Rupal Patel Mansukhani, PharmD

MR is a 43-year-old woman looking for an OTC medication that prevents influenza. She heard on the news that this is a bad flu season, with many hospitalizations and deaths from flu-related complications. MR is concerned and would like to take a drug to prevent the flu. She says that she is relatively healthy and takes no medications. MR received the influenza vaccination 2 months earlier. A friend told her about a medication called Oscillococcinum, and MR wants to know if she could take this.

Let MR know that Oscillococcinum is a homeopathic agent, made from the heart and liver of wild duck. The product is likely safe because it contains no measurable amount of active ingredient.

 Although MR is relatively healthy and has no chronic conditions, she may get no real benefit from taking Oscillococcinum. The authors of a 2015 Cochrane review that evaluated 2 prevention studies and 4 treatment studies concluded that there is insufficient evidence to recommend Oscillococcinum for preventing or treating influenza and flulike illness. In the review, the authors mentioned that the trials evaluated were of low quality.

 If MR decides to take the medication, the drugs facts label recommends that patients 2 years and older dissolve 1 tube of the agent in the mouth every 6 hours, up to 3 times a day.

CASE 2: FLU AND DIABETES: EFFECTS ON BLOOD SUGAR AND TREATMENT OPTIONS

RD, a 66-year-old man, wants something to treat his fever. He has had chills, a cough, and a fever for the past 12 hours and feels tired and weak. He asks for an OTC recommendation, mentioning that he has diabetes and hypertension. RD takes metformin 1000 mg twice daily and lisinopril 10 mg once daily. He got the influenza vaccination a month earlier.

RD’s symptoms are similar to those caused by influenza. Most people can recover from the flu, but some are at higher risk of hospitalization and death. Those patients should be referred immediately to a doctor, who can determine if they would benefit from antiretroviral medications. It is important to advise RD that the risk of complications rises with certain conditions, such as asthma; blood disorders such as sickle cell disease; chronic lung disease such as chronic obstructive pulmonary disease and cystic fibrosis; endocrine disorders such as diabetes; heart conditions such as congenital heart disease, congestive heart disease, and coronary artery disease; kidney and liver disorders; metabolic issues such as inherited metabolic disorders and mitochondrial disorders; and neurodevelopment and neurologic conditions. Other patients at risk include native Americans (Alaskan or American Indian), children younger than 2 years, people who are 65 years and older or live in a long-term-care or nursing home facility, pregnant women and individuals who have given birth within the past 2 weeks, and those with a body mass index of 40 or above or a weakened immune system.4 Because RD has both diabetes and is over 65 years of age, refer him to a physician. He can get a rapid influenza diagnostic test performed and, if he has the flu, be treated with antivirals to reduce the risk of hospitalization and death.

OS, a 30-year-old woman, is looking for elderberry. She says that a colleague uses it to prevent influenza. OS works at a day care center and has been getting sick often. Now that it is flu season, she is concerned about developing the illness and missing workdays. OS is healthy and has no medical conditions. She wants to take a preventive product because she forgot to get her influenza vaccination.

The findings of some studies show that elderberry may reduce flulike symptoms. Two trials demonstrated that 1 teaspoon of elderberry syrup (Sambucol) 4 times daily reduced the symptoms and duration of influenza infection when given within 2 days of symptoms onset. Symptom relief occurred within 2 to 4 days of treatment for most patients.

Although these studies showed benefit in patients who had influenza, minimal data support long-term use of elderberry to prevent the flu. Most formulations in clinical trials have been safe for up to 12 weeks. However, it may not be helpful for OS to take elderberry for influenza prevention long term.

 Sambucol original contains 3.8 g of elderberry extract. The recommendation dosage for adults and children over 4 years is 2 teaspoons daily. Again, it is important to advise OS that elderberry has not proved beneficial in preventing flu. She can take other preventive measures, such as getting the influenza vaccination. OS can also practice regular handwashing to decrease her exposure to illnesses such as influenza.

 UT is a 46-year-old woman seeking something over the counter for her husband, MT, who has been experiencing flulike symptoms for the past 24 hours. He went to an urgent care center last night and tested positive for influenza, and the doctor there suggested a medication called oseltamivir phosphate (Tamiflu). MT, who is 48 years old and has no medical conditions, declined the prescription and said he would deal with the illness at home without a medication. Now he has changed his mind and wants to take oseltamivir. UT heard on the news that Tamiflu will soon be available over the counter.

In July, Sanofi signed an agreement with Roche for the exclusive OTC rights to oseltamivir for the prevention and treatment of influenza. Sanofi will be responsible for leading FDA negotiations for the OTC switch. However, tell MT that the switch has not occurred yet and Tamiflu still requires a prescription. Under the agreement, Sanofi will have exclusive marketing, scientific engagement, and distribution of OTC Tamiflu in the United States.

 The FDA has the final word on reclassifying medications from available by prescription to over the counter. However, OTC medications such as analgesics, antipyretics, cough medications, and decongestants can provide relief from the common symptoms that MT might be experiencing, such as body aches, chills, cough, fever, headache, and nasal congestion.

Rupal Patel Mansukharni, PharmD, CTTS, FAPhA

 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.

 is a clinical assistant professor of pharmacy practice at the Ernest Mario School of Pharmacy and an ambulatory care specialist at RWJBarnabas Health, part of the Barnabas Health Medical Group.

Oscillococcinum. Natural Medicines [database online]. Somerville, MA: Therapeutic Research Center; 2017. naturalmedicines.therapeuticresearch.com. Updated February 13, 2019. Accessed January 2, 2020.

Mathie RT, Frye J, Fisher P. Homeopathic Oscillococcinum for preventing and treating influenza in influenza-like illness. 

. 2015;1:CD001957. doi: 10.1002/14651858.CD001957.pub6.

Oscillococcinum. Oscillococcinum. Boiron website. oscillo.com/about/facts-about-oscillo/. Accessed December 10, 2019.

People at high risk for flu complications. CDC website. cdc.gov/flu/highrisk/index.htm. Updated August 27, 2018. Accessed December 10, 2019.

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. 

. 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. 

. 2004;32:132-140. doi: 10.1177/147323000403200205.

Sanofi signs strategic deal for exclusive US over-the-counter rights to Tamiflu in flu care [news release]. Paris, France: Sanofi; July 23, 2019. sanofi.com/en/media-room/press-releases/2019/2019-07-23-07-00-00. Accessed December 10, 2019.

Articles

Learn about OTC preventions for influenza, handling flu and diabetes, and more.

OTC Focus Case Studies: Influenza

CASE 1: SAW PALMETTO FOR PROSTATE CANCER PREVENTION

PK is a 78-year-old man who complains of frequent urination, especially at night. His urine stream stops and starts frequently, making him feel as if he never fully urinates. PK says that he recently received a diagnosis of an enlarged prostate, and his doctor started him on tamsulosin (Flomax). In addition, PK is concerned that his enlarged prostate will lead to prostate cancer. A few of his friends take saw palmetto for prostate health. PK wants to know whether any evidence shows that taking saw palmetto decreases the risk of prostate cancer, with the additional benefit of helping him urinate normally. What recommendations do you have?

In the VITAL cohort, a study conducted in Washington from 2000 to 2002, more than 35,000 men aged 50 to 76 years without a diagnosis or history of prostate cancer completed a questionnaire evaluating their baseline use of supplements.

 After a median follow-up of 6.1 years, investigators found that the use of saw palmetto was not associated with a lower risk of prostate cancer.

 However, they discovered that grape-seed supplementation may be associated with a reduced risk.

 Regarding urinary symptoms, a Cochrane review of 32 randomized controlled trials comprising more than 5000 men determined that saw palmetto was not effective for treating urinary symptoms, improving urinary flow, or reducing prostate size.

PK should be counseled to look for improvements in urinary symptoms with tamsulosin, adhere to his medications, and receive routine prostate screenings.

CASE 2: BLACK COHOSH FOR BREAST CANCER PREVENTION

RW is a 58-year-old postmenopausal woman who is looking for something natural to prevent breast cancer. Her gynecologist recently started her on estrogen hormone therapy for bothersome hot flashes. RW tried nonhormone therapy in the past without relief. She is willing to give the hormones a chance because the hot flashes are causing her significant discomfort. However, RW read that estrogen therapy increases the risk of breast cancer, making her very concerned, as both of her grandmothers died from breast cancer. RW says that she receives a mammogram every 6 months as preventive care. She heard that black cohosh may reduce the risk of breast cancer and wants to know whether she should start it. What recommendations do you have?

A recent systematic review of 3 prospective and population-based observational studies evaluating black cohosh and breast cancer found conflicting evidence of either a decreased risk of breast cancer or no association.

 In addition, the VITAL cohort, mentioned in the previous case, of nearly 35,000 women aged 50 to 76 years without a diagnosis or history of breast cancer completed a questionnaire evaluating their baseline use of supplements.

 After a median follow-up of 6 years, investigators found that the use of black cohosh was not associated with a lower risk of breast cancer.

 However, they found that fish oil supplementation may be associated with a reduced risk.

 Given the conflicting evidence, RW should discuss these findings with her provider for a risk-benefit evaluation. In addition, she should be encouraged to adhere to a healthy lifestyle, continue receiving mammograms and routine health screenings, and follow up with her provider if she thinks she is experiencing any changes in her health.

BB is a 72-year-old woman who is complaining of diarrhea. She recently received a diagnosis of colorectal cancer, and her doctor started her on a chemotherapy regimen containing irinotecan. BB’s first round of chemotherapy was 5 days ago. She reports 4 loose stools per day accompanied by mild cramps and nausea over the past 3 days. BB denies a decrease in fluid and food consumption or a fever. Her doctor told her that she mostly likely would have diarrhea and, if it was mild, to ask for loperamide at the pharmacy. BB wants to know what dosage she should follow and what adverse effects to watch for. What recommendations do you have?

BB can be classified with mild to moderate uncomplicated diarrhea. She may start with loperamide 4 mg, followed by 2 mg every 2 to 4 hours or after each loose stool, not to exceed 16 mg per day. The most common adverse effects that BB may experience are abdominal cramps, constipation, dizziness, and nausea. She should stay hydrated by consuming 8 to 10 glasses daily of clear liquids with electrolytes, such as Gatorade and soup broth. In addition, BB should eat frequent small, bland meals comprising applesauce, bananas, plain pasta, rice, or toast. Advise her to stop loperamide after 12 hours free of diarrhea. However, if BB’s symptoms do not improve after 12 to 24 hours, she can increase the loperamide dosage to 2 mg every 2 hours. If the diarrhea persists 12 to 24 hours later despite the higher dosage of loperamide, she should call her doctor for further evaluation.

FG is a 64-year-old man looking for something to help him quit smoking. He smokes a pack per day and inhales his first cigarette upon waking. FG has a 40-year pack history and recently received a diagnosis of lung cancer. His oncologist is recommending chemotherapy and advised FG that his chances of survival will improve if he quits smoking. FG tried quitting cold turkey unsuccessfully 3 times more than 20 years ago. He says he wants to see his grandchildren grow up and is willing to do whatever it takes to quit. FG asks for information about programs in the community for smoking cessation. What recommendations do you have? 

FG can try numerous OTC nicotine replacement products, including gum, lozenges, and the patch. Data have demonstrated improved abstinence rates with combination therapy. The patch has the best adherence rate and should be started at 21 mg because FG smokes >10 cigarettes per day. Advise him to apply the patch upon waking and wear it for 16 to 24 hours. If he experiences difficulty sleeping, he may remove it prior to bedtime. FG can also use the 4-mg gum or lozenge because he has his first cigarette within 30 minutes of waking. A minimum of 9 pieces per day is recommended, with a maximum of 24 pieces of gum and 20 lozenges per day. Counsel FG on the proper administration of the gum and lozenge and to avoid drinking or eating for 15 minutes prior to use.

 A good resource is the CDC website, which has information on many programs to quit smoking. These include a mobile app (quitSTART), a phone number (800-QUIT-NOW), and a texting service (SmokefreeTXT).

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.

 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.

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.

Brasky TM, Kristal AR, Navarro SL, et al. Specialty supplements and prostate cancer risk in the vitamins and lifestyle (VITAL) cohort. Nutr Cancer. 2011;63(4):573-582. doi: 10.1080/01635581.2011.553022.

Tacklind J, Macdonald R, Rutks I, Stanke JU, Wilt TJ. Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2012;12:CD001423. doi: 10.1002/14651858.CD001423.pub

Fritz H, Seely D, McGowan J, et al. Black cohosh and breast cancer: a systematic review. Integr Cancer Ther. 2014;13(1):12-29. doi: 10.1177/1534735413477191.

Brasky TM, Lampe JW, Potter JD, Patterson RE, White E. Specialty supplements and breast cancer risk in the VITamins And Lifestyle (VITAL) cohort. 

 2010;19(7):1696-1708. doi: 10.1158/1055-9965.EPI-10-0318.

Benson AB III, Ajani JA, Catalano RB, et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol. 2004;22(14):2918- 2226. doi: 10.1200/JCO.2004.04.132.

US Department of Health & Human Services. Treating tobacco use and dependence: 2008 update. Tobacco Use and Dependence Guideline Panel. 2008.

Smoking and tobacco use. CDC website. cdc.gov/tobacco/quit_smoking/how_to_quit/resources/index.htm. Updated December 11, 2017. Accessed September 21, 2019.

Prostate cancer prevention, irinotecan-induced diarrhea, smoking cessation, and more.

OTC Focus Case Studies: Cancer

CASE 1: HEADACHE TREATMENT DURING PREGNANCY

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?

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.

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?

Advise RB to use a combination of nonpharmacologic and pharmacologic therapies, including the RICE method—rest, ice, compression, and elevation&mdash;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.

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?

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.

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?

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.

 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.

Briggs GG, Freeman RK, Towers CV, et al. 

 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

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.

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. 

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. 

 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. 

 2015;93(12):1021-1027. doi: 10.1139/cjpp-2014-0353.

Papanas N, Ziegler D. Efficacy of α-lipoic acid in diabetic neuropathy. 

. 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. 

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. 

. 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. 

. 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. 

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2015-2020 Dietary Guidelines for Americans

. 8th Ed. Washington, DC: HHS; 2015. health.gov/dietaryguidelines/2015/guidelines/. Accessed May 16, 2019.

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Ford AC, Talley NJ. Laxatives for chronic constipation in adults. 

Swegle JM, Logemann C. Management of common opioid-induced adverse effects. 

OTC case studies for headache treatment during pregnancy and lower-back pain remedies.

OTC Focus Case Studies: Pain

Q: NM is a 41-year-old man who comes into the pharmacy complaining of bloating and flatulence. He says he was recently given a diagnosis of diabetes, and his doctor started him on medication. In addition, the doctor asked NM to increase his fiber, as he gets very little in his diet, and recommended an OTC fiber supplement. NM says he got a powder supplement that contains psyllium. The directions on the package recommended taking it 3 times a day. NM says that the bloating and discomfort started when he began the psyllium. What recommendations do you have?

A: Increasing dietary fiber can lead to bloating and flatulence. The Academy of Nutrition and Dietetics recommends about 38 g of fiber per day.

 NM should have slowly increased his fiber intake to avoid symptoms such as bloating and gas. Importantly, advise him that he can also try to increase his fiber through his diet. Foods high in fiber include beans, fruits, legumes, nuts, and vegetables. Because NM is already taking psyllium, he can try to titrate up slowly to avoid the bloating and flatulence. If that does not work, he can try a soluble, semisynthetic fiber supplement, such as calcium polycarbophil. Calcium polycarbophil is an “inert synthetic polymer (compound) with water-absorbing ability, which is higher than natural fibers such as psyllium or carboxymethylcellulose.”

Q: LL is a 32-year-old woman who comes into the pharmacy complaining of morning sickness. She is 16 weeks pregnant and is nauseated every morning when she wakes up. LL has tried acupressure wristbands, which she used during her past pregnancy. However, the wristbands have provided no relief during this pregnancy. LL is healthy overall but has been feeling this way since becoming pregnant. LL’s friend recommended ginger, but LL does not like the taste and is looking for a natural supplement that she can take to reduce her nausea. She denies vomiting or any other symptoms. Currently, LL is taking a prenatal multivitamin. What recommendations do you have?

A: Morning sickness can vary in severity and can be treated with nonpharmacologic or pharmacologic treatment. For most pregnant women, symptoms of nausea resolve by 20 weeks. However, LL appears to be in discomfort and would like to take something natural to help relieve her symptoms. During pregnancy, women can use ginger in many forms, including capsules, ginger ale, preserves, and teas. According to the American Academy of Family Physicians, one study showed that 1g a day of ginger was more effective than a placebo in reducing the symptoms of nausea. Although no safety data from clinical studies are available, many cultures use ginger as part of their daily diet. It is considered relatively healthy. In addition, LL should be advised about vitamin B6, which, as well as pyridoxine, has also been shown to reduce nausea during pregnancy and can be used alone or in combination with doxylamine. The results of one study showed that small doses of 75 mg a day were more effective than a placebo in reducing symptoms. LL can try either agent, but she should discuss her options with her physician before she starts any new medication, even if it is natural.

Q: RD is a 24-year-old woman who comes in looking for an OTC option to decrease her menstrual pain. She has had

pain every month during her menstrual cycle for the past 10 years. RD typically takes ibuprofen before and during her menstrual cycle to decrease pain. She complains of a dull ache with spasmodic cramping in her midabdominal area. RD has seen a physician, who gave her a diagnosis of primary dysmenorrhea around her menstrual cycle. He recommended that she take ibuprofen as needed for pain. RD read online that fish oil, in addition to being good for heart health, can help decrease menstrual pain. What recommendation do you have regarding fish oil?

A: Omega-3 fish oil has proven benefits in patients who suffer from high triglycerides. In addition, limited data are

available on its use for many other conditions, including attention-deficit/hyperactivity disorder, bipolar disorder, dysmenorrhea, heart failure, and hypertension. Regarding dysmenorrhea, the results of one study evaluated the use of fish oil compared with a placebo. The authors concluded that the intensity and duration of pain decreased with fish oil compared with a placebo.

 Another study evaluated omega-3 fish oil as well as vitamin E compared with a placebo. The study results showed that both supplements effectively relieved menstrual pain. However, the combination reduces the pain significantly (P <.05).

 Overall, individuals can safely use fish oil in doses of 3 g a day and less. It has been generally recognized as safe in the United States.

 Therefore, RD can try taking fish oil to see whether it helps with her dysmenorrhea.

Q: FG is a 39-year-old woman who is looking for something for her heartburn. She recently started a diet and has

been eating healthier. FG gave up regular soda and replaced it with diet soda. She likes it so much that she is drinking 8 to 10 cups of diet soda daily. In addition, FG has been eating salads with spicy jalapen&#771;o dressing. These dietary changes often cause a burning sensation. FG’s physician recommended she take an OTC product to alleviate her heartburn, but she does not know which product to select. What recommendations do you have?

A: Because FG has changed her dietary habits significantly, she should seek counseling on lifestyle modifications.

Many foods can trigger heartburn, especially spicy foods. FG should try to avoid alcohol, caffeinated drinks, citrus fruits, coffee, peppermint, and tomatoes. She should also replace her diet soda with regular water or at least noncaffeinated beverages to see whether her symptoms decrease or resolve. In addition, FG can try eating smaller meals or eating more frequently. OTC medications that might help include antacids, such as calcium carbonate; a histamine 3 receptor antagonist, such as cimetidine, famotidine, or ranitidine; and a proton pump inhibitor (PPI), such as esomeprazole, lansoprazole, or omeprazole. She can start with a histamine 2 receptor agonist (H2RA) as needed when she has symptoms. FG can escalate to a PPI if symptoms do not resolve with H2RAs. If her symptoms persist or worsen, she should be reevaluated by a physician.

, 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.

 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.

 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.

US Department of Health and Human Services, US Department of Agriculture. Dietary guidelines for Americans 2015-2020. Office of Disease Prevention and Health Promotion website. health.gov/dietaryguidelines/2015/guidelines/. Accessed June 17, 2019.

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Quinla JD, Hill DA. Nausea and vomiting of pregnancy. 

Hosseinlou A, Alinejad V, Alinejad M, Aghakhani N. The effects of fish oil capsules and vitamin B1 tablets on duration and severity of dysmenorrhea in students of high school in Urmia-Iran. 

2014;6(spec 7):124-129. doi: 10.5539/gjhs.v6n7p124.

Sadeghi N, Paknezhad F, Rashidi Nooshabadi M, Kavianpour M, Jafari Rad S, Khadem Haghighian H. Vitamin E and fish oil, separately or in combination, on treatment of primary dysmenorrhea: a double-blind, randomized clinical trial. 

 2018;34(9):804-808. doi: 10.1080/09513590.2018.1450377.

GRAS notices. FDA website. www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&sort=Substance&order=ASC&startrow=1&type=basic&search=fish%20 oil. Updated June 14, 2019. Accessed June 17, 2019.

Heartburn and dyspepsia. In: Krinsky DL, Ferreri SP, Hemstreet B, et al, eds. 

Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 18th ed. 

Washington, DC: American Pharmacists Association, 2018.

This edition features 4 case studies with information including adverse effects of fiber consumption, using ginger for morning sickness, help for dysmenorrhea, and products for heartburn.

OTC Case Studies: Stomach Issues

Q: BC, a 68-year-old man, approaches the pharmacy counter looking for advice. Recently, he was seen by a cardiologist at the recommendation of his primary care physician, and after undergoing an electrocardiogram and an evaluation, he was told that he has mild mitral valve regurgitation. BC says that his doctor did not initiate any new drugs to treat this disorder, and he is not completely sure what self-care measures are necessary for this condition. BC is looking for advice on what lifestyle modifications, if any, he should consider making. Upon questioning, BC says that he is a cigarette smoker and has a history of hypertension and hyperlipidemia, managed on a combination of amlodipine, valsartan, hydrochlorothiazide, and atorvastatin. What information can you provide regarding self-care and nonpharmacologic approaches to manage this condition. 

A: Mitral valve regurgitation, characterized by the backflow of blood through the mitral valve with each ventricular contraction, represents a common chronic cardiac condition. There are many interventions that BC can consider implementing to ensure optimal health, despite this new diagnosis. First and foremost, inquiring about his smoking history and identifying whether he has considered quitting represent an important intervention for ensuring optimal cardiac health. Smoking not only increases BC’s risk of heart attack and stroke but may also worsen his mitral valve disease. Numerous OTC and prescription smoking cessation options exist. Beyond smoking cessation, educate BC about the importance of a healthy diet, including consideration of the Dietary Approaches to Stop Hypertension diet, for optimizing blood pressure (BP) control and heart health, along with routine exercise and physical activity for managing his heart function, with the permission of his cardiologist. Although BC was not prescribed a medication specifically to treat his valve disease, reminding him about the importance of compliance with his antihypertensive medications is critical to controlling his BP and reducing the complications of heart disease. Finally, although it is reasonable to encourage BC to share a complete health history with all medical care providers, such as his dentist, it is important to recognize that antibiotic prophylaxis prior to dental procedures is no longer indicated in patients with mitral valve regurgitation.

Case 2: Aspirin for Primary Prevention of Heart Attack 

Q: TW, a 54-year-old woman, is inquiring about a news story she recently read on the safety of low-dose aspirin. Her medical history is significant for diabetes, dyslipidemia, gout, and hypertension, and she says that she takes several medications, including allopurinol, aspirin, atorvastatin, lisinopril, metformin, and metoprolol, to treat these conditions. TW has never had a heart attack or a stroke and says that she started taking a low-dose aspirin each day at the recommendation of her primary care provider many years ago. Now, based on this new information, she is wondering whether it is safe for her to continue taking this aspirin or whether she should ask her physician for new advice. What recommendations can you provide?

A: According to the results of the recently published ASCEND trial, conducted in the United Kingdom, aspirin use, administered at a dose of 100 mg daily, versus a placebo was associated with a reduction in serious cardiovascular events, including myocardial infarction, stroke, and transient ischemic attack, when administered to patients with diabetes but no cardiovascular disease.

 This benefit, however, was offset by a significantly increased risk of major bleeding, including gastrointestinal and extracranial bleeding, seen in the aspirin group compared with the placebo cohort. This trial joins a number of newer studies reporting outcomes that question the efficacy or risk/benefit ratio of the use of aspirin in a population without underlying cardiovascular disease and for the primary prevention of a major cardiovascular event. Although the relationship between cardiovascular disease and hyperglycemia is established, this study has caused clinicians to pause and note other cardiac risk factors, beyond diabetes alone, when considering use of aspirin for primary prophylaxis. Most important, to reduce TW’s risk of the microvascular complications of diabetes, inquire about her glycemic control and compliance with lifestyle interventions and medication. Encourage TW to discuss these new findings with her physician to determine whether she should continue her use of aspirin prophylaxis. 

Case 3: Supplementation with Coenzyme Q10 for Statin-Induced Myopathy 

Q: YI, an 84-year-old woman, approaches the pharmacy counter looking for advice. She heard from a friend that supplementation with coenzyme Q10 could reduce her chances of developing muscle pain with use of her statin medication. Before purchasing this supplement, YI wanted to confirm that it is safe to take. Her medical history is significant for coronary artery disease, with 2 stents placed in 2017 and hypertension, and YI’s current medication list includes aspirin, clopidogrel, metoprolol, and rosuvastatin. She says that she was recently switched to rosuvastatin after having tried all the other statins because she developed an elevation in her muscle enzymes and muscle pains previously. After a discussion with YI’s cardiologist, the decision to try rosuvastatin was made, with close monitoring for potential adverse effects, including symptoms and blood work. What information can you provide regarding the uAse of coenzyme Q10?

A: Coenzyme Q10, also known as ubiquinone, is a fat-soluble nutrient similar in structure to vitamin K and found in dietary sources including liver, oily fish, and whole grains.

 The antioxidant effects of this nutrient, coupled with clinical evaluation of the efficacy of supplementation in patients with diseases known to deplete coenzyme Q10 levels, provide reason that supplementation may be beneficial in certain individuals.

 It is recognized that, according to their pharmacologic actions, statin medications inhibit 3-hydroxy-3-methylglutaryl coenzyme A, which results in not only cholesterol reduction but also a reduced rate of mevalonate production.

 This depletion of mevalonate, in turn, serves to inhibit coenzyme Q10 production, is hypothesized to lead to mitochondrial dysfunction, and represents a potential cause of myopathy in individuals treated with a statin. Supplementation with coenzyme Q10 in patients taking statins has been touted by some to offset the effects of myopathy.

 In YI’s case, it is worth mentioning that there are mixed data regarding the efficacy of coenzyme Q10 supplementation to prevent or treat statin-induced myopathy. Although results from several studies have demonstrated a benefit in taking up to 200 mg of coenzyme Q10 daily to reduce pain in patients experiencing statin myopathy, results from other studies have failed to show an improvement in muscle pain, tolerance of statin therapy, or an effect on creatine kinase blood levels.

 Given YI’s history of statin intolerance and myopathy, it is reasonable to consider a trial of coenzyme Q10 supplementation for this indication. 

Case 4: Use of Fish Oil for Cardiovascular Health 

Q: RT, a 70-year-old woman, is interested in learning whether 

 could help lower her cholesterol. She reports no significant medical history but says she is interested in doing things that can keep her healthy. RT eats well, exercises regularly, and takes several supplements that, she has read, can promote her health. A friend introduced her to fish oil, saying it might improve her heart health and lower her cholesterol, but RT would like more information from her pharmacist before deciding whether there are real benefits. At RT’s last medical evaluation, her physician indicated that she had borderline high cholesterol and that he would give her a trial of dietary modification for 3 months to determine whether this alone might address her issue. What education aAbout the use of fish oil supplementation or recommendations can you offer? 

A: Omega-3 fatty acids, found in fatty fish and some nuts and seeds, may have many beneficial effects, from reducing cholesterol and elevated triglycerides to improving symptoms of rheumatoid arthritis. Although fish oil products exist over the counter as dietary supplements, there are several FDA-approved fish oil products approved for use in treating hypertriglyceridemia. Fish oil may reduce elevated triglycerides, but the evidence regarding its efficacy in reducing low-density lipoprotein (LDL) and total cholesterol levels has been conflicting. Most tips for living with mitral valve regurgitation suggest that fish oil does not reduce elevated cholesterol and may even further increase elevated LDL levels in patients with hyperlipidemia.

 In RT’s case, emphasize the effects of her lifestyle in cholesterol reduction. A diet low in saturated and trans fats and high in fiber, as well as a regular exercise routine, can help reduce cholesterol levels.

Mary Barna Bridgeman, PharmD, BCPS, BCGP, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers University in Piscataway, New Jersey, and an internal medicine clinical pharmacist at Robert Wood Johnson University Hospital in New Brunswick, New Jersey.

Rupal Patel Mansukhani, PharmD, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers University

and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.

Mitral valve regurgitation. Mayo Clinic website. mayoclinic.org/diseases-conditions/mitral-valve-regurgitation/diagnosis-treatment/drc-20350183. Accessed October 31, 2018.

Oral health topics: antibiotic prophylaxis prior to dental procedures. American Dental Association website. ada.org/en/member-center/oral-health-topics/ antibiotic-prophylaxis. Updated June 25, 2018. Accessed October 19, 2018.

ASCEND Study Collaborative Group, Bowman L, Mafham M, et al. Effects of aspirin for primary prevention in persons with diabetes mellitus. 

 2018;379(16):1529-1539. doi: 10.1056/NEJMoa1804988.

Saini R. Coenzyme Q10: the essential nutrient. 

 2011;3(3):466-467. doi: 10.4103/0975-7406.84471.

Coenzyme Q10. In: Natural Medicines [Internet]. Stockton, CA: Therapeutic Research Center; 2018. naturalmedicines.therapeuticresearch.com.

Tricarico PM, Crovella S, Celsi F. Mevalonate pathway blockade, mitochondrial dysfunction and autophagy: a possible link. 

. 2015;16(7):16067-16084. doi: 10.3390/ijms160716067.

Fish oil. In: Natural Medicines [insert]. Stockton, CA: Therapeutic Research Center; 2018. naturalmedicines.therapeuticresearch.com.

Four case studies in cardiovascular health.

Case Studies: Cardiovascular Health 

TR, a 23-year-old man, is seeking advice. Although he is generally in good health, he has recently been developing a mild wheezing and tightness in his chest after exercising and playing soccer. TR does not smoke and has not had any respiratory illnesses recently. However, he does recall using an inhaler as a child for asthma but was told that he had outgrown the condition. TR does not take any medications. He says he does not want to follow up with a physician, if possible, because he is between jobs and does not have health care insurance. What information can you provide regarding nonpharmacologic approaches to managing this condition and self-care?

TR may be suffering from intermittent, exercise-induced asthma symptoms, given his history and symptoms. As far as self-care options, it is important to recognize that the FDA recently approved a new formulation of the OTC epinephrine inhaler Primatene Mist to treat mild, intermittent asthma symptoms. This chlorofluorocarbon-, propellant-free formulation is likely to be available in early 2019 on pharmacy shelves and will replace the original formulation withdrawn from the market in 2011. Approved for use in patients 12 years and older, unlike the original preparation, the new formulation will include a different inhaler device accompanying the active ingredient, epinephrine. Patients should be educated about proper use, including the need for priming and shaking before use and cleaning the device afterward. Although  this is a reasonable option for alleviating TR’s infrequent symptoms, it is nonetheless worth educating him about the chronic and inflammatory nature of asthma. If TR does not respond within 20 minutes of using a dose, experiences more than 2 attacks in a week, notices worsening symptoms, or is using more than 8 doses in a 24-hour period, he should be urged to seek medical evaluation. This medication is an effective bronchodilator but will ultimately not address more moderate-to-severe asthma symptoms and treat the underlying disease.

: AI, a 60-year-old woman, wants to know what OTC remedy is best for treating her cold symptoms. Her medical history includes hypertension and hyperthyroidism, and she is taking several medications, including lisinopril and methimazole. AI is suffering from significant nasal congestion, which is preventing her from sleeping well at night, and she would like to take a nonprescription decongestant, but the label on the medication she selected says to check with a doctor or a pharmacist if individuals have high blood pressure or thyroid disease. What recommendations can you provide? 

 There are an estimated 62 million occurrences of the common cold in the United States each year. Symptoms include congestion, cough, headache, malaise, pain, postnasal drip, rhinorrhea, sinus pressure, and/or sneezing. Given AI’s medical and medication history, she should avoid systemic decongestants containing pseudoephedrine or other active ingredients that cause vasoconstriction to provide symptom relief. These agents can cause increases in blood pressure and may exacerbate symptoms of hyperthyroidism. To err on the side of caution, it is prudent to recommend forms of nonpharmacologic relief of congestion in this case, including nasal decongestant strips, saline or a teapot, or topical camphor- or menthol-containing preparations that may help clear inflamed nasal passages. 

HW, a 74-year-old man, is looking for advice. His wife encouraged him to speak with a pharmacist, as he recently received a diagnosis of chronic obstructive pulmonary disease (COPD) and wants to make sure he is doing everything he can to reduce his chances of complicating or exacerbating his condition. HW has a significant medical history, including coronary artery disease post stent placement, heart failure, hypertension, and high cholesterol, along with his new diagnosis of COPD. He has an extensive medication list, which includes various pharmacologic agents for managing these conditions. HW started smoking as a teenager and quit cold turkey several years ago at the uArging of his cardiologist. What information can you provide regarding self-management of HW’s COPD?

COPD is estimated to affect more than 16 million Americans, with older adults more likely to experience this condition than younger individuals.

 Although COPD necessitates medical evaluation and prescription drug treatment, self-care and self-management are critical to ensuring optimization of symptom control and quality of life through reduction in exacerbations and hospitalizations for complications. In HW’s case, there are several important educational opportunities for the pharmacist. These include asking him to demonstrate his inhaler technique and reviewing it with him; ensuring that he is up-to-date on all indicated vaccines, based on his age and medical comorbidities; inquiring about medical follow-up appointments; and underscoring the importance of using his maintenance medications, even if he is not having trouble breathing. In addition, social support is critical to ensuring optimal health outcomes, particularly with a chronic lung disease such as COPD. Living with a chronic disease is difficult, and the risk of comorbid depression is high. Encourage HW to include his wife, other family members, or caregivers to help him manage his condition and troubleshoot with him if questions arise. 

 AT, a 38-year-old woman, calls the pharmacy inquiring about self-care for influenzalike symptoms. She works as an elementary school teacher and reports a sudden onset of chills, fatigue, general malaise, and muscle pains that caused her to be sent home out of fear that she had the flu, even though she had received her influenza vaccine. Upon arriving home, AT took her temperature and confirmed a fever of 101.6°F. She reports no significant medical history and says she takes no chronic medications other than occasional nonprescription medicines for mild conditions. AT has a cadre of cold and cough preparations at home, along with some pain relievers, but she wants to know what will best alleviate her symptoms and help her recover as quickly as possible. What recommendations or eAducation on self-care for managing flulike symptoms can you offer?

Symptoms associated with the influenza virus can vary and range from mild to severe. Given AT’s age and medical history, she is not considered high risk for developing influenza-associated complications. Nonetheless, it isimportant to educate her about proper self-care to promote recovery and reduce her chances of spreading the illness. First and foremost, encourage AT to stay home and avoid contact with others as much as possible, unless she needs medical care. She may consider seeking medical evaluation for confirmation of influenza and treatment with prescription medications to reduce symptom duration. For the 2018-2019 influenza season in the United States, 4 antiviral medications (oral baloxavir and oseltamivir, inhaled zanamivir, and intravenous peramivir) are approved and recommended to treat influenza.

 Regarding the efficacy of these medications, time is of the essence, as these agents should be initiated within 48 hours of the onset of symptoms. Beyond consideration for antiviral therapy, supportive care interventions should be used. These include controlling the fever with whatever analgesic or antipyretic AT has in her medicine cabinet; hydrating with water, soups, juices, or other noncaffeinated beverages; and washing her hands to avoid spreading the virus. Encourage her to stay home for at least 24 hours after the fever subsides, in accordance with CDC recommendations.

CDER conversation: safely using the newly available OTC asthma inhaler Primatene Mist. FDA website. www.fda.gov/Drugs/NewsEvents/ucm624994.htm. Updated November 8, 2018. Accessed November 17, 2018.

COPD national action plan. National Heart, Lung, and Blood Institute website. nhlbi.nih.gov/health-topics/education-and-awareness/COPD-national-action-plan. Accessed November 18, 2018.

Influenza antiviral medications: summary for clinicians. CDC website. cdc.gov/flu/professionals/antivirals/summary-clinicians.htm. Updated November 28, 2018. Accessed December 13, 2018.

The flu: what to do if you get sick. CDC website. cdc.gov/flu/takingcare.htm. Updated March 9, 2018. Accessed December 13, 2018.

Rupal Patel Mansukhani, PharmD,CTTS, FAPhA, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers University and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.

Four cases address respiratory illnesses.