Clinical Associate Professor, Southern Illinois University Edwardsville (SIUE) School of Pharmacy

Miranda Wilhelm, PharmD

CW is a 51-year-old white male who presents to the community pharmacy requesting an over-the-counter medication recommendation to treat his stuffy nose symptoms associated with a cold.

	Before making an OTC medication recommendation, it is important to determine if the patient is a self-care candidate and does not have any exclusions to self-treatment. One effective method for gathering and assessing patient information is the QuEST/SCHOLAR-MAC problem-solving approach.

 QuEST is a mnemonic for assessing and counseling the patient. SCHOLAR-MAC is a mnemonic to assist with symptom assessment.

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	During the patient interview, CW provides the following SCHOLAR-MAC information: He has a stuffy nose and sinus pressure that makes it hard to breathe through his nose. Attempts to clear his sinuses produce no mucus and he does not have a runny nose, postnasal drip, or fever. The problem started two days earlier in both nostrils and he has not tried any medications yet. Nothing seems to make it worse and the stuffiness lasts all day. Hot, steamy showers help, but only for 10 to 15 minutes.

	CW has hypertension, with an in-pharmacy pressure reading of 138/82 mmHg, and high cholesterol levels.

	Once the patient interview is complete, the self-care candidacy status of the patient is determined. (See Table 1 for a list of exclusions.)

	Up next: Which OTC medication would you recommend to treat CW’s nasal congestion?

Because of CW’s diagnosis of hypertension and his blood pressure reading, there could be a concern when recommending self-treatment for a stuffy nose. Decongestants are a common treatment option. The mechanism of action is as a sympathomimetic adrenergic agonist which stimulates alpha-adrenergic receptors causing the release of catecholamines resulting in vasoconstriction. Decongestants constrict the blood vessels in the nose, reducing the stuffy nose symptoms. But they also constrict blood vessels throughout the body leading to elevations in blood pressure. This is of particular concern if the patient already has hypertension. In addition, the OTC Drug Facts labeling for both topical and systemic decongestants contains a warning that directs patients to their physicians before use if they have high blood pressure.

	The Eighth Joint National Committee (JNC8) states that the blood pressure goal for a patient 60 years of age or less is <140/90 mmHg.

 CW’s current blood pressure reading places him within this goal. Therefore, because CW does not have severe cardiopulmonary disease or any other exclusions for self-treatment, he is a candidate for self-care.

	Due to the mechanism of action of systemic decongestants, some pharmacists may be concerned that CW could experience an increase in his blood pressure. Topical decongestants are minimally absorbed into systemic circulation and therefore reduce the risk of increasing blood pressure.

 Cardiovascular stimulation (e.g., increases in blood pressure, tachycardia, or arrhythmias) and central nervous system stimulation (e.g., insomnia or anxiety) should be minimal compared to oral systemic decongestants. Adverse effects that can be expected with a topical decongestant, include rhinitis medicamentosa (rebound congestion) and local nasal irritation (e.g., burning, stinging, rhinorrhea, sneezing).

 Two nonprescription topical decongestants are commonly available; oxymetazoline and phenylephrine. Either would be an appropriate choice for this patient. However, oxymetazoline has a 12-hour duration of action, which could result in improved adherence, while phenylephrine has to be dosed every 4 hours.

	When selecting a topical decongestant, it is important to counsel patients on preparation (e.g., clear the nasal passages by blowing the nose, washing hands, and priming the inhaler prior to the first use), administration technique (e.g., position head upright, insert tip into nostril, occlude opposite nostril, gently inhale while activating the spray, repeat on opposite nostril), and to use it no more than three days to avoid rhinitis medicamentosa.

	Additionally, nondrug measures could be used alone or in combination with a topical decongestant. A hot, steamy shower, a humidifier (preferred), or a vaporizer could be used to add humidity to the room air. Nasal saline sprays and rinses can be used to moisturize and sooth irritated sinus passages as well as loosen mucus. Nonprescription medical devices such as Breathe Right nasal strips could be used to open the nares, which enlarges breathing passages and temporarily reduces nasal congestion.

While CW has hypertension, his blood pressure appears to be well-controlled. The reading in the pharmacy is near to being uncontrolled, but his illness may be having a slight effect, or it may be elevated from traveling to the pharmacy. Generally, I worry about the impact of systemic decongestants when patients are well above their blood pressure goal with treatment. While hypertension is not listed as an exclusion to self-care in the Handbook of Nonprescription Drugs

-the gold standard for self-care treatment-more severe cardiopulmonary conditions are. Pharmacists should carefully consider systemic decongestant use when dealing with any cardiovascular condition.

	There are two OTC systemic decongestants available, pseudoephedrine and phenylephrine. Phenylephrine can be an attractive option because pseudoephedrine is kept behind the counter for sale record purposes; but concerns have been raised regarding phenylephrine’s clinical efficacy. Further, phenylephrine can be a good option for CV because it has a shorter duration of action compared to pseudoephedrine, theoretically producing less risk of blood pressure elevation. However, with a shorter duration of action for minimizing adverse effect risk comes a shorter duration of symptom control.

	A placebo-controlled trial published in 2015 in the Journal of Allergy and Clinical Immunology: In Practice, found that doses of phenylephrine ranging from 10 mg to 40 mg were no more effective than placebo at relieving nasal congestion, but with increasing risks of adverse effects as the dose increased.

 For this reason, I would not recommend phenylephrine for CV despite his hypertension. If pseudoephedrine were not a safe option, I would recommend saline nasal spray.

	Looking at pseudoephedrine, cardiovascular stimulation is a well-known adverse effect of its use, but it is unclear how clinically significant this is and for which patients it is of greatest concern. In the package insert for pseudoephedrine, hypertension is listed as a precaution for use; however, after a single dose of 150 mg, blood pressure elevation was not produced at the same magnitude or duration as ephedrine.

 A meta-analysis of 24 randomized controlled trials looked at the effect of pseudoephedrine on both blood pressure and heart rate, but only five studies included hypertensive patients in particular. Overall, a small but statistically significant rise in systolic blood pressure (1.2 mmHg) was found, but changes in diastolic blood pressure and heart rate were not significant.

 While statistically significant, a blood pressure elevation of 1.2 mmHg is likely not clinically significant. In the studies that included hypertensive patients, their hypertension was described as controlled, but definition was not always provided. Studies varied in duration from 2 hours to 4 weeks.

	Given CW’s current blood pressure control and the low likelihood that any blood pressure elevation would be clinically significant based on review of the literature, I would feel comfortable recommending a pseudoephedrine-containing systemic decongestant such as Sudafed 4 Hour (pseudoephedrine hydrochloride 30 mg), one or two tablets every 4 to 6 hours. No more than 240 mg should be taken in a 24-hour period. The 4-to-6 hour product was selected so that if the blood pressure increases, it will be elevated for the shortest amount of time. It is important to note that Sudafed makes a product containing phenylephrine (Sudafed PE Congestion), so the active ingredient list should always be checked to ensure the right product is being recommended to the patient. Patients should be warned to avoid taking pseudoephedrine just before bedtime as it may cause insomnia. They may also want to monitor their blood pressure if they have a device at home to ensure that it stays within an acceptable range.

	1. Newton GD, Divine H.  Patient Assessment and Consultation. In:  Krinsky DL, Ferreri SP, Hemstreet BA, et al.  Handbook of Nonprescription Drugs: An Interactive approach to Self-Care. Washington, DC:  American Pharmacists Association; 2015.  p. 17-32.

	2.Scolaro KL.  Colds and Allergy.  In: Krinsky DL, Ferreri SP, Hemstreet BA, et al.  Handbook of Nonprescription Drugs: An Interactive approach to Self-Care. Washington, DC:  American Pharmacists Association; 2015. p. 171-196.

	3.U.S. National Library of Medicine. Afrin. DailyMed. Available at http://bit.ly/2fZjiao.  Accessed on July 31, 2017.

	4.U.S. National Library of Medicine. Sudafed.  DailyMed. Available at http://bit.ly/2vXB4io.  Accessed on July 31, 2017.

	5.James PA, Oparil S, Carter BL, et al.  2014 evidence-based guideline for the management of high blood pressure in adults: Report form the panel members appointed to the Eighth Joint National Committee (JNC8).  JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.

	6.Clinical Pharmacology Oxymetazoline. Available at: http://bit.ly/2uZtAhD.  Accessed on July 31, 2017.

	7.Meltzer EO, Patner PH, McGraw T. Oral phenylephrine HCl for nasal congestion in seasonal allergic rhinitis. J Allergy Clin Immunol Pract. 2015;3(5):702-8.

	8.Eltor [package insert]. Laval, Quebec, Canada. Sanofi-Aventis Canada Inc. May 2016.

	9.Rodriguez JC, Hontjoy HL, Smedra B, Prouty JP. Clinical inquiry: Do oral decongestants have a clinically significant effect on BP in patients with hypertension? J Fam Pract. 2017;86(6):E1-2.

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