recently prescribed opioid therapy. RJ has not had a bowel movement in 3 days and recalls recently reading an article that opioids can cause constipation. He normally has a bowel movement daily. RJ is seeking advice about an OTC medication to help treat his constipation. He denies any other medical conditions or chronic medications. What recommendations do you have?

A: Pharmacists should counsel all patients on lifestyle changes, such as increasing daily fiber intake with high-fiber foods or supplements (ie, Metamucil), increasing fluid intake, and initiating regular exercise. RJ also should seek medical advice, as he may require long-term therapy and/or prescription medications to prevent or treat opioid-induced constipation. There are many OTC laxative options. While awaiting a medical appointment, recommend Senna or bisacodyl with or without docusate as initial treatment. If RJ’s constipation does not resolve within ~72 hours, polyethylene glycol 3350 may be necessary. The most common adverse effects he may experience include abdominal discomfort, bloating, cramping, and flatulence. In addition, Senna may cause urine discoloration ranging from pink to brown. It is critical to counsel RJ about laxative overuse and toxicity and when to seek medical attention.^15-18

Rupal Patel Mansukhani, PharmD, CTTS, FAPhA, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers University in Piscataway, New Jersey, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.Caitlyn Bloom, PharmD, BCACP, AE-C, is a clinical assistant professor at the Ernest Mario School of Pharmacy at Rutgers University and an ambulatory care clinical pharmacist at RWJBarnabas Health, part of the Barnabas Health Medical Group in Eatontown, New Jersey.

Ammie J. Patel, PharmD, BCACP, is a clinical assistant professor of pharmacy practice at the Ernest Mario School of Pharmacy at Rutgers University and an ambulatory care specialist at RWJBarnabas Health, part of the Barnabas Health Medical Group.

REFERENCES

• Briggs GG, Freeman RK, Towers CV, et al. Drugs in Pregnancy and Lactation. 11th ed. Philadelphia, PA: Wolters Kluwer; 2017.
• FDA drug safety communication: FDA has reviewed possible risks of pain medicine use during pregnancy. FDA website. www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-has-reviewed-possible-risks-pain-medicine-use-during-pregnancy. Published January 9, 2015. Accessed May 16, 2019.
• FDA drug safety communication: prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure. FDA website. www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-prescription-acetaminophen-products-be-limited-325-mg-dosage-unit. Published January 13, 2011. Accessed May 16, 2019.
• Adult dosing charts. Tylenol website. tylenolprofessional.com/adult-dosage. Published 2017. Accessed May 16, 2019.
• National Institutes of Health. Questions and answers about sprains and strains. National Institute of Arthritis and Musculoskeletal and Skin Disease website. niams.nih.gov/Health_Info/Sprains_Strains/default.asp. Updated January 30, 2015. Accessed May 16, 2019.
• Qaseem A, Wilt T, McLean R, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. 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.
• Chou R, Deyo R, Friedly J, et al. Systemic pharmacologic therapies for low back pain: a systemic review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017;166(7):480-492. doi: 10.7326/M16-2458.
• FDA drug safety communication: rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers. FDA website. www.fda.gov/Drugs/DrugSafety/ucm318858.htm. Updated February 11, 2016. Accessed May 16, 2019.
• Rochette L, Ghibu S, Muresan A, Vergely C. Alpha-lipoic acid: molecular mechanisms and therapeutic potential in diabetes. Can J Physiol Pharmacol. 2015;93(12):1021-1027. doi: 10.1139/cjpp-2014-0353.
• Papanas N, Ziegler D. Efficacy of α-lipoic acid in diabetic neuropathy. Expert Opin Pharmacother. 2014;15(18):2721-2731. doi: 10.1517/14656566.2014.972935.
• Gleiter CH, Schug BS, Hermann R, Elze M, Blume HH, Gundert-Remy U. Influence of food intake on the bioavailability of thioctic acid enantiomers. Eur J Clin Pharmacol. 1996;50(6):513-514.
• Garcia-Alcala H, Santos Vichido CI, Islas Macedo S, et al. Treatment of α-lipoic acid over 16 weeks in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose loading. J Diabetes Res. 2015;2015:189857. doi: 10.1155/2015/189857.
• Agathos E, Tentolouris A, Eleftheriadou I, et al. Effect of alpha-lipoic acid on symptoms and quality of life in patients with painful diabetic neuropathy. J Int Med Res. 2018;46(5):1779-1790. doi: 10.1177/0300060518756540.
• McIlduff CE, Rutkove SB. Critical appraisal of the use of alpha lipoic acid (thioctic acid) in the treatment of symptomatic diabetic polyneuropathy. Ther Clin Risk Manag. 2011;7:377-385. doi: 10.2147/TCRM.S11325.
• US Department of Health and Human Services, US Department of Agriculture. 2015-2020 Dietary Guidelines for Americans. 8th Ed. Washington, DC: HHS; 2015. health.gov/dietaryguidelines/2015/guidelines/. Accessed May 16, 2019.
• Fabel PH, Shealy KM. Diarrhea, constipation, and irritable bowel syndrome. In: DiPiro JT, Talbert RL, Yee GC, et al, eds. Pharmacotherapy: A Pathophysiologic Approach. 10th ed. New York, NY: McGraw-Hill Professional; 2017:511.
• Ford AC, Talley NJ. Laxatives for chronic constipation in adults. BMJ. 2012;345:e6168. doi: 10.1136/bmj.e6168.
• Swegle JM, Logemann C. Management of common opioid-induced adverse effects. Am Fam Physician. 2006;74(8):1347-1354.