OTC Case Studies: Respiratory Health

Case 1: Asthma Homeopathic

Q: 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 ?

A: 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.¹ 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.

Case 2: Asthma inhalers

Q: 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?

A: 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.² 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.^3. 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.⁴

Case 3: E-cigarettes

Q: 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.

A: 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 The New England Journal of Medicine 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.⁵ 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-up⁶ and nicotine-replacement therapy and bupropion achieve abstinence rates of about 25% to 26% during the same time period.⁷ 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.

Case 4: Influenza

Q: 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?

A: 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.^8. 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.

References

• ProAir HFA [prescribing information]. Miami, FL: IVAX Laboratories, Inc; 2005accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf. Accessed February 18, 2019.
• 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. Accessed February 17, 2019.
• 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. Accessed February 17, 2019.
• Primatene Mist. primatene.com/otc-asthma-medicine.aspx. Accessed February 18, 2019.
• Hajek P, Phillips-Waller A, Przulj D, et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med. 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. Lancet. 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. Addiction. 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.