Nasal Decongestant Notes Update - July 2023 PDF

CONTINUING EDUCATION THIS ACTIVITY IS SUPPORTED BY AN EDUCATIONAL GRANT FROM BAYER CONSUMER HEALTH. Maximizing Patient Safety and Efficacy With Oxymetazoline OTC Products and the Management of Nasal Congestion: A Pharmacist’s Guide to Optimal Use FACULTY...

CONTINUING EDUCATION THIS ACTIVITY IS SUPPORTED BY AN EDUCATIONAL GRANT FROM BAYER CONSUMER HEALTH. Maximizing Patient Safety and Efficacy With Oxymetazoline OTC Products and the Management of Nasal Congestion: A Pharmacist’s Guide to Optimal Use FACULTY EDUCATIONAL OBJECTIVES Marlowe Djuric Kachlic, PharmD, BCACP At the completion of this activity, the pharmacist will be able to: Director, Introductory Pharmacy Practice Analyze the incidence, common causes, and impact of nasal congestion on patient Experiences Director, UIC Community-Based Pharmacy quality of life and productivity Residency Program Explain the etiology of rhinitis medicamentosa Clinical Assistant Professor Examine the role of OTC oxymetazoline in managing nasal congestion, including the Department of Pharmacy Practice efficacy and safety data associated with the long-term use University of Illinois Chicago College of Construct a comprehensive treatment plan for patients with nasal congestion, Pharmacy including appropriate use of OTC options, managing drug interactions, and potential Chicago, Illinois adverse effects of nasal decongestants DISCLOSURES At the completion of this activity, the pharmacy technician will be able to: The following contributors have no relevant Study the incidence, common causes, and impact of nasal congestion on patient financial relationships with commercial interests to quality of life and productivity disclose: Discuss the etiology of rhinitis medicamentosa FACULTY Recognize the role of OTC oxymetazoline in managing nasal congestion, including the Marlowe Djuric Kachlic, PharmD, BCACP efficacy and safety data associated with the long-term use PHARMACY TIMES CONTINUING EDUCATION™ Outline the comprehensive treatment plan drafted by the pharmacist for patients PLANNING STAFF with nasal congestion, including appropriate use of OTC options and managing drug Jim Palatine, RPh, MBA; Maryjo Dixon, RPh, interactions and potential adverse effects of nasal decongestants MBA; Dipti Desai, PharmD, MBA, CHCP; Michelle TARGET AUDIENCE: Community pharmacists, pharmacy technicians C. Carlson, PharmD; Angelica Archibald; Susan ACTIVITY TYPE: Application for pharmacists; Knowledge for pharmacy technicians Pordon; Brianna Winters; and Chloe Taccetta LEARNER LEVEL: Foundational PHARMACY TIMES® EDITORIAL STAFF RELEASE DATE: July 12, 2023 Davy James EXPIRATION DATE: September 30, 2024 An anonymous peer reviewer was part of the content ESTIMATED TIME TO COMPLETE ACTIVITY: 2.0 hours validation and conflict resolution and has no relevant FEE: This lesson is offered for free at www.pharmacytimes.org. financial relationships with commercial interests to disclose. Overview of Nasal Additionally, in patients with obstructive Congestion and Contributing sleep apnea and baseline allergic rhinitis, Factors nasal congestion has been found to worsen Patients who have nasal congestion may or not improve with continuous positive complain of reduced nasal airflow, a sense airway pressure (CPAP) use.3 of fullness, stuffiness, or obstruction.1,2 Mucosal inflammation is the underlying Allergic Rhinitis cause of nasal congestion in allergic rhinitis Allergic rhinitis is the most common and rhinosinusitis.1 Nasal mucosa can atopic condition in the United States and become inflamed due to increased venous affects from 14% to 60% of the popula- blood flow and engorgement, increased tion.2,4 One study reported that 60% of nasal secretions, and nasal tissue edema. those who reported symptoms of allergic Nasal congestion caused by mucosal inflam- rhinitis most frequently experienced nasal mation is a common symptom of allergic congestion every day or on most days.2 In rhinitis, rhinosinusitis, and nasal polyposis. 2003, researchers reported that the total Pharmacy Times Continuing Education™ is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 2.0 contact hours (0.20 CEU) under the ACPE universal activity numbers 0290-0000-23-263-H01-P and 0290-0000-23-264-H01-T. The activity is available for CE credit through September 30, 2024. 82 P HARMACY TIME S.ORG J ULY 20 23  www.pharmacytimes.org direct medical cost of allergic rhinitis in the United States was rhinitis, which is caused by pregnancy or menstrual irregulari- $3.4 billion.5 In a survey of more than 8000 employees in the ties.1 Nasal congestion is also common in these forms of rhinitis, United States, allergic rhinitis was reported by 55% as having particularly in pregnancy-related rhinitis. experienced symptoms on an average of 52.5 days per year. Due to these symptoms, employees missed 3.57 days of work per Rhinosinusitis year and were unproductive for 2.3 hours during the working Inflammation of the mucosa of the nasal passages and paranasal day if they were experiencing symptoms; this results in a mean sinuses is referred to as rhinosinusitis.1 Rhinosinusitis can be productivity loss per employee of $518. caused by infectious and noninfectious as well as immuno- A national survey done in 2006, Allergies in America, sought logic and nonimmunologic inflammation. The most common to better understand the burden of allergies on the American source of rhinosinusitis is viral infection, or the common population.2 In this survey of 2500 patients, 80% reported cold. Research has shown that the viral infection itself is what nasal congestion to be an extremely or moderately bothersome stimulates inflammatory pathways that prolong symptoms even symptom of allergic rhinitis. Patients with allergic rhinitis may after viral replication has stopped. Microorganisms are largely also have fatigue, mood changes, depression, anxiety, and impair- responsible for acute rhinosinusitis, which has a symptom dura- ment of cognitive function, all of which can have a significant tion of fewer than 4 weeks.2 impact on quality of life.5 However, when patients with allergic Similar to allergic rhinitis, proinflammatory cytokines play rhinitis are using medications for their symptoms such as nonse- a large role in causing congestion as a symptom in rhinosi- dating antihistamines, intranasal corticosteroids, and others, nusitis.1 In addition, kinin levels are significantly increased in they reported improvement in their health-related quality of life. patients with viral rhinosinusitis. These kinins cause vascular Nasal congestion is frequently a predominant symptom of leakage and engorgement, or overfilling, of blood vessels, as allergic rhinitis and is due to both the early- and late-phase allergic well as stimulate afferent nerves in nasal mucosa, which leads to inflammatory response.1 In a patient with allergic rhinitis, when hyperresponsiveness. In an acute viral upper respiratory infec- an antigen encounters nasal mucosa, a crosslinking of immu- tion such as this, TNF-α and proinflammatory cytokines are noglobulin E (IgE) receptors on mast cells occurs. The mast elevated, and there is an increased infiltration of neutrophils and cells then degranulate, which releases histamine and proteases. T cells, which causes the inflammation and venous response that Early-phase proinflammatory molecules are released including leads to congestion. leukotrienes, prostaglandins, tumor necrosis factor (TNF)-α, Acute rhinosinusitis is caused frequently by the common cold, and interleukin (IL)-4. This leads to swelling, edema, and fluid which is one of the most common 5 illnesses in the United States, secretion that causes congestion, among other nasal symptoms. with 1 billion cases annually.6 Sales of medications to treat The cellular infiltration of the late-phase inflammatory colds have been increasing steadily since 2020, and account for response causes continued swelling and edema, worsening $11.4 billion spent in 2022.7 Adults experience an average of nasal congestion.1 Inflammatory cells responsible for this reac- 2-3 colds per year, and children experience 6 or more.6 This tion include eosinophils, neutrophils, basophils, mast cells, and results in missed work and school days, and loss of produc- lymphocytes. In patients with allergic rhinitis, the infiltration tivity. A study of 374,799 employees over 6 large employers of eosinophils has been shown to have a significantly nega- determined that rhinosinusitis was one of the top 10 most tive correlation on nasal airflow. Unfortunately, as the allergy costly conditions, with the majority of costs related to medical season progresses, this cellular infiltration primes the mucosa expenditures, and 41% of the costs related to work absence.2 for further antigen exposure and an increased response to it Chronic rhinosinusitis (CRS) is characterized by symptoms ensues, which means symptoms worsen on continued exposure. including nasal blockage, nasal obstruction, congestion, nasal The actions of TNF-α, cell adhesion molecules, proinflamma- discharge with facial pain, and reduction of smell.8 CRS, which tory interleukins, as well as IgE synthesis and eosinophil and has a symptom duration of 12 weeks or longer, may not be caused basophil priming lead to inflammation, venous engorgement, by an infectious source.1,2 Rhinosinusitis can also be the result nasal hyperreactivity, and congestion. of allergic and immunologic causes and can be a risk factor for There are also forms of nonallergic rhinitis that are not acute bacterial rhinosinusitis.1 It is estimated that CRS affects IgE mediated, such as infectious rhinitis, vasomotor rhinitis, more than 12% of the US population.9 Chronic congestion can nonallergic rhinitis with eosinophilia syndrome, and hormonal also cause sleep issues including sleep-disordered breathing, P HA R M ACYT I M ES. O R G JU LY 2 0 2 3 83 sleep fragmentation, reduced sleep time, reduced sleep quality, TABLE 1. ACTION OF DECONGESTANTS6 and as a result, daytime sleepiness and fatigue.2 Drug name Route Type Phenylephrine Oral Direct Nasal Polyposis Pseudoephedrine Oral Mixed Nasal polyposis is a chronic inflammatory disease of the upper Oxymetazoline Topical – nasal Direct airway that affects about 4% of the population.1 While the Phenylephrine Topical – nasal Direct possible causes of nasal polyposis are not clear, it is suggested that chronic infection, aspirin intolerance, trapping of pollutants, epithelial destruction or cell defects, or inhalant or food aller- lating alpha receptors to constrict blood vessels, decreasing gies could be contributing factors. Nasal polyps are commonly vessel engorgement and mucosal edema.6 Direct-acting formed as a result of chronic inflammatory rhinosinusitis.2 decongestants work by binding directly to adrenergic recep- Polyps, which are small sacs filled with cellular fluid, form in the tors. Indirect-acting decongestants such as ephedrine displace middle meatus and originate from the nasal mucous membrane norepinephrine from storage vesicles in prejunctional nerve of the ostia, clefts, and recesses from the paranasal sinuses. terminals. As stored neurotransmitter is depleted, tachyphylaxis, The polyps cause nasal blockage because they hang down in or diminished response to continued exposure of the neurotrans- the nasal passages and swing back and forth, affecting airflow. mitter, can develop. Mixed decongestants have both direct and Patients with nasal polyposis will have symptoms such as nasal indirect activity. The action of commonly used decongestants obstruction, nasal discharge, and impairment of sense of smell. is shown in TABLE 1.6 Similar to nasal congestion caused by allergic rhinitis and Decongestants are useful in treating both short- and medium- rhinosinusitis, inflammation processes causing edema in the term congestion; however, their adverse effects often limit their nasal passages lead to congestion in nasal polyposis.1 Eosino- use in larger populations.11 Oral decongestants’ sympathomi- phils and related mediators are highly present in allergic and metic activity causes cardiovascular stimulation and adverse nonallergic nasal polyposis. Chronic rhinosinusitis and nasal effects such as elevated blood pressure, tachycardia, palpitation, polyposis are differentiated by their T-cell response patterns, and arrhythmia.6 They can also cause central nervous system and Staphylococcus aureus enterotoxins have also been shown stimulation, which can lead to restlessness, insomnia, anxiety, to play a role in the pathophysiology of nasal polyposis. tremors, fear, or hallucinations. Adrenergic stimulation of decon- An estimated 30 million Americans have chronic rhinosinus- gestants can exacerbate certain disease states such as hyperten- itis, and one-third of these patients may have nasal polyposis.10 sion, coronary heart disease, ischemic heart disease, diabetes Results of a Harris on Demand survey conducted in 2021 indi- mellitus, hyperthyroidism, and elevated intraocular pressure. cated that of the 529 patients with chronic congestion (occurring Additionally, due to their α-adrenergic agonism, these drugs for 3 months or more in the past year), nearly 25% endorsed should not be used in patients with prostate disease because they congestion every day, more than half have headaches regularly, may worsen restricted urinary flow or cause urinary retention.11 and almost half said it impacts their ability to smell or taste food. Topical intranasal decongestants are not well absorbed in About 60% of respondents stated that congestion impacts their the nasal mucosa, and do not carry many systemic adverse ability to get a good night’s sleep, and one-third feel fatigued as effects.6,11 Adverse effects experienced are usually due to the a result of their sleep troubles. Overall, 85% of the respondents propellant, vehicle, or the device itself, and include burning, stated that congestion negatively impacts their daily activities. stinging, or dryness. STAR* Oxymetazoline What is the difference between direct- and indirect- Oxymetazoline is the longest acting and most widely available acting decongestants? of the topical decongestants. On average, it works within 25 *S = Stop; T = Think; A = Assess; R = Review seconds after application to reduce edema and inflammation by stimulating α-adrenergic receptors in the arterioles of Treatment of Nasal Congestion the nasal mucosa, producing vasoconstriction.12,13 A study Nasal congestion is commonly treated using decongestants. done in 2017 with patients with acute rhinitis confirmed that Decongestants are sympathomimetics, which work by stimu- oxymetazoline 0.05% nasal spray relieved congestion symptoms 84 P HARMACY TIME S.ORG J ULY 20 23  www.pharmacytimes.org TABLE 2. AVAILABLE OXYMETAZOLINE FORMULATIONS6,15-21 Brand name Active ingredient Adult dosing Children 6 to