Mary Barna Bridgeman, PharmD, BCPS, BCGP

 GS is a 28-year-old woman who is looking for something natural to treat her asthma. She says she found tablets called Asthma Therapy Homeopathic. The active ingredients include arsenicum album HPUS, histaminum hydrochloricum HPUS, house dust mite, magnesia phosphrica, nux vomica HPUS, quebracho HPUS, and sulphur HPUS. GS says that her physician recently diagnosed her with asthma, and she is trying to find a natural way to control her shortness of breath. The doctor put her on a rescue medication called albuterol sulfate and said that she does not need maintenance medications because her symptoms are occasional. GS is concerned about adverse effects, because this is the first time she is taking a prescription medication. What recommendations do you have ? 

It is important to educate GS about the importance of controlling asthma symptoms, especially when she is short of breath. Most homeopathic medications are not regulated by the FDA. Therefore, there are limited data supporting their use in treating asthma. In addition, GS should be advised that many products, such as Asthma Therapy Homeopathic, recommend the use of conventional therapies and not in place of them. Therefore, she should not take Asthma Therapy Homeopathic instead of albuterol sulfate. Because GS is fearful of adverse effects, it may be helpful to share common adverse effects of albuterol sulfate, such as chest pain, nervousness, palpitations, rapid heart rate, and tremors.

 She should be advised as to what to expect when using her prescription medication and when to seek help. GS should also be advised that the safety profile is relatively safe, and albuterol sulfate is used commonly to help occasional shortness of breath in asthma patients. If she continues to be concerned, she should speak to her physician about other asthma treatments instead of albuterol sulfate.   

 NM is a 38-yearold woman who was diagnosed with asthma 15 years ago. She is looking for an inhaler product called Primatene Mist. NM was excited, because she heard that the FDA recently approved the product. She had used Primatene Mist until 2011, when it was taken off the market. Since then, NM has been using albuterol sulfate, which was prescribed by her physician. NM’s asthma was well-controlled when she was using Primatene Mist, and she would like to switch back because albuterol sulfate is expensive. She says she has symptoms such as shortness of breath once a week, but she denies nighttime awakenings and says that she has not used her albuterol sulfate. NM has no medical conditions and does not take other medications. What recommendations do you have regarding her asthma?

Primatene Mist was taken off the market because it contained chlorofluorocarbon propellants, which deplete the ozone layer. At the time, there were no safety concerns when used appropriately. Primatene Mist contains epinephrine inhalation aerosol 0.125-mg per spray. The FDA approved it in late 2018 to treat mild, intermittent asthma.

 It is critical to educate patients about when it is appropriate and not appropriate to use Primatene Mist. Mild, intermittent asthma is classified as having symptoms less than or equal to 2 days per week and nighttime awakening less than or equal to 2 times per month. In addition, patients should use their rescue medication less than or equal to 2 days per week, have no interference with normal activities, and normal lung function between exacerbations.

If a patient does not meet 1 of these classifications, they must be referred to a health care professional to be evaluated. Because NM falls into this category, she qualifies for Primatene Mist. However, because she is already taking a prescription medication, she should discuss discontinuing albuterol and switching over to Primatene Mist with her health care professional, so she can be monitored appropriately. If NM decides to use Primatene Mist, she should inhale 1 spray deeply, and the second spray can be used if symptoms are not relieved in 1 minute. The maximum daily dose is 8 inhalations in 24 hours.  Primatene Mist is only approved for patients 12 and older. If NM experiences more than 2 attacks in a week, she should follow up with a health care professional.

 RM is a 32-year-old woman who is seeking an influenza vaccine. Upon questioning, she says she has been smoking for 10 years and is looking for different options to quit in the next month. RM says that her friend recommended she use e-cigarettes to quit smoking. RM says she heard that e-cigarettes are safer than conventional cigarettes. Her friend quit smoking a few weeks ago and said the e-cigarettes are helping a lot. Aside from smoking, RM is relatively healthy and denies any medical conditions. What are your recommendations on using e-cigarettes to quit smoking.   

RM should be advised that there are many FDA-approved treatments for smoking cessation. She can use nicotine replacement, varenicline, bupropion, with or without behavior therapy. An article published in 

 by Hajek and colleagues evaluated the effectiveness of smoking cessation treatments. They randomized patients to nicotine replacement products or e-cigarettes. The study found the 1-year abstinence rate was 18.0% in the e-cigarette group compared with 9.9% in the nicotine-replacement group (p<0.001). However, the study showed that those in the e-cigarette group were more likely to use their assigned product at 52 weeks (80% versus 9%). The authors concluded that e-cigarettes are more effective for smoking cessation than nicotine replacement.

 Although they were more effective for smoking cessation, 80% were still using e-cigarettes at the 1-year mark.  The safety of e-cigarettes has not been established like conventional agents used for smoking cessation. Therefore, it may be beneficial for RM to try conventional agents before using e-cigarettes, especially since this is her first attempt at quitting. In clinical studies, varenicline has been shown to be beneficial, with a 26% abstinence rate through 24 weeks of follow-up

 and nicotine-replacement therapy and bupropion achieve abstinence rates of about 25% to 26% during the same time period.

 In addition, behavior therapy and smoking cessation group education may be beneficial. If all conventional treatments and behavioral therapy fail, e-cigarettes may be a last resort to assist with smoking cessation. 

 HH is a 68-year-old man who is complaining of body aches, chills, and a fever. He says he has diabetes, heart failure, and hypertension. HH denies having any known allergies. He comes to the pharmacy looking for a product to treat his symptoms. HH already took 500 mg of acetaminophen once to reduce his fever at home but wanted to know if there are any other OTC options that he should try, as he still feels achy and has chills. He says that he has not had the influenza vaccination this year and would like to know if he should get it now. What recommendations do you have?

HH could have the flu, based on his symptoms. Because his symptoms just started, he should be referred to his physician to be evaluated. HH should be advised that antiviral treatment must be started within 2 days, so it is important to see his physician right away. There are 4 FDA-approved medications for the 2018-2019 season to treat influenza: baloxavir marboxil (Xofluza), oseltamivir phosphate (Tamiflu), peramivir (Rapivab), and zanamivir (Relenza). It is important for pharmacists to identify patients that are high risk, such as HH, so that they can be treated with antivirals as soon as symptoms begin. Patients at risk for having serious complications from influenza may benefit from treatment. These include blood, endocrine, kidney, liver, and metabolic disorders; chronic lung disease; heart disease; a history of asthma; neurodevelopmental and neurological conditions; obesity; and patients younger than 19 years who are on long-term aspirin or salicylate-containing medications. In addition, patients who are Alaska natives, American Indians, immunocompromised, live in nursing homes or other long-term-care facilities, or those older than 65 or younger than 2 can be at risk.

Even if HH is diagnosed with the flu, he may still benefit from receiving an influenza vaccine, as it would protect him from other strains in the vaccine. 

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, 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.

ProAir HFA [prescribing information]. Miami, FL: IVAX Laboratories, Inc; 2005

accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma [news release]. Silver Spring, MD: FDA; November 8, 2018. 

fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625338.htm

US Department of Health and Human Services. Asthma care quick reference. National Heart, Lung and Blood Institute. 

nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf. Updated September 2012

Hajek P, Phillips-Waller A, Przulj D, et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. 

. 2019;380(7):629-637. doi: 10.1056/NEJMoa1808779.

Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. 

 2016;387(10037):2507-2520. doi: 10.1016/S0140-6736(16)30272-0.

Rosen LJ, Galili T, Kott J, et al. Diminishing benefit of smoking cessation medications during the first year: a meta-analysis of randomized controlled trials. 

. 2018;113(5):805-816. doi: 10.1111/add.14134.

US Department of Health and Human Services. What you should know about influenza (flu) antiviral drugs. CDC website. 

cdc.gov/flu/pdf/freeresources/updated/antiviral-factsheet-updated.pdf

.  Published December 7, 201 Accessed February 18, 2019. 

Articles

Four cases are presented for patients with respiratory conditions.

OTC Case Studies: Respiratory Health

Case 1: Vitamin D for Cardiovascular Health and Cancer Prevention 

Q: HT, a 45-year-old man, is seeking a recommendation for a vitamin D supplement. His brother was recently given a diagnosis of prostate cancer, and HT recalls hearing about the beneficial effects of vitamin D supplementation in preventing cancer, which he is interested in for himself. HT reports that he follows up routinely with his primary care provider and has undergone all appropriate age-related screenings. He is healthy and reports no allergies or use of chronic maintenance medications. What can you suggest regarding vitamin D supplementation?

A: In 2018, a landmark large-scale, placebo-controlled, randomized study seemed to shed additional light on the potential extraskeletal effects of vitamin D. In the VITAL trial, almost 26,000 middle-aged and older adults without a history of cardiovascular disease (CVD), cancer, or other serious conditions were randomized to receive vitamin D3 at a dose of 2000 IU per day and omega-3 fatty acids at a dose of 1000 IU per day for the prevention of cancer and CVD. After a median follow-up of 5 years, investigators found that the use of these supplements did not reduce the occurrence of major cardiovascular events or invasive cancers.

 For HT, this is an opportunity to emphasize and reiterate the importance of adhering to a healthy lifestyle, which includes eating healthy food, not drinking too much alcohol, and not smoking. Encourage him to continue following up with his provider and to undergo indicated health screenings to reduce his risk of cancer and other diseases. If HT is insistent on a recommendation for a supplement, encourage him to follow national dietary guidelines for his age and gender, including evaluating vitamin D intake from food sources, to ensure that he is receiving 600 IU per day.

Case 2: Health Benefits of Omega-3 Fatty Acid Supplementation 

Q: FS, a 69-year-old woman, has a question about fish oil supplements. She has been taking an 

 fish oil supplement for several years, not at the advice of her physician but because she read that it may be beneficial for brain and heart health and could reduce cancer risk. FS has a significant family history for all these conditions, so she wants to make sure that she is doing everything possible to keep herself healthy. She recently came across a report that suggested there might be no benefit to supplementing with the product. FS denies allergies to medications and reports no other significant medical history. What counseling can you provide regarding the benefits of omega-3 fatty acid supplementation, in light of the findings of this recent study?

A: In the VITAL study, mentioned in the previous case, investigators evaluated the effects of omega-3 fatty acid supplements in preventing CVD.

 In the nearly 26,000 patients with an average age of 67 without known CVD enrolled in this study, randomized to receive either 1 g of fish oil (eicosapentaenoic acid plus docosahexaenoic acid) or a placebo daily, a similar number of major cardiovascular events, such as cardiovascular-related death, nonfatal myocardial infarction (MI), and stroke, occurred in patients receiving the supplement compared with the placebo at the mean follow-up of 5.3 years.

 There was a significantly lower incidence of MI in the group receiving the fish oil supplement, but the absolute difference between the groups was small (1.1% vs 1.5%) during the treatment period. Results of an additional trial in patients with diabetes but without CVD randomized to receive 1 g of fish oil capsules or a placebo showed similar outcomes.3 Given these emerging data, FS should be told that the evidence does not support the use of omega-3 fatty acid supplements for preventing cardiovascular events in patients without a history of CVD. Remind her about the importance of routine medical care, and encourage her to follow up with her primary care provider if she thinks that she is experiencing any changes in her health or has any medical complaints.

Case 3: Lung Cancer Risk with B Vitamin Supplementation 

Q: KW, a 62-year-old man, is seeking advice regarding the dietary supplements he takes. For years, at the advice of his wife, he has taken a B vitamin combination each day. KW recalls recently reading that there may be a relationship between B vitamins and the development of lung cancer in men, and he wants to know whether this is a warning he should consider or just media hype. He suffers from other chronic medical conditions and takes several medications and supplements each day, and he would be happy to discontinue this supplement if it is potentially harmful. What suggestions for use of this supplement can you provide?

A : An analysis of the data of more than 77,000 individuals aged 50 to 76 years participating in the previously mentioned VITAL cohort, a study conducted in Washington from 2000 to 2002, was conducted to evaluate the 10-year average daily doses from individual and multivitamin supplements to evaluate the correlation, if any, with development of primary, invasive lung cancer.

 Investigators concluded that although use of supplemental vitamins B6, B12, and folic acid was not associated with lung cancer risk among women, supplementing with vitamins B6 and B12 from individual supplements, not multivitamins, was associated with a 30% to 40% increase in lung cancer risk in men, with men who consume the highest amounts of daily intake of these nutrients having a nearly 2-fold increase in risk and higher risks observed in male smokers.

 Inquire about KW’s smoking history, and encourage him to discuss these findings and the use of the supplements findings with his physician if he has additional questions.

Case 4: Vitamin Supplements for CVD Prevention and Treatment 

Q: FM, a 64-year-old woman, wants to speak to a pharmacist about the use of vitamin supplements to reduce her risk of a heart attack. She has been managing dyslipidemia and hypertension for years but was recently admitted to a local hospital for evaluation of chest pain. After undergoing a cardiac catheterization, FM was instructed to remain compliant with her medications and encouraged to pursue lifestyle modification. However, she wants to know whether, in addition to losing weight and modifying her diet as instructed by her physician, a vitamin supplement can promote heart health. What information can you provide for the use of vitamin supplements to prevent and treat CVD?

A: A recent systematic review and meta-analysis of systematic reviews, meta-analyses, and randomized controlled trials concluded that of the 4 most commonly used supplements (multivitamins, vitamin D, calcium, and vitamin C), supplementation with none of these had a significant effect on cardiovascular outcomes of all-cause mortality.

 Reiterate FM’s physician’s recommendations for dietary modification and weight loss to lower her blood pressure and cholesterol levels, and remind her that dietary sources are best for ensuring optimal daily intake of nutrients and vitamins. For more information about the evidence for the use of supplements for reducing the risk of cardiovascular events, encourage her to speak with her cardiologist or primary care provider.

, 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.

Manson JE, Cook NR, Lee IM, et al; VITAL Research Group. Vitamin D supplements and prevention of cancer and cardiovascular disease. 

. 2019;380(1):33-44. doi: 10.1056/NEJMoa1809944.

Institute of Medicine, Food and Nutrition Board, Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D. Ross AC, Taylor CL, Yaktine AL, Del Valle HB, eds. Washington, DC: National Academies Press; 2010.

ASCEND Study Collaborative Group, Bowman L, Mafham M, et al. Effects on n-3 fatty acid supplements in diabetes mellitus. 

. 2018;379(16):1540-1550. doi: 10.1056/NEJMoa1804989.

Brasky TM, White E, Chen CL. Long-term, supplemental, one-carbon metabolism-related vitamin B use in relation to lung cancer risk in the Vitamins and Lifestyle (VITAL) cohort. 

. 2017;35(30):3440-3448. doi: 10.1200/JCO.2017.72.7735.

Jenkins DJA, Spence JD, Giovannucci EL, et al. Supplemental vitamins and minerals for CVD prevention and treatment. 

. 2018;71(22):2570-2584. doi:10.1016/j.jacc.2018.04.020.

Four case studies focus on vitamins and supplements.

OTC Case Studies: Vitamins

Case 1: Weight Loss for Controlling High Blood Pressure (HBP)

 TA, a 38-year-old man, has a history of HBP and morbid obesity and has been taking a 3-drug combination pill once daily for many years to control his hypertension. TA’s primary care provider recently brought up his eligibility for weight loss surgery to help with blood pressure (BP) control and reduce his risk for other medical complications. However, TA would like to try to lose weight on his own before taking this approach. He has never attempted weight loss before and is not sure where to start. What information can you provide regarding nonpharmacologic and self-care approaches to weight loss?

 The American College of Cardiology (ACC)/American Heart Association’s (AHA) updated 2017 primary prevention guidelines underscore the importance of weight loss as a nonpharmacologic approach to helping control and reduce BP in patients who are obese or overweight.

 Weight loss efforts should be multimodal, encompassing both dietary modification and exercise. In terms of dietary modifications, individuals should reduce their sodium intake to less than 1500 mg a day and consume a diet low in saturated and total fat that is full of fruits, vegetables, whole grains, and low-fat dairy, all of which are found in the Dietary Approaches to Stop Hypertension and Mediterranean diet plans, along with reducing their daily caloric consumption.

 Finally, if TA consumes alcohol, it is recommend that he limit his intake to 2 or fewer drinks each day. Physical activity recommendations include aerobic, dynamic resistance or isometric resistance exercises several times each week. Nonetheless, although dietary and lifestyle modifications are prudent, weight loss surgery may be indicated based on the degree of obesity and presence of underlying medical complications. Encourage TA to try these changes but to follow up with his physician about next steps after a 3- or 6-month trial period.

Case 2: Smoking Cessation for Reducing Cardiovascular Disease (CVD) Risk 

: WT, a 45-year-old man, recently discharged from the local hospital’s emergency department (ED) after experiencing chest pain, is inquiring about recommendations for smoking cessation. His medical history is significant for dyslipidemia, generalized anxiety, and hypertension, and he says that he takes atorvastatin (Lipitor), escitalopram (Lexapro) with as-needed lorazepam (Ativan), and lisinopril/hydrochlorothiazide for treating these conditions, respectively. WT was ruled out for acute coronary syndrome while in the ED, although the physician there recommended that he stop smoking to improve his BP control and reduce his risk of CVD. WT would like a recommendation for a nonprescription treatment option that he can start immediately to prevent chest pain recurrence and reduce his desire to smoke. He says he has smoked a pack of cigarettes a day for the past 20 years and that he often lights his first cigarette while still in bed each morning. What recommendations can you provide?

: Cigarette smoking is a known modifiable risk factor for development of CVD, and the effects may manifest as acute increases in BP and arterial stiffening. Beyond the obvious health benefits on pulmonary function and reducing other long-term health consequences, smoking cessation may reduce WT’s CVD risk and his elevated BP. Make sure to provide a recommendation for establishing a quit date, along with education on the symptoms of nicotine withdrawal and how to manage those with pharmacologic approaches. Notably, for WT, who has a comorbid anxiety condition, point out that anxiety, insomnia, and irritability may worsen with the withdrawal of nicotine and this should be monitored accordingly. Additionally, discuss exploration of smoking triggers and the need for other lifestyle modifications to support the cessation effort. In terms of supporting quitting smoking using pharmacologic approaches, drug therapy often works best in conjunction with behavioral support and counseling. Sharing local or regional programs to support smoking cessation may be helpful in this case. Because WT is seeking a nonprescription medication to immediately help support this effort, either the nonprescription nicotine gum, lozenge, or patch could be considered, based on his preference. Make sure to offer education on the dosage, depending on the product selected. Appropriate follow-up should be established with the pharmacist or primary care provider to gauge the success of the effort.

Case 3: Nutrient Depletion Associated with Diuretic Therapy

: AA, a 62-year-old man, was recently discharged from the hospital after having palpitations. His physician told him that his potassium level was very low and that, upon discharge, he should continue to take his water pill with a banana each day. AA’s medical history is significant for allergies, diabetes, gout, and hypertension, and he takes allopurinol, amlodipine, atorvastatin, hydrochlorothiazide, an intranasal steroid, metformin, and pioglitazone each day. He was prescribed a potassium supplement. However, the pills are too large to swallow and unpalatable, and AA would like to talk to a pharmacist about alternatives. What information can you provide regarding the need for electrolyte supplementation with concomitant diuretic use?

: Thiazide diuretics are known to deplete many electrolytes and other nutrients through various pathways, including increasing urinary potassium, sodium, zinc, and thiamine excretion and reducing magnesium reabsorption in the kidneys.

 Common electrolyte disturbances associated with thiazides include thiazide-induced hyponatremia, hypokalemia, and hypomagnesemia. Additionally, dietary potassium intake, independent of the need for supplementation, has been linked to improvements in BP control and is recommended as long as comorbid kidney disease and the risks of potassium accumulation do not exceed these benefits.

 In AA’s case, suggest that he consider dissolving the potassium tablets in applesauce or pudding, depending on the formulation, to ensure that he is obtaining the amount of potassium recommended by his physician. If AA’s potassium levels are chronically low upon follow-up, it may be appropriate for him to consider increasing his dietary fruit and vegetable consumption, along with low-fat dairy, some fish and meats, nuts, or soy-containing foods, which are all considered good sources of potassium.

 Remind him that a medium-size banana contains, on average, about 12 mEq of potassium, as well.

: KM, a 30-year-old pregnant woman, is looking for a recommendation for a BP cuff. At her 20-week prenatal visit, her obstetrician/gynecologist (OB/GYN) was concerned about her borderline-high BP. After a 24-hour urine collection, KM was instructed to purchase a BP monitor and to record her reading twice daily at home to share at her next follow-up. She has no significant past medical history, had 1 previous pregnancy with no complications, and only takes a prescription prenatal vitamin. What recommendations or education on self-monitoring BP can you offer?

: BP self-monitoring is commonly recommended for evaluation and medical decision making for patients outside the ambulatory-care office. The ACC/AHA’s 2017 update for detection and management of HBP delineates a 6-step checklist for ensuring patients who are self-monitoring accurately obtain their BP readings to appropriately inform health decisions.

 Notably, ACC/AHA recommends the following

Assurance of optimal technique (eg, supporting the arm with the middle of the cuff placed on the upper arm, depending on the type of device selected; use of proper-sized cuff; and use of a validated/calibrated BP measuring device)

Average BP readings from 2 or more assessments performed on 2 or more occasions

Document findings (eg, helping the patient create or obtain a log for recording results at the frequency recommended by her OB/GYN, specifying the time of day the reading was recorded and any other relevant variables)

Record benchmarking and repeated measures (eg, taking BP in both arms at the first medical visit and separating subsequent measurements by 1 to 2 minutes)

Proper patient preparation (eg, avoiding caffeine, exercise, and smoking in the 30 minutes prior to the assessment and talking during the measurement; back supported for 5 minutes or longer; relaxing; and sitting on a chair with feet flat on the floor)

Provide a record of in-office readings to the patient

A pharmacist is well positioned to help KM select an appropriate BP monitoring device, including a cuff of appropriate size, and reminding the proper technique for using it and recording her readings at home.

1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. 

. 2018;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065.

Nutrient depletion tool: hydrochlorothiazide. Natural Medicines website. naturalmedicines.therapeuticresearch.com. Accessed December 2018.

Mayo Clinic. Potassium supplements (oral route, parenteral route). Mayo Clinic website. mayoclinic.org/drugs-supplements/potassium-supplement-oral-route-parenteral-route/description/drg-20070753. Updated October 1, 2018. Accessed December 15, 2018.

Four pharmacy cases address high blood pressure.

OTC Case Studies: High Blood Pressure

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.

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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.

Case Studies: Respiratory Illnesses 

 BC, a 65-year-old woman, is looking for advice about treating her chronically dry, irritated eyes. She reports frequently experiencing a gritty feeling, like there is something in her eyes, and wants to know if the pharmacist notices a mild redness of her sclera. At BC’s last medical appointment, when she mentioned these symptoms, her physician encouraged her to use a lubricant eye drop, but she was not sure what that meant and never followed up. BC’s medical history includes gastroesophageal reflux disease, hypertension, hypothyroidism, and Parkinson disease, and she takes many medications. She says she is allergic to penicillin and sulfonamide. What recommendations do you have?

: Dry eye disease (DED) is a common health complaint, estimated to account for up to 25% of ophthalmic clinic visits.

 Symptoms of DED often include ocular discomfort, visual changes or disturbance, and disordered tear production, which can occur chronically or episodically. This condition represents a disorder attributed to multifactorial causes: autoimmune disease, environmental factors, hormonal fluctuations, increasing age, inflammation, and a variety of medications, including antidepressants, antihistamines, diuretics, and hormone contraceptives and replacement therapies.

 This condition is particularly common in postmenopausal women, as illustrated by BC’s presentation.

In addition to patient education and medication, pharmacists should identify drugs that may exacerbate symptoms. In BC’s case, conducting a review of her medication profile is warranted, as is recommending an OTC artificial tear solution, which can be instilled into the eye 1 to 2 times daily depending on the selected product, with frequency increased up to 3 to 4 times a day as needed.

Ocular lubricants represent the first-line approach for alleviating irritation of the ocular surface. For persistent symptoms, encourage BC to follow up with her primary care provider or an eye care specialist for further management.

 ST, a 28-year-old man, asks about an OTC treatment option to relieve seasonal allergy symptoms. He reports experiencing allergic rhinitis and irritated eyes twice a year during the spring and fall, which he attributes to seasonal allergies. ST denies cough, fever, or other systemic symptoms. In addition to the nasal congestion and rhinorrhea, he has ocular itching and redness that don’t seem to be relieved with use of his intranasal corticosteroid or daily montelukast tablets. ST reports excessive tearing, which is causing occasional blurred vision, but he does not wear contact lenses or glasses. He takes no other medications and reports no allergies to medications. What recommendations do you have?  

 Allergic conjunctivitis, a condition characterized by ocular pruritus and red, watery eyes, is a common occurrence in individuals suffering from seasonal allergies, as in ST’s case. Numerous environmental allergens, including dander and pollen, can cause patients to suffer from eye irritation.

In providing education on the management of allergic conjunctivitis symptoms, counsel patients on strategies related to allergen or trigger avoidance, therapies that may mitigate ocular symptoms and the severity of the reaction, and how to protect the eye surface from damage.

For ST, underscore the importance of nonpharmacologic approaches, such as applying cool compresses to provide relief from pruritis, changing air filters in the home, and staying indoors on days when pollen counts are high—although these interventions alone are not likely to resolve his symptoms. For nonprescription options, artificial tear drops could be recommended as an initial approach, with ketotifen eye drops the next intervention for persistent symptoms. Counsel ST on the judicious use of ophthalmic decongestants, too. However, while these agents may provide quick relief of ocular redness, they do not address the underlying cause of symptoms and rebound congestion can result from indiscriminate use.

 TW, a 48-year-old woman, is seeking information on how she can prevent diabetic eye disease. Her medical history includes hypertension, dyslipidemia, and type 2 diabetes for the past several years. TW says she is compliant with her recommended diet, is physically active each day, and takes several medications, including atorvastatin, lisinopril, and metformin/sitagliptin each day. She recently participated in a diabetes education course at the recommendation of her primary care provider, where she learned about the importance of receiving a comprehensive eye examination each year. After receiving this education, TW was not sure about how imperative it was to make an appointment for an eye exam, because she has never experienced vision problems. She wants information and a recommendation about how to protect her eyes and guidance about her eye exam visit. What rAecommendations do you have?

 Diabetic retinopathy, a specific microvascular complication that can affect individuals with type 1 or type 2 diabetes, is attributed to a number of factors, including degree of glycemic control, duration of diabetes, and the presence of other ocular conditions or microvascular complications, including nephropathy. In TW’s case, her comorbid dyslipidemia and hypertension may also increase her risk of developing microvascular complications, such as retinopathy.

 She should be reminded that the best things to reduce the risk of eye disease include controlling her blood glucose, blood pressure, and lipid values, according to a recent position statement from the American Diabetes Association.

 In counseling TW, underscore the importance of adherence to a therapeutic lifestyle, which may include dietary education and modification, exercise recommendations, weight loss if indicated, and the importance of compliance with prescription medications. She should be encouraged to follow up with a comprehensive eye exam, as was suggested in her education class. Any vision changes, including blurry or double vision, eye pain, or floaters, should be evaluated by an ophthalmologist immediately.

 LL is a 66-year-old woman who is looking for papain tablets. She said that she read that the tablets can help with herpes zoster (shingles). Some of LL’s friends had shingles, and a few of them tried the tablets and found them beneficial. She has never had shingles but wants to take the tablets preventively. LL’s immunization card shows that she has the influenza vaccine yearly and that she had the pneumococcal conjugate vaccine 13 at age 65, the pneumococcal polysaccharide vaccine 23 at age 66, and the tetanus, diphtheria, and pertussis vaccine at age 63. All of her childhood vaccinations are up-to-date. LL’s medical history includes hypertension, which she manages through diet. Upon questioning, she says that she has not received the herpes zoster vaccine. LL was confused about which to get, so she avoided the tablets and the vaccine. What recommendations do you have?

: LL should be told that the results of one study show that papain may be beneficial for herpes zoster symptoms, but that the trial was a small study and that more studies need to be conducted before recommending papain for symptom management. There are no study results that show papain would be beneficial for the prevention of herpes zoster. The Advisory Committee on Immunization Practices (ACIP) recommends Shingrix (recombinant zoster vaccine) over Zostavax (zoster vaccine live) for the prevention of herpes zoster and related complications. In clinical studies, the results of the recombinant zoster vaccine showed that 2 doses administered 2 months apart had an efficacy of 97.2% in reducing the risk of herpes zoster compared with placebo. The zoster vaccine live had an initial efficacy of 51%, which increased slightly in phase 4 studies. As a result, ACIP has replaced zoster vaccine live with recombinant zoster vaccine as its first-line recommendation for the prevention of shingles. If patients have previously received a dose of zoster vaccine live, they should be revaccinated with the recombinant zoster vaccine. Another difference between the 2 vaccines is that zoster vaccine live is a 1-dose (0.5-mL) vaccine, while 2 doses (0.5 mL) must be given for the recombinant zoster vaccine, the second dose of which must be given within 2 to 6 months of the first dose. Also, zoster vaccine live is a live attenuated vaccine approved for patients 60 years and older, while recombinant zoster vaccine is approved for patients 50 years and older.

In June 2018, the CDC said, “Due to high levels of demand for GSK’s [GlaxoSmithKline’s] Shingrix vaccine, GSK has implemented order limits and providers have experienced shipping delays. It is anticipated these order limits and shipping delays will continue throughout 2018. In response, GSK has increased the US supply available for 2018 and plans to release doses to all customer types on a consistent and predictable schedule for the rest of 2018. Overall, the supply of Shingrix during 2018 is sufficient to support the vaccination of more patients during 2018 than were vaccinated against shingles during 2017.”

Based on the delays, it may be difficult for LL to get the vaccination. Advise her that checking with multiple offices or pharmacies is important, because the vaccine supply is being shipped to many locations. In addition, if LL receives the first dose but has difficulty obtaining the second dose, she can always increase the interval. Although the delay will not affect the way the vaccine works or its efficacy, it will delay being fully protected until both doses are obtained.

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

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What OTC products should these pharamcists recommend?