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CREDIT: 2.0 Continuing Education EARN CE CREDIT FOR THIS ACTIVITY AT WWW.DRUGTOPICS.COM AN ONGOING CE PROGRAM OF THE UNIVERSITY OF CONNECTICUT SCHOOL OF PHARMACY AND DRUG TOPICS educationaL oBJectiVeS Goal: The goal of this activity is to compare and contrast the common cold, influenza, and sinusitis and discuss the role of the pharmacist as the medication expert for various treatment options and as a source to triage patients when needed. After participating in this activity, pharmacists will be able to: ● ● ● ● ● Compare the clinical presentations of the common cold, flu, and sinusitis Describe nonpharmacologic and pharmacologic therapy for the common cold, flu, and sinusitis Summarize the efficacy and safety of popular herbal products for the common cold, flu, and sinusitis Discuss essentials of pharmacist triage for the patient with cold, flu, and sinusitis symptoms Compare differences between adult and pediatric populations as they relate to the common cold, flu, and sinusitis The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Pharmacists are eligible to participate in the knowledge-based activity, and will receive up to 0.2 CEUs (2 contact hours) for completing the activity, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission. ACPE# 0009-9999-15-035-H01-P Grant Funding: This activity is supported by an independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. Supported by an educational grant from Genentech Novartis Pharmaceuticals Corporation Activity Fee: There is no fee for this activity. MtM essentials for cold, flu, and sinusitis management Danielle M. Miller, PharmD ASSISTANT CLINICAL PROFESSOR, NORTHEASTERN UNIVERSITY SCHOOL OF PHARMACY, BOSTON, MASS., AND AMBULATORY CARE CLINICAL PHARMACY SPECIALIST, BOSTON MEDICAL CENTER, BOSTON, MASS. Tayla N. Rose, PharmD ASSISTANT CLINICAL PROFESSOR, NORTHEASTERN UNIVERSITY SCHOOL OF PHARMACY, BOSTON, MASS., AND AMBULATORY CARE CLINICAL PHARMACY SPECIALIST, LYNN COMMUNITY HEALTH CENTER, LYNN, MASS. Abstract The common cold, influenza (flu), and sinusitis are common upper respiratory tract infections (URIs) that frequently result in unnecessary primary care office visits, missed school days among children, and missed work days among adults. Because of their viral etiology (except in less common cases of bacterial sinusitis), these illnesses are considered to be self-limiting. Treatment recommendations are focused on symptom management, including pharmacologic, nonpharmacologic, and/or complementary alternative medicine options. Community pharmacists are uniquely positioned healthcare providers adequately trained to assess patients’ symptoms and triage care. Serving as the initial healthcare provider, pharmacists are able to identify whether patients are eligible for self-care or whether they require a referral to a primacy care provider. In the setting of self-care, pharmacists serve as medication experts to recommend over-the-counter (OTC) pharmacologic options and/or nonpharmacologic options for symptom management. Expiration date: October 10, 2018 To obtain CPE credit, visit www.drugtopics.com/cpe and click on the “Take a Quiz” link. This will direct you to the UConn/Drug Topics website, where you will click on the Online CE Center. Use your NABP E-Profile ID and the session code: 15DT35-PTK48 to access the online quiz and evaluation. First-time users must pre-register in the Online CE Center. Test results will be displayed immediately and your participation will be recorded with CPE Monitor within 72 hours of completing the requirements. For questions concerning the online CPE activities, e-mail: [email protected]. Faculty: danielle M. Miller, Pharmd, and tayla n. Rose, Pharmd Dr. Miller is an assistant clinical professor at Northeastern University School of Pharmacy, Boston, Mass., and an ambulatory care clinical pharmacy specialist at Boston Medical Center, Boston, Mass. Dr. Rose is an assistant clinical professor at Northeastern University School of Pharmacy, Boston, Mass., and an ambulatory care clinical pharmacy specialist at Lynn Community Health Center, Lynn, Mass. Faculty Disclosure: Dr. Miller and Dr. Rose have no actual or potential conflict of interest associated with this article. Disclosure of Discussions of Off-Label and Investigational Uses of Drugs: This activity may contain discussion of unlabeled/unapproved use of drugs in the United States and will be noted if it occurs. The content and views presented in this educational program are those of the faculty and do not necessarily represent those of Drug Topics or University of Connecticut School of Pharmacy. Please refer to the official information for each product for discussion of approved indications, contraindications, and warnings. 36 Drug topics O ctob er 2015 DrugTopics .c om IMAGE: GETTY IMAGES/CANDYBOXIMAGES Initial release date: October 10, 2015 continuing education cpE sEriEs: MtM For tHE pAtiENt WitH rEspirAtorY DisEAsE Welcome to the CPE series, Medication Therapy Management for the Patient with Respiratory Disease, which was designed for pharmacists who take care of patients with respiratory disease. Beginning in April 2015 and continuing through December 2015, pharmacists can earn up to 18 hours of CPE credit with 9 monthly knowledge-based activities from the University of Connecticut School of Pharmacy and Drug Topics. introduction The common cold, influenza (flu), and sinusitis are commonly encountered upper respiratory tract infections (URIs) that comprise a majority of visits to primary care offices and are often inappropriately treated with a prescription antibiotic.1,2 In addition to prescription drug use, there are an abundance of nonprescription products, including herbal and complementary alternative medicine (CAM) products, available to treat symptoms related to the common cold, flu, and sinusitis.3 Community pharmacists are aptly placed as first-line healthcare providers able to assess patients’ symptoms, determine self-care eligibility, and make nonpharmacologic and/or pharmacologic recommendations as appropriate. symptoms associated with the common cold, flu, and sinusitis The common cold, often simply referred to as a cold, is a viral infection of the upper respiratory tract. While there are numerous viruses that may cause a cold, rhinovirus is the most common. Although relatively benign in nature, colds are the primary reason for missed school and workdays for children and adults, respectively.4 Colds often develop slowly, with a one- to three-day incubation period after viral exposure, and begin with a sore or “scratchy” throat and rhinorrhea, followed by sneezing and cough. Other symptoms commonly associated with a cold include itchy or watery eyes (Table 1).5-7 Systemic symptoms such as headache, fever, myDrugTopics .c om This series kicked off in April and May with MTM essentials for asthma management—Part 1 and Part 2. In June and July, the focus shifts to MTM essentials for chronic obstructive pulmonary disease (COPD) management. The August CE activity is a primer on inhalers and nebulizers. In September, pharmacists have the opportunity to learn about allergic rhinitis management. In October, the CE activity covers MTM essentials for cold, flu, and sinusitis management. The November CE activity includes druginduced pulmonary disease recognition and management and idiopathic pulmonary fibrosis. The series concludes in December with a focus on MTM essentials for cough management. The series also offers applicationbased and practice-based activities in 2016. algia, and general malaise are less common with a cold and more indicative of the flu.8 The average duration of a cold varies from seven to 10 days, with the exception of the cough, which can last up to three weeks and is often considered the most bothersome symptom for patients.4,8 Colds are generally considered to be self-limiting; however, because they are often a reason for children and adults staying home from school or work, afflicted individuals may find themselves turning to various overthe-counter (OTC) products to help alleviate their symptoms. Some patients may visit the doctor’s office in search of an antibiotic despite the viral nature of the infection.8 Regardless of the treatment that patients seek, it is important to keep in mind that symptom management is the preferable treatment for colds, as there is no cure for the causative virus. The common cold is a contagious virus spread primarily via self-inoculation through the nasal mucosa or conjunctival membranes. Spread of the infection can be prevented by proper hand washing, disinfecting frequently touched objects such as toys or door handles, and avoiding close contact with others.4 The flu is a highly contagious respiratory infection caused by the influenza virus. Two types of influenza virus, Type A and Type B, cause disease in humans. Type A is further divided into various subtypes based on the genetic makeup of the viral surface proteins.9,10 Influenza Type A is considered more pathogenic than Type B and is responsible for most outbreaks.5 The strains vary yearly and are often unpredict- The best way to prevent the flu is to receive the flu vaccine each year, ideally before flu season, as antibodies against the virus develop approximately two weeks after vaccination. able. Yearly vaccination is prudent because of the constant variability in virus strains caused by “antigenic shift” and “antigenic drift.”11 Although some symptoms of the flu are similar to those of a cold, flu symptoms are more abrupt in onset and more severe in nature. Symptoms typically include a high fever (≥100-102°F), chills, myalgia, fatigue, sore throat, stuffy or runny nose, and headache (Table 1).5-7 Most individuals who are otherwise healthy will recover from the flu in a few days. However, the World Health Organization (WHO) estimates that 250,000 to 500,000 deaths are related to the flu each year. The incubation period of the virus is 18 to 72 hours, but viral shedding begins 24 hours before the onset of symptoms and may last for five to O ctob er 2015 Drug topics 37 Continuing Education TABLE 1 MtM eSSentiaLS FoR coLd, FLu, and SinuSitiS ManageMent symptomatic treatment for the common cold CLiniCAL PResentAtion oF CoMMon ResPiRAtoRY inFeCtions Common cold Influenza Sinusitis Common symptoms: Sore/scratchy throat, cough, nasal congestion, rhinorrhea, itchy/watery eyes, sneezing Common symptoms: Fever, myalgia, headache, rhinitis, sore throat, cough, general body aches/fatigue Common symptoms: Nasal congestion and/or discharge, facial pain, cough, fever Possible symptoms: Low-grade fever, chills, headache, myalgia, general malaise Possible symptoms: Nausea, vomiting, diarrhea Possible symptoms: Sore throat, cough, laryngitis, headache, loss of smell, tooth pain Onset of symptoms: Slowly over the course of 1-3 days Onset of symptoms: Sudden Onset of symptoms: Evolves over days Source: Ref 5-7 10 days. The virus is easily spread among individuals, entering the respiratory tract of the host where it begins to proliferate.5 The best way to prevent the flu is to receive the flu vaccine each year, ideally before flu season, as antibodies against the virus develop approximately two weeks after vaccination. Flu season may begin as early as October, may peak in January and February, and may continue to persist until May. The Centers for Disease Control and Prevention (CDC) therefore recommends that all individuals over the age of six months be vaccinated as early as possible. However, it is appropriate to receive the vaccination at any point during flu season.12 Acute rhinosinusitis, or sinusitis for short, is defined as an inflammation of the mucosal lining of the nasal passage and paranasal sinuses and is usually considered to be mild to moderate in nature.2 Most acute sinusitis cases are viral (90%98%), with the rhinovirus and coronavirus as causative agents. However, bacterial etiology does occur less commonly (2%-10% of cases).13 URIs, although mostly viral in nature, often precede the development of acute bacterial rhinosinusitis (ABRS). TABLE 2 Organisms commonly responsible for ABRS include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.14 Clinical presentation will therefore vary depending on the etiology of the infection. Symptoms commonly associated with sinusitis include nasal discharge beginning as clear and watery and becoming more thick and discolored by day four or five, congestion, cough, and sore or “scratchy” throat (Table 1).5-7 Fever and/or myalgias are possible in the first 24 to 48 hours. Bacterial sinusitis is usually distinguished from viral sinusitis based on the duration of symptoms, severity of symptoms, or worsening of symptoms (Table 2).6 According to the Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for Acute Bacterial Rhinosinusitis in Children and Adults, a patient presenting with any one of the three criteria in Table 2 is clinically considered to have ABRS.6 Duration of sinusitis also varies based on etiology. Viral sinusitis is shorter in duration, lasting approximately five to 10 days with a peak in symptoms around days three to six, whereas bacterial sinusitis usually persists for more than seven to 10 days.6 ACute BACteRiAL RHinosinusitis CLiniCAL PResentAtion Patient must meet any one of the following criteria: • Symptoms of acute sinusitis persisting ≥10 days without signs of improvement • Severe signs/symptoms characterized by high fever ≥102°F and purulent nasal discharge or facial pain lasting ≥3 to 4 consecutive days beginning at symptom onset • Worsening symptoms, such as new-onset fever, headache, or increase in nasal discharge after initial improvement (“double sickening”) Source: Ref 6 38 Drug topics O ctob er 2015 The widespread prevalence of the common cold results in many consumers purchasing OTC products for self-treatment. These OTC medications are viable options for the treatment of cold symptoms such as cough, nasal congestion, runny nose, watery eyes, myalgia, and general malaise. As there are more than 200 available OTC cough/cold products, many formulated as combination products, it is imperative for patients to choose the most appropriate product based on their symptoms.8 Pharmacists are able to quickly and accurately assess a patient’s symptoms with respect to characteristics, history, onset, and any aggravating/remitting factors and establish whether patients are eligible to selftreat. This approach is better known as QuEST SCHOLAR (Figure 1).15 Essential pharmacologic treatment options for cough/cold symptoms include analgesic/anti-inflammatory agents, antihistamines, decongestants, expectorants, and antitussive products. Analgesics such as aspirin, acetaminophen, ibuprofen, and naproxen are commonly employed for both their analgesic and anti-inflammatory properties, with acetaminophen most commonly found in OTC cold products.8 It is thought that respiratory symptoms arise secondary to an inflammatory process caused by the virus, most notably via the prostaglandin E2 mediator, supporting the use of nonsteroidal anti-inflammatory drugs (NSAIDs).16-19 Runny nose, itchy/watery eyes, and sneezing respond well to the use of antihistamines, as these symptoms are thought to result from histamine release caused by an inflammatory response to the causative virus.20 First-generation antihistamines such as chlorpheniramine and doxylamine are efficacious in reducing nasal symptoms as monotherapy but are considered to be more efficacious in treating cold symptoms when combined with other agents.21 Drowsiness is a well-known side effect of first-generation antihistamines because of their ability to cross the blood-brain barrier. Due to this troublesome side effect, first-generation antihistamines should be used with caution in certain patient populations, such as the elderly and those who require mental alertness. Nonsedating second-generation antihistamines such as loratadine, fexofenadine, DrugTopics .c om continuing education and cetirizine lack this side effect but unfortunately have not been shown to effectively treat histamine-mediated cold symptoms.22 Nasal congestion is caused by swelling in the nasal mucosa tissue and obstruction of the airways due to vasodilation and increased vascular permeability as a result of the inflammatory processes associated with the common cold.23,24 Phenylephrine (PE) and pseudoephedrine (PDE) are FDAapproved oral decongestants that constrict dilated blood vessels in the nasal mucosa, thereby relieving nasal congestion. Although still available without a prescription, PDE has been moved to behind pharmacy counters to regulate sales because of its role in the illegal production of methamphetamine.25 This barrier in accessibility led to the reformulation, or brand-name extension, of many products to replace PDE with PE, therefore keeping decongestants readily available in the aisles. The addition of “PE” to commonly known brands was used to distinguish the replacement of PDE with PE.26 Unfortunately, the recommended PE single dose of 10 mg is considered less effective than PDE single dose of 60 mg because PE undergoes extensive systemic metabolism, leading to low bioavailability.27,28 In addition to the low bioavailability, the two agents also differ in duration of action. Because of a shorter half-life (2–3 hours), PE is dosed every four hours compared to PDE, which has a longer half-life and can be dosed every four to six hours.29,30 Following product reformulation, concern grew for the low bioavailability of PE (38%), compared to PDE (90%), resulting in the Citizen’s Petition of February 1, 2007, which was filed with the FDA to increase the maximum allowable PE dose from 10 mg to 25 mg.31 However, following the meeting of the Nonprescription Drug Advisory Committee in December 2007, it was concluded that 10 mg of oral PE is safe and effective as an OTC nasal decongestant in adults and that insufficient evidence exists to increase the dose to 25 mg.32 While there is a plethora of literature to support the efficacy of a single 60-mg oral PDE dose for nasal congestion, there is a FIGURE 1 QuEST SCHOLAR Mnemonic for assessing self-care among patients QuEST • Quickly and accurately assess the patient. • Establish that the patient is an appropriate self-care candidate. • Suggest appropriate self-care strategies. • Talk with the patient. • Symptoms: What are the main and associated/related symptoms? • Characteristics: What are the symptoms like? • History: What has been done so far? Has this ever happened and was prior treatment successful? SCHOLAR • Onset: When did this particular problem start? • Location: Where is the problem? • Aggravating factors: What makes it worse? • Remitting factors: What makes it better? Source: Ref 15 (Used with permission of the American Pharmacists Association) lack of literature available to support the use of PE at a higher dose. Even more conflicting, one study concluded that 10 mg of oral PE was no more effective than placebo in the treatment of nasal symptoms.27,33 Patients should therefore be educated accordingly as brand-name products they had previously used may now contain a different chemical ingredient, increasing concern for potential drug-drug or drug-disease interactions, and differences in efficacy. Cough is often the most irritating and longest lasting symptom associated with the common cold, lingering for up to three weeks. Airway inflammation, excess mucus production, and postnasal drip are mechanisms responsible for cough.34,35 Treatment of cough depends on whether the cough is productive or nonproductive. Productive coughs may warrant the use of an expectorant such as guaifenesin, whereas nonproductive coughs may warrant the use of an antitussive such as dextromethorphan. However, combining the two ingredients can be useful in certain situations to alleviate not only cough frequency but also the physical symptoms of chest discomfort associated with excess mucus. Although many studies have demonstrated efficacy with dextromethorphan alone for non- pause&ponder Which herbal supplements have you recently seen in the media claiming to prevent and/or treat upper respiratory tract infections? DrugTopics .c om productive, dry cough, others have found no difference between dextromethorphan and placebo.36-38 The American College of Chest Physicians recommends the combination of brompheniramine, a first-generation antihistamine, and PDE for acute cough.39 As most people do not typically suffer from just one symptom, cold relief products generally contain a combination of multiple medications targeted at alleviating an array of cold symptoms. This strategy can be beneficial for patients, as evidenced by a placebocontrolled trial that found that acetaminophen and PDE used in combination provided better relief of URI-associated pain and congestion than either agent used as monotherapy.40 However, the use of combination products can also be harmful for patients by exposing them to unnecessary medications and their associated adverse effects. Pharmacists can help patients choose the right product by educating them to properly read OTC product packaging and to select certain agents based on individualized symptoms. Not only is it imperative for patients to understand the symptoms that they are treating, but they must also understand the directions for use, including maximum daily intake of individual medications. OTC products are considered safe when used in recommended amounts; nevertheless, these agents are associated with adverse events that can worsen when dose limitations are exceeded.8 Because of the similarity between cold and flu symptoms (Table 1), patients should be counseled to seek medical attention if O ctob er 2015 Drug topics 39 Continuing Education MtM eSSentiaLS FoR coLd, FLu, and SinuSitiS ManageMent FIGURE 2 Indications for antiviral agents for the treatment and prophylaxis of the influenza virus • Hospitalized patients with severe, complicated Indications to prescribe antiviral treatment influenza-like illness or laboratory-confirmed influenza • Patients with influenza-like illness or laboratory-confirmed influenza who are at risk of complications in the outpatient setting • Patients with severe, complicated influenza-like illness or laboratory-confirmed influenza in the outpatient setting Indications to consider antiviral prophylaxis if close contact* has occurred with an infected person during the infectious period§ • Healthcare workers • Persons at risk of influenza-related complications • Pregnant women *Close contact: Self-inoculation of mucosal surfaces after droplet exposure to respiratory secretions (coughing or sneezing) from an infectious person. § Infectious period: One day before fever until 24 hours after resolution. Source: Ref 5 (Adapted with permission) symptoms do not resolve within seven to 10 days. Pharmacists can also educate patients about nonpharmacologic treatment recommendations such as saline nasal irrigation, gargling with warm salt water, increased fluid intake (such as hot tea with lemon and honey and chicken noodle soup), adequate rest, and increased humidification with mist vaporizers or hot showers.7 treatment recommendations for influenza According to the CDC, WHO, and IDSA, patients presenting with flu-like symptoms should be diagnosed clinically. There are, however, rapid influenza diagnostic tests available. Unfortunately, while the specificity of these tests is high (>95%), rapid flu tests have variable sensitivity, ranging from 10% to 70%, and negative results cannot rule out the flu. Real-time reverse transcriptase polymerase chain reaction tests and viral cultures are available, but these techniques take more than 24 hours pause&ponder How can you more effectively counsel patients on the selection of appropriate combination cough and cold products? 40 Drug topics O ctob er 2015 to produce results.5 Because of the generally self-limiting course of the flu virus, antiviral treatment is recommended only for certain patient populations. Prophylactic treatment is also available and recommended for individuals who may have been in close contact with someone with the flu (Figure 2).5 There are two antiviral drug classes indicated for the treatment and prevention of influenza: neuraminidase (NA) inhibitors and adamantanes. Only two antiviral drugs, both belonging to the NA inhibitor medication class, are FDA approved for the prevention and treatment of the flu in the outpatient setting: oseltamivir (Tamiflu) and zanamivir (Relenza) (Table 3).41,42 NA inhibitors prevent the release of virions from an infected host by inhibiting the enzyme neuraminidase, thereby reducing viral spread. NA inhibitors work on both influenza subtypes.43 Initiation of NA inhibitors within 36 to 48 hours of symptom onset has been associated with a statistically significant reduction in the time to symptom resolution. Initiating these agents in a timely manner is important because they have not shown effectiveness in patients who have been experiencing symptoms for longer than 48 hours. According to a systematic review and meta-analysis of the two NA inhibitors, use of these agents within two days of symptom onset in children resulted in symptom resolution 0.5 to 1.5 days sooner than in those not receiving a NA inhibitor.44,45 In contrast, the adamantanes, rimantadine and amantadine are not routinely recommended in clinical practice. Drug resistance, side effects, and lack of efficacy against influenza Type B virus limit their use.46 Young, healthy individuals are excluded from antiviral therapy and instead should be educated about nonpharmacologic treatment options such as rest and adequate hydration. Specific symptoms may be treated with OTC antipyretic and/or anti-inflammatory agents. The use of aspirin or aspirin-containing products should be avoided in children and teenagers because of the risk of Reye’s syndrome.47 treatment recommendations for sinusitis Pharmacologic recommendations for the treatment of sinusitis vary depending on the cause: bacterial or viral. In general, antibiotics should not be routinely prescribed for acute mild to moderate sinusitis as it is often viral in nature. Pharmacists may help to reassure patients during this watchful waiting period and counsel patients to contact their primary care provider if symptoms last for more than seven days, if symptoms worsen after initial improvement, or if symptoms are accompanied by a high fever (≥102°F), excruciating facial/dental pain, or pain/tenderness over the sinuses.2 Overall, acute sinusitis is a self-limiting viral infection that often co-occurs with a URI or the common cold. Nonpharmacologic treatment recommendations include applying a warm compress over the face or breathing in steam from a hot shower to help alleviate sinus pain and facilitate mucus drainage. Nasal irrigation can also help to clean out the nasal passages. Patients should maintain adequate hydration to dilute mucus buildup and promote drainage. Patients should also elevate the head of the bed when sleeping to prevent congestion and should obtain plenty of sleep to help fight off the infection. However, if a clinical diagnosis of ABRS is made, empiric antibiotic treatment should be initiated immediately. Amoxicillin-clavulanic acid is considered a first-line option for ABRS in both children and adults. In adults with a penicillin allergy, alternative first-line options include doxycycline or a respiratory fluoroquinolone (levofloxacin DrugTopics .c om continuing education TABLE 3 neuRAMiniDAse inHiBitoRs FoR tHe tReAtMent AnD PReVention oF inFLuenZA Antiviral agent FDA-approved indications Oseltamivir • Prophylaxis in patients aged ≥1 year • Treatment of acute, uncomplicated flu in patients aged ≥1 year who have not been symptomatic for >48 hours Zanamivir • Prophylaxis in patients aged ≥5 years • Treatment of acute, uncomplicated flu in patients aged ≥7 years who have not been symptomatic for >48 hours Treatment (by mouth twice daily for 5 days) Prevention (by mouth once daily for 10 days)* Children aged 1-12 years: • ≤15 kg: 30 mg • >15-23 kg: 45 mg • >23-40 kg: 60 mg • >40 kg: use adult dosage Children aged 1-12 years: • ≤15 kg: 30 mg • >15-23 kg: 45 mg • >23-40 kg: 60 mg • >40 kg: use adult dosage Children aged ≥13 years and adults: • 75 mg • CrCl <30 mL/min: 75 mg once daily for 5 days Children aged ≥13 years and adults: • 75 mg • CrCl <30 mL/min: 75 mg every other day for ≥10 days Children aged ≥7 years and adults: • 2 inhalations (10 mg) via the Diskhaler Children aged ≥5 years and adults: • 2 inhalations (10 mg) via the Diskhaler Abbreviations: CrCl, creatinine clearance. *Oseltamivir may be used prophylactically for up to 6 weeks and zanamivir for up to 4 weeks during community influenza outbreaks. or moxifloxacin). Because of increased resistance against S. pneumoniae and S. pneumoniae plus H. influenzae, macrolides and trimethoprim-sulfamethoxazole, respectively, are no longer recommended for initial treatment. In uncomplicated ABRS, the duration of therapy is five to seven days in adults and 10 to 14 days in children. An adjuvant intranasal corticosteroid can be used with antibiotics, particularly in patients with a history of allergic rhinitis. However, the use of topical or systemic decongestants and antihistamines should not be recommended as adjuvant therapy. These agents may dry out the nasal mucosa and prevent normal clearance of secretions.6 Herbal products: Do they work and are they safe? Various vitamins, supplements, and herbal remedies are promoted as “natural” options for the prevention and treatment of URIs. Because of the plethora of these products available on pharmacy shelves, pharmacists will often be asked to provide a recommendation. As such, pharmacists must be well informed regarding the safety and efficacy of these products. Several commonly encountered products are reviewed below. pause&ponder How often do you use the QueSt ScHoLaR method when triaging patient symptoms? DrugTopics .c om Source: Ref 41,42 can flowering plants in the Asteraceae family. Echinacea species are promoted as immune system stimulants and protectors against the common cold. Three species of Echinacea (purpurea, angustifolia, and pallida) are used in herbal products.51 These products may include the aerial (above-ground) and/ or root portions of the plant in varying proportions. Additionally, these products come in various formulations, including oral tablets and capsules, liquid extracts, juices, and teas. These differences in composition and formulation lead to a high degree of variability among products. It is important to consider these inconsistencies and how they might affect the safety and efficacy of the various products. A systematic review conducted in 2013 evaluated a variety of Echinacea products versus placebo for the prevention and treatment of the common cold.52 Investigators concluded that Echinacea is not effective for the treatment of colds. Prophylactic Echinacea did not significantly reduce the incidence of cold; however, a nonsignificant trend toward prevention was observed. Other studies have found that Echinacea purpurea may decrease the duration and severity of cold symptoms when initiated shortly after symptom onset; however, Echinacea angustifolia is not beneficial.1 Echinacea may cause nausea and headache and is known to have a poor taste.51 It has also been associated with rashes, particularly in children.52 Echinacea may Echinacea inhibit cytochrome P450 1A2 and induce Echinacea refers to a genus of North Ameri- cytochrome P450 3A4, leading to potenAndrographis paniculata Andrographis paniculata (andrographis) is an herb with a long history of use in traditional Indian, Chinese, and Thai medicine.48 In addition to its use in many other ailments, it is believed to prevent and treat the common cold. A Swedish formulation of andrographis, Kan Jang, when used prophylactically at a dose of 100 mg twice daily five days per week for a minimum of two months, may reduce the risk of the common cold by twofold.49 In terms of common cold treatment, one particular andrographis product, KalmCold, demonstrated a statistically significant reduction in symptoms versus placebo at a dose of 100 mg twice daily for five days.50 Patients had been symptomatic for fewer than three days upon taking the first dose. Andrographis is generally well tolerated but may cause diarrhea, vomiting, nosebleed, and itchy rash.48,50 Caution should be used in patients taking immunosuppressive, antihypertensive, or anticoagulant medications as andrographis may stimulate the immune system, and increase the risk of bleeding and hypotension.48 Take away: Andrographis, in the form of Kan Jang and KalmCold, may be effective in the prevention and treatment of the common cold, respectively. Results are not generalizable to all andrographis products. If this agent is used for treatment, patients should start taking the medication within 72 hours of symptom onset. O ctob er 2015 Drug topics 41 Continuing Education MtM eSSentiaLS FoR coLd, FLu, and SinuSitiS ManageMent tial drug-drug interactions.51 The clinical impact of these interactions is unclear. Additionally, it may stimulate the immune system and should be avoided in patients who are immunosuppressed, including those taking immunosuppressive medications. Patients should be counseled on the possibility of an allergic reaction, especially those with a history of atopy. Take away: Echinacea products should not be recommended for the prevention or treatment of the common cold because of the lack of consistency among products and the lack of compelling evidence. If patients do elect to use an Echinacea product, Echinacea purpurea may have greater benefit than other species. Elderberry Elderberry (Sambucus nigra) is marketed for the treatment of influenza. Elderberry is thought to stimulate the immune system by significantly increasing the production of cytokines.53 One study showed that patients with the flu who used elderberry extract four times daily experienced pronounced symptom improvement after 3.1 days versus 7.1 days in patients taking placebo.54 Patients included in this study had been symptomatic for less than 48 hours. It is important to note that this study was conducted using a specific product (Sambucol, Nature’s Way); results should not be extrapolated to all elderberry products. Another study found that elderberry lozenges taken four times daily for two days significantly improved influenza symptoms within 48 hours when patients took the first dose within 24 hours of symptom onset.55 Both of these studies were small, with each including approximately 60 patients; therefore, results may not be generalizable to the entire population. Elderberry is well tolerated in supplemental form. Patients should be warned that eating raw elderberries may cause nausea, vomiting, and diarrhea. Cooking the elderberries eliminates this risk.56 Elderberry may stimulate the immune system and should be avoided in patients with autoimmune disease and those taking immunosuppressants. Take away: Elderberry may be beneficial, in addition to other supportive care, in patients with the flu. However, patients at high risk of complications should be 42 Drug topics O ctob er 2015 Pharmacists should use the QuEST SCHOLAR technique for all patients presenting with symptoms of URIs to elicit pertinent information, formulate an assessment, determine eligibility for selfcare, and create a treatment or referral plan as appropriate. referred to their primary care provider for evaluation and potential treatment with antiviral agents. Garlic Garlic is believed to have antibacterial and antiviral properties and therefore is often used for prevention and treatment of the common cold. One small study evaluated the effect of garlic on the occurrence of the common cold when taken once daily for 12 weeks during cold season.57 Results indicated that garlic taken prophylactically may decrease the incidence of cold compared to placebo. However, in patients who did develop cold, there was no difference in the duration of symptoms. Patients may be hesitant to use garlic on a long-term basis because of the side effects of bad breath, body odor, and rash.57 Garlic may decrease plasma concentrations of isoniazid and saquinavir and should not be used concomitantly with these medications. Garlic may have antiplatelet and anticoagulant activity and should be used with caution in patients taking warfarin.58 Take away: Prophylactic use of garlic may reduce the incidence of colds, however, side effects may be intolerable. Ginseng Both American ginseng and Panax ginseng have been studied for use in URIs. Patients may not be aware of the distinction between these two products. This is an important starting point for discussion, as their use differs significantly. One specific extract of American ginseng, CVT-E002, has shown possible efficacy in three randomized controlled trials.59-61 Combined results suggest that American ginseng taken daily for three to four months during flu season may decrease the risk of contracting the common cold and flu in adults and may decrease the severity of symptoms in those patients who do develop URI. Furthermore, the use of this product appears to decrease the likelihood of contracting more than one cold in a given season.60 American ginseng is well tolerated, with headache being the most commonly reported adverse effect.62 Panax ginseng may also be referred to as Asian ginseng. One small study evaluated the effect of Panax ginseng taken daily for 12 weeks on immune response to influenza vaccination.63 Patients received the influenza vaccine during the fourth week of the study. Results showed a significant increase in antibody titers and a decrease in the occurrence of flu. The most common adverse effect associated with Panax ginseng is insomnia.64 Both types of ginseng appear to decrease the efficacy of warfarin and should not be used concomitantly.62,64 Women with estrogen-sensitive cancers and conditions should avoid ginseng due to its potential estrogenic activity. Additionally, ginseng may increase risk of hypoglycemia in patients taking antidiabetic medications. Take away: Prophylactic American ginseng used during flu season may decrease the incidence and severity of URIs. Panax ginseng may improve response to influenza vaccination. Pelargonium sidoides Pelargonium sidoides, also known as Umckaloabo, is a species of a South African flowering plant related to the geranium.65 The active ingredient used in herbal supplements is derived from the root of the plant. It has been evaluated for use in the common cold and sinusitis. A ranDrugTopics .c om continuing education domized controlled trial evaluated the effect of 1.5 mL of liquid P. sidoides extract taken three times daily for 10 days versus placebo for treating symptoms of the common cold.66 Patients in the treatment group experienced less severe symptoms and fewer days until clinical cure versus those patients taking placebo. A small, unpublished study suggested that patients who take 60 drops of Umckaloabo extract three times daily for 21 days may experience decreased duration of sinusitis symptoms.67 Umckaloabo is well tolerated, but potential adverse effects include itchy rash, gastrointestinal upset, and conjunctivitis.65 It is believed to have stimulatory effects on the immune system and should be avoided in patients taking immunosuppressant medications and those with autoimmune diseases. Take away: P. sidoides may be effective for the treatment of the common cold. Further study is needed to determine the effectiveness of Umckaloabo for treating the symptoms of sinusitis. Vitamin C Vitamin C supplementation is often perceived by patients to boost the immune system and to prevent the common cold. Unfortunately, evidence indicates that daily vitamin C supplementation does not in fact decrease the risk of cold. However, in patients who do contract the common cold, a Cochrane review showed that those who regularly use vitamin C as a daily supplement experience a decreased duration of cold: 8% shorter in adults and 14% shorter in children.68 The value of this marginally shortened duration should be weighed against the associated cost and pill burden. Patients may also believe that large doses (1-3 g) of vitamin C are beneficial in treating the symptoms of the common cold. There is no evidence to support the use of high-dose therapeutic vitamin C once a cold has started.68 Although vitamin C is generally well tolerated at doses used for daily supplementation, at high doses, it may cause gastrointestinal symptoms (such as nausea, vomiting, and diarrhea) and urinary tract stones.69 Patients should be encouraged to avoid using more than the recommended upper intake level of 2000 mg per day. DrugTopics .c om Take away: Daily vitamin C supplementation may help to decrease the duration of colds in adults and children; however, high-dose vitamin C should not be recommended for treatment of the common cold. Zinc Zinc has been shown to inhibit rhinoviral replication in in-vitro studies and therefore is often marketed to the public as an effective agent for prevention and treatment of the common cold. Overall, data do not strongly support the prophylactic use of zinc.70 If zinc is taken prophylactically for at least five months, children may experience a decreased incidence of the common cold and associated absences from school.71 In terms of treatment, two systematic reviews have demonstrated that zinc lozenges at doses greater than 75 mg/day reduce the duration of symptoms (nasal discharge, congestion, sneezing, sore throat, hoarseness, cough, and muscle ache) by approximately one day when treatment is initiated within 24 hours of symptom onset.70,71 It is important to counsel patients that to achieve the efficacious dose, one lozenge must be used every two to three hours, depending on the product. This frequency of administration may be burdensome for patients. Oral zinc is normally well tolerated; however, patients may complain of bad taste and nausea.72 Agents used to improve the flavor of zinc-containing products, including citric acid and sugar alcohols (sorbitol, mannitol) may chelate zinc, and therefore decrease efficacy. Zinc interacts with quinolone and tetracycline antibiotics, resulting in reduced absorption of both agents. Patients should be counseled to take antibiotics two hours before or four hours after zinc. Intranasal zinc has been associated with permanent loss of smell, and as such, popular formulations were discontinued in 2009.73 However, these products may still be available online, so patients should be strongly advised to avoid the use of intranasal zinc. Take away: Patients interested in using zinc should be counseled that it does not prevent the common cold. Although zinc may decrease symptoms in patients with the common cold, this benefit is achieved only if treatment is started almost immedi- ately and the lozenges are taken every two to three hours. Other products Patients may inquire about the use of apple cider vinegar as a holistic treatment for a multitude of health concerns, including sinusitis.74 It is believed to have antibacterial properties. At this time, however, there is no clinical evidence to support its use in sinusitis. Bromelain is a digestive enzyme found in pineapple.75 When taken orally, this agent is believed to decrease swelling in the sinus cavity, however, there is no reliable evidence to support its use in sinusitis. The aforementioned products should not be recommended for the prevention or treatment of URIs. Herbal supplements should be avoided in children and women who are pregnant or breastfeeding. Pharmacists should consult the Natural Medicines database for information regarding the safety, efficacy, and drug-drug interactions associated with herbal products and other CAMs. Pharmacist’s referral: Is self-care appropriate? As the most accessible healthcare professionals, pharmacists are in a strong position to decrease the unnecessary use of urgent care services by accurately triaging patients’ symptoms. If a pharmacist can recognize the pattern of a viral illness and recommend appropriate symptomatic self-care treatment, he or she may prevent a costly trip to the doctor’s office and a potentially inappropriate antibiotic prescription. However, it is equally important that a pharmacist be able to identify patients who need further medical evaluation. Therefore, pharmacists should use the QuEST SCHOLAR technique for all patients presenting with symptoms of URIs to elicit pertinent information, formulate an assessment, determine eligibility for self-care, and create a treatment or referral plan as appropriate. Cold Patients presenting with symptoms of the common cold should first be evaluated for appropriateness of self-care. The following patients should be referred to their primary care provider for further evaluation: those presenting with chest O ctob er 2015 Drug topics 43 Continuing Education MtM eSSentiaLS FoR coLd, FLu, and SinuSitiS ManageMent pain, shortness of breath, or a temperature above 101.5°F; patients with chronic diseases that involve the respiratory and immune systems (eg, asthma, chronic obstructive pulmonary disease, congestive heart failure, AIDS); frail elderly patients; children aged less than nine months; and patients with worsening symptoms despite appropriate self-treatment.15 If self-care is deemed appropriate, patients should be educated on the nature of viral illness, mainly that curative therapies are not available and that treatment should focus on individual symptoms that are bothersome. Pharmacists should offer to assist the patient in selecting an appropriate product and counsel the patient on the appropriate use of the product. Finally, patients should be educated on strategies to prevent the spread of the virus to others, such as appropriate hand hygiene. All patients should be encouraged to seek medical evaluation if symptoms have not resolved within seven to 14 days.15 Flu Pharmacists should interview patients with suspected influenza to identify those at high risk for developing complications. High-risk patients include pregnant women, Alaskan natives and American Indians, individuals aged younger than five or older than 65 years, patients aged younger than 19 years who are receiving aspirin therapy, residents of long-term care facilities, immunocompromised patients, morbidly obese patients, and those with chronic disease.76 Patients meeting the aforementioned criteria should be referred to their primary care provider for evaluation and possible treatment with a NA inhibitor. For patients not at high risk for complications, pharmacists should recommend appropriate supportive care and discuss strategies to prevent spread of the infection to others, such as using appropriate hand hygiene, staying home from school/ work until 24 hours after temperature returns to normal, and wearing a facemask if patients must go out.77 Adult patients should be encouraged to seek medical care if they experience chest pain or trouble breathing, confusion or dizziness, or persistent vomiting. Children should see a doctor if they experience increased irritability, unusual fatigue, abnormal breath- 44 Drug topics O ctob er 2015 ing, fever with rash, or dehydration. All patients should seek care if symptoms initially improve before worsening. Sinusitis Patients presenting with symptoms of sinusitis should be evaluated for the presence of symptoms indicative of bacterial illness (Table 2).6 Patients meeting these criteria should be referred to their primary care provider for evaluation and antibiotic therapy. In patients who present with symptoms indicative of viral illness, pharmacists should explain the likelihood of viral infection and recommend watchful waiting and symptomatic treatment (nasal irrigation and intranasal corticosteroids). Patients should be encouraged to avoid antihistamines and decongestants and to seek medical care if improvement is not seen in seven to 10 days or if they experience “double sickening”.6 the common cold, flu, and sinusitis in pediatric populations: Are they the same? As with all medications, it is important to remember that pediatric patients often require different doses of medication. In 2007, manufacturers voluntarily withdrew infant preparations of cough and cold medications, and in 2008, the FDA recommended that OTC cough and cold products should no longer be used in children aged younger than two years.78,79 These changes came as a result of reports of serious adverse effects, such as seizures, tachycardia, loss of consciousness, and in some cases, death. Additionally, these agents had not demonstrated efficacy in patients aged younger than six years. Later in 2008, manufacturers voluntarily further restricted the use of OTC cough and cold products, with labels changed to state that these products should not be used in children aged younger than four years.80 Additionally, improved packaging and measuring devices were developed to prevent accidental overdose. After these changes, emergency department visits for adverse events related to these medications decreased significantly.79 It is crucial that pharmacists counsel patients that OTC cough and cold medications are not appropriate for children aged younger than four years. It is also important to educate parents regarding age- or weight-based dosing of specific products, as parents may plan to use the same agent for multiple children. Parents should be taught to read ingredient labels on combination products to ensure that maximum doses are not exceeded and that aspirin is not inadvertently administered to children. There are many other important considerations that pharmacists must take into account when triaging pediatric patients with URIs. Disease presentation may be different from that in adults, as well as potential complications. For example, children with the flu are more likely to present with vomiting and diarrhea compared to adults, and subsequently they are at increased risk of hospitalization.9, 76 Herbal supplements do not have sufficient data to support their use in the pediatric population and therefore should not be recommended for use in children. Additionally, OTC and prescription medications may need dose adjustments based on the age or weight of the patient. conclusion The high prevalence and viral etiology of the common cold, flu, and sinusitis among both pediatric and adult populations afford community pharmacists the opportunity to assess for self-care eligibility. As highly accessible, uniquely positioned healthcare providers, community pharmacists play a key role in decreasing primary care visits, patient costs, and inappropriate antibiotic use. As medication experts, pharmacists are adequately trained to provide OTC pharmacologic treatment recommendations, as well as nonpharmacologic options for symptom management when appropriate. Pharmacists play a role not only in determining self-care eligibility, but also in identifying patients ineligible for self-care, warranting a referral. The references are available online at www.drugtopics.com/cpe.• For immediate cpE credit, take the test now online at www.drugtopics.com/cpe once there, click on the link below Free cpE Activities DrugTopics .c om test questions 1. Which of the following correctly pairs the upper respiratory infection with its most common causative agent? a. Influenza: influenza B b. Bacterial sinusitis: M. catarrhalis c. Common cold: rhinovirus d. Viral sinusitis: S. pneumoniae 2. Which of the following pairs best matches the upper respiratory infection with its typical clinical course? a. Influenza: sore throat followed by rhinorrhea and cough lasting 10 to 14 days b. Bacterial sinusitis: fever, body aches, and fatigue lasting up to 14 days c. Common cold: headache, facial pain, and fever lasting less than 10 days d. Viral sinusitis: nasal congestion, scratchy throat, and cough lasting five to 10 days 3. Which of the following clinical presentations suggests a patient is likely to have bacterial, rather than viral, sinusitis? a. Symptoms lasting more than 10 days b. Cough c. Fever lasting less than 48 hours d. Nasal discharge 4. Which of the following patient-reported symptoms suggests the presence of influenza versus the common cold? a. Body aches b. Runny nose c. Productive cough d. Stuffy nose 5. JG is a 42-year-old woman diagnosed with acute bacterial rhinosinusitis. She has no history of recent hospitalization, immunodeficiency, or penicillin allergy and has not used antibiotics in the past month. Which of the following treatment options is the most appropriate recommendation for JG? a. Azithromycin 500 mg on day one, then 250 mg daily on days two to five b. Sulfamethoxazole-trimethoprim 800 mg/160 mg twice daily for 10 days c. Amoxicillin-clavulanate 875 mg/125 mg twice daily for five days d. Levofloxacin 750 mg daily for 10 days 6. Which of the following statements regarding influenza antiviral medications is true? a. Influenza antiviral medications are usually prescribed for 14 days. b. Antiviral medications should be recommended for all patients with influenza. c. Oseltamivir should not be recommended in patients with asthma and COPD. d. Influenza antiviral medications are most effective if started within 48 hours of symptom onset. 7. Which of the following nonpharmacologic recommendations would be most appropriate to help alleviate sinus pain in a patient with sinusitis? a. Nasal irrigation b. Warm facial compress DrugTopics .c om c. Gargling with warm salt water d. Increased hydration 8. All of the following antihistamines have been shown to be effective for treating cold symptoms as monotherapy or in combination with other agents except for: a. Doxylamine b. Loratadine c. Chlorpheniramine d. Brompheniramine 9. Andrographis products may decrease symptoms of the common cold if initiated within __ hours of symptom onset: a. 24 b. 36 c. 48 d. 72 10. Which of the following is true regarding daily supplemental use of vitamin C? a. Vitamin C may prevent the common cold, but it has no effect on symptom duration in patients with the common cold. b. Vitamin C may decrease symptom duration in patients with the common cold, but it does not prevent the common cold. c. Vitamin C may be effective in both preventing the common cold and decreasing symptom duration in patients with the common cold. d. Vitamin C is not effective in either preventing the common cold or decreasing symptom duration in patients with the common cold. 11. Which of the following is the most important counseling point regarding the use of zinc? a. Intranasal zinc may result in permanent loss of smell. b. Zinc lozenges are effective when taken two to three times daily. c. Zinc has no effect on the duration of the common cold. d. Prophylactic use of zinc sulfate may reduce the risk of the common cold if taken daily for at least five weeks before exposure. 12. Which herbal product may be effective in decreasing the duration of influenza symptoms? a. Elderberry b. Garlic c. P. sidoides d. Ginseng c. They are unable to provide recommendations regarding herbal supplements. d. They are uniquely positioned healthcare providers equipped to accurately triage patients’ symptoms. 15. The role of pharmacist triage for patients presenting with symptoms of acute sinusitis may include all of the following except: a. Preventing an unnecessary primary care physician visit b. Filling an antibiotic prescription in less than 15 minutes c. Counseling the patient regarding watchful waiting d. Decreasing patient cost (eg, copays) 16. NC is a 27-year-old woman who is 35 weeks pregnant with her first child and presents to the pharmacy counter while you are on duty. She reports that her husband was diagnosed with the flu yesterday and has been running a fever all day today. She wants to know what she can do to remain healthy. Which of the following is the most appropriate recommendation for NC at this time? a. Refer her to her primary care physician, as she may be eligible for prophylactic treatment. b. Wish her luck, as she is most likely going to catch the flu. c. Counsel her to avoid further contact with her husband until symptoms resolve. d. Reassure her she is in the clear, as he is not contagious after 24 hours. 17. Current product labeling states that OTC cough and cold medications should not be used in patients aged younger than: a. One year b. Two years c. Three years d. Four years 18. Which of the following is the best agent to recommend for a three-year-old patient with past medical history of asthma diagnosed with influenza? a. Oseltamivir b. Amantadine c. Zanamivir d. Rimantadine 13. Community pharmacists may employ the QuEST SCHOLAR method to gather patient information in order to: a. Diagnose the patient’s complaint b. Recommend an OTC product c. Determine self-care eligibility d. Accurately fill the prescription 19. Aspirin and aspirin-containing products should be avoided in children and teenagers with flu-like symptoms because of the concern for: a. Raynaud disease b. Rhinoviral replication c. Reye’s syndrome d. Respiratory depression 14. Which of the following statements regarding community pharmacists is true? a. They are unable to provide OTC recommendations without a physiciandiagnosed problem. b. Their job consists solely of pouring pills from big bottles into smaller bottles. 20. Which of the following most appropriately represents the correct duration of antibiotic therapy for ABRS in pediatric patients? a. Five to seven days b. Five to 10 days c. 10 to 14 days d. 14 to 21 days O ctob er 2015 Drug topics 45 Continuing Education MtM eSSentiaLS FoR coLd, FLu, and SinuSitiS ManageMent References 1. Fashner J, Ericson K, Werner S. Treatment of the common cold in children and adults. Am Fam Physician. 2012;86:153-159. 18. Maher SA, Dubuis ED, Belvisi MG. G-protein coupled receptors regulating cough. Curr Opin Pharmacol. 2011;11:248-253. 2. Smith SR, Montgomery LG, Williams JW Jr. Treatment of mild to moderate sinusitis. Arch Intern Med. 2012;172:510-513. 19. Lee LY, Ni D, Hayes D Jr, Lin RL. TRPV1 as a cough sensor and its temperature-sensitive properties. Pulm Pharmacol Ther. 2011;24:280-285. 3. Terrie YC. Nonprescription products for managing cough, cold, and flu. Pharmacy Times website. 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Inflammatory cytokines. Eur Cytokine Netw. 2001;12:290-296. Drug topics 2015 51. Echinacea. Natural Medicines Comprehensive Database. Updated February 14, 2015. https://naturalmedicines-therapeuticresearch-com.ezproxy.neu.edu/ databases/food,-herbs-supplements/professional. aspx?productid=981. Accessed August 9, 2015. DrugTopics .c om continuing education References 54.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. J Int Med Res. 2004;32:132140. 55.Kong F-K. Pilot clinical study on a proprietary elderberry extract: efficacy in addressing influenza symptoms. Online J Pharmacol Pharmacokinet. 2009;5:32-43. 56.Elderberry. Natural Medicines Comprehensive Database. Updated February 14, 2015. https:// naturalmedicines-therapeuticresearch-com.ezproxy. neu.edu/databases/food,-herbs-supplements/professional.aspx?productid=434. Accessed August 9, 2015. 57. 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