Ammie J. Patel, PharmD, BCACP

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.

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.2010;125(6):1412-1412. doi:10.1016/j.jaci.2010.03.009

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. 

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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. 

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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

 SP is a 37-year-old woman who wants information about nonprescription skin bleaching and spot fading products. She has noticed new brown spots on her cheeks, chin, and nose that a friend, who is a physician, identified as melasma. SP asks about hydroquinone, saying that she had heard mixed reviews about its safety and heard using it can increase the risk of developing cancer. What evidence can the pharmacist share with SP and how should she use hydroquinone if she purchases it?

 Hydroquinone is a first-line choice for self-treatment of hyperpigmentation from melasma. Hydroquinone inhibits melanin production within the skin.

 The United States Food and Drug Administration (FDA) has gone back and forth regarding the safety of hydroquinone, because there had been concerns of increased risk for cancer and ochronosis, a bluish-black discoloration of skin upon application. Initially, the FDA considered setting a rule declaring that all nonprescription skin-lightening drug products are not recognized as effective and safe. Later, the FDA proposed that hydroquinone undergo studies to assess safety in humans. Reviews of cases from 1966 to 2007 found ochronosis to be rare with hydroquinone use. The National Toxicology Program conducted a review and was unable to link carcinogenicity to hydroquinone in humans.

If SP uses hydroquinone, instruct her to first clean the affected area, then rub in hydroquinone and follow with a moisturizer. She should discontinue use if no improvement is seen in melasma, and she should then consult a dermatologist.

 VN is a 62-year-old White woman who asks about nonprescription products to address crow’s feet, sun spots, and wrinkles from photoaging. She has been spending more time outdoors in the sun since she reduced her hours at work. VN says she cleanses her skin and uses SPF 50 sunscreen daily, but she fears loss of collagen and is seeking an OTC product to treat photoaging. Can the pharmacist help VN find a product to increase collagen production and reduce the appearance of fine lines?

 Retinoids are vitamin A products with the most evidence supporting their use in photoaging. Retinol and its derivatives are available as topical nonprescription and prescription products. These agents induce epidermal hyperplasia and stimulate collagen production. In VN’s case, though she is using some measures to protect her skin from the sun, pharmacologic treatment may be needed to help reduce the appearance of fine lines and improve skin elasticity. Other benefits of retinoids include correction of skin tone and elasticity and improvement in skin texture.

Some trade products containing retinol include Differin (adapalene 0.1%) gel and Exuviance Super Retinol Concentrate. In terms of adverse effects, advise VN about the possibility of burning, dermatitis, redness, and scaling with retinol use. The pharmacist should also educate her on retinol storage, because retinol is sensitive and degrades in response to light exposure. In addition, inform VN of the realistic expectations of retinol, meaning that wrinkles may not completely diminish because they are a part of natural aging; also note it may take up to 4 months to note benefits from retinol. She should continue to apply sunscreen and wear sun-protective clothing, such as long-sleeved shirts and wide-brimmed hats, to prevent further photoaging.

 RP is a 32-year-old man complaining of itchy, malodorous feet that sometimes sting. He has been on his feet all day for his new job as a dental assistant. RP finds that by the middle of the workday, his feet are sweating and he experiences itching between the fourth and fifth toes of both feet. He suspects he may have athlete’s foot and inquires about the use of nystatin. RP has a topical nystatin cream at home and would like to use it. What advice should the pharmacist provide regarding treatment for athlete’s foot?

 Although RP may have a fungal infection, tinea pedis (athlete’s foot) is caused by dermatophytes. Nystatin is effective against yeast infections, not dermatophyte or tinea infections. As such, advise RP against the use of nystatin for his condition. Nonprescription medications that have been determined to be effective and safe for tinea pedis are clotrimazole 1% and miconazole nitrate 2%. Both agents are topical and are available as Lotrimin or Micatin topical creams.

Other formulations, such as powders and sprays, may not be as effective if they cannot be rubbed into the skin. Instruct RP to clean and dry his feet and then apply the topical antifungal twice daily to the affected areas for 4 weeks. He may experience improvement in a week but advise him to continue the therapy for a full 4 weeks. Advise RP that topical antifungals may cause irritation and redness.

In terms of nonpharmacologic measures, he should avoid nonporous shoes, such as synthetic fabrics that increase the temperature and sweating. RP can consider applying medicated or nonmedicated foot powder to his shoes and using odor- controlling insoles.

 AJ is a 27-year-old woman seeking advice about a recurrent plantar wart. She frequently uses the swimming pool at her gym and suspects that she may have contracted the warts there. AJ describes the wart as calluslike and flat. She is otherwise healthy and other than levocetirizine for her allergies, does not take medications. AJ has tried salicylic acid gel, liquid, and pads but her plantar wart keeps recurring. What other nonprescription treatments can the pharmacist suggest, and what measures can she take to prevent warts?

 Inform AJ about cryotherapy for treatment of plantar warts. Nonprescription cryotherapy is available as nitrous oxide or as a mixture of dimethyl ether and propane. Historically, liquid nitrogen has been used in the office setting to remove warts. Although cryotherapy has not demonstrated superiority to salicylic acid for wart removal, combination therapy has been proven to be effective for some patients with plantar warts. Compound W NitroFreeze and Compound W Freeze Off Wart Removal System are examples of the nonprescription cryotherapy products available. Before treatment with cryotherapy, AJ should wash her hands and soak the affected foot in warm water for 5 minutes. After thoroughly drying, she may use a file or pumice stone to roughen the wart. AJ should then prepare and activate the device per the instructions and then apply it to the wart for about 40 seconds until a halo forms around the wart. She should wash her hands thoroughly after application. AJ can expect the wart to fall off if the cryotherapy was effective. She may repeat the application 2 weeks later and once more for a maximum of 3 applications before physician referral. AJ should not share the applicator with others because that could lead to the virus spreading.

To avoid recurrence or spread, instruct AJ to avoid cutting or picking at warts and wash her hands before and after touching the wart. Additionally, AJ should use a towel designated just for the wart. She should also avoid walking barefoot in bathrooms and public pools.

Ammie J. 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, NCTTP, is
a clinical associate professor at 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.

Chaowattanapanit S, Silpa-archa N, Kohli I, Lim HW, Hamzavi I. Postinflammatory hyperpigmentation: a comprehensive review. 

. 2017;77(4):607-621. doi:10.1016/j.jaad.2017.01.036

Rulemaking history for OTC skin bleaching drug products. Food and Drug Administration. Updated October 4, 2017. Accessed March 13, 2021.

https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-skin-bleaching-drug-products

Matsumoto M, Todo H, Akiyama T, et al. Risk assessment of skin lightening cosmetics containing hydroquinone. 

. 2016;81:128-135. doi:10.1016/j.yrtph.2016.08.005

McCook JP. Topical products for the aging face. 

. 2016;43(3):597-604. doi:10.1016/j.cps.2016.03.005

Ramos-e-Silva M, Celem LR, Ramos-e-Silva S, Fucci-da-Costa AP. Anti-aging cosmetics: facts and controversies. 

. 2013;31(6):750-758. doi:10.1016/j.clindermatol.2013.05.013

Bradley EJ, Griffiths CEM, Sherratt MJ, Bell M, Watson REB. Over-the-counter anti-ageing topical agents and their ability to protect and repair photoaged skin. 

 2015;80(3):265-272. doi:10.1016/j.maturitas.2014.12.019

Sahoo AK, Mahajan R. Management of tinea corporis, tinea cruris, and tinea pedis: a comprehensive review. 

. 2016;7(2):77-86. doi:10.4103/2229-5178.178099

Pray WS. Recognizing and eradicating tinea pedis (athlete’s foot). 

 August 19, 2010. AccessedMarch 31, 2021. 

https://www.uspharmacist.com/article/recognizing-and-eradicating-tinea-pedis-athletes-foot

Evans EG. Tinea pedis: clinical experience and efficacy of short treatment. 

 1997;194(suppl 1):3-6. doi:10.1159/000246173

Drake LA, Celley RI, Cornelison R. Guidelines of care: guidelines of care for warts: human papillomavirus. 

. 1995;32:98-103.doi:10.1016/0190-9622(95)90192-2

Compound W Freeze Off Advanced Wart Remover. Compound W. Accessed March 30, 2021. 

https://www.compoundw.com/wart-removal-products/cryogenic-wart-removal/compound-w-freeze-off-advanced-wart-remover

Micali G, Dall’Oglio F, Nasca MR, Tedeschi A. Management of cutaneous warts

. 2004;5(5):311-317. doi:10.2165/00128071-200405050-00004

OTC Cases: Skin Health

Q: RY is a 34-year-old woman looking for something to treat her daughter’s fever. Her daughter, HY, is 6 years old. She has a sore throat that started very quickly, a fever for the past 2 days, and pain when swallowing. Her oral temperature has been 101 °F to 103 °F. What recommendations does the pharmacist have for RY to treat HY’s fever?

A: In most cases, viruses are the cause of sore throats. In some cases, Group A 

can cause a throat infection. The only way to identify Group A 

 Therefore, RY should be referred to a health care practitioner who can test HY for the virus. In terms of her fever, no evidence suggest that fever worsens illness or causes other complications. Therefore, fever reducers should only be used to reduce HY’s discomfort. If she is uncomfortable, RY can give her acetaminophen or ibuprofen. Data show there is no difference between the efficacy and safety of acetaminophen or ibuprofen in otherwise healthy children. Acetaminophen typically works within 2 hours at the recommended dosage of 10 to 15 mg/kg every 4 to 5 hours. Advise RY not to give more than 5 doses in a 24-hour period. The recommended dosage for ibuprofen is 5 to 10 mg/kg every 6 to 8 hours, with a maximum of 4 doses per day.

 HY should stay hydrated as long as the fever persists.

Q: MR is a 58-year-old man who is looking for something to manage his blood sugar. He has hypertension and type 2 diabetes. MR started taking insulin approximately 6 months ago. He has been doing well on it, but he felt dizzy the previous evening, so he checked his blood sugar. It came back low, so MR ate dinner to raise his blood sugar level. He wants to buy OTC glucose tablets. What recommendations should the pharmacist give MR for managing his low blood sugar?

A: MR likely had an episode of hypoglycemia. The signs and symptoms of hypoglycemia can vary and may include blurred or impaired vision, chills, confusion, dizziness, fainting, fast heartbeat, weakness, headaches, or sweating. The best way to determine if a patient is experiencing hypoglycemia is to check their blood sugar level. Encourage MR to use the 15-15 rule if he is experiencing hypoglycemia. The rule of 15 starts with checking his blood sugar level. If it is low, then MR should take 15 g of carbohydrates to raise it. After 15 minutes, he should recheck his blood sugar level. If it is still lower than 70 mg/dL, he should take another 15 g of carbohydrates, which can include glucose gels or tablets. MR can also have 4 oz (1/2 cup) of juice or regular soda (not diet), hard candy, or 1 tbsp of corn syrup, honey, or sugar. Once his glucose returns to normal, he should have a small snack if it is not near mealtime to prevent another episode.

Q: MB is a 55-year-old woman who wants to know if there are OTC options to prevent pneumococcal disease. MB has had breast cancer, diabetes, and high cholesterol. She is being treated with chemotherapy and other medications. What recommendations should the pharmacist make?

A: The best way for MB to prevent pneumococcal disease, which can cause meningitis, pneumonia, and sepsis, is to get the pneumococcal vaccination. The CDC recommends the pneumococcal vaccination for children younger than 2 years and adults 65 years or older. In certain situations, older children and other adults also can receive the pneumococcal vaccines. There are 2 pneumococcal vaccines on the market: PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23). The recommendations for PCV13 include children younger than 2 years and patients 2 years of age and older with certain medical conditions. PPSV23 is recommend for patients 65 years and older, individuals 2 to 64 years with certain medical conditions, and adults who smoke cigarettes. MB is eligible for both PCV 13 and PPSV23, because she is immunocompromised due to chemotherapy. The CDC recommends that PCV13 should be followed by a dose of PPSV23 a year later in all immunocompetent persons aged 65 years or older who have not previously received the pneumococcal vaccine. Because MB is immunocompromised, the interval between doses would be shortened to 8 weeks.

Q: RD is a 58-year-old woman who is looking for an OTC option to prevent heart failure (HF). She has been taking prescription medications for the past year for HF. RD’s friend recommended she try coenzyme Q10 (CoQ10). What recommendations should the pharmacist give to RD?

A: Because RD has HF, she should discuss treatment with her health care providers before initiating therapy. If she can take CoQ10 safely without drug interactions, it is important to look at longterm efficacy and safety. A meta-analysis demonstrated that patients with HF who took CoQ10 at doses of 30 to 300 mg or 2 mg/kg daily for up to 2 years showed improvements. Improvements included ability to exercise, fewer deaths, and reduced hospitalizations compared with a placebo. Although benefits were seen, all patients were taking conventional therapies in addition to CoQ10. Other markers, such as cardiac output, ejection fraction, and New York Heart Association Functional Classification, did not improve.

 Advise RD to continue taking her prescription medications.

 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, NCTTP

, is a clinical associate professor at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, and a transitions-ofcare clinical pharmacist at Morristown Medical Center in New Jersey.

CDC. Strep throat: all you need to know. Updated January 12, 2021. Accessed January 20, 2021. https://www.cdc.gov/groupastrep/diseases-public/strep-throat.html

Section on Clinical Pharmacology and Therapeutics, Committee on Drugs, Sullivan JE, Farra HC.Fever and antipyretic use in children. 

. 2011;127(3):580-587.doi:10.1542/peds.2010-3852

American Diabetes Association. Hypoglycemia (low blood sugar). Accessed January 20, 2021. https://www.diabetes.org/healthy-living/medication-treatments/blood-glucose-testing-and-control/hypoglycemia

CDC. Pneumococcal ACIP vaccine recommendations. Updated November 21, 2014.Accessed January 20, 2021.https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/pneumo.html

Lei L., Liu Y. Efficacy of coenzyme Q10 in patients with cardiac failure: ameta-analysis of clinical trials. 

. 2017;17(1):196. doi:10.1186/s12872-017-0628-9

Four OTC cases studies are presenting, including a case of strep throat.

OTC Cases: Strep Throat

RD is a 66-year-old woman who is looking for echinacea to prevent influenza. She is relatively healthy and does not take any medications. What should the pharmacist recommend to RD?

Although RD has no medical conditions, she is considered high risk for influenza complications based on her age.

 Let her know that studies show that obtaining the annual vaccine is the most effective way to prevent influenza.

 There are conflicting data related to the use of echinacea for the prevention of influenza. The results of 1 study show that echinacea can help with influenza vaccine response in patients with respiratory conditions

 and may be beneficial to take with the vaccine. Results from another study showed that echinacea with elderberry reduced the rate of influenzarelated respiratory complications like oseltamivir, the gold standard of influenza treatment. However, the sample size included 473 patients and did not have a placebo group.

 Based on the literature, RD should probably try other methods of prevention, such as avoiding individuals who are sick, cleaning and disinfecting surfaces, washing her hands regularly with soap and water, and wearing a mask.

RA is a 56-year-old woman who asks about her OTC aspirin 81 mg daily, which she started taking a few years ago, because she heard it has heart benefits, though she never discussed the matter with a health care provider. She has diabetes but no history of a heart attack, stomach bleeding, or strokes. RD does not drink alcohol and has never smoked. She exercises regularly and has a healthy diet. What recommendation should the pharmacist give?

RA has no secondary prevention indication for aspirin use. The guidance on the use of aspirin for the primary prevention of cardiovascular disease in patients with diabetes is controversial. The results of 1 meta-analysis with 13 studies showed that aspirin reduces the incidence of cardiovascular events.

 However, the results of another meta-analysis with 11 studies showed no reduction in all-cause mortality.

 The results of both meta-analyses showed a higher rate of gastrointestinal (GI) bleeding. Although the data are conflicting, the American Diabetes Association recommends that patients with diabetes use aspirin if they are older than 50 years of age and have any of the following risk factors: albuminuria/chronic kidney disease, dyslipidemia, family history of premature atherosclerotic cardiovascular disease, hypertension, or smoking. It is important to assess that patients taking aspirin are not at risk for GI bleeding before initiating aspirin therapy. Although RA is older than 50 years, she has no additional risk factors and therefore, based on the guidelines, should not take aspirin for primary prevention.

MG, is a 33-year-old woman who is looking for a lice treatment. Her 5-year-old daughter, SG, came home from school and was complaining of an itchy scalp. Upon examination, MG noticed live lice and nit casings on SG’s head. MG is looking for a recommendation for an OTC product. In the past, when SG has had lice, MG has used permethrin and pyrethrin. What recommendation should the pharmacist provide?

In October 2020, the FDA approved ivermectin (Sklice) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older to be converted from prescription to OTC status.

 The results of 1 study showed that patients using ivermectin were louse-free on day 2 (94.9%), day 8 (85.2%), and day 15 (73.8%).

 When treating head lice, it is important to use nondrug strategies with OTC medications.

 For example, any clothing that was worn within the time frame of infestation should be machine-washed in hot water or sealed in a plastic bag and stored for 2 weeks. Soak brushes and combs in hot water and vacuum floors. Use a fine-tooth comb to remove dead lice or nits. Sklice lotion can be applied directly to dry hair and the scalp.

 It is important to rub the lotion throughout the entire head so that all lice and eggs are exposed to it. Use the entire tube. An adult must apply Sklice for children. Let the lotion stay on the head for 10 minutes, and then completely rinse using only water. SG should wait 24 hours before using shampoo. Avoid exposure of Sklice to eyes, but if it does get accidentally get in the eyes, gently flush with water. Adverse effects include burning sensation on the skin, dandruff, and eye redness or soreness. Do not use Sklice lotion again without talking to SG’s health care provider first.

AS is a 49-year-old man who is looking for zinc as he wants to lower his chance of getting the coronavirus disease 2019 (COVID-19). He has a history of diabetes and hypertension. AS heard from his co-workers that zinc supplements boost the immune system, so they will provide protection against the virus. What recommendations should the pharmacist make?

Zinc is important in maintaining cellular homeostasis and can potentially prevent viral replication in the nasal mucosa.

 The National Institutes of Health’s (NIH) recommended dietary allowance is 11 mg daily for men and 8 mg for nonpregnant women.

 With the surge of COVID-19 cases in 2020, some have considered using zinc as prophylaxis for the disease. However, a retrospective study of azithromycin and hydroxychloroquine with or without zinc showed no differences in outcomes.

 Because there are limited studies with COVID-19 and the use of zinc, the NIH guidelines recommend against the use of zinc.

 Additionally, excess zinc consumption is associated with long-term adverse effects, such as anemia, ataxia, copper deficiency, leukopenia, myelopathy, and spasticity.

, 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.

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Kumar N. Copper deficiency myelopathy (human swayback). 

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Four patient cases involving OTC treatments are presented.

OTC Cases: Influenza

: BF is a 61-year-old woman who is seeking advice about vitamins for eye health. She smokes a pack of cigarettes per day and has a medical history of type 2 diabetes. BF wants to prevent the onset of age-related macular degeneration (AMD) and is seeking advice on PreserVision vitamins. What information can the pharmacist provide about vitamin

: Studies show that the PreserVision AREDS and AREDS 2 formulas (beta carotene, copper, vitamins C and E, and zinc; and copper, lutein, vitamins C and E, zeaxanthin, and zinc), which are based on evidence from the trials AREDS (NCT00000145) and AREDS 2 (NCT00345176), have reduced the risk of developing advanced AMD by 25% and central vision loss by 19%. However, combination antioxidant supplements, including PreserVision, do not prevent AMD onset.

Cyanocobalamin (B12) 1000 mcg/day, folic acid (B9) 2500 mcg/day, pyridoxine (B6) 50 mg/day, and the vitamin B preparations have shown efficacy in preventing AMD onset in elderly women. Therefore, instruct BF to take that combination for 7 years, as demonstrated in studies.

Smoking increases the neovascularization in AMD and the risk of progression. Encourage BF to quit smoking using a combination of cognitive behavioral therapy and pharmacologic treatment.

If BF were to develop AMD and was diagnosed with moderate AMD by an eye doctor, she should be encouraged to begin taking PreserVision AREDS 2 formula to decrease the risk of progression to advanced AMD. The AREDS trial found a statistically significant benefit of PreserVision’s formula on the progression of early to late AMD. However, beta carotene is present in the original AREDS formula and has been associated with an increased risk for lung cancer in current and former smokers. Lung cancers were observed in 2% of participants who took AREDS compared with 0.9% of participants who took AREDS 2. About 91% of those who developed lung cancer were former smokers. As such, the new formulation, AREDS 2, does not contain beta carotene and instead includes carotenoids, lutein, and zeaxanthin. If BF does start taking AREDS 2, instruct her to take 1 soft gel 2 times per day with food and to store the product at room temperature.

: BF follows up with a question regarding nutrition for eye health. She has been on a low glycemic index diabetic diet and has incorporated more vegetables into her meals. BF asks if there is good evidence that certain foods boost eye health, lowering the risk of AMD. What evidence can the pharmacist provide to BF?

: Although study results vary, data suggest that a healthy diet rich with antioxidants (carotenoids and vitamins C and E) and omega-3 fatty acids has been associated with a decreased risk of developing AMD. Specific carotenoids lutein and zeaxanthin were most strongly associated with a decreased risk of developing AMD. They are found primarily in dark green, leafy vegetables, such as collard greens, kale, and spinach. Foods rich in vitamin C include citrus fruits, peaches, strawberries, tomatoes, and red bell peppers. Nuts, such as cashews, peanuts, and walnuts, and seeds, such as chia, flax, and hemp, are rich in vitamin E. Cold water fish, such as halibut, salmon, and tuna, are a great source of omega-3 fatty acids. Overall, if BF is following a diet recommended by the American Diabetes Association, it is likely that most of the recommendations for the diabetes and eye health diets overlap.

: JK is a 37-year-old man who suffers from dry and itchy eye. He has used a variety of OTC eye drops, such as Clear Eyes, Moisture Eyes, and Visine, for years and has noticed that the drops no longer relieve his symptoms. His wife heard about toxicity from preservatives in eye drops. What information can the pharmacist provide to JK about ophthalmic preservatives?

 : A preservative that Clear Eyes, Moisture Eyes, and Visine have in common is benzalkonium chloride (BAK). Ophthalmic preservatives such as BAK are bactericidal and protect the ophthalmic solution by damaging the plasma membrane of bacteria that may be introduced to the multidose product. Unfortunately, long-term use of ophthalmic products containing BAK may result in conjunctival and corneal damage, which presents as exacerbated dry eye disease and eye inflammation. Other ophthalmic preservatives appear to be less toxic but also less effective than BAK. Examples include chlorhexidine and chlorobutanol.

Newer formulations of artificial tears have been designed without preservatives or with preservatives that dissociate into a nontoxic product on the ocular surface. Preservative-free (PF) formulations are more expensive and are to be used as a single dose. Examples include Blink Tears (PF), Refresh Optive Advanced (PF), and Soothe (PF). Examples of preservative-dissociating formulations are GenTeal Tears, Refresh Optive, and Refresh Tears.

: RP is a 32-year-old man with seasonal allergies. Because of his frequent exposure to environmental allergens, his itchy, red, and watery eye symptoms have become bothersome over the past week. RP called his cousin who is a pharmacist and learned that he should avoid wearing his contact lenses for a week, try cool water eye compresses, and use OTC antihistamine and/or lubricant eye drops. RP is seeking instruction on how to administer the eye drops. He mentions that he has his sister’s Zaditor bottle from a few months ago and plans to use that. A: Instruct RP to discard his sister’s Zaditor eye-drop bottle if it has been open for more than 30 days, as the labeled expiration date does not apply once the seal is broken. In addition, eye drops should not be shared.

Once he opens a new bottle of Zaditor, instruct RP to follow these steps to insert 1 drop into each eye 2 times per day: tilt head backward; form a pocket with the lower eyelid by pulling down with the index finger or gently pinching the lower lid with the index finger and thumb; look up, hold the bottle upside-down, and squeeze 1 drop into the pocket; and close the eye, and do not blink. RP should contact his eye care provider if symptoms do not resolve after 72 hours of treatment.

, 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 in Piscataway, and an ambulatory care specialist at RWJBarnabas Health Primary Care in Shrewsbury and Eatontown, New Jersey.

Rupal Patel Mansukhani, PharmD, FAPhA, NCTTP

, 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.

Christen WG, Glynn RJ, Chew EY, Albert CM, Manson JE. Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: the Women’s Antioxidant and Folic Acid Cardiovascular Study. 

. 2009;169(4):335-341. doi:10.1001/archinternmed.2008.574

Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for preventing age-related macular degeneration. 

 2017;7(7):CD000253. doi:10.1002/14651858.CD000253.pub4

Chong EWT, Wong TY, Kreis AJ, Simpson JA, Guymer RH. Dietary antioxidants and primary prevention of age related macular degeneration: systematic review and meta-analysis. 

 2007;335(7623):755. doi:10.1136/bmj.39350.500428.47

Seddon JM, George S, Rosner B. Cigarette smoking, fish consumption, omega-3 fatty acid intake, and associations with age-related macular degeneration: the US twin study of age-related macular degeneration. 

. 2006;124(7):995-1001. doi:10.1001/archopht.124.7.995

Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. 

 2001;119(10):1417-1436. doi:10.1001/archopht.119.10.1417

Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. 

. 2013;309(19):2005-2015. doi:10.1001/jama.2013.4997

Seddon JM, Ajani UA, Sperduto RD, et al. Dietary carotenoids, vitamins A, C, and E, and advanced age-related macular degeneration. Eye Disease Case-Control Study Group. 

. 1994;272(18):1413-1420. doi:10.1001/jama.1994.03520180037032

Tressler CS, Beatty R, Lemp MA. Preservative use in topical glaucoma medications. 

 2011;9(3):140-158. doi:10.1016/s1542-0124(11)70024-6

Pensyl CD. Preparations for dry eye and ocular surface disease. In: Bartlett JD, Jaanus SD, eds. 

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Fiscella RG. Ophthalmic drug formulations. In: Bartlett JD, Jaanus SD, eds. 

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Dry eye syndrome PPP — 2018. American Academy of Ophthalmology. November 2018. Accessed July 6, 2020. 

https://www.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp-2018

OTC Case Studies: Eye Health

: 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. 

Four OTC cases are presented for women's health.