Rupal Patel Mansukhani, PharmD, CTTS, FAPHA

AG is a 29-year-old woman who is hesitant about getting the influenza vaccine and is getting it only because her employer requires it. While reading the screening and consent form, she mentions she has an egg allergy, and the influenza vaccine contains egg. She can tolerate foods containing eggs, such as bread and cake, but she has experienced hives and itching after eating scrambled eggs. What should the pharmacist advise?

Most flu vaccines are grown in eggs and include small amounts of egg protein called ovalbumin.

 Cell culture-based (Flucelvax Quadrivalent) and recombinant (Flublok Quadrivalent) influenza vaccines are completely egg free. Approximately 0.2% of adults and 1.3% of children have an egg allergy. It should be noted that in describing her reaction, AG said she experienced hives and itching after consuming lightly cooked eggs. Studies have been conducted to assess the safety of influenza vaccines in individuals who have egg allergies. All individuals with egg allergies in the study, even those with a history of anaphylaxis, received the trivalent inactivated influenza vaccine without serious reactions. Given that AG does not have a history of angioedema or other serious reactions to egg, the CDC recommends such patients receive any licensed form of the influenza vaccine at a pharmacy. Had AG reported a history of serious reactions to eggs, she should have been instructed to receive the influenza vaccine in an inpatient or outpatient medical center under provider supervision, not in a pharmacy. If AG has an allergic reaction to the influenza vaccine with angioedema and/or respiratory distress, the emergency medical system should be activated and a 0.3-mg dose of epinephrine administered intramuscularly, using a premeasured or prefilled syringe or an autoinjector, should be delivered in the midouter thigh while awaiting emergency medical response.

JG is a 17-year-old girl who came to the pharmacy with her mother to get a HPV vaccine. JG is afraid of needles and vaccines and says she had heard about teenagers who have fainted after receiving the human papillomavirus (HPV) vaccine. She asks about syncope after vaccination and how it could be prevented and treated. What should the pharmacist tell her?

Syncope, or fainting, is caused A by decreased blood flow to the brain that leads to temporary loss of consciousness. Although syncope can occur with any vaccine, it is most common after HPV, meningococcal, and tetanus, diphtheria and pertussis vaccines. In addition, syncope is reported more frequently (62%) in adolescents aged 11 to 18 years. Although patients recover from syncope almost immediately, the potential injuries associated with fainting and falling are of greater concern. Per the CDC, 12% of serious syncope episodes reported to the Vaccine Adverse Event Reporting System resulted in head injuries.

Typically, when patients present with a fear of needles or vaccination, the pharmacist should either reassure about the procedure or simply comfort them and consider providing them with a beverage or snack. Most importantly, preventing complications and head injuries from syncope require preparation prior to vaccination and quick action if syncope occurs. Make sure the patient is lying down or seated during vaccination. Monitor patients closely for 15 minutes after they are vaccinated. If syncope occurs, have the patient lie flat and maintain an open airway. Apply a cool, damp cloth to the face and neck and elevate the feet. Monitor the patient closely until full recovery and activate the emergency medical if the patient does not recover immediately or has been injured.

ST is a 70-year-old woman who is getting her influenza and pneumococcal vaccines. She asks to speak with the pharmacist, as she had read about adverse effects of intramuscular vaccines, including shoulder bursitis or subdeltoid bursitis. What information should the pharmacist provide?

Subdeltoid bursitis following intramuscular (IM) vaccination, also called shoulder injury related to vaccine administration (SIRVA), presents as shoulder pain and limited range of motion following IM injection, owing to an anti-inflammatory reaction. Patients who suffer from SIRVA experience pain at rest that worsens with movement. A retrospective study of 3 million individuals who received the influenza vaccine showed 16 cases of subdeltoid bursitis within 2 days of vaccine administration. SIRVA may be treated with anti-inflammatory medications, ice, OTC or prescription analgesics, physical therapy, and rest.

The correct anatomical location of an IM injection is in the lower two-thirds of the deltoid, and the appropriate length needle must be selected based on patient muscle mass to reduce the risk of injecting too deeply, past the muscle and into the bursa. Patients who experienced SIRVA were noted to have received the injection higher than recommended. The CDC has developed and disseminated guidelines for appropriate IM vaccine administration technique and needle selection.

JS is a 42-year-old woman who is getting her second dose of the Moderna COVID-19 vaccine. She was initially hesitant to get the vaccine, but her employer mandates it. JS said she felt fine after the first dose, aside from fatigue on the evening of the vaccination. She is nervous about the second dose because she has heard and read mixed reports about patient reactions. JS inquires about self-care following this dose. What information can the pharmacist provide?

 Some individuals do have adverse effects (AEs) from the COVID-19 vaccines, and JS is right to prepare for self-care to prevent and manage AEs. On a positive note, the reported AEs are the symptoms of building immunity and protection. Reported local AEs at the injection site include pain, redness, and swelling. Systemic reactions include chills, fatigue, fever, headaches, or nausea. OTC acetaminophen and ibuprofen are recommended to treat the AEs, unless a physician indicates otherwise. It is not recommended that patients take either of these agents prior to the vaccination. Nonpharmacologic recommendations for local reactions include the application of a cold, wet washcloth over the injection site and lightly moving the arm that has received the injection after vaccination. Nonpharmacologic recommendations for systemic reactions include drinking plenty of water and wearing loose-fitting clothing to reduce discomfort from fever.

Ammie Patel, PharmD, BCACP, is a clinical assistant professor of pharmacy practice and administration at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey in Piscataway, and an ambulatory care specialist at RWJBarnabas Health Primary Care in Shrewsbury and Eatontown, New Jersey.

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

1.Li JT, Rank MA, Squillace DL, Kita H. Ovalbumin content of influenza vaccines. 

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2.Flu vaccine and people with egg allergies. CDC. Updated December 10, 2021. Accessed June 2, 2022. https://www.cdc.gov/flu/prevent/egg-allergies.htm#algorithm

3.Greenhawt MJ, Spergel JM, Rank MA, et al. Safe administration of the seasonal trivalent influenza vaccine to children with severe egg allergy. 

2012;109(6):426-430. doi:10.1016/j.anai.2012.09.011

4.Syncope after vaccination—United States, January 2005-July 2007. CDC. Morb Mortal Wkly Rep.2008;57(17):457-460. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5717a2.htm

5.Fainting (syncope) after vaccination. CDC. Updated August 25, 2020. Accessed June 2, 2022. https://www.cdc.gov/vaccinesafety/concerns/fainting.html

6.Hesse EM, Navarro RA, Daley MF, et al. Risk for subdeltoid bursitis after influenza vaccination: a population-based cohort study. 

. 2020;173(4):253-261. doi:10.7326/M19-3176

7.Vaccine administration. CDC. Updated April 22, 2022. Accessed June 2, 2022. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html8.Vaccines for COVID-19. CDC. Updated May 17, 2022. Accessed June 2, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html

Articles

Case Studies: Postvaccine Care

: JS is a 58-year-old woman who is interested in taking black cohosh. She said that her hot flashes are “out of control” and frequently cause intense heat and redness to show up on her face and neck. JS says that although the problem is worse at night, she gets hot flashes during the day, as well. A friend suggested JS try black cohosh. JS, who is otherwise relatively healthy, has not yet spoken to her doctor but wants to try this herb. What recommendations do you have regarding black cohosh for menopause?

: JS appears to be suffering from menopausal symptoms but should go to her physician to be assessed and diagnosed. Black cohosh has been shown to reduce symptoms of menopause. However, the evidence varies depending on the formulation. One proprietary preparation that has proven beneficial is Remifemin. The extract is standardized to 1 mg of triterpene glycosides, calculated as 27-deoxyactein, per 20-mg extract tablet.

 Common adverse effects include gastrointestinal issues, headaches, rash, and weight gain. Some case reports have also shown acute hepatitis when using black cohosh. Advise JS to monitor for these symptoms if she plans to use it. Also, safety has not been demonstrated in long-term studies, so she should not use it for more than 6 months.

: BB is a 58-year-old woman who is looking for a calcium supplement. She has been taking a multivitamin for years but is a vegan and recently realized that she is still not getting enough calcium. BB says that she typically does not like to take too many medications but wants to make sure she is taking care of herself as she gets older. She has no medical conditions. What recommendations do you have?

: Advise BB that everyone can benefit from appropriate calcium intake. Based on her age, she should get 1200 mg per day of calcium. Adults who are younger than 50 years should take about 1,000 mg of calcium per day, and women 51 years and older should take 1200 mg per day. Experts also recommend a daily intake of about 600 international units of vitamin D up to age 70 years.

OTC calcium typically comes in 500 or 600 mg, so let BB know that she may need to take 2 tablets to meet her daily recommended intake. Many formulations have calcium with vitamin D, so she can get a combination tablet. BB should separate the dosing to achieve the maximum benefit. Because she is vegan, she can try to increase her dietary calcium by eating oatmeal, soybeans, and tofu. Patients who are not vegan can increase their calcium intake by having milk and yogurt.3 If BB is trying to obtain her calcium through her diet, it is important to stress that she should have a consistent daily intake. BB should also consider following up with a physician to discuss her bone health.

: RD is a 40-year-old woman who, while refilling her prescription, mentions that she got sunburned the day before after not using sunscreen. Her mild sunburn is visible on her face and shoulders. RD says that she is under the impression that sunblock does not work well in the water. She has wellcontrolled diabetes, and is otherwise healthy. What recommendations do you have regarding sunscreen?

: Inform RD that sunblock can be used in the water, and if she plans to swim outside frequently, she should purchase a water-resistant product. It is important to reapply water-resistant sunblock every 40 to 80 minutes and non—water-resistant sunblock every 2 hours. If RD plans on being outdoors and is concerned about insects, she can apply the sunblock and then spray the insect repellent if needed but not rub it in. Let her know that the sun’s rays are most dangerous between 10:00 am and 4:00 pm. During that time, RD should wear protective clothing and apply sunblock with an SPF of 15 or higher. She should consider buying products that contain octocrylene, meradimate, titanium dioxide, benzophenones, or avobenzone with padimate O, which protect against ultraviolet A and B rays.

: PA is a 30-year-old man who wants to start taking vitamin C to prevent the coronavirus disease 2019 (COVID-19). PA works in a grocery store and is concerned about his exposure to other people. He is healthy, with no medical conditions and does not take any medication or vitamins. PA’s friend recommended that he start taking vitamin C, but he does not know which dose to take. What recommendations do you have?

: Vitamin C has a lot of properties that can be beneficial for treating viral infections.

 Therefore, many people use vitamin C to prevent common colds. However, the jury is out. The results of 1 study showed that vitamin C 50 mg/kg intravenous every 6 hours for 96 hours did not significantly alter C-reactive protein levels, disease severity scores, or thrombomodulin levels compared with a placebo in patients with acute respiratory distress syndrome and sepsis. The study results did show that the 28-day all-cause mortality and intensive care unit—free days were significantly lower in both.

 Patients treated in China with moderate to severe COVID-19 with large doses of intravenous vitamin C (10,000 to 20,000 mg/d) had shorter lengths of hospital stays than untreated patients with COVID-19. However, these data have not been published and therefore cannot be recommended. Advise PA that there is no evidence for patients taking vitamin C to prevent COVID-19. If he is really concerned, he should take a multivitamin for overall health and follow guidance to appropriately wash hands often and keep a safe distance from other people.

, is a clinical assistant professor of pharmacy practice and administration at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey, and an ambulatory care specialist at RWJBarnabas Health in New Jersey.

Rupal Patel Mansukhani, 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.

Liske E, Hanggi W, Henneicke-von Zepelin HH, Boblitz NN, Wustenberg P, Rahlfs VW. Physiological investigation of a unique extract of black cohosh (cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. 

 2002;11(2):163-174. doi: 10.1089/152460902753645308

Osmers R, Friede M, Liske E, Schnitker J, Freudenstein J, Henneicke-von Zepelin HH. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. 

 2005;105(5 pt 1):1074-1083. doi: 10.1097/01.AOG.0000158865.98070.89

Calcium and vitamin D: important at every age. National Institutes of Health. National Institute of Arthritis and Musculoskeletal and Skin Disease. Accessed May 27, 2020. 

bones.nih.gov/health-info/bone/bone-health/nutrition/calcium-and-vitamin-d-important-every-age

Crosby KM, O’Neal KS. Prevention of sun-induced skin disorders. In: Krinsky DL, Ferreri SP, Hemstreet B, et al, eds. 

 19th ed. American Pharmacists Association; 2017.

Kashiouris MG, L’Heureux M, Cable CA, Fisher BJ, Leichtle SW, Fowler AA. The emerging role of vitamin C as a treatment for sepsis. 

Hemilä H, Chalker E. Vitamin C for preventing and treating the common cold. 

 2013;(1):CD00980. doi: 10.1002/14651858.CD000980.pub4

Fowler AA, Truwit JD, Hite RD, et al. Effect of vitamin C infusion on organ failure and biomarkers of inflammation and vascular injury in patients with sepsis and severe acute respiratory failure: the CITRIS-ALI randomized clinical trial. 

 2019;322(13):1261-1270. doi: 10.1001/jama.2019.11825

Coronavirus disease (COVID-19) advice for the public. World Health Organization. Updated April 29, 2020. Accessed May 28, 2020. 

who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public

Four OTC cases are presented for women's health.

OTC Case Studies: Women's Health

Q: RD, a 23-year-old man, asks for something to treat a scaly, itchy rash between his toes. He has been running outdoors since the weather got warmer and thinks that the humidity may be causing the rash. RD is training for a marathon in a few months and does not want to stop running. He got new running shoes, but the itchiness continued. RD is otherwise healthy and does not take any medications. He would prefer to use an OTC treatment and heard about powders that absorb humidity. What recommendations do you have?

A: It appears that RD has athlete’s foot, or tinea pedis. The fungus that typically causes the infection can grow in humid conditions. If the area is kept clean, it can be treated over the counter, as long as there is no medical condition or secondary infection. RD can purchase an OTC product that includes at least 1 of the following ingredients: butenafine, clotrimazole 1%, miconazole 2%, tolnaftate 1%, or undecylenic acid. Depending on the ingredient and manufacturer, the product can be applied once or twice daily for up to 4 weeks. It is important to advise RD that he should follow the package directions, because the products differ in duration of treatment and formulation. He should try to avoid using powders or sprays, which are typically less effective because they are not rubbed into the skin.

 RD runs every day, so he may benefit from wearing moisture-wicking socks that keep the fungus from growing. If the infection persists or worsens, he should seek medical attention.

Q: MJ is a 26-year-old woman who is looking for a vitamin D supplement. She says that a friend is taking vitamin D because she thinks that it prevents coronavirus disease 2019 (COVID-19). MJ works at an assisted-living center and often gets sick, so she wants to take something natural that will help her avoid being infected by the virus. She has no medical conditions, she is healthy, and her immunizations are up-to-date. MJ denies taking anything over the counter, including natural products or vitamins. What recommendations do you have regarding prevention of COVID-19 with vitamin D?

A: Some evidence supports the role of vitamin D in reducing viral infections. One study’s findings showed that vitamin D could interfere with viral replication.

 In addition, supplementing with vitamin D prior to infections was shown to reduce expression of angiotensin-converting enzyme 2, which may be beneficial in patients with viral infections.

 Although a few studies have shown that supplementation may be helpful, no well-controlled clinical trials have been conducted, especially in patients with COVID-19. Advise MJ that vitamin D is fat soluble and can lead to toxicity. An overabundance of vitamin D can lead to anorexia, heart arrhythmias, polyuria, and weight loss, as well as damage to the blood vessels, heart, and kidneys. However, during winter months, many patients can be deficient in vitamin D. It is important to let MJ know that the recommended dietary allowance is 600 IU daily for patients aged 19 to 70 years. Patients over 70 years can increase to 800 IU daily.

 A health care provider can recommend an appropriate prescription product for a vitamin D deficiency. If MJ is concerned about COVID-19, the best way to protect herself is by practicing good hygiene. She should avoid touching her face, cough and sneeze into an elbow or a tissue, disinfect surfaces at the office, and wash her hands frequently.

 She should also follow her workplace guidelines on personal protective equipment when she is with patients.

Q: LS, a 54-year-old man, stops in to discuss acetaminophen. He has been taking ibuprofen 600 mg twice daily for several years to treat his arthritis. A few years back, his doctor recommended taking an anti-inflammatory medication for pain that, at the time, was not controlled. Since then, LS says, his pain has been well managed, and he has no complaints. However, he heard a news report that made him concerned that taking ibuprofen will increase his chances of being infected with the COVID-19 virus. LS has not spoken with his physician but would like to know your thoughts on discontinuing ibuprofen and taking acetaminophen instead. What information can you provide on ibuprofen and the coronavirus?

A: The Infectious Diseases Society of America released guidelines on the treatment of COVID-19, addressing statements by the FDA and World Health Organization that no available data suggest that nonsteroidal anti-inflammatory drugs (NSAIDs) worsen COVID-19—related infections. At this time, the data are limited, but the virus is thought to use angiotensin-converting enzyme 2 to cause infections. This enzyme can be upregulated by medications, such as ibuprofen. However, no substantial evidence shows a link to ibuprofen or any NSAIDs harming patients by this process.

 In addition, advise LS that no data connect ibuprofen to an increased risk of being infected by the COVID-19 virus. However, NSAIDs have cardiovascular, gastrointestinal, and renal risks associated with them, so patients should be counseled about the potential for adverse events.

 If LS wants to discontinue his ibuprofen, he should speak with his health care provider to discuss the best OTC or prescription alternative.

Q: TY is a 38-year-old woman in search of a way to treat her eyes, which have been itchy the past few days. She recently started working at a landscaping company and has been outside a lot. TY thinks that she is allergic to pollen, but she has never been tested. Before working at this job, she did not spend much time outdoors, especially in the spring. TY’s physician recommended using OTC eye drops. TY has no other medical conditions and does not take any medication. What recommendations do you have?

A: Avoiding allergens is the best way to treat allergies, but because TY’s work requires her to be outside, that is not an option for her. She should, however, try to stay indoors as much as possible when not at work, keep car windows closed when driving, wear sunglasses, and shower when she gets home to remove some of the pollen. First-line treatment for allergic conjunctivitis is artificial tears, which TY can use according to the package instructions. Gel formulations can be beneficial overnight. If her symptoms do not improve within a few days, she can try using ketotifen ophthalmic solution twice daily, which works directly on the eyes, not systemically. However, if her symptoms persist, she should consider speaking with her health care professional to evaluate and rule out an eye infection.

 TY can use an OTC oral antihistamine such as cetirizine, fexofenadine, levocetirizine, or loratadine if infections have been ruled out.

Gardner A, Walkup N. Fungal skin infections. In: Krinsky DL, Ferreri SP, Hemstreet B, et al, eds. 

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

Teymoori-Rad M, Shokri F, Salimi V, Marashi SM. The interplay between vitamin D and viral infections. 

Xu J, Yang J, Chen J, Luo Q, Zhang Q, Zhang H. Vitamin D alleviates lipopolysaccharide-induced acute lung injury via regulation of the renin-angiotensin system. 

 2017;16(5):7432-7438. doi:10.3892/mmr.2017.7546

Vitamin D. National Institutes of Health. Updated March 24, 2020. Accessed April 18, 2020. 

https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/

How to protect yourself and others. CDC website.

Updated April 24, 2020. Accessed April 30, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

Infectious Diseases Society of America guidelines on the treatment and management of patients with COVID-19. Infectious Diseases Society of America. Published April 11, 2020. Accessed April 18, 2020. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

 2008; 28(1):1-23,v. doi:10.1016/j.iac.20012.011

Systane Aaditor Antihistamine Eye Drops ingredients and usage. Alcon. Accessed April 1 2020. 

https://systane.myalcon.com/eye-care/systane/products/systane-zaditor/ingredients/

Four case studies about skin and eye health.

OTC Case Studies: Skin and Eye Health

: RC is a 34-year-old male truck driver who is seeking information about the use of e-cigarettes. He reports that his primary care physician, who is treating RC’s diabetes, recommended smoking cessation. RC mentions that his friends have been trying to quit cigarette smoking via e-cigarettes. He is skeptical but asks about the latest recommendations. What recommendations do you have?

: Based on the symptoms reported, BA likely has a common cold, for which antibiotics would not be a cure.1 He should try nonpharmacologic and single-ingredient OTC medications to provide supportive care for the symptoms. BA should also increase fluid intake and rest and consider increased humidification with a humidifier, steam, or a vaporizer.

 Per CDC recommendations, encourage him to use alcohol-based hand sanitizer and wash his hands frequently.

BA should start taking a nonsedating antihistamine, such as cetirizine, fexofenadine, levocetirizine, or loratadine. Antihistamines may help alleviate a runny nose.

 Instruct BA to monitor for worsening symptoms; if they present, a medical referral will be necessary.

: RS is a 40-year-old woman who smokes. She has fatigue, fever, and a severe sore throat with inflamed lymph nodes. RS has tried natural remedies that her sister recommended, but she finds that the symptoms have continued, and she has also developed a cough with green and yellow sputum. RS stops by to ask about combination cold and cough products. What recommendations do you have?

: Given this patient’s symptoms of a productive and worsening cough with a persistent fever, she cannot self-treat. Refer RS to her primary care physician, as she may be suffering from a bacterial respiratory infection and requires further evaluation in case she needs an antimicrobial agent.

 For supportive care, advise RS to avoid cigarette smoking, drink hot honey and lemon tea for sore throat relief, increase fluid intake, and rest.

: RP is a 31-year-old man who asks about complementary and natural products for cold and respiratory infection prevention. He has heard about Echinacea purpurea and vitamin C but is unsure of the evidence. What information can you provide?

 : Of the products RP listed, prophylactic high-dose vitamin C (at least 2000 μg) has been shown to reduce the duration and severity of a cold. The results of the same meta-analysis compared the use of prophylactic vitamin C in study participants under physical stress, such as marathon runners and skiers, with use in community participants. Study results showed that vitamin C was effective in preventing colds in participants under stress.

 If RP expects physical stress during his trip, vitamin C may be an appropriate choice for him.

 has been shown to decrease mucin production and symptoms of respiratory infections. Its anti-inflammatory and immune stimulatory effects may be responsible for its efficacy. No standardized dose for 

 exists, and each product may be labeled per concentration and formulation.

 to be more effective in preventing recurrent infections than a placebo. If RP were to choose 

, he should take it at the onset of cold symptoms.

Similarly, elderberry (Sambucol) has been shown to exhibit anti-inflammatory and antiviral properties. Results of a study comparing elderberry with placebo showed a shortened duration of cold symptoms and fever in patients with the influenza virus.

 Additionally, the use of rescue medications, such as analgesics (acetaminophen and nonsteroidal inflammatory drugs) and nasal sprays, was decreased with the use of elderberry compared with a placebo.

Finally, zinc has been shown to reduce the incidence of colds in healthy people. The results of a meta-analysis showed that zinc was effective in reducing the duration and symptoms of the common cold when administered every 2 hours at the onset of symptoms.

Commonly advertised products Airborne and Emergen-C are not proven therapeutics for respiratory infections. However, they include proprietary blends of the above-mentioned complementary therapies.

: PP is a 22-year-old male college student who stops in to purchase nasal decongestant spray Afrin. He moved into a carpeted apartment this semester and suffers from dust mite allergies. PP stopped taking his antihistamine loratadine, as it had stopped working well for him. He has a cough, a postnasal drip, and a stuffy nose with trouble breathing through his nose. He asks whether he should know anything in particular about Afrin. What information can you provide?

: PP’s symptoms are consistent with allergic rhinitis that progressed to congestion and postnasal drip. He should resume a nonsedating antihistamine. If loratadine no longer works, he can try cetirizine, fexofenadine, or levocetirizine.

 For topical decongestant oxymetazoline (Afrin), he should limit use to 2 doses every 24 hours for a maximum duration of 72 hours.

 Rebound congestion has been associated with overuse of oxymetazoline. The therapy duration is controversial because results of some studies have shown a treatment duration up to 8 weeks to be safe without rebound congestion. Counsel PP on appropriate nasal spray technique, as ingestion of oxymetazoline may result in adverse effects, including coma, drooling, hyperthermia, and nausea.

, is a clinical assistant professor of pharmacy practice and administration at the Ernest Mario School of Pharmacy and an ambulatory care specialist at RWJBarnabas Health in New Jersey.

, 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. 

Buensalido JAL, Valencia JCB, Rhinovirus (RV) Infection (common cold) clinical presentation. Medscape website.

emedicine.medscape.com/article/227820-clinical

. Updated July 30, 2019. Accessed March 15, 2020.

Common colds: protect yourself and others. CDC website. 

. Updated February 11, 2019. Accessed March 15, 2020.

De Sutter AI, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. 

 2012;(2):CD004976. doi: 10.1002/14651858.CD004976.pub3. 

Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate antibiotic use for acute respiratory tract infection in adults: advice for high-value care from the American College of Physicians and the Centers for Disease Control and Prevention. 

 2016;164(6):425-434. doi: 10.7326/M15-1840.

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Hudson JB. Applications of the phytomedicine 

 (purple coneflower) in infectious diseases. 

 2012;2012:769896. doi: 10.1155/2012/769896.

Schapowal A, Klein P, Johnston SL. Echinacea reduces the risk of recurrent respiratory tract infections and complications: a meta-analysis of randomized controlled trials. 

 2015;32(3):187-200. doi: 10.1007/s12325-015-0194-4.

Zakay-Rones Z, Varsano N, Zlotnik M, et al. Inhibition of several strains of influenza virus 

 and reduction of symptoms by an elderberry extract (

 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(2):132-140. doi: 10.1177/147323000403200205.

Singh M, Das RR. Zinc for the common cold. 

 2011;(2):CD001364. doi: 10.1002/14651858.CD001364.pub3.

Seidman MD, Gurgel RK, Lin SY, et al. Clinical practice guideline: allergic rhinitis. 

 2015;152(suppl 1):S1-S43. doi: 10.1177/0194599814561600.

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the counter human use. Electronic Code of Federal Regulations website. 

ecfr.gov/cgi-bin/text-idx?SID=694f58669bc9c39632fe5305dd2358e6&mc=true&node=pt21.5.341&rgn=div5#se21.5.341_172

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Mortuaire G, de Gabory L, Francois M, et al. Rebound congestion and rhinitis medicamentosa: nasal decongestants in clinical practice. Critical review of the literature by a medical panel. 

2013;130(3):137-144. doi: 10.1016/j.anorl.2012.09.005.

US Department of Justice. CMEA (Combat Methamphetamine Epidemic Act 2005). Drug Enforcement Administration website. 

Case studies focusing on infectious disease.

OTC Case Studies(April 2020)

RC is a 34-year-old male truck driver who is seeking information about the use of e-cigarettes. He reports that his primary care physician, who is treating RC’s diabetes, recommended smoking cessation. RC mentions that his friends have been trying to quit cigarette smoking via e-cigarettes. He is skeptical but asks about the latest recommendations. What recommendations do you have?

Let RC know that a study conducted in the United Kingdom compared the rates of smoking cessation using a particular brand of e-cigarettes versus nicotine replacement therapy. The 1-year abstinence rate was 18.0% in the e-cigarette group and 9.9% in the nicotine-replacement group.

In addition, given the variability in the composition of e-cigarette products and insufficient evidence supporting the use of e-cigarettes, the 2020 US Surgeon General’s Report on Oral Health does not make generalizations about the efficacy of e-cigarettes for smoking cessation. However, the report does acknowledge that findings from clinical trials suggest that e-cigarettes containing nicotine are associated with increased smoking cessation compared with e-cigarettes that contain no nicotine. Also, more frequent use of e-cigarettes is associated with increased smoking cessation compared with less frequent use. The report summarizes that if smokers were to use e-cigarettes, they would need to stop smoking cigarettes and other tobacco products completely before switching to e-cigarettes, with the ultimate goal of stopping using e-cigarettes as well.

Although e-cigarettes contain fewer toxic chemicals than burned tobacco products, they still carry carcinogenic chemicals and tiny particles that reach deep into the lungs via aerosolization of the liquid. Furthermore, the FDA has not approved the use of nicotine-containing e-cigarettes for smoking cessation. FDA-approved agents for smoking cessation include nicotine replacement therapy using gum; an inhaler; lozenges; nasal spray; prescription medicines, such as bupropion and varenicline; and the transdermal patch.

VH is a 40-year-old woman who recently discussed smoking cessation with her primary care physician (PCP) and is picking up nicotine replacement patches and gum. Although her PCP had informed her about nicotine replacement therapy products and how they work, she asks if there is anything she can use on her smartphone, or alerts she can arrange to help her manage cravings and adhere to her quit plan. What recommendations do you have?

Tell VH that one option is to call the “quitline” 1-800-QUIT-NOW (1-800-784-8669), which is staffed by coaches who are trained in smoking cessation. Another option is the free quitSTART app for smartphones. This app, created by the FDA and the National Cancer Institute, assists the user in getting back on the road to cessation after a slipup by managing cravings, monitoring progress, and staying on track. A third option is SmokefreeTXT, a texting service that asks users screening questions about their smoking history and quit plans. After the questions are answered, the user receives 3 to 5 texts per day for 6 to 8 weeks to assist with smoking cessation. Topics discussed on SmokefreeTXT include cravings, nicotine withdrawal, triggers, and weight gain. Users can sign up by texting QUIT to 47848. Finally, there are a number of social media discussion groups on Facebook, Pinterest, Twitter, and YouTube where VH can find support.

CASE 3: MEDICATIONS AND SMOKING CESSATION

HS is a 42-year-old man who is picking up his clozapine prescription. He has been smoking 10 cigarettes per day for 15 years and is interested in quitting. HS asks about nicotine replacement products. What advice do you have?

Tell HS about smoking cessation, but also counsel him on the importance of speaking with the clozapine prescriber about his plan to quit smoking. Given that tobacco smoking induces cytochrome P450 1A2, patients who smoke require much higher doses of clozapine (a medication metabolized by 1A2) to achieve therapeutic levels.

 If HS were to quit smoking, he would be at risk for clozapine toxicity because of reduced 1A2 induction and increased serum concentration of clozapine if he continued taking the same dosage. The clozapine prescriber and HS should be urged to consider a clozapine dose reduction, monitor changes in smoking habits, and obtain baseline clozapine levels prior to smoking cessation. Inform HS that he could develop symptoms of clozapine toxicity 2 to 3 weeks after smoking cessation if he is not monitored appropriately.

CL is a 32-year-old woman who recently bought nicotine gum from the pharmacy to aid in smoking cessation and manage cravings. She returns a week later with complaints of hiccups and indigestion. These adverse effects are disrupting CL’s workday, and she asks for advice. What do you tell her?

Tell CL that the hiccups and indigestion may be a result of excessive nicotine release from chewing the gum too quickly. Inform her that it is not like regular gum and is meant for buccal absorption. Counsel CL on the chew-and-park method: First, chew the gum slowly until it begins to tingle; then place it between the cheek and gums until the tingle goes away; finally, repeat this process until the tingle is gone after 30 to 60 minutes. Remind CL that the gum’s effectiveness may be reduced by beverages or food, so she should not drink or eat anything 15 minutes before or while using the gum.

 is a clinical assistant professor of pharmacy practice and administration at the Ernest Mario School of Pharmacy and an ambulatory care specialist at RWJBarnabas Health in New Jersey.

Rupal Patel Mansukhani, 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.

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.

CDC. Adult smoking cessation—the use of e-cigarettes. CDC website. cdc.gov/tobacco/data_statistics/sgr/2020-smoking-cessation/fact-sheets/adult-smoking-cessation-e-cigarettes-use/index.html. Updated January 23, 2020. Accessed February 25, 2020.

CDC. How to quit smoking. CDC website. gov/tobacco/campaign/tips/quit-smoking/index.html. Updated August 2, 2019. Accessed February 25, 2020.

Tsuda Y, Saruwatari J, Yasui-Furukori N. Meta-analysis: the effects of smoking on the disposition of two commonly used antipsychotic agents, olanzapine and clozapine. 

. 2014;4(3):e004216. doi: 10.1136/bmjopen-2013-004216.

Lowe EJ, Ackman ML. Impact of tobacco smoking cessation on stable clozapine or olanzapine treatment. 

. 2010;44(4):727-732. doi:10.1345/aph.1M398.

2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service clinical practice guideline executive summary. 

Handling e-cigarettes, technological solutions to smoking, and more.

OTC Case Studies: Smoking Cessation

GG is a 23-year-old woman who says that every month, about 5 days before her period starts, she feels abdominal bloating, breast tenderness, and cramping. She says that her symptoms cause her distress but are mild. Upon questioning, GG says that these symptoms affect her quality of life because she usually does not want to go out during this time. She is looking for something to take monthly prior to her period to prevent these symptoms. Some of GG’s friends take OTC medications to prevent these symptoms, but she does not know what to take. She does not take any other medications and is relatively healthy. What recommendations do you have?

GG appears to be suffering from premenstrual syndrome (PMS). The goals of therapy for this condition are to allow patients to maintain their usual activities and decrease distress. Nonpharmacologic approaches include cutting back on alcohol, caffeine, chocolate, and salt; exercise; and stress management. If GG is looking for something over the counter, she can try taking 1200 mg of elemental calcium divided into 2 doses and 600 IU of vitamin D daily. Results from one large clinical study showed a 48% reduction in total symptom scores from baseline compared with a 30% reduction in the placebo by 3 months. The authors concluded that calcium supplementation is an effective symptom treatment for PMS.

 If calcium and vitamin D do not help GG’s symptoms, she can try other OTC medications, such as magnesium pyrrolidone or pyridoxine.

RM is a 29-year-old woman who says she feels bloated and has mood changes every month a few days before her period. Her cycle is regular, with periods lasting 4 or 5 days, and is typically 28 to 30 days long. RM’s mother recommended that she try chasteberry, but RM is concerned about trying herbal products, because she has heard that they can be harmful. RM does not take any other medications and is relatively healthy. What recommendations do you have?

Chasteberry may inhibit prolactin and interact with estrogen receptors so should be avoided in patients on estrogen therapy or those who should avoid estrogen therapy, such as individuals with certain types of cancer.

 A few trials show that chasteberry can be beneficial for reducing breast tenderness, fluid retention, mood swings, and pain. All 4 symptoms significantly improved after 3 months in 1 study. The authors concluded that chasteberry was “effective in treating moderate to severe PMS in Chinese women, especially in symptoms of negative affect and water retention.”

 Another study demonstrated that symptoms were also significantly lower than the baseline in both groups (P <.0001) after 3 months. In addition, no serious adverse events were reported. Although there are no large clinical trials with chasteberry, it appears that short-term use may be safe. But RM should be advised to try other methods, such as calcium and vitamin D, first.

BD is a 58-year-old man who wants to refill his prescription for metformin 1000 mg twice daily. He has had type 2 diabetes for 15 years and also has hypertension. BD’s friend told him that he recently read that stevia can reduce postprandial glucose levels. BD is thinking about adding stevia into his diet while continuing to take metformin. He exercises most days of the week, has a relatively healthy diet, and is constantly looking for new foods to try to help control his diabetes. What recommendations do you have?

Stevia has grown more popular over time. In 2008, the FDA granted stevia generally recognized as safe status as a food additive sweetener.

 One study evaluated the acute effects of stevia in patients with type 2 diabetes. Although it was a small study with 12 patients, the authors found that 1 g of stevia leaf extract reduced postprandial blood glucose levels.

 Results of another study showed that stevia decreased the desire to eat, thus lowering appetite sensation. Therefore, the authors concluded that stevia does not further increase food intake and postprandial glucose levels.

 Based on the safety evidence, BD could add stevia to his diet without harm. He should be educated to increase his blood glucose monitoring because he is modifying his normal diet. In addition, BD should be advised not to stop taking metformin and should consult with a physician before making any medication changes.

HJ is a 39-year-old single woman who wants to get the human papillomavirus (HPV) vaccine. Over the past year, she has had several partners, though she has never been told she has been exposed to HPV. HJ’s doctor recently suggested that she get the HPV vaccine. However, HJ has heard that the vaccine is effective only in individuals up to age 26 years. She is healthy and has no medical conditions. What recommendations do you have?

The CDC issued an update in August for recommendations on the HPV vaccine for adults. The recommendations changed to increase vaccination to males through age 26 years. Therefore, the vaccine should be routinely recommended at age 11 or 12 years but can start early as 9 years of age. Vaccination is recommended both in females and males through age 26. For patients such as HJ, shared clinical decision making is now recommended. For adults aged 27 to 45 years who have not been vaccinated, it is important to determine whether the patient would benefit from receiving the HPV vaccine. The new recommendations have guidance for patients in this age group. Patients are at an increased risk if they have new sex partners. The guidance document also states that most sexually active adults have been exposed to some HPV types, though it is difficult to determine if they are the same as the ones in the vaccine. At this time, no clinical antibody test can detect if the patient already has HPV. Vaccine effectiveness might be low among patients who have risk factors for HPV, such as multiple sex partners or previous infections. With shared clinical decision making, it is important to determine if the vaccine will be beneficial for the patient. Most patients who are in monogamous relationships are at lower risk of having a new HPV infection. For HJ, because she is sexually active with multiple partners, it may be beneficial to receive the vaccination. It is important to advise HP that the vaccination will not protect her from HPV infections to which she may have already been exposed.

Rupal Patel Mansukhani, 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.

Thys-Jacobs S, Starkey P, Bernstein D, Tian J. Calcium carbonate and the premenstrual syndrome: effect on premenstrual and menstrual symptoms. 

. 1998;179(2):444-452. doi: 10.1016/s0002-9378(98)70377-1.

Ma L, Lin S, Chen R, Wang X. Treatment of moderate to severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women. 

. 2010;26(8):612-616. doi: 10.3109/09513591003632126.

He Z, Chen R, Zhou Y, et al. Treatment for premenstrual syndrome with Vitex agnus castus: a prospective, randomized, multi-center placebo controlled study in China. Maturitas. 2009;63(1):99-103. doi: 10.1016/j.maturitas.2009.01.006.

GRAS Notice (GRN) No. 768. FDA website. fda.gov/media/119340/download. Published March 14, 2018. Accessed January 15, 2020.

Gregersen S, Jeppesen PB, Holst JJ, Hermansen K. Antihyperglycemic effects of stevioside in type 2 diabetic subjects. 

. 2004;53:73-76. doi:10.1016/j.metabol.2003.07.013.

Farhat G, Berset V, Moore L. Effects of stevia extract on postprandial glucose response, satiety and energy intake: a three-arm crossover trial. 

. 2019;11(12):pii: E3036. doi: 10.3390/nu11123036.

This month's OTC case studies ask about PMS symptoms, using stevia for diabetes, and OTC Tamiflu. 